20 USC 5206. Report to Congress
TITLE 20 -- EDUCATION
For any fiscal year for which Eisenhower Exchange Fellowships,
Incorporated, receive funds pursuant to section 5203(a) of this title,
Eisenhower Exchange Fellowships, Incorporated, shall prepare and
transmit to the President and the Congress a report of its activities
for such fiscal year.
(Pub. L. 101-454, 7, Oct. 24, 1990, 104 Stat. 1065.)
20 USC CHAPTER 64 -- EXCELLENCE IN MATHEMATICS, SCIENCE, AND ENGINEERING
EDUCATION
TITLE 20 -- EDUCATION
Sec.
5301. Findings and objectives.
(a) Findings.
(b) National objectives.
5311. Expanding the uses of innovative technologies for mathematics
and science instruction.
(a) Computer technologies.
(b) Distance learning.
(c) Special rule.
(d) Matching requirement.
(e) Coordination.
(f) Planning activities.
5321. Science-technology centers.
(a) In general.
(b) Special consideration.
(c) Geographic distribution.
(d) Use of Clearinghouse.
(e) Authorized activities.
(f) Definitions.
5331. Systemic reform of mathematics and science.
(a) In general.
(b) Improvement components.
(c) Special rule.
5341. Statement of purpose.
5342. Graduate fellowships.
(a) In general.
(b) Special rule.
(c) Omitted.
5343. Graduate traineeships.
(a) In general.
(b) Special rule.
5351. Centers of Excellence for Undergraduate Teaching.
(a) Establishment.
(b) Use of funds.
(c) Criteria.
(d) Designation.
5361. Statement of purpose.
5362. Distinguished Visiting Professors.
5363. Faculty awards for women and minorities.
5364. Alliances for minority participation.
(a) In general.
(b) Special rule.
5371. Science education report.
(a) Report required.
(b) Preparation and updating.
5372. General education report.
5373. Department of Energy programs.
(a) Authorization.
(b) Facilities; non-Federal funds.
(c) Limitations.
(d) Termination provision.
(e) ''Research and development facilities'' defined.
5381. Purpose; appropriations authorized.
(a) Purpose.
(b) Authorization of appropriations.
5382. Scholarships authorized.
(a) Program authority.
(b) Period of awards.
(c) Use at any institution permitted.
(d) National Science Scholars.
5383. Selection of scholars.
(a) Selection criteria for initial awards.
(b) Selection process for initial awards.
(c) Continuation awards.
(d) Disbursal of scholarship proceeds.
(e) Special rule.
5384. Eligibility of scholars.
(a) Requirements for initial award.
(b) Requirements for continuation awards.
(c) Waiver of full-time attendance requirement.
(d) Failure to meet eligibility requirements.
(e) Reinstatement of eligibility.
(f) Notification of secondary schools.
5385. Scholarship amount.
(a) Amount of award.
(b) Relation to cost of attendance.
(c) Adjustments for insufficient appropriations.
5386. Summer employment opportunities for scholars.
(a) Priority for summer employment.
(b) Federal agency cooperation.
5401. Robert Noyce Scholarships.
(a) Program authorized.
(b) Period of awards.
(c) Use at any institution permitted.
(d) Designation.
(e) Selection.
(f) Disbursal of scholarship proceeds.
(g) Eligibility.
(h) Waiver of full-time attendance requirement.
(i) Failure to meet eligibility requirements.
(j) Reinstatement of eligibility.
(k) Notification of schools.
(l) Scholarship amount.
(m) Service requirement.
(n) Authorization of appropriations.
5411. National Academy of Science, Space, and Technology.
(a) Establishment of Academy.
(b) Advisory Board.
(c) Scholarships authorized.
(d) Nominations for scholarship awards.
(e) Selection for initial awards.
(f) Continuation awards.
(g) Disbursal of scholarship proceeds.
(h) Eligibility.
(i) Waiver of full-time attendance requirement.
(j) Failure to meet eligibility requirements.
(k) Reinstatement of eligibility.
(l) Notification of schools.
(m) Scholarship amount.
(n) Service requirement.
(o) Authorization of appropriations.
5421. Effect of certain controlled substance and felony convictions.
(a) General rule.
(b) Exemption.
5422. Report.
5431. Authorization of appropriations.
5441. Definitions.
20 USC SUBCHAPTER I -- FINDINGS AND OBJECTIVES
TITLE 20 -- EDUCATION
20 USC 5301. Findings and objectives
TITLE 20 -- EDUCATION
(a) Findings
The Congress finds that --
(1) science and mathematics are cornerstones of America's efforts to
compete in the global marketplace and improve our standard of living and
quality of life;
(2) international comparisons show American students are consistently
behind their foreign counterparts in mathematics and science
achievement;
(3) projections by the National Science Foundation estimate a
shortage of 675,000 scientists and engineers by the year 2000;
(4) women and minorities are significantly underrepresented in the
fields of mathematics, science and engineering;
(5) the achievement of universal scientific and mathematical literacy
by all Americans is an essential goal of all efforts to strengthen
American competitiveness;
(6) the achievement of scientific and mathematical literacy requires
a strong, coordinated effort to strengthen the teaching of science and
mathematics; and
(7) the Federal Government has a significant role in promoting the
study of mathematics and science, by providing financial assistance to
improve the general quality of programs for the study of mathematics and
science, by acting as a source for information concerning successful
projects and activities, by encouraging talented men and women to pursue
scientific careers and by strengthening the mathematics and science
educational opportunities available to women and minorities.
(b) National objectives
The Congress declares that it shall be a national objective to --
(1) encourage American students to pursue careers in mathematics,
science and engineering;
(2) improve the quality of teaching in mathematics and science made
available to all Americans;
(3) have American students rank first in the world in mathematics and
science;
(4) substantially increase the number of graduates with degrees in
mathematics, science and engineering; and
(5) substantially increase the number of women and minorities
pursuing careers in mathematics, science and engineering.
(Pub. L. 101-589, title I, 101, Nov. 16, 1990, 104 Stat. 2882.)
Section 731 of Pub. L. 101-589 provided that: ''The provisions of
this Act (see Short Title note below) shall take effect on October 1,
1990, or the date of enactment of this Act (Nov. 16, 1990), whichever is
later.''
Section 1 of Pub. L. 101-589 provided that: ''This Act (enacting
this chapter and sections 2994 to 2994g of this title, redesignating
section 2993 of this title as section 2996 of this title, amending
sections 237, 240, 1201a, 1221e-1, 2983 to 2992, and 4512 of this title
and sections 1869 and 1873 of Title 42, the Public Health and Welfare,
and enacting provisions set out as notes under this section and sections
240 and 2982 of this title) may be cited as the 'Excellence in
Mathematics, Science and Engineering Education Act of 1990'.''
20 USC SUBCHAPTER II -- MATHEMATICS, SCIENCE AND TECHNOLOGY IMPROVEMENTS
TITLE 20 -- EDUCATION
20 USC Part A -- Innovative Technologies
TITLE 20 -- EDUCATION
This part was, in the original, designated part B and has been
redesignated part A for purposes of codification.
20 USC 5311. Expanding the uses of innovative technologies for
mathematics and science instruction
TITLE 20 -- EDUCATION
(a) Computer technologies
(1) Program authorized
The Director shall establish research programs on the use of
computers and related technologies in basic mathematics, science, and
technology instruction.
(2) Eligible applicants
In carrying out the program under this subsection, the Director shall
establish a merit review process to make awards on the basis of --
(A) the potential of the proposal to improve the effectiveness and
productivity of basic mathematics and science education;
(B) the potential of the proposal to involve the classroom teacher in
the design of the program and to provide teacher training for optimum
effectiveness in the classroom; and
(C) the capability of the entity developing the innovative computer
technology to provide broad and efficient dissemination of the
technology to schools.
(3) Use of awards
Funds awarded under this subsection may be used for --
(A) research and development of curriculum;
(B) development of computer software; and
(C) research and development of other promising technologies for
educational applications as specified by the Director.
(b) Distance learning
(1) Program authorized
The Director shall establish programs to promote the use of
interactive telecommunications linkages to provide mathematics and
science education in the elementary and secondary classroom.
(2) Eligible applicants
In carrying out the program under this subsection, the Director shall
establish a merit review process to make awards to partnerships which
may involve State educational agencies, local educational agencies,
public television agencies, institutions of higher education, and other
relevant entities, on the basis of --
(A) the potential of the proposal to improve the delivery of quality
mathematics and science instruction to underserved rural and urban
areas; and
(B) the potential of the proposal to provide teacher training
programs for optimum effectiveness in the classroom.
(3) Use of awards
Funds awarded under this subsection may be used for --
(A) the research and development of software and hardware
technologies necessary to implement interstate and intrastate
interactive linkages with several school districts;
(B) research on two-way audio and video interactive
telecommunications and computer linkages designed to be used in
conjunction with each other;
(C) research and development of curriculum;
(D) teacher training in the use of technologies developed under this
section; and
(E) other appropriate telecommunications research projects that will
improve mathematics and science education in underserved areas.
(c) Special rule
In carrying out the provisions of this section, the Director shall --
(1) pay particular attention to the needs of rural and urban areas
which are underserved in fields of mathematics and science instruction
or which have a high percentage of students receiving services under
chapter 1 of title I of the Elementary and Secondary Education Act of
1965 (20 U.S.C. 2701 et seq.);
(2) give special consideration to proposals to extend or adapt for
wider applications technologies, and associated educational materials,
that the eligible applicant making the proposal has demonstrated to be
effective in limited applications;
(3) ensure coordination between the National Science Foundation's
programs for support of teacher training and programs developed under
this section, with the objective of training teachers in the use of
promising educational technologies; and
(4) consult, cooperate and coordinate with analogous programs and
policies of other Federal agencies.
(d) Matching requirement
Awards shall be made under this section only to eligible applicants
that will contribute resources, in cash or in kind, from non-Federal
sources in an amount equal to 25 percent of the Federal award.
(e) Coordination
The Director shall work with the Secretary to encourage use of
technologies and educational materials developed under this section in
Department of Education model programs established under section 2012 of
the Dwight D. Eisenhower Mathematics and Science Education Act (20
U.S.C. 2992) for instruction and training in the use of computers. In
addition, the Director shall ensure that programs and activities
developed under this section are reported to the Clearinghouse
established under section 2012 of such Act for subsequent dissemination
through the regional consortia established under subpart 2 of such Act
(20 U.S.C. 2994 et seq.).
(f) Planning activities
The Office of Science and Technology Policy shall ensure that
planning activities for education and human resource development and for
high performance computing within the Federal Coordinating Council for
Science, Engineering, and Technology include consideration of the use of
national computer networks for educational purposes, including distance
learning and dissemination of curricular materials.
(Pub. L. 101-589, title II, 221, Nov. 16, 1990, 104 Stat. 2891.)
The Elementary and Secondary Education Act of 1965, referred to in
subsec. (c)(1), is Pub. L. 89-10, Apr. 11, 1965, 79 Stat. 27, as
amended generally by Pub. L. 100-297, Apr. 28, 1988, 102 Stat. 140.
Chapter 1 of title I of the Act is classified generally to division 1 (
2701 et seq.) of subchapter I of chapter 47 of this title. For complete
classification of this Act to the Code, see Short Title note set out
under section 2701 of this title and Tables.
The Dwight D. Eisenhower Mathematics and Science Education Act,
referred to in subsec. (e), is part A of title II of Pub. L. 89-10, as
added Pub. L. 100-297, title I, 1001, Apr. 28, 1988, 102 Stat. 219,
as amended. Subpart 2 of the Act is classified generally to subpart 2 (
2994 et seq.) of part A of subchapter II of chapter 47 of this title.
For complete classification of this Act to the Code, see Short Title
note set out under section 2981 of this title and Tables.
20 USC Part B -- Science-Technology Centers
TITLE 20 -- EDUCATION
This part was, in the original, designated part C and has been
redesignated part B for purposes of codification.
20 USC 5321. Science-technology centers
TITLE 20 -- EDUCATION
(a) In general
(1) Awards authorized
The Director is authorized to make awards to science-technology
centers for --
(A) development of more effective, hands-on, interactive mathematics,
science and technology programs and activities;
(B) replication or dissemination of effective programs and
activities, giving special attention to the needs of female and minority
children and economically disadvantaged areas; and
(C) development of new science-technology centers, including support
for such centers to work with established science-technology centers to
acquire proven educational programs.
(2) Award basis
Funds awarded pursuant to this section shall be awarded on a
competitive, merit review basis.
(3) Criteria
Criteria for making awards under paragraph (1) may include --
(A) the potential for the educational program to have a significant
impact on both formal and informal science education;
(B) the capability of the recipient institution to disseminate the
material broadly;
(C) the extent of matching funds provided from non-Federal sources;
(D) the experience and qualifications of the staff of the recipient
institution; and
(E) the overall excellence of the proposed program.
(b) Special consideration
In making awards pursuant to this section the Director shall give
special consideration to programs designed primarily for elementary
school-aged children.
(c) Geographic distribution
In making awards pursuant to this section, the Director shall, to the
extent practicable, ensure an equitable geographic distribution of such
awards.
(d) Use of Clearinghouse
The Director shall report on such programs and activities developed
under this section to the Clearinghouse established under section 2012
of the Dwight D. Eisenhower Mathematics and Science Education Act (20
U.S.C. 2992) for subsequent dissemination through the regional consortia
established under subpart 2 of such Act (20 U.S.C. 2994 et seq.).
(e) Authorized activities
Awards made under this section may be used for --
(1) scientific or technological exhibits developed for public
display, either in a science-technology center or sponsored by a
science-technology center but displayed in another facility;
(2) educational activities, such as curriculum development, teacher
training programs, and student educational kits, developed for use by
teachers for students; and
(3) other formal or informal science educational programs developed
by science-technology centers.
(f) Definitions
As used in this section --
(1) the term ''informal science education'' means those aspects of
science education that occur outside the school classroom, usually
voluntary, recreational, and interdisciplinary in nature, that are not
directed by a specific curriculum;
(2) the term ''science'' means all physical, biological, and social
sciences, mathematics, and engineering; and
(3) the term ''science-technology center'', which may include
museums, planetariums, libraries and zoos, means a nonprofit institution
open to the general public providing interactive exhibits,
demonstrations, and informal science education designed to --
(A) further public understanding of science and technology; and
(B) illustrate how such science and technology interacts with
society.
Such institutions may also be involved in formal educational
activities.
(Pub. L. 101-589, title II, 231, Nov. 16, 1990, 104 Stat. 2892.)
The Dwight D. Eisenhower Mathematics and Science Education Act,
referred to in subsec. (d), is part A of title II of Pub. L. 89-10, as
added Pub. L. 100-297, title I, 1001, Apr. 28, 1988, 102 Stat. 219,
as amended. Subpart 2 of the Act is classified generally to subpart 2 (
2994 et seq.) of part A of subchapter II of chapter 47 of this title.
For complete classification of this Act to the Code, see Short Title
note set out under section 2981 of this title and Tables.
20 USC Part C -- Grants to Educational Agencies for Systemic Reform of
Mathematics and Science Education
TITLE 20 -- EDUCATION
This part was, in the original, designated part D and has been
redesignated part C for purposes of codification.
20 USC 5331. Systemic reform of mathematics and science
TITLE 20 -- EDUCATION
(a) In general
The Director, in consultation with the Secretary, is authorized to
make awards to States or State educational agencies for projects that
implement system-wide improvement in elementary or secondary school
mathematics and science education.
(b) Improvement components
Each project for which an award is made pursuant to subsection (a) of
this section shall include the following components:
(1) increased student achievement in mathematics and science;
(2) improvements in organizational structure and decisionmaking;
(3) modifications in the provision and allocation of resources
regarding mathematics and science instruction;
(4) improvement in the recruitment, retention and continuing
professional development of teachers and other educators who instruct
mathematics and science;
(5) improved mathematics and science curriculum content and learning
goals; and
(6) use of other Federal funds including funds provided for the
Dwight D. Eisenhower Mathematics and Science Education Act (20 U.S.C.
2981 et seq.).
(c) Special rule
In making awards pursuant to subsection (a) of this section, the
Director shall --
(1) to the extent practicable, ensure an equitable geographic
distribution of such awards; and
(2) give priority to States or State educational agencies whose
improvement plans place a strong emphasis on increasing the academic
achievement of females and minority students in mathematics and science.
(Pub. L. 101-589, title II, 241, Nov. 16, 1990, 104 Stat. 2894.)
The Dwight D. Eisenhower Mathematics and Science Education Act,
referred to in subsec. (b)(6), is part A of title II of Pub. L.
89-10, as added Pub. L. 100-297, title I, 1001, Apr. 28, 1988, 102
Stat. 219, as amended, which is classified generally to part A ( 2981
et seq.) of subchapter II of chapter 47 of this title. For complete
classification of this Act to the Code, see Short Title note set out
under section 2981 of this title and Tables.
20 USC SUBCHAPTER III -- HIGHER EDUCATION
TITLE 20 -- EDUCATION
20 USC Part A -- Graduate Fellowships and Traineeships
TITLE 20 -- EDUCATION
20 USC 5341. Statement of purpose
TITLE 20 -- EDUCATION
It is the purpose of this part to avert the substantial shortage of
American scientists and engineers projected to occur over the next 15
years by significantly increasing the number of graduate fellowships
awarded by the National Science Foundation and to institute a program of
graduate traineeships.
(Pub. L. 101-589, title III, 301, Nov. 16, 1990, 104 Stat. 2895.)
20 USC 5342. Graduate fellowships
TITLE 20 -- EDUCATION
(a) In general
The Director is authorized to increase the number of graduate
fellowships awarded by the Foundation, so that, in fiscal year 1993 and
each fiscal year thereafter, at least 1,200 fellowships are awarded
annually.
(b) Special rule
In awarding fellowships pursuant to subsection (a) of this section,
the Director shall ensure that a substantially increasing number of
fellowships shall be awarded to women and minorities in fiscal year 1991
and in each succeeding fiscal year through fiscal year 2000.
(c) Omitted
(Pub. L. 101-589, title III, 302, Nov. 16, 1990, 104 Stat. 2895.)
Section is comprised of section 302 of Pub. L. 101-589. Subsec. (c)
of section 302 of Pub. L. 101-589 amended section 1869 of Title 42, The
Public Health and Welfare.
20 USC 5343. Graduate traineeships
TITLE 20 -- EDUCATION
(a) In general
The Director is authorized to carry out a competitive, merit-based
program of making awards to institutions of higher education to enable
such institutions to conduct traineeship programs which encourage
promising students, especially women and minorities, to continue their
education and research in mathematics, science and engineering.
(b) Special rule
In making awards pursuant to subsection (a) of this section, the
Director shall, to the extent practicable, ensure --
(1) an equitable geographic distribution of such grants;
(2) that institutions of higher education receiving such awards
demonstrate experience in, and a commitment to, educating and graduating
a significant number of women and minority students in mathematics,
science and engineering; and
(3) that special consideration is given to institutions of higher
education that have demonstrated progress and an ongoing commitment to
upgrading their capabilities to perform high quality research, and are
not among the institutions currently receiving a large number of
students with National Science Foundation graduate fellowships.
(Pub. L. 101-589, title III, 303, Nov. 16, 1990, 104 Stat. 2896.)
20 USC Part B -- Centers of Excellence
TITLE 20 -- EDUCATION
20 USC 5351. Centers of Excellence for Undergraduate Teaching
TITLE 20 -- EDUCATION
(a) Establishment
The Director shall establish a program of making awards to encourage
institutions of higher education to improve, and to give greater
attention to, undergraduate instruction in science, mathematics and
engineering. Awards under this section shall be made on a competitive,
merit review basis to faculty with a record of excellence in teaching
using the criteria described in subsection (c) of this section. Awards
under this section shall be for a 3-year period, and the amount of each
award shall be comparable to those under the Presidential Young
Investigator program.
(b) Use of funds
Awards made under this section shall be used to improve the quality
of undergraduate instruction at the recipient institution. Awards made
under this section may be used for such purposes as --
(1) development of innovative curriculum or teaching methods,
including interdisciplinary courses and courses for nonscience majors;
(2) purchase of educational equipment for use by students and
faculty;
(3) support for research and professional activities related to
undergraduate education; and
(4) support of teaching fellows.
(c) Criteria
Awards under this section shall be made on the basis of --
(1) the commitment of the institution to improve undergraduate
education in science, mathematics and engineering and to assign
appropriate importance to undergraduate instruction in determining
faculty compensation and as a criterion for faculty promotion;
(2) the teaching ability and accomplishments of the faculty member
applying for the award, including evidence that the applicant has
remained current with research developments; and
(3) the impact that the award will have on improving the quality of
undergraduate instruction.
(d) Designation
Institutions receiving grants under this section shall be designated
''Centers of Excellence for Undergraduate Teaching''.
(Pub. L. 101-589, title III, 311, Nov. 16, 1990, 104 Stat. 2896.)
20 USC SUBCHAPTER IV -- WOMEN AND MINORITIES IN MATHEMATICS, SCIENCE AND
ENGINEERING
TITLE 20 -- EDUCATION
20 USC 5361. Statement of purpose
TITLE 20 -- EDUCATION
It is the purpose of this subchapter to expand and enhance National
Science Foundation program activities that are specifically focused on
increasing the educational and professional participation of women and
minorities in the fields of mathematics, science and engineering.
(Pub. L. 101-589, title IV, 401, Nov. 16, 1990, 104 Stat. 2897.)
20 USC 5362. Distinguished Visiting Professors
TITLE 20 -- EDUCATION
The Director is authorized to make awards to institutions of higher
education to enable such institutions to support distinguished women and
minority faculty members in mathematics, science and engineering to
enable such faculty members to serve as ''Distinguished Visiting
Professors'' at academic institutions that do not have sufficient
resources to attract and retain faculty members of such professional
stature on a permanent basis.
(Pub. L. 101-589, title IV, 402, Nov. 16, 1990, 104 Stat. 2897.)
20 USC 5363. Faculty awards for women and minorities
TITLE 20 -- EDUCATION
The Director is authorized to make awards to institutions of higher
education, other than research universities, to enable such institutions
to recruit and retain women and minority faculty members in the fields
of mathematics, science and engineering, and to obtain equipment and
facilities necessary for the research activities of such faculty
members.
(Pub. L. 101-589, title IV, 403, Nov. 16, 1990, 104 Stat. 2897.)
20 USC 5364. Alliances for minority participation
TITLE 20 -- EDUCATION
(a) In general
The Director is authorized to make awards to institutions of higher
education to enable such institutions of higher education to establish
or maintain alliances, partnerships, or other cooperative arrangements
between institutions of higher education with predominately minority
enrollments and institutions of higher education with high quality
research programs in mathematics, science or engineering.
(b) Special rule
In making awards pursuant to this subchapter, the Director shall, to
the extent practicable, ensure --
(1) an equitable geographic distribution of such awards; and
(2) that institutions of higher education receiving such awards
demonstrate experience in, and a commitment to, educating and graduating
a significant number of women and minority students from programs in
mathematics, science and engineering.
(Pub. L. 101-589, title IV, 404, Nov. 16, 1990, 104 Stat. 2897.)
20 USC SUBCHAPTER V -- EDUCATION COORDINATION AND DEPARTMENT OF ENERGY
PROGRAMS
TITLE 20 -- EDUCATION
20 USC 5371. Science education report
TITLE 20 -- EDUCATION
(a) Report required
The Director of the Office of Science and Technology Policy, through
the Federal Coordinating Council on Science, Engineering, and
Technology, shall prepare a report on science, mathematics, and
engineering education to be submitted to Congress within 1 year after
November 16, 1990. The report shall include --
(1) a description of current Federal science, mathematics, and
engineering education programs at all education levels;
(2) any specific statutory changes necessary to further assist the
agencies' mathematics and science education goals; and
(3) a strategic plan for an interagency program to enhance science,
mathematics, and engineering education, including --
(A) a statement of program goals;
(B) a description of implementation steps required to achieve such
goals;
(C) a strategy for taking advantage of the strengths of Federal
research and development facilities related to science, mathematics, and
engineering education;
(D) provisions for outreach to teachers and others with direct access
to students;
(E) a system for evaluating program effectiveness, including criteria
for evaluation;
(F) criteria and procedures to facilitate and expedite either the
loan or transfer of title to surplus equipment to schools, school
districts, and colleges and universities;
(G) recommendations on how to enhance exchange of employees among
agencies to share expertise in mathematics and science education; and
(H) mechanisms to coordinate the activities of the agencies which
will implement the plan.
(b) Preparation and updating
Preparation of the plan required by subsection (a)(3) of this section
shall, at a minimum, include representatives of the Departments of
Energy and Education, and the National Science Foundation. In
subsequent years, the plan required by subsection (a)(3) of this section
shall be updated and submitted to Congress annually at the time of the
President's budget request and shall include the funding levels in that
budget for each agency to carry out each agency's portion of the plan.
(Pub. L. 101-589, title V, 501, Nov. 16, 1990, 104 Stat. 2898.)
20 USC 5372. General education report
TITLE 20 -- EDUCATION
The Department of Defense, the Department of Energy, the Department
of Agriculture, the Department of Labor, the Department of Health and
Human Services, the Department of Transportation, the Department of
Justice, the National Aeronautics and Space Administration, the
Environmental Protection Agency, and the Department of Commerce shall
each prepare and submit to the Secretary of Education, within 9 months
of November 16, 1990, a report on all educational activities supported,
excluding activities described in section 5371 of this title. The
Secretary shall compile this information and report to Congress within 1
year after November 16, 1990. The report shall include --
(1) a summary of current education programs at all levels; and
(2) any specific statutory changes necessary to further assist the
agencies' education goals.
(Pub. L. 101-589, title V, 502, Nov. 16, 1990, 104 Stat. 2898.)
20 USC 5373. Department of Energy programs
TITLE 20 -- EDUCATION
(a) Authorization
(1) In general
The Secretary of Energy is authorized to --
(A) provide paid administrative leave for employees of the Department
of Energy or its research and development facilities who volunteer to
interact with schools, colleges, universities, teachers, or students for
the purpose of science, mathematics, and engineering education;
(B) establish a volunteer talent pool of scientists, mathematicians,
and engineers who have retired from the Department of Energy or its
research and development facilities to --
(i) serve as ''Scientists in Residence'' at schools and school
districts for the purpose of assisting teachers with activities such as
experiments, lectures, or materials;
(ii) serve as requested, as a science counselor to students; and
(iii) otherwise assist science, mathematics, and engineering classes;
(C) establish a Young Americans' Summer Science Camp Program to
provide secondary school students with a hands-on science experience as
well as exposure to working scientists and career counseling; and
(D) establish a program for mathematics and science teachers, to
provide such teachers serving large numbers of disadvantaged students
with new strategies for mathematics and science instruction.
(2) Special rule
In carrying out the provisions of paragraph (1)(B) the Secretary of
Energy, wherever possible acting through the Department's research and
development facilities, shall identify and match schools and school
districts with retired scientists, mathematicians, and engineers.
(b) Facilities; non-Federal funds
Education activities assisted under this section may be conducted
through Department of Energy research and development facilities. The
Secretary is authorized to accept non-Federal funds to finance education
activities.
(c) Limitations
(1) National defense production activities
Nothing in this section shall apply to activities of the Department
of Energy or its contractors that are funded as national defense
production activities.
(2) Special rule
Nothing in this section shall be construed to affect mathematics,
science, and engineering education programs administered through the
Department of Energy other than the Office of Energy Research.
(d) Termination provision
The provisions of this section shall not take effect if a
substantially identical program is included in the National Defense
Authorization Act for Fiscal Year 1991.
(e) ''Research and development facilities'' defined
For the purpose of this section, the term ''research and development
facilities'' means, except as provided in subsection (c)(1) of this
section, all Department of Energy single purpose and multipurpose
National Laboratories and research and development facilities and
programs, and any other facility or program operated by a contractor
funded from the Office of Energy Research.
(Pub. L. 101-589, title V, 503, Nov. 16, 1990, 104 Stat. 2899.)
This section not effective pursuant to subsection (f) of this
section, if the National Defense Authorization Act for Fiscal Year 1991
(see References in Text note below) included a substantially identical
program. For substantially identical program, see section 7381 et seq.
of Title 42, The Public Health and Welfare.
The National Defense Authorization Act for Fiscal Year 1991, referred
to in subsec. (d), is Pub. L. 101-510, Nov. 5, 1990, 104 Stat. 1485.
For complete classification of this Act to the Code, see Tables.
20 USC SUBCHAPTER VI -- SCIENCE SCHOLARSHIPS
TITLE 20 -- EDUCATION
20 USC Part A -- National Science Scholars Program
TITLE 20 -- EDUCATION
20 USC 5381. Purpose; appropriations authorized
TITLE 20 -- EDUCATION
(a) Purpose
It is the purpose of this part --
(1) to establish a National Science Scholars Program to recognize
student excellence and achievement in the physical, life, and computer
sciences, mathematics, and engineering;
(2) to provide financial assistance to students under paragraph (1)
to continue their postsecondary education in such fields of study at
sustained high levels of performance;
(3) to contribute to strengthening the leadership of the United
States in such fields;
(4) to strengthen the United States mathematics, science, and
engineering base by offering opportunities to pursue postsecondary
education in life, physical, and computer sciences, mathematics, and
engineering;
(5) to encourage role models in scientific, mathematics, and
engineering fields for young people;
(6) to strengthen the United States mathematics, scientific, and
engineering potential by encouraging equal participation of women with
men in mathematics, scientific, and engineering fields; and
(7) to attract talented students to teaching careers in mathematics
and science in elementary and secondary schools.
(b) Authorization of appropriations
There are authorized to be appropriated to the Department of
Education $4,500,000 for fiscal year 1991, $4,500,000 for fiscal year
1992 and $10,000,000 for fiscal year 1993 for awards to National Science
Scholars.
(Pub. L. 101-589, title VI, 601, Nov. 16, 1990, 104 Stat. 2900; Pub.
L. 102-103, title III, 314(a), Aug. 17, 1991, 105 Stat. 508.)
1991 -- Subsec. (b). Pub. L. 102-103, inserted '', $4,500,000 for
fiscal year 1992 and $10,000,000 for fiscal year 1993'' after ''1991''.
20 USC 5382. Scholarships authorized
TITLE 20 -- EDUCATION
(a) Program authority
The Secretary is authorized, in accordance with the provisions of
this part, to carry out a program of awarding scholarships to students
for the study of the physical, life, or computer sciences, mathematics,
or engineering, who --
(1) are selected by the President;
(2) have demonstrated outstanding academic achievement in the
physical, life, or computer sciences, mathematics, or engineering; and
(3) show promise of continued outstanding academic performance in
such field of study.
(b) Period of awards
(1) Period of initial award
A student who satisfies the requirements of section 5384(a) of this
title may receive a scholarship, for a period of 1 academic year, for
the first year of undergraduate study at an institution of higher
education.
(2) Continuation awards
A student who satisfies the requirements of section 5384(b) of this
title may receive additional scholarships, each awarded for a period of
1 academic year, in order to complete his or her undergraduate course of
study. A student may receive additional scholarships for not more than
3 academic years of undergraduate study, except that, in the case of a
student who is enrolled in an undergraduate course of study that
requires attendance for 5 academic years, the student may receive
additional scholarships for not more than 4 academic years of
undergraduate study.
(c) Use at any institution permitted
A student awarded a scholarship under this part may attend any
institution of higher education, as defined in section 1141(a) of this
title.
(d) National Science Scholars
Students awarded scholarships under this part shall be known as
''National Science Scholars''.
(Pub. L. 101-589, title VI, 602, Nov. 16, 1990, 104 Stat. 2900.)
20 USC 5383. Selection of scholars
TITLE 20 -- EDUCATION
(a) Selection criteria for initial awards
(1) Selection criteria
The Director of the National Science Foundation shall develop and
submit to the Secretary proposed criteria to be used in the selection of
National Science Scholars for initial year awards under section
5382(b)(1) of this title. Such criteria shall provide for the selection
of such scholars on the basis of potential to successfully complete a
postsecondary program in the physical, life, or computer sciences,
mathematics, or engineering, and on the basis of motivation to pursue a
career in such fields. In addition, consideration may be given to the
financial need of the individual, and to promoting participation by
minorities and individuals with disabilities. The Director shall
determine the proposed criteria for measuring the potential and
motivation of nominees.
(2) Publication
The Secretary and the Director shall agree to, and jointly publish in
the Federal Register, appropriate selection criteria.
(b) Selection process for initial awards
(1) Nominating committee
Each State desiring to qualify its students for selection as a
National Science Scholar shall establish a nominating committee. Such
committee shall be appointed by the chief State school officer or by an
existing grant agency or panel designated by such officer, and shall be
approved by the Secretary. The nominating committee shall be a
broad-based committee composed of educators, scientists, mathematicians,
and engineers, who shall serve as volunteers without compensation.
(2) Nominations
The nominating committee in each State shall submit to the President
the nominations of at least four individuals from each congressional
district in the State, at least half of whom are female. Such selections
shall be ranked in order of priority.
(3) Selection
The President, after consultation with the Secretary and the Director
of the National Science Foundation, shall select two National Science
Scholars for each academic year from each congressional district, at
least one of whom shall be female.
(4) Announcement and award of scholarships
The selection process shall be completed, and the announcement of the
selection of National Science Scholars shall be made by the President
prior to January 1st of each fiscal year. The Secretary shall notify
each Member of Congress of selections made from such Member's district
and State before the public announcement by the President. Presentation
of scholarships may be made in a public ceremony.
(5) Congressional district
For purposes of this subsection, the term ''congressional district''
includes the part or all of a State (within the meaning of section
1141(b) of this title) represented by a Member or Delegate of the House
of Representatives, and includes the Commonwealth of the Northern
Mariana Islands.
(c) Continuation awards
The Secretary shall award additional scholarships under section
5382(b)(2) of this title to recipients of initial awards under section
5382(b)(1) of this title who the Secretary determines meet the
requirements of section 5384(b) of this title.
(d) Disbursal of scholarship proceeds
Scholarship proceeds shall be disbursed on behalf of students who
receive scholarships under this part to the institutions of higher
education at which the students are enrolled. No scholarship proceeds
shall be disbursed on behalf of a student until the student is enrolled
at an institution of higher education.
(e) Special rule
The Director and the Secretary shall encourage the support and
assistance of civic groups, the business community, professional
associations, institutions of higher education, and others in providing
scholarship assistance to National Science Scholarship finalists.
(Pub. L. 101-589, title VI, 603, Nov. 16, 1990, 104 Stat. 2901.)
20 USC 5384. Eligibility of scholars
TITLE 20 -- EDUCATION
(a) Requirements for initial award
To be eligible to receive a scholarship under section 5382(b)(1) of
this title, a student shall --
(1) be scheduled to graduate from a public or private secondary
school, or to obtain the equivalent of a certificate of graduation (as
recognized by the State in which the student resides), during the school
year in which the award is made;
(2) be a citizen or national of the United States or the entities set
forth in section 5383(b)(5) of this title, or be an alien lawfully
admitted to the United States for permanent residence;
(3) have demonstrated outstanding academic achievement in secondary
school in physical, life, or computer sciences, mathematics, or
engineering;
(4) have been accepted for enrollment at an institution of higher
education as a full-time undergraduate student (as determined by the
institution); and
(5) have declared a major in 1 of the physical, life, or computer
sciences, mathematics, or engineering, or provided a written statement
to the State of his or her intent to major in 1 of these fields of
study, if it is the policy of the institution at which the student has
been accepted for enrollment that students not declare a major until a
later point in their course of study.
(b) Requirements for continuation awards
A student who has received a scholarship under section 5382(b)(1) of
this title may receive a scholarship for a subsequent academic year of
undergraduate education under section 5382(b)(2) of this title if the
student --
(1) maintains a high level of academic achievement, as determined in
accordance with the regulations of the Secretary;
(2) continues to major in, or provides a statement to the State as
described in subsection (a)(5) of this section of his or her continuing
intent to major in, one of the physical, life, or computer sciences,
mathematics, or engineering; and
(3) continues to be enrolled at an institution of higher education as
a full-time undergraduate student (as determined by the institution).
(c) Waiver of full-time attendance requirement
The Secretary may waive the full-time attendance requirements in this
section in unusual circumstances.
(d) Failure to meet eligibility requirements
In the event that the student fails to meet the requirements of this
section, the student's eligibility to receive further scholarships (or
scholarship proceeds) under this part shall be suspended in accordance
with the regulations of the Secretary.
(e) Reinstatement of eligibility
The Secretary shall determine circumstances under which eligibility
of a scholarship recipient under this part may be reinstated if the
recipient seeks to re-enter school after an interruption of schooling
for personal reasons, including, but not limited to, pregnancy,
child-rearing, and other family responsibilities.
(f) Notification of secondary schools
The Secretary shall notify all public and private secondary schools
and all institutions of higher education in each State annually of the
availability of scholarships under this part.
(Pub. L. 101-589, title VI, 604, Nov. 16, 1990, 104 Stat. 2902.)
20 USC 5385. Scholarship amount
TITLE 20 -- EDUCATION
(a) Amount of award
Except as provided in subsections (b) and (c) of this section, the
amount of a scholarship awarded under this part for any academic year
shall be $5,000.
(b) Relation to cost of attendance
Notwithstanding subsection (a) of this section, the amount of a
scholarship awarded under this part shall be reduced by the amount that
the scholarship exceeds the student's cost of attendance, as defined in
section 1087ll of this title. A scholarship awarded under this part
shall not be reduced on the basis of the student's receipt of other
forms of Federal student financial assistance, but shall be taken into
account in determining the eligibility of the student for those other
forms of Federal student financial assistance.
(c) Adjustments for insufficient appropriations
In the event that funds available in a fiscal year are insufficient
to fully fund all awards under this part, the amount paid to each
student shall be reduced proportionately.
(Pub. L. 101-589, title VI, 605, Nov. 16, 1990, 104 Stat. 2903.)
20 USC 5386. Summer employment opportunities for scholars
TITLE 20 -- EDUCATION
(a) Priority for summer employment
To the extent that they are otherwise qualified, students receiving
scholarships under this part shall be given priority consideration for
federally financed summer employment in federally funded research and
development centers, that, to the maximum extent practicable,
complements and reinforces the educational program of these students.
(b) Federal agency cooperation
Federal agencies shall cooperate fully with the Secretary and
participate actively in providing appropriate summer employment
opportunities for such students.
(Pub. L. 101-589, title VI, 606, Nov. 16, 1990, 104 Stat. 2903.)
20 USC Part B -- Robert Noyce Scholarships
TITLE 20 -- EDUCATION
20 USC 5401. Robert Noyce Scholarships
TITLE 20 -- EDUCATION
(a) Program authorized
There is established a scholarship program for students in a
baccalaureate degree program in physical, life, or computer sciences,
mathematics, or engineering who are willing to commit themselves to
teaching elementary or secondary school mathematics or science.
(b) Period of awards
(1) Period of initial award
A student who satisfies the requirements of subsection (g)(1) of this
section may receive a scholarship, for a period of 1 academic year of
undergraduate study at an institution of higher education.
(2) Continuation awards
(A) First continuation award
A student who satisfies the requirements of subsection (g)(2) of this
section may receive an additional scholarship, awarded for a period of 1
academic year, in order to complete his or her undergraduate course of
study.
(B) Second continuation award
An additional period of scholarship support, not to exceed 1 year,
shall be available to recipients of scholarships under subsection (a) of
this section who have completed requirements for the baccalaureate
degree but require additional education courses in order to obtain
certification to teach.
(c) Use at any institution permitted
A student awarded a scholarship under this section may attend any
institution of higher education.
(d) Designation
The individuals awarded scholarships under subsection (a) of this
section shall be referred to as the ''Robert Noyce Mathematics and
Science Teacher Corps''.
(e) Selection
(1) Selection process for initial awards
(A) Selection criteria
The Director shall develop and submit to the Secretary proposed
application procedures and criteria to be used in the selection of
nominees under this section. Such criteria shall provide for the
selection of such nominees on the basis of academic merit and
demonstrated accomplishment in physical, life, or computer science,
mathematics, or engineering, and on the basis of motivation to pursue a
career in science, mathematics, or engineering. In addition,
consideration may be given to the financial need of the individual, and
to promoting participation by minorities and individuals with
disabilities.
(B) Publication
The Secretary and the Director shall agree to, and jointly publish in
the Federal Register, appropriate selection criteria.
(C) Merit review panel
Award recipients shall be nominated from among applicants by a merit
review panel composed of 8 individuals, 4 of whom shall be appointed by
the Director and 4 of whom shall be appointed by the Secretary. Members
of the panel shall not be employees of the United States and shall serve
as volunteers without compensation. Nominees shall be selected on the
basis of selection criteria, which shall be developed and published in
accordance with subparagraphs (A) and (B). The panel shall rank the
nominees in order of priority.
(D) Awarding of scholarships
The panel shall submit its nominees to the President, who shall,
after consultation with the Director and the Secretary, award not more
than 500 scholarships under subsection (a) of this section.
(2) Continuation awards
The Secretary shall award additional scholarships to recipients of
initial awards under this section who the Secretary determines meet the
requirements of subsection (g)(2) or (b)(2)(B) of this section.
(f) Disbursal of scholarship proceeds
Scholarship proceeds shall be disbursed on behalf of students who
receive scholarships under this section to the institutions of higher
education at which the students are enrolled. No scholarship proceeds
shall be disbursed on behalf of a student unless the student is enrolled
at an institution of higher education.
(g) Eligibility
(1) Initial eligibility
Only individuals who are --
(A) citizens or nationals of the United States, or who are aliens
lawfully admitted to the United States for permanent residence;
(B) majoring in the physical, life, or computer sciences,
mathematics, or engineering;
(C) in the last 2 years of a baccalaureate degree program; and
(D) enrolled in an institution of higher education as a full-time
undergraduate student (as determined by the institution of higher
education),
shall be eligible for awards under this section.
(2) Requirements for first continuation awards
A student who has received a scholarship under this section may
receive a first continuation award under subsection (b)(2)(A) of this
section for a subsequent academic year of undergraduate education if the
student --
(A) maintains a high level of academic achievement, as determined in
accordance with the regulations of the Secretary;
(B) continues to major in one of the physical, life, or computer
sciences, mathematics, or engineering; and
(C) continues to be enrolled at an institution of higher education as
a full-time undergraduate student (as determined by the institution).
(h) Waiver of full-time attendance requirement
The Secretary may waive the full-time attendance requirements in this
section in unusual circumstances.
(i) Failure to meet eligibility requirements
In the event that the student fails to meet the requirements of this
section, the student's eligibility to receive further scholarships (or
scholarship proceeds) under this section shall be suspended in
accordance with the regulations of the Secretary.
(j) Reinstatement of eligibility
The Secretary shall determine circumstances under which eligibility
of a scholarship recipient under this section could be reinstated if the
recipient seeks to re-enter school after an interruption of schooling
for personal reasons, including, but not limited to, pregnancy,
child-rearing, and other family responsibilities.
(k) Notification of schools
The Secretary shall notify all institutions of higher education in
the United States annually of the availability of scholarships under
this section.
(l) Scholarship amount
(1) Amount of award
Except as provided in paragraph (2), the amount of a scholarship
awarded under this section for any academic year shall be $5,000.
(2) Relation to cost of attendance
Notwithstanding paragraph (1), the amount of a scholarship awarded
under this section shall be reduced by the amount that the scholarship
exceeds the student's cost of attendance, as defined in section 472 of
the Higher Education Act of 1965 (20 U.S.C. 1087ll). A scholarship
awarded under this section shall not be reduced on the basis of the
student's receipt of other forms of Federal student financial
assistance, but shall be taken into account in determining the
eligibility of the student for those other forms of Federal student
financial assistance.
(m) Service requirement
(1) Teaching obligation
Each recipient of an award under this section shall, as a condition
of the receipt of such award, agree to complete, within 6 years after
graduation from the baccalaureate degree program for which the award was
made or within 6 years after completion of the additional period of
scholarship support, if applicable, at least 2 years of service as an
elementary or secondary mathematics or science teacher for each year of
scholarship support under this section, except that such requirement
shall not exceed a total of 4 years. Service required under this
paragraph shall be performed at a school receiving assistance under
chapter 1 of title I of the Elementary and Secondary Education Act of
1965 (20 U.S.C. 2701 et seq.).
(2) Repayment alternative
As part of the agreement required under paragraph (1), each recipient
shall agree, in the event of failure to complete the service obligation
described in paragraph (1), to repay an amount equal to --
(A) the total amount of awards received by such individual under this
section; plus
(B) the interest on such amounts which would be payable if at the
time the amounts were received they were loans bearing interest at the
maximum legal prevailing rate, as determined by the Treasurer of the
United States,
except that such payment shall be reduced, for each year of service
that the individual has successfully completed, by a fraction equal to 1
divided by the number of years of service the student is obligated to
perform. Such repayment shall be made within 1 year after the recipient
has ceased to perform the service obligation described in paragraph (1).
(3) Exceptions
The Secretary may provide for the partial or total waiver or
suspension of any service obligation or payment by an individual under
this section in the same manner as is permitted under section 558 of the
Higher Education Act of 1965 (20 U.S.C. 1111g) with respect to
scholarships under subpart 1 of part D of title V of the Higher
Education Act of 1965 (20 U.S.C. 1111 et seq.), except that pregnancy,
child-rearing, or comparable family responsibilities shall also be
grounds for deferral.
(n) Authorization of appropriations
There are authorized to be appropriated to the National Science
Foundation, for transfer to the Department of Education, $2,500,000 for
fiscal year 1991, $5,000,000 for fiscal year 1992, and $7,500,000 for
fiscal year 1993, to carry out the provisions of this part.
(Pub. L. 101-589, title VI, 611, Nov. 16, 1990, 104 Stat. 2904.)
The Elementary and Secondary Education Act of 1965, referred to in
subsec. (m)(1), is Pub. L. 89-10, Apr. 11, 1965, 79 Stat. 27, as
amended generally by Pub. L. 100-297, Apr. 28, 1988, 102 Stat. 140.
Chapter 1 of title I of the Act is classified generally to division 1 (
2701 et seq.) of subchapter I of chapter 47 of this title. For complete
classification of this Act to the Code, see Short Title note set out
under section 2701 of this title and Tables.
The Higher Education Act of 1965, referred to in subsec. (m)(3), is
Pub. L. 89-329, Nov. 8, 1965, 79 Stat. 1219, as amended. Subpart 1 of
part D of title V of the Act is classified generally to subpart 1 ( 1111
et seq.) of part D of subchapter V of chapter 28 of this title. For
complete classification of this Act to the Code, see Short Title note
set out under section 1001 of this title and Tables.
20 USC Part C -- National Academy of Science, Space, and Technology
TITLE 20 -- EDUCATION
20 USC 5411. National Academy of Science, Space, and Technology
TITLE 20 -- EDUCATION
(a) Establishment of Academy
The Secretary shall establish a National Academy of Science, Space,
and Technology for the instruction and preparation of selected
individuals for service in a science, mathematics, or engineering
related capacity in the employ of the United States or a United States
corporation.
(b) Advisory Board
(1) Membership
The Secretary, after consultation with the Director, shall appoint an
Advisory Board for the Academy consisting of a broadly representative
group of scientists, engineers, educators, and businessmen representing
high-technology industries.
(2) Functions
The Advisory Board shall --
(A) develop criteria to be used in the selection of recipients of
scholarships under this section;
(B) select scholarship recipients from among nominations received
under subsection (e) of this section; and
(C) identify fields of science, mathematics, and engineering which
will be given priority in awarding scholarships under this section.
In making determinations under subparagraph (C), the Advisory Board
shall take into consideration requirements of Government and industry
for technical personnel in fields of science, mathematics, and
engineering which are relevant to emerging industrial technologies of
significant economic importance and in which shortages in the work force
of the United States are projected.
(c) Scholarships authorized
(1) The Academy shall establish a scholarship program for students to
pursue the baccalaureate degree in fields of science, mathematics, or
engineering who are willing to commit themselves to service described in
subsection (n) of this section.
(2) A student who satisfies the requirements of subsection (h)(1) of
this section may receive a scholarship for a period of 1 academic year
of undergraduate study at a Member Institute.
(3) A student who satisfies the requirements of subsection (h)(2) of
this section may receive additional scholarships, each awarded for a
period of 1 academic year, in order to complete his or her undergraduate
course of study to a maximum of 3 awards.
(4) The individuals awarded scholarships under this section shall be
referred to as the ''Science, Space, and Technology Corps''.
(5) An individual awarded a scholarship under this section may attend
any institution of higher education that offers the baccalaureate degree
in science, mathematics, or engineering. Such institutions shall be
designated as Member Institutes of the Academy.
(d) Nominations for scholarship awards
Members and Delegates of the House of Representatives may each
nominate 6 or more individuals, at least half of whom are female, for
scholarships.
(e) Selection for initial awards
(1) The Board shall develop criteria for selection of nominees under
this section. Such criteria shall provide for the selection of such
nominees on the basis of academic merit and motivation to pursue a
career in science, mathematics, or engineering. In addition,
consideration may be given to the financial need of the individual, and
to promoting participation by minorities and individuals with
disabilities.
(2) From among nominees received pursuant to subsection (d) of this
section, the Board shall select for award of a scholarship one
individual from each Congressional District.
(f) Continuation awards
The Secretary shall award additional scholarships to recipients of
initial awards under this section who the Secretary determines meet the
requirements of subsection (h)(2) of this section.
(g) Disbursal of scholarship proceeds
Scholarship proceeds shall be disbursed on behalf of students who
receive scholarships under this section to the institutions of higher
education at which the students are enrolled. No scholarship proceeds
shall be disbursed on behalf of a student unless the student is enrolled
at an institution of higher education.
(h) Eligibility
(1) Initial eligibility
Only individuals who are --
(A) citizens or nationals of the United States, or who are aliens
lawfully admitted to the United States for permanent residence;
(B) majoring in the physical, life, or computer sciences,
mathematics, or engineering; and
(C) enrolled in an institution of higher education as a full-time
undergraduate student (as determined by the institution of higher
education),
shall be eligible for awards under this section.
(2) Requirements for continuation awards
A student who has received a scholarship under this section may
receive a continuation award under subsection (f) of this section for a
subsequent academic year of undergraduate education if the student --
(A) maintains a high level of academic achievement, as determined in
accordance with the regulations of the Secretary;
(B) continues to major in one of the physical, life, or computer
sciences, mathematics, or engineering; and
(C) continues to be enrolled at an institution of higher education as
a full-time undergraduate student (as determined by the institution).
(i) Waiver of full-time attendance requirement
The Secretary may waive the full-time attendance requirements in this
section in unusual circumstances.
(j) Failure to meet eligibility requirements
In the event that the student fails to meet the requirements of this
section, the student's eligibility to receive further scholarships (or
scholarship proceeds) under this section shall be suspended in
accordance with the regulations of the Secretary.
(k) Reinstatement of eligibility
The Secretary shall determine circumstances under which eligibility
of a scholarship recipient under this section may be reinstated if the
recipient seeks to re-enter school after an interruption of schooling
for personal reasons, including, but not limited to, pregnancy,
child-rearing, and other family responsibilities.
(l) Notification of schools
The Secretary shall notify all institutions of higher education in
the United States annually of the availability of scholarships under
this section.
(m) Scholarship amount
(1) Amount of award
Except as provided in paragraphs (2) and (3), the amount of a
scholarship awarded under this section for any academic year shall be
$5,000.
(2) Relation to cost of attendance
Notwithstanding paragraph (1), the amount of a scholarship awarded
under this section shall be reduced by the amount that the scholarship
exceeds the student's cost of attendance, as defined in section 472 of
the Higher Education Act of 1965 (20 U.S.C. 1087ll). A scholarship
awarded under this section shall not be reduced on the basis of the
student's receipt of other forms of Federal student financial
assistance, but shall be taken into account in determining the
eligibility of the student for those other forms of Federal student
financial assistance.
(3) Adjustments for insufficient appropriations
In the event that funds available in a fiscal year are insufficient
to fully fund all awards under this section, the amount paid to each
student shall be reduced proportionately.
(n) Service requirement
(1) Science, space, and technology scholarships
Each recipient of an award under this section shall, as a condition
of the receipt of such award, agree to complete four years of --
(A) service in a physical, life, or computer science, mathematics, or
engineering related capacity in the employ of the United States or any
corporation or other entity, organized under the laws of the United
States or of a State of the United States, at least 50 percent of which
is owned by United States nationals, and which is engaged in scientific
or engineering research or endeavor;
(B) postgraduate education in physical, life, or computer science,
mathematics, or engineering at an institution of higher education; or
(C) a combination of service and education described under
subparagraphs (A) and (B).
(2) Repayment obligation
As part of the agreement required under paragraph (1), each recipient
shall agree, in the event of failure to complete the service obligation
described in paragraph (1), to repay an amount equal to --
(A) the total amount of awards received by such individual under this
section; plus
(B) the interest on such amounts which would be payable if at the
time the amounts were received the amounts were loans bearing interest
at the maximum legal prevailing rate, as determined by the Treasurer of
the United States.
Such repayment shall be made within 1 year after the recipient has
ceased to perform the service obligation described in paragraph (1).
(3) Exceptions
The Secretary may provide for the partial or total waiver or
suspension of any service obligation or payment by an individual under
this section in the same manner as is permitted under section 558 of the
Higher Education Act of 1965 (20 U.S.C. 1111g) with respect to
scholarships under subpart 1 of part D of title V of the Higher
Education Act of 1965 (20 U.S.C. 1111 et seq.), except that pregnancy,
child-rearing, or comparable family responsibilities shall also be
grounds for deferral.
(o) Authorization of appropriations
There are authorized to be appropriated to carry out this section
$2,200,000 for each of the fiscal years 1992 and 1993.
(Pub. L. 101-589, title VI, 621, Nov. 16, 1990, 104 Stat. 2907; Pub.
L. 102-103, title III, 314(b), Aug. 17, 1991, 105 Stat. 508.)
The Higher Education Act of 1965, referred to in subsec. (n)(3), is
Pub. L. 89-329, Nov. 8, 1965, 79 Stat. 1219, as amended. Subpart 1 of
part D of title V of the Act is classified generally to subpart 1 ( 1111
et seq.) of part D of subchapter V of chapter 28 of this title. For
complete classification of this Act to the Code, see Short Title note
set out under section 1001 of this title and Tables.
1991 -- Subsec. (o). Pub. L. 102-103 substituted ''each of the
fiscal years 1992 and 1993'' for ''fiscal year 1991''.
Advisory boards established after Jan. 5, 1973, to terminate not
later than the expiration of the 2-year period beginning on the date of
their establishment, unless, in the case of a board established by the
President or an officer of the Federal Government, such board is renewed
by appropriate action prior to the expiration of such 2-year period, or
in the case of a board established by the Congress, its duration is
otherwise provided for by law. See sections 3(2) and 14 of Pub. L.
92-463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to
Title 5, Government Organization and Employees.
20 USC Part D -- Additional Provisions
TITLE 20 -- EDUCATION
20 USC 5421. Effect of certain controlled substance and felony
convictions
TITLE 20 -- EDUCATION
(a) General rule
Except as provided in subsection (b) of this section, or by a court
under the authority of section 5301 /1/ of the Anti-Drug Abuse Act of
1988 (102 Stat. 4310), if any person is convicted under Federal or State
law of the illegal use, possession, or distribution of a controlled
substance (as such term is defined in the Controlled Substances Act (21
U.S.C. 801 et seq.)), or of any crime which is a felony under Federal
law or for an act which, if committed in a Federal jurisdiction, would
be a felony under Federal law, and such crime was committed during a
period in which such person received an award under this subchapter,
such person shall not be eligible to receive any further such awards,
and shall be liable to the United States for the repayment, within 1
year after such conviction, of all amounts received pursuant to such
awards, plus the interest on such amounts which would be payable if at
the time the amounts were received they were loans bearing interest at
the maximum legal prevailing rate, as of the time of such conviction, as
determined by the Treasurer of the United States.
(b) Exemption
A person subject to the provisions of subsection (a) of this section
may be exempted from those provisions in whole or in part if --
(1) that person, within 90 days of a conviction described in
subsection (a) of this section, petitions the Secretary of Education for
a good cause exemption from subsection (a) of this section; and
(2) the Secretary of Education approves the petition.
(Pub. L. 101-589, title VI, 631, Nov. 16, 1990, 104 Stat. 2910.)
Section 5301 of the Anti-Drug Abuse Act of 1988, referred to in
subsec. (a), means section 5301 of Pub. L. 100-690, which was
classified to section 853a of Title 21, Food and Drugs, and was
renumbered section 421 of title II of Pub. L. 91-513 by Pub. L.
101-647, title X, 1002(d)(1), Nov. 29, 1990, 104 Stat. 4827, and
transferred to section 862 of Title 21.
The Controlled Substances Act, referred to in subsec. (a), is title
II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as amended, which
is classified principally to subchapter I ( 801 et seq.) of chapter 13
of Title 21. For complete classification of this Act to the Code, see
Short Title note set out under section 801 of Title 21 and Tables.
/1/ See References in Text note below.
20 USC 5422. Report
TITLE 20 -- EDUCATION
The National Science Foundation shall prepare and submit to the
Congress no later than 1 year after November 16, 1990, a report
examining current efforts to improve the quality of elementary and
secondary mathematics and science education and career potential for the
underprivileged through joint efforts of business, school districts, and
institutions of higher education, and recommending ways the Federal
Government may encourage such efforts. The report shall include, to the
extent possible, a comprehensive list of existing efforts, an assessment
of what factors have made some such efforts more successful than others,
and a review of the extent to which such efforts have drawn on Federal
programs.
(Pub. L. 101-589, title VI, 632, Nov. 16, 1990, 104 Stat. 2910.)
20 USC SUBCHAPTER VII -- GENERAL PROVISIONS AND AUTHORIZATION OF
APPROPRIATIONS
TITLE 20 -- EDUCATION
20 USC Part A -- Authorization of Appropriations
TITLE 20 -- EDUCATION
20 USC 5431. Authorization of appropriations
TITLE 20 -- EDUCATION
From the amounts authorized to be appropriated to the National
Science Foundation pursuant to the National Science Foundation
Authorization Act of 1988, there are authorized to be appropriated --
(1) in addition to any amount obligated in fiscal year 1990 for
programs on applications of advanced technology within the Education and
Human Resources Directorate --
(A) $10,000,000 for fiscal year 1991 to carry out the provisions of
section 5311 of this title, of which $5,000,000 shall be available to
carry out the provisions of subsection (a) of such section and
$5,000,000 shall be available to carry out the provisions of subsection
(b) of such section;
(B) $11,000,000 for fiscal year 1992 to carry out the provisions of
section 5311 of this title, of which $5,500,000 shall be available to
carry out the provisions of subsection (a) of such section and
$5,500,000 shall be available to carry out the provisions of subsection
(b) of such section; and
(C) $12,500,000 for fiscal year 1993 to carry out the provisions of
section 5311 of this title, of which $6,250,000 shall be available to
carry out the provisions of subsection (a) of such section and
$6,250,000 shall be available to carry out the provisions of subsection
(b) of such section;
(2) in addition to any amounts obligated in fiscal year 1990 for
informal science education programs, $15,000,000 for fiscal year 1991,
$17,000,000 for fiscal year 1992, and $19,400,000 for fiscal year 1993
to carry out the provisions of section 5321 of this title;
(3) in addition to any amounts obligated in fiscal year 1990 for
statewide education programs, $17,000,000 for fiscal year 1991,
$19,400,000 for fiscal year 1992, and $22,100,000 for fiscal year 1993
to carry out the provisions of section 5331 of this title;
(4) in addition to any amounts obligated in fiscal year 1990 for
undergraduate education programs, $16,000,000 for fiscal year 1991,
$18,200,000 for fiscal year 1992, and $20,700,000 for fiscal year 1993
to carry out the provisions of section 5351 of this title;
(5) $37,900,000 for fiscal year 1991, $60,600,000 for fiscal year
1992, and $67,800,000 for fiscal year 1993 to support of graduate
fellowships, including expansion of the number of graduate fellowships
pursuant to the provisions of section 5342 of this title;
(6) $10,000,000 for fiscal year 1991, $20,000,000 for fiscal year
1992, and $30,000,000 for fiscal year 1993 to carry out the provisions
of section 5343 of this title; and
(7) in addition to any amounts obligated in fiscal year 1990 for
programs to increase participation by women and minorities in careers in
science, mathematics and engineering, $17,000,000 for fiscal year 1991,
$19,400,000 for fiscal year 1992, and $22,000,000 for fiscal year 1993
to carry out the provisions of subchapter IV of this chapter.
(Pub. L. 101-589, title VII, 701, Nov. 16, 1990, 104 Stat. 2910.)
The National Science Foundation Authorization Act of 1988, referred
to in text, is Pub. L. 100-570, Oct. 31, 1988, 102 Stat. 2865. For
complete classification of this Act to the Code, see Short Title of 1988
Amendments note set out under section 1861 of Title 42, The Public
Health and Welfare, and Tables.
20 USC Part B -- Definitions
TITLE 20 -- EDUCATION
20 USC 5441. Definitions
TITLE 20 -- EDUCATION
As used in this chapter --
(1) the term ''consortium'', refers to a combination of school
districts, colleges, universities, other formal or informal educational
entities, State and local governments, professional organizations,
community groups, businesses and industries, or any combination thereof;
(2) the term ''Director'', unless otherwise specified, shall refer to
the Director of the National Science Foundation;
(3) the term ''elementary school'' has the same meaning given that
term in section 2891(8) of this title;
(4) the term ''Foundation'' refers to the National Science
Foundation;
(5) the term ''institution of higher education'' has the same meaning
given that term in section 1141(a) of this title;
(6) the term ''local educational agency'' has the same meaning given
that term in section 2891(12) of this title;
(7) the term ''minorities'' refers to members of those racial and
ethnic groups underrepresented in mathematics, science and engineering,
including American Indians, Black Americans, Hispanic Americans, Native
Alaskans, or Native Pacific Islanders;
(8) the terms ''scholarship'' and ''fellowship'' refers to a
financial award made to a student which enables a student to pursue a
desired course of study at an institution of higher education;
(9) the term ''secondary school'' has the same meaning given that
term in section 2891(21) of this title;
(10) the term ''Secretary'', unless otherwise specified, refers to
the Secretary of the Department of Education;
(11) the term ''State educational agency'' has the same meaning given
that term in section 2891(23) of this title; and
(12) the term ''traineeship'' means a form of financial support
provided to an institution of higher education to --
(A) be used to provide stipends to graduate students selected by such
institution; and
(B) help defray educational costs of educating such graduate
students.
(Pub. L. 101-589, title VII, 711, Nov. 16, 1990, 104 Stat. 2911.)
This chapter, referred to in text, was in the original ''this Act'',
meaning Pub. L. 101-589, Nov. 16, 1990, 104 Stat. 2881, known as the
Excellence in Mathematics, Science and Engineering Education Act of
1990, which enacted this chapter and sections 2994 to 2994g of this
title, redesignated section 2993 of this title as section 2996 of this
title, amended sections 237, 240, 1201a, 1221e-1, 2983 to 2992, and 4512
of this title and sections 1869 and 1873 of Title 42, The Public Health
and Welfare, and enacted provisions set out as notes under sections 240,
2982, and 5301 of this title. For complete classification of this Act
to the Code, see Short Title note set out under section 5301 of this
title and Tables.
20 USC CHAPTER 65 -- NATIONAL ENVIRONMENTAL EDUCATION
TITLE 20 -- EDUCATION
Sec.
5501. Findings and policy.
(a) Findings.
(b) Policy.
5502. Definitions.
5503. Office of Environmental Education.
(a) Establishment.
(b) Duties and functions.
(c) Director and staff.
5504. Environmental Education and Training Program.
(a) Establishment.
(b) Functions and activities.
(c) Grants.
(d) Eligibility.
5505. Environmental education grants.
(a) Cooperative agreements and grants.
(b) Eligible activities.
(c) Priority projects.
(d) Scope of program and implementing regulations.
(e) Solicitation notices.
(f) Applications.
(g) Performance of projects.
(h) Matching requirements.
(i) Limitations on grants.
5506. Environmental internships and fellowships.
(a) Postsecondary students and in-service teachers.
(b) Purpose.
(c) Minimum number of internships and fellowships.
(d) Management of programs; eligible agencies.
(e) Length of internships and fellowships; funding.
(f) Eligible individuals.
(g) Applications.
(h) Geographic, cultural, and minority representation.
5507. Environmental education awards.
(a) National awards.
(b) Required awards.
(c) Nomination by Environmental Education Advisory Council.
(d) President's Environmental Youth Awards.
(e) Cash awards for elementary and secondary education teachers and
local educational agencies.
5508. Environmental Education Advisory Council and Task Force.
(a) Establishment.
(b) Advisory Council; duties; members; terms of office;
compensation; termination.
(c) Federal Task Force on Environmental Education; duties;
members.
(d) Reports.
5509. National Environmental Education and Training Foundation.
(a) Establishment and purposes.
(b) Board of Directors.
(c) Rights and obligations of Foundation.
(d) Conditions on donations.
(e) Administrative services and support.
(f) Report.
(g) Volunteer status.
(h) Audits and petition of Attorney General for equitable relief.
(i) United States release from liability.
(j) Amendment and repeal.
5510. Authorization.
(a) Authorization of appropriations.
(b) Limitations.
(c) Availability of funds to National Environmental Education and
Training Foundation.
20 USC 5501. Findings and policy
TITLE 20 -- EDUCATION
(a) Findings
The Congress finds that --
(1) Threats to human health and environmental quality are
increasingly complex, involving a wide range of conventional and toxic
contaminants in the air and water and on the land.
(2) There is growing evidence of international environmental
problems, such as global warming, ocean pollution, and declines in
species diversity, and that these problems pose serious threats to human
health and the environment on a global scale.
(3) Environmental problems represent as significant a threat to the
quality of life and the economic vitality of urban areas as they do the
natural balance of rural areas.
(4) Effective response to complex environmental problems requires
understanding of the natural and built environment, awareness of
environmental problems and their origins (including those in urban
areas), and the skills to solve these problems.
(5) Development of effective solutions to environmental problems and
effective implementation of environmental programs requires a well
educated and trained, professional work force.
(6) Current Federal efforts to inform and educate the public
concerning the natural and built environment and environmental problems
are not adequate.
(7) Existing Federal support for development and training of
professionals in environmental fields is not sufficient.
(8) The Federal Government, acting through the Environmental
Protection Agency, should work with local education institutions, State
education agencies, not-for-profit educational and environmental
organizations, noncommercial educational broadcasting entities, and
private sector interests to support development of curricula, special
projects, and other activities, to increase understanding of the natural
and built environment and to improve awareness of environmental
problems.
(9) The Federal Government, acting through the coordinated efforts of
its agencies and with the leadership of the Environmental Protection
Agency, should work with local education institutions, State education
agencies, not-for-profit educational and environmental organizations,
noncommercial educational broadcasting entities, and private sector
interests to develop programs to provide increased emphasis and
financial resources for the purpose of attracting students into
environmental engineering and assisting them in pursuing the programs to
complete the advanced technical education required to provide effective
problem solving capabilities for complex environmental issues.
(10) Federal natural resource agencies such as the United States
Forest Service have a wide range of environmental expertise and a long
history of cooperation with educational institutions and technology
transfer that can assist in furthering the purposes of the /1/ chapter.
(b) Policy
It is the policy of the United States to establish and support a
program of education on the environment, for students and personnel
working with students, through activities in schools, institutions of
higher education, and related educational activities, and to encourage
postsecondary students to pursue careers related to the environment.
(Pub. L. 101-619, 2, Nov. 16, 1990, 104 Stat. 3325.)
Section 1(a) of Pub. L. 101-619 provided that: ''This Act (enacting
this chapter) may be cited as the 'National Environmental Education
Act'.''
/1/ So in original. Probably should be ''this''.
20 USC 5502. Definitions
TITLE 20 -- EDUCATION
For the purposes of this chapter, the term --
(1) ''Administrator'' means the Administrator of the Environmental
Protection Agency;
(2) ''Agency'' means the United States Environmental Protection
Agency;
(3) ''Federal agency'' or ''agency of the United States'' means any
department, agency or other instrumentality of the Federal Government,
any independent agency or establishment of the Federal Government
including any Government corporation;
(4) ''Secretary'' means the Secretary of the Department of Education;
(5) ''local education agency'' means any education agency as defined
in section 198 /1/ of the Elementary and Secondary Education Act of 1965
(20 U.S.C. 3381) and shall include any tribal education agency;
(6) ''not-for-profit'' organization /2/ means an organization,
association, or institution described in section 501(c)(3) of title 26,
which is exempt from taxation pursuant to the provisions of section
501(a) of title 26;
(7) ''noncommercial education broadcasting entities'' means any
noncommercial educational broadcasting station (and/or its legal
nonprofit affiliates) as defined and licensed by the Federal
Communications Commission;
(8) ''tribal education agency'' means a school or community college
which is controlled by an Indian tribe, band, or nation, including any
Alaska Native village, which is recognized as eligible for special
programs and services provided by the United States to Indians because
of their status as Indians and which is not administered by the Bureau
of Indian Affairs;
(9) ''Federal natural resource management agencies'' means the United
States Forest Service, the Bureau of Land Management, the National Park
Service, and the Fish and Wildlife Service;
(10) ''environmental engineering'' means the discipline within
engineering and science concerned with the development and application
of scientific and technical solutions to protecting the aquatic and
atmospheric environment, including, but not limited to, all phases of
water resources planning, water supply, water treatment, air pollution
characterization and control, remediation of hazardous substances,
environmental transport of contaminants in surface and ground water and
atmosphere, and methods for assessment and control of pollution;
(11) ''environmental education'' and ''environmental education and
training'' mean educational activities and training activities involving
elementary, secondary, and postsecondary students, as such terms are
defined in the State in which they reside, and environmental education
personnel, but does not include technical training activities directed
toward environmental management professionals or activities primarily
directed toward the support of noneducational research and development;
(12) ''Foundation'' means the National Environmental Education and
Training Foundation established pursuant to section 5509 of this title;
and
(13) ''Board of Directors'' means the Board of Directors of the
National Environmental Education and Training Foundation.
(Pub. L. 101-619, 3, Nov. 16, 1990, 104 Stat. 3326.)
Section 198 of the Elementary and Secondary Education Act of 1965 (20
U.S.C. 3381), referred to in par. (5), is section 198 of Pub. L.
89-10, title I, as added by Pub. L. 95-561, title I, 101(a), Nov. 1,
1978, 92 Stat. 2198, as amended, which was classified to section 2854
of this title prior to the general revision of Pub. L. 89-10 by Pub.
L. 100-297, title I, 1001, Apr. 28, 1988, 102 Stat. 140. For
definition of ''local educational agency'', see section 2891 of this
title.
/1/ See References in Text note below.
/2/ So in original. Probably should be '''not-for-profit
organization'''.
20 USC 5503. Office of Environmental Education
TITLE 20 -- EDUCATION
(a) Establishment
The Administrator shall establish an Office of Environmental
Education within the Environmental Protection Agency.
(b) Duties and functions
The Office of Environmental Education shall --
(1) develop and support programs and related efforts, in consultation
and coordination with other Federal agencies, to improve understanding
of the natural and built environment, and the relationships between
humans and their environment, including the global aspects of
environmental problems;
(2) support development and the widest possible dissemination of
model curricula, educational materials, and training programs for
elementary and secondary students and other interested groups, including
senior Americans;
(3) develop and disseminate, in cooperation with other Federal
agencies, not-for-profit educational and environmental organizations,
State agencies, and noncommercial educational broadcasting entities,
environmental education publications and audio/visual and other media
materials;
(4) develop and support environmental education seminars, training
programs, teleconferences, and workshops for environmental education
professionals, as provided for in section 5504 of this title;
(5) manage Federal grant assistance provided to local education
agencies, institutions of higher education, other not-for-profit
organizations, and noncommercial education broadcasting entities, under
section 5505 of this title;
(6) administer the environmental internship and fellowship programs
provided for in section 5506 of this title;
(7) administer the environmental awards program provided for in
section 5507 of this title;
(8) provide staff support to the Advisory Council and Task Force
provided for in section 5508 of this title;
(9) assess, in coordination with other Federal agencies, the demand
for professional skills and training needed to respond to current and
anticipated environmental problems and cooperate with appropriate
institutions, organizations, and agencies to develop training programs,
curricula, and continuing education programs for teachers, school
administrators, and related professionals;
(10) assure the coordination of Federal statutes and programs
administered by the Agency relating to environmental education,
consistent with the provisions and purposes of those programs, and work
to reduce duplication or inconsistencies within these programs;
(11) work with the Department of Education, the Federal Interagency
Committee on Education, and with other Federal agencies, including
Federal natural resource management agencies, to assure the effective
coordination of programs related to environmental education, including
environmental education programs relating to national parks, national
forests, and wildlife refuges;
(12) provide information on environmental education and training
programs to local education agencies, State education and natural
resource agencies, and others; and
(13) otherwise provide for the implementation of this chapter.
(c) Director and staff
The Office of Environmental Education shall --
(1) be directed by a Director who shall be a member of the Senior
Executive Service;
(2) include a headquarters staff of not less than six and not more
than ten full-time equivalent employees; and
(3) be supported by one full-time equivalent employee in each Agency
regional office.
(Pub. L. 101-619, 4, Nov. 16, 1990, 104 Stat. 3327.)
20 USC 5504. Environmental Education and Training Program
TITLE 20 -- EDUCATION
(a) Establishment
There is hereby established an Environmental Education and Training
Program. The purpose of the program shall be to train educational
professionals in the development and delivery of environmental education
and training programs and studies.
(b) Functions and activities
The functions and activities of the program shall include, at a
minimum --
(1) classroom training in environmental education and studies
including environmental sciences and theory, educational methods and
practices, environmental career or occupational education, and topical
environmental issues and problems;
(2) demonstration of the design and conduct of environmental field
studies and assessments;
(3) development of environmental education programs and curriculum,
including programs and curriculum to meet the needs of diverse ethnic
and cultural groups;
(4) sponsorship and management of international exchanges of teachers
and other educational professionals between the United States, Canada,
and Mexico involved in environmental programs and issues;
(5) maintenance or support of a library of environmental education
materials, information, literature, and technologies, with electronic as
well as hard copy accessibility;
(6) evaluation and dissemination of environmental education
materials, training methods, and related programs;
(7) sponsorship of conferences, seminars, and related forums for the
advancement and development of environmental education and training
curricula and materials, including international conferences, seminars,
and forums;
(8) supporting effective partnerships and networks and the use of
distant learning technologies; and
(9) such other activities as the Administrator determines to be
consistent with the policies of this chapter.
Special emphasis should be placed on developing environmental
education programs, workshops, and training tools that are portable and
can be broadly disseminated.
(c) Grants
(1) The Administrator shall make a grant on an annual basis to an
institution of higher education or other institution which is a
not-for-profit institution (or consortia of such institutions) to
operate the environmental education and training program required by
this section.
(2) Any institution of higher education or other institution (or
consortia of such institutions) which is a not-for-profit organization
and is interested in receiving a grant under this section may submit to
the Administrator an application in such form and containing such
information as the Administrator may require.
(3) The Administrator shall award grants under this section on the
basis of --
(A) the capability to develop environmental education and training
programs;
(B) the capability to deliver training to a range of participants and
in a range of settings;
(C) the expertise of the staff in a range of appropriate disciplines;
(D) the relative economic effectiveness of the program in terms of
the ratio of overhead costs to direct services;
(E) the capability to make effective use of existing national
environmental education resources and programs;
(F) the results of any evaluation under paragraph (5) of this
subsection; and
(G) such other factors as the Administrator deems appropriate.
(4) No funds made available to carry out this section shall be used
for the acquisition of real property (including buildings) or the
construction or substantial modification of any building.
(5) The Administrator shall establish procedures for a careful and
detailed review and evaluation of the environmental education and
training program to determine whether the quality of the program being
operated by the grantee warrants continued support under this section.
(d) Eligibility
(1) Individuals eligible for participation in the program are
teachers, faculty, administrators and related support staff associated
with local education agencies, colleges, and universities, employees of
State education, environmental protection, and natural resource
departments, and employees of not-for-profit organizations involved in
environmental education activities and issues.
(2) Individuals shall be selected for participation in the program
based on applications which shall be in such form as the Administrator
determines to be appropriate.
(3) In selecting individuals to participate in the program, the
Administrator shall provide for a wide geographic representation and a
mix of individuals, including minorities, working at primary, secondary,
postsecondary levels, and with appropriate other agencies and
departments.
(4) Individuals selected for participation in the program may be
provided with a stipend to cover travel and accommodations from grant
funds awarded pursuant to this section in such amounts as the
Administrator determines to be appropriate.
(Pub. L. 101-619, 5, Nov. 16, 1990, 104 Stat. 3328.)
20 USC 5505. Environmental education grants
TITLE 20 -- EDUCATION
(a) Cooperative agreements and grants
The Administrator may enter into a cooperative agreement or contract,
or provide financial assistance in the form of a grant, to support
projects to design, demonstrate, or disseminate practices, methods, or
techniques related to environmental education and training.
(b) Eligible activities
Activities eligible for grant support pursuant to this section shall
include, but not be limited to, environmental education and training
programs for --
(1) design, demonstration, or dissemination of environmental
curricula, including development of educational tools and materials;
(2) design and demonstration of field methods, practices, and
techniques, including assessment of environmental and ecological
conditions and analysis of environmental pollution problems;
(3) projects to understand and assess a specific environmental issue
or a specific environmental problem;
(4) provision of training or related education for teachers, faculty,
or related personnel in a specific geographic area or region; and
(5) design and demonstration of projects to foster international
cooperation in addressing environmental issues and problems involving
the United States and Canada or Mexico.
(c) Priority projects
In making grants pursuant to this section, the Administrator shall
give priority to those proposed projects which will develop --
(1) a new or significantly improved environmental education practice,
method, or technique;
(2) an environmental education practice, method, or technique which
may have wide application;
(3) an environmental education practice, method, or technique which
addresses a skill or scientific field identified as a priority in the
report developed pursuant to section 5508(d) of this title; and
(4) an environmental education practice, method, or technique which
addresses an environmental issue which, in the judgment of the
Administrator, is of a high priority.
(d) Scope of program and implementing regulations
The program established by this section shall include solicitations
for projects, selection of suitable projects from among those proposed,
supervision of such projects, evaluation of the results of projects, and
dissemination of information on the effectiveness and feasibility of the
practices, methods, techniques and processes. Within one year of
November 16, 1990, the Administrator shall publish regulations to assure
satisfactory implementation of each element of the program authorized by
this section.
(e) Solicitation notices
Within 90 days after the date on which amounts are first appropriated
for carrying out this chapter, and each year thereafter, the
Administrator shall publish a solicitation for environmental education
grants. The solicitation notice shall prescribe the information to be
included in the proposal and other information sufficient to permit the
Administrator to assess the project.
(f) Applications
Any local education agency, college or university, State education
agency or environmental agency, not-for-profit organization, or
noncommercial educational broadcasting entity may submit an application
to the Administrator in response to the solicitations required by
subsection (e) of this section.
(g) Performance of projects
Each project under this section shall be performed by the applicant,
or by a person satisfactory to the applicant and the Administrator.
(h) Matching requirements
Federal funds for any demonstration project under this section shall
not exceed 75 percent of the total cost of such project. For the
purposes of this section, the non-Federal share of project costs may be
provided by inkind contributions and other noncash support. In cases
where the Administrator determines that a proposed project merits
support and cannot be undertaken without a higher rate of Federal
support, the Administrator may approve grants under this section with a
matching requirement other than that specified in this subsection,
including full Federal funding.
(i) Limitations on grants
Grants under this section shall not exceed $250,000. In addition, 25
percent of all funds obligated under this section in a fiscal year shall
be for grants of not more than $5,000.
(Pub. L. 101-619, 6, Nov. 16, 1990, 104 Stat. 3330.)
20 USC 5506. Environmental internships and fellowships
TITLE 20 -- EDUCATION
(a) Postsecondary students and in-service teachers
The Administrator shall, in consultation with the Office of Personnel
Management and other appropriate Federal agencies, provide for
internships by postsecondary level students and fellowships for
in-service teachers with agencies of the Federal Government.
(b) Purpose
The purpose of internships and fellowships pursuant to this section
shall be to provide college level students and in-service teachers with
an opportunity to work with professional staff of Federal agencies
involved in environmental issues and thereby gain an understanding and
appreciation of such issues and the skills and abilities appropriate to
such professions.
(c) Minimum number of internships and fellowships
The Administrator shall, to the extent practicable, support not less
than 250 internships each year and not less than 50 fellowships each
year.
(d) Management of programs; eligible agencies
The internship and fellowship programs shall be managed by the Office
of Environmental Education. Interns and fellows may serve in
appropriate agencies of the Federal Government including, but not
limited to, the Environmental Protection Agency, the Fish and Wildlife
Service, the National Oceanic and Atmospheric Administration, the
Council on Environmental Quality, Federal natural resource management
agencies, the Department of Agriculture, and the National Science
Foundation.
(e) Length of internships and fellowships; funding
Interns shall be hired on a temporary, full-time basis for not to
exceed 6 months and shall be compensated appropriately. Fellows shall
be hired on a temporary full-time basis for not to exceed 12 months and
shall be compensated appropriately. Federal agencies hiring interns
shall provide the funds necessary to support salaries and related costs.
(f) Eligible individuals
(1) Individuals eligible for participation in the internship program
are students enrolled at accredited colleges or universities who have
successfully completed not less than four courses or the equivalent in
environmental sciences or studies, as determined by the Administrator.
(2) Individuals eligible for participation in the fellowship program
are in-service teachers who are currently employed by a local education
agency and have not less than 2 years experience in teaching
environmental education, environmental sciences, or related courses.
(g) Applications
Individuals shall be selected for internships and fellowships based
on applications which shall be in such form as the Administrator
considers appropriate.
(h) Geographic, cultural, and minority representation
In selecting individuals for internships and fellowships, the
Administrator shall provide for wide geographic, cultural, and minority
representation.
(Pub. L. 101-619, 7, Nov. 16, 1990, 104 Stat. 3331.)
20 USC 5507. Environmental education awards
TITLE 20 -- EDUCATION
(a) National awards
The Administrator shall provide for a series of national awards
recognizing outstanding contributions to environmental education.
(b) Required awards
In addition to such other awards as the Administrator may provide
for, national environmental awards shall include --
(1) The ''Theodore Roosevelt Award'' to be given in recognition of an
outstanding career in environmental education, teaching, or
administration;
(2) The ''Henry David Thoreau Award'' to be given in recognition of
an outstanding contribution to literature on the natural environment and
environmental pollution problems;
(3) The ''Rachael Carson Award'' to be given in recognition of an
outstanding contribution in print, film, or broadcast media to public
education and information on environmental issues or problems; and
(4) The ''Gifford Pinchot Award'' to be given in recognition of an
outstanding contribution to education and training concerning forestry
and natural resource management, including multiple use and sustained
yield land management.
(c) Nomination by Environmental Education Advisory Council
Recipients of education awards provided for in subsection (b) of this
section shall be nominated by the Environmental Education Advisory
Council provided for in section 5508 of this title.
(d) President's Environmental Youth Awards
The Administrator may provide for the ''President's Environmental
Youth Awards'' to be given to young people in grades kindergarten
through twelfth for an outstanding project to promote local
environmental awareness.
(e) Cash awards for elementary and secondary education teachers and
local educational agencies
(1) The Chairman of the Council on Environmental Quality, on behalf
of the President, is authorized to develop and administer an awards
program to recognize elementary and secondary education teachers and
their local educational agencies who demonstrate excellence in advancing
environmental education through innovative approaches. One teacher, and
the local education agency employing such teacher, from each State,
including the District of Columbia and the Commonwealth of Puerto Rico,
are eligible to be selected for an award pursuant to this subsection.
(2) The Chairman is authorized to provide a cash award of up to
$2,500 to each teacher selected to receive an award pursuant to this
section, which shall be used to further the recipient's professional
development in environmental education.
(3) The Chairman is also authorized to provide a cash award of up to
$2,500 to the local education agency employing any teacher selected to
receive an award pursuant to this section, which shall be used to fund
environmental educational activities and programs. Such awards may not
be used for construction costs, general expenses, salaries, bonuses, or
other administrative expenses.
(Pub. L. 101-619, 8, Nov. 16, 1990, 104 Stat. 3332.)
20 USC 5508. Environmental Education Advisory Council and Task Force
TITLE 20 -- EDUCATION
(a) Establishment
There is hereby established a National Environmental Education
Advisory Council and a Federal Task Force on Environmental Education.
(b) Advisory Council; duties; members; terms of office;
compensation; termination
(1) The Advisory Council shall advise, consult with, and make
recommendations to, the Administrator on matters relating to activities,
functions, and policies of the Agency under this chapter. With respect
to such matters, the Council shall be the exclusive advisory entity for
the Administrator. The Council may exchange information with other
Advisory Councils established by the Administrator. The Office of
Environmental Education shall provide staff support to the Council.
(2) The Advisory Council shall consist of 11 members appointed by the
Administrator after consultation with the Secretary. Two members shall
be appointed to represent primary and secondary education (one of whom
shall be a classroom teacher); two members shall be appointed to
represent colleges and universities; two members shall be appointed to
represent not-for-profit organizations involved in environmental
education; two members shall be appointed to represent State
departments of education and natural resources; two representatives
shall be appointed to represent business and industry; and one
representative shall be appointed to represent senior Americans. A
representative of the Secretary shall serve as an ex officio member of
the Advisory Council. The conflict of interest provision at section
208(a) of title 18 shall not apply to members' participation in
particular matters which affect the financial interests of employers
which they represent pursuant to this subsection.
(3) The Administrator shall provide that members of the Council
represent the various geographic regions of the country, has minority
representation, and that the professional backgrounds of the members
include scientific, policy, and other appropriate disciplines.
(4) Each member of the Advisory Council shall hold office for a term
of 3 years, except that --
(A) any member appointed to fill a vacancy occurring prior to the
expiration of the term for which his predecessor was appointed shall be
appointed for the remainder of such term; and
(B) the terms of the members first taking office shall expire as
follows: four shall expire 3 years after November 16, 1990, four shall
expire 2 years after November 16, 1990, and three shall expire 1 year
after November 16, 1990, as designated by the Administrator at the time
of appointment.
(5) Members of the Advisory Council appointed under this section
shall, while attending meetings of the Council or otherwise engaged in
business of the Council, receive compensation and allowances at a rate
to be fixed by the Administrator, but not exceeding the daily equivalent
of the annual rate of basic pay in effect for grade GS-18 of the General
Schedule for each day (including travel time) during which they are
engaged in the actual performance of duties vested in the Council.
While away from their homes or regular places of business in the
performance of services for the Council, members of the Council shall be
allowed travel expenses, including per diem in lieu of subsistence, in
the same manner as persons employed intermittently in the Government
service are allowed expenses under section 5703(b) /1/ of title 5.
(6) Section 14(a) of the Federal Advisory Committee Act relating to
termination, shall not apply to the Advisory Council.
(c) Federal Task Force on Environmental Education; duties; members
(1) The Federal Task Force on Environmental Education shall advise,
consult with and make recommendations to the Administrator on matters
relating to implementation of this chapter and assure the coordination
of such implementation activities with related activities of other
Federal agencies.
(2) Membership of the Task Force shall include the --
(A) Department of Education,
(B) Department of the Interior,
(C) Department of Agriculture,
(D) the Environmental Protection Agency,
(E) National Oceanic and Atmospheric Administration,
(F) Council on Environmental Quality,
(G) Tennessee Valley Authority, and
(H) National Science Foundation.
(3) The Environmental Protection Agency shall chair the Task Force.
(4) The Administrator may ask other Federal agencies to participate
in the meetings and activities of the Task Force where the Administrator
finds it appropriate in carrying out the requirements of this chapter.
(d) Reports
(1) The Advisory Council shall, after providing for public review and
comment, submit to the Congress, within 24 months of November 16, 1990,
and biennially thereafter, a report which shall --
(A) describe and assess the extent and quality of environmental
education in the Nation;
(B) provide a general description of the activities conducted
pursuant to this chapter and related authorities over the previous
2-year period;
(C) summarize major obstacles to improving environmental education
(including environmental education programs relating to national parks
and wildlife refuges) and make recommendations for addressing such
obstacles;
(D) identify personnel skills, education, and training needed to
respond to current and anticipated environmental problems and make
recommendations for actions to assure sufficient educational and
training opportunities in these professions; and
(E) describe and assess the extent and quality of environmental
education programs available to senior Americans and make
recommendations thereon; describe the various Federal agency programs
to further senior environmental education; and evaluate and make
recommendations as to how such educational apparatuses could best be
coordinated with nonprofit senior organizations across the Nation, and
environmental education institutions and organizations now in existence.
(2) The Federal Task Force on Environmental Education shall review
and comment on a draft of the report to Congress.
(Pub. L. 101-619, 9, Nov. 16, 1990, 104 Stat. 3333.)
Section 5703 of title 5, referred to in subsec. (b)(5), was amended
generally by Pub. L. 94-22, May 19, 1975, 4, 89 Stat. 85, and, as so
amended, does not contain a subsec. (b).
The Federal Advisory Committee Act, referred to in subsec. (b)(6), is
Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is set
out in the Appendix to Title 5, Government Organization and Employees.
References in laws to the rates of pay for GS-16, 17, or 18, or to
maximum rates of pay under the General Schedule, to be considered
references to rates payable under specified sections of Title 5,
Government Organization and Employees, see section 529 (title I, 101(
c)(1)) of Pub. L. 101-509, set out in a note under section 5376 of
Title 5.
/1/ See References in Text note below.
20 USC 5509. National Environmental Education and Training Foundation
TITLE 20 -- EDUCATION
(a) Establishment and purposes
(1) Establishment
(A) There is hereby established the National Environmental Education
and Training Foundation. The Foundation is established in order to
extend the contribution of environmental education and training to
meeting critical environmental protection needs, both in this country
and internationally; to facilitate the cooperation, coordination, and
contribution of public and private resources to create an
environmentally advanced educational system; and to foster an open and
effective partnership among Federal, State, and local government,
business, industry, academic institutions, community based environmental
groups, and international organizations.
(B) The Foundation is a charitable and nonprofit corporation whose
income is exempt from tax, and donations to which are tax deductible to
the same extent as those organizations listed pursuant to section 501(
c) of title 26. The Foundation is not an agency or establishment of the
United States.
(2) Purposes
The purposes of the Foundation are --
(A) subject to the limitation contained in the final sentence of
subsection (d) of this section, to encourage, accept, leverage, and
administer private gifts for the benefit of, or in connection with, the
environmental education and training activities and services of the
United States Environmental Protection Agency;
(B) to conduct such other environmental education activities as will
further the development of an environmentally conscious and responsible
public, a well-trained and environmentally literate workforce, and an
environmentally advanced educational system;
(C) to participate with foreign entities and individuals in the
conduct and coordination of activities that will further opportunities
for environmental education and training to address environmental issues
and problems involving the United States and Canada or Mexico.
(3) Programs
The Foundation will develop, support, and/or operate programs and
projects to educate and train educational and environmental
professionals, and to assist them in the development and delivery of
environmental education and training programs and studies.
(b) Board of Directors
(1) Establishment and membership
(A) The Foundation shall have a governing Board of Directors
(hereafter referred to in this section as ''the Board''), which shall
consist of 13 directors, each of whom shall be knowledgeable or
experienced in the environment, education and/or training. The Board
shall oversee the activities of the Foundation and shall assure that the
activities of the Foundation are consistent with the environmental and
education goals and policies of the Environmental Protection Agency and
with the intents and purposes of this chapter. The membership of the
Board, to the extent practicable, shall represent diverse points of view
relating to environmental education and training.
(B) The Administrator of the Environmental Protection Agency shall,
pursuant to paragraph (2), appoint the Director of the Office of
Environmental Education established pursuant to section 5502 of this
title as an ex-officio member of the Board. Ex officio membership shall
also be offered to other Federal agencies or departments with an
interest and/or experience in environmental education and training.
(C) Appointment to the Board shall not constitute employment by, or
the holding of an office of, the United States for the purposes of any
Federal law.
(2) Appointment and terms
(A) Members of the Board shall be appointed by the Administrator of
the Environmental Protection Agency.
(B) Within 90 days of November 16, 1990, and as appropriate
thereafter, the Administrator shall publish in the Federal Register an
announcement of appointments of Directors of the Board. At the same
time, the Administrator shall transmit a copy of such announcement to
the Education and Labor Committee and the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Environment and Public Works of the United States Senate. Such
appointments shall become final and effective 90 days after publication
in the Federal Register.
(C) The directors shall be appointed for terms of 4 years, except
that the Administrator, in making the initial appointments to the Board,
shall appoint 5 directors to a term of 2 years, 4 directors to a term of
3 years, and 4 directors to a term of 4 years. The Administrator shall
appoint an individual to serve as a director in the event of a vacancy
on the Board within 60 days of said vacancy in the manner in which the
original appointment was made. No individual may serve more than 2
consecutive terms as a director.
(3) Chair
The Chair shall be elected by the Board from its members for a 2-year
term.
(4) Quorum
A majority of the current membership of the Board shall constitute a
quorum for the transaction of business.
(5) Meetings
The Board shall meet at the call of the Chair at least twice a year.
If a Director misses three consecutive regularly scheduled meetings,
that individual may be removed from the Board and that vacancy filled in
accordance with this subsection.
(6) Reimbursement of expenses
Members of the Board shall serve without pay, but may be reimbursed
for the actual and necessary traveling and subsistence expenses incurred
by them in the performance of the duties of the Foundation.
(7) General powers
(A) The Board may complete the organization of the Foundation by --
(i) appointing officers and employees;
(ii) adopting a constitution and bylaws consistent with the purposes
of the Foundation and the provisions of this section; and
(iii) undertaking such other acts as may be necessary to carry out
the provisions of this section.
(B) The following limitations apply with respect to the appointment
of officers and employees of the Foundation:
(i) Officers and employees may not be appointed until the Foundation
has sufficient funds to pay for their service. Officers and employees
of the Foundation shall be appointed without regard to the provisions of
title 5 governing appointments in the competitive service, and may be
paid without regard to the provisions of chapter 51 or subchapter III of
chapter 53 of title 5 relating to classification and General Schedule
pay rates, except that no individual so appointed may receive pay in
excess of the annual rate of basic pay in effect for grade GS-18 of the
General Schedule.
(ii) The first officer or employee appointed by the Board shall be
the Executive Director of the Foundation who --
(I) shall serve, at the direction of the Board, as the Secretary of
the Board and the Foundation's chief executive officer; and
(II) shall be experienced in matters relating to environmental
education and training.
(c) Rights and obligations of Foundation
(1) In general
The Foundation --
(A) shall have perpetual succession;
(B) may conduct business throughout the several States, territories,
and possessions of the United States and abroad;
(C) shall have its principal offices in the District of Columbia or
in the greater metropolitan area; and
(D) shall at all times maintain a designated agent authorized to
accept service of process for the Foundation.
The service of notice to, or service of notice upon, the agent
required under paragraph (4), or mailed to the business address of such
agent, shall be deemed as service upon or notice to the Foundation.
(2) Seal
The Foundation shall have an official seal selected by the Board
which shall be judicially noticed.
(3) Powers
To carry out its purposes under subsection (a) of this section, the
Foundation shall have, in addition to the powers otherwise given it
under this section, the usual powers of a corporation acting as a
trustee, including the power --
(A) to accept, receive, solicit, hold, administer, and use any gift,
devise, or bequest, either absolutely or in trust, of real or personal
property or any income therefrom or other interest therein;
(B) to acquire by purchase or exchange any real or personal property
or interest therein;
(C) unless otherwise required by the instrument of transfer, to sell,
donate, lease, invest, reinvest, retain, or otherwise dispose of any
property or income therefrom;
(D) to sue, or to be sued, and complain or defend itself in any court
of competent jurisdiction, except that the Directors of the Board shall
not be personally liable, except for gross negligence;
(E) to enter into contracts or other arrangements with public
agencies and private organizations and persons and to make such payments
as may be necessary to carry out its functions; and
(F) to do any and all acts necessary and proper to carry out the
purposes of the Foundation.
(d) Conditions on donations
(1) For the purposes of this section, a gift, devise, or bequest may
be accepted by the Foundation even though it is encumbered, restricted,
or subject to beneficial interests of private persons if any current
future interest therein is for the benefit of the Foundation.
(2) No donation, gift, devise, bequest, property (either real or
personal), voluntary services, or any other thing of value may be
accepted by the Foundation if it --
(A) is contingent upon the transmission by the Foundation of
materials or information prepared by the donor or a third party in such
a fashion as to convey a particular point of view favorable to the
economic interests of the donor or its constituents or associates; or
(B) in the judgment of the Board carries with it an explicit or
implied requirement on the part of the Foundation to do a specific act
or make general representations which are to the benefit of the donor
and which are not consistent with the environmental and education goals
and policies of the Environmental Protection Agency and with the intents
and purposes of this chapter.
(3) No materials bearing ''logos'', letterhead or other means of
identification associated with a donor or third party may be transmitted
by the Foundation, for use in environmental education and training
except as required pursuant to subsection (f) of this section.
(e) Administrative services and support
Subject to the requirements of this subsection, the Administrator may
provide personnel, facilities, and other administrative services to the
Foundation, including reimbursement of expenses under subsection (b)(6)
of this section, not to exceed then current Federal Government per diem
rates, for a period of up to 4 years from November 16, 1990, and may
accept reimbursement therefor, to be deposited in the Treasury to the
credit of the appropriations then current and chargeable for the costs
of providing such services. With respect to personnel, the
Administrator may provide no more than 1 full-time employee to serve the
Foundation in a policy capacity, and may provide clerical and other
support staff at a level equivalent to 2 full-time equivalent employees
to the Foundation, for a period not to exceed 2 years from the date of
initial assignment of any personnel for this purpose.
(f) Report
The Foundation shall, as soon as practicable after the end of each
fiscal year, transmit to Congress a report of its proceedings and
activities during the year, including a full and complete statement of
its receipts, expenditures, and investments.
(g) Volunteer status
The Administrator may accept, without regard to the civil service
classification laws, rules, or regulations, the services of the
Foundation, the Board, and the officers and employees of the Board,
without compensation from the Environmental Protection Agency, as
volunteers in the performance of the functions authorized herein, in the
manner provided for under this section.
(h) Audits and petition of Attorney General for equitable relief
For purposes of the Act entitled ''An Act for audit of accounts of
private corporations established under Federal law'', approved August
30, 1964 (Public Law 88-504; 36 U.S.C. 1101-1103), the Foundation shall
be treated as a private corporation established under Federal law.
(i) United States release from liability
The United States shall not be liable for any debts, defaults, acts,
or omissions of the Foundation nor shall the full faith and credit of
the United States extend to any obligation of the Foundation.
(j) Amendment and repeal
The Congress expressly reserves the right to repeal or amend this
section at any time.
(Pub. L. 101-619, 10, Nov. 16, 1990, 104 Stat. 3335.)
The provisions of title 5 governing appointments in the competitive
service, referred to in subsec. (b)(7)(B)(i), are classified generally
to section 3301 et seq. of Title 5, Government Organization and
Employees.
The civil service classification laws, referred to in subsec. (g),
probably should refer to civil service and classification laws. The
civil service laws are set forth in Title 5. See, particularly, section
3301 et seq. of Title 5. The classification laws are set forth in
chapter 51 and subchapter III of chapter 53 of Title 5.
The Act entitled ''An Act for audit of accounts of private
corporations established under Federal law'', approved August 30, 1964
(Public Law 88-504, 36 U.S.C. 1101-1103), referred to in subsec. (h),
is Pub. L. 88-504, Aug. 30, 1964, 78 Stat. 635, as amended, which is
classified principally to chapter 42 ( 1101 et seq.) of Title 36,
Patriotic Societies and Observances. For complete classification of
this Act to the Code, see Tables.
References in laws to the rates of pay for GS-16, 17, or 18, or to
maximum rates of pay under the General Schedule, to be considered
references to rates payable under specified sections of Title 5,
Government Organization and Employees, see section 529 (title I, 101(
c)(1)) of Pub. L. 101-509, set out in a note under section 5376 of
Title 5.
20 USC 5510. Authorization
TITLE 20 -- EDUCATION
(a) Authorization of appropriations
There is hereby authorized to be appropriated to the Environmental
Protection Agency to carry out this chapter not to exceed $12,000,000
for each fiscal year 1992 and 1993, not to exceed $13,000,000 for fiscal
year 1994, and not to exceed $14,000,000 for each fiscal year 1995 and
1996.
(b) Limitations
Of such sums appropriated in a fiscal year, 25 percent shall be
available for the activities of the Office of Environmental Education,
25 percent shall be available for the operation of the environmental
education and training program, 38 percent shall be available for
environmental education grants, 10 percent shall be available for
support of the National Environmental Education and Training Foundation,
and 2 percent shall be available to support awards pursuant to section
5507(e) of this title.
(c) Availability of funds to National Environmental Education and
Training Foundation
Funds appropriated pursuant to this section may be made available to
the National Environmental Education and Training Foundation to --
(1) match partially or wholly the amount or value of contributions
(whether in currency, services, or property) made to the Foundation by
private persons and State and local governments; and
(2) provide administrative services under section 5509(d) of this
title:
Provided, That the Administrator determines that such funds will be
used to carry out the statutory purposes of the Foundation in a manner
consistent with the goals, objectives and programs of this chapter.
(Pub. L. 101-619, 11, Nov. 16, 1990, 104 Stat. 3339.)
21 USC
TITLE 21 -- FOOD AND DRUGS
21 USC TITLE 21 -- FOOD AND DRUGS
TITLE 21 -- FOOD AND DRUGS
Chap. Sec.
1. Adulterated or Misbranded Foods or Drugs 1
2. Teas 41
3. Filled Milk 61
4. Animals, Meats, and Meat and Dairy Products 71
5. Viruses, Serums, Toxins, Antitoxins, and Analogous Products 151
5A. Bureau of Narcotics (Omitted) 161
6. Narcotic Drugs (Repealed or Transferred) 171
7. Practice of Pharmacy and Sale of Poisons in Consular Districts in
China 201
8. Narcotic Farms (Repealed) 221
9. Federal Food, Drug, and Cosmetic Act 301
10. Poultry and Poultry Products Inspection 451
11. Manufacture of Narcotic Drugs (Repealed) 501
12. Meat Inspection 601
13. Drug Abuse Prevention and Control 801
14. Alcohol and Drug Abuse Educational Programs and Activities
(Repealed) 1001
15. Egg Products Inspection 1031
16. Drug Abuse Prevention, Treatment, and Rehabilitation 1101
17. National Drug Enforcement Policy (Repealed) 1201
18. President's Media Commission on Alcohol and Drug Abuse
Prevention 1301
19. Pesticide Monitoring Improvements 1401
20. National Drug Control Program 1501
Biological products, regulation, see section 262 of Title 42, The
Public Health and Welfare.
Narcotics, instruction as to nature and effect of, see section 111 et
seq. of Title 20, Education.
Packers and Stockyards Act, see section 181 et seq. of Title 7,
Agriculture.
21 USC CHAPTER 1 -- ADULTERATED OR MISBRANDED FOODS OR DRUGS
TITLE 21 -- FOOD AND DRUGS
Sec.
1 to 15. Repealed or Transferred.
16. Introduction into, or sale in, State or Territory or District of
Columbia of dairy or food products falsely labeled or branded.
17. Penalty for sale or introduction of falsely labeled dairy or
food products; venue.
18. Suspension of importation of adulterated articles.
19. Repealed.
20. Apples in interstate commerce; standard grades.
21. Branding grades on barrels of apples.
22. Barrels misbranded.
23. Penalties.
24. Omitted.
25. Oleomargarine, butterine, or imitation butter or cheese
transported into a State subject to its police powers.
26. Omitted.
21 USC SUBCHAPTER I -- FEDERAL FOOD AND DRUGS ACT OF 1906
TITLE 21 -- FOOD AND DRUGS
21 USC 1 to 5. Repealed. June 25, 1938, ch. 675, 902(a), 52 Stat.
1059
TITLE 21 -- FOOD AND DRUGS
Section 1, act June 30, 1906, ch. 3915, 1, 34 Stat. 768, made it
unlawful to manufacture adulterated or misbranded foods or drugs in the
Territories or the District of Columbia and provided penalty for
violations. See sections 331 and 333 of this title.
Section 2, act June 30, 1906, ch. 3915, 2, 34 Stat. 768, prohibited
introduction, shipment, delivery or sale of adulterated or misbranded
foods or drugs in interstate or foreign commerce, provided penalty for
violations and exempted exports conforming to specifications of foreign
purchaser and not in conflict with laws of foreign country importing the
same. See sections 331, 333 and 381 of this title.
Section 3, acts June 30, 1906, ch. 3915, 3, 34 Stat. 768; Mar. 4,
1913, ch. 141, 1, 37 Stat. 736, authorized the Secretaries of the
Treasury, Agriculture and Commerce to make uniform rules and regulations
for enforcement of food and drug laws, including collection and
examination of specimens. See section 371 of this title.
Section 4, act June 30, 1906, ch. 3915, 12, 34 Stat. 772, provided
that act or omission of officer, agent, and so forth, of corporation,
shall be deemed act or omission of corporation.
Section 5, act June 30, 1906, ch. 3915, 12, 34 Stat. 772, defined
''territory'' and ''person''. See section 321 of this title and section
1 of Title 1, General Provisions.
Section 902(a) of act June 25, 1938, ch. 675, 52 Stat. 1059, which
repealed sections 1 to 5, 7 to 14, and 15 of this title, provided that
the repeal of those sections should take effect upon the effective date
of act June 25, 1938, which was to take effect twelve months after the
date of its enactment. Act June 23, 1939, ch. 242, 2(b), 53 Stat.
854, provided that: ''The provisions of such act of June 30, 1906, as
amended, to the extent that they impose, or authorize the imposition of,
any requirement imposed by section 403(k) of the Federal Food, Drug, and
Cosmetic Act (section 343(k) of this title), shall remain in force until
January 1, 1940.''
21 USC 6. Transferred
TITLE 21 -- FOOD AND DRUGS
Section, act Mar. 4, 1923, ch. 268, 42 Stat. 1500, was transferred
to section 321a of this title.
21 USC 7 to 14. Repealed. June 25, 1938, ch. 675, 902(a), 52 Stat.
1059
TITLE 21 -- FOOD AND DRUGS
Section 7, act June 30, 1906, ch. 3915, 6, 34 Stat. 769, defined
''drug'' and ''food''. See section 321 of this title.
Section 8, act June 30, 1906, ch. 3915, 7, 34 Stat. 769, deemed
drugs to be adulterated when sold having a difference from recognized
standards, except where there is an explanatory statement on or in
container, and when sold below professed standard; confectioneries,
when containing mineral substances, poisonous color or flavors, other
deleterious ingredients, liquors or narcotics; food, when concerned
with injurious mixtures, use of substitutes, abstraction of valuable
constituents, concealment of damage or inferiority, deleterious
ingredients, preservatives in shipment conditionally excepted, animal or
vegetable substances unfit for food and products of animals diseased or
having died otherwise than by slaughter. See sections 342 and 351 of
this title.
Section 9, act June 30, 1906, ch. 3915, 8, 34 Stat. 771, defined
''misbranded'' and provided for its application to drugs and food. See
sections 343 and 352 of this title.
Section 10, acts June 30, 1906, ch. 3915, 8, 34 Stat. 771; Aug.
23, 1912, ch. 352, 37 Stat. 416; Mar. 3, 1913, ch. 117, 37 Stat.
732; July 24, 1919, ch. 26, 41 Stat. 271; July 8, 1930, ch. 874, 46
Stat. 1019, deemed drugs to be misbranded when there is an imitation or
use of name of other article, when there is removal and substitution of
contents of package or failure to state on label quantity or proportion
of narcotics therein, and when there is a false statement of curative or
therapeutic effect; and food, when there is an imitation or use of name
of other article, when there is a false label or brand removal and
substitution of contents of package, or failure to state or label
quantity or proportion of narcotics therein, when the packages are not
marked with weight, with certain variations and exemptions permitted,
when there are false or misleading statements on package or label as to
ingredients or substances; and food, when mixtures or compounds under
distinctive names, the articles are labeled, branded as compounds,
imitations, or blends; construed the term ''blend'' and related to
disclosure of trade formulas of proprietary foods, and canned food. See
sections 321b, 341, 343 and 352 of this title.
Section 11, acts June 30, 1906, ch. 3915, 4, 34 Stat. 769; Jan.
18, 1927, ch. 39, 44 Stat. 1003, provided for examination of
specimens, notice of adulteration or misbranding, hearing, certification
of violations to United States district attorney and notice of judgment.
Section 12, act June 30, 1906, ch. 3915, 5, 34 Stat. 769, provided
for prosecution by district attorneys for enforcement of penalties.
Section 13, act June 30, 1906, ch. 3915, 9, 34 Stat. 771, provided
for a seller's guaranty as protection to dealer. See section 333 of
this title.
Section 14, act June 30, 1906, ch. 3915, 10, 34 Stat. 771, provided
for seizure of articles by libel for condemnation, at suit of and in
name of United States, in United States district court where found,
conforming to proceedings in admiralty, with right to trial by jury,
destruction or sale of adulterated or misbranded articles, bond and
payment of proceeds into Treasury of United States. See sections 332,
334 and 337 of this title.
For effective date of repeal, see section 902(a) of act June 25,
1938, set out as a note under sections 1 to 5 of this title.
21 USC 14a. Transferred
TITLE 21 -- FOOD AND DRUGS
Section, act June 30, 1906, ch. 3915, 10A, as added June 22, 1934,
ch. 712, 48 Stat. 1204, and amended Aug. 27, 1935, ch. 739, 49 Stat.
871, which related to the examination of sea food on request of the
packer, the marking of food with the results, fees, and penalties, was
transferred to section 372a of this title.
21 USC 15. Repealed. June 25, 1938, ch. 675, 902(a), 52 Stat. 1059
TITLE 21 -- FOOD AND DRUGS
Section, act June 30, 1906, ch. 3915, 11, 34 Stat. 772, provided
for examination of samples of imports, refusal of admission and delivery
to consignee, delivery to consignee pending examination and decision on
bond and charges for storage and lien therefor. See section 381 of this
title.
For effective date of repeal, see section 902(a) of act June 25,
1938, set out as a note under sections 1 to 5 of this title.
21 USC SUBCHAPTER II -- MISCELLANEOUS PROVISIONS
TITLE 21 -- FOOD AND DRUGS
21 USC 16. Introduction into, or sale in, State or Territory or
District of Columbia of dairy or food products falsely labeled or
branded
TITLE 21 -- FOOD AND DRUGS
No person or persons, company or corporation, shall introduce into
any State or Territory of the United States or the District of Columbia
from any other State or Territory of the United States or the District
of Columbia, or sell in the District of Columbia or in any Territory any
dairy or food products which shall be falsely labeled or branded as to
the State or Territory in which they are made, produced, or grown, or
cause or procure the same to be done by others.
(July 1, 1902, ch. 1357, 1, 32 Stat. 632.)
21 USC 17. Penalty for sale or introduction of falsely labeled dairy or
food products; venue
TITLE 21 -- FOOD AND DRUGS
If any person or persons violate the provisions of section 16 of this
title, either in person or through another, he shall be guilty of a
misdemeanor and shall be punished by a fine of not less than $500 nor
more than $2,000. The jurisdiction for the prosecution of said
misdemeanor shall be within the district of the United States court in
which it is committed.
(July 1, 1902, ch. 1357, 2, 32 Stat. 632.)
Continuance of section under rule 18, see note by Advisory Committee
under rule 18, Title 18, Appendix, Crimes and Criminal Procedure.
21 USC 18. Suspension of importation of adulterated articles
TITLE 21 -- FOOD AND DRUGS
Whenever the President is satisfied that there is good reason to
believe that any importation is being made, or is about to be made, into
the United States, from any foreign country, of any article used for
human food or drink that is adulterated to an extent dangerous to the
health or welfare of the people of the United States, or any of them, he
may issue his proclamation suspending the importation of such articles
from such country for such period of time as he may think necessary to
prevent such importation; and during such period it shall be unlawful
to import into the United States from the countries designated in the
proclamation of the President any of the articles the importation of
which is so suspended.
(Aug. 30, 1890, ch. 839, 4, 26 Stat. 415.)
21 USC 19. Repealed. May 29, 1928, ch. 901, 1(100), 45 Stat. 993
TITLE 21 -- FOOD AND DRUGS
Section, act May 23, 1908, ch. 192, 35 Stat. 261, related to report
to the Congress of expenditures in enforcing food and drug laws.
21 USC 20. Apples in interstate commerce; standard grades
TITLE 21 -- FOOD AND DRUGS
The standard grades for apples when packed in barrels which shall be
shipped or delivered for shipment in interstate or foreign commerce, or
which shall be sold or offered for sale within the District of Columbia
or the Territories of the United States shall be as follows: Apples of
one variety, which are well-grown specimens, hand picked, of good color
for the variety, normal shape, practically free from insect and fungous
injury, bruises, and other defects, except such as are necessarily
caused in the operation of packing, or apples of one variety which are
not more than 10 per centum below the foregoing specifications shall be
''Standard grade minimum size two and one-half inches'', if the minimum
size of the apples is two and one-half inches in transverse diameter;
''Standard grade minimum size two and one-fourth inches'', if the
minimum size of the apples is two and one-fourth inches in transverse
diameter; or ''Standard grade minimum size two inches'', if the minimum
size of the apples is two inches in transverse diameter.
(Aug. 3, 1912, ch. 273, 2, 37 Stat. 250.)
21 USC 21. Branding grades on barrels of apples
TITLE 21 -- FOOD AND DRUGS
The barrels in which apples are packed in accordance with the
provisions of sections 20 to 23 of this title may be branded in
accordance with the provisions of section 20 of this title.
(Aug. 3, 1912, ch. 273, 3, 37 Stat. 251.)
21 USC 22. Barrels misbranded
TITLE 21 -- FOOD AND DRUGS
Barrels packed with apples shall be deemed to be misbranded within
the meaning of sections 20 to 23 of this title --
First. If the barrel bears any statement, design, or device
indicating that the apples contained therein are ''Standard'' grade and
the apples when packed do not conform to the requirements prescribed by
section 20 of this title.
Second. If the barrel bears any statement, design, or device
indicating that the apples contained therein are ''Standard'' grade and
the barrel fails to bear also a statement of the name of the variety,
the name of the locality where grown, and the name of the packer or the
person by whose authority the apples were packed and the barrel marked.
(Aug. 3, 1912, ch. 273, 5, 37 Stat. 251.)
21 USC 23. Penalties
TITLE 21 -- FOOD AND DRUGS
Any person, firm or corporation, or association who shall knowingly
pack or cause to be packed apples in barrels or who shall knowingly sell
or offer for sale such barrels in violation of the provisions of
sections 20 to 23 of this title shall be liable to a penalty of $1 and
costs for each such barrel so sold or offered for sale, to be recovered
at the suit of the United States in any court of the United States
having jurisdiction.
(Aug. 3, 1912, ch. 273, 6, 37 Stat. 251.)
Section is also set out as section 233 of Title 15, Commerce and
Trade.
21 USC 24. Omitted
TITLE 21 -- FOOD AND DRUGS
Section, act Mar. 4, 1915, ch. 144, 38 Stat. 1102, related to
payment of the cost of inspection under a provision authorizing the
investigation of the character of chemical and physical tests applied to
American food products in foreign countries and the inspection of such
products before shipment to such countries at the request of the
shippers or owners. That provision was repeated in subsequent
appropriation acts but was omitted from the appropriation act of July
12, 1943, ch. 221, 57 Stat. 494, and from all subsequent appropriation
acts.
21 USC 25. Oleomargarine, butterine, or imitation butter or cheese
transported into a State subject to its police powers
TITLE 21 -- FOOD AND DRUGS
All articles known as oleomargarine, butterine, imitation, process,
renovated, or adulterated butter, or imitation cheese, or any substance
in the semblance of butter or cheese not the usual product of the dairy
and not made exclusively of pure and unadulterated milk or cream,
transported into any State or Territory or the District of Columbia, and
remaining therein for use, consumption, sale, or storage therein, shall,
upon the arrival within the limits of such State or Territory or the
District of Columbia, be subject to the operation and effect of the laws
of such State or Territory or the District of Columbia, enacted in the
exercise of its police powers to the same extent and in the same manner
as though such articles or substances had been produced in such State or
Territory or the District of Columbia, and shall not be exempt therefrom
by reason of being introduced therein in original packages or otherwise.
(May 9, 1902, ch. 784, 1, 32 Stat. 193.)
Colored oleomargarine, intrastate sales of, see section 347 et seq.
of this title.
21 USC 26. Omitted
TITLE 21 -- FOOD AND DRUGS
Section, which was from the appropriation acts of Jan. 18, 1927, ch.
39, 44 Stat. 984; May 16, 1928, ch. 572, 45 Stat. 548; Feb. 16,
1929, ch. 227, 45 Stat. 1198; May 27, 1930, ch. 341, 46 Stat. 424,
and subsequent Department of Agriculture Appropriation Acts to and
including act June 28, 1944, ch. 296, 4, 58 Stat. 461, and related to
inspection of food and other products, is covered by section 2256 of
Title 7, Agriculture.
21 USC CHAPTER 2 -- TEAS
TITLE 21 -- FOOD AND DRUGS
Sec.
41. Importation of tea inferior to standard.
42. Board of experts; appointment; term; vacancies;
compensation.
43. Standards of purity; duplicate samples at customhouses and for
importers and dealers.
44. Bonds of importers; examination; importations at ports having
no examiner.
45. Permit for delivery; retention of inferior grades;
reexamination; partial delivery.
46. Examiners; examination according to usages of trade.
46a. Deposit of fee before examination of tea.
47. United States Board of Tea Appeals; permit for delivery;
exportation or destruction of inferior grades.
48. Reexamination; findings by examiner; assistance of experts.
49. Reimporting rejected teas; forfeiture.
50. Regulations.
21 USC 41. Importation of tea inferior to standard
TITLE 21 -- FOOD AND DRUGS
It shall be unlawful for any person or persons or corporation to
import or bring into the United States any merchandise as tea which is
inferior in purity, quality, and fitness for consumption to the
standards provided in section 43 of this title, and the importation of
all such merchandise is prohibited, except as provided in the Harmonized
Tariff Schedule of the United States.
(Mar. 2, 1897, ch. 358, 1, 29 Stat. 604; May 16, 1908, ch. 170, 35
Stat. 163; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; May 24,
1962, Pub. L. 87-456, title III, 303(a), 76 Stat. 77; Aug. 23, 1988,
Pub. L. 100-418, title I, 1214(l), 102 Stat. 1158.)
The Harmonized Tariff Schedule of the United States, referred to in
text, is not set out in the Code. See Publication of Harmonized Tariff
Schedule note set out under section 1202 of Title 19, Customs Duties.
1988 -- Pub. L. 100-418 substituted ''Harmonized Tariff Schedule of
the United States'' for ''Tariff Schedules of the United States''.
1962 -- Pub. L. 87-456 inserted ''except as provided in the Tariff
Schedules of the United States'' at end of first sentence, and struck
out second sentence which related to the importation under bond of tea
inferior to standards, tea waste, tea siftings, or tea sweepings, under
regulations prescribed by the Secretary of the Treasury, for the sole
purpose of manufacturing theine, caffeine, or other chemical products
whereby the identity and character of the original material is entirely
destroyed or changed and that the bonds shall be subject to the approval
only of the collector of customs at the port of entry.
Amendment by Pub. L. 100-418 effective Jan. 1, 1989, and applicable
with respect to articles entered on or after such date, see section
1217(b)(1) of Pub. L. 100-418, set out as an Effective Date note under
section 3001 of Title 19, Customs Duties.
Amendment by Pub. L. 87-456 effective with respect to articles
entered, or withdrawn from warehouse, for consumption on or after Aug.
31, 1963, see section 501(a) of Pub. L. 87-456.
Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in
part that act Mar. 2, 1897, which is classified to sections 41 to 46,
and 47 to 50 of this title, may be cited as the ''Tea Importation Act''.
Secretary and Department of Health, Education, and Welfare
redesignated Secretary and Department of Health and Human Services by
Pub. L. 96-88, title V, 509(b), Oct. 17, 1979, 93 Stat. 695, which is
classified to section 3508(b) of Title 20, Education.
Functions of Federal Security Administrator transferred to Secretary
of Health, Education, and Welfare and all agencies of Federal Security
Agency transferred to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out in the Appendix to
Title 5, Government Organization and Employees. Federal Security Agency
and office of Administrator abolished by section 8 of Reorg. Plan No.
1 of 1953.
Food and Drug Administration in Department of Agriculture and its
functions, except those functions relating to administration of
Insecticide Act of 1910 and Naval Stores Act, transferred to Federal
Security Agency, to be administered under direction and supervision of
Federal Security Administrator, by Reorg. Plan No. IV of 1940, set out
in the Appendix to Title 5.
The powers and duties of Secretary of the Treasury under this section
were conferred upon Secretary of Agriculture by act May 31, 1920.
21 USC 42. Board of experts; appointment; term; vacancies;
compensation
TITLE 21 -- FOOD AND DRUGS
On or before February 15 of each year, the Secretary of Health and
Human Services shall appoint a board, to consist of seven members, each
of whom shall be an expert in teas, and who shall prepare and submit to
him standard samples of tea. The persons so appointed shall be at all
times subject to removal by the said Secretary, and shall serve for the
term of one year. Vacancies in the said board occurring by removal,
death, resignation, or any other cause shall be forthwith filled by the
Secretary of Health and Human Services by appointment, such appointee to
hold for the unexpired term. Said board shall appoint a presiding
officer, who shall be the medium of all communications to or from such
board. Each member of said board shall receive as compensation the sum
of $50 per annum, which, together with all necessary expenses while
engaged upon the duty herein provided, shall be paid by the Secretary.
(Mar. 2, 1897, ch. 358, 2, 29 Stat. 605; May 31, 1920, ch. 217, 41
Stat. 712; 1940 Reorg. Plan No. IV, 12, eff. June 30, 1940, 5 F.R.
2421, 54 Stat. 1237; July 12, 1943, ch. 221, title II, 57 Stat. 500;
1953 Reorg. Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat.
631; Oct. 17, 1979, Pub. L. 96-88, title V, 509(b), 93 Stat. 695.)
1943 -- Act July 12, 1943, provided that the Administrator should pay
the salaries and expenses of the board members.
''Secretary of Health and Human Services'' substituted in text for
''Secretary of Health, Education, and Welfare'' pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see Transfer of Functions note set out under section 41 of this
title.
21 USC 43. Standards of purity; duplicate samples at customhouses and
for importers and dealers
TITLE 21 -- FOOD AND DRUGS
The Secretary of Health and Human Services, upon the recommendation
of the board of experts provided in section 42 of this title, shall fix
and establish uniform standards of purity, quality, and fitness for
consumption of all kinds of teas imported into the United States, and
shall procure and deposit in the customhouses of the ports of New York,
Chicago, San Francisco, and such other ports as he may determine,
duplicate samples of such standards. Said Secretary shall procure a
sufficient number of other duplicate samples of such standards to supply
the importers and dealers in tea at all ports desiring the same at cost.
All teas, or merchandise described as tea, of inferior purity, quality,
and fitness for consumption to such standards shall be deemed within the
prohibition of section 41 of this title.
(Mar. 2, 1897, ch. 358, 3, 29 Stat. 605; May 31, 1920, ch. 217, 41
Stat. 712; 1940 Reorg. Plan No. IV, 12, eff. June 30, 1940, 5 F.R.
2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96-88, title V, 509(
b), 93 Stat. 695.)
''Secretary of Health and Human Services'' substituted in text for
''Secretary of Health, Education, and Welfare'' pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see Transfer of Functions note set out under section 41 of this
title.
21 USC 44. Bonds of importers; examination; importations at ports
having no examiner
TITLE 21 -- FOOD AND DRUGS
On making entry at the customhouse of all teas, or merchandise
described as tea, imported into the United States, the importer or
consignee shall give a bond to the collector of the port that such
merchandise shall not be removed from the warehouse until released by
the collector, after it shall have been duly examined with reference to
its purity, quality, and fitness for consumption. For the purpose of
such examination samples of each line in every invoice of tea shall be
submitted by the importer or consignee to the examiner, together with
the sworn statement of such importer or consignee that such samples
represent the true quality of each and every part of the invoice and
accord with the specifications therein contained; or in the discretion
of the Secretary of Health and Human Services, such samples shall be
obtained by the examiner and compared by him with the standards
established by this chapter. In cases where said tea, or merchandise
described as tea, is entered at ports where there is no qualified
examiner as provided in section 46 of this title, the consignee or
importer shall in the manner aforesaid furnish under oath a sample of
each line of tea to the collector or other revenue officer to whom is
committed the collection of duties, and said officer shall also draw or
cause to be drawn samples of each line in every invoice and shall
forward the same to a duly qualified examiner as provided in said
section. The bond required by this section shall also be conditioned
for the payment of all customhouse charges which may attach to such
merchandise prior to its being released or destroyed (as the case may
be) under the provisions of this chapter.
(Mar. 2, 1897, ch. 358, 4, 29 Stat. 605; May 31, 1920, ch. 217, 41
Stat. 712; 1940 Reorg. Plan No. IV, 12, eff. June 30, 1940, 5 F.R.
2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96-88, title V, 509(
b), 93 Stat. 695.)
''Secretary of Health and Human Services'' substituted in text for
''Secretary of Health, Education, and Welfare'' pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see Transfer of Functions note set out under section 41 of this
title.
All offices of collector of customs in Bureau of Customs of
Department of the Treasury ordered abolished, with such offices to be
terminated not later than Dec. 31, 1966, by Reorg. Plan No. 1 of
1965, eff. May 25, 1965, 30 F.R. 7035, 79 Stat. 1317, set out in the
Appendix to Title 5, Government Organization and Employees. All
functions of offices eliminated were already vested in Secretary of the
Treasury by Reorg. Plan No. 26 of 1950, eff. July 31, 1950, 15 F.R.
4935, 64 Stat. 1280, also set out in the Appendix to Title 5.
21 USC 45. Permit for delivery; retention of inferior grades;
reexamination; partial delivery
TITLE 21 -- FOOD AND DRUGS
If, after an examination as provided in section 44 of this title, the
tea is found by the examiner to be equal in purity, quality, and fitness
for consumption to the standards provided in sections 41 to 44 of this
title, and no reexamination shall be demanded by the collector as
provided in section 47 of this title, a permit shall at once be granted
to the importer or consignee declaring the tea free from the control of
the customs authorities; but if on examination such tea, or merchandise
described as tea, is found, in the opinion of the examiner, to be
inferior in purity, quality, and fitness for consumption to the said
standards the importer or consignee shall be immediately notified, and
the tea, or merchandise described as tea, shall not be released by the
customhouse, unless on a reexamination called for by the importer or
consignee the finding of the examiner shall be found to be erroneous.
Should a portion of the invoice be passed by the examiner, a permit
shall be granted for that portion and the remainder held for further
examination, as provided in said section 47.
(Mar. 2, 1897, ch. 358, 5, 29 Stat. 605.)
For abolition of the offices of collector of customs, see note set
out under section 44 of this title.
21 USC 46. Examiners; examination according to usages of trade
TITLE 21 -- FOOD AND DRUGS
The examination provided for by this chapter shall be made by a duly
qualified examiner at a port where standard samples are established, and
where the merchandise is entered at ports where there is no qualified
examiner, the examination shall be made at that one of said ports which
is nearest the port of entry, and that for this purpose samples of the
merchandise, obtained in the manner prescribed by section 44 of this
title, shall be forwarded to the proper port by the collector or chief
officer at the port of entry. In all cases of examination or
reexamination of teas, or merchandise described as tea, by examiners or
the United States Board of Tea Appeals under the provisions of this
chapter, the purity, quality, and fitness for consumption of the same
shall be tested according to the usages and customs of the tea trade,
including the testing of an infusion of the same in boiling water and,
if necessary, chemical analysis.
(Mar. 2, 1897, ch. 358, 7, 29 Stat. 606; May 31, 1920, ch. 217, 41
Stat. 712, 713.)
For abolition of the offices of collector of customs, see note set
out under section 44 of this title.
21 USC 46a. Deposit of fee before examination of tea
TITLE 21 -- FOOD AND DRUGS
On and after July 1, 1940, no tea, or merchandise described as tea,
shall be examined for importation into the United States, or released by
the Collector, under this chapter unless the importer or consignee of
such tea or merchandise, prior to such examination, has paid for deposit
into the Treasury of the United States as miscellaneous receipts, a fee
of 3.5 cents for each hundred weight or fraction thereof of such tea and
merchandise.
(June 27, 1940, ch. 437, title I, 54 Stat. 632; July 1, 1941, ch.
269, title II, 55 Stat. 478.)
Section was not enacted as part of act Mar. 2, 1897, ch. 358, 29
Stat. 604, which comprises this chapter.
1941 -- Act July 1, 1941, reenacted section without change.
For abolition of the offices of collector of customs, see note set
out under section 44 of this title.
21 USC 47. United States Board of Tea Appeals; permit for delivery;
exportation or destruction of inferior grades
TITLE 21 -- FOOD AND DRUGS
In case the collector, importer, or consignee shall protest against
the finding of the examiner, the matter in dispute shall be referred for
decision to the United States Board of Tea Appeals, to consist of three
employees of the Department of Health and Human Services, to be
designated by the Secretary of Health and Human Services. If such board
shall, after due examination, find the tea in question to be equal in
purity, quality, and fitness for consumption to the proper standards, a
permit shall be issued by the collector for its release and delivery to
the importer; but if upon such final reexamination by such board the
tea shall be found to be inferior in purity, quality, and fitness for
consumption to the said standards, the importer or consignee shall give
a bond, with security satisfactory to the collector, to export said tea,
or merchandise described as tea, out of the limits of the United States
within a period of six months after such final reexamination; and if
the same shall not have been exported within the time specified, the
collector, at the expiration of that time, shall cause the same to be
destroyed.
(Mar. 2, 1897, ch. 358, 6, 29 Stat. 606; May 31, 1920, ch. 217, 41
Stat. 712, 713; 1940 Reorg. Plan No. IV, 12, eff. June 30, 1940, 5 F.
R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11, 1953,
18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96-88, title V,
509(b), 93 Stat. 695.)
''Department of Health and Human Services'' substituted in text for
''Department of Health, Education, and Welfare'' and ''Secretary of
Health and Human Services'' substituted for ''Secretary of Health,
Education, and Welfare'' pursuant to section 509(b) of Pub. L. 96-88,
which is classified to section 3508(b) of Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
For abolition of the offices of the collector of customs, see note
set out under section 44 of this title.
21 USC 48. Reexamination; findings by examiner; assistance of experts
TITLE 21 -- FOOD AND DRUGS
In cases of reexamination of teas, or merchandise described as teas,
by the United States Board of Tea Appeals in pursuance of the provisions
of this chapter, samples of the tea, or merchandise described as tea, in
dispute, for transmission to such board for its decision, shall be put
up and sealed by the examiner in the presence of the importer or
consignee if he so desires, and transmitted to such board, together with
a copy of the finding of the examiner, setting forth the cause of
condemnation and the claim or ground of the protest of the importer
relating to the same, such samples, and the papers therewith, to be
distinguished by such mark that the same may be identified. The
decision of such board shall be in writing, signed by them, and
transmitted, together with the record and samples, within three days
after the rendition thereof, to the collector, who shall forthwith
furnish the examiner and the importer or consignee with a copy of said
decision or finding. The United States Board of Tea Appeals shall be
authorized to obtain the advice, when necessary, of persons skilled in
the examination of teas, who shall each receive for his services in any
particular case a compensation not exceeding $5.
(Mar. 2, 1897, ch. 358, 8, 29 Stat. 606; May 31, 1920, ch. 217, 41
Stat. 712.)
For abolition of the offices of the collector of customs, see note
set out under section 44 of this title.
21 USC 49. Reimporting rejected teas; forfeiture
TITLE 21 -- FOOD AND DRUGS
No imported teas which have been rejected by a customs examiner or by
the United States Board of Tea Appeals, and exported under the
provisions of this chapter, shall be reimported into the United States
under the penalty of forfeiture for a violation of this prohibition.
(Mar. 2, 1897, ch. 358, 9, 29 Stat. 606; May 31, 1920, ch. 217, 41
Stat. 712.)
21 USC 50. Regulations
TITLE 21 -- FOOD AND DRUGS
The Secretary of Health and Human Services shall have the power to
enforce the provisions of this chapter by appropriate regulations.
(Mar. 2, 1897, ch. 358, 10, 29 Stat. 607; May 31, 1920, ch. 217, 41
Stat. 712; 1940 Reorg. Plan No. IV, 12, eff. June 30, 1940, 5 F.R.
2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96-88, title V, 509(
b), 93 Stat. 695.)
''Secretary of Health and Human Services'' substituted in text for
''Secretary of Health, Education, and Welfare'' pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC CHAPTER 3 -- FILLED MILK
TITLE 21 -- FOOD AND DRUGS
Sec.
61. Definitions.
62. Manufacture, shipment, or delivery for shipment in interstate or
foreign commerce prohibited.
63. Penalties; acts of agents deemed acts of principals.
64. Regulations for enforcement.
By virtue of act June 25, 1938, ch. 675, 902(c), 52 Stat. 1059
(section 392(b) of this title), nothing contained in section 301 et seq.
of this title shall be construed as in any way affecting, modifying,
repealing, or superseding the provisions of sections 61 to 64 of this
title.
General provisions, see sections 401 to 404 of Title 7, Agriculture.
21 USC 61. Definitions
TITLE 21 -- FOOD AND DRUGS
Whenever used in this chapter --
(a) The term ''person'' includes an individual, partnership,
corporation, or association;
(b) The term ''interstate or foreign commerce'' means commerce (1)
between any State, Territory, or possession, or the District of
Columbia, and any place outside thereof; (2) between points within the
same State, Territory, or possession, or within the District of
Columbia, but through any place outside thereof; or (3) within any
Territory or possession, or within the District of Columbia; and
(c) The term ''filled milk'' means any milk, cream, or skimmed milk,
whether or not condensed, evaporated, concentrated, powdered, dried, or
desiccated, to which has been added, or which has been blended or
compounded with, any fat or oil other than milk fat, so that the
resulting product is in imitation or semblance of milk, cream, or
skimmed milk, whether or not condensed, evaporated, concentrated,
powdered, dried, or desiccated. This definition shall not include any
distinctive proprietary food compound not readily mistaken in taste for
milk or cream or for evaporated, condensed, or powdered milk, or cream
where such compound (1) is prepared and designed for feeding infants and
young children and customarily used on the order of a physician; (2) is
packed in individual cans containing not more than sixteen and one-half
ounces and bearing a label in bold type that the content is to be used
only for said purpose; (3) is shipped in interstate or foreign commerce
exclusively to physicians, wholesale and retail druggists, orphan
asylums, child-welfare associations, hospitals, and similar institutions
and generally disposed of by them.
(Mar. 4, 1923, ch. 262, 1, 42 Stat. 1486.)
Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in
part that act Mar. 4, 1923, which enacted this chapter, may be cited as
the ''Filled Milk Act''.
21 USC 62. Manufacture, shipment, or delivery for shipment in
interstate or foreign commerce prohibited
TITLE 21 -- FOOD AND DRUGS
It is declared that filled milk, as defined in section 61 of this
title, is an adulterated article of food, injurious to the public
health, and its sale constitutes a fraud upon the public. It shall be
unlawful for any person to manufacture within any Territory or
possession, or within the District of Columbia, or to ship or deliver
for shipment in interstate or foreign commerce, any filled milk.
(Mar. 4, 1923, ch. 262, 2, 42 Stat. 1487.)
21 USC 63. Penalties; acts of agents deemed acts of principals
TITLE 21 -- FOOD AND DRUGS
Any person violating any provision of this chapter shall upon
conviction thereof be subject to a fine of not more than $1,000 or
imprisonment of not more than one year, or both. When construing and
enforcing the provisions of this chapter, the act, omission, or failure
of any person acting for or employed by any individual, partnership,
corporation, or association, within the scope of his employment or
office, shall in every case be deemed the act, omission, or failure, of
such individual, partnership, corporation, or association, as well as of
such person.
(Mar. 4, 1923, ch. 262, 3, 42 Stat. 1487.)
The original text of this section contained a further provision that
no penalty should be enforced for any violation occurring within 30 days
after act Mar. 4, 1923 became law and was omitted as temporary and
obsolete.
21 USC 64. Regulations for enforcement
TITLE 21 -- FOOD AND DRUGS
The Secretary of Health and Human Services is authorized and directed
to make and enforce such regulations as may in his judgment be necessary
to carry out the purposes of this chapter.
(Mar. 4, 1923, ch. 262, 4, as added Aug. 27, 1935, ch. 743, 49 Stat.
885; 1940 Reorg. Plan No. IV, 12, eff. June 30, 1940, 5 F.R. 2421, 54
Stat. 1237; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R.
2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96-88, title V, 509(b), 93
Stat. 695.)
''Secretary of Health and Human Services'' substituted in text for
''Secretary of Health, Education, and Welfare'' pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC CHAPTER 4 -- ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
TITLE 21 -- FOOD AND DRUGS
Sec.
71 to 99. Transferred, Repealed, or Omitted.
101. Suspension of importation of all animals.
102. Quarantine of imported animals.
103. Importation, except at quarantine ports, prohibited; slaughter
of infected animals; appraisal; payment.
104. Importation of diseased animals prohibited; exception;
penalties.
105. Inspection of animals imported or intended for export.
106, 107. Omitted.
111. Regulations to prevent contagious diseases.
112. Investigations as to pleuropneumonia, and other diseases;
regulations.
112a. Omitted.
113. Measures to prevent exportation of diseased livestock and live
poultry.
113a. Establishment of research laboratories for foot-and-mouth
disease and other animal diseases; research contracts; employment of
technicians and scientists; appropriations.
114. Regulations for suppression of diseases; cooperation of States
and Territories.
114a. Control and eradication of diseases; cooperation of States
and farmers' associations; purchase and destruction of diseased
animals; ''State'' defined.
114a-1. Interstate movement of domestic animals reacting to tests
for brucellosis; immediate slaughter; rules and regulations.
114b. Cooperation in animal disease control.
114c. Use of funds.
114d. Sale of sterile screwworms.
(a) In general.
(b) Terms of sale.
(c) Deposit of proceeds.
114d-1. Cooperation with public and private entities.
114d-2 to 114d-6. Repealed.
114e. Control and eradication of cattle grubs; research and
investigations.
114f. ''State'' defined; authorization of appropriations.
114g. Hog cholera eradication program.
114h. Advisory committee.
(a) Establishment; membership.
(b) Functions.
(c) Employment status; expenses.
114i. Pseudorabies eradication.
(a) Findings.
(b) Establishment of program.
(c) Use of funds for testing and control of pseudorabies.
(d) Authorization of appropriations.
115. Transportation of diseased livestock and live poultry
prohibited.
116. Shipment of certain cattle excepted.
117. Penalties for transportation of diseased livestock or live
poultry.
(a) Criminal penalty.
(b) Civil penalty.
118. Duty of United States attorneys.
119. Agents to examine and report on methods of treatment of
animals, and means for suppression of diseases.
120. Regulation of exportation and transportation of infected
livestock and live poultry.
121. Shipments from areas suspected infected; control of animals
and live poultry.
122. Offenses; penalty.
123. Quarantine.
124. Transportation or delivery therefor from quarantined State or
Territory or portion thereof, of quarantined animals and live poultry,
forbidden.
125. Regulations for inspection, disinfection, and certification,
and delivery and shipment of quarantined animals and live poultry from
State or Territory.
126. Moving quarantined animals and live poultry from State or
Territory, under regulations.
127. Transportation from quarantined State, Territory, etc.;
penalty.
128. Extension of quarantine law to carriers in interstate commerce.
129. Expenses for arrest and eradication of contagious or infectious
diseases or pests of animals, poultry, or plants.
130. Pleuropneumonia in District of Columbia; duties of Council of
the District of Columbia.
131. Fences along international boundary lines to keep out diseased
animals.
132, 133. Transferred or Repealed.
134. Definitions.
134a. Seizure, quarantine, and disposal of livestock or poultry to
guard against introduction or dissemination of communicable disease.
(a) Authority of Secretary.
(b) Determination of extraordinary emergency due to dangerous
communicable disease; seizure, quarantine, and disposal of animals;
action authorized only if adequate measures not taken by State or other
jurisdiction; notice to State or other jurisdiction.
(c) Notice to owner to quarantine or to dispose of animal, carcass,
product, or article; action on failure to comply; costs.
(d) Compensation of owner; fair market value; payments from State
or other source; availability of funds.
(e) Restriction on payment of compensation in cases of violation of
law or regulation.
134b. Regulations for clean and sanitary movement of animals.
134c. Regulations for movement of animals affected or exposed to
communicable disease.
134d. Inspections and seizures; issuance of warrants.
134e. Enforcement provisions.
(a) Criminal and civil penalties.
(b) Injunctive proceedings.
134f. Promulgation of regulations.
134g. Authority in addition to other laws; repeal of inconsistent
provisions.
134h. Separability.
135. International animal quarantine station; establishment;
acceptance of gifts; cooperation with breeders' organizations;
collection of fees.
135a. Smuggling penalties.
(a) Criminal penalty.
(b) Civil penalty.
135b. Authorization of appropriations.
136. Additional inspection services.
136a. Collection of fees for inspection services.
(a) Quarantine, inspection and transportation fees.
(b) Omitted.
(c) Animal inspection and veterinary diagnostics.
(d) Regulations.
(e) Recovery of amounts owed.
(f) Definitions.
141. Prohibition of importation without permit.
142. Milk or cream when unfit for importation.
143. Inspection; certified statement in lieu thereof; waiver of
requirements of section 142; regulations; suspension and revocation of
permits.
144. Unlawful receiving of imported milk or cream.
145. Penalties.
146. Authorization of appropriations.
147. Repeal of inconsistent laws.
148. Powers of State with respect to milk or cream lawfully
imported.
149. Definitions.
21 USC SUBCHAPTER I -- EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
TITLE 21 -- FOOD AND DRUGS
21 USC 71 to 92. Transferred
TITLE 21 -- FOOD AND DRUGS
Section 71, act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, which
related to inspection of meat and meat food products, examination of
cattle before slaughtering, separate slaughtering of diseased animals
and examination of carcasses, was transferred to section 603 of this
title.
Section 72, act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, which
related to post mortem examination of carcasses, marking and labeling,
destruction of condemned carcasses, and reinspection, was transferred to
section 604 of this title.
Section 73, act Mar. 4, 1907, ch. 2907, 34 Stat. 1261, which
related to examination of carcasses brought into slaughtering or packing
establishments and of meat food products issued from and returned
thereto, was transferred to section 605 of this title.
Section 74, act Mar. 4, 1907, ch. 2907, 34 Stat. 1261, which
related to examination and inspection of meat food products, marks of
inspection, destruction of condemned products, and products for export,
was transferred to section 606 of this title.
Section 75, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
related to labeling of receptacles and coverings of meat and meat food
products inspected and passed, supervision by inspectors, prohibition of
sales under false names, was transferred to section 607 of this title.
Section 76, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
related to sanitary inspection and regulation of slaughtering and
packing establishments, and rejection of meat or meat food products
unfit for food, was transferred to section 608 of this title.
Section 77, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
related to examination of cattle and food products thereof slaughtered
and prepared during night time, was transferred to section 609 of this
title.
Section 78, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
related to prohibition of transportation of carcasses, meat, or meat
food products not properly inspected and marked, was transferred to
section 610 of this title.
Section 79, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to forgery, alteration, and unauthorized use of marks, labels,
and certificates, was transferred to section 611 of this title.
Section 80, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to inspection of animals for export, was transferred to section
612 of this title.
Section 81, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to certificates of condition of animals for export, was
transferred to section 613 of this title.
Section 82, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to clearance to vessels carrying cattle for export with proper
certificate of inspection, was transferred to section 614 of this title.
Section 83, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to inspection of carcasses, the meat of which is intended for
export, was transferred to section 615 of this title.
Section 84, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to certificates of condition of carcasses, the meat of which is
intended for export, was transferred to section 616 of this title.
Section 85, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to clearance to vessels carrying meat for export with proper
certificate of inspection, was transferred to section 617 of this title.
Section 86, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to official certificates of inspection and delivery of copies
thereof to different parties, was transferred to section 618 of this
title.
Section 87, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
related to prohibition of transportation or sale of meat or meat food
products without complying with provisions of inspection law, was
transferred to section 619 of this title.
Section 88, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
related to offenses and penalties, was transferred to section 620 of
this title.
Section 89, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
related to appointment of inspectors, their duties, and rule making
authority of the Secretary of Agriculture, was transferred to section
621 of this title.
Section 90, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
related to penalties for bribery, was transferred to section 622 of this
title.
Section 91, acts Mar. 4, 1907, ch. 2907, 34 Stat. 1265; June 29,
1938, ch. 810, 52 Stat. 1235, which related to definitions, exceptions
to inspection requirements in case of farmers and retailers, and
penalties for sale of meat and meat food products unfit for food, was
transferred to section 623 of this title.
Section 92, act Mar. 4, 1907, ch. 2907, 34 Stat. 1265, which was a
proviso following the first sentence of section 91 of this title, was
restored to that section and has been transferred to section 623 of this
title.
21 USC 93. Repealed. May 29, 1928, ch. 901, 1(92), 45 Stat. 993
TITLE 21 -- FOOD AND DRUGS
Section, act Mar. 4, 1907, ch. 2907, 34 Stat. 1265, related to
statement in annual estimates as to persons employed, their compensation
and expenses.
21 USC 94 to 95. Transferred
TITLE 21 -- FOOD AND DRUGS
Section 94, act June 30, 1914, ch. 131, 38 Stat. 420, which related
to inspection of reindeer, was transferred to section 692 of this title.
Section 94a, act May 23, 1908, ch. 192, 35 Stat. 254, which related
to inspection of dairy products for export, was transferred to section
693 of this title.
Section 95, acts June 30, 1906, ch. 3913, 34 Stat. 679; June 26,
1934, ch. 756, 2, 48 Stat. 1225, which related to authorization of
appropriations for expenses of inspection, was transferred to section
694 of this title.
21 USC 96. Repealed. Pub. L. 90-201, 18, Dec. 15, 1967, 81 Stat. 600
TITLE 21 -- FOOD AND DRUGS
Section, act July 24, 1919, ch. 26, 41 Stat. 241, provided for
marking horse meat transported in interstate commerce. See section 619
of this title.
Repeal effective Dec. 15, 1967, see section 20 of Pub. L. 90-201,
set out as an Effective Date note under section 601 of this title.
21 USC 97 to 97d. Omitted
TITLE 21 -- FOOD AND DRUGS
Sections 97 to 97d, act July 30, 1947, ch. 356, title I, 1, 61 Stat.
531, 532, set up a meat inspection fund and provided for payment for
meat inspection service by the persons or organizations who were
furnished such inspection on and after July 1, 1947. These provisions
ceased to be effective on July 1, 1948, under section 98 of this title
which requires the cost of such inspection to be borne by the United
States. The unobligated balance in the meat inspection fund was carried
to the general fund of the Treasury by act June 19, 1948, ch. 543, 1,
62 Stat. 515.
21 USC 98. Transferred
TITLE 21 -- FOOD AND DRUGS
Section, act June 5, 1948, ch. 423, 62 Stat. 344, which related to
payment of cost of meat inspection, was transferred to section 695 of
this title.
21 USC 99. Repealed. July 28, 1953, ch. 251, title I, 101, 67 Stat.
208
TITLE 21 -- FOOD AND DRUGS
Section, act Aug. 31, 1951, ch. 374, title I, 101, 65 Stat. 229,
related to reimbursement for excess expenses of meat inspection.
21 USC SUBCHAPTER II -- IMPORTATION OF CATTLE AND QUARANTINE
TITLE 21 -- FOOD AND DRUGS
21 USC 101. Suspension of importation of all animals
TITLE 21 -- FOOD AND DRUGS
Whenever, in the opinion of the President, it shall be necessary for
the protection of animals in the United States against infectious or
contagious diseases, he may, by proclamation, suspend the importation of
all or any class of animals for a limited time, and may change, modify,
revoke, or renew such proclamation, as the public good may require; and
during the time of such suspension the importation of any such animals
shall be unlawful.
(Aug. 30, 1890, ch. 839, 9, 26 Stat. 416.)
21 USC 102. Quarantine of imported animals
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture is authorized, at the expense of the
owner, to place and retain in quarantine all neat cattle, sheep, and
other ruminants, and all swine, imported into the United States, at such
ports as he may designate for such purpose, and under such conditions as
he may by regulation prescribe, respectively, for the several classes of
animals above described. For this purpose he may have and maintain
possession of all lands, buildings, animals, tools, fixtures, and
appurtenances in use on August 3, 1890, for the quarantine of neat
cattle, and purchase, construct, or rent as may be necessary, and he may
appoint veterinary surgeons, inspectors, officers, and employees by him
deemed necessary to maintain such quarantine, and provide for the
execution of the other provisions of this subchapter.
(Aug. 30, 1890, ch. 839, 7, 26 Stat. 416.)
This subchapter, referred to in text, was in the original ''this
Act'', meaning act Aug. 30, 1890, ch. 839, 26 Stat. 415, as amended,
which is classified to sections 18, and 101 to 105 of this title and
section 181 of Title 19, Customs Duties. For complete classification of
this Act to the Code, see Tables.
title; title 16 section 1540.
21 USC 103. Importation, except at quarantine ports, prohibited;
slaughter of infected animals; appraisal; payment
TITLE 21 -- FOOD AND DRUGS
The importation of all animals described in this subchapter into any
port in the United States, except such as may be designated by the
Secretary of Agriculture, with the approval of the Secretary of the
Treasury, as quarantine stations, is prohibited. The Secretary of
Agriculture may cause to be slaughtered such of the animals named in
this subchapter as may be, under regulations prescribed by him, adjudged
to be infected with any contagious disease, or to have been exposed to
infection so as to be dangerous to other animals. The value of animals
so slaughtered as being so exposed to infection but not infected may be
ascertained by agreement of the Secretary of Agriculture and the owners
thereof if practicable; otherwise, by the appraisal by two persons
familiar with the character and value of such property, to be appointed
by the Secretary of Agriculture, whose decision, if they agree, shall be
final; otherwise, the Secretary of Agriculture shall decide between
them, and his decision shall be final. The amount of the value thus
ascertained shall be paid to the owner thereof out of money in the
Treasury appropriated for the use of the Bureau of Animal Industry; but
no payment shall be made for any animal imported in violation of the
provisions of this subchapter. If any animal subject to quarantine
according to the provisions of this subchapter are brought into any port
of the United States where no quarantine station is established, the
collector of such port shall require the same to be conveyed, by the
vessel on which they are imported or are found to the nearest quarantine
station, at the expense of the owner.
(Aug. 30, 1890, ch. 839, 8, 26 Stat. 416.)
This subchapter, referred to in text, was in the original ''this
Act'', meaning act Aug. 30, 1890, ch. 839, 26 Stat. 415, as amended,
which is classified to sections 18, and 101 to 105 of this title and
section 181 of Title 19, Customs Duties. For complete classification of
this Act to the Code, see Tables.
Functions of Bureau of Animal Industry transferred to Secretary of
Agriculture by Reorg. Plan No. 1 of 1947, 301, eff. July 1, 1947, 12
F.R. 4534, 61 Stat. 952, set out in the Appendix to Title 5, Government
Organization and Employees.
For abolition of the offices of collector of customs, see note set
out under section 44 of this title.
21 USC 104. Importation of diseased animals prohibited; exception;
penalties
TITLE 21 -- FOOD AND DRUGS
The importation of cattle, sheep, and other ruminants, and swine,
which are diseased or infected with any disease, or which shall have
been exposed to such infection within sixty days next before their
exportation, is prohibited: Provided, That the Secretary of
Agriculture, within his discretion and under such regulations as he may
prescribe, is authorized to permit the admission from Mexico into the
State of Texas of cattle which have been infested with or exposed to
ticks upon being freed therefrom, and the admission from the British
Virgin Islands into the Virgin Islands of the United States, for
slaughter only, of cattle which have been infested with or exposed to
ticks upon being freed therefrom. Any person who knowingly violates any
provision of this section or sections 101, 102, 103, or 105 of this
title or any regulation prescribed by the Secretary of Agriculture under
any such section shall be guilty of a misdemeanor and shall, on
conviction, be punished by a fine not exceeding $5,000, by imprisonment
not exceeding one year, or both. Any person who violates any such
provision or any such regulation may be assessed a civil penalty by the
Secretary of Agriculture not exceeding $1,000. The Secretary may issue
an order assessing such civil penalty only after notice and an
opportunity for an agency hearing on the record. Such order shall be
treated as a final order reviewable under chapter 158 of title 28. The
validity of such order may not be reviewed in an action to collect such
civil penalty.
(Aug. 30, 1890, ch. 839, 6, 26 Stat. 416; June 28, 1926, ch. 700, 2,
44 Stat. 775; Feb. 28, 1931, ch. 348, 46 Stat. 1460; July 22, 1954,
ch. 558, 32, 68 Stat. 510; Jan. 28, 1956, ch. 12, 1, 70 Stat. 5; Jan.
12, 1983, Pub. L. 97-461, 4, 96 Stat. 2524.)
1983 -- Pub. L. 97-461 substituted reference to violation of this
section or sections 101, 102, 103, or 105 of this title or any
regulation prescribed by the Secretary of Agriculture under any such
section, for reference to violation of the foregoing provisions,
substituted imprisonment not exceeding one year for imprisonment not
exceeding three years, inserted provisions relating to civil penalties,
and struck out provision for forfeiture of any vessel used for such
importation if the master or owner knew the importation was diseased or
had been exposed to infection.
1956 -- Act Jan. 28, 1956, struck out ''and the admission into the
Virgin Islands'' in proviso and limited importation of cattle into
Virgin Islands of the United States to cattle from the British Virgin
Islands intended for slaughter.
1954 -- Act July 22, 1954, inserted ''and the admission into the
Virgin Islands'' in proviso.
1931 -- Act Feb. 28, 1931, struck out ''meat'' and substituted
''before their exportation'' for ''before their importation'' in
provisions relating to the prohibition of importation of diseased or
infected animals.
For effective date of amendment by act July 22, 1954, see section 34
of act July 22, 1954, set out as an Effective Date note under section
1541 of Title 48, Territories and Insular Possessions.
Cattle, sheep, swine and meats; importation prohibited in certain
cases, see section 1306 of Title 19, Customs Duties.
21 USC 105. Inspection of animals imported or intended for export
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture shall cause careful inspection to be
made by a suitable officer of all imported animals described in this
subchapter, to ascertain whether such animals are infected with
contagious diseases or have been exposed to infection so as to be
dangerous to other animals, which shall then either be placed in
quarantine or dealt with according to the regulations of the Secretary
of Agriculture. All food, litter, manure, clothing, utensils, and other
appliances that have been so related to such animals on board ship as to
be judged liable to convey infection shall be dealt with according to
the regulations of the Secretary of Agriculture. The Secretary of
Agriculture may cause inspection to be made of all animals described in
this subchapter intended for exportation, and provide for the
disinfection of all vessels engaged in the transportation thereof, and
of all barges or other vessels used in the conveyance of such animals
intended for export to the ocean steamer or other vessels, and of all
attendants and their clothing, and of all headropes and other appliances
used in such exportation, by such orders and regulations as he may
prescribe; and if, upon such inspection, any such animals shall be
adjudged, under the regulations of the Secretary of Agriculture, to be
infected or to have been exposed to infection so as to be dangerous to
other animals, they shall not be allowed to be placed upon any vessel
for exportation; the expense of all the inspection and disinfection
provided for in this section to be borne by the owners of the vessels on
which such animals are exported.
(Aug. 30, 1890, ch. 839, 10, 26 Stat. 417.)
This subchapter, referred to in text, was in the original ''this
Act'', meaning act Aug. 30, 1890, ch. 839, 26 Stat. 415, as amended,
which is classified to sections 18, and 101 to 105 of this title and
section 181 of Title 19, Customs Duties. For complete classification of
this Act to the Code, see Tables.
Inspection of animals for export, see section 612 et seq. of this
title.
21 USC 106, 107. Omitted
TITLE 21 -- FOOD AND DRUGS
Sections, acts Aug. 10, 1917, ch. 52, 9, 40 Stat. 275; Nov. 21,
1918, ch. 212, 3, 40 Stat. 1048, related to slaughter of tick-infested
cattle. Section 12 of act Aug. 10, 1917, provided that the act should
cease to be in effect when the national emergency resulting from World
War I had passed.
21 USC SUBCHAPTER III -- PREVENTION OF INTRODUCTION AND SPREAD OF
CONTAGION
TITLE 21 -- FOOD AND DRUGS
21 USC 111. Regulations to prevent contagious diseases
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture shall have authority to make such
regulations and take such measures as he may deem proper to prevent the
introduction or dissemination of the contagion of any contagious,
infectious, or communicable disease of animals and/or live poultry from
a foreign country into the United States or from one State or Territory
of the United States or the District of Columbia to another, and to
seize, quarantine, and dispose of any hay, straw, forage, or similar
material, or any meats, hides, or other animal products coming from an
infected foreign country to the United States, or from one State or
Territory or the District of Columbia in transit to another State or
Territory or the District of Columbia whenever in his judgment such
action is advisable in order to guard against the introduction or spread
of such contagion.
(Feb. 2, 1903, ch. 349, 2, 32 Stat. 792; Feb. 7, 1928, ch. 30, 45
Stat. 59; July 22, 1954, ch. 558, 33, 68 Stat. 510; Jan. 28, 1956, ch.
12, 2, 70 Stat. 5.)
1956 -- Act Jan. 28, 1956, struck out proviso ''that no such
regulations or measures shall pertain to the introduction of live
poultry into the Virgin Islands of the United States''.
1954 -- Act July 22, 1954, inserted proviso containing an exception
with respect to admission of live poultry into the Virgin Islands.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry''.
For effective date of amendment by act July 22, 1954, see section 34
of act July 22, 1954, set out as an Effective Date note under section
1541 of Title 48, Territories and Insular Possessions.
21 USC 112. Investigations as to pleuropneumonia, and other diseases;
regulations
TITLE 21 -- FOOD AND DRUGS
In order to promote the exportation of livestock and/or live poultry
from the United States the Secretary of Agriculture shall make special
investigation as to the existence of pleuropneumonia, or any contagious,
infectious, or communicable disease, along the dividing lines between
the United States and foreign countries, and along the lines of
transportation from all parts of the United States to ports from which
livestock and/or live poultry are exported, and shall, from time to
time, establish such regulations concerning the exportation and
transportation of livestock and/or live poultry as the results of said
investigations may require.
(May 29, 1884, ch. 60, 4, 23 Stat. 32; Feb. 2, 1903, ch. 349, 1, 32
Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59.)
Originally this section and sections 113, 114, 117, 119, 120, and 130
of this title read ''Commissioner'' instead of ''Secretary'' of
Agriculture, and this section contained between the words ''and'' and
''shall,'' the additional words ''make report of the results of such
investigation to the Secretary of the Treasury, who''.
Designation of office of Commissioner of Agriculture changed by
change of department into an executive department under a Secretary of
Agriculture, by act Feb. 9, 1889, ch. 122, 1, 25 Stat. 659, set out
as section 2202 of Title 7, Agriculture. Authority granted to
Commissioner by act May 29, 1884, vested in Secretary of Agriculture by
a provision of act July 14, 1890, ch. 707, 26 Stat. 288, set out as
section 2205 of Title 7.
Powers conferred on Secretary of the Treasury by act May 29, 1884,
were conferred on Secretary of Agriculture by part of section 1 of act
Feb. 2, 1903. Remainder of such section 1 is classified to sections
113, 120, and 121 of this title.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry'' after
''livestock'' wherever appearing.
Act Feb. 2, 1903, classified to sections 112 and 120 to 122 of this
title, entitled, ''An act to enable the Secretary of Agriculture to more
effectually suppress and prevent the spread of contagious and infectious
diseases of live stock, and for other purposes'' is popularly known as
the Cattle Contagious Diseases Act of 1903.
Act May 29, 1884, entitled, ''An act for the establishment of a
Bureau of Animal Industry, to prevent the exportation of diseased
cattle, and to provide means for the suppression and extirpation of
pleuro-pneumonia and other contagious diseases among domestic animals''
is popularly known as the Animal Industry Act. The Act is classified to
sections 112, 113 to 114a-1, 115, 116, 117 to 120, and 130 of this title
and section 391 of Title 7, Agriculture.
21 USC 112a. Omitted
TITLE 21 -- FOOD AND DRUGS
Section, act Feb. 7, 1928, ch. 30, 45 Stat. 59, amended acts May
29, 1884, ch. 60, 22 Stat. 31; Feb. 2, 1903, ch. 349, 32 Stat. 791;
and Mar. 3, 1905, ch. 1496, 33 Stat. 1264, to include live poultry in
their provisions, added ''and/or live poultry'' following ''live stock''
wherever the term ''live stock'' appeared, and extended the penalty
provisions of said acts to live poultry.
21 USC 113. Measures to prevent exportation of diseased livestock and
live poultry
TITLE 21 -- FOOD AND DRUGS
In order to prevent the exportation from any port of the United
States to any port in a foreign country of livestock and/or live poultry
affected with any contagious, infectious, or communicable disease, and
especially pleuropneumonia, the Secretary of Agriculture is authorized
to take such steps and adopt such measures, not inconsistent with the
provisions of this Act, as he may deem necessary.
(May 29, 1884, ch. 60, 5, 23 Stat. 32; Feb. 2, 1903, ch. 349, 1, 32
Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59.)
This Act, referred to in text, is act May 29, 1884, ch. 60, 23 Stat.
31, as amended, which is popularly known as the Animal Industry Act.
For complete classification of this Act to the Code, see Short Title
note set out under section 112 of this title and Tables.
Section is comprised of part of section 1 of act Feb. 2, 1903.
Remainder of such section 1 is classified to sections 112, 120, and 121
of this title.
Substitution of Secretary of Agriculture for Commissioner of
Agriculture, see note set out under section 112 of this title.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry''.
21 USC 113a. Establishment of research laboratories for foot-and-mouth
disease and other animal diseases; research contracts; employment of
technicians and scientists; appropriations
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture is authorized to establish research
laboratories, including the acquisition of necessary land, buildings, or
facilities, and also the making of research contracts under the
authority contained in section 427i(a) of title 7, for research and
study, in the United States or elsewhere, of foot-and-mouth disease and
other animal diseases which in the opinion of the Secretary constitute a
threat to the livestock industry of the United States: Provided, That
no live virus of foot-and-mouth disease may be introduced for any
purpose into any part of the mainland of the United States (except
coastal islands separated therefrom by water navigable for deep-water
navigation and which shall not be connected with the mainland by any
tunnel) unless the Secretary determines that it is necessary and in the
public interest for the conduct of research and study in the United
States (except at Brookhaven National Laboratory in Upton, New York) and
issues a permit under such rules as the Secretary shall promulgate to
protect animal health, except that the Secretary of Agriculture may
transport said virus in the original package across the mainland under
adequate safeguards, and except further, that in the event of outbreak
of foot-and-mouth disease in this country, the Secretary of Agriculture
may, at his discretion, permit said virus to be brought into the United
States under adequate safeguards. To carry out the provisions of this
section, the Secretary is authorized to employ technical experts or
scientists: Provided, That the number so employed shall not exceed five
and that the maximum compensation for each shall not exceed the highest
rate of grade 18 of the General Schedule. There is authorized to be
appropriated such sums as Congress may deem necessary; in addition, the
Secretary is authorized to utilize in carrying out this section, funds
otherwise available for the control or eradication of such diseases.
(May 29, 1884, ch. 60, 12, as added Apr. 24, 1948, ch. 229, 62 Stat.
198, and amended July 31, 1956, ch. 804, title I, 119, 70 Stat. 742;
July 31, 1958, Pub. L. 85-573, 72 Stat. 454; Oct. 11, 1962, Pub. L.
87-793, 1001(e), 76 Stat. 864; Aug. 14, 1964, Pub. L. 88-426, title
III, 305(1), 78 Stat. 422; Nov. 28, 1990, Pub. L. 101-624, title XVI,
1618(b), 104 Stat. 3733.)
Provisions that authorized the Secretary to employ technical experts
and scientists ''without regard to the Classification Act'', meaning the
Classification Act of 1923, were omitted as obsolete. Sections 1202 and
1204 of the Classification Act of 1949, 63 Stat. 972, 973, repealed the
1923 Act and all laws or parts of laws inconsistent with the 1949 Act.
While section 1106(a) of the 1949 Act provided that references in other
laws to the 1923 Act should be held and considered to mean the 1949 Act,
it did not have the effect of continuing the exception contained in this
section because of section 1106(b) which provided that the application
of the 1949 Act to any position, officer, or employee shall not be
affected by section 1106(a). The Classification Act of 1949 was
repealed by Pub. L. 89-554, Sept. 6, 1966, 8(a), 80 Stat. 632 (the
first section of which revised and enacted Title 5, Government
Organization and Employees, into law). Section 5102 of Title 5 contains
the applicability provisions of the 1949 Act, and section 5103 of Title
5 authorizes the Office of Personnel Management to determine the
applicability to specific positions and employees.
1990 -- Pub. L. 101-624 substituted ''United States (except'' for
''United States except'' and ''tunnel) unless the Secretary determines
that it is necessary and in the public interest for the conduct of
research and study in the United States (except at Brookhaven National
Laboratory in Upton, New York) and issues a permit under such rules as
the Secretary shall promulgate to protect animal health,'' for ''tunnel,
and''.
1962 -- Pub. L. 87-793 substituted ''shall not exceed the highest
rate of grade 18 of the General Schedule'' for ''shall not exceed
$19,000 per annum''.
1958 -- Pub. L. 85-573 inserted in proviso clause of first sentence
the exception clause respecting transportation of virus in original
package across mainland under adequate safeguards.
Amendment by Pub. L. 87-793 effective on first day of first pay
period which begins on or after Oct. 11, 1962.
Act July 31, 1956, ch. 804, title I, 119, 70 Stat. 742, which
increased the maximum compensation of technical experts or scientists,
was repealed by Pub. L. 88-426, title III, 305(1), Aug. 14, 1964, 78
Stat. 422.
References in laws to the rates of pay for GS-16, 17, or 18, or to
maximum rates of pay under the General Schedule, to be considered
references to rates payable under specified sections of Title 5,
Government Organization and Employees, see section 529 (title I, 101(
c)(1)) of Pub. L. 101-509, set out in a note under section 5376 of
Title 5.
21 USC 114. Regulations for suppression of diseases; cooperation of
States and Territories
TITLE 21 -- FOOD AND DRUGS
It shall be the duty of the Secretary of Agriculture to prepare such
rules and regulations as he may deem necessary for the speedy and
effectual suppression and extirpation of pleuropneumonia and other
dangerous, contagious, infectious, and communicable diseases, and to
certify such rules and regulations to the executive authority of each
State and Territory, and invite said authorities to cooperate in the
execution and enforcement of the provisions of this Act. Whenever the
plans and methods of the Secretary of Agriculture shall be accepted by
any State or Territory in which pleuropneumonia or other contagious,
infectious, or communicable disease is declared to exist, or such State
or Territory shall have adopted plans and methods for the suppression
and extirpation of said diseases, and such plans and methods shall be
accepted by the Secretary of Agriculture, and whenever the governor of a
State or other properly constituted authorities signify their readiness
to cooperate for the extinction of any contagious, infectious, or
communicable disease in conformity with the provisions of this Act, the
Secretary of Agriculture is authorized to expend so much of the money
appropriated for carrying out the provisions of this Act as may be
necessary in such investigations, and in such disinfection and
quarantine measures as may be necessary to prevent the spread of the
disease from one State or Territory into another.
(May 29, 1884, ch. 60, 3, 23 Stat. 32.)
This Act, referred to in text, is act May 29, 1884, ch. 60, 23 Stat.
31, as amended, which is popularly known as the Animal Industry Act.
For complete classification of this Act to the Code, see Short Title
note set out under section 112 of this title and Tables.
Substitution of Secretary of Agriculture for Commissioner of
Agriculture, see note set out under section 112 of this title.
Act Feb. 7, 1928, ch. 30, 45 Stat. 59, extended the provisions of
this section to live poultry.
21 USC 114a. Control and eradication of diseases; cooperation of
States and farmers' associations; purchase and destruction of diseased
animals; ''State'' defined
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture, either independently or in cooperation
with States or political subdivisions thereof, farmers' associations and
similar organizations, and individuals, is authorized to control and
eradicate any communicable diseases of livestock or poultry, including,
but not limited to, tuberculosis and paratuberculosis of animals, avian
tuberculosis, brucellosis of domestic animals, southern cattle ticks,
hog cholera and related swine diseases, scabies in sheep and cattle,
dourine in horses, scrapie and blue tongue in sheep, incipient or
potentially serious minor outbreaks of diseases of animals, and
contagious or infectious diseases of animals (such as foot-and-mouth
disease, rinderpest, and contagious pleuropneumonia) which in the
opinion of the Secretary constitute an emergency and threaten the
livestock industry of the country, including the payment of claims
growing out of destruction of animals (including poultry), and of
materials, affected by or exposed to any such disease, in accordance
with such regulations as the Secretary may prescribe. The Secretary of
Agriculture is authorized to prescribe and collect fees to recover the
costs of carrying out the provisions of this section which relate to
veterinary diagnostics. As used in this section, the term ''State''
includes the District of Columbia, Puerto Rico, and the Territories and
possessions of the United States.
(May 29, 1884, ch. 60, 11, as added Sept. 21, 1944, ch. 412, title I,
101(a), 58 Stat. 734, and amended Oct. 30, 1951, ch. 637, 1, 65 Stat.
693; Aug. 8, 1953, ch. 381, 67 Stat. 493; Aug. 3, 1956, ch. 950, 2,
70 Stat. 1032; July 2, 1962, Pub. L. 87-518, 7, 76 Stat. 131; Nov. 28,
1990, Pub. L. 101-624, title XXV, 2509(c)(2), 104 Stat. 4071.)
A prior section 11 of act May 29, 1884, which required annual reports
to Congress concerning the suppression of contagious diseases among
domestic animals, and which was classified to section 560 of former
Title 5, was repealed by act May 29, 1928, ch. 901, 1, 45 Stat. 993.
1990 -- Pub. L. 101-624 inserted after first sentence ''The
Secretary of Agriculture is authorized to prescribe and collect fees to
recover the costs of carrying out the provisions of this section which
relate to veterinary diagnostics.''
1962 -- Pub. L. 87-518 inserted ''any communicable diseases of
livestock or poultry, including, but not limited to,'' after
''eradicate''.
1956 -- Act Aug. 3, 1956, authorized payment of claims for
destruction of material affected or exposed to disease.
1953 -- Act Aug. 8, 1953, provided for control and eradication of
scrapie and blue tongue in sheep, as well as incipient and potentially
serious minor outbreaks of diseases of animals.
1951 -- Act Oct. 30, 1951, substituted ''brucellosis of domestic
animals'' for ''Bang's disease of cattle''.
Section 101(g) of act Sept. 21, 1944, provided that Congress may
appropriate such funds as are necessary to accomplish the purpose of
this section.
1540.
21 USC 114a-1. Interstate movement of domestic animals reacting to
tests for brucellosis; immediate slaughter; rules and regulations
TITLE 21 -- FOOD AND DRUGS
Domestic animals which have reacted to a test recognized by the
Secretary of Agriculture for paratuberculosis or which, never having
been vaccinated for brucellosis, have reacted to a test recognized by
the Secretary of Agriculture for brucellosis, may be shipped,
transported, or otherwise moved from one State, Territory, or the
District of Columbia to any other State, Territory, or the District of
Columbia for immediate slaughter in accordance with such rules and
regulations as the Secretary of Agriculture may prescribe to prevent the
dissemination of said diseases from one State, Territory, or the
District of Columbia to any other State, Territory, or the District of
Columbia. The Secretary of Agriculture may, in his discretion and under
such rules and regulations as he may prescribe, permit domestic animals
which have been moved from one State, Territory, or the District of
Columbia to any other State, Territory, or the District of Columbia, for
breeding purposes, and which, subsequent to such movement, have reacted
to a test for brucellosis or paratuberculosis recognized by the
Secretary of Agriculture, to be reshipped in interstate commerce to the
original owner at the point of origin.
(May 29, 1884, ch. 80, 13, as added Oct. 30, 1951, ch. 637, 2, 65
Stat. 693.)
21 USC 114b. Cooperation in animal disease control
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture is authorized to cooperate with the
Governments of foreign countries, and with foreign or international
organizations or associations in carrying out operations or measures to
eradicate, suppress, or control, or to prevent or retard, any
communicable disease of animals or vectors thereof, including but not
limited to foot-and-mouth disease, rinderpest, or screwworm in such
countries where he deems such action necessary to protect the livestock,
poultry, and related industries of the United States. In performing the
operations or measures authorized in sections 114b to 114d-1 of this
title, the Governments of such countries shall be responsible for the
authority necessary to carry out such operations or measures on all
lands and properties therein and for such other facilities and means as
in the discretion of the Secretary of Agriculture are necessary. The
measure and character of cooperation carried out under said sections on
the part of the United States and on the part of the Governments of such
countries, including the expenditure or use of funds appropriated
pursuant to said sections, shall be such as may be prescribed by the
Secretary of Agriculture. Arrangements for the cooperation authorized
by said sections shall be made through and in consultation with the
Secretary of State. The authority contained in said sections is in
addition to and not in substitution for the authority of existing law.
(Feb. 28, 1947, ch. 8, 1, 61 Stat. 7; July 27, 1966, Pub. L.
89-521, 1, 80 Stat. 330; Nov. 5, 1971, Pub. L. 92-152, 1, 85 Stat.
418; Mar. 15, 1976, Pub. L. 94-231, 3, 90 Stat. 216; Mar. 15, 1990,
Pub. L. 101-255, 1(1), 104 Stat. 114; Nov. 28, 1990, Pub. L. 101-624,
title XXV, 2505, 104 Stat. 4068.)
1990 -- Pub. L. 101-624 substituted ''foreign countries'' for
''Mexico, Guatemala, El Salvador, Costa Rica, Honduras, Nicaragua,
Belize, Panama, Colombia, and Canada, the Bahama Islands, the Greater
Antilles, and the Lesser Antilles'' and inserted ''foreign or'' before
''international''.
Pub. L. 101-255 inserted section catchline and substituted
''screwworm'' for ''screw-worm'' in text.
1976 -- Pub. L. 94-231 substituted ''Belize'' for ''British
Honduras'', inserted '', the Bahama Islands, the Greater Antilles, and
the Lesser Antilles, and with international organizations or
associations'' after ''Canada'', and inserted ''or vectors thereof''
after ''any communicable disease of animals''.
1971 -- Pub. L. 92-152 made provisions applicable to and authorized
cooperation of Secretary of Agriculture with Governments of Guatemala,
El Salvador, Costa Rica, Honduras, Nicaragua, British Honduras, Panama,
Columbia, and Canada, directed operations and measures to be taken
against communicable diseases of animals, and included protection of
poultry within its scope.
1966 -- Pub. L. 89-521 authorized the Secretary of Agriculture to
cooperate in screw-worm eradication in Mexico.
Section 6 of act Feb. 28, 1947, as added by Pub. L. 101-255, 1( 6),
Mar. 15, 1990, 104 Stat. 114, provided that: ''This Act (enacting
this section and sections 114c to 114d-1 of this title and provisions
set out as a note under this section) may be referred to as the 'Animal
Disease Control Cooperation Act of 1947'.''
Act Mar. 27, 1947, ch. 22, 61 Stat. 24, provided for an
appropriation of $9,000,000 to carry out the provisions of this section
during fiscal year 1947.
Section 4 of act Feb. 28, 1947, as amended by Pub. L. 101-255, 1(
4), Mar. 15, 1990, 104 Stat. 114, provided: ''There are authorized to
be appropriated such sums as may be necessary to carry out this Act
(sections 114b to 114d of this title).''
147b; title 16 section 1540.
21 USC 114c. Use of funds
TITLE 21 -- FOOD AND DRUGS
For purposes of sections 114a, and 114b to 114d-1 of this title,
insofar as sections 114b to 114d-1 of this title relate to diseases
which in the opinion of the Secretary constitute an emergency and
threaten the livestock industry of the country, funds appropriated
pursuant thereto may also be used for the purchase or hire of passenger
motor vehicles and aircraft, for printing and binding without regard to
section 501 of title 44, for personal services in the District of
Columbia and elsewhere without regard to the limitations contained in
section 607(g) of the Federal Employees Pay Act of 1945, as amended,
including the employment of civilian nationals of Mexico, Guatemala, El
Salvador, Costa Rica, Honduras, Nicaragua, British Honduras, Panama,
Columbia, and Canada, and for the construction and operation of research
laboratories, quarantine stations and other buildings and facilities.
(Feb. 28, 1947, ch. 8, 2, 61 Stat. 7; Aug. 3, 1956, ch. 950, 3, 70
Stat. 1033; Nov. 5, 1971, Pub. L. 92-152, 2, 85 Stat. 419; Mar. 15,
1990, Pub. L. 101-255, 1(2), 104 Stat. 114.)
Section 607(g) of the Federal Employees Pay Act of 1945, as amended
(former 5 U.S.C. 947(g)), referred to in text, was repealed by act Sept.
12, 1950, ch. 946, title III, 301(85), 64 Stat. 843.
''Section 501 of title 44'' substituted in text for ''section 87 of
the Act of January 12, 1895, or section 11 of the Act of March 1, 1919
(U.S.C., title 44, sec. 111)'' on authority of Pub. L. 90-620, 2(b),
Oct. 22, 1968, 82 Stat. 1305, the first section of which enacted Title
44, Public Printing and Documents.
1990 -- Pub. L. 101-255 inserted section catchline.
1971 -- Pub. L. 92-152 provided for use of funds for employment of
civilian nationals of Guatemala, El Salvador, Costa Rica, Honduras,
Nicaragua, British Honduras, Panama, Columbia, and Canada.
1956 -- Act Aug. 3, 1956, inserted ''and section 114a of this title,
insofar as sections 114b-114d of this title relate to diseases which in
the opinion of the Secretary constitute an emergency and threaten the
livestock industry of the country'' in first sentence.
21 USC 114d. Sale of sterile screwworms
TITLE 21 -- FOOD AND DRUGS
(a) In general
Notwithstanding section 114b of this title, the Secretary of
Agriculture may, independently or in cooperation with any foreign
government or any international organization or association, produce and
sell sterile screwworms to any foreign government or to any
international organization or association, if the Secretary determines
that the protection of livestock and related industries of the United
States will not be adversely affected by such production and sale.
(b) Terms of sale
The Secretary may provide for the sale of screwworms under subsection
(a) of this section under such terms and conditions as the Secretary
considers appropriate.
(c) Deposit of proceeds
(1) Independent sales
If the Secretary independently produces and sells screwworms under
subsection (a) of this section, the proceeds of such sales shall be
deposited in the Treasury of the United States and be credited to the
appropriation from which the operating expenses of the facility
producing the screwworms have been paid.
(2) Cooperative sales
If the Secretary produces and sells screwworms in cooperation with a
foreign government or an international organization or association, the
proceeds of such sale shall be divided between the United States and
such government, organization, or association, as determined by the
Secretary, and the United States portion of such proceeds shall be
deposited into the Treasury of the United States and be credited to the
appropriation from which the operating expenses of the facility
producing the screwworms have been paid.
(Feb. 28, 1947, ch. 8, 3, as added Mar. 15, 1990, Pub. L. 101-255,
1(3), 104 Stat. 114.)
A prior section 114d, act Feb. 28, 1947, ch. 8, 3, 61 Stat. 8,
which related to reports by Secretary of Agriculture to Congress with
respect to activities carried on under sections 114b and 114c of this
title, was repealed by Pub. L. 86-533, 1(20), June 29, 1960, 74 Stat.
249.
21 USC 114d-1. Cooperation with public and private entities
TITLE 21 -- FOOD AND DRUGS
In carrying out sections 114b to 114d-1 of this title the Secretary
of Agriculture is further authorized to cooperate with other public and
private organizations and individuals.
(Feb. 28, 1947, ch. 8, 5, as added July 27, 1966, Pub. L. 89-521, 2,
80 Stat. 330, and amended Mar. 15, 1990, Pub. L. 101-255, 1(5), 104
Stat. 114.)
1990 -- Pub. L. 101-255 inserted section catchline.
21 USC 114d-2 to 114d-6. Repealed. Pub. L. 92-152, 3, Nov. 5, 1971, 85
Stat. 419
TITLE 21 -- FOOD AND DRUGS
Section 114d-2, Pub. L. 90-388, 1, July 6, 1968, 82 Stat. 294,
provided for cooperation with Central America in control and eradication
of foot-and-mouth disease or rinderpest. See section 114b of this
title.
Section 114d-3, Pub. L. 90-388, 2, July 6, 1968, 82 Stat. 294,
provided for uses of funds. See section 114c of this title.
Section 114d-4, Pub. L. 90-388, 3, July 6, 1968, 82 Stat. 294,
defined governments of Central America. See sections 114b and 114c of
this title.
Section 114d-5, Pub. L. 90-388, 4, July 6, 1968, 82 Stat. 294,
provided for cooperation with public and private organizations and
individuals. See section 114d-1 of this title.
Section 114d-6, Pub. L. 90-388, 5, July 6, 1968, 82 Stat. 294,
provided for authorization of appropriations. See Appropriations note
set out under section 114b of this title.
21 USC 114e. Control and eradication of cattle grubs; research and
investigations
TITLE 21 -- FOOD AND DRUGS
In order to protect, promote, and conserve livestock and livestock
products and to minimize losses, the Secretary of Agriculture, either
independently or in cooperation with States or subdivisions thereof,
farmers' associations, and other organizations and individuals, it /1/
is authorized to increase and intensify research and investigations into
problems and methods relating to the eradication of cattle grubs and to
undertake measures to eradicate these parasites.
(June 16, 1948, ch. 477, 1, 62 Stat. 458.)
/1/ So in original.
21 USC 114f. ''State'' defined; authorization of appropriations
TITLE 21 -- FOOD AND DRUGS
As used in section 114e of this title, the term ''State'' includes
the District of Columbia and the Territories and possessions of the
United States. There is authorized to be appropriated such sums as may
be necessary to carry out section 114e of this title. Funds
appropriated pursuant to this section shall be expended in accordance
with procedures prescribed by the Secretary.
(June 16, 1948, ch. 477, 2, 62 Stat. 458.)
21 USC 114g. Hog cholera eradication program
TITLE 21 -- FOOD AND DRUGS
In order to safeguard the health of the swine herds of the Nation, to
prevent the spread of hog cholera, to decrease substantially the
estimated $50,000,000 annual loss from hog cholera, to expand export
markets for pork and pork products now restricted on account of hog
cholera, and to otherwise protect the public interest, the Secretary of
Agriculture is directed (1) to initiate a national hog cholera
eradication program in cooperation with the several States under the
provisions of section 114a of this title and related legislation, and
(2) to prohibit or restrict, pursuant to the authority vested in him
under the provisions of section 111 of this title the interstate
movement of virulent hog cholera virus or other hog cholera virus to the
extent he determines necessary in order to effectuate such eradication
program.
(Pub. L. 87-209, 1, Sept. 6, 1961, 75 Stat. 481.)
21 USC 114h. Advisory committee
TITLE 21 -- FOOD AND DRUGS
(a) Establishment; membership
The Secretary of Agriculture is authorized and directed to establish
an advisory committee composed of (1) eleven members selected from
representatives of the swine and related industries, State and local
government agencies, professional and scientific groups, and the general
public, and (2) one member selected from the officers and employees of
the Department of Agriculture who shall serve as chairman of the
Committee. The Committee shall meet at the call of the Secretary.
(b) Functions
It shall be the function of the Committee to advise the Secretary
with respect to the initiation of the national hog cholera eradication
program referred to in section 114g of this title, and with respect to
the development of plans and procedures for carrying out such program.
(c) Employment status; expenses
Committee members other than the chairman shall not be deemed to be
employees of the United States and shall not be entitled to
compensation, but the Secretary is authorized to pay their travel and
subsistence expenses (or per diem in lieu thereof) in connection with
their attendance at meetings of the Committee.
(Pub. L. 87-209, 2, Sept. 6, 1961, 75 Stat. 481.)
Advisory committees in existence on Jan. 5, 1973, to terminate not
later than the expiration of the 2-year period following Jan. 5, 1973,
unless, in the case of a committee established by the President or an
officer of the Federal Government, such committee is renewed by
appropriate action prior to the expiration of such 2-year period, or in
the case of a committee established by the Congress, its duration is
otherwise provided by law. See section 14 of Pub. L. 92-463, Oct. 6,
1972, 86 Stat. 776, set out in the Appendix to Title 5, Government
Organization and Employees.
21 USC 114i. Pseudorabies eradication
TITLE 21 -- FOOD AND DRUGS
(a) Findings
Congress finds that efforts to eradicate pseudorabies in United
States swine populations by the Department of Agriculture in cooperation
with State agencies and the pork industry have a high priority and
should be continued until pseudorabies is completely eradicated in the
United States.
(b) Establishment of program
The Secretary of Agriculture shall establish and carry out a program
for the eradication of pseudorabies in United States swine populations.
(c) Use of funds for testing and control of pseudorabies
The Secretary shall ensure that not less than 65 percent of the funds
appropriated for the program established under subsection (b) of this
section shall be used for testing and screening of animals and for other
purposes directly related to the eradication or control of pseudorabies.
This requirement on the use of appropriated funds for this program
shall not be implemented in a manner that would adversely affect any
other animal or plant disease or pest eradication or control program.
(d) Authorization of appropriations
There are authorized to be appropriated for each of the fiscal years
1991 through 1995 such sums as may be necessary for the purpose of
carrying out the program established under subsection (b) of this
section.
(Pub. L. 101-624, title XXV, 2506, Nov. 28, 1990, 104 Stat. 4068.)
21 USC 115. Transportation of diseased livestock and live poultry
prohibited
TITLE 21 -- FOOD AND DRUGS
No railroad company within the United States, or the owners or
masters of any steam or sailing or other vessel or boat, shall receive
for transportation or transport from one State or Territory to another,
or from any State into the District of Columbia, or from the District
into any State, any livestock and/or live poultry affected with any
contagious, infectious, or communicable disease, and especially the
disease known as pleuropneumonia; nor shall any person, company, or
corporation deliver for such transportation to any railroad company, or
master or owner of any boat or vessel, any livestock and/or live
poultry, knowing them to be affected with any contagious, infectious, or
communicable disease; nor shall any person, company, or corporation
drive on foot, or transport in private conveyance from one State or
Territory to another, or from any State into the District of Columbia,
or from the District into any State, any livestock and/or live poultry,
knowing them to be affected with any contagious, infectious, or
communicable disease, and especially the disease known as
pleuropneumonia: Provided, That such livestock or poultry may be so
delivered and received for such transportation and so transported and
moved if the Secretary of Agriculture determines that such action will
not endanger the livestock or poultry of the United States and
authorizes such action, and such delivery, receipt, transportation, and
movement are made in strict compliance with such rules and regulations
as the Secretary of Agriculture may prescribe to protect the livestock
and poultry of the United States.
(May 29, 1884, ch. 60, 6, 23 Stat. 32; June 28, 1926, ch. 700, 1, 44
Stat. 774; Feb. 7, 1928, ch. 30, 45 Stat. 59; Oct. 9, 1962, Pub. L.
87-763, 76 Stat. 762.)
Act May 29, 1884, as amended by act June 28, 1926, also contained the
following proviso: ''That until May 1, 1928, cattle infested with or
exposed to cattle fever ticks may be shipped in interstate commerce for
immediate slaughter after one dipping in accordance with such
regulations as the Secretary of Agriculture may prescribe.''
1962 -- Pub. L. 87-763 inserted proviso permitting such livestock or
poultry to be delivered and received for transportation and so
transported and moved if the Secretary determines that such action will
not endanger the livestock or poultry of the United States and
authorizes such action, and such delivery, receipt, transportation, and
movement are made in strict compliance with such rules and regulations
as the Secretary may prescribe.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry'' after
''livestock'' wherever appearing.
1926 -- Act June 28, 1926, struck out provision deeming splenetic or
Texas fever not a communicable disease as to cattle unloaded only to be
fed and watered on the way by rail to market for slaughter.
21 USC 116. Shipment of certain cattle excepted
TITLE 21 -- FOOD AND DRUGS
Cattle which have reacted to the tuberculin test may be shipped,
transported, or moved from one State, Territory, or the District of
Columbia to any other State, Territory, or the District of Columbia, for
immediate slaughter, in accordance with such rules and regulations as
shall be prescribed by the Secretary of Agriculture. The said Secretary
of Agriculture may, in his discretion, and under such rules and
regulations as he may prescribe, permit cattle which have been shipped
for breeding or feeding purposes from one State, Territory, or the
District of Columbia to another State, Territory, or the District of
Columbia, and which have reacted to the tuberculin test subsequent to
such shipment, to be reshipped in interstate commerce to the original
owner.
(May 29, 1884, ch. 60, 23 Stat. 31; May 31, 1920, ch. 217, 41 Stat.
699.)
1920 -- Act May 31, 1920, amended act May 29, 1884, without amending
any particular section thereof, by enacting provisions set out as this
section. For classification of act May 29, 1884, to the Code, see Short
Title note set out under section 112 of this title and Tables.
21 USC 117. Penalties for transportation of diseased livestock or live
poultry
TITLE 21 -- FOOD AND DRUGS
(a) Criminal penalty
Any person or persons operating any railroad, or master or owner of
any boat or vessel, or owner or custodian of, or person having control
over, cattle or other livestock or live poultry who shall knowingly
violate the provisions of section 115 of this title or the rules and
regulations prescribed by the Secretary of Agriculture under such
section shall be guilty of a misdemeanor and, upon conviction, shall be
punished by a fine of not more than $5,000 or by imprisonment for not
more than one year, or by both such fine and imprisonment.
(b) Civil penalty
Any person or persons operating any railroad, or master or owner of
any boat or vessel, or owner or custodian of, or person having control
over, cattle or other livestock or live poultry who shall violate the
provisions of section 115 of this title or the rules and regulations
prescribed by the Secretary of Agriculture under such section may be
assessed a civil penalty by the Secretary of not more than $1,000. The
Secretary may issue an order assessing such civil penalty only after
notice and an opportunity for an agency hearing on the record. Such
order shall be treated as a final order reviewable under chapter 158 of
title 28. The validity of such order may not be reviewed in an action
to collect such civil penalty.
(May 29, 1884, ch. 60, 7, 23 Stat. 32; Feb. 7, 1928, ch. 30, 45
Stat. 59; Oct. 10, 1978, Pub. L. 95-439, 1, 92 Stat. 1061; Jan. 12,
1983, Pub. L. 97-461, 5, 96 Stat. 2524.)
1983 -- Pub. L. 97-461 designated existing provisions as subsec.
(a), inserted ''or the rules and regulations prescribed by the Secretary
of Agriculture under such section'' after ''title'', and added subsec.
(b).
1978 -- Pub. L. 95-439 struck out provision requiring the Secretary
of Agriculture to notify in writing the proper officials of any
railroad, steamboat, or other transportation company doing business in
an infected area of the existence of a contagion and to publish in
newspapers the existence of a contagion.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry'' after
''livestock''.
21 USC 118. Duty of United States attorneys
TITLE 21 -- FOOD AND DRUGS
It shall be the duty of the several United States attorneys to
prosecute all violations of this Act which shall be brought to their
notice or knowledge by any person making the complaint under oath; and
the same shall be heard before any district court of the United States
or Territorial court holden within the district in which such violation
of this Act has been committed.
(May 29, 1884, ch. 60, 9, 23 Stat. 33; June 25, 1948, ch. 646, 1, 62
Stat. 909.)
This Act, referred to in text, is act May 29, 1884, ch. 60, 23 Stat.
31, as amended, which is popularly known as the Animal Industry Act.
For complete classification of this Act to the Code, see Short Title
note set out under section 112 of this title and Tables.
Act June 25, 1948, eff. Sept. 1, 1948, substituted ''United States
attorneys'' for ''United States district attorneys''. See section 541
of Title 28, Judiciary and Judicial Procedure.
Act June 25, 1948, ch. 646, 39, 62 Stat. 992, repealed act Mar. 3,
1911, ch. 231, 289, 36 Stat. 1167, formerly cited as a credit to this
section.
Act Feb. 7, 1928, ch. 30, 45 Stat. 59, extended the provisions of
this section to live poultry.
Continuance of section under rule 18, see note by Advisory Committee
under rule 18, Title 18, Appendix, Crimes and Criminal Procedure.
21 USC 119. Agents to examine and report on methods of treatment of
animals, and means for suppression of diseases
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture is authorized to appoint two competent
agents, who shall be practical stock raisers or experienced business men
familiar with questions pertaining to commercial transactions in
livestock and/or live poultry, whose duty it shall be, under the
instructions of the said Secretary of Agriculture, to examine and report
upon the best methods of treating, transporting, and caring for animals,
and the means to be adopted for the suppression and extirpation of
contagious pleuropneumonia, and to provide against the spread of other
dangerous contagious, infectious, and communicable diseases. The
compensation of said agents shall be at the rate of $10 per diem, with
all necessary expenses, while engaged in the actual performance of their
duties under this Act, when absent from their usual place of business or
residence as such agent.
(May 29, 1884, ch. 60, 2, 23 Stat. 31; Feb. 9, 1889, ch. 122, 1, 25
Stat. 659; July 14, 1890, ch. 707, 26 Stat. 288; Feb. 7, 1928, ch.
30, 45 Stat. 59.)
This Act, referred to in text, is act May 29, 1884, ch. 60, 23 Stat.
31, as amended, which is popularly known as the Animal Industry Act.
For complete classification of this Act to the Code, see Short Title
note set out under section 112 of this title and Tables.
Substitution of Secretary of Agriculture for Commissioner of
Agriculture, see note set out under section 112 of this title.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry'' after
''livestock''.
21 USC 120. Regulation of exportation and transportation of infected
livestock and live poultry
TITLE 21 -- FOOD AND DRUGS
In order to enable the Secretary of Agriculture to effectually
suppress and extirpate contagious pleuropneumonia, foot-and-mouth
disease, and other dangerous contagious, infectious, and communicable
diseases in cattle and other livestock and/or live poultry, and to
prevent the spread of such diseases, he is authorized and directed from
time to time to establish such rules and regulations concerning the
exportation and transportation of livestock and/or live poultry from any
place within the United States where he may have reason to believe such
diseases may exist into and through any State or Territory, and into and
through the District of Columbia and to foreign countries as he may deem
necessary, and all such rules and regulations shall have the force of
law.
(May 29, 1884, ch. 60, 4, 5, 23 Stat. 32; Feb. 2, 1903, ch. 349, 1,
32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59.)
Section is comprised of part of section 1 of act Feb. 2, 1903.
Remainder of such section 1 is classified to sections 112, 113, and 121
of this title. The words ''including the Indian Territory'' which
followed the word ''Territory'' in the original text of this section
were omitted as obsolete.
Substitution of Secretary of Agriculture for Commissioner of
Agriculture, see note set out under section 112 of this title.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry'' after
''livestock'' wherever appearing.
1540.
21 USC 121. Shipments from areas suspected infected; control of
animals and live poultry
TITLE 21 -- FOOD AND DRUGS
Whenever any inspector or assistant inspector of the Bureau of Animal
Industry shall issue a certificate showing that such officer had
inspected any cattle or other livestock and/or live poultry which were
about to be shipped, driven, or transported from such locality to
another as stated in section 120 of this title, and had found them free
from Texas or splenetic fever infection, pleuropneumonia, foot-and-mouth
disease, or any other infectious, contagious, or communicable disease,
such animals, so inspected and certified, may be shipped, driven, or
transported from such place into and through any State or Territory, and
into and through the District of Columbia, or they may be exported from
the United States without further inspection or the exaction of fees of
any kind, except such as may at any time be ordered or exacted by the
Secretary of Agriculture; and all such animals shall at all times be
under the control and supervision of the Bureau of Animal Industry of
the Agricultural Department for the purposes of such inspection.
(Feb. 2, 1903, ch. 349, 1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45
Stat. 59.)
Section is comprised of part of section 1 of act Feb. 2, 1903.
Remainder of such section 1 is classified to sections 112, 113 and 120
of this title.
The words ''including the Indian territory'' which followed
''Territory'' in the original text of this section were omitted as
obsolete.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry'' after
''livestock''.
21 USC 122. Offenses; penalty
TITLE 21 -- FOOD AND DRUGS
Any person, company, or corporation knowingly violating the
provisions of this Act or the orders or regulations made in pursuance
thereof shall be guilty of a misdemeanor, and on conviction shall be
punished by a fine of not less than one hundred dollars nor more than
five thousand dollars, or by imprisonment not more than one year, or by
both such fine and imprisonment. Any person, company, or corporation
violating such provisions, orders, or regulations may be assessed a
civil penalty by the Secretary of Agriculture of not more than one
thousand dollars. The Secretary may issue an order assessing such civil
penalty only after notice and an opportunity for an agency hearing on
the record. Such order shall be treated as a final order reviewable
under chapter 158 of title 28. The validity of such order may not be
reviewed in an action to collect such civil penalty.
(Feb. 2, 1903, ch. 349, 3, 32 Stat. 792; Jan. 12, 1983, Pub. L.
97-461, 6, 96 Stat. 2525.)
This Act, referred to in text, is act Feb. 2, 1903, ch. 349, 32
Stat. 791, as amended, which enacted sections 111, 121, and 122 of this
title and amended sections 112, 113, and 120 of this title. For
complete classification of this Act to the Code, see Tables.
1983 -- Pub. L. 97-461 substituted ''five thousand dollars'' for
''one thousand dollars'' and inserted provisions relating to a civil
penalty.
Act Feb. 7, 1928, ch. 30, 45 Stat. 59, extended the provisions of
this section to live poultry.
21 USC 123. Quarantine
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture is authorized to quarantine by
regulation any State or Territory or the District of Columbia, or any
portion of any State or Territory or the District of Columbia, when he
shall determine the fact that any animals or live poultry in such State
or Territory or District of Columbia are affected with any contagious,
infectious, or communicable disease of livestock or poultry or that the
contagion of any such disease exists or that vectors which may
disseminate any such disease exist in such State or Territory or the
District of Columbia.
(Mar. 3, 1905, ch. 1496, 1, 33 Stat. 1264; Feb. 7, 1928, ch. 30, 45
Stat. 59; July 2, 1962, Pub. L. 87-518, 8(a), 76 Stat. 131; Oct. 10,
1978, Pub. L. 95-439, 2, 92 Stat. 1061.)
1978 -- Pub. L. 95-439 struck out provision requiring the Secretary
of Agriculture to give written notice of the establishment of quarantine
to the proper officials of railroads, steamboats, or other
transportation systems and to publish notice of the establishment of
quarantine in newspapers in the quarantined State or Territory or the
District of Columbia.
1962 -- Pub. L. 87-518 authorized quarantine upon the determination
that any animals or poultry are affected with a communicable disease of
livestock or poultry or that the contagion of any such disease exists or
that vectors which may disseminate any such disease exist.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry'' after
''livestock''.
This section and sections 124 to 127 of this title are from act Mar.
3, 1905, entitled ''An act to enable the Secretary of Agriculture to
establish and maintain quarantine districts, to permit and regulate the
movement of cattle and other live stock therefrom, and for other
purposes and constitute the Cattle Contagious Diseases Act of 1905.''
21 USC 124. Transportation or delivery therefor from quarantined State
or Territory or portion thereof, of quarantined animals and live
poultry, forbidden
TITLE 21 -- FOOD AND DRUGS
No railroad company or the owners or masters of any steam or sailing
or other vessel or boat shall receive for transportation or transport
from any quarantined State or Territory or the District of Columbia, or
from the quarantined portion of any State or Territory or the District
of Columbia, into any other State or Territory or the District of
Columbia, any quarantined animals, and/or live poultry, except as
hereinafter provided; nor shall any person, company, or corporation
deliver for such transportation to any railroad company, or to the
master or owner of any boat or vessel, any quarantined animals and/or
live poultry, except as hereinafter provided; nor shall any person,
company, or corporation drive on foot, or cause to be driven on foot, or
transport in private conveyance or cause to be transported in private
conveyance, from a quarantined State or Territory or the District of
Columbia, or from the quarantined portion of any State or Territory or
the District of Columbia, into any other State or Territory or the
District of Columbia, and quarantined animals and/or live poultry,
except as hereinafter provided.
(Mar. 3, 1905, ch. 1496, 2, 33 Stat. 1264; Feb. 7, 1928, ch. 30, 45
Stat. 59; July 2, 1962, Pub. L. 87-518, 8(b), 76 Stat. 131.)
1962 -- Pub. L. 87-518 substituted ''quarantined animals'' for
''cattle or other livestock'' wherever appearing.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry'' after
''livestock'' wherever appearing.
21 USC 125. Regulations for inspection, disinfection, and
certification, and delivery and shipment of quarantined animals and live
poultry from State or Territory
TITLE 21 -- FOOD AND DRUGS
It shall be the duty of the Secretary of Agriculture, and he is
authorized and directed, when the public safety will permit, to make and
promulgate rules and regulations which shall permit and govern the
inspection, disinfection, certification, treatment, handling, and method
and manner of delivery and shipment of quarantined animals or live
poultry from a quarantined State or Territory or the District of
Columbia, and from the quarantined portion of any State or Territory or
the District of Columbia, into any other State or Territory or the
District of Columbia.
(Mar. 3, 1905, ch. 1496, 3, 33 Stat. 1265; Feb. 7, 1928, ch. 30, 45
Stat. 59; July 2, 1962, Pub. L. 87-518, 8(b), 76 Stat. 131; Oct. 10,
1978, Pub. L. 95-439, 3, 92 Stat. 1061.)
1978 -- Pub. L. 95-439 struck out provision requiring the Secretary
of Agriculture to give notice of rules and regulations in the manner
prescribed in section 123 of this title for notice of establishment of
quarantine.
1962 -- Pub. L. 87-518 substituted ''quarantined animals'' for
''cattle or other livestock''.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry'' after
''livestock''.
21 USC 126. Moving quarantined animals and live poultry from State or
Territory, under regulations
TITLE 21 -- FOOD AND DRUGS
Quarantined animals and/or live poultry may be moved from a
quarantined State or Territory or the District of Columbia, or from the
quarantined portion of any State or Territory or the District of
Columbia, into any other State or Territory or the District of Columbia,
under and in compliance with the rules and regulations of the Secretary
of Agriculture, made and promulgated in pursuance of the provisions of
section 125 of this title; but it shall be unlawful to move, or to
allow to be moved, any quarantined animals and/or live poultry from any
quarantined State or Territory or the District of Columbia, or from the
quarantined portion of any State or Territory or the District of
Columbia, into any other State or Territory or the District of Columbia,
in manner or method or under conditions other than those prescribed by
the Secretary of Agriculture.
(Mar. 3, 1905, ch. 1496, 4, 33 Stat. 1265; Feb. 7, 1928, ch. 30, 45
Stat. 59; July 2, 1962, Pub. L. 87-518, 8(b), 76 Stat. 131.)
1962 -- Pub. L. 87-518 substituted ''quarantined animals'' for
''cattle or other livestock'' wherever appearing.
1928 -- Act Feb. 7, 1928, inserted ''and/or live poultry'' after
''livestock'' wherever appearing.
21 USC 127. Transportation from quarantined State, Territory, etc.;
penalty
TITLE 21 -- FOOD AND DRUGS
Any person, company, or corporation violating the provisions of
sections 124 or 126 of this title shall be guilty of a misdemeanor, and
on conviction shall be punished by a fine of not less than one hundred
dollars nor more than five thousand dollars, or by imprisonment not more
than one year, or by both such fine and imprisonment. Any person,
company, or corporation violating such provisions may be assessed a
civil penalty by the Secretary of Agriculture of not more than one
thousand dollars. The Secretary may issue an order assessing such civil
penalty only after notice and an opportunity for an agency hearing on
the record. Such order shall be treated as a final order reviewable
under chapter 158 of title 28. The validity of such order may not be
reviewed in an action to collect such civil penalty.
(Mar. 3, 1905, ch. 1496, 6, 33 Stat. 1265; Jan. 12, 1983, Pub. L.
97-461, 7, 96 Stat. 2525.)
1983 -- Pub. L. 97-461 substituted ''five thousand dollars'' for
''one thousand dollars'' and inserted provisions relating to a civil
penalty.
Act Feb. 7, 1928, ch. 30, 45 Stat. 59, extended the provisions of
this section to live poultry.
21 USC 128. Extension of quarantine law to carriers in interstate
commerce
TITLE 21 -- FOOD AND DRUGS
The provisions of sections 123 to 127 of this title shall apply to
any railroad company or other common carrier whose road or line forms
any part of a route over which quarantined animals are transported in
the course of shipment from any quarantined State or Territory or the
District of Columbia, or from the quarantined portion of any State or
Territory or the District of Columbia into any other State or Territory
or the District of Columbia.
(June 30, 1914, ch. 131, 38 Stat. 419; July 2, 1962, Pub. L.
87-518, 9, 76 Stat. 131.)
Section is from the Department of Agriculture Appropriation Act,
1915.
1962 -- Pub. L. 87-518 substituted ''quarantined animals'' for
''cattle or other livestock''.
21 USC 129. Expenses for arrest and eradication of contagious or
infectious diseases or pests of animals, poultry, or plants
TITLE 21 -- FOOD AND DRUGS
In emergencies which threaten any segment of the agricultural
production industry of this country, the Secretary may transfer from
other appropriations or funds available to the agencies or corporations
of the Department such sums as he may deem necessary, to be available
only in such emergencies for the arrest and eradication of contagious or
infectious disease or pests of animals, poultry, or plants, and for
expenses in accordance with sections 114b to 114d-1 of this title and
section 147a of title 7, and any unexpended balances of funds
transferred for such emergency purposes in the next preceding fiscal
year shall be merged with such transferred amounts.
(Pub. L. 102-142, title I, Oct. 28, 1991, 105 Stat. 886.)
Section is from the appropriation act cited as the credit to this
section.
Similar provisions were contained in the following prior
appropriation acts:
Nov. 5, 1990, Pub. L. 101-506, title I, 104 Stat. 1323.
Nov. 21, 1989, Pub. L. 101-161, title I, 103 Stat. 959.
Oct. 1, 1988, Pub. L. 100-460, title I, 102 Stat. 2237.
Dec. 22, 1987, Pub. L. 100-202, 101(k) (title I), 101 Stat.
1329-322, 1329-331.
Oct. 18, 1986, Pub. L. 99-500, 101(a) (title I), 100 Stat. 1783,
1783-8, and Oct. 30, 1986, Pub. L. 99-591, 101(a) (title I), 100 Stat.
3341, 3341-8.
Dec. 19, 1985, Pub. L. 99-190, 101(a) (H.R. 3037, title I), 99 Stat.
1185.
Oct. 12, 1984, Pub. L. 98-473, title I, 101(a) (H.R. 5743, title I),
98 Stat. 1837.
Nov. 14, 1983, Pub. L. 98-151, 101(d) (H.R. 3223, title I), 97 Stat.
972.
Dec. 18, 1982, Pub. L. 97-370, title I, 96 Stat. 1792.
Dec. 23, 1981, Pub. L. 97-103, title I, 95 Stat. 1472.
Dec. 15, 1980, Pub. L. 96-528, title I, 94 Stat. 3099.
Nov. 9, 1979, Pub. L. 96-108, title I, 93 Stat. 826.
Oct. 11, 1978, Pub. L. 95-448, title I, 92 Stat. 1076.
Aug. 12, 1977, Pub. L. 95-97, title I, 91 Stat. 813.
July 12, 1976, Pub. L. 94-351, title I, 90 Stat. 854.
Oct. 21, 1975, Pub. L. 94-122, title I, 89 Stat. 645.
Dec. 31, 1974, Pub. L. 93-563, title I, 88 Stat. 1824.
Oct. 24, 1973, Pub. L. 93-135, title I, 87 Stat. 472.
Aug. 22, 1972, Pub. L. 92-399, title I, 86 Stat. 594.
Aug. 10, 1971, Pub. L. 92-73, title I, 85 Stat. 185.
Dec. 22, 1970, Pub. L. 91-566, title I, 84 Stat. 1482.
Nov. 26, 1969, Pub. L. 91-127, title I, 83 Stat. 246.
Aug. 8, 1968, Pub. L. 90-463, title I, 82 Stat. 640.
Oct. 24, 1967, Pub. L. 90-113, title I, 81 Stat. 321.
Sept. 7, 1966, Pub. L. 89-556, title I, 80 Stat. 690.
Nov. 2, 1965, Pub. L. 89-316, title I, 79 Stat. 1166.
Sept. 2, 1964, Pub. L. 88-573, title I, 78 Stat. 863.
Dec. 30, 1963, Pub. L. 88-250, title I, 77 Stat. 821.
Oct. 24, 1962, Pub. L. 87-879, title I, 76 Stat. 1204.
July 26, 1961, Pub. L. 87-112, title I, 75 Stat. 228.
June 29, 1960, Pub. L. 86-532, title I, 74 Stat. 233.
July 8, 1959, Pub. L. 86-80, title I, 73 Stat. 168.
June 13, 1958, Pub. L. 85-459, title I, 72 Stat. 189.
Aug. 2, 1957, Pub. L. 85-118, title I, 71 Stat. 330.
June 4, 1956, ch. 355, title I, 70 Stat. 230.
May 23, 1955, ch. 43, title I, 69 Stat. 52.
June 29, 1954, ch. 409, title I, 68 Stat. 305.
July 28, 1953, ch. 251, title III, 67 Stat. 223.
July 5, 1952, ch. 574, title III, 66 Stat. 354.
Aug. 31, 1951, ch. 374, title II, 65 Stat. 243.
Sept. 6, 1950, ch. 896, Ch. VI, title I, 64 Stat. 661.
June 29, 1949, ch. 280, title I, 63 Stat. 332.
June 19, 1948, ch. 543, 62 Stat. 515.
July 30, 1947, ch. 356, title I, 61 Stat. 532.
June 22, 1946, ch. 445, 60 Stat. 278.
May 5, 1945, ch. 109, 59 Stat. 144.
June 28, 1944, ch. 296, 58 Stat. 434.
July 12, 1943, ch. 215, 57 Stat. 403.
July 22, 1942, ch. 516, 56 Stat. 676.
July 1, 1941, ch. 267, 55 Stat. 418.
June 25, 1940, ch. 421, 54 Stat. 542.
June 30, 1939, ch. 253, title I, 53 Stat. 951.
June 16, 1938, ch. 464, title I, 52 Stat. 722.
June 29, 1937, ch. 404, 50 Stat. 406.
June 4, 1936, ch. 489, 49 Stat. 1432.
May 17, 1935, ch. 131, title I, 49 Stat. 257.
Mar. 26, 1934, ch. 89, 48 Stat. 477.
Mar. 3, 1933, ch. 203, 47 Stat. 1442.
July 7, 1932, ch. 443, 47 Stat. 620.
Feb. 23, 1931, ch. 278, 46 Stat. 1252.
May 27, 1930, ch. 341, 46 Stat. 403.
Feb. 16, 1929, ch. 227, 45 Stat. 1198.
May 16, 1928, ch. 572, 45 Stat. 548.
Jan. 18, 1927, ch. 39, 44 Stat. 1005.
May 11, 1926, ch. 286, 44 Stat. 529.
Feb. 10, 1925, ch. 200, 43 Stat. 851.
Dec. 5, 1924, ch. 4, 43 Stat. 683.
June 5, 1924, ch. 266, 43 Stat. 458.
Apr. 2, 1924, ch. 81, 43 Stat. 40.
Feb. 26, 1923, ch. 119, 42 Stat. 1318.
May 11, 1922, ch. 185, 42 Stat. 536.
Mar. 4, 1917, ch. 179, 39 Stat. 1167.
21 USC 130. Pleuropneumonia in District of Columbia; duties of Council
of the District of Columbia
TITLE 21 -- FOOD AND DRUGS
Whenever any contagious, infectious, or communicable disease
affecting domestic animals or live poultry, and especially the disease
known as pleuropneumonia, shall be brought into or shall break out in
the District of Columbia, it shall be the duty of the Council of the
District of Columbia to take measures to suppress the same promptly and
to prevent the same from spreading; and for this purpose the said
Council is empowered to order and require that any premises, farm, or
farms where such disease exists, or has existed, be put in quarantine;
to order all or any animals coming into the District to be detained at
any place or places for the purpose of inspection and examination; to
prescribe regulations for and to require the destruction of animals or
live poultry affected with contagious, infectious, or communicable
disease, and for the proper disposition of their hides and carcasses;
to prescribe regulations for disinfection, and such other regulations as
they may deem necessary to prevent infection or contagion being
communicated, and shall report to the Secretary of Agriculture whatever
it may do in pursuance of the provisions of this section.
(May 29, 1884, ch. 60, 8, 23 Stat. 33; 1967 Reorg. Plan No. 3, 402(
430), eff. Aug. 11, 1967, 32 F.R. 11669, 81 Stat. 948; Pub. L. 93-198,
title IV, 401, Dec. 24, 1973, 87 Stat. 793.)
Substitution of Secretary of Agriculture for Commissioner of
Agriculture, see note set out under section 112 of this title.
Section is also set out in D.C. Code 1-324.
''Council of the District of Columbia'' substituted in text for
''District of Columbia Council'' pursuant to section 401 of Pub. L.
93-198. District of Columbia Council, as established by Reorg. Plan No.
3 of 1967, abolished as of noon Jan. 2, 1975, by Pub. L. 93-198,
title VII, 711, Dec. 24, 1973, 87 Stat. 818, classified to section
1-211 of the District of Columbia Code, and replaced by Council of the
District of Columbia, as provided by section 401 of Pub. L. 93-198,
classified to section 1-221 of the District of Columbia Code.
Previously, references to Commissioners of District of Columbia had
been changed to District of Columbia Council pursuant to section 402(
430) of Reorganization Plan No. 3 of 1967, 32 F.R. 11669, effective
Aug. 11, 1967, set out in the Appendix to Title 5, Government
Organization and Employees, which transferred regulatory and other
functions of Board of Commissioners relating to prescribing of
regulations for destruction of animals or live poultry affected by
contagious, infectious, or communicable disease, and for proper
disposition of their hides and carcasses, and prescribing of regulations
for disinfection and other regulations under this section to District of
Columbia Council, subject to right of Commissioner as provided by
section 406 of Plan. For provisions establishing District of Columbia
Council, see section 201 of Reorg. Plan No. 3 of 1967.
Act Feb. 7, 1928, ch. 30, 45 Stat. 59, extended the provisions of
this section to live poultry.
Diseases and quarantine in the District of Columbia, see sections 111
and 123 to 127 of this title.
21 USC 131. Fences along international boundary lines to keep out
diseased animals
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture may permit the erection of fences along
international boundary lines, but entirely within the territory of the
United States, for the purpose of keeping out diseased animals.
(May 26, 1910, ch. 256, 36 Stat. 440.)
21 USC 132. Transferred
TITLE 21 -- FOOD AND DRUGS
Section, act May 23, 1908, ch. 192, 35 Stat. 254, which related to
inspection of dairy products for export, was transferred to section 693
of this title.
21 USC 133. Repealed. July 13, 1949, ch. 307, 63 Stat. 410
TITLE 21 -- FOOD AND DRUGS
Section, act July 24, 1946, ch. 592, 60 Stat. 633, related to
establishment of a quarantine station on Swan Island.
21 USC 134. Definitions
TITLE 21 -- FOOD AND DRUGS
As used in this Act unless the context indicates otherwise --
(a) The term ''Secretary'' means the Secretary of Agriculture.
(b) The term ''animals'' means all members of the animal kingdom
including birds, whether domesticated or wild, but not including man.
(c) The term ''United States'' means the States, Puerto Rico, Guam,
the Virgin Islands of the United States, and the District of Columbia.
(d) The term ''interstate'' means from a State or other area included
in the definition of ''United States'' to or through any other State or
other such area.
(Pub. L. 87-518, 1, July 2, 1962, 76 Stat. 129.)
This Act, referred to in text, is Pub. L. 87-518, July 2, 1962, 76
Stat. 129, as amended, which enacted sections 134 to 134h of this title
and amended sections 114a, 123 to 126, and 128 of this title and section
1114 of Title 18, Crimes and Criminal Procedure. For complete
classification of this Act to the Code, see Tables.
21 USC 134a. Seizure, quarantine, and disposal of livestock or poultry
to guard against introduction or dissemination of communicable disease
TITLE 21 -- FOOD AND DRUGS
(a) Authority of Secretary
The Secretary, whenever he deems it necessary in order to guard
against the introduction or dissemination of a communicable disease of
livestock or poultry, may seize, quarantine, and dispose of, in a
reasonable manner taking into consideration the nature of the disease
and the necessity of such action to protect the livestock or poultry of
the United States: (1) any animals which he finds are moving or are
being handled or have moved or have been handled in interstate or
foreign commerce contrary to any law or regulation administered by him
for the prevention of the introduction or dissemination of any
communicable disease of livestock or poultry; (2) any animals which he
finds are moving into the United States, or interstate, and are affected
with or have been exposed to any communicable disease dangerous to
livestock or poultry; and (3) any animals which he finds have moved
into the United States, or interstate, and at the time of such movement
were so affected or exposed.
(b) Determination of extraordinary emergency due to dangerous
communicable disease; seizure, quarantine, and disposal of animals;
action authorized only if adequate measures not taken by State or other
jurisdiction; notice to State or other jurisdiction
Whereas the existence of any dangerous, communicable disease of
livestock or poultry, such as foot-and-mouth disease, rinderpest, or
European fowl pest, on any premises in the United States would
constitute a threat to livestock and poultry of the Nation and would
seriously burden interstate and foreign commerce, whenever the Secretary
determines that an extraordinary emergency exists because of the
outbreak of such a disease anywhere in the United States, and that such
outbreak threatens the livestock or poultry of the United States, he may
seize, quarantine, and dispose of, in such manner as he deems necessary
or appropriate, any animals in the United States which he finds are or
have been affected with or exposed to any such disease and the carcasses
of any such animals and any products and articles which he finds were so
related to such animals as to be likely to be a means of disseminating
any such disease: Provided, That action shall be taken under this
subsection only if the Secretary finds that adequate measures are not
being taken by the State or other jurisdiction. The Secretary shall
notify the appropriate official of the State or other jurisdiction
before any action is taken in any such State or other jurisdiction
pursuant to this subsection.
(c) Notice to owner to quarantine or to dispose of animal, carcass,
product, or article; action on failure to comply; costs
The Secretary in writing may order the owner of any animal, carcass,
product, or article referred to in subsection (a) or (b) of this
section, or the agent of such owner, to maintain in quarantine, and to
dispose of such animal, carcass, product, or article in such manner as
the Secretary may direct pursuant to authority vested in him by such
subsections. If such owner or agent fails to do so after receipt of
such notice, the Secretary may take action as authorized by said
subsections (a) and (b) and recover from such owner or agent the
reasonable costs of any care, handling, and disposal incurred by the
Secretary in connection therewith. Such costs shall not constitute a
lien against the animals, carcasses, products, or articles involved.
Costs collected under this section shall be credited to the current
appropriation for carrying out animal disease control activities of the
Department.
(d) Compensation of owner; fair market value; payments from State
or other source; availability of funds
Except as provided in subsection (e) of this section, the Secretary
shall compensate the owner of any animal, carcass, product, or article
destroyed pursuant to the provisions of this section. Such compensation
shall be based upon the fair market value as determined by the
Secretary, of any such animal, carcass, product, or article at the time
of the destruction thereof. Compensation paid any owner under this
subsection shall not exceed the difference between any compensation
received by such owner from a State or other source and such fair market
value of the animal, carcass, product, or article. Funds in the
Treasury available for carrying out animal disease control activities of
the Department of Agriculture shall be used for carrying out this
subsection.
(e) Restriction on payment of compensation in cases of violation of
law or regulation
No such payment shall be made by the Secretary for any animal,
carcass, product, or article which has been moved or handled by the
owner thereof or his agent knowingly in violation of a law or regulation
administered by the Secretary for the prevention of the interstate
dissemination of the communicable disease, for which the animal,
carcass, product, or article was destroyed or a law or regulation for
the enforcement of which the Secretary enters or has entered into a
cooperative agreement for the control and eradication of such disease,
or for any animal which has moved into the United States contrary to
such law or regulation administered by the Secretary for the prevention
of the introduction of a communicable disease of livestock or poultry.
(Pub. L. 87-518, 2, July 2, 1962, 76 Stat. 129.)
1540.
21 USC 134b. Regulations for clean and sanitary movement of animals
TITLE 21 -- FOOD AND DRUGS
The Secretary, in order to protect the health of the livestock or
poultry of the Nation, may promulgate regulations requiring that railway
cars; vessels; airplanes; trucks; and other means of conveyance;
stockyards; feed, water, and rest stations; and other facilities, used
in connection with the movement of animals into or from the United
States, or interstate, be maintained in a clean and sanitary condition,
including requirements for inspection, cleaning, and disinfection.
(Pub. L. 87-518, 3, July 2, 1962, 76 Stat. 130.)
1540.
21 USC 134c. Regulations for movement of animals affected or exposed to
communicable disease
TITLE 21 -- FOOD AND DRUGS
The Secretary is authorized to promulgate regulations prohibiting or
regulating the movement into the United States of any animals which are
or have been affected with or exposed to any communicable animal
disease, or which have been vaccinated or otherwise treated for any such
disease, or which he finds would otherwise be likely to introduce or
disseminate any such disease, when he determines that such action is
necessary to protect the livestock or poultry of the United States.
(Pub. L. 87-518, 4, July 2, 1962, 76 Stat. 130.)
1540.
21 USC 134d. Inspections and seizures; issuance of warrants
TITLE 21 -- FOOD AND DRUGS
Employees of the Department of Agriculture designated by the
Secretary for the purpose, when properly identified, shall have
authority (1) to stop and inspect, without a warrant, any person or
means of conveyance, moving into the United States from a foreign
country, to determine whether such person or means of conveyance is
carrying any animal, carcass, product, or article regulated or subject
to disposal under any law or regulation administered by the Secretary
for prevention of the introduction or dissemination of any communicable
animal disease; (2) to stop and inspect, without a warrant, any means
of conveyance moving interstate upon probable cause to believe that such
means of conveyance is carrying any animal, carcass, product, or article
regulated or subject to disposal under any law or regulation
administered by the Secretary for the prevention of the introduction or
dissemination of any communicable animal disease; and (3) to enter
upon, with a warrant, any premises for the purpose of making inspections
and seizures necessary under such laws and regulations. Any Federal
judge, or any judge of a court of record in the United States, or any
United States magistrate judge, may, within his jurisdiction, upon
proper oath or affirmation indicating probable cause to believe that
there is on certain premises any animal, carcass, product, or article
regulated or subject to disposal under any law or regulation
administered by the Secretary for the prevention of the introduction or
dissemination of any communicable animal disease, issue warrants for the
entry upon such premises and for inspections and seizures necessary
under such laws and regulations. Such warrants may be executed by any
authorized employee of the Department of Agriculture.
(Pub. L. 87-518, 5, July 2, 1962, 76 Stat. 130; Pub. L. 90-578,
title IV, 402(b)(2), Oct. 17, 1968, 82 Stat. 1118; Pub. L. 101-650,
title III, 321, Dec. 1, 1990, 104 Stat. 5117.)
''United States magistrate judge'' substituted in text for ''United
States magistrate'' pursuant to section 321 of Pub. L. 101-650, set out
as a note under section 631 of Title 28, Judiciary and Judicial
Procedure. Previously, ''United States magistrate'' substituted for
''United States commissioner'' pursuant to Pub. L. 90-578. See chapter
43 ( 631 et seq.) of Title 28.
1540.
21 USC 134e. Enforcement provisions
TITLE 21 -- FOOD AND DRUGS
(a) Criminal and civil penalties
(1) Whoever knowingly violates any regulation promulgated pursuant to
the provisions of sections 134 through 134d of this title shall be
punished by a fine not exceeding $5,000 or by imprisonment not exceeding
one year, or both.
(2) Whoever violates any such regulation may be assessed a civil
penalty by the Secretary not exceeding $1,000. The Secretary may issue
an order assessing such civil penalty only after notice and an
opportunity for an agency hearing on the record. Such order shall be
treated as a final order reviewable under chapter 158 of title 28. The
validity of such order may not be reviewed in an action to collect such
civil penalty.
(b) Injunctive proceedings
The Secretary may bring an action to enjoin the violation of, or to
compel compliance with, any regulation promulgated or order issued under
said sections, or to enjoin any interference by any person with an
employee of the Department of Agriculture in carrying out any duties
under said sections, whenever the Secretary has reason to believe that
such person has violated, or is about to violate, any such regulation or
order, or has interfered, or is about to interfere, with any such
employee. Such action shall be brought in the United States district
court, or the United States court of any Territory or possession, for
the judicial district in which such person resides or transacts business
or in which the violation, omission, or interference has occurred or is
about to occur. Process in such cases may be served in any judicial
district wherein the defendant resides or transacts business or wherever
the defendant may be found, and subpenas for witnesses who are required
to attend the court in any judicial district in any such cases may run
into any other judicial district.
(Pub. L. 87-518, 6, July 2, 1962, 76 Stat. 131; Pub. L. 97-461, 8,
Jan. 12, 1983, 96 Stat. 2525.)
1983 -- Subsec. (a). Pub. L. 97-461 designated existing provisions
as par. (1), substituted ''$5,000'' for ''$1,000'', and added par.
(2).
21 USC 134f. Promulgation of regulations
TITLE 21 -- FOOD AND DRUGS
The Secretary is authorized to issue such regulations as he deems
necessary to carry out the provisions of this Act.
(Pub. L. 87-518, 11, July 2, 1962, 76 Stat. 132.)
This Act, referred to in text, is Pub. L. 87-518, July 2, 1962, 76
Stat. 129, as amended, which enacted sections 134 to 134h of this title
and amended sections 114a, 123 to 126, and 128 of this title and section
1114 of Title 18, Crimes and Criminal Procedure. For complete
classification of this Act to the Code, see Tables.
21 USC 134g. Authority in addition to other laws; repeal of
inconsistent provisions
TITLE 21 -- FOOD AND DRUGS
The authority conferred by this Act shall be in addition to authority
conferred by other statutes. Any provision of any other Act
inconsistent with the provisions of this Act is repealed.
(Pub. L. 87-518, 12, July 2, 1962, 76 Stat. 132.)
This Act, referred to in text, is Pub. L. 87-518, July 2, 1962, 76
Stat. 129, as amended, which enacted sections 134 to 134h of this title
and amended sections 114a, 123 to 126, and 128 of this title and section
1114 of Title 18, Crimes and Criminal Procedure. For complete
classification of this Act to the Code, see Tables.
21 USC 134h. Separability
TITLE 21 -- FOOD AND DRUGS
If any provision of this Act or application thereof to any person or
circumstances is held invalid, the remainder of the Act and the
application of such provision to other persons and circumstances shall
not be affected thereby.
(Pub. L. 87-518, 13, July 2, 1962, 76 Stat. 132.)
This Act, referred to in text, is Pub. L. 87-518, July 2, 1962, 76
Stat. 129, as amended, which enacted sections 134 to 134h of this title
and amended sections 114a, 123 to 126, and 128 of this title and section
1114 of Title 18, Crimes and Criminal Procedure. For complete
classification of this Act to the Code, see Tables.
21 USC 135. International animal quarantine station; establishment;
acceptance of gifts; cooperation with breeders' organizations;
collection of fees
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture is authorized, in his discretion, to
establish and maintain an international animal quarantine station within
the territory of the United States. The quarantine station shall be
located on an island selected by the Secretary of Agriculture where, in
his judgment, maximum animal disease and pest security measures can be
maintained. The Secretary of Agriculture is authorized to acquire land
or any interest therein, by purchase, donation, exchange, or otherwise
and construct or lease buildings, improvements, and other facilities as
may be necessary for the establishment and maintenance of such
quarantine station. The Secretary of Agriculture, on behalf of the
United States, is authorized to accept any gift or donation of money,
personal property, buildings, improvements, and other facilities for the
purpose of conducting the functions authorized under sections 135 to
135b of this title. Notwithstanding the provisions of any other law to
prevent the introduction or dissemination of livestock or poultry
disease or pests, animals may be brought into the quarantine station
from any country, including but not limited to those countries in which
the Secretary of Agriculture determines that rinderpest or
foot-and-mouth disease exists, and subsequently moved into other parts
of the United States in accordance with such conditions as the Secretary
of Agriculture shall determine are adequate in order to prevent the
introduction into and the dissemination within the United States of
livestock or poultry diseases or pests. The Secretary of Agriculture is
authorized to cooperate in such manner as he deems appropriate, with
other North American countries or with breeders' organizations or
similar organizations or with individuals within the United States
regarding importation of animals into and through the quarantine station
and to charge and collect reasonable fees for use of the facilities of
such station from importers. Such fees shall be deposited into the
Treasury of the United States to the credit of the appropriation charged
with the operating expenses of the quarantine station. The Secretary is
authorized to issue such regulations as he deems necessary to carry out
the provisions of sections 135 to 135b of this title.
(Pub. L. 91-239, 1, May 6, 1970, 84 Stat. 202.)
21 USC 135a. Smuggling penalties
TITLE 21 -- FOOD AND DRUGS
(a) Criminal penalty
The provisions and penalties of section 545 of title 18 shall apply
to the bringing of animals to the quarantine station or the subsequent
movement of animals to other parts of the United States, including
Puerto Rico, Guam, and the Virgin Islands, contrary to the conditions
prescribed by the Secretary in regulations issued hereunder.
(b) Civil penalty
Any person who brings any animal to the quarantine station or moves
any animal from the quarantine station, contrary to the conditions
prescribed by the Secretary in regulations issued hereunder, may be
assessed a civil penalty by the Secretary not to exceed $1,000. The
Secretary may issue an order assessing such civil penalty only after
notice and an opportunity for an agency hearing on the record. Such
order shall be treated as a final order reviewable under chapter 158 of
title 28. The validity of such order may not be reviewed in an action
to collect such civil penalty.
(Pub. L. 91-239, 2, May 6, 1970, 84 Stat. 202; Pub. L. 97-461, 9,
Jan. 12, 1983, 96 Stat. 2525.)
1983 -- Pub. L. 97-461 designated existing provisions as subsec.
(a) and added subsec. (b).
21 USC 135b. Authorization of appropriations
TITLE 21 -- FOOD AND DRUGS
There are hereby authorized to be appropriated such sums as are
necessary to carry out the provisions of sections 135 to 135b of this
title.
(Pub. L. 91-239, 3, May 6, 1970, 84 Stat. 202.)
21 USC 136. Additional inspection services
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture, in carrying out regulations prohibiting
or restricting the entry of materials that may harbor pests, or
diseases, is authorized to enter into agreements with operators or
owners of vessels or aircraft for the purpose of providing inspection
services at points of entry in the United States in addition to the
regular or on-call basis currently available in connection with such
vessels or aircraft. Any such agreement shall provide for the payment
by the operator or owner of an amount determined by the Secretary to be
necessary to defray the costs of providing additional service pursuant
to such agreement.
(Pub. L. 101-624, title XXV, 2508, Nov. 28, 1990, 104 Stat. 4069.)
21 USC 136a. Collection of fees for inspection services
TITLE 21 -- FOOD AND DRUGS
(a) Quarantine, inspection and transportation fees
(1) Quarantine and inspection
(A) In general
The Secretary of Agriculture (hereafter referred to in this section
as the ''Secretary'') may prescribe and collect fees to cover the cost
of providing agricultural quarantine and inspection services in
connection with the arrival at a port in the customs territory of the
United States, or the preclearance or preinspection at a site outside
the customs territory of the United States, of an international
passenger, commercial vessel, commercial aircraft, commercial truck, or
railroad car.
(B) Airport inspection services
For airport inspection services, the Secretary shall collect no more
than $69,000,000 in fiscal year 1992 and $75,000,000 in fiscal year 1993
from international airline passengers and commercial aircraft operators.
(C) Commercial truck and railroad car inspection services
For commercial truck and railroad car inspection services, the
Secretary shall collect no more than $3,667,000 in fiscal year 1992 and
$3,890,000 in fiscal year 1993 from commercial truck and railroad car
operators.
(D) Costs
Fees, including fees from international airline passengers and
commercial aircraft operators, may only be collected to the extent that
the Secretary reasonably estimates that the amount of the fees are
commensurate with the costs of agricultural quarantine and inspection
services with respect to the class of persons or entities paying the
fees. The costs of such services with respect to passengers as a class
includes the costs of related inspections of the aircraft.
(2) Treasury
Any person who collects a fee under this subsection shall remit such
fee to the Treasury of the United States prior to the date that is 31
days after the close of the calendar quarter in which such fee is
collected.
(3) Agricultural Quarantine Inspection User Fee Account
(A) Establishment
There is established in the Treasury of the United States a no-year
fund, to be known as the ''Agricultural Quarantine Inspection User Fee
Account'' (hereafter referred to in this section as the ''Account''),
for the use of the Secretary for quarantine or inspection services under
this section.
(B) Amounts in Account
(i) Deposits
All of the fees collected under this subsection shall be deposited in
the Account.
(ii) Reimbursement
The Secretary of the Treasury shall use the Account to provide
reimbursements to any appropriation accounts that incur the costs
associated with the administration of this subsection and all other
activities carried out by the Secretary at ports in the customs
territory of the United States and at preclearance or preinspection
sites outside the customs territory of the United States in connection
with the enforcement of the animal quarantine laws. Any such
reimbursement shall be subject to appropriations under clause (v).
(iii) Procedure
The Secretary of the Treasury shall make reimbursement under clause
(ii) on a quarterly basis. Amounts required to be reimbursed under
clause (ii), shall be made on the basis of estimates made by the
Secretary of the expenses described in clause (ii) that are incurred by
the Secretary in the 3-month period immediately preceding such
reimbursement.
(iv) Adjustments
Adjustments of reimbursements made under clause (ii) shall be made to
the extent necessary to correct prior estimates that were in excess of,
or less than, the amount required to be reimbursed under clause (iii).
(v) Authorization of appropriations
There are authorized to be appropriated each fiscal year amounts in
the Fund /1/ for use for quarantine or inspection services.
(4) Adjustment in fee amounts
Subject to the limits set forth in paragraph (1), the Secretary shall
adjust the amount of the fees to be assessed under this subsection to
reflect the cost to the Secretary in administering such subsection, in
carrying out the activities at ports in customs territory of the United
States and preclearance and preinspection sites outside the customs
territory of the United States in connection with the provision of
agricultural quarantine inspection services, and in maintaining a
reasonable balance in the Account.
(b) Omitted
(c) Animal inspection and veterinary diagnostics
(1) Animal inspection
The Secretary may prescribe and collect fees to reimburse the
Secretary for the cost of carrying out the provisions of the Federal
Animal Quarantine Laws that relate to the importation, entry, and
exportation of animals, articles, or means of conveyance.
(2) Omitted
(3) Fees
All fees collected pursuant to this subsection and any late payment
penalties or accrued interest collected pursuant to this subsection
shall be credited to the accounts that incur the cost and shall remain
available until expended without fiscal year limitation.
(4) Liability
Any person for whom an activity related to the importation, entry, or
exportation of an animal, article, or means of conveyance or relating to
veterinary diagnostics, is performed pursuant to the section, shall be
liable for payment of fees assessed. Upon failure to pay such fees when
due, the Secretary shall assess a late payment penalty, and such overdue
fees shall accrue interest, as required by section 3717 of title 31.
All fees, late payment penalties, and accrued interest collected shall
be credited to such accounts that incur the costs and shall remain
available until expended without fiscal year limitation.
(5) Leins /2/
(A) In general
The Secretary shall have a lien against the animal, article, means of
conveyance, or facility for which services have been provided under this
section for the fees, any late payment penalty, and any accrued interest
assessed under this subsection.
(B) Other animals, etc.
In the case of any person who fails to make payment when due under
this subsection, the Secretary shall have a lien against any animal,
article, or means of conveyance thereafter imported, moved in interstate
commerce, or attempted to be exported by the person after the date of
such failure until the date on which such owner or operator make /3/
full payment to the Secretary under this subsection.
(C) Sales of animals, etc.
(i) Authority
The Secretary may, if a person does not pay fees, late payment
penalties, or accrued interest on such, after providing reasonable
notice of default to such person, sell at public sale after reasonable
public notice, or otherwise dispose of, any such animal, article, means
of conveyance or facility on which the Secretary has a lien under this
paragraph.
(ii) Excess proceeds
If the sale proceeds under clause (i) exceed the fees due, any late
payment penalty assessed, any accrued interest on such, and the expenses
associated with the sale, such excess shall be paid to the owner of the
animal, article, means of conveyance, or facility if such owner submits
an application for such excess together with proof of ownership not
later than 6 months after the date of such sale. If no such application
is made, such excess shall be credited to accounts that incur the costs
associated with the fees collected and shall remain available until
expended, without fiscal year limitation. The Secretary shall suspend
performance of services to persons who have failed to pay fees, late
payment penalty, or accrued interest under this section.
(d) Regulations
The Secretary may prescribe such regulations as the Secretary
determines necessary to carry out the provisions of this section.
(e) Recovery of amounts owed
An action may be brought for the recovery of fees, late payment
penalties, and accrued interest which have not been paid in accordance
with this section against any person obligated for payment of such
assessments under this section in any United States district court or
other United States court for any territory or possession in any
jurisdiction in which such person is found or resides or transacts
business, and such court shall have jurisdiction to hear and decide such
action.
(f) Definitions
(1) Animal quarantine laws
For purposes of this section, the term ''animal quarantine laws''
means --
(A) section 306 of the Tariff Act of 1930 (19 U.S.C. 1306);
(B) sections 6 through 10 of the Act of August 30, 1890 (26 Stat.
416, chapter 839; 21 U.S.C. 101-105);
(C) section 2 of the Act of February 2, 1903 (32 Stat. 792, chapter
349; 21 U.S.C. 111);
(D) the Act of May 29, 1884 (23 Stat. 32, chapter 60; 21 U.S.C. 112
to 114a-1, 115, 117-119, and 130) (commonly known as the ''Animal
Industry Act'');
(E) the Act of February 28, 1947 (61 Stat. 7, chapter 8; 21 U.S.C.
114b, 114c, and 114d-1);
(F) the Act of June 16, 1948 (62 Stat. 458, chapter 477; 21 U.S.C.
114e and 114f);
(G) Public Law 87-209 (21 U.S.C. 114g and 114h);
(H) the Act of May 31, 1920 (41 Stat. 699, chapter 217; 21 U.S.C.
116);
(I) the Act of February 2, 1903 (32 Stat. 791, chapter 349; 21 U.S.
C. 112 and 120-122) (commonly known as the ''Cattle Contagious Diseases
Act of 1903'');
(J) the Act of March 3, 1905 (33 Stat. 1264, chapter 1496; 21 U.S.
C. 123-127) (commonly known as the ''Cattle Contagious Diseases Act of
1905'');
(K) the matter under the heading ''Bureau of Animal Industry'' of the
Act of June 30, 1914 (38 Stat. 419, chapter 131; 21 U.S.C. 128);
(L) section 101 of Public Law 92-73 (21 U.S.C. 129);
(M) the matter under the heading ''Miscellaneous'' of the Act of May
26, 1910 (36 Stat. 440, chapter 256; 21 U.S.C. 131);
(N) sections 1 through 6 and 11 through 13 of Public Law 87-518 (21
U.S.C. 134-134h); or
(O) any other Act administered by the Secretary relating to plant or
animal diseases or pests, other than the first section of Public Law
91-239 (21 U.S.C. 135).
(2) Customs territory
For the purposes of subsection (a) of this section, the term
''customs territory of the United States'' means the 50 States, the
District of Columbia, and Puerto Rico.
(3) Person
For the purposes of this section, the term ''person'' means an
individual, corporation, partnership, trust, association, or any other
public or private entity, or any officer, employee, or agent thereof.
(4) United States
For the purposes of subsection (b) of this section, the term ''United
States'' means the several States of the United States, the District of
Columbia, Guam, the Commonwealth of the Northern Mariana Islands, the
Commonwealth of Puerto Rico, the Virgin Islands of the United States,
and all other territories and possessions of the United States.
(5) Vessel
For the purposes of subsection (a) of this section, the term
''vessel'' does not include any ferry.
(Pub. L. 101-624, title XXV, 2509, Nov. 28, 1990, 104 Stat. 4069;
Pub. L. 101-508, title I, 1203, Nov. 5, 1990, 104 Stat. 1388-11; Pub.
L. 102-237, title X, 1015, Dec. 13, 1991, 105 Stat. 1902.)
Section 101 of Public Law 92-73, referred to in subsec. (f)(1)(L), is
listed in a Similar Provisions note set out under section 129 of this
title.
Section is comprised of section 2509 of Pub. L. 101-624. Subsecs.
(b) and (c)(2) of section 2509 of Pub. L. 101-624 amended section
147a(f) of Title 7, Agriculture, and section 114a of this title,
respectively.
1991 -- Subsec. (a)(1). Pub. L. 102-237, 1015(1), designated
existing provisions as subpar. (A), realigned margin, added heading,
and added subpars. (B) to (D).
Subsec. (a)(3)(B)(ii). Pub. L. 102-237, 1015(2), added cl. (ii) and
struck out former cl. (ii) which read as follows: ''The Secretary of
Treasury shall use the Account to provide reimbursements to any
appropriations accounts that incur the costs associated with the
services authorized in paragraph (1). Any such reimbursement shall be
subject to appropriations under clause (v).''
Subsec. (a)(4). Pub. L. 102-237, 1015(3), substituted ''Subject to
the limits set forth in paragraph (1), the'' for ''The''.
1990 -- Subsec. (a)(1). Pub. L. 101-508, 1203(1), substituted ''an
international passenger, commercial vessel, commercial aircraft,
commercial truck, or railroad car.'' for ''a commercial vessel,
commercial aircraft, commercial truck, or railroad car,''.
Subsec. (a)(3)(B)(ii). Pub. L. 101-508, 1203(2)(A), inserted at end
''Any such reimbursement shall be subject to appropriations under clause
(v).''
Subsec. (a)(3)(B)(v). Pub. L. 101-508, 1203(2)(B), added cl. (v).
Amendment by Pub. L. 101-508 effective Nov. 29, 1990, see section
1301 of Pub. L. 101-508, set out as a note under section 511r of Title
7, Agriculture.
/1/ So in original. Probably should be ''Account''.
/2/ So in original. Probably should be ''Liens''.
/3/ So in original. Probably should be ''makes''.
21 USC SUBCHAPTER IV -- IMPORTATION OF MILK AND CREAM
TITLE 21 -- FOOD AND DRUGS
By virtue of act June 25, 1938, ch. 675, 902(c), 52 Stat. 1059
(section 392(b) of this title), nothing contained in section 301 et seq.
of this title shall be construed as in any way affecting, modifying,
repealing, or superseding the provisions of this subchapter.
21 USC 141. Prohibition of importation without permit
TITLE 21 -- FOOD AND DRUGS
On and after May 16, 1927, the importation into the United States of
milk and cream is prohibited unless the person by whom such milk or
cream is shipped or transported into the United States holds a valid
permit from the Secretary of Health and Human Services.
(Feb. 15, 1927, ch. 155, 1, 44 Stat. 1101; 1940 Reorg. Plan No. IV,
12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan
No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17,
1979, Pub. L. 96-88, title V, 509(b), 93 Stat. 695.)
''Secretary of Health and Human Services'' substituted in text for
''Secretary of Health, Education, and Welfare'' pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in
part that act Feb. 15, 1927, which is classified to this subchapter,
may be cited as ''Import Milk Act''.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Federal Food, Drug, and Cosmetic Act as not affecting, modifying,
repealing, or superseding this subchapter, see section 392 of this
title.
21 USC 142. Milk or cream when unfit for importation
TITLE 21 -- FOOD AND DRUGS
Milk or cream shall be considered unfit for importation (1) when all
cows producing such milk or cream are not healthy and a physical
examination of all such cows has not been made within one year previous
to such milk being offered for importation; (2) when such milk or
cream, if raw, is not produced from cows which have passed a tuberculin
test applied by a duly authorized official veterinarian of the United
States, or of the country in which such milk or cream is produced,
within one year previous to the time of the importation, showing that
such cows are free from tuberculosis; (3) when the sanitary conditions
of the dairy farm or plant in which such milk or cream is produced or
handled do not score at least fifty points out of one hundred points
according to the methods for scoring as provided by the score cards,
used by the Bureau of Dairy Industry of the United States Department of
Agriculture at the time such dairy farms or plants are scored; (4) in
the case of raw milk if the number of bacteria per cubic centimeter
exceeds three hundred thousand and in the case of raw cream seven
hundred and fifty thousand, in the case of pasteurized milk if the
number of bacteria per cubic centimeter exceeds one hundred thousand,
and in the case of pasteurized cream five hundred thousand; (5) when
the temperature of milk or cream at the time of importation exceeds
fifty degrees Fahrenheit.
(Feb. 15, 1927, ch. 155, 2, 44 Stat. 1101.)
Agricultural Research Service became the successor to functions of
Bureau of Dairy Industry under Secretary of Agriculture's Memorandum
1320, Supplement 4, Nov. 2, 1953.
21 USC 143. Inspection; certified statement in lieu thereof; waiver
of requirements of section 142; regulations; suspension and revocation
of permits
TITLE 21 -- FOOD AND DRUGS
The Secretary of Health and Human Services shall cause such
inspections to be made as are necessary to insure that milk and cream
are so produced and handled as to comply with the provisions of section
142 of this title, and in all cases when he finds that such milk and/or
cream is produced and handled so as not to be unfit for importation
under clauses 1, 2, and 3 of section 142 of this title, he shall issue
to persons making application therefor permits to ship milk and/or cream
into the United States: Provided, That in lieu of the inspections to be
made by or under the direction of the Secretary he may, in his
discretion, accept a duly certified statement signed by a duly
accredited official of an authorized department of any foreign
government and/or of any State of the United States or any municipality
thereof that the provisions in clauses 1, 2, and 3 of section 142 of
this title have been complied with. Such certificate of the accredited
official of an authorized department of any foreign government shall be
in the form prescribed by the Secretary, who is authorized and directed
to prescribe such form as well as rules and regulations regulating the
issuance of permits to import milk or cream into the United States.
The Secretary is authorized, in his discretion, to waive the
requirement of clause 4 of section 142 of this title when issuing
permits to operators of condenseries in which milk and/or cream is used
when sterilization of the milk and/or cream is a necessary process:
Provided, however, That no milk and/or cream shall be imported whose
bacterial count per cubic centimeter in any event exceeds one million
two hundred thousand: Provided, further, That such requirements shall
not be waived unless the farm producing such milk to be imported is
within a radius of fifteen miles of the condensery in which it is to be
processed: Provided further, That if milk and/or cream imported when
the requirements of clause 4 of section 142 of this title, have been so
waived, is sold, used, or disposed of in its raw state or otherwise than
as condensed milk by any person, the permit shall be revoked and the
importer shall be subject to fine, imprisonment, or other penalty
prescribed by this subchapter.
The Secretary is directed to waive the requirements of clauses 2 and
5 of section 142 of this title insofar as the same relate to milk when
issuing permits to operators of, or to producers for delivery to,
creameries and condensing plants in the United States within twenty
miles of the point of production of the milk, and who import no raw milk
except for pasteurization or condensing: Provided, That if milk
imported when the requirements of clauses 2 and 5 of section 142 of this
title have been so waived is sold, used, or disposed of in its raw
state, or otherwise than as pasteurized, condensed, or evaporated milk
by any person, the permit shall be revoked and the importer shall be
subjected to fine, imprisonment, or other penalty prescribed by this
subchapter.
The Secretary is authorized and directed to make and enforce such
regulations as may in his judgment be necessary to carry out the purpose
of this subchapter for the handling of milk and cream, for the
inspection of milk, cream, cows, barns, and other facilities used in the
production and handling of milk and/or cream and the handling, keeping,
transporting, and importing of milk and/or cream: Provided, however,
That unless and until the Secretary shall provide for inspections to
ascertain that clauses 1, 2, and 3 of section 142 of this title have
been complied with, the Secretary shall issue temporary permits to any
applicants therefor to ship or transport milk and/or cream into the
United States.
The Secretary is authorized to suspend or revoke any permit for the
shipment of milk or cream into the United States when he shall find that
the holder thereof has failed to comply with the provisions of or has
violated this subchapter or any of the regulations made hereunder, or
that the milk and/or cream brought or shipped by the holder of such
permit into the United States is not produced and handled in conformity
with, or that the quality thereof does not conform to, all of the
provisions of section 142 of this title.
(Feb. 15, 1927, ch. 155, 3, 44 Stat. 1102; 1940 Reorg. Plan No. IV,
12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan
No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17,
1979, Pub. L. 96-88, title V, 509(b), 93 Stat. 695.)
''Secretary of Health and Human Services'' substituted in text for
''Secretary of Health, Education, and Welfare'' pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 144. Unlawful receiving of imported milk or cream
TITLE 21 -- FOOD AND DRUGS
It shall be unlawful for any person in the United States to receive
milk or cream imported into the United States unless the importation is
in accordance with the provisions of this subchapter.
(Feb. 15, 1927, ch. 155, 4, 44 Stat. 1103.)
21 USC 145. Penalties
TITLE 21 -- FOOD AND DRUGS
Any person who knowingly violates any provision of this subchapter
shall, in addition to all other penalties prescribed by law, be punished
by a fine of not less than $50 nor more than $2,000, or by imprisonment
for not more than one year, or by both such fine and imprisonment.
(Feb. 15, 1927, ch. 155, 5, 44 Stat. 1103.)
21 USC 146. Authorization of appropriations
TITLE 21 -- FOOD AND DRUGS
There is authorized to be appropriated, out of any moneys in the
Treasury not otherwise appropriated, the sum of $50,000 per annum, to
enable the Secretary of Health and Human Services to carry out the
provisions of this subchapter.
(Feb. 15, 1927, ch. 155, 6, 44 Stat. 1103; 1940 Reorg. Plan No. IV,
12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan
No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17,
1979, Pub. L. 96-88, title V, 509(b), 93 Stat. 695.)
''Secretary of Health and Human Services'' substituted in text for
''Secretary of Health, Education, and Welfare'' pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see Transfer of Functions note set out under section 41 of this
title.
21 USC 147. Repeal of inconsistent laws
TITLE 21 -- FOOD AND DRUGS
Any laws or parts of laws inconsistent with this subchapter are
repealed.
(Feb. 15, 1927, ch. 155, 7, 44 Stat. 1103.)
Federal Food, Drug, and Cosmetic Act as not affecting, modifying,
repealing, or superseding this subchapter, see section 392 of this
title.
21 USC 148. Powers of State with respect to milk or cream lawfully
imported
TITLE 21 -- FOOD AND DRUGS
Nothing in this subchapter is intended nor shall be construed to
affect the powers of any State, or any political subdivision thereof, to
regulate the shipment of milk or cream into, or the handling, sale, or
other disposition of milk or cream in, such State or political
subdivision after the milk and/or cream shall have been lawfully
imported under the provisions of this subchapter.
(Feb. 15, 1927, ch. 155, 8, 44 Stat. 1103.)
21 USC 149. Definitions
TITLE 21 -- FOOD AND DRUGS
When used in this subchapter --
(a) The term ''person'' means an individual, partnership,
association, or corporation.
(b) The term ''United States'' means the fifty States and the
District of Columbia.
(Feb. 15, 1927, ch. 155, 9, 44 Stat. 1103; June 25, 1959, Pub. L.
86-70, 19, 73 Stat. 145; July 12, 1960, Pub. L. 86-624, 15, 74 Stat.
415.)
1960 -- Subsec. (b). Pub. L. 86-624 substituted ''means the fifty
States and the District of Columbia'' for ''means continental United
States, including Alaska''.
1959 -- Subsec. (b). Pub. L. 86-70 inserted '', including Alaska''
after ''continental United States''.
21 USC CHAPTER 5 -- VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
TITLE 21 -- FOOD AND DRUGS
Sec.
151. Preparation and sale of worthless or harmful products for
domestic animals prohibited; preparation to be in compliance with rules
at licensed establishments.
152. Importation regulated and prohibited.
153. Inspection of imports; denial of entry and destruction.
154. Regulations for preparation and sale; licenses.
154a. Special licenses for special circumstances; expedited
procedure; conditions; exemptions; criteria.
155. Permits for importation.
156. Licenses conditioned on permitting inspection; suspension of
licenses.
157. Inspection.
158. Offenses; punishment.
159. Enforcement; penalties applicable; Congressional findings.
By virtue of act June 25, 1938, ch. 675, 902(c), 52 Stat. 1059
(section 392(b) of this title), nothing contained in section 301 et seq.
of this title shall be construed as in any way affecting, modifying,
repealing, or superseding the provisions of this chapter.
Biological products, regulation, see section 262 of Title 42, The
Public Health and Welfare.
271.
21 USC 151. Preparation and sale of worthless or harmful products for
domestic animals prohibited; preparation to be in compliance with rules
at licensed establishments
TITLE 21 -- FOOD AND DRUGS
It shall be unlawful for any person, firm, or corporation to prepare,
sell, barter, or exchange in the District of Columbia, or in the
Territories, or in any place under the jurisdiction of the United
States, or to ship or deliver for shipment in or from the United States,
the District of Columbia, any territory of the United States, or any
place under the jurisdiction of the United States, any worthless,
contaminated, dangerous, or harmful virus, serum, toxin, or analogous
product intended for use in the treatment of domestic animals, and no
person, firm, or corporation shall prepare, sell, barter, exchange, or
ship as aforesaid any virus, serum, toxin, or analogous product
manufactured within the United States and intended for use in the
treatment of domestic animals, unless and until the said virus, serum,
toxin, or analogous product shall have been prepared, under and in
compliance with regulations prescribed by the Secretary of Agriculture,
at an establishment holding an unsuspended and unrevoked license issued
by the Secretary of Agriculture as hereinafter authorized.
(Mar. 4, 1913, ch. 145, 1 (part), 37 Stat. 832; Dec. 23, 1985, Pub.
L. 99-198, title XVII, 1768(a), 99 Stat. 1654.)
The sections of this chapter are comprised of the sentences of the
eighth paragraph under the heading ''Bureau of Animal Industry,'' in the
Department of Agriculture Appropriation Act, 1914, as amended.
Another section 1768 of Pub. L. 99-198, cited as a credit to this
section, amended section 136y of Title 7, Agriculture.
1985 -- Pub. L. 99-198 substituted ''in or from the United States,
the District of Columbia, any territory of the United States, or any
place under the jurisdiction of the United States'' for ''from one State
or Territory or the District of Columbia to any other State or Territory
or the District of Columbia''.
Section 1768(f) of Pub. L. 99-198 provided that:
''(1) Except as provided in paragraph (2), the amendments made by
this section (enacting sections 154a and 159 of this title and amending
this section and sections 154 and 157 of this title) shall become
effective on the date of enactment of this Act (Dec. 23, 1985).
''(2)(A) Subject to subparagraphs (B) through (D), in the case of a
person, firm, or corporation preparing, selling, bartering, exchanging,
or shipping a virus, serum, toxin, or analogous product during the
12-month period ending on the date of enactment of this Act (Dec. 23,
1985) solely for intrastate commerce or for exportation, such product
shall not after such date of enactment, as a result of its not having
been licensed or produced in a licensed establishment, be considered in
violation of the eighth paragraph of the matter under the heading
'BUREAU OF ANIMAL INDUSTRY' of the Act entitled 'An Act making
appropriations for the Department of Agriculture for the fiscal year
ending June thirtieth, nineteen hundred and fourteen', approved March
14, 1913 (as amended by this section) (this chapter), until the first
day of the 49th month following the date of enactment of this Act.
''(B) The exemption granted by subparagraph (A) may be extended by
the Secretary of Agriculture for a period up to 12 months in an
individual case on a showing by a person, firm, or corporation of good
cause and a good faith effort to comply with such eighth paragraph with
due diligence.
''(C) The exemption granted by subparagraph (A) must be claimed by
the person, firm, or corporation preparing such product by the first day
of the 13th month following the date of enactment of this Act (Dec. 23,
1985), in the form and manner prescribed by the Secretary, unless the
Secretary grants an extension of the time to claim such exemption in an
individual case for good cause shown.
''(D) On the issuance by the Secretary of a license to such person,
firm, or corporation for such product prior to the first day of the 49th
month following the date of enactment of this Act (Dec. 23, 1985), or
the end of an extension of the exemption granted by the Secretary, the
exemption granted by subparagraph (A) shall terminate with respect to
such product.''
Act Mar. 4, 1913, ch. 145, 1 (part), 37 Stat. 832, which is
classified to this chapter, is popularly known as the
''Virus-Serum-Toxin Act''.
An appropriation of $25,000 was made by act Mar. 4, 1913, for the
purpose of carrying into effect these provisions. The appropriation for
the fiscal year 1926 was by act Feb. 10, 1925, ch. 200, 43 Stat. 827.
21 USC 152. Importation regulated and prohibited
TITLE 21 -- FOOD AND DRUGS
The importation into the United States of any virus, serum, toxin, or
analogous product for use in the treatment of domestic animals, and the
importation of any worthless, contaminated, dangerous, or harmful virus,
serum, toxin, or analogous product for use in the treatment of domestic
animals, is prohibited without (1) a permit from the Secretary of
Agriculture, or (2) in the case of an article originating in Canada,
such permit or, in lieu of such permit, such certification by Canada as
may be prescribed by the Secretary of Agriculture.
(Mar. 4, 1913, ch. 145, 1 (part), 37 Stat. 832; Sept. 28, 1988, Pub.
L. 100-449, title III, 301(d), 102 Stat. 1868.)
See Codification note set out under section 151 of this title.
1988 -- Pub. L. 100-449 amended section generally. Prior to
amendment, section read as follows: ''The importation into the United
States, without a permit from the Secretary of Agriculture, of any
virus, serum, toxin, or analogous product for use in the treatment of
domestic animals, and the importation of any worthless, contaminated,
dangerous, or harmful virus, serum, toxin, or analogous product for use
in the treatment of domestic animals, are prohibited.''
Amendment by Pub. L. 100-449 effective on the date the United
States-Canada Free-Trade Agreement enters into force (Jan. 1, 1989), and
to cease to have effect on the date the Agreement ceases to be in force,
see section 501(a), (c) of Pub. L. 100-449, set out in a note under
section 2112 of Title 19, Customs Duties.
21 USC 153. Inspection of imports; denial of entry and destruction
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture is authorized to cause the Bureau of
Animal Industry to examine and inspect all viruses, serums, toxins, and
analogous products, for use in the treatment of domestic animals, which
are being imported or offered for importation into the United States, to
determine whether such viruses, serums, toxins, and analogous products
are worthless, contaminated, dangerous, or harmful, and if it shall
appear that any such virus, serum, toxin, or analogous product, for use
in the treatment of domestic animals, is worthless, contaminated,
dangerous, or harmful, the same shall be denied entry and shall be
destroyed or returned at the expense of the owner or importer.
(Mar. 4, 1913, ch. 145, 1 (part), 37 Stat. 832.)
See Codification note set out under section 151 of this title.
21 USC 154. Regulations for preparation and sale; licenses
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture is authorized to make and promulgate
from time to time such rules and regulations as may be necessary to
prevent the preparation, sale, barter, exchange, or shipment as
aforesaid of any worthless, contaminated, dangerous, or harmful virus,
serum, toxin, or analogous product for use in the treatment of domestic
animals, or otherwise to carry out this chapter, and to issue, suspend,
and revoke licenses for the maintenance of establishments for the
preparation of viruses, serums, toxins, and analogous products, for use
in the treatment of domestic animals, intended for sale, barter,
exchange, or shipment as aforesaid.
(Mar. 4, 1913, ch. 145, 1 (part), 37 Stat. 832; Dec. 23, 1985, Pub.
L. 99-198, title XVII, 1768(b), 99 Stat. 1654.)
See Codification note set out under section 151 of this title.
Another section 1768 of Pub. L. 99-198, cited as a credit to this
section, amended section 136y of Title 7, Agriculture.
1985 -- Pub. L. 99-198 inserted ''or otherwise to carry out this
chapter,'' after ''domestic animals,''.
Amendment by Pub. L. 99-198 effective Dec. 23, 1985, except as
otherwise provided, see section 1768(f) of Pub. L. 99-198, set out as a
note under section 151 of this title.
21 USC 154a. Special licenses for special circumstances; expedited
procedure; conditions; exemptions; criteria
TITLE 21 -- FOOD AND DRUGS
In order to meet an emergency condition, limited market or local
situation, or other special circumstance (including production solely
for intrastate use under a State-operated program), the Secretary may
issue a special license under an expedited procedure on such conditions
as are necessary to assure purity, safety, and a reasonable expectation
of efficacy. The Secretary shall exempt by regulation from the
requirement of preparation pursuant to an unsuspended and unrevoked
license any virus, serum, toxin, or analogous product prepared by any
person, firm, or corporation --
(1) solely for administration to animals of such person, firm, or
corporation;
(2) solely for administration to animals under a
veterinarian-client-patient relationship in the course of the State
licensed professional practice of veterinary medicine by such person,
firm, or corporation; or
(3) solely for distribution within the State of production pursuant
to a license granted by such State under a program determined by the
Secretary to meet criteria under which the State --
(A) may license virus, serum, toxin, and analogous products and
establishments that produce such products;
(B) may review the purity, safety, potency, and efficacy of such
products prior to licensure;
(C) may review product test results to assure compliance with
applicable standards for purity, safety, and potency, prior to release
to the market;
(D) may deal effectively with violations of State law regulating
virus, serum, toxin, and analogous products; and
(E) exercises the authority referred to in subclauses (A) through (D)
consistent with the intent of this chapter of prohibiting the
preparation, sale, barter, exchange, or shipment of worthless,
contaminated, dangerous, or harmful virus, serum, toxin, or analogous
products.
(Mar. 4, 1913, ch. 145, 1 (part), as added Dec. 23, 1985, Pub. L.
99-198, title XVII, 1768(c), 99 Stat. 1654.)
See Codification note set out under section 151 of this title.
Another section 1768 of Pub. L. 99-198, cited as a credit to this
section, amended section 136y of Title 7, Agriculture.
Section effective Dec. 23, 1985, except as otherwise provdied, see
section 1768(f) of Pub. L. 99-198, set out as an Effective Date of 1985
Amendment note under section 151 of this title.
21 USC 155. Permits for importation
TITLE 21 -- FOOD AND DRUGS
The Secretary of Agriculture is authorized to issue permits for the
importation into the United States of viruses, serums, toxins, and
analogous products, for use in the treatment of domestic animals, which
are not worthless, contaminated, dangerous, or harmful.
(Mar. 4, 1913, ch. 145, 1 (part), 37 Stat. 833.)
See Codification note set out under section 151 of this title.
21 USC 156. Licenses conditioned on permitting inspection; suspension
of licenses
TITLE 21 -- FOOD AND DRUGS
All licenses issued under authority of this chapter to establishments
where such viruses, serums, toxins, or analogous products are prepared
for sale, barter, exchange, or shipment as aforesaid, shall be issued on
condition that the licensee shall permit the inspection of such
establishments and of such products and their preparation; and the
Secretary of Agriculture may suspend or revoke any permit or license
issued under authority of said chapter, after opportunity for hearing
has been granted the licensee or importer, when the Secretary of
Agriculture is satisfied that such license or permit is being used to
facilitate or effect the preparation, sale, barter, exchange, or
shipment as aforesaid, or the importation into the United States of any
worthless, contaminated, dangerous, or harmful virus, serum, toxin, or
analogous product for use in the treatment of domestic animals.
(Mar. 4, 1913, ch. 145, 1 (part), 37 Stat. 833.)
This chapter, referred to in text, was in the original ''this Act'',
meaning act Mar. 4, 1913, ch. 145, 37 Stat. 828, which enacted this
chapter, sections 155 and 393 of Title 7, Agriculture, section 316 of
Title 15, Commerce and Trade, sections 501, 502, 512, 558, and 560 of
Title 16, Conservation, and section 630 of former Title 31, Money and
Finance, and amended section 83 of former Title 5, Executive Departments
and Government Officers and Employees, and sections 518 and 673 of Title
16.
Section 316 of Title 15 was omitted from the Code as superseded by
section 5701 et seq. of Title 5, Government Organization and Employees.
Section 630 of former Title 31 was repealed by act Sept. 12, 1950, ch.
946, title III, 301(64), 64 Stat. 842. Section 83 of former Title 5
was repealed and reenacted as section 5946 of Title 5 by Pub. L.
89-554, Sept. 6, 1966, 80 Stat. 514. For complete classification of
act Mar. 4, 1913, to the Code, see Tables.
See Codification note set out under section 151 of this title.
21 USC 157. Inspection
TITLE 21 -- FOOD AND DRUGS
Any officer, agent, or employee of the Department of Agriculture duly
authorized by the Secretary of Agriculture for the purpose may, at any
hour during the daytime or nighttime, enter and inspect any
establishment where any virus, serum, toxin, or analogous product for
use in the treatment of domestic animals is prepared for sale, barter,
exchange, or shipment as aforesaid.
(Mar. 4, 1913, ch. 145, 1 (part), 37 Stat. 833; Dec. 23, 1985, Pub.
L. 99-198, title XVII, 1768(d), 99 Stat. 1655.)
See Codification note set out under section 151 of this title.
Another section 1768 of Pub. L. 99-198, cited as a credit to this
section, amended section 136y of Title 7, Agriculture.
1985 -- Pub. L. 99-198 struck out ''licensed under this chapter''
after ''enter and inspect any establishment''.
Amendment by Pub. L. 99-198 effective Dec. 23, 1985, except as
otherwise provided, see section 1768(f) of Pub. L. 99-198, set out as a
note under section 151 of this title.
Overtime of employees working at establishments which prepare virus,
serum, toxin and analogous products, see section 394a of Title 7,
Agriculture.
21 USC 158. Offenses; punishment
TITLE 21 -- FOOD AND DRUGS
Any person, firm, or corporation who shall violate any of the
provisions of this chapter shall be deemed guilty of a misdemeanor, and
shall, upon conviction, be punished by a fine of not exceeding $1,000 or
by imprisonment not exceeding one year, or by both such fine and
imprisonment, in the discretion of the court.
(Mar. 4, 1913, ch. 145, 1 (part), 37 Stat. 833.)
For explanation of ''this chapter'', referred to in text, see
References in Text note set out under section 156 of this title.
See Codification note set out under section 151 of this title.
21 USC 159. Enforcement; penalties applicable; Congressional findings
TITLE 21 -- FOOD AND DRUGS
The procedures of sections 672, 673, and 674 of this title (relating
to detentions, seizures and condemnations, and injunctions,
respectively) shall apply to the enforcement of this chapter with
respect to any product prepared, sold, bartered, exchanged, or shipped
in violation of this chapter or a regulation promulgated under this
chapter. The provisions (including penalties) of section 675 of this
title shall apply to the performance of official duties under this
chapter. Congress finds that (i) the products and activities that are
regulated under this chapter are either in interstate or foreign
commerce or substantially affect such commerce or the free flow thereof,
and (ii) regulation of the products and activities as provided in this
chapter is necessary to prevent and eliminate burdens on such commerce
and to effectively regulate such commerce.
(Mar. 4, 1913, ch. 145, 1 (part), as added Dec. 23, 1985, Pub. L.
99-198, title XVII, 1768(e), 99 Stat. 1655.)
See Codification note set out under section 151 of this title.
Another section 1768 of Pub. L. 99-198, cited as a credit to this
section, amended section 136y of Title 7, Agriculture.
Section effective Dec. 23, 1985, except as otherwise provided, see
section 1768(f) of Pub. L. 99-198, set out as an Effective Date of 1985
Amendment note under section 151 of this title.
21 USC CHAPTER 5A -- BUREAU OF NARCOTICS
TITLE 21 -- FOOD AND DRUGS
21 USC 161 to 165. Omitted
TITLE 21 -- FOOD AND DRUGS
Section 161, acts June 14, 1930, ch. 488, 1, 46 Stat. 585; Oct.
15, 1949, ch. 695, 6(a), 63 Stat. 881, established a Bureau of
Narcotics in the Department of the Treasury and provided for appointment
of a Commissioner of Narcotics for the Bureau with duty of making an
annual report to Congress.
Section 162, acts June 14, 1930, ch. 488, 2, 46 Stat. 585; June
26, 1930, ch. 623, 1, 46 Stat. 819; Oct. 27, 1970, Pub. L. 91-513,
title III, 1101(a)(4), 84 Stat. 1291, provided for appointment and
compensation of a deputy commissioner and other personnel for the Bureau
of Narcotics, required the deputy to be an acting Commissioner during
absence or disability of the Commissioner or a vacancy in the office,
and authorized designation of a member of the Treasury Department as an
acting Commissioner in event there is no Commissioner or deputy
commissioner.
Section 163, act Mar. 3, 1927, ch. 348, 4(a), 44 Stat. 1382,
provided for transfer of control of narcotic drugs to the Secretary of
the Treasury from the Commissioner of Internal Revenue and his
assistants, agents, and inspectors.
Section 164, acts June 14, 1930, ch. 488, 3, 46 Stat. 586; June
26, 1930, ch. 623, 2, 46 Stat. 819; Ex. Ord. No. 6639, Mar. 10, 1934,
abolished the Federal Narcotics Control Board and transferred powers of
such Board to the Commissioner of Narcotics, authorized the Secretary of
the Treasury to confer or impose his duties under section 163 of this
title upon the Commissioner or other personnel of the Bureau of
Narcotics, continued in effect orders, rules, and regulations in
existence on July 1, 1930, until modified, superseded, or repealed by
the Commissioner, with approval of the Secretary of the Treasury, and
provided for determination before such Bureau of Narcotics of
proceedings, investigations, and other matters pending on July 1, 1930
before Bureau of Prohibition or Federal Narcotics Control Board
respecting narcotic drug law administration or enforcement. Bureau of
Prohibition personnel, records, property, and unexpended balances of
appropriations were previously transferred to Bureau of Narcotics as
were powers of the Attorney General respecting the Bureau of Prohibition
to the Commissioner of Internal Revenue.
Section 165, act June 14, 1930, ch. 488, 5, 46 Stat. 587, provided
for review of decisions of Commissioner of Narcotics by the Secretary of
the Treasury.
Functions of the Secretary of the Treasury administered through or
respecting the Bureau of Narcotics and all functions of the Bureau, the
Commissioner of Narcotics, and the officers, employees and agencies of
the Bureau were transferred to the Attorney General and the Bureau and
the office of Commissioner of Narcotics were abolished by Reorg. Plan
No. 1 of 1968, eff. Apr. 8, 1968, 33 F.R. 5611, 82 Stat. 1367, set
out in the Appendix to Title 5, Government Organization and Employees.
All positions, personnel, property, records, and unexpended balances of
appropriations, allocations, and other funds of the Bureau and the
Treasury Department, in connection with functions transferred under this
reorganization plan, were transferred to the Justice Department.
The Bureau of Narcotics and Dangerous Drugs, including the office of
Director thereof, in the Department of Justice was abolished by Reorg.
Plan No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091,
set out in the Appendix to Title 5, Government Organization and
Employees. Reorg. Plan No. 2 of 1973 also created in the Department of
Justice a single, comprehensive agency for the enforcement of drug laws
to be known as the Drug Enforcement Administration, empowered the
Attorney General to authorize the performance by officers, employees,
and agencies of the Department of functions transferred to him, and
directed the Attorney General to coordinate all drug law enforcement
functions to assure maximum cooperation between the Drug Enforcement
Administration, the Federal Bureau of Investigation, and the other units
of the Department of Justice involved in drug law enforcement.
21 USC CHAPTER 6 -- NARCOTIC DRUGS
TITLE 21 -- FOOD AND DRUGS
Ex. Ord. No. 10302, Nov. 5, 1951, 16 F.R. 11257, formerly set out as
a note preceding section 171, which established the Interdepartmental
Committee on Narcotics, was revoked by Ex. Ord. No. 11529, Apr. 24,
1970, 35 F.R. 6697.
21 USC IMPORTATION OR EXPORTATION
TITLE 21 -- FOOD AND DRUGS
21 USC 171 to 174. Repealed. Pub. L. 91-513, title III, 1101(a)(2),
(4), Oct. 27, 1970, 84 Stat. 1291
TITLE 21 -- FOOD AND DRUGS
Section 171, acts Feb. 9, 1909, ch. 100, 1, 35 Stat. 614; Jan.
17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, 1, 42 Stat.
596; June 14, 1930, ch. 488, 3, 46 Stat. 586; July 1, 1944, ch.
377, 8, 58 Stat. 721; Mar. 8, 1946, ch. 81, 7, 60 Stat. 39; Aug.
8, 1953, ch. 394, 8, 67 Stat. 506, defined ''narcotic drug'', ''United
States'', and ''person''. See section 801 et seq. of this title.
Section 172, acts Feb. 9, 1909, ch. 100, 2(a), 35 Stat. 614; Jan.
17, 1914, ch. 9, 38 Stat. 275; June 7, 1924, ch. 352, 43 Stat. 657,
established a Federal Narcotics Control Board. Act May 26, 1922, ch.
202, 1, 42 Stat. 596, also classified to this section, was repealed by
Pub. L. 89-554, 8(a), Sept. 6, 1966, 80 Stat. 645.
Section 173, acts Feb. 9, 1909, ch. 100, 2(b), (d), 35 Stat. 614;
Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, 1, 42
Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; June 14, 1930, ch.
488, 3, 46 Stat. 586, prohibited importation of narcotic drugs. See
section 801 et seq. of this title.
Section 173a, act June 14, 1930, ch. 488, 6, 46 Stat. 587, provided
for importation of additional amounts of coca leaves.
Section 174, acts Feb. 9, 1909, ch. 100, 2(c), (f), 35 Stat. 614;
Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, 1, 42
Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; Nov. 2, 1951, ch.
666, 1, 5(1), 65 Stat. 767; July 18, 1956, ch. 629, title I, 105, 70
Stat. 570, set penalties for bringing narcotic drugs into the United
States contrary to law. See chapter 13 of this title.
Repeal effective on first day of seventh calendar month that begins
after Oct. 27, 1970, see section 1105(a) of Pub. L. 91-513, set out as
an Effective Date note under section 951 of this title.
Section 1103 of Pub. L. 91-513 provided that:
''(a) Prosecutions for any violation of law occurring prior to the
effective date of section 1101 (the first day of the seventh calendar
month that begins after Oct. 26, 1970) shall not be affected by the
repeals or amendments made by such section or section 1102 (repealing
sections 171 to 174, 176 to 185, 188 to 188n, 191 to 193, 197, 198, 199,
501 to 517 of this title, sections 1401 to 1407, and 3616 of Title 18,
Crimes and Criminal Procedure, sections 4701 to 4707, 4711 to 4716, 4721
to 4726, 4731 to 4736, 4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to
4776, 7237, 7238, and 7491 of Title 26, Internal Revenue Code, sections
529a and 529g of former Title 31, Money and Finance, section 1421m of
Title 48, Territories and Insular Possessions, and amending sections 162
and 967 of this title and sections 4251 of Title 18, 1584 of Title 19,
Customs Duties, sections 4901, 4905, 6808, 7012, 7103, 7236, 7607, 7609,
7641, 7651, and 7655 of Title 26, section 2901 of Title 28, Judiciary
and Judicial Procedure, sections 529d, 529e, and 529f of former Title
31, section 304m of Title 40, Public Buildings, Property, and Works,
sections 3411 of Title 42, The Public Health and Welfare, section 239a
of Title 46, Shipping, and section 787 of Title 49, Appendix,
Transportation), or abated by reason thereof.
''(b) Civil seizures or forfeitures and injunctive proceedings
commenced prior to the effective date of section 1101 (the first day of
the seventh calendar month that begins after Oct. 26, 1970) shall not be
affected by the repeals or amendments made by such section or section
1102 (repealing this section and sections 172 to 174, 176 to 185, 188 to
188n, 191 to 193, 197, 198, 199, 501 to 517 of this title, sections 1401
to 1407 and 3616 of Title 18, Crimes and Criminal Procedure, sections
4701, 4707, 4711 to 4716, 4721 to 4726, 4731 to 4736, 4741 to 4746, 4751
to 4757, 4761, 4762, 4771 to 4776, 7237, 7238, and 7491 of Title 26,
Internal Revenue Code, sections 529a and 529g of former Title 31, Money
and Finance, section 1421m of Title 48, Territories and Insular
Possessions, and amending sections 162 and 967 of this title and
sections 4251 of Title 18, 1584 of Title 19, Customs Duties, sections
4901, 4905, 6808, 7012, 7103, 7326, 7607, 7609, 7641, 7651, and 7655 of
Title 26, section 2901 of Title 28, Judiciary and Judicial Procedure,
sections 529d, 529e, and 529f of former Title 31, section 304m of Title
40, Public Buildings, Property, and Works, section 3411 of Title 42, The
Public Health and Welfare, section 239a of Title 46, Shipping, and
section 787 of Title 49, Appendix, Transportation), or abated by reason
thereof.''
21 USC 175. Repealed. June 27, 1952, ch. 477, title IV, 403(a)(10), 66
Stat. 279
TITLE 21 -- FOOD AND DRUGS
Section, acts Feb. 9, 1909, ch. 100, 2(e), 35 Stat. 614; Jan.
17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, 1, 42 Stat.
596; June 7, 1924, ch. 352, 43 Stat. 657, related to deportation of
convicted aliens. See section 1251 et seq. of Title 8, Aliens and
Nationality.
21 USC 176 to 185. Repealed. Pub. L. 91-513, title III, 1101(a)(2),
(9), Oct. 27, 1970, 84 Stat. 1291, 1292
TITLE 21 -- FOOD AND DRUGS
Section 176, acts Feb. 9, 1909, ch. 100, 2(g), 35 Stat. 614; Jan.
17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202 1, 42 Stat.
596; June 7, 1924, ch. 352, 43 Stat. 657, covered liability of
masters of vessels and persons in charge of railroad cars and other
vehicles used to carry narcotic drugs.
Section 176a, act Feb. 9, 1909, ch. 100, 2(h), as added July 18,
1956, ch. 629, title I, 106, 70 Stat. 570, covered illegal importation
of marihuana and set penalties for such illegal importation. See
section 801 et seq. of this title.
Section 176b, act Feb. 9, 1909, ch. 100, 2(i), as added July 18,
1956, ch. 629, title I, 107, 70 Stat. 571, prohibited sale of heroin
to juveniles and set penalties for such illegal sale. See section 801
et seq. of this title.
Section 177, acts Feb. 9, 1909, ch. 100, 2(a), 35 Stat. 614; Jan.
17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, 1, 42 Stat.
596; June 7, 1924, ch. 352, 43 Stat. 657, vested administration of
Narcotic Drugs Import and Export Act in Department of the Treasury.
Section 178, act Feb. 9, 1909, ch. 100, 4, as added Jan. 17, 1914,
ch. 9, 38 Stat. 275, prohibited possession of smoking opium. See
section 801 et seq. of this title.
Section 179, act Feb. 9, 1909, ch. 100, 4, as added Jan. 17, 1914,
ch. 9, 38 Stat. 275, covered liability of masters of vessels and
persons in charge of railroad cars or other vehicles for possession of
smoking heroin. See section 801 et seq. of this title.
Section 180, act Feb. 9, 1909, ch. 100, 5, as added Jan. 17, 1914,
ch. 9, 38 Stat. 275, and amended May 26, 1922, ch. 202, 2, 42 Stat.
597; June 14, 1930, ch. 488, 3, 46 Stat. 586, prohibited admission of
smoking opium even for transportation to another country or for
transferal from one vessel to another.
Section 181, act Feb. 9, 1909, ch. 100, 3, as added Jan. 17, 1914,
ch. 9, 38 Stat. 275, created a presumption of illegal importation
based upon presence of smoking opium in United States.
Section 182, act Feb. 9, 1909, ch. 100, 6, as added Jan. 17, 1914,
ch. 9, 348 Stat. 275, and amended May 26, 1922, ch. 202, 2, 42 Stat.
597; June 14, 1930, ch. 488, 3, 46 Stat. 586; Apr. 22, 1960, Pub.
L. 86-429, 15, 74 Stat. 66, forbade exportation of narcotic drugs. See
section 801 et seq. of this title.
Section 183, act Feb. 9, 1909, ch. 100, 7, as added Jan. 17, 1914,
ch. 9, 38 Stat. 277, set out penalties for illegal exportation of
narcotic drugs.
Section 184, act Feb. 9, 1909, ch. 100, 8, as added Jan. 17, 1914,
ch. 9, 38 Stat. 277, and amended May 26, 1922, ch. 202, 3, 42 Stat.
598, provided for seizure and forfeiture of narcotic drugs found on
vessels and not shown on manifest or landed from vessels without a
permit.
Section 184a, acts July 11, 1941, ch. 289, 1, 55 Stat. 584; July
18, 1956, ch. 629, title I, 108, 70 Stat. 571, made illegal bringing
on board a vessel of United States any narcotic drugs not constituting a
part of the cargo.
Section 185, act Feb. 9, 1909, ch. 100, 9, as added May 26, 1922,
ch. 202, 4, 42 Stat. 598, authorized the citation of act Feb. 9, 1909,
ch. 100, as the ''Narcotic Drugs Import and Export Act''.
Repeal effective on first day of seventh calendar month that begins
after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513, set out as
an Effective Date note under section 951 of this title.
Prosecutions for any violation of law occurring, and civil seizures
or forfeitures and injunctive proceedings commenced, prior to the
effective date of repeal of these sections by section 1101 of Pub. L.
91-513 not to be affected or abated by reason thereof, see section 1103
of Pub. L. 91-513, set out as a note under sections 171 to 174 of this
title.
21 USC MARIHUANA AND HEALTH REPORTING
TITLE 21 -- FOOD AND DRUGS
21 USC 186, 187. Transferred
TITLE 21 -- FOOD AND DRUGS
Section 186, Pub. L. 91-296, title V, 501, June 30, 1970, 84 Stat.
352, which related to congressional findings as to marihuana use, the
need for a better understanding of the health consequences, and the lack
of information thereto, was transferred and set out as a note under
section 242 of Title 42, The Public Health and Welfare.
Section 187, Pub. L. 91-296, title V, 502, June 30, 1970, 84 Stat.
352, which directed the Secretary of Health, Education and Welfare to
report to Congress on the current information on the health consequence
of marihuana use, with recommendations for legislative and
administrative action and to submit a preliminary report no later than
90 days after June 30, 1970, was transferred and set out as a note under
section 242 of Title 42.
21 USC DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF THE OPIUM
POPPY
TITLE 21 -- FOOD AND DRUGS
21 USC 188 to 188n. Repealed. Pub. L. 91-513, title III, 1101(a)( 7),
Oct. 27, 1970, 84 Stat. 1292
TITLE 21 -- FOOD AND DRUGS
Sections, acts Dec. 11, 1942, ch. 720, 56 Stat. 1045; June 25,
1959, Pub. 86-70, 20, 73 Stat. 145; July 12, 1960, Pub. L. 86-624,
16, 74 Stat. 415, known as the ''Opium Poppy Control Act of 1942'',
provided for the domestic control of production and distribution of the
opium poppy. Sections 1 to 17 of said Act of Dec. 11, 1942, were
classified, respectively, to sections 188, 188 notes, and 188a to 188n
of this title.
Repeal effective on first day of seventh calendar month that begins
after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513, set out as
an Effective Date note under section 951 of this title.
Prosecutions for any violation of law occurring, and civil seizures
or forfeitures and injunctive proceedings commenced, prior to the
effective date of repeal of these sections by section 1101 of Pub. L.
91-513 not to be affected or abated by reason thereof, see section 1103
of Pub. L. 91-513, set out as a note under section 171 of this title.
21 USC IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN, IN CHINA, BY
UNITED STATES CITIZENS
TITLE 21 -- FOOD AND DRUGS
21 USC 191 to 193. Repealed. Pub. L. 91-513, title III, 1101(a)(1),
Oct. 27, 1970, 84 Stat. 1291
TITLE 21 -- FOOD AND DRUGS
Sections, acts Feb. 23, 1887, ch. 210, 24 Stat. 409; June 25,
1948, ch. 646, 5, 39, 62 Stat. 986, 992, prohibited importation of
opium by Chinese subjects and the trafficking in, in China, of opium by
United States citizens. Sections 1 to 3 of said Act of Feb. 23, 1887,
were classified to sections 191 to 193, respectively, of this title.
Repeal effective on first day of seventh calendar month that begins
after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513, set out as
an Effective Date note under section 951 of this title.
Prosecutions for any violation of law occurring, and civil seizures
or forfeitures and injunctive proceedings commenced, prior to the
effective date of repeal of these sections by section 1101 of Pub. L.
91-513 not to be affected or abated by reason thereof, see section 1103
of Pub. L. 91-513, set out as a Savings Provision note under section
171 of this title.
21 USC MISCELLANEOUS
TITLE 21 -- FOOD AND DRUGS
21 USC 196. Repealed. July 1, 1944, ch. 373, title XIII, 1313, 58
Stat. 714
TITLE 21 -- FOOD AND DRUGS
Section, act June 14, 1930, ch. 488, 4(b), (c), 46 Stat. 587; 1939
Reorg. Plan No. I, 201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat.
1424, related to studies and investigations by Surgeon General of the
Public Health Service. See section 242 of Title 42, The Public Health
and Welfare.
Section 611 of act July 1, 1944, which repealed this section, was
renumbered 711 by act Aug. 13, 1946, ch. 958, 5, 60 Stat. 1049, 713
by act Feb. 28, 1948, ch. 83, 9(b), 62 Stat. 47, 813 by act July 30,
1956, ch. 779, 3(b), 70 Stat. 720, 913 by Pub. L. 88-581, 4( b),
Sept. 4, 1964, 78 Stat. 919, 1013 by Pub. L. 89-239, 3(b), Oct. 6,
1965, 79 Stat. 931, 1113 by Pub. L. 91-572, 6(b), Dec. 24, 1970, 84
Stat. 1506, 1213 by Pub. L. 92-294, 3(b), May 16, 1972, 86 Stat. 137,
1313 by Pub. L. 93-154, 2(b)(2), Nov. 16, 1973, 87 Stat. 604, and was
repealed by Pub. L. 93-222, 7(b), Dec. 29, 1973, 87 Stat. 936.
21 USC 197, 198. Repealed. Pub. L. 91-513, title III, 1101(a)(4), Oct.
27, 1970, 84 Stat. 1291
TITLE 21 -- FOOD AND DRUGS
Section 197, act June 14, 1930, ch. 488, 7, 46 Stat. 587, directed
the Secretary of the Treasury to cooperate with the Secretary of State
in the discharge of the international obligations of the United States
concerning the traffic in narcotic drugs.
Section 198, acts June 14, 1930, ch. 488, 8, 46 Stat. 587; July
18, 1956, ch. 629, title III, 302, 70 Stat. 575, directed the
Secretary of the Treasury to cooperate with the several States in the
suppression of the abuse of narcotic drugs in their respective
jurisdictions.
Repeal effective on first day of seventh calendar month that begins
after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513, set out as
an Effective Date note under section 951 of this title.
Prosecutions for any violation of law occurring, and civil seizures
or forfeitures and injunctive proceedings commenced, prior to the
effective date of repeal of these sections by section 1101 of Pub. L.
91-513 not to be affected or abated by reason thereof, see section 1103
of Pub. L. 91-513, set out as a note under sections 171 to 174 of this
title.
21 USC 198a to 198c. Transferred
TITLE 21 -- FOOD AND DRUGS
Section 198a, act Aug. 11, 1955, ch. 800, 1, 69 Stat. 684; Oct.
27, 1970, Pub. L. 91-513, title III, 1102(t), 84 Stat. 1294, which
related to the authority of the Secretary of the Treasury to issue
subpenas, administer oaths and compel attendance of witnesses for the
purpose of any investigation, was transferred to section 967 of this
title.
Section 198b, act Aug. 11, 1955, ch. 800, 2, 69 Stat. 685, which
related to service of subpenas and proof of service, was transferred to
section 968 of this title.
Section 198c, act Aug. 11, 1955, ch. 800, 3, 69 Stat. 685, which
related to contempt proceedings, was transferred to section 969 of this
title.
21 USC 199. Repealed. Pub. L. 91-513, title III, 1101(a)(5), Oct. 27,
1970, 84 Stat. 1292
TITLE 21 -- FOOD AND DRUGS
Section, act July 3, 1930, ch. 829, 46 Stat. 850, authorized
payment to persons giving information concerning violations of narcotics
laws. See section 886(a) of this title.
Repeal effective on first day of seventh calendar month that begins
after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513, set out as
an Effective Date note under section 951 of this title.
Prosecutions for any violation of law occurring, and civil seizures
or forfeitures and injunctive proceedings commenced, prior to the
effective date of repeal of this section by section 1101 of Pub. L.
91-513 not to be affected or abated by reason thereof, see section 1103
of Pub. L. 91-513, set out as a note under section 171 of this title.
21 USC 200 to 200b. Repealed. Nov. 2, 1951, ch. 666, 5(2), 65 Stat.
769
TITLE 21 -- FOOD AND DRUGS
Sections, acts Aug. 12, 1937, ch. 598, 1-3, 50 Stat. 627; July 1,
1944, ch. 377, 9, 58 Stat. 721; Mar. 8, 1946, ch. 81, 8, 60 Stat.
39, related to punishment for offenses after first offense. See section
801 et seq. of this title.
Section 6 of act Nov. 2, 1951, provided that any rights or
liabilities now existing under former sections 200 to 200b of this title
should not be affected by their repeal.
21 USC CHAPTER 7 -- PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
TITLE 21 -- FOOD AND DRUGS
Sec.
201. Doing business without a license unlawful; employment of
Chinese subjects.
202. Certain classes of persons and corporations excepted;
insecticides.
203. Application for license; requirements; qualifications for
license.
204. Issuance of license.
205. Display of license in pharmacy.
206. Revocation of license.
207. Restrictions on sales; written orders or prescriptions.
208. Certain preparations and sales excepted.
209. Poisons; book entry of sale; labels.
210. Pharmacist; unauthorized use of title.
211. Preservation of originals of prescriptions compounded and
copies thereof; inspection of prescriptions by consular officers;
marking containers of drugs.
212. Offenses; punishment; duty to enforce provisions.
213. Fraudulent representations to evade or defeat restrictions.
214. Previous laws unaffected.
215. ''Consul'' defined.
21 USC 201. Doing business without a license unlawful; employment of
Chinese subjects
TITLE 21 -- FOOD AND DRUGS
It shall be unlawful in the consular districts of the United States
in China for any person whose permanent allegiance is due to the United
States not licensed as a pharmacist within the meaning of this chapter
to conduct or manage any pharmacy, drug or chemical store, apothecary
shop, or other place of business for the retailing, compounding, or
dispensing of any drugs, chemicals, or poisons, or for the compounding
of physicians' prescriptions, or to keep exposed for sale at retail, any
drugs, chemicals, or poisons, except as hereinafter provided, or, except
as hereinafter provided, for any person whose permanent allegiance is
due to the United States not licensed as a pharmacist within the meaning
of this chapter to compound, dispense, or sell, at retail, any drug,
chemical, poison, or pharmaceutical preparation upon the prescription of
a physician, or otherwise, or to compound physicians' prescriptions,
except as an aid to and under the proper supervision of a pharmacist
licensed under this chapter. And it shall be unlawful for any person,
firm, or corporation owing permanent allegiance to the United States
owning partly or wholly or managing a pharmacy, drug store, or other
place of business to cause or permit any person other than a licensed
pharmacist to compound, dispense, or sell at retail any drug, medicine,
or poison, except as an aid to and under the proper supervision of a
licensed pharmacist. Where it is necessary for a person, firm, or
corporation whose permanent allegiance is due to the United States and
owning partly or wholly or managing a pharmacy, drug store, or other
place of business to employ Chinese subjects to compound, dispense, or
sell at retail any drug, medicine, or poison, such person, firm, or
corporation, owner, part owner, or manager of a pharmacy, drug store, or
other place of business may employ such Chinese subjects when their
character, ability, and age of twenty-one years or over have been
certified to by at least two recognized and reputable practitioners of
medicine, or two pharmacists licensed under this chapter whose permanent
allegiance is due to the United States.
(Mar. 3, 1915, ch. 74, 1, 38 Stat. 817.)
Section is comprised of part of section 1 of act Mar. 3, 1915.
Remainder of such section 1 is classified to section 202 of this title.
21 USC 202. Certain classes of persons and corporations excepted;
insecticides
TITLE 21 -- FOOD AND DRUGS
Nothing in section 201 of this title shall be construed to interfere
with any recognized and reputable practitioner of medicine, dentistry,
or veterinary surgery in the compounding of his own prescriptions, or to
prevent him from supplying to his patients such medicines as he may deem
proper, except as hereinafter provided; nor with the exclusively
wholesale business of any person, firm, or corporation whose permanent
allegiance is due to the United States dealing and licensed as
pharmacists, or having in their employ at least one person who is so
licensed, except as hereinafter provided; nor with the sale by persons,
firms, or corporations whose permanent allegiance is due to the United
States other than pharmacists of poisonous substances sold exclusively
for use in the arts, or as insecticides, when such substances are sold
in unbroken packages bearing labels having plainly printed upon them the
name of the contents, the word ''Poison'', when practicable the name of
at least one suitable antidote, and the name and address of the vender.
(Mar. 3, 1915, ch. 74, 1, 38 Stat. 818.)
Section is comprised of part of section 1 of act Mar. 3, 1915.
Remainder of such section 1 is classified to section 201 of this title.
21 USC 203. Application for license; requirements; qualifications for
license
TITLE 21 -- FOOD AND DRUGS
Every person whose permanent allegiance is due to the United States
desiring to practice as a pharmacist in the consular districts in China
shall file with the consul an application, duly verified under oath,
setting forth the name and age of the applicant, the place or places at
which he pursued and the time spent in the study of pharmacy, the
experience which the applicant has had in compounding physicians'
prescriptions under the direction of a licensed pharmacist, and the name
and location of the school or college of pharmacy, if any, of which he
is a graduate, and shall submit evidence sufficient to show to the
satisfaction of said consul that he is of good moral character and not
addicted to the use of alcoholic liquors or narcotic drugs so as to
render him unfit to practice pharmacy. Applicants shall be not less than
twenty-one years of age and shall have had at least four years'
experience in the practice of pharmacy or shall have served three years
under the instruction of a regularly licensed pharmacist, and any
applicant who has been graduated from a school or college of pharmacy
recognized by the proper board of his State, Territory, District of
Columbia, or other possession of the United States as in good standing
shall be entitled to practice upon presentation of his diploma.
(Mar. 3, 1915, ch. 74, 2, 38 Stat. 818.)
The words ''now practicing as a pharmacist or,'' which preceded
''desiring to practice'' in the original text of this section, were
omitted as obsolete.
21 USC 204. Issuance of license
TITLE 21 -- FOOD AND DRUGS
If the applicant for license as a pharmacist has complied with the
requirements of section 203 of this title, the consul shall issue to him
a license which shall entitle him to practice pharmacy in the consular
districts of the United States in China, subject to the provisions of
this chapter.
(Mar. 3, 1915, ch. 74, 3, 38 Stat. 819.)
21 USC 205. Display of license in pharmacy
TITLE 21 -- FOOD AND DRUGS
Every license to practice pharmacy shall be conspicuously displayed
by the person to whom the same has been issued in the pharmacy, drug
store, or place of business, if any, of which the said person is the
owner or part owner or manager.
(Mar. 3, 1915, ch. 74, 5, 38 Stat. 819.)
21 USC 206. Revocation of license
TITLE 21 -- FOOD AND DRUGS
The license of any person whose permanent allegiance is due to the
United States to practice pharmacy in the consular districts of the
United States in China may be revoked by the consul if such person be
found to have obtained such license by fraud, or be addicted to the use
of any narcotic or stimulant, or to be suffering from physical or mental
disease, in such manner and to such extent as to render it expedient
that in the interests of the public his license be canceled; or to be
of an immoral character; or if such person be convicted in any court of
competent jurisdiction of any offense involving moral turpitude. It
shall be the duty of the consul to investigate any case in which it is
discovered by him or made to appear to his satisfaction that any license
issued under the provisions of this chapter is revocable and shall,
after full hearing, if in his judgment the facts warrant it, revoke such
license.
(Mar. 3, 1915, ch. 74, 4, 38 Stat. 819.)
21 USC 207. Restrictions on sales; written orders or prescriptions
TITLE 21 -- FOOD AND DRUGS
It shall be unlawful for any person, firm, or corporation whose
permanent allegiance is due to the United States, either personally or
by servant or agent or as the servant or agent of any other person or of
any firm or corporation, to sell, furnish, or give away any cocaine,
salts of cocaine, or preparation containing cocaine or salts of cocaine,
or morphine or preparation containing morphine or salts of morphine, or
any opium or preparation containing opium, or any chloral hydrate or
preparation containing chloral hydrate, except upon the original written
order or prescription of a recognized and reputable practitioner of
medicine, dentistry, or veterinary medicine, which order or prescription
shall be dated and shall contain the name of the person for whom
prescribed, or, if ordered by a practitioner of veterinary medicine,
shall state the kind of animal for which ordered and shall be signed by
the person giving the order or prescription. Such order or prescription
shall be, for a period of three years, retained on file by the person,
firm, or corporation who compounds or dispenses the article ordered or
prescribed, and it shall not be compounded or dispensed after the first
time except upon the written order of the original prescriber.
(Mar. 3, 1915, ch. 74, 6, 38 Stat. 819.)
Section is comprised of part of section 6 of act Mar. 3, 1915.
Remainder of such section 6 is classified to section 208 of this title.
21 USC 208. Certain preparations and sales excepted
TITLE 21 -- FOOD AND DRUGS
The provisions of section 207 of this title shall not apply to
preparations containing not more than two grains of opium or not more
than one-quarter grain of morphine, or not more than one-quarter grain
of cocaine, or not more than two grains of chloral hydrate in the fluid
ounce, or, of a solid preparation, in one avoirdupois ounce, nor shall
they apply to preparations sold in good faith for diarrhea and cholera,
each bottle or package of which is accompanied by specific directions
for use and caution against habitual use, nor to liniments or ointments
sold in good faith as such when plainly labeled ''for external use
only'', nor to powder of ipecac and opium, commonly known as Dover's
powder, when sold in quantities not exceeding twenty grains. The
provisions of this section or section 207 of this title shall not be
construed to permit the selling, furnishing, giving away, or prescribing
for the use of any habitual users of the same any cocaine, salts of
cocaine, or preparation containing cocaine or salts of cocaine, or
morphine or salts of morphine, or preparations containing morphine or
salts of morphine, or any opium or preparation containing opium, or any
chloral hydrate or preparation containing chloral hydrate. But the
preceding sentence shall not be construed to prevent any recognized or
reputable practitioner of medicine whose permanent allegiance is due to
the United States from furnishing in good faith for the use of any
habitual user of narcotic drugs who is under his professional care such
substances as he may deem necessary for their treatment, when such
prescriptions are not given or substances furnished for the purpose of
evading the provisions of this section. But the provisions of this
section or section 207 of this title shall not apply to sales at
wholesale between jobbers, manufacturers, and retail druggists,
hospitals, and scientific or public institutions.
(Mar. 3, 1915, ch. 74, 6, 38 Stat. 819.)
Section is comprised of section 6 of act Mar. 3, 1915. Remainder of
such section 6 is classified to section 207 of this title.
21 USC 209. Poisons; book entry of sale; labels
TITLE 21 -- FOOD AND DRUGS
It shall be unlawful for any person, firm, or corporation whose
permanent allegiance is due to the United States to sell or deliver to
any other person any of the following-described substances, or any
poisonous compound, combination, or preparation thereof, to wit: The
compounds of and salts of antimony, arsenic, barium, chromium, copper,
gold, lead, mercury, silver, and zinc, the caustic hydrates of sodium
and potassium, solution or water of ammonia, methyl alcohol, paregoric,
the concentrated mineral acids, oxalic and hydrocyanic acids and their
salts, yellow phosphorus, Paris green, carbolic acid, the essential oils
of almonds, pennyroyal, tansy, rue, and savin; croton oil, creosote,
chloroform, cantharides, or aconite, belladonna, bitter almonds,
colchicum, cotton root, cocculus indicus, conium, cannabis indica,
digitalis, ergot, hyoscyamus, ignatia, lobelia, nux vomica, physostigma,
phytolacca, strophanthus, stramonium, veratrum viride, or any of the
poisonous alkaloids or alkaloidal salts derived from the foregoing, or
any other poisonous alkaloids or their salts, or any other virulent
poison, except in the manner following, and, moreover, if the applicant
be less than eighteen years of age, except upon the written order of a
person known or believed to be an adult.
It shall first be learned, by due inquiry, that the person to whom
delivery is about to be made is aware of the poisonous character of the
substance and that it is desired for a lawful purpose, and the box,
bottle, or other package shall be plainly labeled with the name of the
substance, the word ''Poison'', the name of at least one suitable
antidote, when practicable, and the name and address of the person,
firm, or corporation dispensing the substance. And before delivery be
made of any of the foregoing substances, excepting solution or water of
ammonia and sulphate of copper, there shall be recorded in a book kept
for that purpose the name of the article, the quantity delivered, the
purpose for which it is to be used, the date of delivery, the name and
address of the person for whom it is procured, and the name of the
individual personally dispensing the same; and said book shall be
preserved by the owner thereof for at least three years after the date
of the last entry therein. The foregoing provisions shall not apply to
articles dispensed upon the order of persons believed by the dispenser
to be recognized and reputable practitioners of medicine, dentistry, or
veterinary surgery. When a physician writes upon his prescription a
request that it be marked or labeled ''Poison'' the pharmacist shall, in
the case of liquids, place the same in a colored glass, roughened
bottle, of the kind commonly known in trade as a ''poison bottle'', and,
in the case of dry substances, he shall place a poison label upon the
container. The record of sale and delivery above mentioned shall not be
required of manufacturers and wholesalers who shall sell any of the
foregoing substances at wholesale to licensed pharmacists, but the box,
bottle, or other package containing such substance, when sold at
wholesale, shall be properly labeled with the name of the substance, the
word ''poison'', and the name and address of the manufacturer or
wholesaler. It shall not be necessary, in sales either at wholesale or
at retail, to place a poison label upon, nor to record the delivery of,
the sulphide of antimony, or the oxide or carbonate of zinc, or of
colors ground in oil and intended for use as paints, or calomel; nor in
the case of preparations containing any of the substances named in this
section, when a single box, bottle, or other package, or when the bulk
of one-half fluid ounce or the weight of one-half avoirdupois ounce does
not contain more than an adult medicinal dose of such substance; nor in
the case of liniments or ointments sold in good faith as such, when
plainly labeled ''For external use only''; nor, in the case of
preparations put up and sold in the form of pills, tablets, or lozenges,
containing any of the substances enumerated in this section and intended
for internal use, when the dose recommended does not contain more than
one-fourth of an adult medicinal dose of such substance.
For the purpose of this and of every other section of this chapter no
box, bottle, or other package shall be regarded as having been labeled
''Poison'' unless the word ''Poison'' appears conspicuously thereon,
printed in plain, uncondensed gothic letters in red ink.
(Mar. 3, 1915, ch. 74, 7, 38 Stat. 820.)
21 USC 210. Pharmacist; unauthorized use of title
TITLE 21 -- FOOD AND DRUGS
It shall be unlawful for any person whose permanent allegiance is due
to the United States, not legally licensed as a pharmacist, to take,
use, or exhibit the title of pharmacist, or licensed or registered
pharmacist, or the title of druggist or apothecary, or any other title
or description of like import.
(Mar. 3, 1915, ch. 74, 10, 38 Stat. 821.)
21 USC 211. Preservation of originals of prescriptions compounded and
copies thereof; inspection of prescriptions by consular officers;
marking containers of drugs
TITLE 21 -- FOOD AND DRUGS
Every person, firm, or corporation whose permanent allegiance is due
to the United States owning, partly owning, or managing a drug store or
pharmacy shall keep in his place of business a suitable book or file, in
which shall be preserved for a period of not less than three years the
original of every prescription compounded or dispensed at such store or
pharmacy, or a copy of such prescription, except when the preservation
of the original is required by section 207 or 208 of this title. Upon
request the owner, part owner, or manager of such store shall furnish to
the prescribing physician, or to the person for whom such prescription
was compounded or dispensed, a true and correct copy thereof. Any
prescription required by section 207 or 208 of this title, and any
prescription for, or register of sales of, substances mentioned in such
sections shall at all times be open to inspection by duly authorized
consular officers in the consular districts of the United States in
China. No person, firm, or corporation whose permanent allegiance is
due to the United States shall, in a consular district, compound or
dispense any drug or drugs or deliver the same to any other person
without marking on the container thereof the name of the drug or drugs
contained therein and directions for using the same.
(Mar. 3, 1915, ch. 74, 9, 38 Stat. 821.)
21 USC 212. Offenses; punishment; duty to enforce provisions
TITLE 21 -- FOOD AND DRUGS
Any person, firm, or corporation, whose permanent allegiance is due
to the United States, violating any of the provisions of this chapter
shall be deemed guilty of a misdemeanor and, upon conviction thereof,
shall be punished by a fine of not less than $50 and not more than $100
or by imprisonment for not less than one month and not more than sixty
days, or by both such fine and imprisonment, in the discretion of the
court, and if the offense be continuing in its character, each week or
part of a week during which it continues shall constitute a separate and
distinct offense. And it shall be the duty of the consular and judicial
officers of the United States in China to enforce the provisions of this
chapter.
(Mar. 3, 1915, ch. 74, 11, 38 Stat. 821.)
21 USC 213. Fraudulent representations to evade or defeat restrictions
TITLE 21 -- FOOD AND DRUGS
No person, firm, or corporation whose permanent allegiance is due to
the United States seeking to procure in the consular districts of the
United States in China any substance the sale of which is regulated by
the provisions of this chapter shall make any fraudulent representations
so as to evade or defeat the restrictions herein imposed.
(Mar. 3, 1915, ch. 74, 8, 38 Stat. 821.)
21 USC 214. Previous laws unaffected
TITLE 21 -- FOOD AND DRUGS
Nothing in this chapter shall be construed as modifying or revoking
any of the provisions of sections 191 to 193 /1/ of this title.
(Mar. 3, 1915, ch. 74, 13, 38 Stat. 822.)
Sections 191 to 193 of this title, referred to in text, were repealed
by Pub. L. 91-513, title III, 1101(a)(1), Oct. 27, 1970, 84 Stat.
1291. See section 801 et seq. of this title.
/1/ See References in Text note below.
21 USC 215. ''Consul'' defined
TITLE 21 -- FOOD AND DRUGS
The word ''consul'' as used in this chapter shall mean the consular
officer in charge of the district concerned.
(Mar. 3, 1915, ch. 74, 12, 38 Stat. 822.)
21 USC CHAPTER 8 -- NARCOTIC FARMS
TITLE 21 -- FOOD AND DRUGS
21 USC 221 to 237. Repealed. July 1, 1944, ch. 373, title XIII, 1313,
58 Stat. 714
TITLE 21 -- FOOD AND DRUGS
Section 221, act Jan. 19, 1929, ch. 82, 1, 45 Stat. 1085, defined
''habit-forming narcotic drug'', ''narcotic'', and ''addict''. See
section 201 of Title 42, The Public Health and Welfare.
Section 222, act Jan. 19, 1929, ch. 82, 2, 45 Stat. 1085, provided
for narcotic farms. See section 257 of Title 42.
Section 222a, act June 23, 1935, ch. 725, 1, 49 Stat. 1840,
provided name for narcotic farm at Lexington, Ky.
Section 222b, act Mar. 28, 1938, ch. 55, 1, 52 Stat. 134, provided
name for narcotic farm at Fort Worth, Texas.
Section 223, act Jan. 19, 1929, ch. 82, 3, 45 Stat. 1085; 1939
Reorg. Plan No. I, 205(b), eff. July 1, 1939, 4 F.R. 2728, 53 Stat.
1425, provided for an annual estimate of expenses of maintenance of
narcotic farms.
Section 224, act Jan. 19, 1929, ch. 82, 4, 45 Stat. 1086, provided
for construction of buildings for two of the narcotic farms.
Section 225, act Jan. 19, 1929, ch. 82, 5, 45 Stat. 1086; June
14, 1930, ch. 488, 4(a), 46 Stat. 586; 1939 Reorg. Plan No. I,
201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, provided
for control and management of narcotic farms.
Section 226, act Jan. 19, 1929, ch. 82, 6, 45 Stat. 1086; 1939
Reorg. Plan No. I, 201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat.
1424, 1425, provided for care and treatment of addicts. See section
257 of Title 42.
Section 227, act Jan. 19, 1929, ch. 82, 7, 45 Stat. 1086, provided
for transfer to and from farms of addicts who are prisoners. See
section 259 of Title 42.
Section 228, act Jan. 19, 1929, ch. 82, 8, 45 Stat. 1087, provided
that it was the duty of prosecuting officers to report convicted persons
believed to be addicts. See section 259 of Title 42.
Section 229, act Jan. 19, 1929, ch. 82, 9, 45 Stat. 1087; 1939
Reorg. Plan No. I, 201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat.
1424, 1425, provided for employment of addicts. See section 258 of
Title 42.
Section 230, act Jan. 19, 1929, ch. 82, 10, 45 Stat. 1087,
provided for parole of inmates. See section 259 of Title 42.
Section 231, act Jan. 19, 1929, ch. 82, 11, 45 Stat. 1087; 1939
Reorg. Plan No. I, 201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat.
1424, 1425, provided for discharge of addicts. See section 259 of
Title 42.
Section 232, act Jan. 19, 1929, ch. 82, 12, 45 Stat. 1088; 1939
Reorg. Plan No. I, 201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat.
1424, 1425, provided for admission of voluntary patients. See section
260 of Title 42.
Section 233, act Jan. 19, 1929, ch. 82, 13, 45 Stat. 1088; 1939
Reorg. Plan No. I, 201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat.
1424, 1425, provided for furnishing of gratuities and transportation to
discharged convicts. See section 259 of Title 42.
Section 234, act. Jan. 19, 1929, ch. 82, 14, 45 Stat. 1089; 1939
Reorg. Plan No. I, 201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat.
1424, 1425, provided penalties for introduction of narcotic drugs into
a narcotic farm. See section 261 of Title 42.
Section 235, act Jan. 19, 1929, ch. 82, 15, 45 Stat. 1089,
provided penalties for escape of inmates. See section 261 of Title 42.
Section 236, act Jan. 19, 1929, ch. 82, 16, 45 Stat. 1089,
provided penalties for procuring of escape by inmates. See section 261
of Title 42.
Section 237, act Jan. 19, 1929, ch. 82, 17, 45 Stat. 1089,
provided for deportation of alien inmates who are entitled to a
discharge from narcotic farms.
Section 611 of act July 1, 1944, which repealed this section, was
renumbered 711 by act Aug. 13, 1946, ch. 958, 5, 60 Stat. 1049, 713
by act Feb. 28, 1948, ch. 83, 9(b), 62 Stat. 47, 813 by act July 30,
1956, ch. 779, 3(b), 70 Stat. 720, 913 by Pub. L. 88-581, 4(b), Sept.
4, 1964, 78 Stat. 919, 1013 by Pub. L. 89-239, 3(b), Oct. 6, 1965,
79 Stat. 931, 1113 by Pub. L. 91-572, 6(b), Dec. 24, 1970, 84 Stat.
1506, 1213 by Pub. L. 92-294, 3(b), May 16, 1972, 86 Stat. 137, 1313 by
Pub. L. 93-154, 2(b)(2), Nov. 16, 1973, 87 Stat. 604, and was
repealed by Pub. L. 93-222, 7(b), Dec. 29, 1973, 87 Stat. 936.
21 USC
TITLE 21 -- FOOD AND DRUGS
21 USC CHAPTER 9 -- FEDERAL FOOD, DRUG, AND COSMETIC ACT
TITLE 21 -- FOOD AND DRUGS
Sec.
301. Short title.
321. Definitions; generally.
321a. ''Butter'' defined.
321b. ''Package'' defined.
321c. Nonfat dry milk; ''milk'' defined.
331. Prohibited acts.
332. Injunction proceedings.
(a) Jurisdiction of courts.
(b) Violation of injunction.
333. Penalties.
(a) Violation of section 331 of this title; second violation;
intent to defraud or mislead.
(b) Prescription drug marketing violations.
(c) Exceptions in certain cases of good faith, etc.
(d) Exceptions involving misbranded food.
(e) Prohibited distribution of human growth hormone.
(f) Violations related to devices.
333a. Repealed.
334. Seizure.
(a) Grounds and jurisdiction.
(b) Procedure; multiplicity of pending proceedings.
(c) Availability of samples of seized goods prior to trial.
(d) Disposition of goods after decree of condemnation; claims for
remission or mitigation of forfeitures.
(e) Costs.
(f) Removal of case for trial.
(g) Administrative restraint; detention orders.
335. Hearing before report of criminal violation.
336. Report of minor violations.
337. Proceedings in name of United States; provision as to
subpoenas.
341. Definitions and standards for food.
342. Adulterated food.
(a) Poisonous, insanitary, etc., ingredients.
(b) Absence, substitution, or addition of constituents.
(c) Color additives.
(d) Confectionery containing alcohol or nonnutritive substance.
(e) Oleomargarine containing filthy, putrid, etc., matter.
343. Misbranded food.
(a) False or misleading label.
(b) Offer for sale under another name.
(c) Imitation of another food.
(d) Misleading container.
(e) Package form.
(f) Prominence of information on label.
(g) Representation as to definition and standard of identity.
(h) Representation as to standards of quality and fill of container.
(i) Label where no representation as to definition and standard of
identity.
(j) Representation for special dietary use.
(k) Artificial flavoring, artificial coloring, or chemical
preservatives.
(l) Pesticide chemicals on raw agricultural commodities.
(m) Color additives.
(n) Packaging or labeling of drugs in violation of regulations.
(o) Saccharin for immediate consumption.
(p) Saccharin not for immediate consumption.
(q) Nutrition information.
(r) Nutrition levels and health-related claims.
343-1. National uniform nutrition labeling.
343a. Health risks presented by use of saccharin.
(a) Statement on vending machines dispensing food containing
saccharin respecting health risk; regulations.
(b) Availability and distribution of information; review and
revision.
344. Emergency permit control.
(a) Conditions on manufacturing, processing, etc., as health measure.
(b) Violation of permit; suspension and reinstatement.
(c) Inspection of permit-holding establishments.
345. Regulations making exemptions.
346. Tolerances for poisonous or deleterious substances in food;
regulations.
346a. Tolerances for pesticide chemicals in or on raw agricultural
commodities.
(a) Conditions of safety.
(b) Establishment of tolerances.
(c) Exemptions.
(d) Regulations pursuant to petition; publication of notice; time
for issuance; referral to advisory committees; effective date;
hearings.
(e) Regulations pursuant to Administrator's proposals.
(f) Data submitted as confidential.
(g) Advisory committees; appointment; composition; compensation;
clerical assistance.
(h) Right of consultation.
(i) Judicial review.
(j) Temporary tolerances.
(k) Regulations based on public hearings before January 1, 1953.
(l) Pesticides under Federal Insecticide, Fungicide, and Rodenticide
Act; functions of Administrator of the Environmental Protection Agency;
certifications; hearing; time limitations; opinion; regulations.
(m) Amendment of regulations.
(n) Guaranties.
(o) Payment of fees; services or functions as conditioned on;
waiver or refund of fees.
346b. Authorization of appropriations.
347. Intrastate sales of colored oleomargarine.
(a) Law governing.
(b) Labeling and packaging requirements.
(c) Sales in public eating places.
(d) Exemption from labeling requirements.
(e) Color content of oleomargarine.
347a. Congressional declaration of policy regarding oleomargarine
sales.
347b. Contravention of State laws.
348. Food additives.
(a) Unsafe food additives; exception for conformity with exemption
or regulation.
(b) Petition for regulation prescribing conditions of safe use;
contents; description of production methods and controls; samples;
notice of regulation.
(c) Approval or denial of petition; time for issuance of order;
evaluation of data; factors.
(d) Regulation issued on Secretary's initiative.
(e) Publication and effective date of orders.
(f) Objections and public hearing; basis and contents of order;
statement.
(g) Judicial review.
(h) Amendment or repeal of regulations.
(i) Exemptions for investigational use.
349. Bottled drinking water standards; publication in Federal
Register.
350. Vitamins and minerals.
(a) Authority and limitations of Secretary; applicability.
(b) Labeling and advertising requirements for foods.
(c) Definitions.
350a. Infant formulas.
(a) Adulteration.
(b) Requirements for quality factors, good manufacturing practices,
and retention of records.
(c) Registration of persons distributing new infant formula.
(d) Submission of information about new infant formula required.
(e) Additional notice requirements for manufacturer.
(f) Procedures applicable to recalls by manufacturer; regulatory
oversight.
(g) Recordkeeping requirements for manufacturer; regulatory
oversight and enforcement.
(h) Exemptions; regulatory oversight.
(i) Nutrient requirements.
351. Adulterated drugs and devices.
(a) Poisonous, insanitary, etc., ingredients; adequate controls in
manufacture.
(b) Strength, quality, or purity differing from official compendium.
(c) Misrepresentation of strength, etc., where drug is unrecognized
in compendium.
(d) Mixture with or substitution of another substance.
(e) Devices not in conformity with performance standards.
(f) Certain class III devices.
(g) Banned devices.
(h) Manufacture, packing, storage, or installation of device not in
conformity with applicable requirements or conditions.
(i) Failure to comply with requirements under which device was
exempted for investigational use.
352. Misbranded drugs and devices.
(a) False or misleading label.
(b) Package form; contents of label.
(c) Prominence of information on label.
(d) Habit forming substances.
(e) Designation of drugs or devices by established names.
(f) Directions for use and warnings on label.
(g) Representations as recognized drug; packing and labeling;
inconsistent requirements for designation of drug.
(h) Deteriorative drugs; packing and labeling.
(i) Drug; misleading container; imitation; offer for sale under
another name.
(j) Health-endangering when used as prescribed.
(k) Insulin not properly certified.
(l) Antibiotic drugs improperly certified.
(m) Color additives; packing and labeling.
(n) Prescription drug advertisements: established name;
quantitative formula; side effects, contraindications, and
effectiveness; prior approval; false advertising; labeling;
construction of the Convention on Pyschotropic Substances.
(o) Drugs or devices from nonregistered establishments.
(p) Packaging or labeling of drugs in violation of regulations.
(q) Restricted devices using false or misleading advertising or used
in violation of regulations.
(r) Restricted devices not carrying requisite accompanying statements
in advertisements and other descriptive printed matter.
(s) Devices subject to performance standards not bearing requisite
labeling.
(t) Devices for which there has been a failure or refusal to give
required notification or to furnish required material or information.
353. Exemptions and consideration for certain drugs, devices, and
biological products.
(a) Regulations for goods to be processed, labeled, or repacked
elsewhere.
(b) Prescription by physician; exemption from labeling and
prescription requirements; misbranded drugs; compliance with narcotic
and marihuana laws.
(c) Sales restrictions.
(d) Distribution of drug samples.
(e) Wholesale distributors; guidelines for licensing; definitions.
(f) Veterinary prescription drugs.
(g) Regulation of combination products.
354. Repealed.
355. New drugs.
(a) Necessity of effective approval of application.
(b) Filing application; contents.
(c) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order.
(d) Grounds for refusing application; approval of application;
''substantial evidence'' defined.
(e) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to public health.
(f) Revocation of order refusing, withdrawing or suspending approval
of application.
(g) Service of orders.
(h) Appeal from order.
(i) Exemptions of drugs for research; discretionary and mandatory
conditions; direct reports to Secretary.
(j) Abbreviated new drug applications.
(k) Records and reports; required information; regulations and
orders; access to records.
(l) Public disclosure of safety and effectiveness data.
(m) ''Patent'' defined.
356. Certification of drugs containing insulin.
(a) Standards for certification.
(b) Regulations.
(c) Tests or methods of assay; revision.
357. Certification of drugs containing penicillin, streptomycin,
chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic
drug.
(a) Regulations prescribed by Secretary; release prior to
certification; ''antibiotic drug'' defined.
(b) Provisions of regulations.
(c) Exemption of drugs not involving safety and efficacy of use;
considerations; certification after exemption; labeling and
advertising claims.
(d) Exemption of drugs stored, processed, and labeled at plants other
than manufacturer's, used in manufacture of other drugs or for
investigational purposes; discretionary and mandatory conditions;
direct reports to Secretary.
(e) Exempted new drugs subject to section 355 of this title; request
for certification of exempted drug; determination of compliance with
sections 351(b) and 352(g) of this title.
(f) Filing of petitions; contents; notice; answer; public
hearing; orders.
(g) Records and reports; professional ethics and interests of
patients; examination of data; access to records.
(h) Issuance of regulations; conditions; amendment or repeal of
regulations; effective date; procedure; lack of substantial evidence.
358. Authority to designate official names.
(a) Necessity or desirability; use in official compendiums;
infringement of trademarks.
(b) Review of names in official compendiums.
(c) Determinations of complexity, usefulness, multiplicity, or lack
of name; designation by Secretary.
(d) Revised official names; compilation, publication, and public
distribution of listings.
(e) Request by compiler of official compendium for designation of
name.
359. Nonapplicability of subchapter to cosmetics.
360. Registration of producers of drugs or devices.
(a) Definitions.
(b) Annual registration.
(c) New producers.
(d) Additional establishments.
(e) Registration number; uniform system for identification of
devices intended for human use.
(f) Availability of registrations for inspection.
(g) Exclusions from application of section.
(h) Inspection of premises.
(i) Foreign establishments.
(j) Filing of lists of drugs and devices manufactured, prepared,
propagated and compounded by registrants; statements; accompanying
disclosures.
(k) Report preceding introduction of devices into interstate
commerce.
360a. Repealed.
360b. New animal drugs.
(a) Unsafe new animal drugs and animal feed containing such drugs;
conditions of safety; exemption of drugs for research.
(b) Filing application for uses of new animal drug; contents;
patent information; abbreviated application.
(c) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order; abbreviated
applications; withdrawal periods; effective date of approval;
relationship to other applications; withdrawal or suspension of
approval; bioequivalence; filing of additional patent information.
(d) Grounds for refusing application; approval of application;
factors; ''substantial evidence'' defined.
(e) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to health of man or animals.
(f) Revocation of order refusing, withdrawing or suspending approval
of application.
(g) Service of orders.
(h) Appeal from order.
(i) Publication in Federal Register; effective date and revocation
or suspension of regulation.
(j) Exemption of drugs for research; discretionary and mandatory
conditions.
(k) Food containing new animal drug considered unadulterated while
approval of application for such drug is effective.
(l) Records and reports; required information; regulations and
orders; examination of data; access to records.
(m)(1) Filing application for uses of animal feed containing new
animal drug; contents.
(2) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order.
(3) Grounds for refusing application; approval of application;
approval effective during existence of subsection (i) regulation.
(4) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to health of man or animals.
(5) Records and reports; regulations and orders; access to records.
(n) Abbreviated applications for new animal drugs; contents, filing,
etc.; lists of approved drugs.
(o) ''Patent'' defined.
(p) Safety and effectiveness data.
360c. Classification of devices intended for human use.
(a) Classes of devices.
(b) Classification panels.
(c) Classification panel organization and operation.
(d) Panel recommendation; publication; priorities.
(e) Classification changes.
(f) Initial classification and reclassification of certain devices.
(g) Information.
(h) Definitions.
(i) Substantial equivalence.
360d. Performance standards.
(a) Reasonable assurance of safe and effective performance; periodic
evaluation.
(b) Establishment of a standard.
360e. Premarket approval.
(a) General requirement.
(b) Regulation to require premarket approval.
(c) Application for premarket approval.
(d) Action on application for premarket approval.
(e) Withdrawal and temporary suspension of approval of application.
(f) Product development protocol.
(g) Review.
(h) Service of orders.
(i) Revision.
360f. Banned devices.
(a) General rule.
(b) Special effective date.
360g. Judicial review.
(a) Petition; record.
(b) Additional data, views, and arguments.
(c) Standard for review.
(d) Finality of judgments.
(e) Remedies.
(f) Statement of reasons.
360h. Notification and other remedies.
(a) Notification.
(b) Repair, replacement, or refund.
(c) Reimbursement.
(d) Effect on other liability.
(e) Recall authority.
360i. Records and reports on devices.
(a) General rule.
(b) User reports.
(c) Persons exempt.
(d) Certification.
(e) Device tracking.
(f) Reports of removals and corrections.
360j. General provisions respecting control of devices intended for
human use.
(a) General rule.
(b) Custom devices.
(c) Trade secrets.
(d) Notices and findings.
(e) Restricted devices.
(f) Good manufacturing practice requirements.
(g) Exemption for devices for investigational use.
(h) Release of information respecting safety and effectiveness.
(i) Proceedings of advisory panels and committees.
(j) Traceability.
(k) Research and development.
(l) Transitional provisions for devices considered as new drugs or
antibiotic drugs.
(m) Humanitarian device exemption.
360k. State and local requirements respecting devices.
(a) General rule.
(b) Exempt requirements.
360l. Postmarket surveillance.
(a) In general.
(b) Surveillance approval.
360aa. Recommendations for investigations of drugs for rare diseases
or conditions.
(a) Request by sponsor; response by Secretary.
(b) Regulations.
360bb. Designation of drugs for rare diseases or conditions.
(a) Request by sponsor; preconditions; ''rare disease or
condition'' defined.
(b) Notification of discontinuance of drug or application as
condition.
(c) Notice to public.
(d) Regulations.
360cc. Protection for drugs for rare diseases or conditions.
(a) Exclusive approval, certification, or license.
(b) Exceptions.
360dd. Open protocols for investigations of drugs for rare diseases
or conditions.
360ee. Grants and contracts for development of drugs for rare
diseases and conditions.
(a) Authority of Secretary.
(b) Definitions.
(c) Authorization of appropriations.
360gg. Repealed.
360hh. Definitions.
360ii. Program of control.
(a) Establishment.
(b) Powers of Secretary.
(c) Record keeping.
360jj. Studies by the Secretary.
(a) Report to Congress.
(b) Participation of other Federal agencies.
(c) Organization of studies and participation.
360kk. Performance standards for electronic products.
(a) Promulgation of regulations.
(b) Administrative procedure.
(c) Publication in Federal Register.
(d) Judicial review.
(e) Availability of record.
(f) Technical Electronic Product Radiation Safety Standards
Committee.
(g) Review and evaluation.
(h) Product certification.
360ll. Notification of defects in and repair or replacement of
electronic products.
(a) Notification; exemption.
(b) Method of notification.
(c) Requisite elements of notification.
(d) Copies to Secretary of communications by manufacturers to dealers
or distributors regarding defects.
(e) Notice from Secretary to manufacturer of defects or failure to
comply with standards.
(f) Correction of defects.
(g) Effective date.
360mm. Imports.
(a) Refusal of admission to noncomplying electronic products.
(b) Bond.
(c) Liability of owner or consignee for expenses connected with
refusal of admission.
(d) Designation of agent for purposes of service.
360nn. Inspection, records, and reports.
(a) Inspection of premises.
(b) Record keeping.
(c) Disclosure of technical data.
(d) Public nature of reports.
(e) Trade secrets.
(f) Information required to identify and locate first purchasers of
electronic products.
360oo. Prohibited acts.
360pp. Enforcement.
(a) Jurisdiction of courts.
(b) Penalties.
(c) Venue; process.
(d) Warnings.
(e) Compliance with regulations.
(f) Additional remedies.
360qq. Annual report.
360rr. Federal-State cooperation.
360ss. State standards.
361. Adulterated cosmetics.
362. Misbranded cosmetics.
363. Regulations making exemptions.
364. Repealed.
371. Regulations and hearings.
(a) Authority to promulgate regulations.
(b) Regulations for imports and exports.
(c) Conduct of hearings.
(d) Effectiveness of definitions and standards of identity.
(e) Procedure for establishment.
(f) Review of order.
(g) Copies of records of hearings.
372. Examinations and investigations.
(a) Authority to conduct.
(b) Availability to owner of part of analysis samples.
(c) Records of other departments and agencies.
(d) Information on patents for drugs.
(e) Powers of enforcement personnel.
372a. Examination of sea food on request of packer; marking food
with results; fees; penalties.
373. Records of interstate shipment.
374. Inspection.
(a) Right of agents to enter; scope of inspection; notice;
promptness; exclusions.
(b) Written report to owner; copy to Secretary.
(c) Receipt for samples taken.
(d) Analysis of samples furnished owner.
(e) Accessibility of records.
375. Publicity.
(a) Reports.
(b) Information regarding certain goods.
376. Listing and certification of color additives for foods, drugs,
devices, and cosmetics.
(a) Unsafe color additives.
(b) Listing of colors; regulations; issuance, amendment or repeal;
referral to advisory committee; report and recommendations;
appointment and compensation of advisory committee.
(c) Certification of colors.
(d) Procedure for issuance, amendment, or repeal of regulations.
(e) Fees.
(f) Exemptions.
377. Revision of United States Pharmacopoeia; development of
analysis and mechanical and physical tests.
378. Advertising of foods.
(a) Determination of misbranding; notification of Federal Trade
Commission by Secretary; contents.
(b) Action by Federal Trade Commission precluding action by
Secretary; exception.
(c) Secretary's determination of imminent hazard to health as
suspending applicability of provisions.
(d) Coordination of action by Secretary with Federal Trade
Commission.
379. Confidential information.
379a. Presumption of existence of jurisdiction.
379b. Consolidated administrative and laboratory facility.
(a) Authority.
(b) Awarding of contract.
(c) Donations.
(d) Authorization of appropriations.
379c. Recovery and retention of fees for freedom of information
requests.
(a) In general.
(b) Use of fees.
(c) Waiver of fees.
379d. Automation of Food and Drug Administration.
(a) In general.
(b) Authorization of appropriations.
381. Imports and exports.
(a) Imports; list of registered foreign establishments; samples
from unregistered foreign establishments; examination and refusal of
admission.
(b) Disposition of refused articles.
(c) Charges concerning refused articles.
(d) Reimportation.
(e) Exports.
382. Exports of certain unapproved products.
(a) Drugs intended for human or animal use which require approval or
licensing.
(b) Conditions for export; active pursuit of drug approval or
licensing; application for export, contents, approval or disapproval;
list of eligible countries for export; criteria for list change.
(c) Report to Secretary by holder of approved application; events
requiring report; annual report to Secretary on pursuit of approval of
drug.
(d) Export of drug under approved application prohibited.
(e) Determination by Secretary of noncompliance, failure of active
pursuit of drug approval, imminent hazard of drug to public health, or
exportation of drug to noneligible country; notices and hearings;
prohibition on exportation of drug.
(f) Drugs used in prevention or treatment of tropical disease.
(g) Reference to Secretary and holder of application.
383. Office of International Relations.
391. Separability clause.
392. Exemption of meats and meat food products.
(a) Law determinative of exemption.
(b) Laws unaffected.
393. Food and Drug Administration.
(a) In general.
(b) Commissioner.
(c) Technical and scientific review groups.
394. Scientific review groups.
sections 136v, 138i, 1431c, 5341, 6519; title
15 sections 70j, 1261, 1263, 1277, 1457, 1459, 1460,
2057a, 2057b, 2079; title 18 section 42; title 26
sections 170, 4817; title 35 sections 155, 156, 271;
title 42 sections 262, 300aa-22, 300aa-23, 1396r-8,
1786, 3512, 7671.
21 USC SUBCHAPTER I -- SHORT TITLE
TITLE 21 -- FOOD AND DRUGS
21 USC 301. Short title
TITLE 21 -- FOOD AND DRUGS
This chapter may be cited as the Federal Food, Drug, and Cosmetic
Act.
(June 25, 1938, ch. 675, 1, 52 Stat. 1040.)
Act June 23, 1939, ch. 242, 1, 2, 53 Stat. 853, 854, provided that:
''(Sec. 1) (a) The effective date of the following provisions of the
Federal Food, Drug, and Cosmetic Act is hereby postponed until January
1, 1940: Sections 402(c) (342(c) of this title); 403(e)(1) (343(e)(1)
of this title); 403(g), (h), (i), (j), and (k) (343(g) to (k) of this
title); 501(a), (4) (351(a)(4) of this title); 502(b), (d), (e), (f),
(g), and (h) (352(b), (d) to (h) of this title); 601(e) (361(e) of this
title); and 602(b) (362(b) of this title).
''(b) The Secretary of Agriculture shall promulgate regulations
further postponing to July 1, 1940 the effective date of the provisions
of sections 403(e)(1) (343(e)(1) of this title); 403(g), (h), (i), (j),
and (k) (343(g) to (k)); 502(b), (d), (e), (f), (g), and (h) (352(b),
(d) to (h) of this title); and 602(b) (362(b) of this title) of such
Act with respect to lithographed labeling which was manufactured prior
to February 1, 1939, and to containers bearing labeling which, prior to
February 1, 1939, was lithographed, etched, stamped, pressed, printed,
fused or blown on or in such containers, where compliance with such
provisions would be unduly burdensome by reason of causing the loss of
valuable stocks of such labeling or containers, and where such
postponement would not prevent the public interest being adequately
served: Provided, That in no case shall such regulations apply to
labeling which would not have complied with the requirements of the Food
and Drugs Act of June 30, 1906, as amended.
''Sec. 2. (a) The provisions of section 8 (section 10 of this title),
paragraph fifth, under the heading 'In the case of food:', of the Food
and Drugs Act of June 30, 1906, as amended, and regulations promulgated
thereunder, and all other provisions of such Act to the extent that they
may relate to the enforcement of such section 8 (section 10 of this
title) and of such regulations, shall remain in force until January 1,
1940.
''(b) The provisions of such Act of June 30, 1906, as amended,
(sections 1 to 5, 7 to 15, and 372a of this title) to the extent that
they impose, or authorize the imposition of, any requirement imposed by
section 403(k) of the Federal Food, Drug, and Cosmetic Act (section
343(k) of this title), shall remain in force until January 1, 1940.
''(c) Notwithstanding the provisions of section 1 of this Act, such
section shall not apply --
''(1) to the provisions of section 502(d) and (e) of the Federal
Food, Drug, and Cosmetic Act (352(d), (e) of this title), insofar as
such provisions relate to any substance named in section 8 (section 10
of this title), paragraph second, under the heading 'In the case of
drugs:', of the Food and Drugs Act of June 30, 1906, as amended, or a
derivative of any such substance; or
''(2) to the provisions of section 502(b), (d), (e), (f), (g), and
(h) of the Federal Food, Drug, and Cosmetic Act (352(b), (d) to (h) of
this title), insofar as such provisions relate to drugs to which section
505 (355 of this title) of such Act applies.''
Section 902(a) of act June 25, 1938, provided that: ''This Act
(enacting this chapter and repealing sections 1 to 5 and 7 to 15 of this
title), shall take effect twelve months after the date of its enactment
(June 25, 1938). The Federal Food and Drugs Act of June 30, 1906, as
amended (U.S.C., 1934 ed., title 21, secs. 1-15), shall remain in force
until such effective date, and, except as otherwise provided in this
subsection, is hereby repealed effective upon such date: Provided, That
the provisions of section 701 (section 371 of this title) shall become
effective on the enactment of this Act, and thereafter the Secretary is
authorized hereby to (1) conduct hearings and to promulgate regulations
which shall become effective on or after the effective date of this Act
as the Secretary shall direct, and (2) designate prior to the effective
date of this Act food having common or usual names and exempt such food
from the requirements of clause (2) of section 403(i) (section 343(i) of
this title) for a reasonable time to permit the formulation,
promulgation, and effective application of definitions and standards of
identity therefor as provided by section 401 (section 341 of this
title): Provided further, That sections 502( j), 505, and 601(a)
(sections 352(j), 355, 361(a), respectively of this title), and all
other provisions of this Act to the extent that they may relate to the
enforcement of such sections, shall take effect on the date of the
enactment of this Act, except that in the case of a cosmetic to which
the proviso of section 601(a) (section 361(a) of this title), relates,
such cosmetic shall not, prior to the ninetieth day after such date of
enactment, be deemed adulterated by reason of the failure of its label
to bear the legend prescribed in such proviso: Provided further, That
the Act of March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6 (section
321a of this title); 42 Stat. 1500, ch. 268), defining butter and
providing a standard therefor; the Act of July 24, 1919 (U.S.C., 1934
ed., title 21, sec. 10 (section 321b of this title); 41 Stat. 271, ch.
26), defining wrapped meats as in package form; and the amendment to
the Food and Drugs Act, section 10A, approved August 27, 1935 (U.S.C.
1934 ed., Sup. III, title 21, sec. 14a (section 372a of this title))
shall remain in force and effect and be applicable to the provisions of
this Act.''
Federal Hazardous Substances Act as not modifying this chapter, see
Pub. L. 86-613, 18, July 12, 1960, 74 Stat. 380, set out as an Effect
Upon Federal and State Laws note under section 1261 of Title 15,
Commerce and Trade.
Pub. L. 101-635, 1(a), Nov. 28, 1990, 104 Stat. 4583, provided
that: ''This Act (enacting sections 379b to 379d and 394 of this title)
may be cited as the 'Food and Drug Administration Revitalization Act'.''
Pub. L. 101-629, 1(a), Nov. 28, 1990, 104 Stat. 4511, provided
that: ''This Act (enacting sections 360l and 383 of this title,
amending sections 321, 333, 351, 353, and 360c to 360j of this title and
sections 263b to 263n of Title 42, The Public Health and Welfare,
redesignating sections 263b to 263n of Title 42 as sections 360gg to
360ss of this title, repealing section 263b of Title 42, and enacting
provisions set out as notes under sections 333, 360c, 360i, 360j, 360hh
and 383 of this title) may be cited as the 'Safe Medical Devices Act of
1990'.''
Pub. L. 101-535, 1(a), Nov. 8, 1990, 104 Stat. 2353, provided that:
''This Act (enacting section 343-1 of this title, amending sections
321, 337, 343, 345, and 371 of this title, and enacting provisions set
out as notes under sections 343 and 343-1 of this title) may be cited as
the 'Nutrition Labeling and Education Act of 1990'.''
Pub. L. 100-670, 1(a), Nov. 16, 1988, 102 Stat. 3971, provided
that: ''This Act (amending sections 321, 353, and 360b of this title,
section 2201 of Title 28, Judiciary and Judicial Procedure, and sections
156 and 271 of Title 35, Patents, and enacting provisions set out as
notes under section 360b of this title) may be cited as the 'Generic
Animal Drug and Patent Term Restoration Act'.''
Pub. L. 100-607, title V, 501, Nov. 4, 1988, 102 Stat. 3120,
provided that: ''This title (enacting section 393 of this title,
amending sections 5315 and 5316 of Title 5, Government Organization and
Employees, and enacting provisions set out as notes under section 393 of
this title) may be cited as the 'Food and Drug Administration Act of
1988'.''
Pub. L. 100-293, 1(a), Apr. 22, 1988, 102 Stat. 95, provided that:
''This Act (amending sections 331, 333, 353, and 381 of this title and
enacting provisions set out as notes under section 353 of this title)
may be cited as the 'Prescription Drug Marketing Act of 1987'.''
Pub. L. 100-290, 1, Apr. 18, 1988, 102 Stat. 90, provided that:
''This Act (amending sections 360bb and 360ee of this title, enacting
provisions set out as a note under section 360aa of this title, and
amending provisions set out as a note under section 236 of Title 42, The
Public Health and Welfare) may be cited as the 'Orphan Drug Amendments
of 1988'.''
Pub. L. 99-660, title I, 101(a), Nov. 14, 1986, 100 Stat. 3743,
provided that: ''This title (enacting section 382 of this title,
amending sections 241 and 262 of Title 42, The Public Health and
Welfare, and enacting provisions set out as notes under section 333 of
this title and section 262 of Title 42) may be cited as the 'Drug Export
Amendments Act of 1986'.''
Pub. L. 99-91, 1, Aug. 15, 1985, 99 Stat. 387, provided that:
''This Act (amending sections 360aa to 360cc, and 360ee of this title,
and sections 295g-1 and 6022 of Title 42, The Public Health and Welfare,
and enacting provisions set out as notes under section 360aa of this
title and section 236 of Title 42) may be cited as the 'Orphan Drug
Amendments of 1985'.''
Pub. L. 98-417, 1, Sept. 24, 1984, 98 Stat. 1585, provided: ''That
this Act (enacting section 156 of Title 35, Patents, amending sections
355 and 360cc of this title, sections 68b, 68c, and 70b of Title 15,
Commerce and Trade, section 2201 of Title 28, Judiciary and Judicial
Procedure, and sections 271 and 282 of Title 35, and enacting provisions
set out as notes under section 355 of this title and section 68b of
Title 15) may be cited as the 'Drug Price Competition and Patent Term
Restoration Act of 1984'.''
Pub. L. 98-22, 1, Apr. 22, 1983, 97 Stat. 173, provided: ''That
this Act (amending provisions set out as a note under section 348 of
this title) may be cited as the 'Saccharin Study and Labeling Act
Amendment of 1983'.''
Pub. L. 97-414, 1(a), Jan. 4, 1983, 96 Stat. 2049, provided that:
''This Act (enacting part B of subchapter V of chapter 9 of this title,
section 44H of Title 26, Internal Revenue Code, section 155 of Title 35,
Patents, and sections 236, 255, and 298b-4 of Title 42, The Public
Health and Welfare, amending sections 1274, 1472, 2055, 2060, 2064,
2068, and 2080 of Title 15, Commerce and Trade, section 904 of this
title, sections 280C and 6096 of Title 26, and sections 209, 231, 242k,
242m, 243, 254c, 254j, 254m, 254o, 254p, 256, 294j, 295g-1, 295g-4,
295h, 295h-1a, 297-1, 300, 300a-1, 300a-3, 300b, 300e-1, 300m, 300n-5,
300q-2, 300u-5, 300w-3, 300x-1, 300x-4, 300y-11, 4577, and 4588 of Title
42, enacting provisions set out as notes under section 360aa of this
title, section 44H of Title 26, and sections 241, 255, 287i, and 300x-1
of Title 42, and repealing provisions set out as a note under section
300t-11 of Title 42) may be cited as the 'Orphan Drug Act'.''
Pub. L. 97-42, 1, Aug. 14, 1981, 95 Stat. 946, provided: ''That
this Act (amending provisions set out as a note under section 348 of
this title) may be cited as the 'Saccharin Study and Labeling Act
Amendment of 1981'.''
Pub. L. 96-359, 1, Sept. 26, 1980, 94 Stat. 1190, provided: ''That
this Act (enacting section 350a of this title, amending sections 321,
331, 374, 830, 841 to 843, and 873 of this title, and enacting a
provision set out as a note under section 350a of this title) may be
cited as the 'Infant Formula Act of 1980'.''
Pub. L. 95-203, 1, Nov. 23, 1977, 91 Stat. 1451, provided that:
''This Act (enacting section 343a of this title, amending sections 321
and 343 of this title, enacting provisions set out as notes under
sections 343 and 348 of this title, and amending provisions set out as
notes under sections 218 and 289l-1 of Title 42, The Public Health and
Welfare) may be cited as the 'Saccharin Study and Labeling Act'.''
Pub. L. 94-295, 1(a), May 28, 1976, 90 Stat. 539, provided that:
''This Act (enacting sections 360c to 360k, 379, and 379a of this title
and section 3512 of Title 42, The Public Health and Welfare, and
amending sections 321, 331, 334, 351, 352, 358, 360, 374, 376, and 381
of this title and section 55 of Title 15, Commerce and Trade) may be
cited as the 'Medical Device Amendments of 1976'.''
Pub. L. 92-387, 1, Aug. 16, 1972, 86 Stat. 559, provided that:
''This Act (amending sections 331, 335, and 360 of this title and
enacting provisions set out as notes under section 360 of this title)
may be cited as the 'Drug Listing Act of 1972'.''
Pub. L. 90-602, 1, Oct. 18, 1968, 82 Stat. 1173, provided that:
''This Act (enacting provisions now comprising part C ( 360gg-360ss) of
subchapter III of this chapter and provisions set out as notes under
section 360hh of this title) may be cited as the 'Radiation Control for
Health and Safety Act of 1968'.''
Pub. L. 90-399, 1, July 13, 1968, 82 Stat. 342, provided: ''That
this Act (enacting section 360b of this title, amending sections 321,
331, 342, 351, 352, 357, 381, and 392 of this title, and enacting
provisions set out as a note under section 360b of this title) may be
cited as the 'Animal Drug Amendments of 1968'.''
Pub. L. 89-74, 1, July 15, 1965, 79 Stat. 226, provided: ''That
this Act (amending sections 321, 331, 333, 334, 360, and 372 of this
title and section 1114 of Title 18, Crimes and Criminal Procedure, and
enacting provisions set out as notes under sections 321 and 352 of this
title) may be cited as the 'Drug Abuse Control Amendments of 1965'.''
Pub. L. 87-781, 1, Oct. 10, 1962, 76 Stat. 780, provided in part
that such Act (enacting sections 358 to 360 of this title, amending
sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 376, and
381 of this title, and enacting provisions set out as notes under
sections 321, 331, 332, 352, 355, 358, 360, and 374 of this title) may
be cited as the 'Drug Amendments of 1962'.''
Pub. L. 86-618, 1, July 12, 1960, 74 Stat. 397, provided: ''That
this Act (amending sections 321, 331, 333, 342, 346, 351, 352, 361, 362,
371, and 376 of this title, repealing sections 354 and 364 of this
title, and enacting notes set out under this section) may be cited as
the 'Color Additive Amendments of 1960'.''
Pub. L. 85-929, 1, Sept. 6, 1958, 72 Stat. 1784, provided: ''That
this Act (amending sections 321, 331, 342, 346, 348 of this title and
section 210 of Title 42, The Public Health and Welfare, and enacting
provisions set out as notes under sections 321, 342, and 451 of this
title) may be cited as the 'Food Additives Amendment of 1958'.''
21 USC SUBCHAPTER II -- DEFINITIONS
TITLE 21 -- FOOD AND DRUGS
21 USC 321. Definitions; generally
TITLE 21 -- FOOD AND DRUGS
For the purposes of this chapter --
(a)(1) The term ''State'', except as used in the last sentence of
section 372(a) of this title, means any State or Territory of the United
States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term ''Territory'' means any Territory or possession of the
United States, including the District of Columbia, and excluding the
Commonwealth of Puerto Rico and the Canal Zone.
(b) The term ''interstate commerce'' means (1) commerce between any
State or Territory and any place outside thereof, and (2) commerce
within the District of Columbia or within any other Territory not
organized with a legislative body.
(c) The term ''Department'' means Department of Health and Human
Services.
(d) The term ''Secretary'' means the Secretary of Health and Human
Services.
(e) The term ''person'' includes individual, partnership,
corporation, and association.
(f) The term ''food'' means (1) articles used for food or drink for
man or other animals, (2) chewing gum, and (3) articles used for
components of any such article.
(g)(1) The term ''drug'' means (A) articles recognized in the
official United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, or official National Formularly, or
any supplement to any of them; and (B) articles intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease in man
or other animals; and (C) articles (other than food) intended to affect
the structure or any function of the body of man or other animals; and
(D) articles intended for use as a component of any article specified in
clauses (A), (B), or (C) of this paragraph.
(2) The term ''counterfeit drugs'' means a drug which, or the
container or labeling of which, without authorization, bears the
trademark, trade name, or other identifying mark, imprint, or device, or
any likeness thereof, of a drug manufacturer, processor, packer, or
distributor other than the person or persons who in fact manufactured,
processed, packed, or distributed such drug and which thereby falsely
purports or is represented to be the product of, or to have been packed
or distributed by, such other drug manufacturer, processor, packer, or
distributor.
(h) The term ''device'' (except when used in paragraph (n) of this
section and in sections 331(i), 343(f), 352(c), and 362(c) of this
title) means an instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory, which is --
(1) recognized in the official National Formulary, or the United
States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions,
or in the cure, mitigation, treatment, or prevention of disease, in man
or other animals, or
(3) intended to affect the structure or any function of the body of
man or other animals, and
which does not achieve its primary intended purposes through chemical
action within or on the body of man or other animals and which is not
dependent upon being metabolized for the achievement of any of its
principal intended purposes.
(i) The term ''cosmetic'' means (1) articles intended to be rubbed,
poured, sprinkled, or sprayed on, introduced into, or otherwise applied
to the human body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance, and (2) articles
intended for use as a component of any such articles; except that such
term shall not include soap.
(j) The term ''official compendium'' means the official United States
Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States,
official National Formulary, or any supplement to any of them.
(k) The term ''label'' means a display of written, printed, or
graphic matter upon the immediate container of any article; and a
requirement made by or under authority of this chapter that any word,
statement, or other information appear on the label shall not be
considered to be complied with unless such word, statement, or other
information also appears on the outside container or wrapper, if any
there be, of the retail package of such article, or is easily legible
through the outside container or wrapper.
(l) The term ''immediate container'' does not include package liners.
(m) The term ''labeling'' means all labels and other written,
printed, or graphic matter (1) upon any article or any of its containers
or wrappers, or (2) accompanying such article.
(n) If an article is alleged to be misbranded because the labeling or
advertising is misleading, then in determining whether the labeling or
advertising is misleading there shall be taken into account (among other
things) not only representations made or suggested by statement, word,
design, device, or any combination thereof, but also the extent to which
the labeling or advertising fails to reveal facts material in the light
of such representations or material with respect to consequences which
may result from the use of the article to which the labeling or
advertising relates under the conditions of use prescribed in the
labeling or advertising thereof or under such conditions of use as are
customary or usual.
(o) The representation of a drug, in its labeling, as an antiseptic
shall be considered to be a representation that it is a germicide,
except in the case of a drug purporting to be, or represented as, an
antiseptic for inhibitory use as a wet dressing, ointment, dusting
powder, or such other use as involves prolonged contact with the body.
(p) The term ''new drug'' means --
(1) Any drug (except a new animal drug or an animal feed bearing or
containing a new animal drug) the composition of which is such that such
drug is not generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness of
drugs, as safe and effective for use under the conditions prescribed,
recommended, or suggested in the labeling thereof, except that such a
drug not so recognized shall not be deemed to be a ''new drug'' if at
any time prior to June 25, 1938, it was subject to the Food and Drugs
Act of June 30, 1906, as amended, and if at such time its labeling
contained the same representations concerning the conditions of its use;
or
(2) Any drug (except a new animal drug or an animal feed bearing or
containing a new animal drug) the composition of which is such that such
drug, as a result of investigations to determine its safety and
effectiveness for use under such conditions, has become so recognized,
but which has not, otherwise than in such investigations, been used to a
material extent or for a material time under such conditions.
(q) The term ''pesticide chemical'' means any substance which, alone,
in chemical combination or in formulation with one or more other
substances, is ''a pesticide'' within the meaning of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) as
now in force or as hereafter amended, and which is used in the
production, storage, or transportation of raw agricultural commodities.
(r) The term ''raw agricultural commodity'' means any food in its raw
or natural state, including all fruits that are washed, colored, or
otherwise treated in their unpeeled natural form prior to marketing.
(s) The term ''food additive'' means any substance the intended use
of which results or may reasonably be expected to result, directly or
indirectly, in its becoming a component or otherwise affecting the
characteristics of any food (including any substance intended for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food; and including any source of
radiation intended for any such use), if such substance is not generally
recognized, among experts qualified by scientific training and
experience to evaluate its safety, as having been adequately shown
through scientific procedures (or, in the case as a substance used in
food prior to January 1, 1958, through either scientific procedures or
experience based on common use in food) to be safe under the conditions
of its intended use; except that such term does not include --
(1) a pesticide chemical in or on a raw agricultural commodity; or
(2) a pesticide chemical to the extent that it is intended for use or
is used in the production, storage, or transportation of any raw
agricultural commodity; or
(3) a color additive; or
(4) any substance used in accordance with a sanction or approval
granted prior to September 6, 1958, pursuant to this chapter, the
Poultry Products Inspection Act (21 U.S.C. 451 et seq.) or the Meat
Inspection Act of March 4, 1907, as amended and extended (21 U.S.C. 601
et seq.); or
(5) a new animal drug.
(t)(1) The term ''color additive'' means a material which --
(A) is a dye, pigment, or other substance made by a process of
synthesis or similar artifice, or extracted, isolated, or otherwise
derived, with or without intermediate or final change of identity, from
a vegetable, animal, mineral, or other source, and
(B) when added or applied to a food, drug, or cosmetic, or to the
human body or any part thereof, is capable (alone or through reaction
with other substance) of imparting color thereto;
except that such term does not include any material which the
Secretary, by regulation, determines is used (or intended to be used)
solely for a purpose or purposes other than coloring.
(2) The term ''color'' includes black, white, and intermediate grays.
(3) Nothing in subparagraph (1) of this paragraph shall be construed
to apply to any pesticide chemical, soil or plant nutrient, or other
agricultural chemical solely because of its effect in aiding, retarding,
or otherwise affecting, directly or indirectly, the growth or other
natural physiological processes of produce of the soil and thereby
affecting its color, whether before or after harvest.
(u) The term ''safe'' as used in paragraph (s) of this section and in
sections 348, 360b, and 376 of this title, has reference to the health
of man or animal.
(v) Repealed. Pub. L. 91-513, title II, 701(a), Oct. 27, 1970, 84
Stat. 1281.
(w) The term ''new animal drug'' means any drug intended for use for
animals other than man, including any drug intended for use in animal
feed but not including such animal feed, --
(1) the composition of which is such that such drug is not generally
recognized, among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of animal drugs, as
safe and effective for use under the conditions prescribed, recommended,
or suggested in the labeling thereof; except that such a drug not so
recognized shall not be deemed to be a ''new animal drug'' if at any
time prior to June 25, 1938, it was subject to the Food and Drug Act of
June 30, 1906, as amended, and if at such time its labeling contained
the same representations concerning the conditions of its use; or
(2) the composition of which is such that such drug, as a result of
investigations to determine its safety and effectiveness for use under
such conditions, has become so recognized but which has not, otherwise
than in such investigations, been used to a material extent or for a
material time under such conditions.
(x) The term ''animal feed'', as used in paragraph (w) of this
section, in section 360b of this title, and in provisions of this
chapter referring to such paragraph or section, means an article which
is intended for use for food for animals other than man and which is
intended for use as a substantial source of nutrients in the diet of the
animal, and is not limited to a mixture intended to be the sole ration
of the animal.
(y) The term ''informal hearing'' means a hearing which is not
subject to section 554, 556, or 557 of title 5 and which provides for
the following:
(1) The presiding officer in the hearing shall be designated by the
Secretary from officers and employees of the Department of Health and
Human Services who have not participated in any action of the Secretary
which is the subject of the hearing and who are not directly responsible
to an officer or employee of the Department who has participated in any
such action.
(2) Each party to the hearing shall have the right at all times to be
advised and accompanied by an attorney.
(3) Before the hearing, each party to the hearing shall be given
reasonable notice of the matters to be considered at the hearing,
including a comprehensive statement of the basis for the action taken or
proposed by the Secretary which is the subject of the hearing and a
general summary of the information which will be presented by the
Secretary at the hearing in support of such action.
(4) At the hearing the parties to the hearing shall have the right to
hear a full and complete statement of the action of the Secretary which
is the subject of the hearing together with the information and reasons
supporting such action, to conduct reasonable questioning, and to
present any oral or written information relevant to such action.
(5) The presiding officer in such hearing shall prepare a written
report of the hearing to which shall be attached all written material
presented at the hearing. The participants in the hearing shall be
given the opportunity to review and correct or supplement the presiding
officer's report of the hearing.
(6) The Secretary may require the hearing to be transcribed. A party
to the hearing shall have the right to have the hearing transcribed at
his expense. Any transcription of a hearing shall be included in the
presiding officer's report of the hearing.
(z) The term ''saccharin'' includes calcium saccharin, sodium
saccharin, and ammonium saccharin.
(aa) The term ''infant formula'' means a food which purports to be or
is represented for special dietary use solely as a food for infants by
reason of its simulation of human milk or its suitability as a complete
or partial substitute for human milk.
(June 25, 1938, ch. 675, 201, 52 Stat. 1041; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 78 Stat. 631; July 22,
1954, ch. 559, 1, 68 Stat. 511; Sept. 6, 1958, Pub. L. 85-929, 2, 72
Stat. 1784; July 12, 1960, Pub. L. 86-618, title I, 101, 74 Stat. 397;
Oct. 10, 1962, Pub. L. 87-781, title I, 102(a), title III, 307( a), 76
Stat. 781, 796; July 15, 1965, Pub. L. 89-74, 3(a), 9( b), 79 Stat.
227, 234; July 13, 1968, Pub. L. 90-399, 102, 82 Stat. 351; Oct. 24,
1968, Pub. L. 90-639, 1, 4(a), 82 Stat. 1361, 1362; Oct. 27, 1970, Pub.
L. 91-513, title II, 701(a), (g), 84 Stat. 1281, 1282; Oct. 21, 1972,
Pub. L. 92-516, 3(3), 86 Stat. 998; Apr. 22, 1976, Pub. L. 94-278,
title V, 502(a)(2)(A), 90 Stat. 411; May 28, 1976, Pub. L. 94-295,
3(a)(1)(A), (2), 90 Stat. 575; Nov. 23, 1977, Pub. L. 95-203, 4(b)(3),
91 Stat. 1453; Oct. 17, 1979, Pub. L. 96-88, title V, 509(b), 93 Stat.
695; Sept. 26, 1980, Pub. L. 96-359, 3, 94 Stat. 1193; Nov. 16, 1988,
Pub. L. 100-670, title I, 107(a)(1), 102 Stat. 3984; Nov. 8, 1990, Pub.
L. 101-535, 5(b), 104 Stat. 2362; Nov. 28, 1990, Pub. L. 101-629,
16(b), 104 Stat. 4526.)
Pub. L. 101-535, 5(b), 10(a), Nov. 8, 1990, 104 Stat. 2362, 2365,
provided that, effective six months after the date of promulgation of
final regulations to implement section 343(r) of this title, or if such
regulations are not promulgated, the date proposed regulations are to be
considered as such final regulations, with certain exceptions,
subsection (g)(1) of this section is amended by inserting at the end ''A
food for which a claim, subject to sections 343(r)(1)(B) and 343( r)(3)
of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title,
is made in accordance with the requirements of section 343(r) of this
title is not a drug under clause (B) solely because the label or
labeling contains such a claim.''
The Food and Drugs Act of June 30, 1906, as amended, referred to in
subsec. (p)(1), and the Food and Drug Act of June 30, 1906, as amended,
referred to in subsec. (w)(1), is act June 30, 1906, ch. 3915, 34
Stat. 768, as amended, which was classified to subchapter I ( 1 et
seq.) of chapter 1 of this title, was repealed (except for section 14a
which was transferred to section 372a of this title) by act June 25,
1938, ch. 675, 902(a), 52 Stat. 1059, and is covered by this chapter.
The Federal Insecticide, Fungicide, and Rodenticide Act, referred to
in subsec. (q), is act June 25, 1947, ch. 125, as amended generally by
Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is classified
generally to subchapter II ( 136 et seq.) of chapter 6 of Title 7,
Agriculture. For complete classification of this Act to the Code, see
Short Title note set out under section 136 of Title 7 and Tables.
The Poultry Products Inspection Act, referred to in subsec. (s)(4),
is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which is
classified generally to chapter 10 ( 451 et seq.) of this title. For
complete classification of this Act to the Code, see Short Title note
set out under section 451 of this title and Tables.
The Meat Inspection Act of March 4, 1907, as amended and extended,
referred to in subsec. (s)(4), is act Mar. 4, 1907, ch. 2907, titles
I to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81 Stat. 584, which
are classified generally to subchapters I to IV ( 601 et seq.) of
chapter 12 of this title. For complete classification of this Act to
the Code, see Short Title note set out under section 601 of this title
and Tables.
1990 -- Subsec. (g)(1). Pub. L. 101-629, 16(b)(1), struck out before
period at end ''; but does not include devices or their components,
parts, or accessories''.
Subsec. (h). Pub. L. 101-629, 16(b)(2), which directed the amendment
of par. (3) by substituting ''its primary'' for ''any of its
principal'', was executed by making the substitution in the concluding
provisions of subsec. (h) to reflect the probable intent of Congress.
1988 -- Subsec. (w)(3). Pub. L. 100-670 struck out par. (3) which
read as follows: ''which drug is composed wholly or partly of any kind
of penicillin, streptomycin, chlortetracycline, chloramphenicol, or
bacitracin, or any derivative thereof, except when there is in effect a
published order of the Secretary declaring such drug not to be a new
animal drug on the grounds that (A) the requirement of certification of
batches of such drug, as provided for in section 360b(n) of this title,
is not necessary to insure that the objectives specified in paragraph
(3) thereof are achieved and (B) that neither subparagraph (1) nor (2)
of this paragraph (w) applies to such drug.''
1980 -- Subsec. (aa). Pub. L. 96-359 added subsec. (aa).
1977 -- Subsec. (z). Pub. L. 95-203 added subsec. (z).
1976 -- Subsec. (h). Pub. L. 94-295, 3(a)(1)(A), expanded definition
of ''device'' to include implements, machines, implants, in vitro
reagents, and other similar or related articles, added recognition in
the National Formulary or the United States Pharmacopeia, or any
supplement to the Formulary or Pharmacopeia, to the enumeration of
conditions under which a device may qualify for inclusion under this
chapter, and inserted requirements that a device be one which does not
achieve any of its principal intended purposes through chemical action
within or on the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its principal
intended purposes.
Subsec. (n). Pub. L. 94-278 inserted ''or advertising'' after
''labeling'' wherever appearing.
Subsec. (y). Pub. L. 94-295, 3(a)(2), added subsec. (y).
1972 -- Subsec. (q). Pub. L. 92-516 substituted reference to
pesticide for reference to economic poison.
1970 -- Subsec. (a)(2). Pub. L. 91-513, 701(g), struck out reference
to sections 321, 331(i), 331(p), 331(q), 332, 333, 334, 337, 360, 360a,
372, 373, 374, and 375 of this title as they apply to depressant or
stimulant drugs.
Subsec. (v). Pub. L. 91-513, 701(a), struck out subsec. (v) which
defined ''depressant or stimulant drug''.
1968 -- Subsec. (a)(2). Pub. L. 90-639, 4(a), extended provisions to
cover depressant and stimulant drugs, the containers thereof, and
equipment used in manufacturing, compounding, or processing such drugs,
to the Canal Zone.
Subsec. (p). Pub. L. 90-399, 102(a), (b), inserted ''(except a new
animal drug or an animal feed bearing or containing a new animal drug)''
after ''Any drug'' in subpars. (1) and (2), respectively.
Subsec. (s)(5). Pub. L. 90-399, 102(c), added subpar. (5).
Subsec. (u). Pub. L. 90-399, 102(d), inserted reference to section
360b of this title.
Subsec. (v)(3). Pub. L. 90-639, 1, inserted reference to lysergic
acid diethylamide.
Subsecs. (w), (x). Pub. L. 90-399, 102(e), added subsecs. (w) and
(x).
1965 -- Subsec. (g). Pub. L. 89-74, 9(b), designated existing
provisions as subpar. (1), redesignated cls. (1) to (4) thereof as (A)
to (D), substituted ''(A), (B), or (C)'' for ''(1), (2), or (3)'' and
added subpar. (2).
Subsec. (v). Pub. L. 89-74, 3(a), added subsec. (v).
1962 -- Subsec. (a). Pub. L. 87-781, 307(a), designated existing
provisions as cl. (2), inserted ''Commonwealth of Puerto Rico and
the'', and added cl. (1).
Subsec. (p)(1). Pub. L. 87-781, 102(a)(1), inserted ''and
effectiveness'' after ''to evaluate the safety'', and ''and effective''
after ''as safe''.
Subsec. (p)(2). Pub. L. 87-781, 102(a)(2), inserted ''and
effectiveness'' after ''safety''.
1960 -- Subsec. (s). Pub. L. 86-618, 101(a), excluded color
additives from definition of ''food additive''.
Subsec. (t). Pub. L. 86-618, 101(c), added subsec. (t). Former
subsec. (t) redesignated (u).
Subsec. (u). Pub. L. 86-618, 101(b), redesignated former subsec. (t)
as (u) and included a reference to section 376 of this title.
1958 -- Subsecs. (s), (t). Pub. L. 85-929 added subsecs. (s) and
(t).
1954 -- Subsecs. (q), (r). Act July 22, 1954, added subsecs. (q)
and (r).
''Department of Health and Human Services'' substituted for
''Department of Health, Education, and Welfare'' in subsecs. (c) and
(y)(1), ''Secretary of Health and Human Services'' for ''Secretary of
Health, Education, and Welfare'' in subsec. (d), pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
Amendment by Pub. L. 101-535 effective six months after the date of
the promulgation of final regulations to implement section 343(r) of
this title, or if such regulations are not promulgated, the date
proposed regulations are to be considered as such final regulations,
with exception for persons marketing food the brand name of which
contains a term defined by the Secretary under section 343(r)(2)(A)(i)
of this title, see section 10(a) of Pub. L. 101-535, set out as a note
under section 343 of this title.
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22, 1976,
see section 502(c) of Pub. L. 94-278, set out as a note under section
334 of this title.
Amendment by Pub. L. 92-516 effective at the close of Oct. 21,
1972, except if regulations are necessary for the implementation of any
provision that becomes effective on Oct. 21, 1972, and continuation in
effect of subchapter I of chapter 6 of Title 7, and regulations
thereunder, relating to the control of economic poisons, as in existence
prior to Oct. 21, 1972, until superseded by provisions of Pub. L.
92-516, and regulations thereunder, see section 4 of Pub. L. 92-516,
set out as an Effective Date note under section 136 of Title 7,
Agriculture.
Amendment by Pub. L. 91-513 effective on the first day of the
seventh calendar month that begins after Oct. 26, 1970, see section 704
of Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
Provisions
Section 6 of Pub. L. 90-639 provided that: ''The amendments made by
this Act (amending this section, sections 331, 333, 334, and 360a of
this title, and provisions set out as a note under section 289a of Title
42, The Public Health and Welfare) shall apply only with respect to
violations of the Federal Food, Drug, and Cosmetic Act (this chapter)
committed after the date of the enactment of this Act (Oct. 24,
1968).''
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, except that in the case of a drug
(other than one subject to section 360b(n) of this title) intended for
use in animals other than man which, on Oct. 9, 1962, was commercially
used or sold in the United States, was not a new drug as defined in
subsec. (p) of this section then in force, and was not covered by an
effective application under section 355 of this title, the words
''effectiveness'' and ''effective'' contained in subsec. (w) of this
section not applicable to such drug when intended solely for use under
conditions prescribed, recommended, or suggested in labeling with
respect to such drug on that day, see section 108(a), (b)(3) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions note
under section 360b of this title.
Section 11 of Pub. L. 89-74 provided that: ''The foregoing
provisions of this Act (see Short Title of 1965 Amendment note set out
under section 301 of this title) shall take effect on the first day of
the seventh calendar month (Feb. 1, 1966) following the month in which
this Act is enacted (July 15, 1965); except that (1) the Secretary
shall permit persons, owning or operating any establishment engaged in
manufacturing, preparing, propagating, compounding, processing,
wholesaling, jobbing, or distributing any depressant or stimulant drug,
as referred to in the amendments made by section 4 of this Act to
section 510 of the Federal Food, Drug, and Cosmetic Act (section 360 of
this title), to register their name, places of business, and
establishments, and other information prescribed by such amendments,
with the Secretary prior to such effective date, and (2) sections 201(
v) and 511(g) of the Federal Food, Drug, and Cosmetic Act, as added by
this act (subsec. (v) of this section and subsec. (g) of section 360a of
this title), and the provisions of sections 8 (amending section 372 of
this title and section 1114 of Title 18, Crimes and Criminal Procedure)
and 10 (set out as a note under this section) shall take effect upon the
date of enactment of this Act (July 15, 1965).''
Section 107 of Pub. L. 87-781 provided that:
''(a) Except as otherwise provided in this section, the amendments
made by the foregoing sections of this part A (amending this section and
sections 331, 332, 348, 351 to 353, 355, 357, 376 of this title, and
enacting provisions set out as a note under section 355 of this title)
shall take effect on the date of enactment of this Act (Oct. 10, 1962).
''(b) The amendments made by sections 101, 103, 105, and 106 of this
part A (amending sections 331, 332, 351, 352, 355, and 357 of this
title) shall, with respect to any drug, take effect on the first day of
the seventh calendar month following the month in which this Act is
enacted (Oct. 1962).
''(c)(1) As used in this subsection, the term 'enactment date' means
the date of enactment of this Act; and the term 'basic Act' means the
Federal Food, Drug, and Cosmetic Act (this chapter).
''(2) An application filed pursuant to section 505(b) of the basic
Act (section 355(b) of this title) which was 'effective' within the
meaning of that Act on the day immediately preceding the enactment date
shall be deemed as of the enactment date, to be an application
'approved' by the Secretary within the meaning of the basic Act as
amended by this Act.
''(3) In the case of any drug with respect to which an application
filed under section 505(b) of the basic Act is deemed to be an approved
application on the enactment date by virtue of paragraph (2) of this
subsection --
''(A) the amendments made by this Act to section 201(p), and to
subsections (b) and (d) of section 505, of the basic Act (subsec. (p) of
this section, and subsecs. (b) and (d) of section 355 of this title),
insofar as such amendments relate to the effectiveness of drugs, shall
not, so long as approval of such application is not withdrawn or
suspended pursuant to section 505(e) of that Act (section 355(e) of this
title), apply to such drug when intended solely for use under conditions
prescribed, recommended, or suggested in labeling covered by such
approved application, but shall apply to any changed use, or conditions
of use, prescribed, recommended, or suggested in its labeling, including
such conditions of use as are the subject of an amendment or supplement
to such application pending on, or filed after, the enactment date; and
''(B) clause (3) of the first sentence of section 505(e) of the basic
Act, as amended by this Act (section 355(e) of this title), shall not
apply to such drug when intended solely for use under conditions
prescribed, recommended, or suggested in labeling covered by such
approved application (except with respect to such use, or conditions of
use, as are the subject of an amendment or supplement to such approved
application, which amendment or supplement has been approved after the
enactment date under section 505 of the basic Act as amended by this Act
(section 355 of this title)) until whichever of the following first
occurs: (i) the expiration of the two-year period beginning with the
enactment date; (ii) the effective date of an order under section 505(
e) of the basic Act (section 355(e) of this title), other than clause
(3) of the first sentence of such section 505(e) (section 355(e) of this
title), withdrawing or suspending the approval of such application.
''(4) In the case of any drug which, on the day immediately preceding
the enactment date, (A) was commercially used or sold in the United
States, (B) was not a new drug as defined by section 201(p) of the basic
Act as then in force (subsec. (p) of this section), and (C) was not
covered by an effective application under section 505 of that Act
(section 355 of this title), the amendments to section 201(p) (subsec.
(p) of this section) made by this Act shall not apply to such drug when
intended solely for use under conditions prescribed, recommended, or
suggested in labeling with respect to such drug on that day.''
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
6(a) of Pub. L. 85-929, set out as a note under section 342 of this
title.
For effective date of amendment by act July 22, 1954, see section 5
of that act, set out as a note under section 342 of this title.
Amendments by Pub. L. 101-535 not to be construed to alter authority
of Secretary of Health and Human Services and Secretary of Agriculture
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L.
101-535, set out as a note under section 343 of this title.
Section 702 of Pub. L. 91-513, as amended by Pub. L. 93-481, 2,
Oct. 26, 1974, 88 Stat. 1455, provided that:
''(a) Prosecutions for any violation of law occurring prior to the
effective date (see Effective Date of 1970 Amendment note above) of
section 701 (repealing section 360a of this title, and amending sections
321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114 and
1952 of Title 18, Crimes and Criminal Procedure, and section 242 of
Title 42, The Public Health and Welfare) shall not be affected by the
repeals or amendments made by such section, or abated by reason thereof.
''(b) Civil seizures or forfeitures and injunctive proceedings
commenced prior to the effective date of section 701 shall not be
affected by the repeals or amendments made by such section, or abated by
reason thereof.
''(c) All administrative proceedings pending before the Bureau of
Narcotics and Dangerous Drugs (now the Drug Enforcement Administration)
on the date of enactment of this Act (Oct. 27, 1970) shall be continued
and brought to final determination in accord with laws and regulations
in effect prior to such date of enactment. Where a drug is finally
determined under such proceedings to be a depressant or stimulant drug,
as defined in section 201(v) of the Federal Food, Drug, and Cosmetic Act
(subsec. (v) of this section), such drug shall automatically be
controlled under this title (subchapter I of chapter 13 of this title)
by the Attorney General without further proceedings and listed in the
appropriate schedule after he has obtained the recommendation of the
Secretary. Any drug with respect to which such a final determination
has been made prior to the date of enactment of this Act which is not
listed in section 202 (section 812 of this title) within schedules I
through V shall automatically be controlled under this title (subchapter
I of chapter 13 of this title) by the Attorney General without further
proceedings, and be listed in the appropriate schedule, after he has
obtained the recommendations of the Secretary.
''(d) Notwithstanding subsection (a) of this section or section 1103
(of Pub. L. 91-513, set out as a note under sections 171 to 174 of this
title), section 4202 of title 18, United States Code, shall apply to any
individual convicted under any of the laws repealed by this title or
title III (subchapter I or subchapter II of chapter 13 of this title)
without regard to the terms of any sentence imposed on such individual
under such law.''
Functions of Secretary of Health, Education, and Welfare (now Health
and Human Services) under Federal Food, Drug, and Cosmetic Act, to the
extent such functions related to administration and enforcement of the
Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.),
transferred to Consumer Product Safety Commission by section 2079 of
Title 15, Commerce and Trade.
Functions of Secretary of Health, Education, and Welfare (now Health
and Human Services) under Drug Abuse Control Amendments of 1965 (see
Short Title of 1965 Amendment note set out under section 301 of this
title) transferred to Attorney General except function of regulating
counterfeiting of those drugs which are not ''depressant or stimulant''
drugs, see section 2 of Reorg. Plan No. 1 of 1968, set out in the
Appendix to Title 5, Government Organization and Employees.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see Transfer of Functions note set out under section 41 of this
title.
Section 5 of Pub. L. 90-639 provided that: ''It is the sense of the
Congress that, because of the inadequate knowledge on the part of the
people of the United States of the substantial adverse effects of misuse
of depressant and stimulant drugs, and of other drugs liable to abuse,
on the individual, his family, and the community, the highest priority
should be given to Federal programs to disseminate information which may
be used to educate the public, particularly young persons, regarding the
dangers of drug abuse.''
Section 2 of Pub. L. 89-74 provided that: ''The Congress hereby
finds and declares that there is a widespread illicit traffic in
depressant and stimulant drugs moving in or otherwise affecting
interstate commerce; that the use of such drugs, when not under the
supervision of a licensed practitioner, often endangers safety on the
highways (without distinction of interstate and intrastate traffic
thereon) and otherwise has become a threat to the public health and
safety, making additional regulation of such drugs necessary regardless
of the intrastate or interstate origin of such drugs; that in order to
make regulation and protection of interstate commerce in such drugs
effective, regulation of intrastate commerce is also necessary because,
among other things, such drugs, when held for illicit sale, often do not
bear labeling showing their place of origin and because in the form in
which they are so held or in which they are consumed a determination of
their place of origin is often extremely difficult or impossible; and
that regulation of interstate commerce without the regulation of
intrastate commerce in such drugs, as provided in this Act (see Short
Title of 1965 Amendment note set out under section 301 of this title),
would discriminate against and adversely affect interstate commerce in
such drugs.''
Section 10 of Pub. L. 89-74 provided that:
''(a) Nothing in this Act (enacting section 360a of this title,
amending sections 321, 331, 333, 334, 360, and 372 of this title and
section 1114 of Title 18, Crimes and Criminal Procedure, and enacting
provisions set out as notes under sections 321, 352, and 360a of this
title) shall be construed as authorizing the manufacture, compounding,
processing, possession, sale, delivery, or other disposal of any drug in
any State in contravention of the laws of such State.
''(b) No provision of this Act nor any amendment made by it shall be
construed as indicating an intent on the part of the Congress to occupy
the field in which such provision or amendment operates to the exclusion
of any State law on the same subject matter, unless there is a direct
and positive conflict between such provision or amendment and such State
law so that the two cannot be reconciled or consistently stand together.
''(c) No amendment made by this Act shall be construed to prevent the
enforcement in the courts of any State of any statute of such State
prescribing any criminal penalty for any act made criminal by any such
amendment.''
Section 202 of Pub. L. 87-781 provided that: ''Nothing in the
amendments made by this Act (enacting sections 358 to 360, amending
sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 376, and
381 of this title, and enacting provisions set out as notes under
sections 321, 331, 332, 352, 355, 360, and 374 of this title) to the
Federal Food, Drug, and Cosmetic Act (this chapter) shall be construed
as invalidating any provision of State law which would be valid in the
absence of such amendments unless there is a direct and positive
conflict between such amendments and such provision of State law.''
Appropriations for purpose and administration of subsecs. (q) and
(r) of this section, see section 346b of this title.
section 136; title 15 sections 1454, 1456, 1471,
2052, 2602; title 18 sections 842, 1365; title 35
section 156; title 42 sections 274e, 300cc-12,
1396r-8; title 49 App. section 2802.
21 USC 321a. ''Butter'' defined
TITLE 21 -- FOOD AND DRUGS
For the purposes of the Food and Drug Act of June 30, 1906
(Thirty-fourth Statutes at Large, page 768) ''butter'' shall be
understood to mean the food product usually known as butter, and which
is made exclusively from milk or cream, or both, with or without common
salt, and with or without additional coloring matter, and containing not
less than 80 per centum by weight of milk fat, all tolerances having
been allowed for.
(Mar. 4, 1923, ch. 268, 42 Stat. 1500.)
The Food and Drug Act of June 30, 1906, referred to in text, is act
June 30, 1906, ch. 3915, 34 Stat. 768, as amended, which was
classified to subchapter I ( 1 et seq.) of chapter 1 of this title, was
repealed (except for section 14a which was transferred to section 372a
of this title) by act June 25, 1938, ch. 675, 902(a), 52 Stat. 1059,
and is covered by this chapter.
Section, which was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter, was formerly classified to
section 6 of this title. Section 902(a) of act June 25, 1938, set out
as an Effective Date note under section 301 of this title, provided that
this section should remain in force and effect and be applicable to the
provisions of this chapter.
21 USC 321b. ''Package'' defined
TITLE 21 -- FOOD AND DRUGS
The word ''package'' where it occurs the second and last time in the
act entitled ''An act to amend section 8 of an act entitled, 'An act for
preventing the manufacture, sale, or transportation of adulterated or
misbranded or poisonous deleterious foods, drugs, medicines, and
liquors, and for regulating traffic therein, and for other purposes,'''
approved March 3, 1913, shall include and shall be construed to include
wrapped meats inclosed in papers or other materials as prepared by the
manufacturers thereof for sale.
(July 24, 1919, ch. 26, 41 Stat. 271.)
An act approved March 3, 1913, referred to in text, is act Mar. 3,
1913, ch. 117, 37 Stat. 732, which amended section 10 of this title.
For complete classification of this Act to the Code, see Tables.
''An act for preventing the manufacture, sale, or transportation of
adulterated or misbranded or poisonous deleterious foods, drugs,
medicines, and liquors, and for regulating traffic therein, and for
other purposes,'', referred to in text, is act June 30, 1906, ch. 3915,
34 Stat. 768, which was classified to subchapter I ( 1 et seq.) of
chapter 1 of this title, was repealed (except for section 14a which was
transferred to section 372a of this title) by act June 25, 1938, ch.
675, 902(a), 52 Stat. 1059, and is covered by this chapter.
Section, which was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter, was formerly classified to
the last sentence of paragraph third of section 10 of this title.
Section 902(a) of act June 25, 1938, set out as an Effective Date note
under section 301 of this title, provided that this section should
remain in force and effect and be applicable to the provisions of this
chapter.
21 USC 321c. Nonfat dry milk; ''milk'' defined
TITLE 21 -- FOOD AND DRUGS
For the purposes of the Federal Food, Drug, and Cosmetic Act of June
26, 1938, (ch. 675, sec. 1, 52 Stat. 1040) (21 U.S.C. 301 et seq.)
nonfat dry milk is the product resulting from the removal of fat and
water from milk, and contains the lactose, milk proteins, and milk
minerals in the same relative proportions as in the fresh milk from
which made. It contains not over 5 per centum by weight of moisture.
The fat content is not over 1 1/2 per centum by weight unless otherwise
indicated.
The term ''milk'', when used herein, means sweet milk of cows.
(Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70 Stat.
486.)
The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch. 675,
sec. 1, 52 Stat. 1040), referred to in text, probably means act June 25,
1938, ch. 675, 52 Stat. 1040, as amended, which is classified
generally to this chapter ( 301 et seq.). For complete classification of
this Act to the Code, see section 301 of this title and Tables.
Section was not enacted as a part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter, but was made applicable
thereto.
1956 -- Act July 2, 1956, substituted ''nonfat dry milk'' for
''nonfat dry milk solids or defatted milk solids''.
21 USC SUBCHAPTER III -- PROHIBITED ACTS AND PENALTIES
TITLE 21 -- FOOD AND DRUGS
21 USC 331. Prohibited acts
TITLE 21 -- FOOD AND DRUGS
The following acts and the causing thereof are prohibited:
(a) The introduction or delivery for introduction into interstate
commerce of any food, drug, device, or cosmetic that is adulterated or
misbranded.
(b) The adulteration or misbranding of any food, drug, device, or
cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device, or
cosmetic that is adulterated or misbranded, and the delivery or
proffered delivery thereof for pay or otherwise.
(d) The introduction or delivery for introduction into interstate
commerce of any article in violation of section 344 or 355 of this
title.
(e) The refusal to permit access to or copying of any record as
required by section 350a or 373 of this title; or the failure to
establish or maintain any record, or make any report, required under
section 350a, 355(i) or (k), 357(d) or (g), 360b(j), (l), or (m), 360e(
f), or 360i of this title, or the refusal to permit access to or
verification or copying of any such required record.
(f) The refusal to permit entry or inspection as authorized by
section 374 of this title.
(g) The manufacture within any Territory of any food, drug, device,
or cosmetic that is adulterated or misbranded.
(h) The giving of a guaranty or undertaking referred to in section
333(c)(2) of this title, which guaranty or undertaking is false, except
by a person who relied upon a guaranty or undertaking to the same effect
signed by, and containing the name and address of, the person residing
in the United States from whom he received in good faith the food, drug,
device, or cosmetic; or the giving of a guaranty or undertaking
referred to in section 333(c)(3) of this title, which guaranty or
undertaking is false.
(i)(1) Forging, counterfeiting, simulating, or falsely representing,
or without proper authority using any mark, stamp, tag, label, or other
identification device authorized or required by regulations promulgated
under the provisions of section 344, 356, 357, or 376 of this title.
(2) Making, selling, disposing of, or keeping in possession, control,
or custody, or concealing any punch, die, plate, stone, or other thing
designed to print, imprint, or reproduce the trademark, trade name, or
other identifying mark, imprint, or device of another or any likeness of
any of the foregoing upon any drug or container or labeling thereof so
as to render such drug a counterfeit drug.
(3) The doing of any act which causes a drug to be a counterfeit
drug, or the sale or dispensing, or the holding for sale or dispensing,
of a counterfeit drug.
(j) The using by any person to his own advantage, or revealing, other
than to the Secretary or officers or employees of the Department, or to
the courts when relevant in any judicial proceeding under this chapter,
any information acquired under authority of section 344, 348, 350a, 355,
356, 357, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 374, 376,
or 379 of this title concerning any method or process which as a trade
secret is entitled to protection. This paragraph /1/ does not authorize
the withholding of information from either House of Congress or from, to
the extent of matter within its jurisdiction, any committee or
subcommittee of such committee or any joint committee of Congress or any
subcommittee of such joint committee.
(k) The alteration, mutilation, destruction, obliteration, or removal
of the whole or any part of the labeling of, or the doing of any other
act with respect to, a food, drug, device, or cosmetic, if such act is
done while such article is held for sale (whether or not the first sale)
after shipment in interstate commerce and results in such article being
adulterated or misbranded.
(l) The using, on the labeling of any drug or device or in any
advertising relating to such drug or device, of any representation or
suggestion that approval of an application with respect to such drug or
device is in effect under section 355, 360e, or 360j(g) of this title,
as the case may be, or that such drug or device complies with the
provisions of such section.
(m) The sale or offering for sale of colored oleomargarine or colored
margarine, or the possession or serving of colored oleomargarine or
colored margarine in violation of subsections (b) or (c) of section 347
of this title.
(n) The using, in labeling, advertising or other sales promotion of
any reference to any report or analysis furnished in compliance with
section 374 of this title.
(o) In the case of a prescription drug distributed or offered for
sale in interstate commerce, the failure of the manufacturer, packer, or
distributor thereof to maintain for transmittal, or to transmit, to any
practitioner licensed by applicable State law to administer such drug
who makes written request for information as to such drug, true and
correct copies of all printed matter which is required to be included in
any package in which that drug is distributed or sold, or such other
printed matter as is approved by the Secretary. Nothing in this
paragraph shall be construed to exempt any person from any labeling
requirement imposed by or under other provisions of this chapter.
(p) The failure to register in accordance with section 360 of this
title, the failure to provide any information required by section 360(
j) or 360(k) of this title, or the failure to provide a notice required
by section 360(j)(2) of this title.
(q)(1) The failure or refusal to (A) comply with any requirement
prescribed under section 360h or 360j(g) of this title, or (B) furnish
any notification or other material or information required by or under
section 360i or 360j(g) of this title.
(2) With respect to any device, the submission of any report that is
required by or under this chapter that is false or misleading in any
material respect.
(r) The movement of a device in violation of an order under section
334(g) of this title or the removal or alteration of any mark or label
required by the order to identify the device as detained.
(s) The failure to provide the notice required by section 350a(c) or
350a(d) /2/ of this title, the failure to make the reports required by
section 350a(f)(1)(B) of this title, the failure to retain the records
required by section 350a(b)(4) of this title, or the failure to meet the
requirements prescribed under section 350a(f)(3) of this title.
(t) The importation of a drug in violation of section 381(d)(1) of
this title, the sale, purchase, or trade of a drug or drug sample or the
offer to sell, purchase, or trade a drug or drug sample in violation of
section 353(c) of this title, the sale, purchase, or trade of a coupon,
the offer to sell, purchase, or trade such a coupon, or the
counterfeiting of such a coupon in violation of section 353(c)(2) of
this title, the distribution of a drug sample in violation of section
353(d) of this title or the failure to otherwise comply with the
requirements of section 353(d) of this title, or the distribution of
drugs in violation of section 353(e) of this title or the failure to
otherwise comply with the requirements of section 353(e) of this title.
(June 25, 1938, ch. 675, 301, 52 Stat. 1042; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; Dec. 22, 1941,
ch. 613, 1, 55 Stat. 851; July 6, 1945, ch. 281, 1, 59 Stat. 463; Mar.
10, 1947, ch. 16, 1, 61 Stat. 11; June 24, 1948, ch. 613, 1, 62 Stat.
582; Mar. 16, 1950, ch. 61, 3(b), 64 Stat. 20; 1953 Reorg. Plan No.
1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Aug. 7, 1953, ch.
350, 2, 67 Stat. 477; Sept. 6, 1958, Pub. L. 85-929, 5, 72 Stat. 1788;
July 12, 1960, Pub. L. 86-618, title I,
104, 105(a), 74 Stat. 403; Oct. 10, 1962, Pub. L. 87-781, title I,
103(c), 104(e)(1), 106(c), 114(a), title III, 304, 76 Stat. 784, 785,
788, 791, 795; July 15, 1965, Pub. L. 89-74, 5, 9(c), 79 Stat. 232,
235; July 13, 1968, Pub. L. 90-399, 103, 82 Stat. 352; Oct. 24, 1968,
Pub. L. 90-639, 2(b), 82 Stat. 1361; Oct. 27, 1970, Pub. L. 91-513,
title II, 701(a), 84 Stat. 1281; Aug. 16, 1972, Pub. L. 92-387, 4(e),
86 Stat. 562; May 28, 1976, Pub. L. 94-295, 3(b), 4( b)( 1), 7(b), 90
Stat. 576, 580, 582; Sept. 26, 1980, Pub. L. 96-359, 5, 94 Stat. 1193;
Oct. 27, 1986, Pub. L. 99-570, title IV, 4014(b)( 2), 100 Stat.
3207-120; Apr. 22, 1988, Pub. L. 100-293, 7(a), 102 Stat. 99; Nov. 3,
1990, Pub. L. 101-502, 5(j), 104 Stat. 1289; Nov. 5, 1990, Pub. L.
101-508, title IV, 4755(c)(2), 104 Stat. 1388-210.)
1990 -- Subsec. (e). Pub. L. 101-502 substituted ''or (k)'' for ''or
(j)''.
Subsec. (j). Pub. L. 101-508 inserted at end ''This paragraph does
not authorize the withholding of information from either House of
Congress or from, to the extent of matter within its jurisdiction, any
committee or subcommittee of such committee or any joint committee of
Congress or any subcommittee of such joint committee.''
1988 -- Subsec. (t). Pub. L. 100-293 added subsec. (t).
1986 -- Subsec. (s). Pub. L. 99-570 amended subsec. (s) generally.
Prior to amendment, subsec. (s) read as follows: ''The failure to
provide the notice required by section 350a(b) or 350a(c), the failure
to make the reports required by section 350a(d)(1)(B), or the failure to
meet the requirements prescribed under section 350a(d)(2).''
1980 -- Subsec. (e). Pub. L. 96-359, 5(b), inserted reference to
section 350a of this title in two places.
Subsec. (j). Pub. L. 96-359, 5(c), inserted reference to section 350a
of this title.
Subsec. (s). Pub. L. 96-359, 5(a), added subsec. (s).
1976 -- Subsec. (e). Pub. L. 94-295, 3(b)(2), inserted references to
sections 360e(f) and 360i of this title.
Subsec. (j). Pub. L. 94-295, 3(b)(3), inserted references to sections
360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of this title.
Subsec. (l). Pub. L. 94-295, 3(b)(4), substituted ''drug or device''
for ''drug'' wherever appearing, and inserted references to sections
360e and 360j(g) of this title.
Subsec. (p). Pub. L. 94-295, 4(b)(1), substituted ''section 360(j) or
360(k) of this title,'' for ''section 360(j) of this title,''.
Subsec. (q). Pub. L. 94-295, 3(b)(1), added subsec. (q).
Subsec. (r). Pub. L. 94-295, 7(b), added subsec. (r).
1972 -- Subsec. (p). Pub. L. 92-387 added failure to provide
information required by section 360(j) of this title, and failure to
provide notice required by section 360(j)(2) of this title as prohibited
acts.
1970 -- Subsec. (q). Pub. L. 91-513 struck out subsec. (q) which
set out penalties for illegal manufacture, sale, disposition, possession
and other traffic in stimulant and depressant drugs. See section 801 et
seq. of this title.
1968 -- Subsec. (e). Pub. L. 90-399, 103(1), inserted reference to
section 360b(j), (l), and (m) of this title.
Subsec. (j). Pub. L. 90-399, 103(2), inserted reference to section
360b of this title.
Subsec. (q). Pub. L. 90-639 divided cl. (3), which had formerly
referred simply to possession in violation of section 360a(c) of this
title, into parts (A) and (B) which refer, respectively, to possession
in violation of section 360a(c)(1) of this title and possession in
violation of section 360a(c)(2) of this title.
1965 -- Subsec. (i). Pub. L. 89-74, 9(c), designated existing
provisions as subpar. (1) and added subpars. (2) and (3).
Subsec. (q). Pub. L. 89-74, 5, added subsec. (q).
1962 -- Subsec. (e). Pub. L. 87-781, 103(c), 106(c), prohibited the
failure to establish or maintain any record, or make any report,
required under sections 355(i) or (j) and 507(d) or (g) of this title,
or the refusal to permit access to, or verification or copying of, any
such required record.
Subsec. (l). Pub. L. 87-781, 104(e)(1), inserted ''approval of''
before ''an application'', and substituted ''in effect'' for
''effective''.
Subsec. (o). Pub. L. 87-781, 114(a), added subsec. (o).
Subsec. (p). Pub. L. 87-781, 304, added subsec. (p).
1960 -- Subsec. (i). Pub. L. 86-618, 105(a), struck out references
to sections 346(b), 354, and 364 of this title and inserted a reference
to section 376 of this title.
Subsec. (j). Pub. L. 86-618, 104, inserted reference to section 376
of this title.
1958 -- Subsec. (j). Pub. L. 85-929, inserted reference to section
348 of this title.
1953 -- Subsec. (n). Act Aug. 7, 1953, added subsec. (n).
1950 -- Subsec. (m). Act Mar. 16, 1950, added subsec. (m).
1948 -- Subsec. (k). Act June 24, 1948, inserted ''(whether or not
the first sale)'' so as to make it clear that this subsection is not
limited to the case where the act occurs while the article is held for
the first sale after interstate shipment, and extended coverage of
subsection to acts which result in adulteration.
1947 -- Subsec. (j). Act Mar. 10, 1947, inserted reference to
sections 356 and 357 of this title.
1945 -- Subsec. (i). Act July 6, 1945, inserted reference to section
357 of this title.
1941 -- Subsec. (i). Act Dec. 22, 1941, inserted reference to
section 356 of this title.
Section 4755(c)(2) of Pub. L. 101-508 provided that the amendment
made by that section is effective as if included in subtitle D of title
VI of the Omnibus Budget Reconciliation Act of 1989, Pub. L. 101-239,
title VI, 6601, 6602, Dec. 19, 1989, 103 Stat. 2285, see 42 U.S.C.
300aa-1 note, 300aa-10 note.
Amendment by Pub. L. 100-293 effective upon expiration of 90 days
after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out as a
note under section 353 of this title.
Amendment by Pub. L. 92-387 effective on first day of sixth month
beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set
out as a note under section 360 of this title.
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of Pub.
L. 91-513, set out as an Effective Date note under section 801 of this
title.
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions note
under section 360b of this title.
Amendment by Pub. L. 90-639 applicable only with respect to
violations of this chapter committed after Oct. 24, 1968, see section 6
of Pub. L. 90-639, set out as an Effective Date of 1968 Amendments;
Transitional Provisions note under section 321 of this title.
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
of Pub. L. 89-74, set out as a note under section 321 of this title.
Amendment by sections 103(c) and 106(c) of Pub. L. 87-781 effective
on first day of seventh calendar month following Oct. 1962, and
amendment by section 104(e)(1) of Pub. L. 87-781 effective Oct. 10,
1962, see section 107 of Pub. L. 87-781, set out as a note under
section 321 of this title.
Section 114(b) of Pub. L. 87-781 provided that: ''This section
(amending this section) shall take effect on the first day of the
seventh calendar month following the month in which this Act is enacted
(October 1962).''
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
6(a) of Pub. L. 85-929, set out as a note under section 342 of this
title.
Amendment by act Mar. 16, 1950, effective July 1, 1950, see section
7 of that act, set out as an Effective Date note under section 347 of
this title.
Amendment by Pub. L. 91-513 not to affect or abate any prosecutions
for violation of law or any civil seizures or forfeitures and injunctive
proceedings commenced prior to the effective date of such amendment, and
all administrative proceedings pending before the Bureau of Narcotics
and Dangerous Drugs (now the Drug Enforcement Administration) on Oct.
27, 1970, to be continued and brought to final determination in accord
with laws and regulations in effect prior to Oct. 27, 1970, see section
702 of Pub. L. 91-513, set out as a note under section 321 of this
title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
1456; title 42 section 1396r-8.
/1/ So in original. Probably should be ''subsection''.
/2/ So in original. Probably should be ''350a(e)''.
21 USC 332. Injunction proceedings
TITLE 21 -- FOOD AND DRUGS
(a) Jurisdiction of courts
The district courts of the United States and the United States courts
of the Territories shall have jurisdiction, for cause shown, and subject
to the provisions of section 17 (relating to notice to opposite party)
of the Act entitled ''An Act to supplement existing laws against
unlawful restraints and monopolies, and for other purposes'', approved
October 15, 1914, as amended (U.S.C., 1934 ed., title 28, sec. 381), to
restrain violations of section 331 of this title, except paragraphs (h),
(i), and (j).
(b) Violation of injunction
In case of violation of an injunction or restraining order issued
under this section, which also constitutes a violation of this chapter,
trial shall be by the court, or, upon demand of the accused, by a jury.
Such trial shall be conducted in accordance with the practice and
procedure applicable in the case of proceedings subject to the
provisions of section 22 of such Act of October 15, 1914, as amended
(U.S.C., 1934 ed., title 28, sec. 387).
(June 25, 1938, ch. 675, 302, 52 Stat. 1043; Oct. 10, 1962, Pub. L.
87-781, title I, 103(d), title II, 201(c), 76 Stat. 784, 793.)
Section 17 of the Act approved October 15, 1914, referred to in
subsec. (a), was repealed by act June 25, 1948, ch. 646, 39, 62 Stat.
992, eff. Sept. 1, 1948, and is covered by rule 65 of Federal Rules of
Civil Procedure, set out in the Appendix to Title 28, Judiciary and
Judicial Procedure.
Section 22 of such Act of October 15, 1914, referred to in subsec.
(b), was repealed by act June 25, 1948, ch. 645, 21, 62 Stat. 862, and
is covered by section 402 of Title 18, Crimes and Criminal Procedure,
and rule 42(b) of the Federal Rules of Criminal Procedure, set out in
the Appendix to Title 18.
1962 -- Subsec. (a). Pub. L. 87-781, 103(d), struck out ''(e),''
after ''paragraphs''.
Pub. L. 87-781, 201(c), struck out ''(f),'' after ''paragraphs''.
Amendment by section 103(c) of Pub. L. 87-781 effective on first day
of seventh calendar month following October 1962, see section 107 of
Pub. L. 87-781, set out as a note under section 321 of this title.
Section 203 of title II of Pub. L. 87-781 provided that: ''The
amendments made by this title (amending this section and section 374 of
this title and enacting provisions set out as notes under sections 321
and 374 of this title) shall take effect on the date of enactment of
this Act (Oct. 10, 1962).''
1396r-8.
21 USC 333. Penalties
TITLE 21 -- FOOD AND DRUGS
(a) Violation of section 331 of this title; second violation;
intent to defraud or mislead
(1) Any person who violates a provision of section 331 of this title
shall be imprisoned for not more than one year or fined not more than
$1,000, or both.
(2) Notwithstanding the provisions of paragraph (1), if any person
commits such a violation after a conviction of him under this section
has become final, or commits such a violation with the intent to defraud
or mislead, such person shall be imprisoned for not more than three
years or fined not more than $10,000, or both.
(b) Prescription drug marketing violations
(1) Notwithstanding subsection (a) of this section, any person who
violates section 331(t) of this title because of an importation of a
drug in violation of section 381(d)(1) of this title, because of a sale,
purchase, or trade of a drug or drug sample or the offer to sell,
purchase, or trade a drug or drug sample in violation of section 353(c)
of this title, because of the sale, purchase, or trade of a coupon, the
offer to sell, purchase, or trade such a coupon, or the counterfeiting
of such a coupon in violation of section 353(c)(2) of this title, or the
distribution of drugs in violation of section 353(e)(2)(A) of this title
shall be imprisoned for not more than 10 years or fined not more than
$250,000, or both.
(2) Any manufacturer or distributor who distributes drug samples by
means other than the mail or common carrier whose representative, during
the course of the representative's employment or association with that
manufacturer or distributor, violated section 331(t) of this title
because of a violation of section 353(c)(1) of this title or violated
any State law prohibiting the sale, purchase, or trade of a drug sample
subject to section 353(b) of this title or the offer to sell, purchase,
or trade such a drug sample shall, upon conviction of the representative
for such violation, be subject to the following civil penalties:
(A) A civil penalty of not more than $50,000 for each of the first
two such violations resulting in a conviction of any representative of
the manufacturer or distributor in any 10-year period.
(B) A civil penalty of not more than $1,000,000 for each violation
resulting in a conviction of any representative after the second
conviction in any 10-year period.
For the purposes of this paragraph, multiple convictions of one or
more persons arising out of the same event or transaction, or a related
series of events or transactions, shall be considered as one violation.
(3) Any manufacturer or distributor who violates section 331(t) of
this title because of a failure to make a report required by section
353(d)(3)(E) of this title shall be subject to a civil penalty of not
more than $100,000.
(4)(A) If a manufacturer or distributor or any representative of such
manufacturer or distributor provides information leading to the arrest
and conviction of any representative of that manufacturer or distributor
for a violation of section 331(t) of this title because of a sale,
purchase, or trade or offer to purchase, sell, or trade a drug sample in
violation of section 353(c)(1) of this title or for a violation of State
law prohibiting the sale, purchase, or trade or offer to sell, purchase,
or trade a drug sample, the conviction of such representative shall not
be considered as a violation for purposes of paragraph (2).
(B) If, in an action brought under paragraph (2) against a
manufacturer or distributor relating to the conviction of a
representative of such manufacturer or distributor for the sale,
purchase, or trade of a drug or the offer to sell, purchase, or trade a
drug, it is shown, by clear and convincing evidence --
(i) that the manufacturer or distributor conducted, before the arrest
of such representative for the violation which resulted in such
conviction, an investigation of events or transactions which would have
led to the reporting of information leading to the arrest and conviction
of such representative for such purchase, sale, or trade or offer to
purchase, sell, or trade, or
(ii) that, except in the case of the conviction of a representative
employed in a supervisory function, despite diligent implementation by
the manufacturer or distributor of an independent audit and security
system designed to detect such a violation, the manufacturer or
distributor could not reasonably have been expected to have detected
such violation,
the conviction of such representative shall not be considered as a
conviction for purposes of paragraph (2).
(5) If a person provides information leading to the arrest and
conviction of a person for a violation of section 331(t) of this title
because of the sale, purchase, or trade of a drug sample or the offer to
sell, purchase, or trade a drug sample in violation of section 353(
c)(1) of this title, such person shall be entitled to one-half of the
criminal fine imposed and collected for such violation but not more than
$125,000.
(c) Exceptions in certain cases of good faith, etc.
No person shall be subject to the penalties of subsection (a) of this
section, (1) for having received in interstate commerce any article and
delivered it or proffered delivery of it, if such delivery or proffer
was made in good faith, unless he refuses to furnish on request of an
officer or employee duly designated by the Secretary the name and
address of the person from whom he purchased or received such article
and copies of all documents, if any there be, pertaining to the delivery
of the article to him; or (2) for having violated section 331(a) or (d)
of this title, if he establishes a guaranty or undertaking signed by,
and containing the name and address of, the person residing in the
United States from whom he received in good faith the article, to the
effect, in case of an alleged violation of section 331(a) of this title,
that such article is not adulterated or misbranded, within the meaning
of this chapter designating this chapter or to the effect, in case of an
alleged violation of section 331(d) of this title, that such article is
not an article which may not, under the provisions of section 344 or 355
of this title, be introduced into interstate commerce; or (3) for
having violated section 331(a) of this title, where the violation exists
because the article is adulterated by reason of containing a color
additive not from a batch certified in accordance with regulations
promulgated by the Secretary under this chapter, if such person
establishes a guaranty or undertaking signed by, and containing the name
and address of, the manufacturer of the color additive, to the effect
that such color additive was from a batch certified in accordance with
the applicable regulations promulgated by the Secretary under this
chapter; or (4) for having violated section 331(b), (c) or (k) of this
title by failure to comply with section 352( f) of this title in respect
to an article received in interstate commerce to which neither section
353(a) nor 353(b)(1) of this title is applicable, if the delivery or
proffered delivery was made in good faith and the labeling at the time
thereof contained the same directions for use and warning statements as
were contained in the labeling at the time of such receipt of such
article; or (5) for having violated section 331(i)(2) of this title if
such person acted in good faith and had no reason to believe that use of
the punch, die, plate, stone, or other thing involved would result in a
drug being a counterfeit drug, or for having violated section 331(i)(3)
of this title if the person doing the act or causing it to be done acted
in good faith and had no reason to believe that the drug was a
counterfeit drug.
(d) Exceptions involving misbranded food
No person shall be subject to the penalties of subsection (a) of this
section for a violation of section 331 of this title involving
misbranded food if the violation exists solely because the food is
misbranded under section 343(a)(2) of this title because of its
advertising, and no person shall be subject to the penalties of
subsection (b) of this section for such a violation unless the violation
is committed with the intent to defraud or mislead.
(e) Prohibited distribution of human growth hormone
(1) Except as provided in paragraph (2), whoever knowingly
distributes, or possesses with intent to distribute, human growth
hormone for any use in humans other than the treatment of a disease or
other recognized medical condition, where such use has been authorized
by the Secretary of Health and Human Services under section 355 of this
title and pursuant to the order of a physician, is guilty of an offense
punishable by not more than 5 years in prison, such fines as are
authorized by title 18, or both.
(2) Whoever commits any offense set forth in paragraph (1) and such
offense involves an individual under 18 years of age is punishable by
not more than 10 years imprisonment, such fines as are authorized by
title 18, or both.
(3) Any conviction for a violation of paragraphs (1) and (2) of this
subsection shall be considered a felony violation of the Controlled
Substances Act (21 U.S.C. 801 et seq.) for the purposes of forfeiture
under section 413 of such Act (21 U.S.C. 853).
(4) As used in this subsection the term ''human growth hormone''
means somatrem, somatropin, or an analogue of either of them.
(5) The Drug Enforcement Administration is authorized to investigate
offenses punishable by this subsection.
(f) Violations related to devices
(1)(A) Except as provided in subparagraph (B), any person who
violates a requirement of this chapter which relates to devices shall be
liable to the United States for a civil penalty in an amount not to
exceed $15,000 for each such violation, and not to exceed $1,000,000 for
all such violations adjudicated in a single proceeding.
(B) Subparagraph (A) shall not apply --
(i) to any person who violates the requirements of section 360i(a) or
360j(f) of this title unless such violation constitutes (I) a
significant or knowing departure from such requirements, or (II) a risk
to public health,
(ii) to any person who commits minor violations of section 360i(e) or
360i(f) of this title (only with respect to correction reports) if such
person demonstrates substantial compliance with such section, or
(iii) to violations of section 351(a)(2)(A) of this title which
involve one or more devices which are not defective.
(2)(A) A civil penalty under paragraph (1) shall be assessed by the
Secretary by an order made on the record after opportunity for a hearing
provided in accordance with this subparagraph and section 554 of title
5. Before issuing such an order, the Secretary shall give written
notice to the person to be assessed a civil penalty under such order of
the Secretary's proposal to issue such order and provide such person an
opportunity for a hearing on the order. In the course of any
investigation, the Secretary may issue subpoenas requiring the
attendance and testimony of witnesses and the production of evidence
that relates to the matter under investigation.
(B) In determining the amount of a civil penalty, the Secretary shall
take into account the nature, circumstances, extent, and gravity of the
violation or violations and, with respect to the violator, ability to
pay, effect on ability to continue to do business, any history of prior
such violations, the degree of culpability, and such other matters as
justice may require.
(C) The Secretary may compromise, modify, or remit, with or without
conditions, any civil penalty which may be assessed under paragraph (1).
The amount of such penalty, when finally determined, or the amount
agreed upon in compromise, may be deducted from any sums owing by the
United States to the person charged.
(3) Any person who requested, in accordance with paragraph (2)(A), a
hearing respecting the assessment of a civil penalty and who is
aggrieved by an order assessing a civil penalty may file a petition for
judicial review of such order with the United States Court of Appeals
for the District of Columbia Circuit or for any other circuit in which
such person resides or transacts business. Such a petition may only be
filed within the 60-day period beginning on the date the order making
such assessment was issued.
(4) If any person fails to pay an assessment of a civil penalty --
(A) after the order making the assessment becomes final, and if such
person does not file a petition for judicial review of the order in
accordance with paragraph (3), or
(B) after a court in an action brought under paragraph (3) has
entered a final judgment in favor of the Secretary,
the Attorney General shall recover the amount assessed (plus interest
at currently prevailing rates from the date of the expiration of the
60-day period referred to in paragraph (3) or the date of such final
judgment, as the case may be) in an action brought in any appropriate
district court of the United States. In such an action, the validity,
amount, and appropriateness of such penalty shall not be subject to
review.
(June 25, 1938, ch. 675, 303, 52 Stat. 1043; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; Oct. 26, 1951,
ch. 578, 2, 65 Stat. 649; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; July 12, 1960, Pub. L. 86-618, title
I, 105(b), 74 Stat. 403; July 15, 1965, Pub. L. 89-74, 7, 9( d), 79
Stat. 233, 235; Oct. 24, 1968, Pub. L. 90-639, 3, 82 Stat. 1361; Oct.
27, 1970, Pub. L. 91-513, title II, 701(b), 84 Stat. 1281; Apr. 22,
1976, Pub. L. 94-278, title V, 502(a)(2)(B), 90 Stat. 411; Apr. 22,
1988, Pub. L. 100-293, 7(b), 102 Stat. 99; Nov. 18, 1988, Pub. L.
100-690, title II, 2403, 102 Stat. 4230; Nov. 28, 1990, Pub. L.
101-629, 17(a), 104 Stat. 4526; Nov. 29, 1990, Pub. L. 101-647, title
XIX, 1904, 104 Stat. 4853.)
The Controlled Substances Act, referred to in subsec. (e)(3), is
title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as amended,
which is classified principally to subchapter I ( 801 et seq.) of
chapter 13 of this title. For complete classification of this Act to
the Code, see Short Title note set out under section 801 of this title
and Tables.
1990 -- Subsec. (e). Pub. L. 101-647, 1904, which directed the
amendment of this section by ''inserting a new subsection (e) as
follows:'' was executed by inserting the new subsec. (e) in place of
the existing subsec. (e) to reflect the probable intent of Congress. A
predecessor bill (H.R. 5269, 303) which directed the amendment of
subsec. (e) by substituting ''human growth hormone'' for ''anabolic
steroid'' and defining ''human growth hormone'' was replaced by section
1904 of S. 3266 which became section 1904 of Pub. L. 101-647, which
made similar changes, and in addition increased the terms of
imprisonment, authorized the DEA to investigate punishable offenses, and
incorporated the provisions of section 333a of this title (repealed by
section 1905 of Pub. L. 101-647) which related to forfeiture of property
for convictions in violation of subsec. (e) of this section. Prior to
amendment, subsec. (e) read as follows:
''(1) Except as provided in paragraph (2), any person who distributes
or possesses with the intent to distribute any anabolic steroid for any
use in humans other than the treatment of disease pursuant to the order
of a physician shall be imprisoned for not more than three years or
fined under title 18, or both.
''(2) Any person who distributes or possesses with the intent to
distribute to an individual under 18 years of age, any anabolic steroid
for any use in humans other than the treatment of disease pursuant to
the order of a physician shall be imprisoned for not more than six years
or fined under title 18, or both.''
Subsec. (f). Pub. L. 101-629 added subsec. (f).
1988 -- Subsecs. (a), (b). Pub. L. 100-293 designated existing
subsecs. (a) and (b) as pars. (1) and (2) of subsec. (a), substituted
''paragraph (1)'' for ''subsection (a) of this section'' in par. (2),
and added subsec. (b).
Subsec. (e). Pub. L. 100-690 added subsec. (e).
1976 -- Subsec. (d). Pub. L. 94-278 added subsec. (d).
1970 -- Subsec. (a). Pub. L. 91-513 struck out reference to subsec.
(b) of this section and transferred to subsec. (b) provisions covering
second offenses and offenses committed with intent to defraud or
mislead.
Subsec. (b). Pub. L. 91-513 inserted provisions covering second
offenses and offenses committed with intent to defraud or mislead
formerly set out in subsec. (a) and struck out provisions covering
violations involving depressant and stimulant drugs. See section 801 et
seq. of this title.
1968 -- Subsecs. (a), (b). Pub. L. 90-639 made a general revision
in the penalties prescribed for offenses involving depressant or
stimulant drugs, set a fine of not to exceed $10,000 or imprisonment of
not more than 5 years for offenses involving the unlawful manufacturing
of, sale, or disposal of, or possession with intent to sell, a
depressant or stimulant drug or involving counterfeit depressant or
stimulant drugs, stiffened the penalties for unlawful sales or other
disposals by persons over 18 to persons under 21, and set new penalties
for possession of a depressant or stimulant drug for purposes other than
sale or other disposal.
1965 -- Subsec. (a). Pub. L. 89-74, 7(a), inserted proviso limiting
the penalties for depressant or stimulant drug violations to two years
imprisonment or $5,000 fine or both for first offense and to two years
imprisonment or $15,000 fine or both for subsequent offenses.
Subsec. (b). Pub. L. 89-74, 7(b), inserted parenthetical exception
provision.
Subsec. (c)(5). Pub. L. 89-74, 9(d), added cl. (5).
1960 -- Subsec. (c)(3). Pub. L. 86-618 substituted ''a color
additive'' for ''a coal-tar color'', ''the color additive'' for ''the
coal-tar color'' and ''such color additive was'' for ''such color was''.
1951 -- Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).
Section 17(b) of Pub. L. 101-629 provided that:
''(b) Effective Date of Application to Device User Facilities. --
''(1) The Secretary of Health and Human Services shall conduct a
study to determine whether there has been substantial compliance with
the requirements of section 519(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360i(b)) by device user facilities (as defined
in section 519(b)(5)(A) of such Act). The Secretary shall report the
results of the study to the Congress after the expiration of 45 months
after the date of the enactment of this Act (Nov. 28, 1990).
''(2)(A) If upon the expiration of 48 months after the date of the
enactment of this Act the Secretary has not made the report required by
paragraph (1), section 303(f) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 333(f)), as added by the amendment made by subsection
(a), shall take effect with respect to device user facilities (as
defined in section 519(b)(5)(A) of such Act).
''(B) If in the report under paragraph (1) the Secretary reports that
there has been substantial compliance with the requirements of such
section 519(b) by a type of device user facility and if the Secretary
does not make a determination under subparagraph (C) with respect to
such type of facility, such section 303(f) shall not take effect with
respect to such type of facility.
''(C) If the Secretary determines in the report under paragraph (1)
that there is not substantial compliance with the requirements of such
section 519(b) by a type of device user facility or if the Secretary
makes such a determination after making the report under paragraph (1),
such section 303(f) shall take effect with respect to such type of
facility upon the effective date of the report.''
Amendment by Pub. L. 100-293 effective upon expiration of 90 days
after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out as a
note under section 353 of this title.
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22, 1976,
see section 502(c) of Pub. L. 94-278, set out as a note under section
334 of this title.
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of Pub.
L. 91-513, set out as an Effective Date note under section 801 of this
title.
Amendment by Pub. L. 90-639 applicable only with respect to
violations of this chapter committed after Oct. 24, 1968, see section 6
of Pub. L. 90-639, set out as an Effective Date of 1968 Amendments;
Transitional Provisions note under section 321 of this title.
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
of Pub. L. 89-74, set out as a note under section 321 of this title.
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Section 3 of act Oct. 26, 1951, provided that: ''The provisions of
this Act (amending this section and section 353 of this title) shall
take effect six months after the date of its enactment (Oct. 26,
1951).''
Amendment by Pub. L. 91-513 not to affect or abate any prosecutions
for violation of law or any civil seizures or forfeitures and injunctive
proceedings commenced prior to the effective date of such amendment, and
all administrative proceedings pending before the Bureau of Narcotics
and Dangerous Drugs (now the Drug Enforcement Administration) on Oct.
27, 1970, to be continued and brought to final determination in accord
with laws and regulations in effect prior to Oct. 27, 1970, see section
702 of Pub. L. 91-513, set out as a note under section 321 of this
title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Pub. L. 99-660, title I, 103, Nov. 14, 1986, 100 Stat. 3751,
provided that: ''For the fines authorized to be imposed under section
303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), see
section 3623 of title 18, United States Code, for the period ending
October 31, 1986 (probably should be October 31, 1987), and sections
3559 and 3571 of such title for the period beginning November 1, 1986
(probably should be November 1, 1987).''
Furnishing of guaranties, applicability to raw agricultural
commodities, see section 346a of this title.
21 USC 333a. Repealed. Pub. L. 101-647, title XIX, 1905, Nov. 29, 1990,
104 Stat. 4853
TITLE 21 -- FOOD AND DRUGS
Section, Pub. L. 100-690, title II, 2401, Nov. 18, 1988, 102 Stat.
4230, related to forfeiture and illegal trafficking in steroids or human
growth hormones.
21 USC 334. Seizure
TITLE 21 -- FOOD AND DRUGS
(a) Grounds and jurisdiction
(1) Any article of food, drug, or cosmetic that is adulterated or
misbranded when introduced into or while in interstate commerce or while
held for sale (whether or not the first sale) after shipment in
interstate commerce, or which may not, under the provisions of section
344 or 355 of this title, be introduced into interstate commerce, shall
be liable to be proceeded against while in interstate commerce, or at
any time thereafter, on libel of information and condemned in any
district court of the United States or United States court of a
Territory within the jurisdiction of which the article is found:
Provided, however, That no libel for condemnation shall be instituted
under this chapter, for any alleged misbranding if there is pending in
any court a libel for condemnation proceeding under this chapter based
upon the same alleged misbranding, and not more than one such proceeding
shall be instituted if no such proceeding is so pending, except that
such limitations shall not apply (A) when such misbranding has been the
basis of a prior judgment in favor of the United States, in a criminal,
injunction, or libel for condemnation proceeding under this chapter, or
(B) when the Secretary has probable cause to believe from facts found,
without hearing, by him or any officer or employee of the Department
that the misbranded article is dangerous to health, or that the labeling
of the misbranded article is fraudulent, or would be in a material
respect misleading to the injury or damage of the purchaser or consumer.
In any case where the number of libel for condemnation proceedings is
limited as above provided the proceeding pending or instituted shall, on
application of the claimant, seasonably made, be removed for trial to
any district agreed upon by stipulation between the parties, or, in case
of failure to so stipulate within a reasonable time, the claimant may
apply to the court of the district in which the seizure has been made,
and such court (after giving the United States attorney for such
district reasonable notice and opportunity to be heard) shall by order,
unless good cause to the contrary is shown, specify a district of
reasonable proximity to the claimant's principal place of business, to
which the case shall be removed for trial.
(2) The following shall be liable to be proceeded against at any time
on libel of information and condemned in any district court of the
United States or United States court of a Territory within the
jurisdiction of which they are found: (A) Any drug that is a
counterfeit drug, (B) Any container of a counterfeit drug, (C) Any
punch, die, plate, stone, labeling, container, or other thing used or
designed for use in making a counterfeit drug or drugs, and (D) Any
adulterated or misbranded device.
(3)(A) Except as provided in subparagraph (B), no libel for
condemnation may be instituted under paragraph (1) or (2) against any
food which --
(i) is misbranded under section 343(a)(2) of this title because of
its advertising, and
(ii) is being held for sale to the ultimate consumer in an
establishment other than an establishment owned or operated by a
manufacturer, packer, or distributor of the food.
(B) A libel for condemnation may be instituted under paragraph (1) or
(2) against a food described in subparagraph (A) if --
(i)(I) the food's advertising which resulted in the food being
misbranded under section 343(a)(2) of this title was disseminated in the
establishment in which the food is being held for sale to the ultimate
consumer,
(II) such advertising was disseminated by, or under the direction of,
the owner or operator of such establishment, or
(III) all or part of the cost of such advertising was paid by such
owner or operator; and
(ii) the owner or operator of such establishment used such
advertising in the establishment to promote the sale of the food.
(b) Procedure; multiplicity of pending proceedings
The article, equipment, or other thing proceeded against shall be
liable to seizure by process pursuant to the libel, and the procedure in
cases under this section shall conform, as nearly as may be, to the
procedure in admiralty; except that on demand of either party any issue
of fact joined in any such case shall be tried by jury. When libel for
condemnation proceedings under this section, involving the same claimant
and the same issues of adulteration or misbranding, are pending in two
or more jurisdictions, such pending proceedings, upon application of the
claimant seasonably made to the court of one such jurisdiction, shall be
consolidated for trial by order of such court, and tried in (1) any
district selected by the claimant where one of such proceedings is
pending; or (2) a district agreed upon by stipulation between the
parties. If no order for consolidation is so made within a reasonable
time, the claimant may apply to the court of one such jurisdiction and
such court (after giving the United States attorney for such district
reasonable notice and opportunity to be heard) shall by order, unless
good cause to the contrary is shown, specify a district of reasonable
proximity to the claimant's principal place of business, in which all
such pending proceedings shall be consolidated for trial and tried.
Such order of consolidation shall not apply so as to require the removal
of any case the date for trial of which has been fixed. The court
granting such order shall give prompt notification thereof to the other
courts having jurisdiction of the cases covered thereby.
(c) Availability of samples of seized goods prior to trial
The court at any time after seizure up to a reasonable time before
trial shall by order allow any party to a condemnation proceeding, his
attorney or agent, to obtain a representative sample of the article
seized and a true copy of the analysis, if any, on which the proceeding
is based and the identifying marks or numbers, if any, of the packages
from which the samples analyzed were obtained.
(d) Disposition of goods after decree of condemnation; claims for
remission or mitigation of forfeitures
(1) Any food, drug, device, or cosmetic condemned under this section
shall, after entry of the decree, be disposed of by destruction or sale
as the court may, in accordance with the provisions of this section,
direct and the proceeds thereof, if sold, less the legal costs and
charges, shall be paid into the Treasury of the United States; but such
article shall not be sold under such decree contrary to the provisions
of this chapter or the laws of the jurisdiction in which sold:
Provided, That after entry of the decree and upon the payment of the
costs of such proceedings and the execution of a good and sufficient
bond conditioned that such article shall not be sold or disposed of
contrary to the provisions of this chapter or the laws of any State or
Territory in which sold, the court may by order direct that such article
be delivered to the owner thereof to be destroyed or brought into
compliance with the provisions of this chapter, under the supervision of
an officer or employee duly designated by the Secretary, and the
expenses of such supervision shall be paid by the person obtaining
release of the article under bond. If the article was imported into the
United States and the person seeking its release establishes (A) that
the adulteration, misbranding, or violation did not occur after the
article was imported, and (B) that he had no cause for believing that it
was adulterated, misbranded, or in violation before it was released from
customs custody, the court may permit the article to be delivered to the
owner for exportation in lieu of destruction upon a showing by the owner
that all of the conditions of section 381(d) /1/ of this title can and
will be met: Provided, however, That the provisions of this sentence
shall not apply where condemnation is based upon violation of section
342(a)(1), (2), or (6), section 351(a)(3), section 352(j), or section
361(a) or (d) of this title: And provided further, That where such
exportation is made to the original foreign supplier, then clauses (1)
and (2) of section 381( d) /1/ of this title and the foregoing proviso
shall not be applicable; and in all cases of exportation the bond shall
be conditioned that the article shall not be sold or disposed of until
the applicable conditions of section 381(d) /1/ of this title have been
met. Any article condemned by reason of its being an article which may
not, under section 344 or 355 of this title, be introduced into
interstate commerce, shall be disposed of by destruction.
(2) The provisions of paragraph (1) of this subsection shall, to the
extent deemed appropriate by the court, apply to any equipment or other
thing which is not otherwise within the scope of such paragraph and
which is referred to in paragraph (2) of subsection (a) of this section.
(3) Whenever in any proceeding under this section, involving
paragraph (2) of subsection (a) of this section, the condemnation of any
equipment or thing (other than a drug) is decreed, the court shall allow
the claim of any claimant, to the extent of such claimant's interest,
for remission or mitigation of such forfeiture if such claimant proves
to the satisfaction of the court (i) that he has not committed or caused
to be committed any prohibited act referred to in such paragraph (2) and
has no interest in any drug referred to therein, (ii) that he has an
interest in such equipment or other thing as owner or lienor or
otherwise, acquired by him in good faith, and (iii) that he at no time
had any knowledge or reason to believe that such equipment or other
thing was being or would be used in, or to facilitate, the violation of
laws of the United States relating to counterfeit drugs.
(e) Costs
When a decree of condemnation is entered against the article, court
costs and fees, and storage and other proper expenses, shall be awarded
against the person, if any, intervening as claimant of the article.
(f) Removal of case for trial
In the case of removal for trial of any case as provided by
subsection (a) or (b) of this section --
(1) The clerk of the court from which removal is made shall promptly
transmit to the court in which the case is to be tried all records in
the case necessary in order that such court may exercise jurisdiction.
(2) The court to which such case was removed shall have the powers
and be subject to the duties, for purposes of such case, which the court
from which removal was made would have had, or to which such court would
have been subject, if such case had not been removed.
(g) Administrative restraint; detention orders
(1) If during an inspection conducted under section 374 of this title
of a facility or a vehicle, a device which the officer or employee
making the inspection has reason to believe is adulterated or misbranded
is found in such facility or vehicle, such officer or employee may order
the device detained (in accordance with regulations prescribed by the
Secretary) for a reasonable period which may not exceed twenty days
unless the Secretary determines that a period of detention greater than
twenty days is required to institute an action under subsection (a) of
this section or section 332 of this title, in which case he may
authorize a detention period of not to exceed thirty days. Regulations
of the Secretary prescribed under this paragraph shall require that
before a device may be ordered detained under this paragraph the
Secretary or an officer or employee designated by the Secretary approve
such order. A detention order under this paragraph may require the
labeling or marking of a device during the period of its detention for
the purpose of identifying the device as detained. Any person who would
be entitled to claim a device if it were seized under subsection (a) of
this section may appeal to the Secretary a detention of such device
under this paragraph. Within five days of the date an appeal of a
detention is filed with the Secretary, the Secretary shall after
affording opportunity for an informal hearing by order confirm the
detention or revoke it.
(2)(A) Except as authorized by subparagraph (B), a device subject to
a detention order issued under paragraph (1) shall not be moved by any
person from the place at which it is ordered detained until --
(i) released by the Secretary, or
(ii) the expiration of the detention period applicable to such order,
whichever occurs first.
(B) A device subject to a detention order under paragraph (1) may be
moved --
(i) in accordance with regulations prescribed by the Secretary, and
(ii) if not in final form for shipment, at the discretion of the
manufacturer of the device for the purpose of completing the work
required to put it in such form.
(June 25, 1938, ch. 675, 304, 52 Stat. 1044; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; June 24, 1948,
ch. 613, 2, 62 Stat. 582; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; Aug. 7, 1953, ch. 350, 3, 67 Stat.
477; Aug. 31, 1957, Pub. L. 85-250, 71 Stat. 567; July 15, 1965, Pub.
L. 89-74, 6, 79 Stat. 232; Oct. 24, 1968, Pub. L. 90-639, 4(b), 82
Stat. 1362; Oct. 27, 1970, Pub. L. 91-513, title II, 701( c), (d), 84
Stat. 1281, 1282; Apr. 22, 1976, Pub. L. 94-278, title V, 502(a)(2)(
C), 90 Stat. 411; May 28, 1976, Pub. L. 94-295, 3(c), 7( a), 90 Stat.
576, 582.)
Section 381(d) of this title, referred to in subsec. (d)(1), was
redesignated section 381(e) of this title by Pub. L. 100-293, 3, Apr.
22, 1988, 102 Stat. 96.
1976 -- Subsec. (a)(1). Pub. L. 94-295, 3(c)(1), struck out
''device,'' after ''Any article of food, drug,''.
Subsec. (a)(2). Pub. L. 94-295, 3(c)(2), (3), added cl. (D) covering
adulterated or misbranded devices.
Subsec. (a)(3). Pub. L. 94-278 added par. (3).
Subsec. (g). Pub. L. 94-295, 7(a), added subsec. (g).
1970 -- Subsec. (a)(2). Pub. L. 91-513, 701(c), struck out cls. (A)
and (D) which dealt with depressant or stimulant drugs, struck out
reference to depressant or stimulant drugs in cl. (C), and redesignated
cls. (B), (C), and (E) as cls. (A), (B), and (C), respectively.
Subsec. (d)(3)(iii). Pub. L. 91-513, 701(d), struck out reference to
depressant or stimulant drugs.
1968 -- Subsec. (a). Pub. L. 90-639 inserted references to the
United States courts of Territories.
1965 -- Subsec. (a). Pub. L. 89-74, 6(a), designated existing
provisions as par. (1), redesignated cls. (1) and (2) of proviso as
(A) and (B), and added par. (2).
Subsec. (b). Pub. L. 89-74, 6(b)(1), inserted ''equipment, or other
thing proceeded against'' after ''article'' in first sentence.
Subsec. (d). Pub. L. 89-74, 6(b)(2), designated existing provisions
as par. (1), redesignated cls. (1) and (2) of the second sentence
thereof as (A) and (B), and added pars. (2) and (3).
1957 -- Subsec. (d). Pub. L. 85-250 permitted, under certain
circumstances, reexportation of articles condemned at places other than
original port of entry.
1953 -- Subsec. (c). Act Aug. 7, 1953, provided that a true copy of
the analysis in any case shall be furnished the owner.
1948 -- Subsec. (a). Act June 24, 1948, inserted ''or while held for
sale (whether or not the first sale) after shipment in interstate
commerce'' to make this subsection coextensive with section 331(k) of
this title.
Section 502(c) of Pub. L. 94-278 provided that: ''The amendments
made by subsection (a) (amending this section and sections 321, 333, and
343 of this title) shall take effect 180 days after the date of the
enactment of this Act (Apr. 22, 1976).''
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of Pub.
L. 91-513, set out as an Effective Date note under section 801 of this
title.
Amendment by Pub. L. 90-639 applicable only with respect to
violations of this chapter committed after Oct. 24, 1968, see section 6
of Pub. L. 90-639, set out as an Effective Date of 1968 Amendments;
Transitional Provisions note under section 321 of this title.
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
of Pub. L. 89-74, set out as a note under section 321 of this title.
Amendment by Pub. L. 91-513 not to affect or abate any prosecutions
for any violation of law or any civil seizures or forfeitures and
injunctive proceedings commenced prior to the effective date of such
amendment, and all administrative proceedings pending before the Bureau
of Narcotics and Dangerous Drugs (now the Drug Enforcement
Administration) on Oct. 27, 1970, to be continued and brought to final
determination in accord with laws and regulations in effect prior to
Oct. 27, 1970, see section 702 of Pub. L. 91-513, set out as a note
under section 321 of this title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Admiralty and maritime rules of practice (which included libel
procedures) were superseded, and civil and admiralty procedures in
United States district courts were unified, effective July 1, 1966, see
rule 1 and Supplemental Rules for Certain Admiralty and Maritime Claims,
Title 28, Appendix, Judiciary and Judicial Procedure.
this title; title 15 section 1456; title 42 section
1396r-8.
/1/ See References in Text note below.
21 USC 335. Hearing before report of criminal violation
TITLE 21 -- FOOD AND DRUGS
Before any violation of this chapter is reported by the Secretary to
any United States attorney for institution of a criminal proceeding, the
person against whom such proceeding is contemplated shall be given
appropriate notice and an opportunity to present his views, either
orally or in writing, with regard to such contemplated proceeding.
(June 25, 1938, ch. 675, 305, 52 Stat. 1045; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 336. Report of minor violations
TITLE 21 -- FOOD AND DRUGS
Nothing in this chapter shall be construed as requiring the Secretary
to report for prosecution, or for the institution of libel or injunction
proceedings, minor violations of this chapter whenever he believes that
the public interest will be adequately served by a suitable written
notice or warning.
(June 25, 1938, ch. 675, 306, 52 Stat. 1045; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Admiralty and maritime rules of practice (which included libel
procedures) were superseded, and civil and admiralty procedures in
United States district courts were unified, effective July 1, 1966, see
rule 1 and Supplemental Rules for Certain Admiralty and Maritime Claims,
Title 28, Appendix, Judiciary and Judicial Procedure.
21 USC 337. Proceedings in name of United States; provision as to
subpoenas
TITLE 21 -- FOOD AND DRUGS
All such proceedings for the enforcement, or to restrain violations,
of this chapter shall be by and in the name of the United States.
Subpoenas for witnesses who are required to attend a court of the United
States, in any district, may run into any other district in any such
proceeding.
(June 25, 1938, ch. 675, 307, 52 Stat. 1046; Sept. 3, 1954, ch.
1263, 37, 68 Stat. 1239; Nov. 8, 1990, Pub. L. 101-535, 4, 104 Stat.
2362.)
Pub. L. 101-535, 4, 10(a)(1)(C), Nov. 8, 1990, 104 Stat. 2362,
2365, provided that, effective 24 months after Nov. 8, 1990, this
section is amended by substituting ''(a) Except as provided in
subsection (b) of this section, all such proceedings'' for ''All such
proceedings'' and ''any proceeding under this section'' for ''any such
proceeding'' and by adding at the end the following:
(b)(1) A State may bring in its own name and within its jurisdiction
proceedings for the civil enforcement, or to restrain violations, of
section 341, 343(b), 343(c), 343(d), 343(e), 343(f), 343(g), 343(h),
343(i), 343(k), 343(q), or 343(r) of this title if the food that is the
subject of the proceedings is located in the State.
(2) No proceeding may be commenced by a State under paragraph (1) --
(A) before 30 days after the State has given notice to the Secretary
that the State intends to bring such proceeding,
(B) before 90 days after the State has given notice to the Secretary
of such intent if the Secretary has, within such 30 days, commenced an
informal or formal enforcement action pertaining to the food which would
be the subject of such proceeding, or
(C) if the Secretary is diligently prosecuting a proceeding in court
pertaining to such food, has settled such proceeding, or has settled the
informal or formal enforcement action pertaining to such food.
In any court proceeding described in subparagraph (C), a State may
intervene as a matter of right.
1954 -- Act Sept. 3, 1954, struck out reference to section 654 of
title 28.
Amendment by Pub. L. 101-535 effective 24 months after Nov. 8,
1990, see section 10(a)(1)(C) of Pub. L. 101-535, set out as a note
under section 343 of this title.
Amendments by Pub. L. 101-535 not to be construed to alter authority
of Secretary of Health and Human Services and Secretary of Agriculture
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L.
101-535, set out as a note under section 343 of this title.
21 USC SUBCHAPTER IV -- FOOD
TITLE 21 -- FOOD AND DRUGS
21 USC 341. Definitions and standards for food
TITLE 21 -- FOOD AND DRUGS
Whenever in the judgment of the Secretary such action will promote
honesty and fair dealing in the interest of consumers, he shall
promulgate regulations fixing and establishing for any food, under its
common or usual name so far as practicable, a reasonable definition and
standard of identity, a reasonable standard of quality, and/or
reasonable standards of fill of container: Provided, That no definition
and standard of identity and no standard of quality shall be established
for fresh or dried fruits, fresh or dried vegetables, or butter, except
that definitions and standards of identity may be established for
avocadoes, cantaloupes, citrus fruits, and melons. In prescribing any
standard of fill of container, the Secretary shall give due
consideration to the natural shrinkage in storage and in transit of
fresh natural food and to need for the necessary packing and protective
material. In the prescribing of any standard of quality for any canned
fruit or canned vegetable, consideration shall be given and due
allowance made for the differing characteristics of the several
varieties of such fruit or vegetable. In prescribing a definition and
standard of identity for any food or class of food in which optional
ingredients are permitted, the Secretary shall, for the purpose of
promoting honesty and fair dealing in the interest of consumers,
designate the optional ingredients which shall be named on the label.
Any definition and standard of identity prescribed by the Secretary for
avocadoes, cantaloupes, citrus fruits, or melons shall relate only to
maturity and to the effects of freezing.
(June 25, 1938, ch. 675, 401, 52 Stat. 1046; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Apr.
15, 1954, ch. 143, 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, 1, 70 Stat.
919.)
1956 -- Act Aug. 1, 1956, designated provisions constituting subsec.
(a) as entire section and repealed subsec. (b) which provided the
procedure for establishment of regulations and is covered by section
371(e) of this title.
1954 -- Act Apr. 15, 1954, designated existing provisions as subsec.
(a) and added subsec. (b).
Section 3 of act Aug. 1, 1956, provided that: ''In any case in
which, prior to the enactment of this Act (Aug. 1, 1956), a public
hearing has been begun in accordance with section 401 of the Federal
Food, Drug, and Cosmetic Act (341 of this title) upon a proposal to
issue, amend, or repeal any regulation contemplated by such section, or
has been begun in accordance with section 701(e) of such Act (section
371(e) of this title) upon a proposal to issue, amend, or repeal any
regulation contemplated by section 403(j), 404(a), 406(a) or (b), 501(
b), 502(d), 502(h), 504 or 604 of such Act (section 343(j), 344(a),
346(a) or (b), 351(b), 352(d), 352(h), 354, or 364 of this title), the
provisions of such section 401 or 701(e), as the case may be, as in
force immediately prior to the date of the enactment of this Act (Aug.
1, 1956), shall be applicable as though this Act (amending this section
and section 371(e) of this title) had not been enacted.''
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 342. Adulterated food
TITLE 21 -- FOOD AND DRUGS
A food shall be deemed to be adulterated --
(a) Poisonous, insanitary, etc., ingredients
(1) If it bears or contains any poisonous or deleterious substance
which may render it injurious to health; but in case the substance is
not an added substance such food shall not be considered adulterated
under this clause if the quantity of such substance in such food does
not ordinarily render it injurious to health; or (2)(A) if it bears or
contains any added poisonous or added deleterious substance (other than
one which is (i) a pesticide chemical in or on a raw agricultural
commodity; (ii) a food additive; (iii) a color additive; or (iv) a
new animal drug) which is unsafe within the meaning of section 346 of
this title, or (B) if it is a raw agricultural commodity and it bears or
contains a pesticide chemical which is unsafe within the meaning of
section 346a(a) of this title, or (C) if it is, or if it bears or
contains, any food additive which is unsafe within the meaning of
section 348 of this title: Provided, That where a pesticide chemical
has been used in or on a raw agricultural commodity in conformity with
an exemption granted or a tolerance prescribed under section 346a of
this title and such raw agricultural commodity has been subjected to
processing such as canning, cooking, freezing, dehydrating, or milling,
the residue of such pesticide chemical remaining in or on such processed
food shall, notwithstanding the provisions of sections 346 and 348 of
this title, not be deemed unsafe if such residue in or on the raw
agricultural commodity has been removed to the extent possible in good
manufacturing practice and the concentration of such residue in the
processed food when ready to eat is not greater than the tolerance
prescribed for the raw agricultural commodity, or (D) if it is, or it
bears or contains, a new animal drug (or conversion product thereof)
which is unsafe within the meaning of section 360b of this title; (3)
if it consists in whole or in part of any filthy, putrid, or decomposed
substance, or if it is otherwise unfit for food; or (4) if it has been
prepared, packed, or held under insanitary conditions whereby it may
have become contaminated with filth, or whereby it may have been
rendered injurious to health; or (5) if it is, in whole or in part, the
product of a diseased animal or of an animal which has died otherwise
than by slaughter; or (6) if its container is composed, in whole or in
part, of any poisonous or deleterious substance which may render the
contents injurious to health; or (7) if it has been intentionally
subjected to radiation, unless the use of the radiation was in
conformity with a regulation or exemption in effect pursuant to section
348 of this title.
(b) Absence, substitution, or addition of constituents
(1) If any valuable constituent has been in whole or in part omitted
or abstracted therefrom; or (2) if any substance has been substituted
wholly or in part therefor; or (3) if damage or inferiority has been
concealed in any manner; or (4) if any substance has been added thereto
or mixed or packed therewith so as to increase its bulk or weight, or
reduce its quality or strength, or make it appear better or of greater
value than it is.
(c) Color additives
If it is, or it bears or contains, a color additive which is unsafe
within the meaning of section 376(a) of this title.
(d) Confectionery containing alcohol or nonnutritive substance
If it is confectionery, and --
(1) has partially or completely imbedded therein any nonnutritive
object: Provided, That this clause shall not apply in the case of any
nonnutritive object if, in the judgment of the Secretary as provided by
regulations, such object is of practical functional value to the
confectionery product and would not render the product injurious or
hazardous to health;
(2) bears or contains any alcohol other than alcohol not in excess of
one-half of 1 per centum by volume derived solely from the use of
flavoring extracts, except that this clause shall not apply to
confectionery which is introduced or delivered for introduction into, or
received or held for sale in, interstate commerce if the sale of such
confectionery is permitted under the laws of the State in which such
confectionery is intended to be offered for sale;
(3) bears or contains any nonnutritive substance: Provided, That
this clause shall not apply to a safe nonnutritive substance which is in
or on confectionery by reason of its use for some practical functional
purpose in the manufacture, packaging, or storage of such confectionery
if the use of the substance does not promote deception of the consumer
or otherwise result in adulteration or misbranding in violation of any
provision of this chapter: And provided further, That the Secretary
may, for the purpose of avoiding or resolving uncertainty as to the
application of this clause, issue regulations allowing or prohibiting
the use of particular nonnutritive substances.
(e) Oleomargarine containing filthy, putrid, etc., matter
If it is oleomargarine or margarine or butter and any of the raw
material used therein consisted in whole or in part of any filthy,
putrid, or decomposed substance, or such oleomargarine or margarine or
butter is otherwise unfit for food.
(June 25, 1938, ch. 675, 402, 52 Stat. 1046; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; Mar. 16, 1950,
ch. 61, 3(d), 64 Stat. 21; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; July 22, 1954, ch. 559, 2, 68 Stat.
511; July 9, 1956, ch. 530, 70 Stat. 512; Sept. 6, 1958, Pub. L.
85-929, 3(a), (b), 72 Stat. 1784; Mar. 17, 1959, Pub. L. 86-2, 73 Stat.
3; July 12, 1960, Pub. L. 86-618, title I, 102(a)(1), (2), 105( c), 74
Stat. 397, 398, 404; June 29, 1966, Pub. L. 89-477, 80 Stat. 231;
July 13, 1968, Pub. L. 90-399, 104, 82 Stat. 352; Feb. 27, 1986, Pub.
L. 99-252, 10, 100 Stat. 35.)
1986 -- Subsec. (d)(2). Pub. L. 99-252 inserted provision that this
clause not apply to confectionery introduced or delivered for
introduction into or received or held for sale in, interstate commerce
if the sale is permitted under the laws of the State in which the
confectionery is intended to be offered for sale.
1968 -- Subsec. (a)(2). Pub. L. 90-399 added cls. (A)(iv) and (D).
1966 -- Subsec. (d). Pub. L. 89-477 permitted the imbedding of
nonnutritive objects in confectionery foods if in the judgment of the
Secretary of Health, Education, and Welfare, as provided by regulation,
the imbedding of the object is of practical functional value to the
confectionery product and would not render it injurious or hazardous to
health, raised to one-half of 1 per centum by volume the upper limit for
the allowable use of alcohol derived solely from the use of flavoring
extracts, allowed the use of safe nonnutritive substances in and on
confectionery foods by reason of their use for some practical and
functional purpose in the manufacture, packaging, or storage of the
confectionery foods if the use of the substances does not promote
deception of the consumer or otherwise result in adulteration or
misbranding, authorized the Secretary to issue regulations on the use of
particular nonnutritive substances, and removed reference to
nonnutritive masticatory substances added to chewing gum and harmless
flavoring, harmless resinous glaze not in excess of four-tenths of 1 per
centum, natural gum, authorized coloring, and pectin.
1960 -- Subsec. (a). Pub. L. 86-618, 102(a)(1), substituted ''other
than one which is (i) a pesticide chemical in or on a raw agricultural
commodity; (ii) a food additive; or (iii) a color additive'' for
''(except a pesticide chemical in or on a raw agricultural commodity and
except a food additive)'' in cl. (2)(A).
Subsec. (c). Pub. L. 86-618, 102(a)(2), amended subsection (c)
generally, substituting provisions deeming a food adulterated if it is,
or it bears or contains, a color additive which is unsafe within the
meaning of section 376 of this title for provisions which related to
food that bears or contains a coal-tar color other than one from a batch
that has been certified in accordance with regulations as provided by
section 346 of this title, and struck out provisos which related to the
use of color on oranges.
Subsec. (d). Pub. L. 86-618, 105(c), substituted ''authorized
coloring'' for ''harmless coloring''.
1959 -- Subsec. (c). Pub. L. 86-2 extended from March 1, 1959, to
May 1, 1959, the period during which subsection is inapplicable to
oranges which have been colored with F.D. & C. Red 32, and inserted
proviso requiring Secretary to establish regulations prescribing the
conditions under which Citrus Red No. 2 may be safely used in coloring
certain mature oranges, and providing for separately listing and for
certification of batches of such color.
1958 -- Subsec. (a). Pub. L. 85-929, among other changes, inserted
cl. (2)(C) relating to food additive unsafe within the meaning of
section 348 of this title, and to pesticide chemical, and added cl.
(7), relating to radiated food.
1956 -- Subsec. (c). Act July 9, 1956, inserted second proviso
relating to coloring of oranges.
1954 -- Subsec. (a)(2). Act July 22, 1954, provided in the case of
any raw agricultural commodity bearing or containing a pesticide
chemical, that such commodity shall be deemed to be adulterated if such
pesticide chemical is unsafe within the meaning of section 346a of this
title.
1950 -- Subsec. (e). Act Mar. 16, 1950, added subsec. (e).
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions note
under section 360b of this title.
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Effective date of subsec. (a)(2) as in force prior to July 22, 1954,
with respect to particular commercial use of a nematocide, plant
regulator, defoliant, or desiccant in or on a raw agricultural commodity
made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-139, Aug.
7, 1959, 73 Stat. 288.
Section 6 of Pub. L. 85-929, as amended by Pub. L. 87-19, 2, Apr.
7, 1961, 75 Stat. 42; Pub. L. 88-625, 2, Oct. 3, 1964, 78 Stat.
1002, provided that:
''(a) Except as provided in subsections (b) and (c) of this section,
this Act (amending this section, sections 321, 331, 346, and 348 of this
title, and section 210 of Title 42, The Public Health and Welfare, and
enacting provisions set out as notes under sections 321 and 451 of this
title) shall take effect on the date of its enactment (Sept. 6, 1958).
''(b) Except as provided in subsection (c) of this section, section 3
of this Act (amending this section and section 346 of this title) shall
take effect on the one hundred and eightieth day after the date of
enactment of this Act (Sept. 6, 1958).
''(c) With respect to any particular commercial use of a food
additive, if such use was made of such additive before January 1, 1958,
section 3 of this Act (amending this section and section 346 of this
title) shall take effect --
''(1) Either (A) one year after the effective date established in
subsection (b) of this section, or (B) at the end of such additional
period (but not later than two years from such effective date
established in subsection (b)) as the Secretary of Health, Education,
and Welfare (now Health and Human Services) may prescribe on the basis
of a finding that such extension involves no undue risk to the public
health and that conditions exist which necessitate the prescribing of
such an additional period, or
''(2) on the date on which an order with respect to such use under
section 409 of the Federal Food, Drug, and Cosmetic Act (section 348 of
this title) becomes effective,
whichever date first occurs. Whenever the Secretary has, pursuant to
clause (1)(B) of this subsection, extended the effective date of section
3 of this Act (amending this section) to March 5, 1961, or has on that
date a request for such extension pending before him, with respect to
any such particular use of a food additive, he may, notwithstanding the
parenthetical time limitation in that clause, further extend such
effective date, not beyond June 30, 1964, under the authority of that
clause (but subject to clause (2)) with respect to such use of the
additive (or a more limited specified use or uses thereof) if, in
addition to making the findings required by clause (1)( B), he finds (i)
that bona fide action to determine the applicability of such section 409
(section 348 of this title) to such use or uses, or to develop the
scientific data necessary for action under such section, was commenced
by an interested person before March 6, 1960, and was thereafter pursued
with reasonable diligence, and (ii) that in the Secretary's judgment
such extension is consistent with the objective of carrying to
completion in good faith, as soon as reasonably practicable, the
scientific investigations necessary as a basis for action under such
section 409 (section 348 of this title): Provided, That if the
Secretary has, pursuant to this sentence, granted an extension to June
30, 1964, he may, upon making the findings required by clause (1)(B) of
this subsection and clauses (i) and (ii) of this sentence, further
extend such effective date, but not beyond December 31, 1965. The
Secretary may at any time terminate an extension so granted if he finds
that it should not have been granted, or that by reason of a change in
circumstances the basis for such extension no longer exists, or that
there has been a failure to comply with a requirement for submission of
progress reports or with other conditions attached to such extension.''
Section 5 of act July 22, 1954, provided that: ''This Act (amending
this section and section 321 of this title and enacting sections 346a
and 346b of this title) shall take effect upon the date of its enactment
(July 22, 1954), except that with respect to pesticide chemicals for
which tolerances or exemptions have not been established under section
408 of the Federal Food, Drug, and Cosmetic Act (section 346a of this
title), the amendment to section 402(a) of such Act (subsec. (a) of this
section) made by section 2 of this Act shall not be effective --
''(1) for the period of one year following the date of the enactment
of this Act (July 22, 1954); or
''(2) for such additional period following such period of one year,
but not extending beyond two years after the date of the enactment of
this Act (July 22, 1954) as the Secretary of Health, Education, and
Welfare (now Health and Human Services) may prescribe on the basis of a
finding that conditions exist which necessitate the prescribing of such
additional period.''
Amendment by act Mar. 16, 1950, effective July 1, 1950, see section
7 of act Mar. 16, 1950, set out as an Effective Date note under section
347 of this title.
Subsec. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,
53 Stat. 853, set out as an Effective Date; Postponement in Certain
Cases note under section 301 of this title.
Pub. L. 88-625, 1, Oct. 3, 1964, 78 Stat. 1002, provided: ''That
this Act (amending provisions set out as a note under this section and
section 135 of Title 7, Agriculture) may be cited as the 'Food Additives
Transitional Provisions Amendment of 1964'.''
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Appropriations for establishing tolerances for pesticide chemicals,
see section 346b of this title.
21 USC 343. Misbranded food
TITLE 21 -- FOOD AND DRUGS
A food shall be deemed to be misbranded --
(a) False or misleading label
If (1) its labeling is false or misleading in any particular, or (2)
in the case of a food to which section 350 of this title applies, its
advertising is false or misleading in a material respect or its labeling
is in violation of section 350(b)(2) of this title.
(b) Offer for sale under another name
If it is offered for sale under the name of another food.
(c) Imitation of another food
If it is an imitation of another food, unless its label bears, in
type of uniform size and prominence, the word ''imitation'' and,
immediately thereafter, the name of the food imitated.
(d) Misleading container
If its container is so made, formed, or filled as to be misleading.
(e) Package form
If in package form unless it bears a label containing (1) the name
and place of business of the manufacturer, packer, or distributor; and
(2) an accurate statement of the quantity of the contents in terms of
weight, measure, or numerical count: Provided, That under clause (2) of
this subsection reasonable variations shall be permitted, and exemptions
as to small packages shall be established, by regulations prescribed by
the Secretary.
(f) Prominence of information on label
If any word, statement, or other information required by or under
authority of this chapter to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with
other words, statements, designs, or devices, in the labeling) and in
such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.
(g) Representation as to definition and standard of identity
If it purports to be or is represented as a food for which a
definition and standard of identity has been prescribed by regulations
as provided by section 341 of this title, unless (1) it conforms to such
definition and standard, and (2) its label bears the name of the food
specified in the definition and standard, and, insofar as may be
required by such regulations, the common names of optional ingredients
(other than spices, flavoring, and coloring) present in such food.
(h) Representation as to standards of quality and fill of container
If it purports to be or is represented as --
(1) a food for which a standard of quality has been prescribed by
regulations as provided by section 341 of this title, and its quality
falls below such standard, unless its label bears, in such manner and
form as such regulations specify, a statement that it falls below such
standard; or
(2) a food for which a standard or standards of fill of container
have been prescribed by regulations as provided by section 341 of this
title, and it falls below the standard of fill of container applicable
thereto, unless its label bears, in such manner and form as such
regulations specify, a statement that it falls below such standard.
(i) Label where no representation as to definition and standard of
identity
Unless its label bears (1) the common or usual name of the food, if
any there be, and (2) in case it is fabricated from two or more
ingredients, the common or usual name of each such ingredient and if the
food purports to be a beverage containing vegetable or fruit juice, a
statement with appropriate prominence on the information panel of the
total percentage of such fruit or vegetable juice contained in the food;
except that spices, flavorings, and colors not required to be certified
under section 376(c) of this title, other than those sold as such, may
be designated as spices, flavorings, and colorings without naming each:
Provided, That, to the extent that compliance with the requirements of
clause (2) of this subsection is impracticable, or results in deception
or unfair competition, exemptions shall be established by regulations
promulgated by the Secretary.
(j) Representation for special dietary use
If it purports to be or is represented for special dietary uses,
unless its label bears such information concerning its vitamin, mineral,
and other dietary properties as the Secretary determines to be, and by
regulations prescribes as, necessary in order fully to inform purchasers
as to its value for such uses.
(k) Artificial flavoring, artificial coloring, or chemical
preservatives
If it bears or contains any artificial flavoring, artificial
coloring, or chemical preservative, unless it bears labeling stating
that fact: Provided, That to the extent that compliance with the
requirements of this subsection is impracticable, exemptions shall be
established by regulations promulgated by the Secretary. The provisions
of this subsection and subsections (g) and (i) of this section with
respect to artificial coloring shall not apply in the case of butter,
cheese, or ice cream. The provisions of this subsection with respect to
chemical preservatives shall not apply to a pesticide chemical when used
in or on a raw agricultural commodity which is the produce of the soil.
(l) Pesticide chemicals on raw agricultural commodities
If it is a raw agricultural commodity which is the produce of the
soil, bearing or containing a pesticide chemical applied after harvest,
unless the shipping container of such commodity bears labeling which
declares the presence of such chemical in or on such commodity and the
common or usual name and the function of such chemical: Provided,
however, That no such declaration shall be required while such
commodity, having been removed from the shipping container, is being
held or displayed for sale at retail out of such container in accordance
with the custom of the trade.
(m) Color additives
If it is a color additive, unless its packaging and labeling are in
conformity with such packaging and labeling requirements, applicable to
such color additive, as may be contained in regulations issued under
section 376 of this title.
(n) Packaging or labeling of drugs in violation of regulations
If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 1472 or 1473 of title 15.
(o) Saccharin for immediate consumption
(1) If it contains saccharin, unless, except as provided in paragraph
(2), its label and labeling bear the following statement: ''USE OF THIS
PRODUCT MAY BE HAZARDOUS TO YOUR HEALTH. THIS PRODUCT CONTAINS
SACCHARIN WHICH HAS BEEN DETERMINED TO CAUSE CANCER IN LABORATORY
ANIMALS''. Such statement shall be located in a conspicuous place on
such label and labeling as proximate as possible to the name of such
food and shall appear in conspicuous and legible type in contrast by
typography, layout, and color with other printed matter on such label
and labeling.
(2) The Secretary may by regulation review and revise or remove the
requirement of paragraph (1) if the Secretary determines such action is
necessary to reflect the current state of knowledge concerning
saccharin.
(p) Saccharin not for immediate consumption
(1) If it contains saccharin and is offered for sale, but not for
immediate consumption, at a retail establishment, unless such retail
establishment displays prominently, where such food is held for sale,
notice (provided by the manufacturer of such food pursuant to paragraph
(2) for consumers respecting the information required by subsection (o)
of this section to be on food labels and labeling.
(2) Each manufacturer of food which contains saccharin and which is
offered for sale by retail establishments but not for immediate
consumption shall, in accordance with regulations promulgated by the
Secretary pursuant to paragraph (4), take such action as may be
necessary to provide such retail establishments with the notice required
by paragraph (1).
(3) The Secretary may by regulation review and revise or remove the
requirement of paragraph (1) if he determines such action is necessary
to reflect the current state of knowledge concerning saccharin.
(4) The Secretary shall by regulation prescribe the form, text, and
manner of display of the notice required by paragraph (1) and such other
matters as may be required for the implementation of the requirements of
that paragraph and paragraph (2). Regulations of the Secretary under
this paragraph shall be promulgated after an oral hearing but without
regard to the National Environmental Policy Act of 1969 (42 U.S.C. 4321
et seq.) and chapter 5 of title 5. In any action brought for judicial
review of any such regulation, the reviewing court may not postpone the
effective date of such regulation.
(q) Nutrition information
(1) Except as provided in paragraphs (3), (4), and (5), if it is a
food intended for human consumption and is offered for sale, unless its
label or labeling bears nutrition information that provides --
(A)(i) the serving size which is an amount customarily consumed and
which is expressed in a common household measure that is appropriate to
the food, or
(ii) if the use of the food is not typically expressed in a serving
size, the common household unit of measure that expresses the serving
size of the food,
(B) the number of servings or other units of measure per container,
(C) the total number of calories --
(i) derived from any source, and
(ii) derived from the total fat,
in each serving size or other unit of measure of the food,
(D) the amount of the following nutrients: Total fat, saturated fat,
cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars,
dietary fiber, and total protein contained in each serving size or other
unit of measure,
(E) any vitamin, mineral, or other nutrient required to be placed on
the label and labeling of food under this chapter before October 1,
1990, if the Secretary determines that such information will assist
consumers in maintaining healthy dietary practices.
The Secretary may by regulation require any information required to
be placed on the label or labeling by this paragraph or paragraph (2)(
A) to be highlighted on the label or labeling by larger type, bold type,
or contrasting color if the Secretary determines that such highlighting
will assist consumers in maintaining healthy dietary practices.
(2)(A) If the Secretary determines that a nutrient other than a
nutrient required by paragraph (1)(C), (1)(D), or (1)(E) should be
included in the label or labeling of food subject to paragraph (1) for
purposes of providing information regarding the nutritional value of
such food that will assist consumers in maintaining healthy dietary
practices, the Secretary may by regulation require that information
relating to such additional nutrient be included in the label or
labeling of such food.
(B) If the Secretary determines that the information relating to a
nutrient required by paragraph (1)(C), (1)(D), or (1)(E) or subparagraph
(A) of this paragraph to be included in the label or labeling of food is
not necessary to assist consumers in maintaining healthy dietary
practices, the Secretary may by regulation remove information relating
to such nutrient from such requirement.
(3) For food that is received in bulk containers at a retail
establishment, the Secretary may, by regulation, provide that the
nutrition information required by paragraphs (1) and (2) be displayed at
the location in the retail establishment at which the food is offered
for sale.
(4)(A) The Secretary shall provide for furnishing the nutrition
information required by paragraphs (1) and (2) with respect to raw
agricultural commodities and raw fish by issuing voluntary nutrition
guidelines, as provided by subparagraph (B) or by issuing regulations
that are mandatory as provided by subparagraph (D).
(B)(i) Upon the expiration of 12 months after November 8, 1990, the
Secretary, after providing an opportunity for comment, shall issue
guidelines for food retailers offering raw agricultural commodities or
raw fish to provide nutrition information specified in paragraphs (1)
and (2). Such guidelines shall take into account the actions taken by
food retailers during such 12-month period to provide to consumers
nutrition information on raw agricultural commodities and raw fish.
Such guidelines shall only apply --
(I) in the case of raw agricultural commodities, to the 20 varieties
of vegetables most frequently consumed during a year and the 20
varieties of fruit most frequently consumed during a year, and
(II) to the 20 varieties of raw fish most frequently consumed during
a year.
The vegetables, fruits, and raw fish to which such guidelines apply
shall be determined by the Secretary by regulation and the Secretary may
apply such guidelines regionally.
(ii) Upon the expiration of 12 months after November 8, 1990, the
Secretary shall issue a final regulation defining the circumstances that
constitute substantial compliance by food retailers with the guidelines
issued under clause (i). The regulation shall provide that there is not
substantial compliance if a significant number of retailers have failed
to comply with the guidelines. The size of the retailers and the
portion of the market served by retailers in compliance with the
guidelines shall be considered in determining whether the
substantial-compliance standard has been met.
(C)(i) Upon the expiration of 30 months after November 8, 1990, the
Secretary shall issue a report on actions taken by food retailers to
provide consumers with nutrition information for raw agricultural
commodities and raw fish under the guidelines issued under subparagraph
(A). Such report shall include a determination of whether there is
substantial compliance with the guidelines.
(ii) If the Secretary finds that there is substantial compliance with
the guidelines, the Secretary shall issue a report and make a
determination of the type required in clause (i) every two years.
(D)(i) If the Secretary determines that there is not substantial
compliance with the guidelines issued under subparagraph (A), the
Secretary shall at the time such determination is made issue proposed
regulations requiring that any person who offers raw agricultural
commodities or raw fish to consumers provide, in a manner prescribed by
regulations, the nutrition information required by paragraphs (1) and
(2). The Secretary shall issue final regulations imposing such
requirements 6 months after issuing the proposed regulations. The final
regulations shall become effective 6 months after the date of their
promulgation.
(ii) Regulations issued under clause (i) may require that the
nutrition information required by paragraphs (1) and (2) be provided for
more than 20 varieties of vegetables, 20 varieties of fruit, and 20
varieties of fish most frequently consumed during a year if the
Secretary finds that a larger number of such products are frequently
consumed. Such regulations shall permit such information to be provided
in a single location in each area in which raw agricultural commodities
and raw fish are offered for sale. Such regulations may provide that
information shall be expressed as an average or range per serving of the
same type of raw agricultural commodity or raw fish. The Secretary shall
develop and make available to the persons who offer such food to
consumers the information required by paragraphs (1) and (2).
(iii) Regulations issued under clause (i) shall permit the required
information to be provided in each area of an establishment in which raw
agricultural commodities and raw fish are offered for sale. The
regulations shall permit food retailers to display the required
information by supplying copies of the information provided by the
Secretary, by making the information available in brochure, notebook or
leaflet form, or by posting a sign disclosing the information. Such
regulations shall also permit presentation of the required information
to be supplemented by a video, live demonstration, or other media which
the Secretary approves.
(E) For purposes of this paragraph, the term ''fish'' includes
freshwater or marine fin fish, crustaceans, and mollusks, including
shellfish, amphibians, and other forms of aquatic animal life.
(F) No person who offers raw agricultural commodities or raw fish to
consumers may be prosecuted for minor violations of this paragraph if
there has been substantial compliance with the requirements of this
subsection.
(5)(A) Paragraphs (1), (2), (3), and (4) shall not apply to food --
(i) which is served in restaurants or other establishments in which
food is served for immediate human consumption or which is sold for sale
or use in such establishments,
(ii) which is processed and prepared primarily in a retail
establishment, which is ready for human consumption, which is of the
type described in clause (i), and which is offered for sale to consumers
but not for immediate human consumption in such establishment and which
is not offered for sale outside such establishment,
(iii) which is an infant formula subject to section 350a of this
title,
(iv) which is a medical food as defined in section 360ee(b) of this
title, or
(v) which is described in section 345(2) of this title.
(B) Paragraphs (1) and (2) shall not apply to the label of a food if
the Secretary determines by regulations that compliance with such
paragraphs is impracticable because the package of such food is too
small to comply with the requirements of such paragraphs and if the
label of such food does not contain any nutrition information.
(C) If a food contains insignificant amounts, as determined by the
Secretary, of all the nutrients required by paragraphs (1) and (2) to be
listed in the label or labeling of food, the requirements of such
paragraphs shall not apply to such food if the label, labeling, or
advertising of such food does not make any claim with respect to the
nutritional value of such food. If a food contains insignificant
amounts, as determined by the Secretary, of more than one-half the
nutrients required by paragraphs (1) and (2) to be in the label or
labeling of the food, the Secretary shall require the amounts of such
nutrients to be stated in a simplified form prescribed by the Secretary.
(D) If a person offers food for sale and has annual gross sales made
or business done in sales to consumers which is not more than $500,000
or has annual gross sales made or business done in sales of food to
consumers which is not more than $50,000, the requirements of paragraphs
(1), (2), (3), and (4) shall not apply with respect to food sold by such
person to consumers unless the label or labeling of food offered by such
person provides nutrition information or makes a nutrition claim.
(E) If a food to which section 350 of this title applies (as defined
in section 350(c) of this title) contains one or more of the nutrients
required by paragraph (1) or (2) to be in the label or labeling of the
food, the label or labeling of such food shall comply with the
requirements of paragraphs (1) and (2) in a manner which is appropriate
for such food and which is specified in regulations of the Secretary.
(F) Paragraphs (1), (2), (3), and (4) shall not apply to food which
is sold by a food distributor if the food distributor principally sells
food to restaurants or other establishments in which food is served for
immediate human consumption and does not manufacture, process, or
repackage the food it sells.
(r) Nutrition levels and health-related claims
(1) Except as provided in subparagraphs (A) through (C) of paragraph
(5), if it is a food intended for human consumption which is offered for
sale and for which a claim is made in the label or labeling of the food
which expressly or by implication --
(A) characterizes the level of any nutrient which is of the type
required by subsection (q)(1) or (q)(2) of this section to be in the
label or labeling of the food unless the claim is made in accordance
with paragraph (2), or
(B) characterizes the relationship of any nutrient which is of the
type required by subsection (q)(1) or (q)(2) of this section to be in
the label or labeling of the food to a disease or a health-related
condition unless the claim is made in accordance with paragraph (3) or
5(D). /1/
A statement of the type required by subsection (q) of this section
that appears as part of the nutrition information required or permitted
by such subsection is not a claim which is subject to this subsection
and a claim subject to subparagraph (A) is not subject to subparagraph
(B).
(2)(A) Except as provided in paragraphs (4)(A)(ii) and (4)(A)(iii)
and subparagraphs (A) through (C) of paragraph (5), a claim described in
paragraph (1)(A) --
(i) may be made only if the characterization of the level made in the
claim uses terms which are defined in regulations of the Secretary,
(ii) may not state the absence of a nutrient unless --
(I) the nutrient is usually present in the food or in a food which
substitutes for the food as defined by the Secretary by regulation, or
(II) the Secretary by regulation permits such a statement on the
basis of a finding that such a statement would assist consumers in
maintaining healthy dietary practices and the statement discloses that
the nutrient is not usually present in the food,
(iii) may not be made with respect to the level of cholesterol in the
food if the food contains, as determined by the Secretary by regulation,
fat or saturated fat in an amount which increases to persons in the
general population the risk of disease or a health related condition
which is diet related unless --
(I) the Secretary finds by regulation that the level of cholesterol
is substantially less than the level usually present in the food or in a
food which substitutes for the food and which has a significant market
share, or the Secretary by regulation permits a statement regarding the
absence of cholesterol on the basis of a finding that cholesterol is not
usually present in the food and that such a statement would assist
consumers in maintaining healthy dietary practices and the regulation
requires that the statement disclose that cholesterol is not usually
present in the food, and
(II) the label or labeling of the food discloses the level of such
fat or saturated fat in immediate proximity to such claim and with
appropriate prominence which shall be no less than one-half the size of
the claim with respect to the level of cholesterol,
(iv) may not be made with respect to the level of saturated fat in
the food if the food contains cholesterol unless the label or labeling
of the food discloses the level of cholesterol in the food in immediate
proximity to such claim and with appropriate prominence which shall be
no less than one-half the size of the claim with respect to the level of
saturated fat,
(v) may not state that a food is high in dietary fiber unless the
food is low in total fat as defined by the Secretary or the label or
labeling discloses the level of total fat in the food in immediate
proximity to such statement and with appropriate prominence which shall
be no less than one-half the size of the claim with respect to the level
of dietary fiber, and
(vi) may not be made if the Secretary by regulation prohibits the
claim because the claim is misleading in light of the level of another
nutrient in the food.
(B) If a claim described in paragraph (1)(A) is made with respect to
a nutrient in a food, the label or labeling of such food shall contain,
prominently and in immediate proximity to such claim, the following
statement: ''See XXXXX for nutrition information.''. In the statement
--
(i) the blank shall identify the panel on which the information
described in the statement may be found, and
(ii) if the Secretary determines that the food contains a nutrient at
a level which increases to persons in the general population the risk of
a disease or health-related condition which is diet related, taking into
account the significance of the food in the total daily diet, the
statement shall also identify such nutrient.
(C) Paragraph (2)(A) does not apply to a claim described in paragraph
(1)(A) and contained in the label or labeling of a food if such claim is
contained in the brand name of such food and such brand name was in use
on such food before October 25, 1989, unless the brand name contains a
term defined by the Secretary under paragraph (2)(A)( i). Such a claim
is subject to subsection (a) of this section.
(D) Paragraph (2) does not apply to a claim described in paragraph
(1)(A) which uses the term ''diet'' and is contained in the label or
labeling of a soft drink if (i) such claim is contained in the brand
name of such soft drink, (ii) such brand name was in use on such soft
drink before October 25, 1989, and (iii) the use of the term ''diet''
was in conformity with section 105.66 of title 21 of the Code of Federal
Regulations. Such a claim is subject to subsection (a) of this section.
(E) Clauses (i) through (v) of paragraph (2)(A) do not apply to a
statement in the label or labeling of food which describes the
percentage of vitamins and minerals in the food in relation to the
amount of such vitamins and minerals recommended for daily consumption
by the Secretary.
(3)(A) Except as provided in paragraph (5), a claim described in
paragraph (1)(B) may only be made --
(i) if the claim meets the requirements of the regulations of the
Secretary promulgated under subparagraph (B), and
(ii) if the food for which the claim is made does not contain, as
determined by the Secretary by regulation, any nutrient in an amount
which increases to persons in the general population the risk of a
disease or health-related condition which is diet related, taking into
account the significance of the food in the total daily diet, except
that the Secretary may by regulation permit such a claim based on a
finding that such a claim would assist consumers in maintaining healthy
dietary practices and based on a requirement that the label contain a
disclosure of the type required by paragraph (2)(B).
(B)(i) The Secretary shall promulgate regulations authorizing claims
of the type described in paragraph (1)(B) only if the Secretary
determines, based on the totality of publicly available scientific
evidence (including evidence from well-designed studies conducted in a
manner which is consistent with generally recognized scientific
procedures and principles), that there is significant scientific
agreement, among experts qualified by scientific training and experience
to evaluate such claims, that the claim is supported by such evidence.
(ii) A regulation described in clause (i) shall describe --
(I) the relationship between a nutrient of the type required in the
label or labeling of food by subsection (q)(1) or (q)(2) of this section
and a disease or health-related condition, and
(II) the significance of each such nutrient in affecting such disease
or health-related condition.
(iii) A regulation described in clause (i) shall require such claim
to be stated in a manner so that the claim is an accurate representation
of the matters set out in clause (ii) and so that the claim enables the
public to comprehend the information provided in the claim and to
understand the relative significance of such information in the context
of a total daily diet.
(4)(A)(i) Any person may petition the Secretary to issue a regulation
under paragraph (2)(A)(i) or (3)(B) relating to a claim described in
paragraph (1)(A) or (1)(B). Not later than 100 days after the petition
is received by the Secretary, the Secretary shall issue a final decision
denying the petition or file the petition for further action by the
Secretary. If the Secretary denies the petition, the petition shall not
be made available to the public. If the Secretary files the petition,
the Secretary shall deny the petition or issue a proposed regulation to
take the action requested in the petition not later than 90 days after
the date of such decision.
(ii) Any person may petition the Secretary for permission to use in a
claim described in paragraph (1)(A) terms that are consistent with the
terms defined by the Secretary under paragraph (2)(A)(i). Within 90 days
of the submission of such a petition, the Secretary shall issue a final
decision denying the petition or granting such permission.
(iii) Any person may petition the Secretary for permission to use an
implied claim described in paragraph (1)(A) in a brand name. After
publishing notice of an opportunity to comment on the petition in the
Federal Register and making the petition available to the public, the
Secretary shall grant the petition if the Secretary finds that such
claim is not misleading and is consistent with terms defined by the
Secretary under paragraph (2)(A)(i). The Secretary shall grant or deny
the petition within 100 days of the date it is submitted to the
Secretary and the petition shall be considered granted if the Secretary
does not act on it within such 100 days.
(B) A petition under subparagraph (A)(i) respecting a claim described
in paragraph (1)(A) or (1)(B) shall include an explanation of the
reasons why the claim meets the requirements of this subsection and a
summary of the scientific data which supports such reasons.
(C) If a petition for a regulation under paragraph (3)(B) relies on a
report from an authoritative scientific body of the United States, the
Secretary shall consider such report and shall justify any decision
rejecting the conclusions of such report.
(5)(A) This subsection does not apply to infant formulas subject to
section 350a(h) of this title and medical foods as defined in section
360ee(b) of this title.
(B) Clauses (iii) through (v) of paragraph (2)(A) and paragraph (2)(
B) do not apply to food which is served in restaurants or other
establishments in which food is served for immediate human consumption
or which is sold for sale or use in such establishments.
(C) A paragraph (1)(A) claim made with respect to a food which claim
is required by a standard of identity issued under section 341 of this
title shall not be subject to paragraph (2)(A)(i) or (2)(B).
(D) A paragraph (1)(B) claim made with respect to a dietary
supplement of vitamins, minerals, herbs, or other similar nutritional
substances shall not be subject to paragraph (3) but shall be subject to
a procedure and standard, respecting the validity of such claim,
established by regulation of the Secretary.
(June 25, 1938, ch. 675, 403, 52 Stat. 1047; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; June 29,
1960, Pub. L. 86-537, 1, 74 Stat. 251; July 12, 1960, Pub. L. 86-618,
title I, 102(a)(3), 74 Stat. 398; Dec. 30, 1970, Pub. L. 91-601, 6(c),
formerly 7(c), 84 Stat. 1673, renumbered Aug. 13, 1981, Pub. L. 97-35,
title XII, 1205(c), 95 Stat. 716; Apr. 22, 1976, Pub. L. 94-278, title
V, 502(a)(1), 90 Stat. 411; Nov. 23, 1977, Pub. L. 95-203, 4(a)(1),
(b)(1), 91 Stat. 1452, 1453; Nov. 8, 1990, Pub. L. 101-535, 2(a),
3(a), 7, 104 Stat. 2353, 2357, 2364; Aug. 17, 1991, Pub. L. 102-108,
2(a), (c), 105 Stat. 549.)
The National Environmental Policy Act of 1969, referred to in subsec.
(p)(4), is Pub. L. 91-190, Jan. 1, 1970, 83 Stat. 852, as amended,
which is classified generally to chapter 55 ( 4321 et seq.) of Title 42,
The Public Health and Welfare. For complete classification of this Act
to the Code, see Short Title note set out under section 4321 of Title 42
and Tables.
1991 -- Subsec. (i). Pub. L. 102-108, 2(c), amended directory
language of Pub. L. 101-535, 7(1), (3). See 1990 Amendment note below.
Subsec. (q)(4)(A). Pub. L. 102-108, 2(a), substituted ''(D)'' for
''(C)''.
1990 -- Subsec. (i). Pub. L. 101-535, 7, as amended by Pub. L.
102-108, 2(c), substituted ''Unless'' for ''If it is not subject to the
provisions of subsection (g) of this section unless'', inserted ''and if
the food purports to be a beverage containing vegetable or fruit juice,
a statement with appropriate prominence on the information panel of the
total percentage of such fruit or vegetable juice contained in the
food'', and substituted ''colors not required to be certified under
section 376(c) of this title'' for ''colorings'' the first time
appearing.
Subsec. (q). Pub. L. 101-535, 2(a), added subsec. (q).
Subsec. (r). Pub. L. 101-535, 3(a), added subsec. (r).
1977 -- Subsec. (o). Pub. L. 95-203, 4(a)(1), added subsec. (o).
Subsec. (p). Pub. L. 95-203, 4(b)(1), added subsec. (p).
1976 -- Subsec. (a). Pub. L. 94-278 inserted ''(1)'' after ''If''
and inserted '', or (2) in the case of a food to which section 350 of
this title applies, its advertising is false or misleading in a material
respect or its labeling is in violation of section 350(b)(2) of this
title'' after ''any particular''.
1970 -- Subsec. (n). Pub. L. 91-601 added subsec. (n).
1960 -- Subsec. (k). Pub. L. 86-537, 1(1), exempted pesticide
chemicals when used in or on a raw agricultural commodity which is the
produce of the soil.
Subsec. (l). Pub. L. 86-537, 1(2), added subsec. (l).
Subsec. (m). Pub. L. 86-618 added subsec. (m).
Section 10(a) of Pub. L. 101-535 provided that:
''(1) Except as provided in paragraph (2) --
''(A) the amendments made by section 2 (amending this section) shall
take effect 6 months after --
''(i) the date of the promulgation of all final regulations required
to implement section 403(q) of the Federal Food, Drug, and Cosmetic Act
(subsec. (q) of this section), or
''(ii) if such regulations are not promulgated, the date proposed
regulations are to be considered as such final regulations,
except that section 403(q)(4) of such Act shall take effect as
prescribed by such section,
''(B) the amendments made by section 3 (amending this section) shall
take effect 6 months after --
''(i) the date of the promulgation of final regulations to implement
section 403(r) of the Federal Food, Drug, and Cosmetic Act, or
''(ii) if such regulations are not promulgated, the date proposed
regulations are to be considered as such final regulations, except that
any person marketing a food the brand name of which contains a term
defined by the Secretary under section 403(r)(2)(A)(i) of the Federal
Food, Drug, and Cosmetic Act shall be given an additional 6 months to
comply with section 3,
''(C) the amendments made by section 4 (amending section 337 of this
title) shall take effect 24 months after the date of the enactment of
this Act (Nov. 8, 1990), and
''(D) the amendments made by section 5 (amending sections 321 and 345
of this title) shall take effect on the date the amendments made by
section 3 take effect.
''(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act (as
added by section 2) shall not apply with respect to food which was
labeled before the effective date of the amendments made by section 2
and section 403(r) of the Federal Food, Drug, and Cosmetic Act (as added
by section 3) shall not apply with respect to food which was labeled
before the effective date of the amendments made by section 3.
''(3)(A) If the Secretary finds that a person who is subject to
section 403(q)(4) of such Act is unable to comply with the requirements
of such section upon the effective date of final regulations to
implement section 403(q) of such Act or of proposed regulations to be
considered as such final regulations because the Secretary has not made
available to such person the information required by such section, the
Secretary shall delay the application of such section to such person for
such time as the Secretary may require to provide such information.
''(B) If the Secretary finds that compliance with section 403(q) or
403(r)(2) of such Act would cause an undue economic hardship, the
Secretary may delay the application of such sections for no more than
one year.''
Section 10(c) of Pub. L. 101-535, as amended by Pub. L. 102-108, 1,
Aug. 17, 1991, 105 Stat. 549, provided that:
''(1) Except as provided in paragraphs (2) and (3), the amendments
made by section 7 (amending this section) shall take effect one year
after the date of the enactment of this Act (Nov. 8, 1990).
''(2)(A) If a food subject to section 403(g) of the Federal Food,
Drug, and Cosmetic Act (subsec. (g) of this section) or a food with one
or more colors required to be certified under section 706(c) (of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 376(c)) bears a label
which was printed before July 1, 1991, and which is attached to the food
before May 8, 1993, such food shall not be subject to the amendments
made by section 7(1) and section 7(3) (amending this section).
''(B) If a food described in subparagraph (A) --
''(i) bears a label which was printed after July 1, 1991, but before
the date the proposed regulation described in clause (ii) takes effect
as a final regulation and which was attached to the food before May 8,
1993, and
''(ii) meets the requirements of the proposed regulation of the
Secretary of Health and Human Services published in 56 Fed. Reg.
28592-28636 (June 21, 1991) as it pertains to the amendments made by
this Act (see Short Title of 1990 Amendment note set out under section
301 of this title),
such food shall not be subject to the amendments made by section 7(
1) and section 7(3) (amending this section).
''(3) A food purported to be a beverage containing a vegetable or
fruit juice which bears a label attached to the food before May 8, 1993,
shall not be subject to the amendments made by section 7(2) (amending
this section).''
Section 4(a)(2) of Pub. L. 95-203 provided that: ''The amendment
made by paragraph (1) (amending this section) shall apply only with
respect to food introduced or delivered for introduction in interstate
commerce on and after the 90th day after the date of the enactment of
this Act (Nov. 23, 1977).''
Section 4(b)(2) of Pub. L. 95-203 provided that: ''The amendment
made by paragraph (1) (amending this section) shall apply with respect
to food which is sold in retail establishments on or after the 90th day
after the effective date of the regulations of the Secretary of Health,
Education, and Welfare (now Secretary of Health and Human Services)
under paragraph (p)(4) of the Federal Food, Drug, and Cosmetic Act
(subsec. (p)(4) of this section).''
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22, 1976,
see section 502(c) of Pub. L. 94-278, set out as a note under section
334 of this title.
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no sooner
than 180 days or later than one year from date regulations are final, or
an earlier date published in Federal Register, see section 8 of Pub. L.
91-601, set out as an Effective Date note under section 1471 of Title
15, Commerce and Trade.
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Subsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such
subsections effective July 1, 1940, as provided by regulations for
certain lithographed labeling and containers bearing certain labeling,
see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective
Date; Postponement in Certain Cases note under section 301 of this
title.
Section 2(b) of Pub. L. 101-535 provided that:
''(1) The Secretary of Health and Human Services shall issue proposed
regulations to implement section 403(q) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343(q)) within 12 months after the date of the
enactment of this Act (Nov. 8, 1990). Not later than 24 months after
the date of the enactment of this Act, the Secretary shall issue final
regulations to implement the requirements of such section. Such
regulations shall --
''(A) require the required information to be conveyed to the public
in a manner which enables the public to readily observe and comprehend
such information and to understand its relative significance in the
context of a total daily diet,
''(B) include regulations which establish standards, in accordance
with paragraph (1)(A), to define serving size or other unit of measure
for food,
''(C) permit the label or labeling of food to include nutrition
information which is in addition to the information required by such
section 403(q) and which is of the type described in subparagraph (1) or
(2) of such section, and
''(D) permit the nutrition information on the label or labeling of a
food to remain the same or permit the information to be stated as a
range even though (i) there are minor variations in the nutritional
value of the food which occur in the normal course of the production or
processing of the food, or (ii) the food is comprised of an assortment
of similar foods which have variations in nutritional value.
''(2) If the Secretary of Health and Human Services does not
promulgate final regulations under paragraph (1) upon the expiration of
24 months after the date of the enactment of this Act, the proposed
regulations issued in accordance with paragraph (1) shall be considered
as the final regulations upon the expiration of such 24 months. There
shall be promptly published in the Federal Register notice of new status
of the proposed regulations.
''(3) If the Secretary of Health and Human Services does not
promulgate final regulations under section 403(q)(4) of the Federal
Food, Drug, and Cosmetic Act upon the expiration of 6 months after the
date on which the Secretary makes a finding that there has been no
substantial compliance with section 403(q)(4)(C) of such Act, the
proposed regulations issued in accordance with such section shall be
considered as the final regulations upon the expiration of such 6
months. There shall be promptly published in the Federal Register
notice of new status of the proposed regulations.''
Section 3(b) of Pub. L. 101-535 provided that:
''(1)(A) Within 12 months of the date of the enactment of this Act
(Nov. 8, 1990), the Secretary of Health and Human Services shall issue
proposed regulations to implement section 403(r) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 343(r)). Such regulations --
''(i) shall identify claims described in section 403(r)(1)(A) of such
Act which comply with section 403(r)(2) of such Act,
''(ii) shall identify claims described in section 403(r)(1)(B) of
such Act which comply with section 403(r)(3) of such Act,
''(iii) shall, in defining terms used to characterize the level of
any nutrient in food under section 403(r)(2)(A)(i) of such Act, define
--
''(I) free,
''(II) low,
''(III) light or lite,
''(IV) reduced,
''(V) less, and
''(VI) high,
unless the Secretary finds that the use of any such term would be
misleading,
''(iv) shall permit statements describing the amount and percentage
of nutrients in food which are not misleading and are consistent with
the terms defined in section 403(r)(2)(A)(i) of such Act,
''(v) shall provide that if multiple claims subject to section 403(
r)(1)(A) of such Act are made on a single panel of the food label or
page of a labeling brochure, a single statement may be made to satisfy
section 403(r)(2)(B) of such Act,
''(vi) shall determine whether claims respecting the following
nutrients and diseases meet the requirements of section 403(r)(3) of
such Act: Calcium and osteoporosis, dietary fiber and cancer, lipids
and cardiovascular disease, lipids and cancer, sodium and hypertension,
and dietary fiber and cardiovascular disease,
''(vii) shall not require a person who proposes to make a claim
described in section 403(r)(1)(B) of such Act which is in compliance
with such regulations to secure the approval of the Secretary before
making such claim,
''(viii) may permit a claim described in section 403(r)(1)(A) of such
Act to be made for butter,
''(ix) may, in defining terms under section 403(r)(2)(A)(i), include
similar terms which are commonly understood to have the same meaning,
and
''(x) shall establish, as required by section 403(r)(5)(D), the
procedure and standard respecting the validity of claims made with
respect to a dietary supplement of vitamins, minerals, herbs, or other
similar nutritional substances and shall determine whether claims
respecting the following nutrients and diseases meet the requirements of
section 403(r)(5)(D) of such Act: folic acid and neural tube defects,
antioxident vitamins and cancer, zinc and immune function in the
elderly, and omega-3 fatty acids and heart disease.
''(B) Not later than 24 months after the date of the enactment of
this Act, the Secretary shall issue final regulations to implement
section 403(r) of the Federal Food, Drug, and Cosmetic Act.
''(2) If the Secretary does not promulgate final regulations under
paragraph (1)(B) upon the expiration of 24 months after the date of the
enactment of this Act, the proposed regulations issued in accordance
with paragraph (1)(A) shall be considered as the final regulations upon
the expiration of such 24 months. There shall be promptly published in
the Federal Register notice of the new status of the proposed
regulations.''
Section 9 of Pub. L. 101-535 provided that: ''The amendments made
by this Act (enacting section 343-1 of this title and amending this
section and sections 321, 337, 345, and 371 of this title) shall not be
construed to alter the authority of the Secretary of Health and Human
Services and the Secretary of Agriculture under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection
Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.
S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031
et seq.).''
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Section 2(c) of Pub. L. 101-535 provided that: ''The Secretary of
Health and Human Services shall carry out activities which educate
consumers about --
''(1) the availability of nutrition information in the label or
labeling of food, and
''(2) the importance of that information in maintaining healthy
dietary practices.''
Section 2 of Pub. L. 95-203 provided that the Secretary of Health,
Education, and Welfare conduct a study concerning carcinogenic and other
toxic substances in food and impurities in and toxicity of saccharin and
make a report respecting the carcinogenic and other substances to the
Committee on Human Resources of the Senate within 12 months of Nov. 23,
1977, and a report respecting saccharin to such committee within 15
months of Nov. 23, 1977.
Section 4(a)(3) of Pub. L. 95-203 provided that: ''The Secretary
shall report to the Committee on Human Resources of the Senate (now the
Committee on Labor and Human Resources of the Senate) and the Committee
on Interstate and Foreign Commerce (now the Committee on Energy and
Commerce) of the House of Representatives any action taken under section
403(o)(2) of the Federal Food, Drug, and Cosmetic Act (subsec. (o)(2)
of this section).''
Section 2 of Pub. L. 86-537 provided that: ''Nothing in the
amendments made by the first section of this Act (amending this section)
shall affect any requirement of the laws of any State or Territory.''
/1/ So in original. Probably should be ''(5)(D).''
21 USC 343-1. National uniform nutrition labeling
TITLE 21 -- FOOD AND DRUGS
(a) Except as provided in subsection (b) of this section, no State or
political subdivision of a State may directly or indirectly establish
under any authority or continue in effect as to any food in interstate
commerce --
(1) any requirement for a food which is the subject of a standard of
identity established under section 341 of this title that is not
identical to such standard of identity or that is not identical to the
requirement of section 343(g) of this title,
(2) any requirement for the labeling of food of the type required by
section 343(c), 343(e), or 343(i)(2) of this title that is not identical
to the requirement of such section,
(3) any requirement for the labeling of food of the type required by
section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or 343(k) of this
title that is not identical to the requirement of such section,
(4) any requirement for nutrition labeling of food that is not
identical to the requirement of section 343(q) of this title, except a
requirement for nutrition labeling of food which is exempt under clause
(i) or (ii) of section 343(q)(5)(A) of this title, or
(5) any requirement respecting any claim of the type described in
section 343(r)(1) of this title made in the label or labeling of food
that is not identical to the requirement of section 343(r) of this
title, except a requirement respecting a claim made in the label or
labeling of food which is exempt under section 343(r)(5)(B) of this
title.
Paragraph (3) shall take effect in accordance with section 6(b) of
the Nutrition Labeling and Education Act of 1990.
(b) Upon petition of a State or a political subdivision of a State,
the Secretary may exempt from subsection (a) of this section, under such
conditions as may be prescribed by regulation, any State or local
requirement that --
(1) would not cause any food to be in violation of any applicable
requirement under Federal law,
(2) would not unduly burden interstate commerce, and
(3) is designed to address a particular need for information which
need is not met by the requirements of the sections referred to in
subsection (a) of this section.
(June 25, 1938, ch. 675, 403A, as added Nov. 8, 1990, Pub. L.
101-535, 6(a), 104 Stat. 2362, and amended Aug. 17, 1991, Pub. L.
102-108, 2(b), 105 Stat. 549.)
Section 6(b) of the Nutrition Labeling and Education Act of 1990
(Pub. L. 101-535), referred to in subsec. (a), is set out below.
1991 -- Subsec. (a)(5). Pub. L. 102-108 substituted ''section 343(
r)(5)(B) of this title'' for ''clause (B) of such section''.
Section 10(b) of Pub. L. 101-535 provided that:
''(1) In general. -- Except as provided in paragraph (2), the
amendments made by section 6 (enacting this section) shall take effect
--
''(A) with respect to a requirement of a State or political
subdivision described in paragraph (1) of section 403A(a) of the Federal
Food, Drug, and Cosmetic Act (subsec. (a)(1) of this section), on the
date of the enactment of this Act (Nov. 8, 1990),
''(B) with respect to a requirement of a State or political
subdivision described in paragraph (2) of section 403A(a) of the Federal
Food, Drug, and Cosmetic Act, one year after the date of the enactment
of this Act,
''(C) with respect to a requirement of a State or political
subdivision described in paragraph (3) of section 403A(a) of the Federal
Food, Drug, and Cosmetic Act, as prescribed by section 6(b) of the
Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535, set out
below),
''(D) with respect to a requirement of a State or political
subdivision described in paragraph (4) of section 403A(a) of the Federal
Food, Drug, and Cosmetic Act, on the date regulations to implement
section 403(q) of such Act (21 U.S.C. 343(q)) take effect, and
''(E) with respect to a requirement of a State or political
subdivision described in paragraph (5) of section 403A(a) of the Federal
Food, Drug, and Cosmetic Act, on the date regulations to implement
section 403(r) of such Act take effect.
''(2) Exception. -- If a State or political subdivision submits a
petition under section 403A(b) of the Federal Food, Drug, and Cosmetic
Act for a requirement described in section 403A(a) of such Act within 18
months of the date of the enactment of this Act, paragraphs (3) through
(5) of such section 403A(a) shall not apply with respect to such State
or political subdivision requirement until --
''(1) 24 months after the date of the enactment of this Act, or
''(2) action on the petition,
whichever occurs later.''
Section 6(b) of Pub. L. 101-535 provided that:
''(1) For the purpose of implementing section 403A(a)(3) (21 U.S.C.
343-1(a)(3)), the Secretary of Health and Human Services shall enter
into a contract with a public or nonprofit private entity to conduct a
study of --
''(A) State and local laws which require the labeling of food that is
of the type required by sections 403(b), 403(d), 403(f), 403(h),
403(i)(1), and 403(k) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343(b), (d), (f), (h), (i)(1), (k)), and
''(B) the sections of the Federal Food, Drug, and Cosmetic Act
referred to in subparagraph (A) and the regulations issued by the
Secretary to enforce such sections to determine whether such sections
and regulations adequately implement the purposes of such sections.
''(2) The contract under paragraph (1) shall provide that the study
required by such paragraph shall be completed within 6 months of the
date of the enactment of this Act (Nov. 8, 1990).
''(3)(A) Within 9 months of the date of the enactment of this Act,
the Secretary shall publish a proposed list of sections which are
adequately being implemented by regulations as determined under
paragraph (1)(B) and sections which are not adequately being implemented
by regulations as so determined. After publication of the lists, the
Secretary shall provide 60 days for comments on such lists.
''(B) Within 24 months of the date of the enactment of this Act, the
Secretary shall publish a final list of sections which are adequately
being implemented by regulations and a list of sections which are not
adequately being implemented by regulations. With respect to a section
which is found by the Secretary to be adequately implemented, no State
or political subdivision of a State may establish or continue in effect
as to any food in interstate commerce any requirement which is not
identical to the requirement of such section.
''(C) Within 24 months of the date of the enactment of this Act, the
Secretary shall publish proposed revisions to the regulations found to
be inadequate under subparagraph (B) and within 30 months of such date
shall issue final revisions. Upon the effective date of such final
revisions, no State or political subdivision may establish or continue
in effect any requirement which is not identical to the requirement of
the section which had its regulations revised in accordance with this
subparagraph.
''(D)(i) If the Secretary does not issue a final list in accordance
with subparagraph (B), the proposed list issued under subparagraph (A)
shall be considered the final list and States and political subdivisions
shall be preempted with respect to sections found to be adequate in such
proposed list in accordance with subparagraph (B).
''(ii) If the Secretary does not issue final revisions of regulations
in accordance with subparagraph (C), the proposed revisions issued under
such subparagraph shall be considered the final revisions and States and
political subdivisions shall be preempted with respect to sections the
regulations of which are revised by the proposed revisions.
''(E) Subsection (b) of section 403A of the Federal Food, Drug, and
Cosmetic Act shall apply with respect to the prohibition prescribed by
subparagraphs (B) and (C).''
Section 6(c) of Pub. L. 101-535 provided that:
''(1) The Nutrition Labeling and Education Act of 1990 (Pub. L.
101-535, see Short Title of 1990 Amendment note set out under section
301 of this title) shall not be construed to preempt any provision of
State law, unless such provision is expressly preempted under section
403A of the Federal Food, Drug, and Cosmetic Act (this section).
''(2) The amendment made by subsection (a) (enacting this section)
and the provisions of subsection (b) (set out as a note above) shall not
be construed to apply to any requirement respecting a statement in the
labeling of food that provides for a warning concerning the safety of
the food or component of the food.
''(3) The amendment made by subsection (a), the provisions of
subsection (b) and paragraphs (1) and (2) of this subsection shall not
be construed to affect preemption, express or implied, of any such
requirement of a State or political subdivision, which may arise under
the Constitution, any provision of the Federal Food, Drug, and Cosmetic
Act (this chapter) not amended by subsection (a), any other Federal law,
or any Federal regulation, order, or other final agency action
reviewable under chapter 7 of title 5, United States Code.''
Amendments by Pub. L. 101-535 not to be construed to alter the
authority of the Secretary of Health and Human Services and the
Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),
and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see
section 9 of Pub. L. 101-535, set out as a note under section 343 of
this title.
21 USC 343a. Health risks presented by use of saccharin
TITLE 21 -- FOOD AND DRUGS
(a) Statement on vending machines dispensing food containing
saccharin respecting health risk; regulations
The Secretary may by regulation require vending machines through
which food containing saccharin is sold to bear a statement of the risks
to health which may be presented by the use of saccharin. A regulation
under this subsection shall require such statement to be located in a
conspicuous place on such vending machine and as proximate as possible
to the name of each food containing saccharin which is sold through such
machine. Any food containing saccharin which is sold in a vending
machine which does not meet any applicable requirement promulgated under
this subsection shall, for purposes of this chapter, be considered a
misbranded food.
(b) Availability and distribution of information; review and
revision
The Secretary shall (1) prepare information respecting the nature of
the controversy surrounding the use of food containing saccharin, and
(2) provide for the distribution of such information for display by
retail establishments where such food is sold but not for immediate
consumption. The Secretary may review and revise such information if he
determines such action is necessary to reflect the current state of
knowledge concerning the risks to health presented by the use of
saccharin.
(Pub. L. 95-203, 4(c), (d), Nov. 23, 1977, 91 Stat. 1453, 1454.)
Subsecs. (a) and (b) of this section were, in the original,
designated as ''(c)'' and ''(d)'' and have been editorially changed for
codification purposes.
Section was enacted as part of Pub. L. 95-203, known as the
Saccharin Study and Labeling Act and not as part of act June 25, 1938,
ch. 675, 52 Stat. 1040, known as the Federal Food, Drug, and Cosmetic
Act, which comprises this chapter.
21 USC 344. Emergency permit control
TITLE 21 -- FOOD AND DRUGS
(a) Conditions on manufacturing, processing, etc., as health measure
Whenever the Secretary finds after investigation that the
distribution in interstate commerce of any class of food may, by reason
of contamination with micro-organisms during the manufacture,
processing, or packing thereof in any locality, be injurious to health,
and that such injurious nature cannot be adequately determined after
such articles have entered interstate commerce, he then, and in such
case only, shall promulgate regulations providing for the issuance, to
manufacturers, processors, or packers of such class of food in such
locality, of permits to which shall be attached such conditions
governing the manufacture, processing, or packing of such class of food,
for such temporary period of time, as may be necessary to protect the
public health; and after the effective date of such regulations, and
during such temporary period, no person shall introduce or deliver for
introduction into interstate commerce any such food manufactured,
processed, or packed by any such manufacturer, processor, or packer
unless such manufacturer, processor, or packer holds a permit issued by
the Secretary as provided by such regulations.
(b) Violation of permit; suspension and reinstatement
The Secretary is authorized to suspend immediately upon notice any
permit issued under authority of this section if it is found that any of
the conditions of the permit have been violated. The holder of a permit
so suspended shall be privileged at any time to apply for the
reinstatement of such permit, and the Secretary shall, immediately after
prompt hearing and an inspection of the establishment, reinstate such
permit if it is found that adequate measures have been taken to comply
with and maintain the conditions of the permit, as originally issued or
as amended.
(c) Inspection of permit-holding establishments
Any officer or employee duly designated by the Secretary shall have
access to any factory or establishment, the operator of which holds a
permit from the Secretary, for the purpose of ascertaining whether or
not the conditions of the permit are being complied with, and denial of
access for such inspection shall be ground for suspension of the permit
until such access is freely given by the operator.
(June 25, 1938, ch. 675, 404, 52 Stat. 1048; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 345. Regulations making exemptions
TITLE 21 -- FOOD AND DRUGS
The Secretary shall promulgate regulations exempting from any
labeling requirement of this chapter (1) small open containers of fresh
fruits and fresh vegetables and (2) food which is, in accordance with
the practice of the trade, to be processed, labeled, or repacked in
substantial quantities at establishments other than those where
originally processed or packed, on condition that such food is not
adulterated or misbranded under the provisions of this chapter upon
removal from such processing, labeling, or repacking establishment.
(June 25, 1938, ch. 675, 405, 52 Stat. 1049; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Nov. 8,
1990, Pub. L. 101-535, 5(a), 104 Stat. 2362.)
Pub. L. 101-535, 5(a), 10(a), Nov. 8, 1990, 104 Stat. 2362, 2365,
provided that, effective six months after the date of promulgation of
final regulations to implement section 343(r) of this title, or if such
regulations are not promulgated, the date proposed regulations are to be
considered as such final regulations, with certain exceptions, this
section is amended by inserting at the end ''This section does not apply
to the labeling requirements of sections 343(q) and 343(r) of this
title.''
Amendment by Pub. L. 101-535 effective six months after the date of
the promulgation of final regulations to implement section 343(r) of
this title, or if such regulations are not promulgated, the date
proposed regulations are to be considered as such final regulations,
with exception for persons marketing food the brand name of which
contains a term defined by the Secretary under section 343(r)(2)(A)(i)
of this title, see section 10(a) of Pub. L. 101-535, set out as a note
under section 343 of this title.
Amendments by Pub. L. 101-535 not to be construed to alter authority
of Secretary of Health and Human Services and Secretary of Agriculture
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L.
101-535, set out as a note under section 343 of this title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 346. Tolerances for poisonous or deleterious substances in food;
regulations
TITLE 21 -- FOOD AND DRUGS
Any poisonous or deleterious substance added to any food, except
where such substance is required in the production thereof or cannot be
avoided by good manufacturing practice shall be deemed to be unsafe for
purposes of the application of clause (2)(A) of section 342(a) of this
title; but when such substance is so required or cannot be so avoided,
the Secretary shall promulgate regulations limiting the quantity therein
or thereon to such extent as he finds necessary for the protection of
public health, and any quantity exceeding the limits so fixed shall also
be deemed to be unsafe for purposes of the application of clause (2)(A)
of section 342(a) of this title. While such a regulation is in effect
limiting the quantity of any such substance in the case of any food,
such food shall not, by reason of bearing or containing any added amount
of such substance, be considered to be adulterated within the meaning of
clause (1) of section 342(a) of this title. In determining the quantity
of such added substance to be tolerated in or on different articles of
food the Secretary shall take into account the extent to which the use
of such substance is required or cannot be avoided in the production of
each such article, and the other ways in which the consumer may be
affected by the same or other poisonous or deleterious substances.
(June 25, 1938, ch. 675, 406, 52 Stat. 1049; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Sept.
6, 1958, Pub. L. 85-929, 3(c), 72 Stat. 1785; July 12, 1960, Pub. L.
86-618, title I, 103(a)(1), 74 Stat. 398.)
1960 -- Pub. L. 86-618 repealed subsec. (b) which required the
Secretary to promulgate regulations for the listing of coal-tar colors.
1958 -- Subsec. (a). Pub. L. 85-929 substituted ''clause (2)(A)''
for ''clause (2)'' in first sentence.
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Effective date of subsec. (a) as in force prior to July 22, 1954,
with respect to particular commercial use of a nematocide, plant
regulator, defoliant, or desiccant in or on a raw agricultural commodity
made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-139, Aug.
7, 1959, 73 Stat. 288.
For effective date of amendment by Pub. L. 85-929, see section 6(
b), (c) of Pub. L. 85-929, set out as a note under section 342 of this
title.
Functions vested in Secretary of Health, Education, and Welfare in
establishing tolerances for pesticide chemicals under this section
together with authority to monitor compliance with tolerances and
effectiveness of surveillance and enforcement and to provide technical
assistance to States and conduct research under this chapter and section
201 et seq. of Title 42, The Public Health and Welfare, transferred to
Administrator of Environmental Protection Agency by Reorg. Plan No. 3
of 1970, 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. 2086,
set out in the Appendix to Title 5, Government Organization and
Employees.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Pesticide chemical regulations, see section 346a of this title.
21 USC 346a. Tolerances for pesticide chemicals in or on raw
agricultural commodities
TITLE 21 -- FOOD AND DRUGS
(a) Conditions of safety
Any poisonous or deleterious pesticide chemical, or any pesticide
chemical which is not generally recognized, among experts qualified by
scientific training and experience to evaluate the safety of pesticide
chemicals, as safe for use, added to a raw agricultural commodity, shall
be deemed unsafe for the purposes of the application of clause (2) of
section 342(a) of this title unless --
(1) a tolerance for such pesticide chemical in or on the raw
agricultural commodity has been prescribed by the Administrator of the
Environmental Protection Agency under this section and the quantity of
such pesticide chemical in or on the raw agricultural commodity is
within the limits of the tolerance so prescribed; or
(2) with respect to use in or on such raw agricultural commodity, the
pesticide chemical has been exempted from the requirement of a tolerance
by the Administrator under this section.
While a tolerance or exemption from tolerance is in effect for a
pesticide chemical with respect to any raw agricultural commodity, such
raw agricultural commodity shall not, by reason of bearing or containing
any added amount of such pesticide chemical, be considered to be
adulterated within the meaning of clause (1) of section 342(a) of this
title.
(b) Establishment of tolerances
The Administrator shall promulgate regulations establishing
tolerances with respect to the use in or on raw agricultural commodities
of poisonous or deleterious pesticide chemicals and of pesticide
chemicals which are not generally recognized, among experts qualified by
scientific training and experience to evaluate the safety of pesticide
chemicals, as safe for use, to the extent necessary to protect the
public health. In establishing any such regulation, the Administrator
shall give appropriate consideration, among other relevant factors, (1)
to the necessity for the production of an adequate, wholesome, and
economical food supply; (2) to the other ways in which the consumer may
be affected by the same pesticide chemical or by other related
substances that are poisonous or deleterious; and (3) to the opinion
submitted with a certification of usefulness under subsection (l) of
this section. Such regulations shall be promulgated in the manner
prescribed in subsection (d) or (e) of this section. In carrying out
the provisions of this section relating to the establishment of
tolerances, the Administrator may establish the tolerance applicable
with respect to the use of any pesticide chemical in or on any raw
agricultural commodity at zero level if the scientific data before the
Administrator does not justify the establishment of a greater tolerance.
(c) Exemptions
The Administrator shall promulgate regulations exempting any
pesticide chemical from the necessity of a tolerance with respect to use
in or on any or all raw agricultural commodities when such a tolerance
is not necessary to protect the public health. Such regulations shall
be promulgated in the manner prescribed in subsection (d) or (e) of this
section.
(d) Regulations pursuant to petition; publication of notice; time
for issuance; referral to advisory committees; effective date;
hearings
(1) Any person who has registered, or who has submitted an
application for the registration of, a pesticide under the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) may
file with the Administrator a petition proposing the issuance of a
regulation establishing a tolerance for a pesticide chemical which
constitutes, or is an ingredient of, such pesticide, or exempting the
pesticide chemical from the requirement of a tolerance. The petition
shall contain data showing --
(A) the name, chemical identity, and composition of the pesticide
chemical;
(B) the amount, frequency, and time of application of the pesticide
chemical;
(C) full reports of investigations made with respect to the safety of
the pesticide chemical;
(D) the results of tests on the amount of residue remaining,
including a description of the analytical methods used;
(E) practicable methods for removing residue which exceeds any
proposed tolerance;
(F) proposed tolerances for the pesticide chemical if tolerances are
proposed; and
(G) reasonable grounds in support of the petition.
Samples of the pesticide chemical shall be furnished to the
Administrator upon request. Notice of the filing of such petition shall
be published in general terms by the Administrator within thirty days
after filing. Such notice shall include the analytical methods
available for the determination of the residue of the pesticide chemical
for which a tolerance or exemption is proposed.
(2) Within ninety days after a certification of usefulness under
subsection (l) of this section with respect to the pesticide chemical
named in the petition, the Administrator shall, after giving due
consideration to the data submitted in the petition or otherwise before
him, by order make public a regulation --
(A) establishing a tolerance for the pesticide chemical named in the
petition for the purposes for which it is so certified as useful, or
(B) exempting the pesticide chemical from the necessity of a
tolerance for such purposes,
unless within such ninety-day period the person filing the petition
requests that the petition be referred to an advisory committee or the
Administrator within such period otherwise deems such referral
necessary, in either of which events the provisions of paragraph (3) of
this subsection shall apply in lieu hereof.
(3) In the event that the person filing the petition requests, within
ninety days after a certification of usefulness under subsection (l) of
this section with respect to the pesticide chemical named in the
petition, that the petition be referred to an advisory committee, or in
the event the Administrator within such period otherwise deems such
referral necessary, the Administrator shall forthwith submit the
petition and other data before him to an advisory committee to be
appointed in accordance with subsection (g) of this section. As soon as
practicable after such referral, but not later than sixty days
thereafter, unless extended as hereinafter provided, the committee
shall, after independent study of the data submitted to it by the
Administrator and other data before it, certify to the Administrator a
report and recommendations on the proposal in the petition to the
Administrator, together with all underlying data and a statement of the
reasons or basis for the recommendations. The sixty-day period provided
for herein may be extended by the advisory committee for an additional
thirty days if the advisory committee deems this necessary. Within
thirty days after such certification, the Administrator shall, after
giving due consideration to all data then before him, including such
report, recommendations, underlying data, and statement, by order make
public a regulation --
(A) establishing a tolerance for the pesticide chemical named in the
petition for the purposes for which it is so certified as useful; or
(B) exempting the pesticide chemical from the necessity of a
tolerance for such purposes.
(4) The regulations published under paragraph (2) or (3) of this
subsection will be effective upon publication.
(5) Within thirty days after publication, any person adversely
affected by a regulation published pursuant to paragraph (2) or (3) of
this subsection, or pursuant to subsection (e) of this section, may file
objections thereto with the Administrator, specifying with particularity
the provisions of the regulation deemed objectionable, stating
reasonable grounds therefor, and requesting a public hearing upon such
objections. A copy of the objections filed by a person other than the
petitioner shall be served on the petitioner, if the regulation was
issued pursuant to a petition. The petitioner shall have two weeks to
make a written reply to the objections. The Administrator shall
thereupon, after due notice, hold such public hearing for the purpose of
receiving evidence relevant and material to the issues raised by such
objections. Any report, recommendations, underlying data, and reasons
certified to the Secretary by an advisory committee shall be made a part
of the record of the hearing, if relevant and material, subject to the
provisions of section 556(d) of title 5. The National Academy of
Sciences shall designate a member of the advisory committee to appear
and testify at any such hearing with respect to the report and
recommendations of such committee upon request of the Administrator, the
petitioner, or the officer conducting the hearing: Provided, That this
shall not preclude any other member of the advisory committee from
appearing and testifying at such hearing. As soon as practicable after
completion of the hearing, the Administrator shall act upon such
objections and by order make public a regulation. Such regulation shall
be based only on substantial evidence of record at such hearing,
including any report, recommendations, underlying data, and reasons
certified to the Administrator by an advisory committee, and shall set
forth detailed findings of fact upon which the regulation is based. No
such order shall take effect prior to the ninetieth day after its
publication, unless the Administrator finds that emergency conditions
exist necessitating an earlier effective date, in which event the
Administrator shall specify in the order his findings as to such
conditions.
(e) Regulations pursuant to Administrator's proposals
The Administrator may at any time, upon his own initiative or upon
the request of any interested person, propose the issuance of a
regulation establishing a tolerance for a pesticide chemical or
exempting it from the necessity of a tolerance. Thirty days after
publication of such a proposal, the Administrator may by order publish a
regulation based upon the proposal which shall become effective upon
publication unless within such thirty-day period a person who has
registered, or who has submitted an application for the registration of,
a pesticide under the Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136 et seq.) containing the pesticide chemical named in
the proposal, requests that the proposal be referred to an advisory
committee. In the event of such a request, the Administrator shall
forthwith submit the proposal and other relevant data before him to an
advisory committee to be appointed in accordance with subsection (g) of
this section. As soon as practicable after such referral, but not later
than sixty days thereafter, unless extended as hereinafter provided, the
committee shall, after independent study of the data submitted to it by
the Administrator and other data before it, certify to the Administrator
a report and recommendations on the proposal together with all
underlying data and a statement of the reasons or basis for the
recommendations. The sixty-day period provided for herein may be
extended by the advisory committee for an additional thirty days if the
advisory committee deems this necessary. Within thirty days after such
certification, the Administrator may, after giving due consideration to
all data before him, including such report, recommendations, underlying
data and statement, by order publish a regulation establishing a
tolerance for the pesticide chemical named in the proposal or exempting
it from the necessity of a tolerance which shall become effective upon
publication. Regulations issued under this subsection shall upon
publication be subject to paragraph (5) of subsection (d) of this
section.
(f) Data submitted as confidential
All data submitted to the Administrator or to an advisory committee
in support of a petition under this section shall be considered
confidential by the Administrator and by such advisory committee until
publication of a regulation under paragraph (2) or (3) of subsection (d)
of this section. Until such publication, such data shall not be
revealed to any person other than those authorized by the Administrator
or by an advisory committee in the carrying out of their official duties
under this section.
(g) Advisory committees; appointment; composition; compensation;
clerical assistance
Whenever the referral of a petition or proposal to an advisory
committee is requested under this section, or the Administrator
otherwise deems such referral necessary the Administrator shall
forthwith appoint a committee of competent experts to review the
petition or proposal and to make a report and recommendations thereon.
Each such advisory committee shall be composed of experts, qualified in
the subject matter of the petition and of adequately diversified
professional background selected by the National Academy of Sciences and
shall include one or more representatives from land-grant colleges. The
size of the committee shall be determined by the Administrator. Members
of an advisory committee shall receive compensation and travel expenses
in accordance with section 376(b)(5)(D) of this title. The members
shall not be subject to any other provision of law regarding the
appointment and compensation of employees of the United States. The
Administrator shall furnish the Committee with adequate clerical and
other assistance, and shall by rules and regulations prescribe the
procedure to be followed by the committee.
(h) Right of consultation
A person who has filed a petition or who has requested the referral
of a proposal to an advisory committee in accordance with the provisions
of this section, as well as representatives of the Environmental
Protection Agency, shall have the right to consult with any advisory
committee provided for in subsection (g) of this section in connection
with the petition or proposal.
(i) Judicial review
(1) In a case of actual controversy as to the validity of any order
under subsections (d)(5), (e), or (l) of this section any person who
will be adversely affected by such order may obtain judicial review by
filing in the United States Court of Appeals for the circuit wherein
such person resides or has his principal place of business, or in the
United States Court of Appeals for the District of Columbia Circuit,
within sixty days after the entry of such order, a petition praying that
the order be set aside in whole or in part.
(2) In the case of a petition with respect to an order under
subsection (d)(5) or (e) of this section, a copy of the petition shall
be forthwith transmitted by the clerk of the court to the Administrator,
or any officer designated by him for that purpose, and thereupon the
Administrator shall file in the court the record of the proceedings on
which he based his order, as provided in section 2112 of title 28. Upon
the filing of such petition, the court shall have exclusive jurisdiction
to affirm or set aside the order complained of in whole or in part. The
findings of the Administrator with respect to questions of fact shall be
sustained if supported by substantial evidence when considered on the
record as a whole, including any report and recommendation of an
advisory committee.
(3) In the case of a petition with respect to an order under
subsection (l) of this section, a copy of the petition shall be
forthwith transmitted by the clerk of the court to the Administrator, or
any officer designated by him for that purpose, and thereupon the
Administrator shall file in the court the record of the proceedings on
which he based his order, as provided in section 2112 of title 28. Upon
the filing of such petition, the court shall have exclusive jurisdiction
to affirm or set aside the order complained of in whole or in part. The
findings of the Administrator with respect to questions of fact shall be
sustained if supported by substantial evidence when considered on the
record as a whole.
(4) If application is made to the court for leave to adduce
additional evidence, the court may order such additional evidence to be
taken before the Administrator and to be adduced upon the hearing in
such manner and upon such terms and conditions as to the court may seem
proper, if such evidence is material and there were reasonable grounds
for failure to adduce such evidence in the proceedings below. The
Administrator may modify his findings as to the facts and order by
reason of the additional evidence so taken, and shall file with the
court such modified findings and order.
(5) The judgment of the court affirming or setting aside, in whole or
in part, any order under this section shall be final, subject to review
by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28. The commencement
of proceedings under this section shall not, unless specifically ordered
by the court to the contrary, operate as a stay of an order.
(j) Temporary tolerances
The Administrator may, upon the request of any person who has
obtained an experimental permit for a pesticide chemical under the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et
seq.) or upon his own initiative, establish a temporary tolerance for
the pesticide chemical for the uses covered by the permit whenever in
his judgment such action is deemed necessary to protect the public
health, or may temporarily exempt such pesticide chemical from a
tolerance. In establishing such a tolerance, the Administrator shall
give due regard to the necessity for experimental work in developing an
adequate, wholesome, and economical food supply and to the limited
hazard to the public health involved in such work when conducted in
accordance with applicable regulations under the Federal Insecticide,
Fungicide, and Rodenticide Act.
(k) Regulations based on public hearings before January 1, 1953
Regulations affecting pesticide chemicals in or on raw agricultural
commodities which are promulgated under the authority of section 346(a)
of this title upon the basis of public hearings instituted before
January 1, 1953, in accordance with section 371(a) of this title, shall
be deemed to be regulations under this section and shall be subject to
amendment or repeal as provided in subsection (m) of this section.
(l) Pesticides under Federal Insecticide, Fungicide, and Rodenticide
Act; functions of Administrator of the Environmental Protection Agency;
certifications; hearing; time limitation; opinion; regulations
The Administrator, upon request of any person who has registered, or
who has submitted an application for the registration of, a pesticide
under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136 et seq.), and whose request is accompanied by a copy of a petition
filed by such person under subsection (d)(1) of this section with
respect to a pesticide chemical which constitutes, or is an ingredient
of, such pesticide, shall, within thirty days or within sixty days if
upon notice prior to the termination of such thirty days the
Administrator deems it necessary to postpone action for such period, on
the basis of data before him, either --
(1) certify that such pesticide chemical is useful for the purpose
for which a tolerance or exemption is sought; or
(2) notify the person requesting the certification of his proposal to
certify that the pesticide chemical does not appear to be useful for the
purpose for which a tolerance or exemption is sought, or appears to be
useful for only some of the purposes for which a tolerance or exemption
is sought.
In the event that the Administrator takes the action described in
clause (2) of the preceding sentence, the person requesting the
certification, within one week after receiving the proposed
certification, may either (A) request the Administrator to certify on
the basis of the proposed certification; (B) request a hearing on the
proposed certification or the parts thereof objected to; or (C) request
both such certification and such hearing. If no such action is taken,
the Administrator may by order make the certification as proposed. In
the event that the action described in clause (A) or (C) is taken, the
Administrator shall by order make the certification as proposed with
respect to such parts thereof as are requested. It /1/
the event a hearing is requested, the Administrator shall provide
opportunity for a prompt hearing. The certification of the
Administrator as the result of such hearing shall be made by order and
shall be based only on substantial evidence of record at the hearing and
shall set forth detailed findings of fact. In no event shall the time
elapsing between the making of a request for a certification under this
subsection and final certification by the Administrator exceed one
hundred and sixty days. The Administrator shall submit with any
certification of usefulness under this subsection an opinion, based on
the data before him, whether the tolerance or exemption proposed by the
petitioner reasonably reflects the amount of residue likely to result
when the pesticide chemical is used in the manner proposed for the
purpose for which the certification is made. The Administrator, after
due notice and opportunity for public hearing, is authorized to
promulgate rules and regulations for carrying out the provisions of this
subsection.
(m) Amendment of regulations
The Administrator shall prescribe by regulations the procedure by
which regulations under this section may be amended or repealed, and
such procedure shall conform to the procedure provided in this section
for the promulgation of regulations establishing tolerances, including
the appointment of advisory committees and the procedure for referring
petitions to such committees.
(n) Guaranties
The provisions of section 333(c) of this title with respect to the
furnishing of guaranties shall be applicable to raw agricultural
commodities covered by this section.
(o) Payment of fees; services or functions as conditioned on;
waiver or refund of fees
The Administrator shall by regulation require the payment of such
fees as will in the aggregate, in the judgment of the Administrator, be
sufficient over a reasonable term to provide, equip, and maintain an
adequate service for the performance of the Administrator's functions
under this section. Under such regulations, the performance of the
Administrator's services or other functions pursuant to this section,
including any one or more of the following, may be conditioned upon the
payment of such fees: (1) The acceptance of filing of a petition
submitted under subsection (d) of this section; (2) the promulgation of
a regulation establishing a tolerance, or an exemption from the
necessity of a tolerance, under this section, or the amendment or repeal
of such a regulation; (3) the referral of a petition or proposal under
this section to an advisory committee; (4) the acceptance for filing of
objections under subsection (d)(5) of this section; or (5) the
certification and filing in court of a transcript of the proceedings and
the record under subsection (i)(2) of this section. Such regulations
may further provide for waiver or refund of fees in whole or in part
when in the judgment of the Administrator such waiver or refund is
equitable and not contrary to the purposes of this subsection.
(June 25, 1938, ch. 675, 408, as added July 22, 1954, ch. 559, 3, 68
Stat. 511, and amended Aug. 28, 1958, Pub. L. 85-791, 20, 72 Stat. 947;
Oct. 30, 1970, Pub. L. 91-515, title VI, 601(d)(1), 84 Stat. 1311; 1970
Reorg. Plan No. 3, 2(a)(4), (8)(ii), eff. Dec. 2, 1970, 35 F.R. 15623,
84 Stat. 2086; Nov. 18, 1971, Pub. L. 92-157, title III, 303( a), 85
Stat. 464; Oct. 21, 1972, Pub. L. 92-516, 3(3), 86 Stat. 998; Nov. 8,
1984, Pub. L. 98-620, title IV, 402(25)(A), 98 Stat. 3359.)
The Federal Insecticide, Fungicide, and Rodenticide Act, referred to
in subsecs. (d)(1), (e), (j), and (l), is act June 25, 1947, ch. 125,
as amended generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973,
which is classified generally to subchapter II ( 136 et seq.) of chapter
6 of Title 7, Agriculture. For complete classification of this Act to
the Code, see Short Title note set out under section 136 of Title 7 and
Tables.
In subsec. (d)(5), ''section 556(d) of title 5'' was substituted for
''section 7(c) of the Administrative Procedure Act (5 U.S.C. sec.
1006(c))'' on authority of Pub. L. 89-554, 7(b), Sept. 6, 1966, 80
Stat. 631, the first section of which enacted Title 5, Government
Organization and Employees.
1984 -- Subsec. (i)(5). Pub. L. 98-620 struck out provision that
required the court to advance on the docket and expedite the disposition
of all causes filed therein pursuant to this section.
1972 -- Subsecs. (d)(1), (e), (l). Pub. L. 92-516 substituted
references to pesticide for references to economic poison wherever
appearing therein.
1971 -- Subsec. (g). Pub. L. 92-157 struck out '', which the
Secretary shall by rules and regulations prescribe,'' after ''as
compensation for their services a reasonable per diem'' prior to
amendment in 1970, by Pub. L. 91-515, which overlooked such language
when amending subsec. (g) as provided in 1970 Amendment note.
1970 -- Subsec. (g). Pub. L. 91-515 substituted provisions
authorizing members of an advisory committee to receive compensation and
travel expenses in accordance with section 376(b)(5)(D) of this title,
for provisions authorizing such members to receive as compensation a
reasonable per diem for time actually spent on committee work, and
necessary traveling and subsistence expenses while serving away from
their places of residence.
1958 -- Subsec. (i)(2). Pub. L. 85-791, 20(a), in first sentence,
substituted ''transmitted by the clerk of the court to the Secretary,
or'' for ''served upon the Secretary, or upon'', substituted ''file in
the court the record of the proceedings'' for ''certify and file in the
court a transcript of the proceedings and the record'', and inserted
''as provided in section 2112 of title 28'', and which, in second
sentence, substituted ''the filing of such petition'' for ''such
filing''.
Subsec. (i)(3). Pub. L. 85-791, 20(b), in first sentence, substituted
''transmitted by the clerk of the court to the Secretary of Agriculture,
or'' for ''served upon the Secretary of Agriculture, or upon'',
substituted ''file in the court the record of the proceedings'' for
''certify and file in the court a transcript of the proceedings and the
record'', and inserted ''as provided in section 2112 of title 28'', and,
in second sentence, substituted ''the filing of such petition'' for
''such filing''.
Amendment by Pub. L. 98-620 not applicable to cases pending on Nov.
8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective
Date note under section 1657 of Title 28, Judiciary and Judicial
Procedure.
Amendment by Pub. L. 92-516 effective at close of Oct. 21, 1972,
except if regulations are necessary for implementation of any provision
that becomes effective on Oct. 21, 1972, and continuation in effect of
subchapter I of chapter 6 of Title 7, Agriculture, and regulations
thereunder, relating to control of economic poisons, as in existence
prior to Oct. 21, 1972, until superseded by provisions of Pub. L.
92-516 and regulations thereunder, see section 4 of Pub. L. 92-516, set
out as an Effective Date note under section 136 of Title 7.
''Administrator of the Environmental Protection Agency'' substituted
in subsecs. (a) to (j), (l), (m), and (o), for ''Secretary of Health,
Education, and Welfare'' and in subsecs. (b), (d), (i), and (l), for
''Secretary of Agriculture'' pursuant to Reorg. Plan No. 3 of 1970, set
out in the Appendix to Title 5, Government Organization and Employees,
which transferred to Administrator of Environmental Protection Agency
functions vested in Secretary of Health, Education, and Welfare in
establishing tolerances for pesticide chemicals under this section
together with authority to monitor compliance with tolerances and
effectiveness of surveillance and enforcement and to provide technical
assistance to States and conduct research under this chapter and section
201 et seq. of Title 42, The Public Health and Welfare, and which also
transferred to Administrator of Environmental Protection Agency
functions of Agriculture Department and Secretary of Agriculture under
subsec. (l) of this section.
Federal Advisory Committee Act, see Appendix to Title 5, Government
Organization and Employees.
/1/ So in original. Probably should be ''In''.
21 USC 346b. Authorization of appropriations
TITLE 21 -- FOOD AND DRUGS
There are authorized to be appropriated, out of any moneys in the
Treasury not otherwise appropriated, such sums as may be necessary for
the purpose and administration of sections 321(q), (r), 342(a)(2), and
346a of this title.
(July 22, 1954, ch. 559, 4, 68 Stat. 517.)
Section was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
21 USC 347. Intrastate sales of colored oleomargarine
TITLE 21 -- FOOD AND DRUGS
(a) Law governing
Colored oleomargarine or colored margarine which is sold in the same
State or Territory in which it is produced shall be subject in the same
manner and to the same extent to the provisions of this chapter as if it
had been introduced in interstate commerce.
(b) Labeling and packaging requirements
No person shall sell, or offer for sale, colored oleomargarine or
colored margarine unless --
(1) such oleomargarine or margarine is packaged,
(2) the net weight of the contents of any package sold in a retail
establishment is one pound or less,
(3) there appears on the label of the package (A) the word
''oleomargarine'' or ''margarine'' in type or lettering at least as
large as any other type or lettering on such label, and (B) a full and
accurate statement of all the ingredients contained in such
oleomargarine or margarine, and
(4) each part of the contents of the package is contained in a
wrapper which bears the word ''oleomargarine'' or ''margarine'' in type
or lettering not smaller than 20-point type.
The requirements of this subsection shall be in addition to and not
in lieu of any of the other requirements of this chapter.
(c) Sales in public eating places
No person shall possess in a form ready for serving colored
oleomargarine or colored margarine at a public eating place unless a
notice that oleomargarine or margarine is served is displayed
prominently and conspicuously in such place and in such manner as to
render it likely to be read and understood by the ordinary individual
being served in such eating place or is printed or is otherwise set
forth on the menu in type or lettering not smaller than that normally
used to designate the serving of other food items. No person shall
serve colored oleomargarine or colored margarine at a public eating
place, whether or not any charge is made therefor, unless (1) each
separate serving bears or is accompanied by labeling identifying it as
oleomargarine or margarine, or (2) each separate serving thereof is
triangular in shape.
(d) Exemption from labeling requirements
Colored oleomargarine or colored margarine when served with meals at
a public eating place shall at the time of such service be exempt from
the labeling requirements of section 343 of this title (except
subsection (a) and (f) of section 343 of this title) if it complies with
the requirements of subsection (b) of this section.
(e) Color content of oleomargarine
For the purpose of this section colored oleomargarine or colored
margarine is oleomargarine or margarine having a tint or shade
containing more than one and six-tenths degrees of yellow, or of yellow
and red collectively, but with an excess of yellow over red, measured in
terms of Lovibond tintometer scale or its equivalent.
(June 25, 1938, ch. 675, 407, as added Mar. 16, 1950, ch. 61, 3( c),
64 Stat. 20.)
Section 7 of act Mar. 16, 1950, provided that: ''This Act (enacting
this section and sections 347a and 347b of this title and amending
sections 331 and 342 of this title and sections 45 and 55 of Title 15,
Commerce and Trade) shall become effective on July 1, 1950.''
Section 5 of act Mar. 16, 1950, provided that: ''So much of the
unexpended balances of appropriations, allocations, or other funds
(including funds available for the fiscal year ending June 30, 1950) for
the use of the Bureau of Internal Revenue of the Treasury Department in
the exercise of functions under the Oleomargarine Tax Act (26 U.S.C.,
2300, subchapter A) (now section 4591 et seq. of Title 26, Internal
Revenue Code), as the Director of the Bureau of the Budget (now Director
of the Office of Management and Budget) may determine, shall be
transferred to the Federal Security Agency (Food and Drug
Administration) (now the Department of Health and Human Services) for
use in the enforcement of this Act (see Effective Date note above).''
21 USC 347a. Congressional declaration of policy regarding
oleomargarine sales
TITLE 21 -- FOOD AND DRUGS
The Congress finds and declares that the sale, or the serving in
public eating places, of colored oleomargarine or colored margarine
without clear identification as such or which is otherwise adulterated
or misbranded within the meaning of this chapter depresses the market in
interstate commerce for butter and for oleomargarine or margarine
clearly identified and neither adulterated nor misbranded, and
constitutes a burden on interstate commerce in such articles. Such
burden exists, irrespective of whether such oleomargarine or margarine
originates from an interstate source or from the State in which it is
sold.
(Mar. 16, 1950, ch. 61, 3(a), 64 Stat. 20.)
Section was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
Section effective July 1, 1950, see section 7 of act Mar. 16, 1950,
set out as a note under section 347 of this title.
21 USC 347b. Contravention of State laws
TITLE 21 -- FOOD AND DRUGS
Nothing in this Act shall be construed as authorizing the possession,
sale, or serving of colored oleomargarine or colored margarine in any
State or Territory in contravention of the laws of such State or
Territory.
(Mar. 16, 1950, ch. 61, 6, 64 Stat. 22.)
This Act, referred to in text, is act Mar. 16, 1950, ch. 61, 64
Stat. 20, which is classified to sections 331, 342, 347 to 347b of this
title, and sections 45 and 55 of Title 15, Commerce and Trade. For
complete classification of this Act to the Code, see Tables.
Section was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
Section effective July 1, 1950, see section 7 of act Mar. 16, 1950,
set out as a note under section 347 of this title.
21 USC 348. Food additives
TITLE 21 -- FOOD AND DRUGS
(a) Unsafe food additives; exception for conformity with exemption
or regulation
A food additive shall, with respect to any particular use or intended
use of such additives, be deemed to be unsafe for the purposes of the
application of clause (2)(C) of section 342(a) of this title, unless --
(1) it and its use or intended use conform to the terms of an
exemption which is in effect pursuant to subsection (i) of this section;
or
(2) there is in effect, and it and its use or intended use are in
conformity with, a regulation issued under this section prescribing the
conditions under which such additive may be safely used.
While such a regulation relating to a food additive is in effect, a
food shall not, by reason of bearing or containing such an additive in
accordance with the regulation, be considered adulterated within the
meaning of clause (1) of section 342(a) of this title.
(b) Petition for regulation prescribing conditions of safe use;
contents; description of production methods and controls; samples;
notice of regulation
(1) Any person may, with respect to any intended use of a food
additive, file with the Secretary a petition proposing the issuance of a
regulation prescribing the conditions under which such additive may be
safely used.
(2) Such petition shall, in addition to any explanatory or supporting
data, contain --
(A) the name and all pertinent information concerning such food
additive, including, where available, its chemical identity and
composition;
(B) a statement of the conditions of the proposed use of such
additive, including all directions, recommendations, and suggestions
proposed for the use of such additive, and including specimens of its
proposed labeling;
(C) all relevant data bearing on the physical or other technical
effect such additive is intended to produce, and the quantity of such
additive required to produce such effect;
(D) a description of practicable methods for determining the quantity
of such additive in or on food, and any substance formed in or on food,
because of its use; and
(E) full reports of investigations made with respect to the safety
for use of such additive, including full information as to the methods
and controls used in conducting such investigations.
(3) Upon request of the Secretary, the petitioner shall furnish (or,
if the petitioner is not the manufacturer of such additive, the
petitioner shall have the manufacturer of such additive furnish, without
disclosure to the petitioner) a full description of the methods used in,
and the facilities and controls used for, the production of such
additive.
(4) Upon request of the Secretary, the petitioner shall furnish
samples of the food additive involved, or articles used as components
thereof, and of the food in or on which the additive is proposed to be
used.
(5) Notice of the regulation proposed by the petitioner shall be
published in general terms by the Secretary within thirty days after
filing.
(c) Approval or denial of petition; time for issuance of order;
evaluation of data; factors
(1) The Secretary shall --
(A) by order establish a regulation (whether or not in accord with
that proposed by the petitioner) prescribing, with respect to one or
more proposed uses of the food additive involved, the conditions under
which such additive may be safely used (including, but not limited to,
specifications as to the particular food or classes of food in or in
which such additive may be used, the maximum quantity which may be used
or permitted to remain in or on such food, the manner in which such
additive may be added to or used in or on such food, and any directions
or other labeling or packaging requirements for such additive deemed
necessary by him to assure the safety of such use), and shall notify the
petitioner of such order and the reasons for such action; or
(B) by order deny the petition, and shall notify the petitioner of
such order and of the reasons for such action.
(2) The order required by paragraph (1)(A) or (B) of this subsection
shall be issued within ninety days after the date of filing of the
petition, except that the Secretary may (prior to such ninetieth day),
by written notice to the petitioner, extend such ninety-day period to
such time (not more than one hundred and eighty days after the date of
filing of the petition) as the Secretary deems necessary to enable him
to study and investigate the petition.
(3) No such regulation shall issue if a fair evaluation of the data
before the Secretary --
(A) fails to establish that the proposed use of the food additive,
under the conditions of use to be specified in the regulation, will be
safe: Provided, That no additive shall be deemed to be safe if it is
found to induce cancer when ingested by man or animal, or if it is
found, after tests which are appropriate for the evaluation of the
safety of food additives, to induce cancer in man or animal, except that
this proviso shall not apply with respect to the use of a substance as
an ingredient of feed for animals which are raised for food production,
if the Secretary finds (i) that, under the conditions of use and feeding
specified in proposed labeling and reasonably certain to be followed in
practice, such additive will not adversely affect the animals for which
such feed is intended, and (ii) that no residue of the additive will be
found (by methods of examination prescribed or approved by the Secretary
by regulations, which regulations shall not be subject to subsections
(f) and (g) of this section) in any edible portion of such animal after
slaughter or in any food yielded by or derived from the living animal;
or
(B) shows that the proposed use of the additive would promote
deception of the consumer in violation of this chapter or would
otherwise result in adulteration or in misbranding of food within the
meaning of this chapter.
(4) If, in the judgment of the Secretary, based upon a fair
evaluation of the data before him, a tolerance limitation is required in
order to assure that the proposed use of an additive will be safe, the
Secretary --
(A) shall not fix such tolerance limitation at a level higher than he
finds to be reasonably required to accomplish the physical or other
technical effect for which such additive is intended; and
(B) shall not establish a regulation for such proposed use if he
finds upon a fair evaluation of the data before him that such data do
not establish that such use would accomplish the intended physical or
other technical effect.
(5) In determining, for the purposes of this section, whether a
proposed use of a food additive is safe, the Secretary shall consider
among other relevant factors --
(A) the probable consumption of the additive and of any substance
formed in or on food because of the use of the additive;
(B) the cumulative effect of such additive in the diet of man or
animals, taking into account any chemically or pharmacologically related
substance or substances in such diet; and
(C) safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of animal
experimentation data.
(d) Regulation issued on Secretary's initiative
The Secretary may at any time, upon his own initiative, propose the
issuance of a regulation prescribing, with respect to any particular use
of a food additive, the conditions under which such additive may be
safely used, and the reasons therefor. After the thirtieth day
following publication of such a proposal, the Secretary may by order
establish a regulation based upon the proposal.
(e) Publication and effective date of orders
Any order, including any regulation established by such order, issued
under subsection (c) or (d) of this section, shall be published and
shall be effective upon publication, but the Secretary may stay such
effectiveness if, after issuance of such order, a hearing is sought with
respect to such order pursuant to subsection (f) of this section.
(f) Objections and public hearing; basis and contents of order;
statement
(1) Within thirty days after publication of an order made pursuant to
subsection (c) or (d) of this section, any person adversely affected by
such an order may file objections thereto with the Secretary, specifying
with particularity the provisions of the order deemed objectionable,
stating reasonable grounds therefor, and requesting a public hearing
upon such objections. The Secretary shall, after due notice, as
promptly as possible hold such public hearing for the purpose of
receiving evidence relevant and material to the issues raised by such
objections. As soon as practicable after completion of the hearing, the
Secretary shall by order act upon such objections and make such order
public.
(2) Such order shall be based upon a fair evaluation of the entire
record at such hearing, and shall include a statement setting forth in
detail the findings and conclusions upon which the order is based.
(3) The Secretary shall specify in the order the date on which it
shall take effect, except that it shall not be made to take effect prior
to the ninetieth day after its publication, unless the Secretary finds
that emergency conditions exist necessitating an earlier effective date,
in which event the Secretary shall specify in the order his findings as
to such conditions.
(g) Judicial review
(1) In a case of actual controversy as to the validity of any order
issued under subsection (f) of this section, including any order
thereunder with respect to amendment or repeal of a regulation issued
under this section, any person who will be adversely affected by such
order may obtain judicial review by filing in the United States Court of
Appeals for the circuit wherein such person resides or has his principal
place of business, or in the United States Court of Appeals for the
District of Columbia Circuit, within sixty days after the entry of such
order, a petition praying that the order be set aside in whole or in
part.
(2) A copy of such petition shall be forthwith transmitted by the
clerk of the court to the Secretary, or any officer designated by him
for that purpose, and thereupon the Secretary shall file in the court
the record of the proceedings on which he based his order, as provided
in section 2112 of title 28. Upon the filing of such petition the court
shall have jurisdiction, which upon the filing of the record with it
shall be exclusive, to affirm or set aside the order complained of in
whole or in part. Until the filing of the record the Secretary may
modify or set aside his order. The findings of the Secretary with
respect to questions of fact shall be sustained if based upon a fair
evaluation of the entire record at such hearing.
(3) The court, on such judicial review, shall not sustain the order
of the Secretary if he failed to comply with any requirement imposed on
him by subsection (f)(2) of this section.
(4) If application is made to the court for leave to adduce
additional evidence, the court may order such additional evidence to be
taken before the Secretary and to be adduced upon the hearing in such
manner and upon such terms and conditions as to the court may seem
proper, if such evidence is material and there were reasonable grounds
for failure to adduce such evidence in the proceedings below. The
Secretary may modify his findings as to the facts and order by reason of
the additional evidence so taken, and shall file with the court such
modified findings and order.
(5) The judgment of the court affirming or setting aside, in whole or
in part, any order under this section shall be final, subject to review
by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28. The commencement
of proceedings under this section shall not, unless specifically ordered
by the court to the contrary, operate as a stay of an order.
(h) Amendment or repeal of regulations
The Secretary shall by regulation prescribe the procedure by which
regulations under the foregoing provisions of this section may be
amended or repealed, and such procedure shall conform to the procedure
provided in this section for the promulgation of such regulations.
(i) Exemptions for investigational use
Without regard to subsections (b) to (h), inclusive, of this section,
the Secretary shall by regulation provide for exempting from the
requirements of this section any food additive, and any food bearing or
containing such additive, intended solely for investigational use by
qualified experts when in his opinion such exemption is consistent with
the public health.
(June 25, 1938, ch. 675, 409, as added Sept. 6, 1958, Pub. L.
85-929, 4, 72 Stat. 1785, and amended June 29, 1960, Pub. L. 86-546, 2,
74 Stat. 255; Oct. 10, 1962, Pub. L. 87-781, title I, 104(f)(1), 76
Stat. 785; Nov. 8, 1984, Pub. L. 98-620, title IV, 402(25)(B), 98 Stat.
3359.)
1984 -- Subsec. (g)(2). Pub. L. 98-620 struck out provision that
required the court to advance on the docket and expedite the disposition
of all causes filed therein pursuant to this section.
1962 -- Subsec. (c)(3)(A). Pub. L. 87-781 excepted proviso from
applying to use of a substance as an ingredient of feed for animals
raised for food production, if under conditions of use specified in
proposed labeling, and which conditions are reasonably certain to be
followed in practice, such additive will not adversely affect the
animals and no residue will be found in any edible portion of such
animal after slaughter, or in any food from the living animal.
1960 -- Subsec. (g)(2). Pub. L. 86-546 substituted ''forthwith
transmitted by the clerk of the court to the Secretary, or any officer''
for ''served upon the Secretary, or upon any officer'', ''shall file in
the court the record of the proceedings on which he based his order, as
provided in section 2112 of title 28'' for ''shall certify and file in
the court a transcript of the proceedings and the record on which he
based his order'', and ''Upon the filing of such petition the court
shall have jurisdiction, which upon the filing of the record with it
shall be exclusive,'' for ''Upon such filing, the court shall have
exclusive jurisdiction'', and inserted sentence authorizing the
Secretary to modify or set aside his order until the filing of the
record.
Amendment by Pub. L. 98-620 not applicable to cases pending on Nov.
8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective
Date note under section 1657 of Title 28, Judiciary and Judicial
Procedure.
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
107 of Pub. L. 87-781, set out as an Effective Date of 1962 Amendment
note under section 321 of this title.
Section effective Sept. 6, 1958, see section 6(a) of Pub. L.
85-929, set out as an Effective Date of 1958 Amendment note under
section 342 of this title.
Functions vested in Secretary of Health, Education, and Welfare in
establishing tolerances for pesticide chemicals under this section
together with authority to monitor compliance with tolerances and
effectiveness of surveillance and enforcement and to provide technical
assistance to States and conduct research under this chapter and section
201 et seq. of Title 42, The Public Health and Welfare, transferred to
Administrator of Environmental Protection Agency by Reorg. Plan No. 3
of 1970, 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. 2086,
set out in the Appendix to Title 5, Government Organization and
Employees.
Pub. L. 95-203, 3, Nov. 23, 1977, 91 Stat. 1452, as amended by Pub.
L. 96-88, title V, 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L.
96-273, June 17, 1980, 94 Stat. 536; Pub. L. 97-42, 2, Aug. 14, 1981,
95 Stat. 946; Pub. L. 98-22, 2, Apr. 22, 1983, 97 Stat. 173; Pub. L.
99-46, May 24, 1985, 99 Stat. 81; Pub. L. 100-71, title I, 101, July
11, 1987, 101 Stat. 431; Pub. L. 102-142, title VI, Oct. 28, 1991,
105 Stat. 910, provided that: ''During the period ending May 1, 1997,
the Secretary --
''(1) may not amend or revoke the interim food additive regulation of
the Food and Drug Administration of the Department of Health and Human
Services applicable to saccharin and published on March 15, 1977
(section 180.37 of part 180, subchapter B, chapter 1, title 21, Code of
Federal Regulations (42 Fed. Reg. 14638)), or
''(2) may, except as provided in section 4 (enacting section 343a of
this title, amending sections 321 and 343 of this title, and enacting
provisions set out as notes under section 343 of this title) and the
amendments made by such section, not take any other action under the
Federal Food, Drug, and Cosmetic Act (this chapter) to prohibit or
restrict the sale or distribution of saccharin, any food permitted by
such interim food additive regulation to contain saccharin, or any drug
or cosmetic containing saccharin,
solely on the basis of the carcinogenic or other toxic effect of
saccharin as determined by any study made available to the Secretary
before the date of the enactment of this Act (Nov. 23, 1977) which
involved human studies or animal testing, or both.''
For definition of ''saccharin'' as used in this note, see section 2(
d) of Pub. L. 95-203.
450i; title 15 section 1262; title 35 section 155.
21 USC 349. Bottled drinking water standards; publication in Federal
Register
TITLE 21 -- FOOD AND DRUGS
Whenever the Administrator of the Environmental Protection Agency
prescribes interim or revised national primary drinking water
regulations under section 300g-1 of title 42, the Secretary shall
consult with the Administrator and within 180 days after the
promulgation of such drinking water regulations either promulgate
amendments to regulations under this chapter applicable to bottled
drinking water or publish in the Federal Register his reasons for not
making such amendments.
(June 25, 1938, ch. 675, 410, as added Dec. 16, 1974, Pub. L.
93-523, 4, 88 Stat. 1694.)
21 USC 350. Vitamins and minerals
TITLE 21 -- FOOD AND DRUGS
(a) Authority and limitations of Secretary; applicability
(1) Except as provided in paragraph (2) --
(A) the Secretary may not establish, under section 321(n), 341, or
343 of this title, maximum limits on the potency of any synthetic or
natural vitamin or mineral within a food to which this section applies;
(B) the Secretary may not classify any natural or synthetic vitamin
or mineral (or combination thereof) as a drug solely because it exceeds
the level of potency which the Secretary determines is nutritionally
rational or useful;
(C) the Secretary may not limit, under section 321(n), 341, or 343 of
this title, the combination or number of any synthetic or natural --
(i) vitamin,
(ii) mineral, or
(iii) other ingredient of food,
within a food to which this section applies.
(2) Paragraph (1) shall not apply in the case of a vitamin, mineral,
other ingredient of food, or food, which is represented for use by
individuals in the treatment or management of specific diseases or
disorders, by children, or by pregnant or lactating women. For purposes
of this subparagraph, the term ''children'' means individuals who are
under the age of twelve years.
(b) Labeling and advertising requirements for foods
(1) A food to which this section applies shall not be deemed under
section 343 of this title to be misbranded solely because its label
bears, in accordance with section 343(i)(2) of this title, all the
ingredients in the food or its advertising contains references to
ingredients in the food which are not vitamins or minerals.
(2)(A) The labeling for any food to which this section applies may
not list its ingredients which are not vitamins or minerals (i) except
as a part of a list of all the ingredients of such food, and (ii) unless
such ingredients are listed in accordance with applicable regulations
under section 343 of this title. To the extent that compliance with
clause (i) of this subparagraph is impracticable or results in deception
or unfair competition, exemptions shall be established by regulations
promulgated by the Secretary.
(B) Notwithstanding the provisions of subparagraph (A), the labeling
and advertising for any food to which this section applies may not give
prominence to or emphasize ingredients which are not --
(i) vitamins,
(ii) minerals, or
(iii) represented as a source of vitamins or minerals.
(c) Definitions
(1) For purposes of this section, the term ''food to which this
section applies'' means a food for humans which is a food for special
dietary use --
(A) which is or contains any natural or synthetic vitamin or mineral,
and
(B) which --
(i) is intended for ingestion in tablet, capsule, or liquid form, or
(ii) if not intended for ingestion in such a form, does not simulate
and is not represented as conventional food and is not represented for
use as a sole item of a meal or of the diet.
(2) For purposes of paragraph (1)(B)(i), a food shall be considered
as intended for ingestion in liquid form only if it is formulated in a
fluid carrier and it is intended for ingestion in daily quantities
measured in drops or similar small units of measure.
(3) For purposes of paragraph (1) and of section 343(j) of this title
insofar as that section is applicable to food to which this section
applies, the term ''special dietary use'' as applied to food used by man
means a particular use for which a food purports or is represented to be
used, including but not limited to the following:
(A) Supplying a special dietary need that exists by reason of a
physical, physiological, pathological, or other condition, including but
not limited to the condition of disease, convalescence, pregnancy,
lactation, infancy, allergic hypersensitivity to food, underweight,
overweight, or the need to control the intake of sodium.
(B) Supplying a vitamin, mineral, or other ingredient for use by man
to supplement his diet by increasing the total dietary intake.
(C) Supplying a special dietary need by reason of being a food for
use as the sole item of the diet.
(June 25, 1938, ch. 675, 411, as added Apr. 22, 1976, Pub. L.
94-278, title V, 501(a), 90 Stat. 410.)
Section 501(b) of Pub. L. 94-278, as amended by Pub. L. 96-88,
title V, 509(b), Oct. 17, 1979, 93 Stat. 695, provided that: ''The
Secretary of Health and Human Services shall amend any regulation
promulgated under the Federal Food, Drug, and Cosmetic Act (this
chapter) which is inconsistent with section 411 of such Act (section 350
of this title) (as added by subsection (a)) and such amendments shall be
promulgated in accordance with section 553 of title 5, United States
Code.''
21 USC 350a. Infant formulas
TITLE 21 -- FOOD AND DRUGS
(a) Adulteration
An infant formula, including an infant formula powder, shall be
deemed to be adulterated if --
(1) such infant formula does not provide nutrients as required by
subsection (i) of this section,
(2) such infant formula does not meet the quality factor requirements
prescribed by the Secretary under subsection (b)(1) of this section, or
(3) the processing of such infant formula is not in compliance with
the good manufacturing practices and the quality control procedures
prescribed by the Secretary under subsection (b)(2) of this section.
(b) Requirements for quality factors, good manufacturing practices,
and retention of records
(1) The Secretary shall by regulation establish requirements for
quality factors for infant formulas to the extent possible consistent
with current scientific knowledge, including quality factor requirements
for the nutrients required by subsection (i) of this section.
(2)(A) The Secretary shall by regulation establish good manufacturing
practices for infant formulas, including quality control procedures that
the Secretary determines are necessary to assure that an infant formula
provides nutrients in accordance with this subsection and subsection (i)
of this section and is manufactured in a manner designed to prevent
adulteration of the infant formula.
(B) The good manufacturing practices and quality control procedures
prescribed by the Secretary under subparagraph (A) shall include
requirements for --
(i) the testing, in accordance with paragraph (3) and by the
manufacturer of an infant formula or an agent of such manufacturer, of
each batch of infant formula for each nutrient required by subsection
(i) of this section before the distribution of such batch,
(ii) regularly scheduled testing, by the manufacturer of an infant
formula or an agent of such manufacturer, of samples of infant formulas
during the shelf life of such formulas to ensure that such formulas are
in compliance with this section,
(iii) in-process controls including, where necessary, testing
required by good manufacturing practices designed to prevent
adulteration of each batch of infant formula, and
(iv) the conduct by the manufacturer of an infant formula or an agent
of such manufacturer of regularly scheduled audits to determine that
such manufacturer has complied with the regulations prescribed under
subparagraph (A).
In prescribing requirements for audits under clause (iv), the
Secretary shall provide that such audits be conducted by appropriately
trained individuals who do not have any direct responsibility for the
manufacture or production of infant formula.
(3)(A) At the final product stage, each batch of infant formula shall
be tested for vitamin A, vitamin B1, vitamin C, and vitamin E to ensure
that such infant formula is in compliance with the requirements of this
subsection and subsection (i) of this section relating to such vitamins.
(B) Each nutrient premix used in the manufacture of an infant formula
shall be tested for each relied upon nutrient required by subsection (i)
of this section which is contained in such premix to ensure that such
premix is in compliance with its specifications or certifications by a
premix supplier.
(C) During the manufacturing process or at the final product stage
and before distribution of an infant formula, an infant formula shall be
tested for all nutrients required to be included in such formula by
subsection (i) of this section for which testing has not been conducted
pursuant to subparagraph (A) or (B). Testing under this subparagraph
shall be conducted to --
(i) ensure that each batch of such infant formula is in compliance
with the requirements of subsection (i) of this section relating to such
nutrients, and
(ii) confirm that nutrients contained in any nutrient premix used in
such infant formula are present in each batch of such infant formula in
the proper concentration.
(D) If the Secretary adds a nutrient to the list of nutrients in the
table in subsection (i) of this section, the Secretary shall by
regulation require that the manufacturer of an infant formula test each
batch of such formula for such new nutrient in accordance with
subparagraph (A), (B), or (C).
(E) For purposes of this paragraph, the term ''final product stage''
means the point in the manufacturing process, before distribution of an
infant formula, at which an infant formula is homogenous and is not
subject to further degradation.
(4)(A) The Secretary shall by regulation establish requirements
respecting the retention of records. Such requirements shall provide
for --
(i) the retention of all records necessary to demonstrate compliance
with the good manufacturing practices and quality control procedures
prescribed by the Secretary under paragraph (2), including records
containing the results of all testing required under paragraph (2)(B),
(ii) the retention of all certifications or guarantees of analysis by
premix suppliers,
(iii) the retention by a premix supplier of all records necessary to
confirm the accuracy of all premix certifications and guarantees of
analysis,
(iv) the retention of --
(I) all records pertaining to the microbiological quality and purity
of raw materials used in infant formula powder and in finished infant
formula, and
(II) all records pertaining to food packaging materials which show
that such materials do not cause an infant formula to be adulterated
within the meaning of section 342(a)(2)(C) of this title,
(v) the retention of all records of the results of regularly
scheduled audits conducted pursuant to the requirements prescribed by
the Secretary under paragraph (2)(B)(iv), and
(vi) the retention of all complaints and the maintenance of files
with respect to, and the review of, complaints concerning infant
formulas which may reveal the possible existence of a hazard to health.
(B)(i) Records required under subparagraph (A) with respect to an
infant formula shall be retained for at least one year after the
expiration of the shelf life of such infant formula. Except as provided
in clause (ii), such records shall be made available to the Secretary
for review and duplication upon request of the Secretary.
(ii) A manufacturer need only provide written assurances to the
Secretary that the regularly scheduled audits required by paragraph
(2)(B)(iv) are being conducted by the manufacturer, and need not make
available to the Secretary the actual written reports of such audits.
(c) Registration of persons distributing new infant formula
(1) No person shall introduce or deliver for introduction into
interstate commerce any new infant formula unless --
(A) such person has, before introducing such new infant formula, or
delivering such new infant formula for introduction, into interstate
commerce, registered with the Secretary the name of such person, the
place of business of such person, and all establishments at which such
person intends to manufacture such new infant formula, and
(B) such person has at least 90 days before marketing such new infant
formula, made the submission to the Secretary required by subsection
(c)(1) of this section.
(2) For purposes of paragraph (1), the term ''new infant formula''
includes --
(A) an infant formula manufactured by a person which has not
previously manufactured an infant formula, and
(B) an infant formula manufactured by a person which has previously
manufactured infant formula and in which there is a major change, in
processing or formulation, from a current or any previous formulation
produced by such manufacturer.
For purposes of this paragraph, the term ''major change'' has the
meaning given to such term in section 106.30(c)(2) of title 21, Code of
Federal Regulations (as in effect on August 1, 1986), and guidelines
issued thereunder.
(d) Submission of information about new infant formula required
(1) A person shall, with respect to any infant formula subject to
subsection (c) of this section, make a submission to the Secretary which
shall include --
(A) the quantitative formulation of the infant formula,
(B) a description of any reformulation of the formula or change in
processing of the infant formula,
(C) assurances that the infant formula will not be marketed unless it
meets the requirements of subsections (b)(1) and (i) of this section, as
demonstrated by the testing required under subsection (b)( 3) of this
section, and
(D) assurances that the processing of the infant formula complies
with subsection (b)(2) of this section.
(2) After the first production of an infant formula subject to
subsection (c) of this section, and before the introduction into
interstate commerce of such formula, the manufacturer of such formula
shall submit to the Secretary, in such form as may be prescribed by the
Secretary, a written verification which summarizes test results and
records demonstrating that such formula complies with the requirements
of subsections (b)(1), (b)(2)(A), (b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(
A), (b)(3)(C), and (i) of this section.
(3) If the manufacturer of an infant formula for commercial or
charitable distribution for human consumption determines that a change
in the formulation of the formula or a change in the processing of the
formula may affect whether the formula is adulterated under subsection
(a) of this section, the manufacturer shall, before the first processing
of such formula, make the submission to the Secretary required by
paragraph (1).
(e) Additional notice requirements for manufacturer
(1) If the manufacturer of an infant formula has knowledge which
reasonably supports the conclusion that an infant formula which has been
processed by the manufacturer and which has left an establishment
subject to the control of the manufacturer --
(A) may not provide the nutrients required by subsection (i) of this
section, or
(B) may be otherwise adulterated or misbranded,
the manufacturer shall promptly notify the Secretary of such
knowledge. If the Secretary determines that the infant formula presents
a risk to human health, the manufacturer shall immediately take all
actions necessary to recall shipments of such infant formula from all
wholesale and retail establishments, consistent with recall regulations
and guidelines issued by the Secretary.
(2) For purposes of paragraph (1), the term ''knowledge'' as applied
to a manufacturer means (A) the actual knowledge that the manufacturer
had, or (B) the knowledge which a reasonable person would have had under
like circumstances or which would have been obtained upon the exercise
of due care.
(f) Procedures applicable to recalls by manufacturer; regulatory
oversight
(1) If a recall of infant formula is begun by a manufacturer, the
recall shall be carried out in accordance with such requirements as the
Secretary shall prescribe under paragraph (2) and --
(A) the Secretary shall, not later than the 15th day after the
beginning of such recall and at least once every 15 days thereafter
until the recall is terminated, review the actions taken under the
recall to determine whether the recall meets the requirements prescribed
under paragraph (2), and
(B) the manufacturer shall, not later than the 14th day after the
beginning of such recall and at least once every 14 days thereafter
until the recall is terminated, report to the Secretary the actions
taken to implement the recall.
(2) The Secretary shall by regulation prescribe the scope and extent
of recalls of infant formulas necessary and appropriate for the degree
of risks to human health presented by the formula subject to the recall.
(3) The Secretary shall by regulation require each manufacturer of an
infant formula who begins a recall of such formula because of a risk to
human health to request each retail establishment at which such formula
is sold or available for sale to post at the point of purchase of such
formula a notice of such recall at such establishment for such time that
the Secretary determines necessary to inform the public of such recall.
(g) Recordkeeping requirements for manufacturer; regulatory
oversight and enforcement
(1) Each manufacturer of an infant formula shall make and retain such
records respecting the distribution of the infant formula through any
establishment owned or operated by such manufacturer as may be necessary
to effect and monitor recalls of the formula. Such records shall be
retained for at least one year after the expiration of the shelf life of
the infant formula.
(2) To the extent that the Secretary determines that records are not
being made or maintained in accordance with paragraph (1), the Secretary
may by regulation prescribe the records required to be made under
paragraph (1) and requirements respecting the retention of such records
under such paragraph. Such regulations shall take effect on such date
as the Secretary prescribes but not sooner than the 180th day after the
date such regulations are promulgated. Such regulations shall apply
only with respect to distributions of infant formulas made after such
effective date.
(h) Exemptions; regulatory oversight
(1) Any infant formula which is represented and labeled for use by an
infant --
(A) who has an inborn error of metabolism or a low birth weight, or
(B) who otherwise has an unusual medical or dietary problem,
is exempt from the requirements of subsections (a), (b), and (c) of
this section. The manufacturer of an infant formula exempt under this
paragraph shall, in the case of the exempt formula, be required to
provide the notice required by subsection (e)(1) of this section only
with respect to adulteration or misbranding described in subsection
(d)(1)(B) /1/ of this section, and to comply with the regulations
prescribed by the Secretary under paragraph (2).
(2) The Secretary may by regulation establish terms and conditions
for the exemption of an infant formula from the requirements of
subsections (a), (b), and (c) of this section. An exemption of an
infant formula under paragraph (1) may be withdrawn by the Secretary if
such formula is not in compliance with applicable terms and conditions
prescribed under this paragraph.
(i) Nutrient requirements
(1) An infant formula shall contain nutrients in accordance with the
table set out in this subsection or, if revised by the Secretary under
paragraph (2), as so revised.
(2) The Secretary may by regulation --
(A) revise the list of nutrients in the table in this subsection, and
(B) revise the required level for any nutrient required by the table.
(June 25, 1938, ch. 675, 412, as added Sept. 26, 1980, Pub. L.
96-359, 2, 94 Stat. 1190, and amended Oct. 27, 1986, Pub. L. 99-570,
title IV, 4014(a), (b)(1), 100 Stat. 3207-116, 3207-120.)
1986 -- Subsecs. (a) to (d). Pub. L. 99-570, 4014(a)(7), added
subsecs. (a) to (d) and struck out former subsecs. (a) relating to
adulteration and regulatory oversight, (b) relating to notice to the
Secretary by a manufacturer and requirements and scope of that notice,
(c) relating to additional notice requirements for the manufacturer, and
(d) relating to procedures applicable to recalls by a manufacturer.
Subsecs. (e), (f). Pub. L. 99-570, 4014(a)(1), (7), added subsecs.
(e) and (f) and redesignated former subsecs. (e) and (f) as (g) and
(h), respectively.
Subsec. (g). Pub. L. 99-570, 4014(a)(1), (2), redesignated former
subsec. (e) as (g) and substituted ''Such records shall be retained for
at least one year after the expiration of the shelf life of the infant
formula'' for ''No manufacturer shall be required under this subsection
to retain any record respecting the distribution of an infant formula
for a period of longer than 2 years from the date the record was made''.
Former subsec. (g) redesignated (i).
Subsec. (h). Pub. L. 99-570, 4014(a)(1), redesignated former subsec.
(f) as (h).
Subsec. (h)(1). Pub. L. 99-570, 4014(a)(3), (4), substituted ''(a),
(b), and (c)'' for ''(a) and (b)'' and ''(e)(1)'' for ''(c)(1)''.
Pub. L. 99-570, 4014(a)(5), which directed that ''(d)(1)(B)'' be
substituted for ''(e)(1)(B)'' in second sentence of subsec. (h)(1), was
executed by substituting ''subsection (d)(1)(B)'' for ''subsection
(c)(1)(B)'' as the probable intent of Congress.
Subsec. (h)(2). Pub. L. 99-570, 4014(a)(6), substituted ''(a), (b),
and (c)'' for ''(a) and (b)''.
Subsec. (i). Pub. L. 99-570, 4014(a)(1), (b)(1), redesignated former
subsec. (g) as (i), designated existing provisions as par. (1),
substituted ''paragraph (2)'' for ''subsection (a)(2) of this section'',
substituted a period for the colon after ''as so revised'', and added
par. (2).
Section 6 of Pub. L. 96-359 provided that: ''Section 412 of the
Federal Food, Drug, and Cosmetic Act (added by section 2) (this section)
shall apply with respect to infant formulas manufactured on or after the
90th day after the date of the enactment of this Act (Sept. 26,
1980).''
/1/ So in original. Probably should be subsection ''(e)(1)(B)''.
21 USC SUBCHAPTER V -- DRUGS AND DEVICES
TITLE 21 -- FOOD AND DRUGS
21 USC Part A -- Drugs and Devices
TITLE 21 -- FOOD AND DRUGS
21 USC 351. Adulterated drugs and devices
TITLE 21 -- FOOD AND DRUGS
A drug or device shall be deemed to be adulterated --
(a) Poisonous, insanitary, etc., ingredients; adequate controls in
manufacture
(1) If it consists in whole or in part of any filthy, putrid, or
decomposed substance; or (2)(A) if it has been prepared, packed, or
held under insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered injurious to health;
or (B) if it is a drug and the methods used in, or the facilities or
controls used for, its manufacture, processing, packing, or holding do
not conform to or are not operated or administered in conformity with
current good manufacturing practice to assure that such drug meets the
requirements of this chapter as to safety and has the identity and
strength, and meets the quality and purity characteristics, which it
purports or is represented to possess; or (3) if its container is
composed, in whole or in part, of any poisonous or deleterious substance
which may render the contents injurious to health; or (4) if (A) it
bears or contains, for purposes of coloring only, a color additive which
is unsafe within the meaning of section 376(a) of this title, or (B) it
is a color additive the intended use of which in or on drugs or devices
is for purposes of coloring only and is unsafe within the meaning of
section 376(a) of this title; or (5) if it is a new animal drug which
is unsafe within the meaning of section 360b of this title; or (6) if
it is an animal feed bearing or containing a new animal drug, and such
animal feed is unsafe within the meaning of section 360b of this title.
(b) Strength, quality, or purity differing from official compendium
If it purports to be or is represented as a drug the name of which is
recognized in an official compendium, and its strength differs from, or
its quality or purity falls below, the standard set forth in such
compendium. Such determination as to strength, quality, or purity shall
be made in accordance with the tests or methods of assay set forth in
such compendium, except that whenever tests or methods of assay have not
been prescribed in such compendium, or such tests or methods of assay as
are prescribed are, in the judgment of the Secretary, insufficient for
the making of such determination, the Secretary shall bring such fact to
the attention of the appropriate body charged with the revision of such
compendium, and if such body fails within a reasonable time to prescribe
tests or methods of assay which, in the judgment of the Secretary, are
sufficient for purposes of this subsection, then the Secretary shall
promulgate regulations prescribing appropriate tests or methods of assay
in accordance with which such determination as to strength, quality, or
purity shall be made. No drug defined in an official compendium shall
be deemed to be adulterated under this subsection because it differs
from the standard of strength, quality, or purity therefor set forth in
such compendium, if its difference in strength, quality, or purity from
such standard is plainly stated on its label. Whenever a drug is
recognized in both the United States Pharmacopoeia and the Homoeopathic
Pharmacopoeia of the United States it shall be subject to the
requirements of the United States Pharmacopoeia unless it is labeled and
offered for sale as a homoeopathic drug, in which case it shall be
subject to the provisions of the Homoeopathic Pharmacopoeia of the
United States and not to those of the United States Pharmacopoeia.
(c) Misrepresentation of strength, etc., where drug is unrecognized
in compendium
If it is not subject to the provisions of subsection (b) of this
section and its strength differs from, or its purity or quality falls
below, that which it purports or is represented to possess.
(d) Mixture with or substitution of another substance
If it is a drug and any substance has been (1) mixed or packed
therewith so as to reduce its quality or strength or (2) substituted
wholly or in part therefor.
(e) Devices not in conformity with performance standards
If it is, or purports to be or is represented as, a device which is
subject to a performance standard established under section 360d of this
title unless such device is in all respects in conformity with such
standard.
(f) Certain class III devices
(1) If it is a class III device --
(A)(i) which is required by a regulation promulgated under subsection
(b) of section 360e of this title to have an approval under such section
of an application for premarket approval and which is not exempt from
section 360e of this title under section 360j(g) of this title, and
(ii)(I) for which an application for premarket approval or a notice
of completion of a product development protocol was not filed with the
Secretary within the ninety-day period beginning on the date of the
promulgation of such regulation, or
(II) for which such an application was filed and approval of the
application has been denied, suspended, or withdrawn, or such a notice
was filed and has been declared not completed or the approval of the
device under the protocol has been withdrawn;
(B)(i) which was classified under section 360c(f) of this title into
class III, which under section 360e(a) of this title is required to have
in effect an approved application for premarket approval, and which is
not exempt from section 360e of this title under section 360j( g) of
this title, and
(ii) which has an application which has been suspended or is
otherwise not in effect; or
(C) which was classified under section 360j(l) of this title into
class III, which under such section is required to have in effect an
approved application under section 360e of this title, and which has an
application which has been suspended or is otherwise not in effect.
(2)(A) In the case of a device classified under section 360c(f) of
this title into class III and intended solely for investigational use,
paragraph (1)(B) shall not apply with respect to such device during the
period ending on the ninetieth day after the date of the promulgation of
the regulations prescribing the procedures and conditions required by
section 360j(g)(2) of this title.
(B) In the case of a device subject to a regulation promulgated under
subsection (b) of section 360e of this title, paragraph (1) shall not
apply with respect to such device during the period ending --
(i) on the last day of the thirtieth calendar month beginning after
the month in which the classification of the device in class III became
effective under section 360c of this title, or
(ii) on the ninetieth day after the date of the promulgation of such
regulation,
whichever occurs later.
(g) Banned devices
If it is a banned device.
(h) Manufacture, packing, storage, or installation of device not in
conformity with applicable requirements or conditions
If it is a device and the methods used in, or the facilities or
controls used for, its manufacture, packing, storage, or installation
are not in conformity with applicable requirements under section 360j(
f)(1) of this title or an applicable condition prescribed by an order
under section 360j(f)(2) of this title.
(i) Failure to comply with requirements under which device was
exempted for investigational use
If it is a device for which an exemption has been granted under
section 360j(g) of this title for investigational use and the person who
was granted such exemption or any investigator who uses such device
under such exemption fails to comply with a requirement prescribed by or
under such section.
(June 25, 1938, ch. 675, 501, 52 Stat. 1049; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; July 12,
1960, Pub. L. 86-618, title I, 102(b)(1), 74 Stat. 398; Oct. 10, 1962,
Pub. L. 87-781, title I, 101, 76 Stat. 780; July 13, 1968, Pub. L.
90-399, 101(a), 82 Stat. 343; May 28, 1976, Pub. L. 94-295, 3( d),
9(b)(1), 90 Stat. 576, 583; Nov. 28, 1990, Pub. L. 101-629, 9(b), 104
Stat. 4521.)
1990 -- Subsec. (f)(1). Pub. L. 101-629, 9(b), which directed the
amendment of subpars. (A) to (C) of subsec. (f), was executed by
making the amendments in subpars. (A) to (C) of par. (1) of subsec.
(f) as follows to reflect the probable intent of Congress: in subpar.
(A)(ii)(II), substituted '', suspended, or withdrawn'' for ''or
withdrawn''; in subpar. (B)(ii), substituted ''which has an
application which has been suspended or is otherwise not in effect'' for
''which does not have such an application in effect''; and in subpar.
(C), substituted ''which has an application which has been suspended or
is otherwise not in effect'' for ''which does not have such an
application in effect''.
1976 -- Subsec. (a). Pub. L. 94-295, 9(b)(1), substituted ''(3) if
its'' for ''(3) if it is a drug and its'' in cl. (3), substituted ''(4)
if (A) it bears or contains'' for ''(4) if (A) it is a drug which bears
or contains'' in cl. (4)(A), and substituted ''drugs or devices'' for
''drugs'' in cl. (4)(B).
Subsecs. (e) to (i). Pub. L. 94-295, 3(d), added subsecs. (e) to
(i).
1968 -- Subsec. (a). Pub. L. 90-399 added cls. (5) and (6).
1962 -- Subsec. (a). Pub. L. 87-781 designated existing provisions
of cl. (2) as (A) and added (B).
1960 -- Subsec. (a). Pub. L. 86-618 substituted provisions in cl.
(4) relating to unsafe color additives for provisions which related to a
coal-tar color other than one from a batch that has been certified in
accordance with regulations as provided by section 354 of this title.
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions note
under section 360b of this title.
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L.
87-781, set out as a note under section 321 of this title.
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Subsec. (a)(4) effective Jan. 1, 1940, see act June 23, 1939, ch.
242, 53 Stat. 853, set out as an Effective Date; Postponement in
Certain Cases note under section 301 of this title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 352. Misbranded drugs and devices
TITLE 21 -- FOOD AND DRUGS
A drug or device shall be deemed to be misbranded --
(a) False or misleading label
If its labeling is false or misleading in any particular.
(b) Package form; contents of label
If in package form unless it bears a label containing (1) the name
and place of business of the manufacturer, packer, or distributor; and
(2) an accurate statement of the quantity of the contents in terms of
weight, measure, or numerical count: Provided, That under clause (2) of
this subsection reasonable variations shall be permitted, and exemptions
as to small packages shall be established, by regulations prescribed by
the Secretary.
(c) Prominence of information on label
If any word, statement, or other information required by or under
authority of this chapter to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with
other words, statements, designs, or devices, in the labeling) and in
such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.
(d) Habit forming substances
If it is for use by man and contains any quantity of the narcotic or
hypnotic substance alpha eucaine, barbituric acid, betaeucaine, bromal,
cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana,
morphine, opium, paraldehyde, peyote, or sulphonmethane; or any
chemical derivative of such substance, which derivative has been by the
Secretary, after investigation, found to be, and by regulations
designated as, habit forming; unless its label bears the name and
quantity or proportion of such substance or derivative and in
juxtaposition therewith the statement ''Warning -- May be habit
forming.''
(e) Designation of drugs or devices by established names
(1) If it is a drug, unless (A) its label bears, to the exclusion of
any other nonproprietary name (except the applicable systematic chemical
name or the chemical formula), (i) the established name (as defined in
subparagraph (3)) of the drug, if such there be, and (ii), in case it is
fabricated from two or more ingredients, the established name and
quantity of each active ingredient, including the quantity, kind, and
proportion of any alcohol, and also including, whether active or not,
the established name and quantity or proportion of any bromides, ether,
chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine,
atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis
glucosides, mercury ouabain strophanthin, strychnine, thyroid, or any
derivative or preparation of any such substances, contained therein;
Provided, That the requirement for stating the quantity of the active
ingredients, other than the quantity of those specifically named in this
paragraph, shall apply only to prescription drugs; and (B) for any
prescription drug the established name of such drug or ingredient, as
the case may be, on such label (and on any labeling on which a name for
such drug or ingredient is used) is printed prominently and in type at
least half as large as that used thereon for any proprietary name or
designation for such drug or ingredient: Provided, That to the extent
that compliance with the requirements of clause (A)(ii) or clause (B) of
this subparagraph is impracticable, exemptions shall be established by
regulations promulgated by the Secretary.
(2) If it is a device and it has an established name, unless its
label bears, to the exclusion of any other nonproprietary name, its
established name (as defined in subparagraph (4)) prominently printed in
type at least half as large as that used thereon for any proprietary
name or designation for such device, except that to the extent
compliance with the requirements of this subparagraph is impracticable,
exemptions shall be established by regulations promulgated by the
Secretary.
(3) As used in subparagraph (1), the term ''established name'', with
respect to a drug or ingredient thereof, means (A) the applicable
official name designated pursuant to section 358 of this title, or (B),
if there is no such name and such drug, or such ingredient, is an
article recognized in an official compendium, then the official title
thereof in such compendium, or (C) if neither clause (A) nor clause (B)
of this subparagraph applies, then the common or usual name, if any, of
such drug or of such ingredient: Provided further, That where clause
(B) of this subparagraph applies to an article recognized in the United
States Pharmacopeia and in the Homoeopathic Pharmacopoeia under
different official titles, the official title used in the United States
Pharmacopeia shall apply unless it is labeled and offered for sale as a
homoeopathic drug, in which case the official title used in the
Homoeopathic Pharmacopoeia shall apply.
(4) As used in subparagraph (2), the term ''established name'' with
respect to a device means (A) the applicable official name of the device
designated pursuant to section 358 of this title, (B) if there is no
such name and such device is an article recognized in an official
compendium, then the official title thereof in such compendium, or (C)
if neither clause (A) nor clause (B) of this subparagraph applies, then
any common or usual name of such device.
(f) Directions for use and warnings on label
Unless its labeling bears (1) adequate directions for use; and (2)
such adequate warnings against use in those pathological conditions or
by children where its use may be dangerous to health, or against unsafe
dosage or methods or duration of administration or application, in such
manner and form, as are necessary for the protection of users:
Provided, That where any requirement of clause (1) of this subsection,
as applied to any drug or device, is not necessary for the protection of
the public health, the Secretary shall promulgate regulations exempting
such drug or device from such requirement.
(g) Representations as recognized drug; packing and labeling;
inconsistent requirements for designation of drug
If it purports to be a drug the name of which is recognized in an
official compendium, unless it is packaged and labeled as prescribed
therein: Provided, That the method of packing may be modified with the
consent of the Secretary. Whenever a drug is recognized in both the
United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the
United States, it shall be subject to the requirements of the United
States Pharmacopoeia with respect to packaging and labeling unless it is
labeled and offered for sale as a homoeopathic drug, in which case it
shall be subject to the provisions of the Homoeopathic Pharmacopoeia of
the United States, and not those of the United States Pharmacopoeia:
Provided further, That, in the event of inconsistency between the
requirements of this subsection and those of subsection (e) of this
section as to the name by which the drug or its ingredients shall be
designated, the requirements of subsection (e) of this section shall
prevail.
(h) Deteriorative drugs; packing and labeling
If it has been found by the Secretary to be a drug liable to
deterioration, unless it is packaged in such form and manner, and its
label bears a statement of such precautions, as the Secretary shall by
regulations require as necessary for the protection of the public
health. No such regulation shall be established for any drug recognized
in an official compendium until the Secretary shall have informed the
appropriate body charged with the revision of such compendium of the
need for such packaging or labeling requirements and such body shall
have failed within a reasonable time to prescribe such requirements.
(i) Drug; misleading container; imitation; offer for sale under
another name
(1) If it is a drug and its container is so made, formed, or filled
as to be misleading; or (2) if it is an imitation of another drug; or
(3) if it is offered for sale under the name of another drug.
(j) Health-endangering when used as prescribed
If it is dangerous to health when used in the dosage or manner, or
with the frequency or duration prescribed, recommended, or suggested in
the labeling thereof.
(k) Insulin not properly certified
If it is, or purports to be, or is represented as a drug composed
wholly or partly of insulin, unless (1) it is from a batch with respect
to which a certificate or release has been issued pursuant to section
356 of this title, and (2) such certificate or release is in effect with
respect to such drug.
(l) Antibiotic drugs improperly certified
If it is, or purports to be, or is represented as a drug (except a
drug for use in animals other than man) composed wholly or partly of any
kind of penicillin, streptomycin, chlortetracycline, chloramphenicol,
bacitracin, or any other antibiotic drug, or any derivative thereof,
unless (1) it is from a batch with respect to which a certificate or
release has been issued pursuant to section 357 of this title, and (2)
such certificate or release is in effect with respect to such drug:
Provided, That this subsection shall not apply to any drug or class of
drugs exempted by regulations promulgated under section 357(c) or (d) of
this title.
(m) Color additives; packing and labeling
If it is a color additive the intended use of which is for the
purpose of coloring only, unless its packaging and labeling are in
conformity with such packaging and labeling requirements applicable to
such color additive, as may be contained in regulations issued under
section 376 of this title.
(n) Prescription drug advertisements: established name;
quantitative formula; side effects, contraindications, and
effectiveness; prior approval; false advertising; labeling;
construction of the Convention on Psychotropic Substances
In the case of any prescription drug distributed or offered for sale
in any State, unless the manufacturer, packer, or distributor thereof
includes in all advertisements and other descriptive printed matter
issued or caused to be issued by the manufacturer, packer, or
distributor with respect to that drug a true statement of (1) the
established name as defined in subsection (e) of this section, printed
prominently and in type at least half as large as that used for any
trade or brand name thereof, (2) the formula showing quantitatively each
ingredient of such drug to the extent required for labels under
subsection (e) of this section, and (3) such other information in brief
summary relating to side effects, contraindications, and effectiveness
as shall be required in regulations which shall be issued by the
Secretary in accordance with the procedure specified in section 371(e)
of this title: Provided, That (A) except in extraordinary
circumstances, no regulation issued under this subsection shall require
prior approval by the Secretary of the content of any advertisement, and
(B) no advertisement of a prescription drug, published after the
effective date of regulations issued under this subsection applicable to
advertisements of prescription drugs, shall with respect to the matters
specified in this subsection or covered by such regulations, be subject
to the provisions of sections 52 to 57 of title 15. This subsection (n)
shall not be applicable to any printed matter which the Secretary
determines to be labeling as defined in section 321(m) of this title.
Nothing in the Convention on Psychotropic Substances, signed at Vienna,
Austria, on February 21, 1971, shall be construed to prevent drug price
communications to consumers.
(o) Drugs or devices from nonregistered establishments
If it was manufactured, prepared, propagated, compounded, or
processed in an establishment in any State not duly registered under
section 360 of this title, if it was not included in a list required by
section 360(j) of this title, if a notice or other information
respecting it was not provided as required by such section or section
360(k) of this title, or if it does not bear such symbols from the
uniform system for identification of devices prescribed under section
360(e) of this title as the Secretary by regulation requires.
(p) Packaging or labeling of drugs in violation of regulations
If it is a drug and its packaging or labeling is in violation of an
applicable regulation issued pursuant to section 1472 or 1473 of title
15.
(q) Restricted devices using false or misleading advertising or used
in violation of regulations
In the case of any restricted device distributed or offered for sale
in any State, if (1) its advertising is false or misleading in any
particular, or (2) it is sold, distributed, or used in violation of
regulations prescribed under section 360j(e) of this title.
(r) Restricted devices not carrying requisite accompanying statements
in advertisements and other descriptive printed matter
In the case of any restricted device distributed or offered for sale
in any State, unless the manufacturer, packer, or distributor thereof
includes in all advertisements and other descriptive printed matter
issued or caused to be issued by the manufacturer, packer, or
distributor with respect to that device (1) a true statement of the
device's established name as defined in subsection (e) of this section,
printed prominently and in type at least half as large as that used for
any trade or brand name thereof, and (2) a brief statement of the
intended uses of the device and relevant warnings, precautions, side
effects, and contraindications and, in the case of specific devices made
subject to a finding by the Secretary after notice and opportunity for
comment that such action is necessary to protect the public health, a
full description of the components of such device or the formula showing
quantitatively each ingredient of such device to the extent required in
regulations which shall be issued by the Secretary after an opportunity
for a hearing. Except in extraordinary circumstances, no regulation
issued under this paragraph shall require prior approval by the
Secretary of the content of any advertisement and no advertisement of a
restricted device, published after the effective date of this paragraph
shall, with respect to the matters specified in this paragraph or
covered by regulations issued hereunder, be subject to the provisions of
sections 52 through 55 of title 15. This paragraph shall not be
applicable to any printed matter which the Secretary determines to be
labeling as defined in section 321(m) of this title.
(s) Devices subject to performance standards not bearing requisite
labeling
If it is a device subject to a performance standard established under
section 360d of this title, unless it bears such labeling as may be
prescribed in such performance standard.
(t) Devices for which there has been a failure or refusal to give
required notification or to furnish required material or information
If it is a device and there was a failure or refusal (1) to comply
with any requirement prescribed under section 360h of this title
respecting the device, or (2) to furnish any material or information
required by or under section 360i of this title respecting the device.
(June 25, 1938, ch. 675, 502, 52 Stat. 1050; June 23, 1939, ch.
242, 3, 53 Stat. 854; 1940 Reorg. Plan No. IV, 12, 13, eff. June 30,
1940, 5 F.R. 2422, 54 Stat. 1237; Dec. 22, 1941, ch. 613, 2, 55 Stat.
851; July 6, 1945, ch. 281, 2, 59 Stat. 463; Mar. 10, 1947, ch. 16, 2,
61 Stat. 11; July 13, 1949, ch. 305, 1, 63 Stat. 409; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Aug. 5,
1953, ch. 334, 1, 67 Stat. 389; July 12, 1960, Pub. L. 86-618, title I,
102(b)(2), 74 Stat. 398; Oct. 10, 1962, Pub. L. 87-781, title I,
105(c), 112(a), (b), 131(a), title III, 305, 76 Stat. 785, 790, 791,
795; July 13, 1968, Pub. L. 90-399, 105(a), 82 Stat. 352; Dec. 30,
1970, Pub. L. 91-601, 6(d), formerly 7(d), 84 Stat. 1673, renumbered
Aug. 13, 1981, Pub. L. 97-35, title XII, 1205( c), 95 Stat. 716; May
28, 1976, Pub. L. 94-295, 3(e), 4(b)(2), 5(a), 9(b)(2), 90 Stat. 577,
580, 583; Nov. 10, 1978, Pub. L. 95-633, title I, 111, 92 Stat. 3773.)
1978 -- Subsec. (n). Pub. L. 95-633 inserted provision relating to
the construction of the Convention on Psychotropic Substances.
1976 -- Subsec. (e). Pub. L. 94-295, 5(a), substituted
''subparagraph (3)'' for ''subparagraph (2)'' in par. (1), added par.
(2), redesignated former par. (2) as (3) and in par. (3) as so
redesignated substituted ''subparagraph (1)'' for ''this paragraph
(e)'', and added par. (4).
Subsec. (j). Pub. L. 94-295, 3(e)(2), substituted ''dosage or
manner,'' for ''dosage,''.
Subsec. (m). Pub. L. 94-295, 9(b)(2), substituted ''the intended use
of which is for'' for ''the intended use of which in or on drugs is
for''.
Subsec. (o). Pub. L. 94-295, 4(b)(2), substituted ''If it was
manufactured'' for ''If it is a drug and was manufactured'' and inserted
'', if it was not included in a list required by section 360( j) of this
title, if a notice or other information respecting it was not provided
as required by such section or section 360(k) of this title, or if it
does not bear such symbols from the uniform system for identification of
devices prescribed under section 360(e) of this title as the Secretary
by regulation requires''.
Subsecs. (q) to (t). Pub. L. 94-295, 3(e)(1), added subsecs. (q) to
(t).
1970 -- Subsec. (p). Pub. L. 91-601 added subsec. (p).
1968 -- Subsec. (l). Pub. L. 90-399 inserted ''(except a drug for
use in animals other than man)'' after ''represented as a drug''.
1962 -- Subsec. (e). Pub. L. 87-781, 112(a), designated existing
provisions as par. (1), substituted '', unless (A) its label bears, to
the exclusion of any other nonproprietary name (except the applicable
systematic chemical name or the chemical formula), (i) the established
name (as defined in par. (2) of this subsection) of the drug, if such
there be, and (ii), in case it is fabricated from two or more
ingredients, the established name and quantity'' for ''and is not
designated solely by a name recognized in an official compendium unless
its label bears (1) the common or usual name of the drug, if such there
be; and (2), in case it is fabricated from two or more ingredients, the
common or usual name'', and ''the established name'' for ''the name'',
provided that the requirement for stating the quantity of active
ingredients, other than those specified in this subsection, applies only
to prescription drugs, and that the established name of a drug on a
label is to be printed prominently and in type at least half as large as
used for any proprietary designation, and added par. (2) defining
''established name''.
Subsec. (g). Pub. L. 87-781, 112(b), provided that if there is an
inconsistency between the provisions of this subsection and those of
subsec. (e) of this section, as to the name of a drug, the requirements
of subsec. (e) should prevail.
Subsec. (l). Pub. L. 87-781, 105(c), substituted ''bacitracin, or any
other antibiotic drug'' for ''or bacitracin.''
Subsec. (n). Pub. L. 87-781, 131(a), added subsec. (n).
Subsec. (o). Pub. L. 87-781, 305, added subsec. (o).
1960 -- Subsec. (m). Pub. L. 86-618 added subsec. (m).
1953 -- Subsec. (l). Act Aug. 5, 1953, substituted
''chlortetracycline'' for ''aureomycin''.
1949 -- Subsec. (l). Act July 13, 1949, inserted '', aureomycin,
chloramphenicol, or bacitracin'' after ''streptomycin''.
1947 -- Subsec. (l). Act Mar. 10, 1947, inserted ''or
streptomycin'' after ''penicillin''.
1945 -- Subsec. (l). Act July 6, 1945, added subsec. (l).
1941 -- Subsec. (k). Act Dec. 22, 1941, added subsec. (k).
1939 -- Subsec. (d). Act June 29, 1939, substituted ''name, and
quality or proportion'' for ''name, quantity, and percentage''.
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States (July 15,
1980), see section 112 of Pub. L. 95-633, set out as an Effective Date
note under section 801a of this title.
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no sooner
than 180 days or later than one year from date regulations are final, or
an earlier date published in Federal Register, see section 8 of Pub. L.
91-601, set out as an Effective Date note under section 1471 of Title
15, Commerce and Trade.
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions note
under section 360b of this title.
Section 112(c) of Pub. L. 87-781 provided that: ''This section
(amending this section) shall take effect on the first day of the
seventh calendar month following the month in which this Act is enacted
(October 1962).''
Section 131(b) of Pub. L. 87-781 provided that: ''No drug which was
being commercially distributed prior to the date of enactment of this
Act (Oct. 10, 1962) shall be deemed to be misbranded under paragraph (n)
of section 502 of the Federal Food, Drug, and Cosmetic Act (subsec. (n)
of this section), as added by this section, until the earlier of the
following dates: (1) the first day of the seventh month following the
month in which this Act is enacted; or (2) the effective date of
regulations first issued under clause (3) of such paragraph (n) in
accordance with the procedure specified in section 701(e) of the Federal
Food, Drug, and Cosmetic Act (section 371(e) of this title).''
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L.
87-781, set out as a note under section 321 of this title.
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Subsecs. (b) and (d) to (h) effective Jan. 1, 1940, and such
subsections effective July 1, 1940, as provided by regulations for
certain lithographed labeling and containers bearing certain labeling,
see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective
Date: Postponement in Certain Cases note under section 301 of this
title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Declaration of Policy
Section 9(a) of Pub. L. 89-74, July 15, 1965, 79 Stat. 234,
provided that: ''The Congress finds and declares that there is a
substantial traffic in counterfeit drugs simulating the brand or other
identifying mark or device of the manufacturer of the genuine article;
that such traffic poses a serious hazard to the health of innocent
consumers of such drugs because of the lack of proper qualifications,
facilities, and manufacturing controls on the part of the counterfeiter,
whose operations are clandestine; that, while such drugs are deemed
misbranded within the meaning of section 502(i) of the Federal Food,
Drug, and Cosmetic Act (subsec. (i) of this section), the controls for
the suppression of the traffic in such drugs are inadequate because of
the difficulty of determining the place of interstate origin of such
drugs and, if that place is discovered, the fact that the implements for
counterfeiting are not subject to seizure, and that these factors
require enactment of additional controls with respect to such drugs
without regard to their interstate or intrastate origins.''
Provisions as effective Feb. 1, 1966, see section 11 of Pub. L.
89-74, set out as an Effective Date of 1965 Amendment note under section
321 of this title.
section 1396r-8.
21 USC 353. Exemptions and consideration for certain drugs, devices,
and biological products
TITLE 21 -- FOOD AND DRUGS
(a) Regulations for goods to be processed, labeled, or repacked
elsewhere
The Secretary is directed to promulgate regulations exempting from
any labeling or packaging requirement of this chapter drugs and devices
which are, in accordance with the practice of the trade, to be
processed, labeled, or repacked in substantial quantities at
establishments other than those where originally processed or packed, on
condition that such drugs and devices are not adulterated or misbranded
under the provisions of this chapter upon removal from such processing,
labeling, or repacking establishment.
(b) Prescription by physician; exemption from labeling and
prescription requirements; misbranded drugs; compliance with narcotic
and marihuana laws
(1) A drug intended for use by man which --
(A) is a habit-forming drug to which section 352(d) of this title
applies; or
(B) because of its toxicity or other potentiality for harmful effect,
or the method of its use, or the collateral measures necessary to its
use, is not safe for use except under the supervision of a practitioner
licensed by law to administer such drug; or
(C) is limited by an approved application under section 355 of this
title to use under the professional supervision of a practitioner
licensed by law to administer such drug;
shall be dispensed only (i) upon a written prescription of a
practitioner licensed by law to administer such drug, or (ii) upon an
oral prescription of such practitioner which is reduced promptly to
writing and filed by the pharmacist, or (iii) by refilling any such
written or oral prescription if such refilling is authorized by the
prescriber either in the original prescription or by oral order which is
reduced promptly to writing and filed by the pharmacist. The act of
dispensing a drug contrary to the provisions of this paragraph shall be
deemed to be an act which results in the drug being misbranded while
held for sale.
(2) Any drug dispensed by filling or refilling a written or oral
prescription of a practitioner licensed by law to administer such drug
shall be exempt from the requirements of section 352 of this title,
except subsections (a), (i)(2) and (3), (k), and (l) of said section,
and the packaging requirements of subsections (g), (h), and (p) of said
section, if the drug bears a label containing the name and address of
the dispenser, the serial number and date of the prescription or of its
filling, the name of the prescriber, and, if stated in the prescription,
the name of the patient, and the directions for use and cautionary
statements, if any, contained in such prescription. This exemption
shall not apply to any drug dispensed in the course of the conduct of a
business of dispensing drugs pursuant to diagnosis by mail, or to a drug
dispensed in violation of paragraph (1) of this subsection.
(3) The Secretary may by regulation remove drugs subject to sections
352(d) and 355 of this title from the requirements of paragraph (1) of
this subsection when such requirements are not necessary for the
protection of the public health.
(4) A drug which is subject to paragraph (1) of this subsection shall
be deemed to be misbranded if at any time prior to dispensing its label
fails to bear the statement ''Caution: Federal law prohibits dispensing
without prescription''. A drug to which paragraph (1) of this
subsection does not apply shall be deemed to be misbranded if at any
time prior to dispensing its label bears the caution statement quoted in
the preceding sentence.
(5) Nothing in this subsection shall be construed to relieve any
person from any requirement prescribed by or under authority of law with
respect to drugs now included or which may hereafter be included within
the classifications stated in sections 4721, 6001, and 6151 of title 26,
or to marihuana as defined in section 4761 of title 26.
(c) Sales restrictions
(1) No person may sell, purchase, or trade or offer to sell,
purchase, or trade any drug sample. For purposes of this paragraph and
subsection (d) of this section, the term ''drug sample'' means a unit of
a drug, subject to subsection (b) of this section, which is not intended
to be sold and is intended to promote the sale of the drug. Nothing in
this paragraph shall subject an officer or executive of a drug
manufacturer or distributor to criminal liability solely because of a
sale, purchase, trade, or offer to sell, purchase, or trade in violation
of this paragraph by other employees of the manufacturer or distributor.
(2) No person may sell, purchase, or trade, offer to sell, purchase,
or trade, or counterfeit any coupon. For purposes of this paragraph,
the term ''coupon'' means a form which may be redeemed, at no cost or at
a reduced cost, for a drug which is prescribed in accordance with
subsection (b) of this section.
(3)(A) No person may sell, purchase, or trade, or offer to sell,
purchase, or trade, any drug --
(i) which is subject to subsection (b) of this section, and
(ii)(I) which was purchased by a public or private hospital or other
health care entity, or
(II) which was donated or supplied at a reduced price to a charitable
organization described in section 501(c)(3) of title 26.
(B) Subparagraph (A) does not apply to --
(i) the purchase or other acquisition by a hospital or other health
care entity which is a member of a group purchasing organization of a
drug for its own use from the group purchasing organization or from
other hospitals or health care entities which are members of such
organization,
(ii) the sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug by an organization described in subparagraph
(A)(ii)(II) to a nonprofit affiliate of the organization to the extent
otherwise permitted by law,
(iii) a sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug among hospitals or other health care entities
which are under common control,
(iv) a sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug for emergency medical reasons, or
(v) a sale, purchase, or trade of a drug, an offer to sell, purchase,
or trade a drug, or the dispensing of a drug pursuant to a prescription
executed in accordance with subsection (b) of this section.
For purposes of this paragraph, the term ''entity'' does not include
a wholesale distributor of drugs or a retail pharmacy licensed under
State law and the term ''emergency medical reasons'' includes transfers
of a drug between health care entities or from a health care entity to a
retail pharmacy undertaken to alleviate temporary shortages of the drug
arising from delays in or interruptions of regular distribution
schedules.
(d) Distribution of drug samples
(1) Except as provided in paragraphs (2) and (3), no representative
of a drug manufacturer or distributor may distribute any drug sample.
(2)(A) The manufacturer or distributor of a drug subject to
subsection (b) of this section may, in accordance with this paragraph,
distribute drug samples by mail or common carrier to practitioners
licensed to prescribe such drugs or, at the request of a licensed
practitioner, to pharmacies of hospitals or other health care entities.
Such a distribution of drug samples may only be made --
(i) in response to a written request for drug samples made on a form
which meets the requirements of subparagraph (B), and
(ii) under a system which requires the recipient of the drug sample
to execute a written receipt for the drug sample upon its delivery and
the return of the receipt to the manufacturer or distributor.
(B) A written request for a drug sample required by subparagraph
(A)(i) shall contain --
(i) the name, address, professional designation, and signature of the
practitioner making the request,
(ii) the identity of the drug sample requested and the quantity
requested,
(iii) the name of the manufacturer of the drug sample requested, and
(iv) the date of the request.
(C) Each drug manufacturer or distributor which makes distributions
by mail or common carrier under this paragraph shall maintain, for a
period of 3 years, the request forms submitted for such distributions
and the receipts submitted for such distributions and shall maintain a
record of distributions of drug samples which identifies the drugs
distributed and the recipients of the distributions. Forms, receipts,
and records required to be maintained under this subparagraph shall be
made available by the drug manufacturer or distributor to Federal and
State officials engaged in the regulation of drugs and in the
enforcement of laws applicable to drugs.
(3) The manufacturer or distributor of a drug subject to subsection
(b) of this section may, by means other than mail or common carrier,
distribute drug samples only if the manufacturer or distributor makes
the distributions in accordance with subparagraph (A) and carries out
the activities described in subparagraphs (B) through (F) as follows:
(A) Drug samples may only be distributed --
(i) to practitioners licensed to prescribe such drugs if they make a
written request for the drug samples, or
(ii) at the written request of such a licensed practitioner, to
pharmacies of hospitals or other health care entities.
A written request for drug samples shall be made on a form which
contains the practitioner's name, address, and professional designation,
the identity of the drug sample requested, the quantity of drug samples
requested, the name of the manufacturer or distributor of the drug
sample, the date of the request and signature of the practitioner making
the request.
(B) Drug manufacturers or distributors shall store drug samples under
conditions that will maintain their stability, integrity, and
effectiveness and will assure that the drug samples will be free of
contamination, deterioration, and adulteration.
(C) Drug manufacturers or distributors shall conduct, at least
annually, a complete and accurate inventory of all drug samples in the
possession of representatives of the manufacturer or distributor. Drug
manufacturers or distributors shall maintain lists of the names and
address of each of their representatives who distribute drug samples and
of the sites where drug samples are stored. Drug manufacturers or
distributors shall maintain records for at least 3 years of all drug
samples distributed, destroyed, or returned to the manufacturer or
distributor, of all inventories maintained under this subparagraph, of
all thefts or significant losses of drug samples, and of all requests
made under subparagraph (A) for drug samples. Records and lists
maintained under this subparagraph shall be made available by the drug
manufacturer or distributor to the Secretary upon request.
(D) Drug manufacturers or distributors shall notify the Secretary of
any significant loss of drug samples and any known theft of drug
samples.
(E) Drug manufacturers or distributors shall report to the Secretary
any conviction of their representatives for violations of subsection
(c)(1) of this section or a State law because of the sale, purchase, or
trade of a drug sample or the offer to sell, purchase, or trade a drug
sample.
(F) Drug manufacturers or distributors shall provide to the Secretary
the name and telephone number of the individual responsible for
responding to a request for information respecting drug samples.
(e) Wholesale distributors; guidelines for licensing; definitions
(1) Each person who is engaged in the wholesale distribution of drugs
subject to subsection (b) of this section and who is not an authorized
distributor of record of such drugs shall provide to each wholesale
distributor of such drugs a statement identifying each sale of the drug
(including the date of the sale) before the sale to such wholesale
distributor. Each manufacturer shall maintain at its corporate offices
a current list of such authorized distributors.
(2)(A) No person may engage in the wholesale distribution in
interstate commerce of drugs subject to subsection (b) of this section
in a State unless such person is licensed by the State in accordance
with the guidelines issued under subparagraph (B).
(B) The Secretary shall by regulation issue guidelines establishing
minimum standards, terms, and conditions for the licensing of persons to
make wholesale distributions in interstate commerce of drugs subject to
subsection (b) of this section. Such guidelines shall prescribe
requirements for the storage and handling of such drugs and for the
establishment and maintenance of records of the distributions of such
drugs.
(3) For the purposes of this subsection --
(A) the term ''authorized distributors of record'' means those
distributors with whom a manufacturer has established an ongoing
relationship to distribute such manufacturer's products, and
(B) the term ''wholesale distribution'' means distribution of drugs
subject to subsection (b) of this section to other than the consumer or
patient but does not include intracompany sales and does not include
distributions of drugs described in subsection (c)(3)(B) of this
section.
(f) Veterinary prescription drugs
(1)(A) A drug intended for use by animals other than man which --
(i) because of its toxicity or other potentiality for harmful effect,
or the method of its use, or the collateral measures necessary for its
use, is not safe for animal use except under the professional
supervision of a licensed veterinarian, or
(ii) is limited by an approved application under subsection (b) of
section 360b of this title to use under the professional supervision of
a licensed veterinarian,
shall be dispensed only by or upon the lawful written or oral order
of a licensed veterinarian in the course of the veterinarian's
professional practice.
(B) For purposes of subparagraph (A), an order is lawful if the order
--
(i) is a prescription or other order authorized by law,
(ii) is, if an oral order, promptly reduced to writing by the person
lawfully filling the order, and filed by that person, and
(iii) is refilled only if authorized in the original order or in a
subsequent oral order promptly reduced to writing by the person lawfully
filling the order, and filed by that person.
(C) The act of dispensing a drug contrary to the provisions of this
paragraph shall be deemed to be an act which results in the drug being
misbranded while held for sale.
(2) Any drug when dispensed in accordance with paragraph (1) of this
subsection --
(A) shall be exempt from the requirements of section 352 of this
title, except subsections (a), (g), (h), (i)(2), (i)(3), and (p) of such
section, and
(B) shall be exempt from the packaging requirements of subsections
(g), (h), and (p) of such section, if --
(i) when dispensed by a licensed veterinarian, the drug bears a label
containing the name and address of the practitioner and any directions
for use and cautionary statements specified by the practitioner, or
(ii) when dispensed by filling the lawful order of a licensed
veterinarian, the drug bears a label containing the name and address of
the dispenser, the serial number and date of the order or of its
filling, the name of the licensed veterinarian, and the directions for
use and cautionary statements, if any, contained in such order.
The preceding sentence shall not apply to any drug dispensed in the
course of the conduct of a business of dispensing drugs pursuant to
diagnosis by mail.
(3) The Secretary may by regulation exempt drugs for animals other
than man subject to section 360b of this title from the requirements of
paragraph (1) when such requirements are not necessary for the
protection of the public health.
(4) A drug which is subject to paragraph (1) shall be deemed to be
misbranded if at any time prior to dispensing its label fails to bear
the statement ''Caution: Federal law restricts this drug to use by or
on the order of a licensed veterinarian.''. A drug to which paragraph
(1) does not apply shall be deemed to be misbranded if at any time prior
to dispensing its label bears the statement specified in the preceding
sentence.
(g) Regulation of combination products
(1) The Secretary shall designate a component of the Food and Drug
Administration to regulate products that constitute a combination of a
drug, device, or biological product. The Secretary shall determine the
primary mode of action of the combination product. If the Secretary
determines that the primary mode of action is that of --
(A) a drug (other than a biological product), the persons charged
with premarket review of drugs shall have primary jurisdiction,
(B) a device, the persons charged with premarket review of devices
shall have primary jurisdiction, or
(C) a biological product, the persons charged with premarket review
of biological products shall have primary jurisdiction.
(2) Nothing in this subsection shall prevent the Secretary from using
any agency resources of the Food and Drug Administration necessary to
ensure adequate review of the safety, effectiveness, or substantial
equivalence of an article.
(3) The Secretary shall promulgate regulations to implement market
approval procedures in accordance with paragraphs (1) and (2) not later
than 1 year after November 28, 1990.
(4) As used in this subsection:
(A) The term ''biological product'' has the meaning given the term in
section 262(a) of title 42.
(B) The term ''market clearance'' includes --
(i) approval of an application under section 355, 357, 360e, or
360j(g) of this title,
(ii) a finding of substantial equivalence under this part, and
(iii) approval of a product or establishment license under subsection
(a) or (d) of section 262 of title 42.
(June 25, 1938, ch. 675, 503, 52 Stat. 1051; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; Oct. 26, 1951,
ch. 578, 1, 65 Stat. 648; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; Oct. 10, 1962, Pub. L. 87-781, title
I, 104(e)(2), 76 Stat. 785; Dec. 30, 1970, Pub. L. 91-601, 6( e),
formerly 7(e), 84 Stat. 1673, renumbered Aug. 13, 1981, Pub. L. 97-35,
title XII, 1205(c), 95 Stat. 716; Apr. 22, 1988, Pub. L. 100-293, 4-6,
102 Stat. 96-98; Nov. 16, 1988, Pub. L. 100-670, title I, 105, 102
Stat. 3983; Nov. 28, 1990, Pub. L. 101-629, 16(a), 104 Stat. 4526;
Aug. 17, 1991, Pub. L. 102-108, 2(d), 105 Stat. 550.)
In subsec. (b)(5), ''sections 4721, 6001, and 6151 of title 26'' and
''section 4761 of title 26'' substituted for ''section 3220 of the
Internal Revenue Code (26 U.S.C. 3220)'' and ''section 3238(b) of the
Internal Revenue Code (26 U.S.C. 3238(b))'', respectively, on authority
of section 7852(b) of Title 26, Internal Revenue Code.
1991 -- Subsec. (c). Pub. L. 102-108, 2(d)(3), redesignated subsec.
(c), relating to veterinary prescription drugs, as (f). Former subsec.
(f) redesignated (g).
Subsec. (c)(2), (3)(B)(v). Pub. L. 102-108, 2(d)(1), made technical
amendment to reference to subsection (b) of this section involving
corresponding provision of original act.
Subsec. (d)(3)(E). Pub. L. 102-108, 2(d)(2), made technical amendment
to reference to subsection (c)(1) of this section involving
corresponding provision of original act.
Subsec. (f). Pub. L. 102-108, 2(d)(4), redesignated subsec. (f),
relating to regulation of combination products, as (g).
Pub. L. 102-108, 2(d)(3), redesignated subsec. (c), relating to
veterinary prescription drugs, as (f).
Subsec. (g). Pub. L. 102-108, 2(d)(4), redesignated subsec. (f),
relating to regulation of combination products, as (g).
1990 -- Pub. L. 101-629, 16(a)(1), substituted ''Exemptions and
consideration for certain drugs, devices, and biological products'' for
''Exemptions in case of drugs and devices'' in section catchline.
Subsec. (f). Pub. L. 101-629, 16(a)(2), added subsec. (f).
1988 -- Subsec. (c). Pub. L. 100-670 added subsec. (c) relating to
veterinary prescription drugs.
Pub. L. 100-293, 4, added subsec. (c) relating to sales
restrictions.
Subsec. (d). Pub. L. 100-293, 5, added subsec. (d).
Subsec. (e). Pub. L. 100-293, 6, added subsec. (e).
1970 -- Subsec. (b)(2). Pub. L. 91-601 included exemption from
packaging requirements of subsec. (p) of section 352 of this title.
1962 -- Subsec. (b)(1)(C). Pub. L. 87-781 substituted ''approved''
for ''effective''.
1951 -- Subsec. (b). Act Oct. 26, 1951, amended section generally
to protect the public from abuses in the sale of potent prescription
drugs, and to relieve retail pharmacists and the public from unnecessary
restrictions on the dispensation of drugs that are safe to use without
supervision of a doctor.
Section 8 of Pub. L. 100-293 provided that:
''(a) General Rule. -- Except as provided in subsection (b), this Act
and the amendments made by this Act (amending this section and sections
331, 333, and 381 of this title and enacting provisions set out as notes
under this section and section 301 of this title) shall take effect upon
the expiration of 90 days after the date of the enactment of this Act
(Apr. 22, 1988).
''(b) Exception. --
''(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353(d)) (as added by section 5 of this Act) shall take effect
upon the expiration of 180 days after the date of the enactment of this
Act (Apr. 22, 1988).
''(2) The Secretary of Health and Human Services shall by regulation
issue the guidelines required by section 503(e)(2)(B) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)(2)(B)) (as added by
section 6 of this Act) not later than 180 days after the date of the
enactment of this Act. Section 503(e)(2)(A) of such Act shall take
effect upon the expiration of 2 years after the date such regulations
are promulgated and take effect.''
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no sooner
than 180 days or later than one year from date regulations are final, or
an earlier date published in Federal Register, see section 8 of Pub. L.
91-601, set out as an Effective Date note under section 1471 of Title
15, Commerce and Trade.
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
107 of Pub. L. 87-781, set out as a note under section 321 of this
title.
Amendment by act Oct. 26, 1951, effective six months after Oct. 26,
1951, see section 3 of act Oct. 26, 1951, set out as a note under
section 333 of this title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Section 2 of Pub. L. 100-293 provided that: ''The Congress finds
the following:
''(1) American consumers cannot purchase prescription drugs with the
certainty that the products are safe and effective.
''(2) The integrity of the distribution system for prescription drugs
is insufficient to prevent the introduction and eventual retail sale of
substandard, ineffective, or even counterfeit drugs.
''(3) The existence and operation of a wholesale submarket, commonly
known as the 'diversion market', prevents effective control over or even
routine knowledge of the true sources of prescription drugs in a
significant number of cases.
''(4) Large amounts of drugs are being reimported to the United
States as American goods returned. These imports are a health and
safety risk to American consumers because they may have become subpotent
or adulterated during foreign handling and shipping.
''(5) The ready market for prescription drug reimports has been the
catalyst for a continuing series of frauds against American
manufacturers and has provided the cover for the importation of foreign
counterfeit drugs.
''(6) The existing system of providing drug samples to physicians
through manufacturer's representatives has been abused for decades and
has resulted in the sale to consumers of misbranded, expired, and
adulterated pharmaceuticals.
''(7) The bulk resale of below wholesale priced prescription drugs by
health care entities, for ultimate sale at retail, helps fuel the
diversion market and is an unfair form of competition to wholesalers and
retailers that must pay otherwise prevailing market prices.
''(8) The effect of these several practices and conditions is to
create an unacceptable risk that counterfeit, adulterated, misbranded,
subpotent, or expired drugs will be sold to American consumers.''
1459; title 35 section 156.
21 USC 354. Repealed. Pub. L. 86-618, title I, 103(a)(2), July 12,
1960, 74 Stat. 398
TITLE 21 -- FOOD AND DRUGS
Section, act June 25, 1938, ch. 675, 504, 52 Stat. 1052, required
the Secretary to promulgate regulations for the listing of coal-tar
colors. See section 376 of this title.
Repeal effective July 12, 1960, subject to the provisions of section
203 of Pub. L. 86-618, see section 202 of Pub. L. 86-618, set out as
an Effective Date of 1960 Amendment note under section 376 of this
title.
21 USC 355. New drugs
TITLE 21 -- FOOD AND DRUGS
(a) Necessity of effective approval of application
No person shall introduce or deliver for introduction into interstate
commerce any new drug, unless an approval of an application filed
pursuant to subsection (b) or (j) of this section is effective with
respect to such drug.
(b) Filing application; contents
(1) Any person may file with the Secretary an application with
respect to any drug subject to the provisions of subsection (a) of this
section. Such person shall submit to the Secretary as a part of the
application (A) full reports of investigations which have been made to
show whether or not such drug is safe for use and whether such drug is
effective in use; (B) a full list of the articles used as components of
such drug; (C) a full statement of the composition of such drug; (D) a
full description of the methods used in, and the facilities and controls
used for, the manufacture, processing, and packing of such drug; (E)
such samples of such drug and of the articles used as components thereof
as the Secretary may require; and (F) specimens of the labeling
proposed to be used for such drug. The applicant shall file with the
application the patent number and the expiration date of any patent
which claims the drug for which the applicant submitted the application
or which claims a method of using such drug and with respect to which a
claim of patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture, use, or sale of
the drug. If an application is filed under this subsection for a drug
and a patent which claims such drug or a method of using such drug is
issued after the filing date but before approval of the application, the
applicant shall amend the application to include the information
required by the preceding sentence. Upon approval of the application,
the Secretary shall publish information submitted under the two
preceding sentences.
(2) An application submitted under paragraph (1) for a drug for which
the investigations described in clause (A) of such paragraph and relied
upon by the applicant for approval of the application were not conducted
by or for the applicant and for which the applicant has not obtained a
right of reference or use from the person by or for whom the
investigations were conducted shall also include --
(A) a certification, in the opinion of the applicant and to the best
of his knowledge, with respect to each patent which claims the drug for
which such investigations were conducted or which claims a use for such
drug for which the applicant is seeking approval under this subsection
and for which information is required to be filed under paragraph (1) or
subsection (c) of this section --
(i) that such patent information has not been filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will expire, or
(iv) that such patent is invalid or will not be infringed by the
manufacture, use, or sale of the new drug for which the application is
submitted; and
(B) if with respect to the drug for which investigations described in
paragraph (1)(A) were conducted information was filed under paragraph
(1) or subsection (c) of this section for a method of use patent which
does not claim a use for which the applicant is seeking approval under
this subsection, a statement that the method of use patent does not
claim such a use.
(3)(A) An applicant who makes a certification described in paragraph
(2)(A)(iv) shall include in the application a statement that the
applicant will give the notice required by subparagraph (B) to --
(i) each owner of the patent which is the subject of the
certification or the representative of such owner designated to receive
such notice, and
(ii) the holder of the approved application under subsection (b) of
this section for the drug which is claimed by the patent or a use of
which is claimed by the patent or the representative of such holder
designated to receive such notice.
(B) The notice referred to in subparagraph (A) shall state that an
application has been submitted under this subsection for the drug with
respect to which the certification is made to obtain approval to engage
in the commercial manufacture, use, or sale of the drug before the
expiration of the patent referred to in the certification. Such notice
shall include a detailed statement of the factual and legal basis of the
applicant's opinion that the patent is not valid or will not be
infringed.
(C) If an application is amended to include a certification described
in paragraph (2)(A)(iv), the notice required by subparagraph (B) shall
be given when the amended application is submitted.
(c) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order
(1) Within one hundred and eighty days after the filing of an
application under subsection (b) of this section, or such additional
period as may be agreed upon by the Secretary and the applicant, the
Secretary shall either --
(A) approve the application if he then finds that none of the grounds
for denying approval specified in subsection (d) of this section
applies, or
(B) give the applicant notice of an opportunity for a hearing before
the Secretary under subsection (d) of this section on the question
whether such application is approvable. If the applicant elects to
accept the opportunity for hearing by written request within thirty days
after such notice, such hearing shall commence not more than ninety days
after the expiration of such thirty days unless the Secretary and the
applicant otherwise agree. Any such hearing shall thereafter be
conducted on an expedited basis and the Secretary's order thereon shall
be issued within ninety days after the date fixed by the Secretary for
filing final briefs.
(2) If the patent information described in subsection (b) of this
section could not be filed with the submission of an application under
subsection (b) of this section because the application was filed before
the patent information was required under subsection (b) of this section
or a patent was issued after the application was approved under such
subsection, the holder of an approved application shall file with the
Secretary the patent number and the expiration date of any patent which
claims the drug for which the application was submitted or which claims
a method of using such drug and with respect to which a claim of patent
infringement could reasonably be asserted if a person not licensed by
the owner engaged in the manufacture, use, or sale of the drug. If the
holder of an approved application could not file patent information
under subsection (b) of this section because it was not required at the
time the application was approved, the holder shall file such
information under this subsection not later than thirty days after
September 24, 1984, and if the holder of an approved application could
not file patent information under subsection (b) of this section because
no patent had been issued when an application was filed or approved, the
holder shall file such information under this subsection not later than
thirty days after the date the patent involved is issued. Upon the
submission of patent information under this subsection, the Secretary
shall publish it.
(3) The approval of an application filed under subsection (b) of this
section which contains a certification required by paragraph (2) of such
subsection shall be made effective on the last applicable date
determined under the following:
(A) If the applicant only made a certification described in clause
(i) or (ii) of subsection (b)(2)(A) of this section or in both such
clauses, the approval may be made effective immediately.
(B) If the applicant made a certification described in clause (iii)
of subsection (b)(2)(A) of this section, the approval may be made
effective on the date certified under clause (iii).
(C) If the applicant made a certification described in clause (iv) of
subsection (b)(2)(A) of this section, the approval shall be made
effective immediately unless an action is brought for infringement of a
patent which is the subject of the certification before the expiration
of forty-five days from the date the notice provided under paragraph
(3)(B) is received. If such an action is brought before the expiration
of such days, the approval may be made effective upon the expiration of
the thirty-month period beginning on the date of the receipt of the
notice provided under paragraph (3)(B) or such shorter or longer period
as the court may order because either party to the action failed to
reasonably cooperate in expediting the action, except that --
(i) if before the expiration of such period the court decides that
such patent is invalid or not infringed, the approval may be made
effective on the date of the court decision,
(ii) if before the expiration of such period the court decides that
such patent has been infringed, the approval may be made effective on
such date as the court orders under section 271(e)(4)(A) of title 35, or
(iii) if before the expiration of such period the court grants a
preliminary injunction prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug until the court decides the
issues of patent validity and infringement and if the court decides that
such patent is invalid or not infringed, the approval shall be made
effective on the date of such court decision.
In such an action, each of the parties shall reasonably cooperate in
expediting the action. Until the expiration of forty-five days from the
date the notice made under paragraph (3)(B) is received, no action may
be brought under section 2201 of title 28 for a declaratory judgment
with respect to the patent. Any action brought under such section 2201
shall be brought in the judicial district where the defendant has its
principal place of business or a regular and established place of
business.
(D)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) of this section for a drug,
no active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application under
subsection (b) of this section, was approved during the period beginning
January 1, 1982, and ending on September 24, 1984, the Secretary may not
make the approval of another application for a drug for which the
investigations described in clause (A) of subsection (b)( 1) of this
section and relied upon by the applicant for approval of the application
were not conducted by or for the applicant and for which the applicant
has not obtained a right of reference or use from the person by or for
whom the investigations were conducted effective before the expiration
of ten years from the date of the approval of the application previously
approved under subsection (b) of this section.
(ii) If an application submitted under subsection (b) of this section
for a drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other application
under subsection (b) of this section, is approved after September 24,
1984, no application which refers to the drug for which the subsection
(b) application was submitted and for which the investigations described
in clause (A) of subsection (b)(1) of this section and relied upon by
the applicant for approval of the application were not conducted by or
for the applicant and for which the applicant has not obtained a right
of reference or use from the person by or for whom the investigations
were conducted may be submitted under subsection (b) of this section
before the expiration of five years from the date of the approval of the
application under subsection (b) of this section, except that such an
application may be submitted under subsection (b) of this section after
the expiration of four years from the date of the approval of the
subsection (b) application if it contains a certification of patent
invalidity or noninfringement described in clause (iv) of subsection
(b)(2)(A) of this section. The approval of such an application shall be
made effective in accordance with this paragraph except that, if an
action for patent infringement is commenced during the one-year period
beginning forty-eight months after the date of the approval of the
subsection (b) application, the thirty-month period referred to in
subparagraph (C) shall be extended by such amount of time (if any) which
is required for seven and one-half years to have elapsed from the date
of approval of the subsection (b) application.
(iii) If an application submitted under subsection (b) of this
section for a drug, which includes an active ingredient (including any
ester or salt of the active ingredient) that has been approved in
another application approved under subsection (b) of this section, is
approved after September 24, 1984, and if such application contains
reports of new clinical investigations (other than bioavailability
studies) essential to the approval of the application and conducted or
sponsored by the applicant, the Secretary may not make the approval of
an application submitted under subsection (b) of this section for the
conditions of approval of such drug in the approved subsection (b)
application effective before the expiration of three years from the date
of the approval of the application under subsection (b) of this section
if the investigations described in clause (A) of subsection (b)(1) of
this section and relied upon by the applicant for approval of the
application were not conducted by or for the applicant and if the
applicant has not obtained a right of reference or use from the person
by or for whom the investigations were conducted.
(iv) If a supplement to an application approved under subsection (b)
of this section is approved after September 24, 1984, and the supplement
contains reports of new clinical investigations (other than
bioavailabilty studies) essential to the approval of the supplement and
conducted or sponsored by the person submitting the supplement, the
Secretary may not make the approval of an application submitted under
subsection (b) of this section for a change approved in the supplement
effective before the expiration of three years from the date of the
approval of the supplement under subsection (b) of this section if the
investigations described in clause (A) of subsection (b)(1) of this
section and relied upon by the applicant for approval of the application
were not conducted by or for the applicant and if the applicant has not
obtained a right of reference or use from the person by or for whom the
investigations were conducted.
(v) If an application (or supplement to an application) submitted
under subsection (b) of this section for a drug, which includes an
active ingredient (including any ester or salt of the active ingredient)
that has been approved in another application under subsection (b) of
this section, was approved during the period beginning January 1, 1982,
and ending on September 24, 1984, the Secretary may not make the
approval of an application submitted under this subsection and for which
the investigations described in clause (A) of subsection (b)(1) of this
section and relied upon by the applicant for approval of the application
were not conducted by or for the applicant and for which the applicant
has not obtained a right of reference or use from the person by or for
whom the investigations were conducted and which refers to the drug for
which the subsection (b) application was submitted effective before the
expiration of two years from September 24, 1984.
(d) Grounds for refusing application; approval of application;
''substantial evidence'' defined
If the Secretary finds, after due notice to the applicant in
accordance with subsection (c) of this section and giving him an
opportunity for a hearing, in accordance with said subsection, that (1)
the investigations, reports of which are required to be submitted to the
Secretary pursuant to subsection (b) of this section, do not include
adequate tests by all methods reasonably applicable to show whether or
not such drug is safe for use under the conditions prescribed,
recommended, or suggested in the proposed labeling thereof; (2) the
results of such tests show that such drug is unsafe for use under such
conditions or do not show that such drug is safe for use under such
conditions; (3) the methods used in, and the facilities and controls
used for, the manufacture, processing, and packing of such drug are
inadequate to preserve its identity, strength, quality, and purity; (4)
upon the basis of the information submitted to him as part of the
application, or upon the basis of any other information before him with
respect to such drug, he has insufficient information to determine
whether such drug is safe for use under such conditions; or (5)
evaluated on the basis of the information submitted to him as part of
the application and any other information before him with respect to
such drug, there is a lack of substantial evidence that the drug will
have the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the proposed
labeling thereof; or (6) the application failed to contain the patent
information prescribed by subsection (b) of this section; or (7) based
on a fair evaluation of all material facts, such labeling is false or
misleading in any particular; he shall issue an order refusing to
approve the application. If, after such notice and opportunity for
hearing, the Secretary finds that clauses (1) through (6) do not apply,
he shall issue an order approving the application. As used in this
subsection and subsection (e) of this section, the term ''substantial
evidence'' means evidence consisting of adequate and well-controlled
investigations, including clinical investigations, by experts qualified
by scientific training and experience to evaluate the effectiveness of
the drug involved, on the basis of which it could fairly and responsibly
be concluded by such experts that the drug will have the effect it
purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling or proposed
labeling thereof.
(e) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to public health
The Secretary shall, after due notice and opportunity for hearing to
the applicant, withdraw approval of an application with respect to any
drug under this section if the Secretary finds (1) that clinical or
other experience, tests, or other scientific data show that such drug is
unsafe for use under the conditions of use upon the basis of which the
application was approved; (2) that new evidence of clinical experience,
not contained in such application or not available to the Secretary
until after such application was approved, or tests by new methods, or
tests by methods not deemed reasonably applicable when such application
was approved, evaluated together with the evidence available to the
Secretary when the application was approved, shows that such drug is not
shown to be safe for use under the conditions of use upon the basis of
which the application was approved; or (3) on the basis of new
information before him with respect to such drug, evaluated together
with the evidence available to him when the application was approved,
that there is a lack of substantial evidence that the drug will have the
effect it purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling thereof; or (4)
the patent information prescribed by subsection (c) of this section was
not filed within thirty days after the receipt of written notice from
the Secretary specifying the failure to file such information; or (5)
that the application contains any untrue statement of a material fact:
Provided, That if the Secretary (or in his absence the officer acting as
Secretary) finds that there is an imminent hazard to the public health,
he may suspend the approval of such application immediately, and give
the applicant prompt notice of his action and afford the applicant the
opportunity for an expedited hearing under this subsection; but the
authority conferred by this proviso to suspend the approval of an
application shall not be delegated. The Secretary may also, after due
notice and opportunity for hearing to the applicant, withdraw the
approval of an application submitted under subsection (b) or (j) of this
section with respect to any drug under this section if the Secretary
finds (1) that the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately failed
to maintain such records or to make required reports, in accordance with
a regulation or order under subsection (k) of this section or to comply
with the notice requirements of section 360(k)(2) of this title, or the
applicant has refused to permit access to, or copying or verification
of, such records as required by paragraph (2) of such subsection; or
(2) that on the basis of new information before him, evaluated together
with the evidence before him when the application was approved, the
methods used in, or the facilities and controls used for, the
manufacture, processing, and packing of such drug are inadequate to
assure and preserve its identity, strength, quality, and purity and were
not made adequate within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of; or (3)
that on the basis of new information before him, evaluated together with
the evidence before him when the application was approved, the labeling
of such drug, based on a fair evaluation of all material facts, is false
or misleading in any particular and was not corrected within a
reasonable time after receipt of written notice from the Secretary
specifying the matter complained of. Any order under this subsection
shall state the findings upon which it is based.
(f) Revocation of order refusing, withdrawing or suspending approval
of application
Whenever the Secretary finds that the facts so require, he shall
revoke any previous order under subsection (d) or (e) of this section
refusing, withdrawing, or suspending approval of an application and
shall approve such application or reinstate such approval, as may be
appropriate.
(g) Service of orders
Orders of the Secretary issued under this section shall be served (1)
in person by any officer or employee of the department designated by the
Secretary or (2) by mailing the order by registered mail or by certified
mail addressed to the applicant or respondent at his last-known address
in the records of the Secretary.
(h) Appeal from order
An appeal may be taken by the applicant from an order of the
Secretary refusing or withdrawing approval of an application under this
section. Such appeal shall be taken by filing in the United States
court of appeals or the circuit wherein such applicant resides or has
his principal place of business, or in the United States Court of
Appeals for the District of Columbia Circuit, within sixty days after
the entry of such order, a written petition praying that the order of
the Secretary be set aside. A copy of such petition shall be forthwith
transmitted by the clerk of the court to the Secretary, or any officer
designated by him for that purpose, and thereupon the Secretary shall
certify and file in the court the record upon which the order complained
of was entered, as provided in section 2112 of title 28. Upon the
filing of such petition such court shall have exclusive jurisdiction to
affirm or set aside such order, except that until the filing of the
record the Secretary may modify or set aside his order. No objection to
the order of the Secretary shall be considered by the court unless such
objection shall have been urged before the Secretary or unless there
were reasonable grounds for failure so to do. The finding of the
Secretary as to the facts, if supported by substantial evidence, shall
be conclusive. If any person shall apply to the court for leave to
adduce additional evidence, and shall show to the satisfaction of the
court that such additional evidence is material and that there were
reasonable grounds for failure to adduce such evidence in the proceeding
before the Secretary, the court may order such additional evidence to be
taken before the Secretary and to be adduced upon the hearing in such
manner and upon such terms and conditions as to the court may seem
proper. The Secretary may modify his findings as to the facts by reason
of the additional evidence so taken, and he shall file with the court
such modified findings which, if supported by substantial evidence,
shall be conclusive, and his recommendation, if any, for the setting
aside of the original order. The judgment of the court affirming or
setting aside any such order of the Secretary shall be final, subject to
review by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28. The commencement
of proceedings under this subsection shall not, unless specifically
ordered by the court to the contrary, operate as a stay of the
Secretary's order.
(i) Exemptions of drugs for research; discretionary and mandatory
conditions; direct reports to Secretary
The Secretary shall promulgate regulations for exempting from the
operation of the foregoing subsections of this section drugs intended
solely for investigational use by experts qualified by scientific
training and experience to investigate the safety and effectiveness of
drugs. Such regulations may, within the discretion of the Secretary,
among other conditions relating to the protection of the public health,
provide for conditioning such exemption upon --
(1) the submission to the Secretary, before any clinical testing of a
new drug is undertaken, of reports, by the manufacturer or the sponsor
of the investigation of such drug, of preclinical tests (including tests
on animals) of such drug adequate to justify the proposed clinical
testing;
(2) the manufacturer or the sponsor of the investigation of a new
drug proposed to be distributed to investigators for clinical testing
obtaining a signed agreement from each of such investigators that
patients to whom the drug is administered will be under his personal
supervision, or under the supervision of investigators responsible to
him, and that he will not supply such drug to any other investigator, or
to clinics, for administration to human beings; and
(3) the establishment and maintenance of such records, and the making
of such reports to the Secretary, by the manufacturer or the sponsor of
the investigation of such drug, of data (including but not limited to
analytical reports by investigators) obtained as the result of such
investigational use of such drug, as the Secretary finds will enable him
to evaluate the safety and effectiveness of such drug in the event of
the filing of an application pursuant to subsection (b) of this section.
Such regulations shall provide that such exemption shall be
conditioned upon the manufacturer, or the sponsor of the investigation,
requiring that experts using such drugs for investigational purposes
certify to such manufacturer or sponsor that they will inform any human
beings to whom such drugs, or any controls used in connection therewith,
are being administered, or their representatives, that such drugs are
being used for investigational purposes and will obtain the consent of
such human beings or their representatives, except where they deem it
not feasible or, in their professional judgment, contrary to the best
interests of such human beings. Nothing in this subsection shall be
construed to require any clinical investigator to submit directly to the
Secretary reports on the investigational use of drugs.
(j) Abbreviated new drug applications
(1) Any person may file with the Secretary an abbreviated application
for the approval of a new drug.
(2)(A) An abbreviated application for a new drug shall contain --
(i) information to show that the conditions of use prescribed,
recommended, or suggested in the labeling proposed for the new drug have
been previously approved for a drug listed under paragraph (6)
(hereinafter in this subsection referred to as a ''listed drug'');
(ii)(I) if the listed drug referred to in clause (i) has only one
active ingredient, information to show that the active ingredient of the
new drug is the same as that of the listed drug;
(II) if the listed drug referred to in clause (i) has more than one
active ingredient, information to show that the active ingredients of
the new drug are the same as those of the listed drug, or
(III) if the listed drug referred to in clause (i) has more than one
active ingredient and if one of the active ingredients of the new drug
is different and the application is filed pursuant to the approval of a
petition filed under subparagraph (C), information to show that the
other active ingredients of the new drug are the same as the active
ingredients of the listed drug, information to show that the different
active ingredient is an active ingredient of a listed drug or of a drug
which does not meet the requirements of section 321(p) of this title,
and such other information respecting the different active ingredient
with respect to which the petition was filed as the Secretary may
require;
(iii) information to show that the route of administration, the
dosage form, and the strength of the new drug are the same as those of
the listed drug referred to in clause (i) or, if the route of
administration, the dosage form, or the strength of the new drug is
different and the application is filed pursuant to the approval of a
petition filed under subparagraph (C), such information respecting the
route of administration, dosage form, or strength with respect to which
the petition was filed as the Secretary may require;
(iv) information to show that the new drug is bioequivalent to the
listed drug referred to in clause (i), except that if the application is
filed pursuant to the approval of a petition filed under subparagraph
(C), information to show that the active ingredients of the new drug are
of the same pharmacological or therapeutic class as those of the listed
drug referred to in clause (i) and the new drug can be expected to have
the same therapeutic effect as the listed drug when administered to
patients for a condition of use referred to in clause (i);
(v) information to show that the labeling proposed for the new drug
is the same as the labeling approved for the listed drug referred to in
clause (i) except for changes required because of differences approved
under a petition filed under subparagraph (C) or because the new drug
and the listed drug are produced or distributed by different
manufacturers;
(vi) the items specified in clauses (B) through (F) of subsection
(b)(1) of this section;
(vii) a certification, in the opinion of the applicant and to the
best of his knowledge, with respect to each patent which claims the
listed drug referred to in clause (i) or which claims a use for such
listed drug for which the applicant is seeking approval under this
subsection and for which information is required to be filed under
subsection (b) or (c) of this section --
(I) that such patent information has not been filed,
(II) that such patent has expired,
(III) of the date on which such patent will expire, or
(IV) that such patent is invalid or will not be infringed by the
manufacture, use, or sale of the new drug for which the application is
submitted; and
(viii) if with respect to the listed drug referred to in clause (i)
information was filed under subsection (b) or (c) of this section for a
method of use patent which does not claim a use for which the applicant
is seeking approval under this subsection, a statement that the method
of use patent does not claim such a use.
The Secretary may not require that an abbreviated application contain
information in addition to that required by clauses (i) through (viii).
(B)(i) An applicant who makes a certification described in
subparagraph (A)(vii)(IV) shall include in the application a statement
that the applicant will give the notice required by clause (ii) to --
(I) each owner of the patent which is the subject of the
certification or the representative of such owner designated to receive
such notice, and
(II) the holder of the approved application under subsection (b) of
this section for the drug which is claimed by the patent or a use of
which is claimed by the patent or the representative of such holder
designated to receive such notice.
(ii) The notice referred to in clause (i) shall state that an
application, which contains data from bioavailability or bioequivalence
studies, has been submitted under this subsection for the drug with
respect to which the certification is made to obtain approval to engage
in the commercial manufacture, use, or sale of such drug before the
expiration of the patent referred to in the certification. Such notice
shall include a detailed statement of the factual and legal basis of the
applicant's opinion that the patent is not valid or will not be
infringed.
(iii) If an application is amended to include a certification
described in subparagraph (A)(vii)(IV), the notice required by clause
(ii) shall be given when the amended application is submitted.
(C) If a person wants to submit an abbreviated application for a new
drug which has a different active ingredient or whose route of
administration, dosage form, or strength differ from that of a listed
drug, such person shall submit a petition to the Secretary seeking
permission to file such an application. The Secretary shall approve or
disapprove a petition submitted under this subparagraph within ninety
days of the date the petition is submitted. The Secretary shall approve
such a petition unless the Secretary finds --
(i) that investigations must be conducted to show the safety and
effectiveness of the drug or of any of its active ingredients, the route
of administration, the dosage form, or strength which differ from the
listed drug; or
(ii) that any drug with a different active ingredient may not be
adequately evaluated for approval as safe and effective on the basis of
the information required to be submitted in an abbreviated application.
(3) Subject to paragraph (4), the Secretary shall approve an
application for a drug unless the Secretary finds --
(A) the methods used in, or the facilities and controls used for, the
manufacture, processing, and packing of the drug are inadequate to
assure and preserve its identity, strength, quality, and purity;
(B) information submitted with the application is insufficient to
show that each of the proposed conditions of use have been previously
approved for the listed drug referred to in the application;
(C)(i) if the listed drug has only one active ingredient, information
submitted with the application is insufficient to show that the active
ingredient is the same as that of the listed drug;
(ii) if the listed drug has more than one active ingredient,
information submitted with the application is insufficient to show that
the active ingredients are the same as the active ingredients of the
listed drug, or
(iii) if the listed drug has more than one active ingredient and if
the application is for a drug which has an active ingredient different
from the listed drug, information submitted with the application is
insufficient to show --
(I) that the other active ingredients are the same as the active
ingredients of the listed drug, or
(II) that the different active ingredient is an active ingredient of
a listed drug or a drug which does not meet the requirements of section
321(p) of this title,
or no petition to file an application for the drug with the different
ingredient was approved under paragraph (2)(C);
(D)(i) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is the same as the
route of administration, dosage form, or strength of the listed drug
referred to in the application, information submitted in the application
is insufficient to show that the route of administration, dosage form,
or strength is the same as that of the listed drug, or
(ii) if the application is for a drug whose route of administration,
dosage form, or strength of the drug is different from that of the
listed drug referred to in the application, no petition to file an
application for the drug with the different route of administration,
dosage form, or strength was approved under paragraph (2)(C);
(E) if the application was filed pursuant to the approval of a
petition under paragraph (2)(C), the application did not contain the
information required by the Secretary respecting the active ingredient,
route of administration, dosage form, or strength which is not the same;
(F) information submitted in the application is insufficient to show
that the drug is bioequivalent to the listed drug referred to in the
application or, if the application was filed pursuant to a petition
approved under paragraph (2)(C), information submitted in the
application is insufficient to show that the active ingredients of the
new drug are of the same pharmacological or therapeutic class as those
of the listed drug referred to in paragraph (2)(A)(i) and that the new
drug can be expected to have the same therapeutic effect as the listed
drug when administered to patients for a condition of use referred to in
such paragraph;
(G) information submitted in the application is insufficient to show
that the labeling proposed for the drug is the same as the labeling
approved for the listed drug referred to in the application except for
changes required because of differences approved under a petition filed
under paragraph (2)(C) or because the drug and the listed drug are
produced or distributed by different manufacturers;
(H) information submitted in the application or any other information
available to the Secretary shows that (i) the inactive ingredients of
the drug are unsafe for use under the conditions prescribed,
recommended, or suggested in the labeling proposed for the drug, or (ii)
the composition of the drug is unsafe under such conditions because of
the type or quantity of inactive ingredients included or the manner in
which the inactive ingredients are included;
(I) the approval under subsection (c) of this section of the listed
drug referred to in the application under this subsection has been
withdrawn or suspended for grounds described in the first sentence of
subsection (e) of this section, the Secretary has published a notice of
opportunity for hearing to withdraw approval of the listed drug under
subsection (c) of this section for grounds described in the first
sentence of subsection (e) of this section, the approval under this
subsection of the listed drug referred to in the application under this
subsection has been withdrawn or suspended under paragraph (5), or the
Secretary has determined that the listed drug has been withdrawn from
sale for safety or effectiveness reasons;
(J) the application does not meet any other requirement of paragraph
(2)(A); or
(K) the application contains an untrue statement of material fact.
(4)(A) Within one hundred and eighty days of the initial receipt of
an application under paragraph (2) or within such additional period as
may be agreed upon by the Secretary and the applicant, the Secretary
shall approve or disapprove the application.
(B) The approval of an application submitted under paragraph (2)
shall be made effective on the last applicable date determined under the
following:
(i) If the applicant only made a certification described in subclause
(I) or (II) of paragraph (2)(A)(vii) or in both such subclauses, the
approval may be made effective immediately.
(ii) If the applicant made a certification described in subclause
(III) of paragraph (2)(A)(vii), the approval may be made effective on
the date certified under subclause (III).
(iii) If the applicant made a certification described in subclause
(IV) of paragraph (2)(A)(vii), the approval shall be made effective
immediately unless an action is brought for infringement of a patent
which is the subject of the certification before the expiration of
forty-five days from the date the notice provided under paragraph (2)(
B)(i) is received. If such an action is brought before the expiration
of such days, the approval shall be made effective upon the expiration
of the thirty-month period beginning on the date of the receipt of the
notice provided under paragraph (2)(B)(i) or such shorter or longer
period as the court may order because either party to the action failed
to reasonably cooperate in expediting the action, except that --
(I) if before the expiration of such period the court decides that
such patent is invalid or not infringed, the approval shall be made
effective on the date of the court decision,
(II) if before the expiration of such period the court decides that
such patent has been infringed, the approval shall be made effective on
such date as the court orders under section 271(e)(4)(A) of title 35, or
(III) if before the expiration of such period the court grants a
preliminary injunction prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug until the court decides the
issues of patent validity and infringement and if the court decides that
such patent is invalid or not infringed, the approval shall be made
effective on the date of such court decision.
In such an action, each of the parties shall reasonably cooperate in
expediting the action. Until the expiration of forty-five days from the
date the notice made under paragraph (2)(B)(i) is received, no action
may be brought under section 2201 of title 28, for a declaratory
judgment with respect to the patent. Any action brought under section
2201 shall be brought in the judicial district where the defendant has
its principal place of business or a regular and established place of
business.
(iv) If the application contains a certification described in
subclause (IV) of paragraph (2)(A)(vii) and is for a drug for which a
previous application has been submitted under this subsection continuing
such a certification, the application shall be made effective not
earlier than one hundred and eighty days after --
(I) the date the Secretary receives notice from the applicant under
the previous application of the first commercial marketing of the drug
under the previous application, or
(II) the date of a decision of a court in an action described in
clause (iii) holding the patent which is the subject of the
certification to be invalid or not infringed,
whichever is earlier.
(C) If the Secretary decides to disapprove an application, the
Secretary shall give the applicant notice of an opportunity for a
hearing before the Secretary on the question of whether such application
is approvable. If the applicant elects to accept the opportunity for
hearing by written request within thirty days after such notice, such
hearing shall commence not more than ninety days after the expiration of
such thirty days unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an expedited basis
and the Secretary's order thereon shall be issued within ninety days
after the date fixed by the Secretary for filing final briefs.
(D)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) of this section for a drug,
no active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application under
subsection (b) of this section, was approved during the period beginning
January 1, 1982, and ending on September 24, 1984, the Secretary may not
make the approval of an application submitted under this subsection
which refers to the drug for which the subsection (b) application was
submitted effective before the expiration of ten years from the date of
the approval of the application under subsection (b) of this section.
(ii) If an application submitted under subsection (b) of this section
for a drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other application
under subsection (b) of this section, is approved after September 24,
1984, no application may be submitted under this subsection which refers
to the drug for which the subsection (b) application was submitted
before the expiration of five years from the date of the approval of the
application under subsection (b) of this section, except that such an
application may be submitted under this subsection after the expiration
of four years from the date of the approval of the subsection (b)
application if it contains a certification of patent invalidity or
noninfringement described in subclause (IV) of paragraph (2)(A)(vii).
The approval of such an application shall be made effective in
accordance with subparagraph (B) except that, if an action for patent
infringement is commenced during the one-year period beginning
forty-eight months after the date of the approval of the subsection (b)
application, the thirty-month period referred to in subparagraph
(B)(iii) shall be extended by such amount of time (if any) which is
required for seven and one-half years to have elapsed from the date of
approval of the subsection (b) application.
(iii) If an application submitted under subsection (b) of this
section for a drug, which includes an active ingredient (including any
ester or salt of the active ingredient) that has been approved in
another application approved under subsection (b) of this section, is
approved after September 24, 1984, and if such application contains
reports of new clinical investigations (other than bioavailability
studies) essential to the approval of the application and conducted or
sponsored by the applicant, the Secretary may not make the approval of
an application submitted under this subsection for the conditions of
approval of such drug in the subsection (b) application effective before
the expiration of three years from the date of the approval of the
application under subsection (b) of this section for such drug.
(iv) If a supplement to an application approved under subsection (b)
of this section is approved after September 24, 1984, and the supplement
contains reports of new clinical investigations (other than
bioavailability studies) essential to the approval of the supplement and
conducted or sponsored by the person submitting the supplement, the
Secretary may not make the approval of an application submitted under
this subsection for a change approved in the supplement effective before
the expiration of three years from the date of the approval of the
supplement under subsection (b) of this section.
(v) If an application (or supplement to an application) submitted
under subsection (b) of this section for a drug, which includes an
active ingredient (including any ester or salt of the active ingredient)
that has been approved in another application under subsection (b) of
this section, was approved during the period beginning January 1, 1982,
and ending on September 24, 1984, the Secretary may not make the
approval of an application submitted under this subsection which refers
to the drug for which the subsection (b) application was submitted or
which refers to a change approved in a supplement to the subsection (b)
application effective before the expiration of two years from September
24, 1984.
(5) If a drug approved under this subsection refers in its approved
application to a drug the approval of which was withdrawn or suspended
for grounds described in the first sentence of subsection (e) of this
section or was withdrawn or suspended under this paragraph or which, as
determined by the Secretary, has been withdrawn from sale for safety or
effectiveness reasons, the approval of the drug under this subsection
shall be withdrawn or suspended --
(A) for the same period as the withdrawal or suspension under
subsection (e) of this section or this paragraph, or
(B) if the listed drug has been withdrawn from sale, for the period
of withdrawal from sale or, if earlier, the period ending on the date
the Secretary determines that the withdrawal from sale is not for safety
or effectiveness reasons.
(6)(A)(i) Within sixty days of September 24, 1984, the Secretary
shall publish and make available to the public --
(I) a list in alphabetical order of the official and proprietary name
of each drug which has been approved for safety and effectiveness under
subsection (c) of this section before September 24, 1984;
(II) the date of approval if the drug is approved after 1981 and the
number of the application which was approved; and
(III) whether in vitro or in vivo bioequivalence studies, or both
such studies, are required for applications filed under this subsection
which will refer to the drug published.
(ii) Every thirty days after the publication of the first list under
clause (i) the Secretry /1/ shall revise the list to include each drug
which has been approved for safety and effectiveness under subsection
(c) of this section or approved under this subsection during the
thirty-day period.
(iii) When patent information submitted under subsection (b) or (c)
of this section respecting a drug included on the list is to be
published by the Secretary /2/ the Secretary shall, in revisions made
under clause (ii), include such information for such drug.
(B) A drug approved for safety and effectiveness under subsection (c)
of this section or approved under this subsection shall, for purposes of
this subsection, be considered to have been published under subparagraph
(A) on the date of its approval or September 24, 1984, whichever is
later.
(C) If the approval of a drug was withdrawn or suspended for grounds
described in the first sentence of subsection (e) of this section or was
withdrawn or suspended under paragraph (5) or if the Secretary
determines that a drug has been withdrawn from sale for safety or
effectiveness reasons, it may not be published in the list under
subparagraph (A) or, if the withdrawal or suspension occurred after its
publication in such list, it shall be immediately removed from such list
--
(i) for the same period as the withdrawal or suspension under
subsection (e) of this section or paragraph (5), or
(ii) if the listed drug has been withdrawn from sale, for the period
of withdrawal from sale or, if earlier, the period ending on the date
the Secretary determines that the withdrawal from sale is not for safety
or effectiveness reasons.
A notice of the removal shall be published in the Federal Register.
(7) For purposes of this subsection:
(A) The term ''bioavailability'' means the rate and extent to which
the active ingredient or therapeutic ingredient is absorbed from a drug
and becomes available at the site of drug action.
(B) A drug shall be considered to be bioequivalent to a listed drug
if --
(i) the rate and extent of absorption of the drug do not show a
significant difference from the rate and extent of absorption of the
listed drug when administered at the same molar dose of the therapeutic
ingredient under similar experimental conditions in either a single dose
or multiple doses; or
(ii) the extent of absorption of the drug does not show a significant
difference from the extent of absorption of the listed drug when
administered at the same molar dose of the therapeutic ingredient under
similar experimental conditions in either a single dose or multiple
doses and the difference from the listed drug in the rate of absorption
of the drug is intentional, is reflected in its proposed labeling, is
not essential to the attainment of effective body drug concentrations on
chronic use, and is considered medically insignificant for the drug.
(k) Records and reports; required information; regulations and
orders; access to records
(1) In the case of any drug for which an approval of an application
filed under subsection (b) or (j) of this section is in effect, the
applicant shall establish and maintain such records, and make such
reports to the Secretary, of data relating to clinical experience and
other data or information, received or otherwise obtained by such
applicant with respect to such drug, as the Secretary may by general
regulation, or by order with respect to such application, prescribe on
the basis of a finding that such records and reports are necessary in
order to enable the Secretary to determine, or facilitate a
determination, whether there is or may be ground for invoking subsection
(e) of this section: Provided, however, That regulations and orders
issued under this subsection and under subsection (i) of this section
shall have due regard for the professional ethics of the medical
profession and the interests of patients and shall provide, where the
Secretary deems it to be appropriate, for the examination, upon request,
by the persons to whom such regulations or orders are applicable, of
similar information received or otherwise obtained by the Secretary.
(2) Every person required under this section to maintain records, and
every person in charge or custody thereof, shall, upon request of an
officer or employee designated by the Secretary, permit such officer or
employee at all reasonable times to have access to and copy and verify
such records.
(l) Public disclosure of safety and effectiveness data
Safety and effectiveness data and information which has been
submitted in an application under subsection (b) of this section for a
drug and which has not previously been disclosed to the public shall be
made available to the public, upon request, unless extraordinary
circumstances are shown --
(1) if no work is being or will be undertaken to have the application
approved,
(2) if the Secretary has determined that the application is not
approvable and all legal appeals have been exhausted,
(3) if approval of the application under subsection (c) of this
section is withdrawn and all legal appeals have been exhausted,
(4) if the Secretary has determined that such drug is not a new drug,
or
(5) upon the effective date of the approval of the first application
under subsection (j) of this section which refers to such drug or upon
the date upon which the approval of an application under subsection (j)
of this section which refers to such drug could be made effective if
such an application had been submitted.
(m) ''Patent'' defined
For purposes of this section, the term ''patent'' means a patent
issued by the Patent and Trademark Office of the Department of Commerce.
(June 25, 1938, ch. 675, 505, 52 Stat. 1052; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; June 11,
1960, Pub. L. 86-507, 1(18), 74 Stat. 201; Oct. 10, 1962, Pub. L.
87-781, title I, 102(b)-(d), 103(a), (b), 104(a)-(d)(2), 76 Stat.
781-783, 784, 785; Aug. 16, 1972, Pub. L. 92-387, 4(d), 86 Stat. 562;
Sept. 24, 1984, Pub. L. 98-417, title I, 101, 102(a)-(b)(5), 103, 104,
98 Stat. 1585, 1592, 1593, 1597.)
1984 -- Subsec. (a). Pub. L. 98-417, 102(b)(1), inserted ''or (j)''
after ''subsection (b)''.
Subsec. (b). Pub. L. 98-417, 102(a)(1), 103(a), designated existing
provisions of subsec. (b) as par. (1) thereof and redesignated
existing cls. (1) through (6) of such par. (1) as cls. (A) through (F)
thereof, respectively, inserted requirement that the applicant file with
the application the patent number and the expiration date of any patent
which claims the drug for which the applicant submitted the application
or which claims a method of using such drug and with respect to which a
claim of patent infringement could reasonably by asserted if a person
not licensed by the owner engaged in the manufacture, use, or sale of
the drug, that the applicant amend the application to include such
information if an application is filed under this subsection for a drug
and a patent which claims such drug or a method of using such drug is
issued after the filing date but before approval of the application, and
that upon approval of the application, the Secretary publish the
information submitted, and added pars. (2) and (3).
Subsec. (c). Pub. L. 98-417, 102(a)(2), (b)(2), 103(b), designated
existing provisions of subsec. (c) as par. (1) thereof and in par.
(1) as so designated substituted ''subsection (b) of this section'' for
''this subsection'' and redesignated former pars. (1) and (2) as
subpars. (A) and (B), respectively, and added pars. (2) and (3).
Subsec. (d)(6), (7). Pub. L. 98-417, 102(a)(3)(A), added cl. (6)
relating to the failure of the application to contain the patent
information prescribed by subsec. (b) of this section, and redesignated
former cl. (6) as (7).
Subsec. (e). Pub. L. 98-417, 102(a)(3)(B), in first sentence, added a
new cl. (4) relating to the failure to file the patent information
prescribed by subsec. (c) of this section within 30 days after the
receipt of written notice from the Secretary specifying the failure to
file such information, and redesignated former cl. (4) as (5).
Pub. L. 98-417, 102(b)(3), (4), in second sentence, inserted in
provisions preceding cl. (1) ''submitted under subsection (b) or (j) of
this section'' and in cl. (1) substituted ''under subsection (k) of
this section or to comply with the notice requirements of section 360(
k)(2) of this title'' for ''under subsection (j) of this section or to
comply with the notice requirements of section 360(j)(2) of this
title''.
Subsecs. (j), (k). Pub. L. 98-417, 101, added subsec. (j) and
redesignated former subsec. (j) as (k).
Subsec. (k)(1). Pub. L. 98-417, 102(b)(5), substituted ''under
subsection (b) or (j) of this section'' for ''pursuant to this
section''.
Subsecs. (l), (m). Pub. L. 98-417, 104, added subsecs. (l) and (m).
1972 -- Subsec. (e). Pub. L. 92-387 inserted ''or to comply with the
notice requirements of section 360(j)(2) of this title'' in cl. (1) of
second sentence relating to the maintenance of records.
1962 -- Subsec. (a). Pub. L. 87-781, 104(a), inserted ''an approval
of'' before ''an application''.
Subsec. (b). Pub. L. 87-781, 102(b), inserted ''and whether such drug
is effective in use'' after ''is safe for use''.
Subsec. (c). Pub. L. 87-781, 104(b), substituted provisions requiring
the Secretary, within 180 days after filing an application, or such
additional period as the Secretary and the applicant agree upon, to
either approve the application, if meeting the requirements of subsec.
(d) of this section, or give notice of opportunity for hearing on
question of whether such application is approvable, and providing that
if applicant requests hearing in writing within 30 days, the hearing
shall begin within 90 days after expiration of said 30 days, unless the
Secretary and applicant agree otherwise, that such hearing shall be
expedited, and that the Secretary's order shall be issued within 90 days
after date for filing final briefs, for provisions which had an
application become effective on the sixtieth day after filing thereof
unless prior thereto the Secretary postponed the date by written notice
to such time, but not more than 180 days after filing, as the Secretary
deemed necessary to study and investigate the application.
Subsec. (d). Pub. L. 87-781, 102(c), inserted references to subsec.
(c), added cls. (5) and (6), provided that if after notice and
opportunity for hearing, the Secretary finds that cls. (1) to (6) do
not apply, he shall approve the application, and defined ''substantial
evidence'' as used in this subsection and subsec. (e) of this section.
Subsec. (e). Pub. L. 87-781, 102(d), amended subsec. (e) generally,
and among other changes, directed the Secretary to withdraw approval of
an application if by tests, other scientific data or experience, or new
evidence of clinical experience not contained in the application or
available at the time of its approval, the drug is shown to be unsafe,
or on the basis of new information, there is shown a lack of substantial
evidence that the drug has the effect it is represented to have, and
provided that if the Secretary, or acting Secretary, finds there is an
imminent hazard to the public health, he may suspend approval
immediately, notify the applicant, and give him opportunity for an
expedited hearing, that the Secretary may withdraw approval if the
applicant fails to establish a system for maintaining required records,
or has repeatedly or deliberately failed to maintain records and make
reports, or has refused access to, or copying or verification of such
records, or if the Secretary finds on new evidence that the methods,
facilities and controls in the manufacturing, processing, and packing
are inadequate to assure and preserve the drugs' identity, strength,
quality and purity, and were not made adequate within a reasonable time
after receipt of written notice thereof, or finds on new evidence, that
the labeling is false or misleading and was not corrected within a
reasonable time after receipt of written notice thereof.
Subsec. (f). Pub. L. 87-781, 104(c), substituted provisions requiring
the Secretary to revoke any previous order under subsecs. (d) or (e) of
this section refusing, withdrawing, or suspending approval of an
application and to approve such application or reinstate such approval,
for provisions which required him to revoke an order refusing
effectiveness to an application.
Subsec. (h). Pub. L. 87-781, 104(d)(1), (2), inserted ''as provided
in section 2112 of title 28'', and ''except that until the filing of the
record the Secretary may modify or set aside his order'', substituted
''or withdrawing approval of an application under this section'' for
''to permit the application to become effective, or suspending the
effectiveness of the application'', ''United States court of appeals for
the circuit'' for ''district court of the United States within any
district'', ''Court of Appeals for the District of Columbia Circuit''
for ''District Court for the District of Columbia'', ''transmitted by
the clerk of the court to'' for ''served upon'', and ''by the Supreme
Court of the United States upon certiorari or certification as provided
in section 1254 of title 28'' for ''as provided in sections 225, 346,
and 347 of title 28, as amended, and in section 7, as amended, of the
Act entitled 'An Act to establish a Court of Appeals for the District of
Columbia', approved February 9, 1893'', and eliminated ''upon'' before
''any officer designated'', ''a transcript of'' before ''the record''
and ''and decree'' before ''of the court affirming''.
Subsec. (i). Pub. L. 87-781, 103(b), inserted ''the foregoing
subsections of'' after ''operation of'', and ''and effectiveness'' after
''safety'', and provided that the regulations may condition exemptions
upon the submission of reports of preclinical tests to justify the
proposed clinical testing, upon the obtaining by the manufacturer or
sponsor of the investigation of a new drug of a signed agreement from
each of the investigators that patients to whom the drug is administered
will be under his supervision or under investigators responsible to him,
and that he will not supply such drug to any other investigator, or to
clinics, for administration to human beings, or upon the establishment
and maintenance of records and reports of data obtained by the
investigational use of such drug, as the Secretary finds will enable him
to evaluate the safety and effectiveness of such drug, and provided that
the regulations shall condition an exemption upon the manufacturer or
sponsor of the investigation requiring that experts using such drugs
certify that they will inform humans to whom such drugs or any controls
connected therewith are administered, or their representatives, and will
obtain the consent of such people where feasible and not contrary to the
best interests of such people, and that reports on the investigational
use of drugs are not required to be submitted directly to the Secretary.
Subsec. (j). Pub. L. 87-781, 103(a), added subsec. (j).
1960 -- Subsec. (g). Pub. L. 86-507 inserted ''or by certified
mail'' after ''registered mail''.
Section 105 of Pub. L. 98-417 provided that:
''(a) The Secretary of Health and Human Services shall promulgate, in
accordance with the notice and comment requirements of section 553 of
title 5, United States Code, such regulations as may be necessary for
the administration of section 505 of the Federal Food, Drug, and
Cosmetic Act (this section), as amended by sections 101, 102, and 103 of
this Act, within one year of the date of enactment of this Act (Sept.
24, 1984).
''(b) During the period beginning sixty days after the date of the
enactment of this Act (Sept. 24, 1984), and ending on the date
regulations promulgated under subsection (a) take effect, abbreviated
new drug applications may be submitted in accordance with the provisions
of section 314.2 of title 21 of the Code of Federal Regulations and
shall be considered as suitable for any drug which has been approved for
safety and effectiveness under section 505(c) of the Federal Food, Drug,
and Cosmetic Act (subsec. (c) of this section) before the date of the
enactment of this Act. If any such provision is inconsistent with the
requirements of section 505(j) of the Federal Food, Drug, and Cosmetic
Act, the Secretary shall consider the application under the applicable
requirements of such section. The Secretary of Health and Human
Services may not approve such an abbreviated new drug application which
is filed for a drug which is described in sections 505(c)(3)(D) and
505(j)(4)(D) of the Federal Food, Drug, and Cosmetic Act, except in
accordance with such section.''
Amendment by Pub. L. 92-387 effective on first day of sixth month
beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set
out as a note under section 360 of this title.
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L.
87-781, set out as a note under section 321 of this title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Section 104(d)(3) of Pub. L. 87-781 made amendments to subsec. (h)
of this section inapplicable to any appeal taken prior to Oct. 10, 1962.
28; title 28 section 2201; title 35 sections 155A,
156, 271; title 42 sections 236, 300cc-12, 300cc-13,
300cc-17, 1395y, 1396r-8.
/1/ So in original. Probably should be ''Secretary''.
/2/ So in original. Probably should be followed by a comma.
21 USC 356. Certification of drugs containing insulin
TITLE 21 -- FOOD AND DRUGS
(a) Standards for certification
The Secretary of Health and Human Services, pursuant to regulations
promulgated by him, shall provide for the certification of batches of
drugs composed wholly or partly of insulin. A batch of any such drug
shall be certified if such drug has such characteristics of identity and
such batch has such characteristics of strength, quality, and purity, as
the Secretary prescribes in such regulations as necessary to adequately
insure safety and efficacy of use, but shall not otherwise be certified.
Prior to the effective date of such regulations the Secretary, in lieu
of certification, shall issue a release for any batch which, in his
judgment, may be released without risk as to the safety and efficacy of
its use. Such release shall prescribe the date of its expiration and
other conditions under which it shall cease to be effective as to such
batch and as to portions thereof.
(b) Regulations
Regulations providing for such certification shall contain such
provisions as are necessary to carry out the purposes of this section,
including provisions prescribing (1) standards of identity and of
strength, quality, and purity; (2) tests and methods of assay to
determine compliance with such standards; (3) effective periods for
certificates, and other conditions under which they shall cease to be
effective as to certified batches and as to portions thereof; (4)
administration and procedure; and (5) such fees, specified in such
regulations, as are necessary to provide, equip, and maintain an
adequate certification service. Such regulations shall prescribe no
standard of identity or of strength, quality, or purity for any drug
different from the standard of identity, strength, quality, or purity
set forth for such drug in an official compendium.
(c) Tests or methods of assay; revision
Such regulations, insofar as they prescribe tests or methods of assay
to determine strength, quality, or purity of any drug, different from
the tests or methods of assay set forth for such drug in an official
compendium, shall be prescribed, after notice and opportunity for
revision of such compendium, in the manner provided in the second
sentence of section 351(b) of this title. The provisions of subsections
(e), (f), and (g) of section 371 of this title shall be applicable to
such portion of any regulation as prescribes any such different test or
method, but shall not be applicable to any other portion of any such
regulation.
(June 25, 1938, ch. 675, 506, as added Dec. 22, 1941, ch. 613, 3, 55
Stat. 851, and amended 1953 Reorg. Plan No. 1, 5, eff. Apr. 11, 1953, 18
F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96-88, title V, 509(b),
93 Stat. 695.)
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in subsec. (a) pursuant
to section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
Section 4 of act Dec. 22, 1941, directed that regulations initially
prescribed under this section were to be promulgated and made effective
within forty-five days after Dec. 22, 1941.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
1396r-8.
21 USC 357. Certification of drugs containing penicillin, streptomycin,
chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic
drug
TITLE 21 -- FOOD AND DRUGS
(a) Regulations prescribed by Secretary; release prior to
certification; ''antibiotic drug'' defined
The Secretary of Health and Human Services, pursuant to regulations
promulgated by him, shall provide for the certification of batches of
drugs (except drugs for use in animals other than man) composed wholly
or partly of any kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, bacitracin, or any other antibiotic drug, or any
derivative thereof. A batch of any such drug shall be certified if such
drug has such characteristics of identity and such batch has such
characteristics of strength, quality, and purity, as the Secretary
prescribes in such regulations as necessary to adequately insure safety
and efficacy of use, but shall not otherwise be certified. Prior to the
effective date of such regulations the Secretary, in lieu of
certification, shall issue a release for any batch which, in his
judgment, may be released without risk as to the safety and efficacy of
its use. Such release shall prescribe the date of its expiration and
other conditions under which it shall cease to be effective as to such
batch and as to portions thereof. For purposes of this section and of
section 352(l) of this title, the term ''antibiotic drug'' means any
drug intended for use by man containing any quantity of any chemical
substance which is produced by a microorganism and which has the
capacity to inhibit or destroy microorganisms in dilute solution
(including the chemically synthesized equivalent of any such substance).
(b) Provisions of regulations
Regulations providing for such certifications shall contain such
provisions as are necessary to carry out the purposes of this section,
including provisions prescribing (1) standards of identity and of
strength, quality, and purity; (2) tests and methods of assay to
determine compliance with such standards; (3) effective periods for
certificates, and other conditions under which they shall cease to be
effective as to certified batches and as to portions thereof; (4)
administration and procedure; and (5) such fees, specified in such
regulations, as are necessary to provide, equip, and maintain an
adequate certification service. Such regulations shall prescribe only
such tests and methods of assay as will provide for certification or
rejection within the shortest time consistent with the purposes of this
section.
(c) Exemption of drugs not involving safety and efficacy of use;
considerations; certification after exemption; labeling and
advertising claims
Whenever in the judgment of the Secretary, the requirements of this
section and of section 352(l) of this title with respect to any drug or
class of drugs are not necessary to insure safety and efficacy of use,
the Secretary shall promulgate regulations exempting such drug or class
of drugs from such requirements. In deciding whether an antibiotic
drug, or class of antibiotic drugs, is to be exempted from the
requirement of certification the Secretary shall give consideration,
among other relevant factors, to --
(1) whether such drug or class of drugs is manufactured by a person
who has, or hereafter shall have, produced fifty consecutive batches of
such drug or class of drugs in compliance with the regulations for the
certification thereof within a period of not more than eighteen calendar
months, upon the application by such person to the Secretary; or
(2) whether such drug or class of drugs is manufactured by any person
who has otherwise demonstrated such consistency in the production of
such drug or class of drugs, in compliance with the regulations for the
certification thereof, as in the judgment of the Secretary is adequate
to insure the safety and efficacy of use thereof.
When an antibiotic drug or a drug manufacturer has been exempted from
the requirement of certification, the manufacturer may still obtain
certification of a batch or batches of that drug if he applies for and
meets the requirements for certification. Nothing in this chapter shall
be deemed to prevent a manufacturer or distributor of an antibiotic drug
from making a truthful statement in labeling or advertising of the
product as to whether it has been certified or exempted from the
requirement of certification.
(d) Exemption of drugs stored, processed, and labeled at plants other
than manufacturer's, used in manufacture of other drugs or for
investigational purposes; discretionary and mandatory conditions;
direct reports to Secretary
The Secretary shall promulgate regulations exempting from any
requirement of this section and of section 352(l) of this title, (1)
drugs which are to be stored, processed, labeled, or repacked at
establishments other than those where manufactured, on condition that
such drugs comply with all such requirements upon removal from such
establishments; (2) drugs which conform to applicable standards of
identity, strength, quality, and purity prescribed by these regulations
and are intended for use in manufacturing other drugs; and (3) drugs
which are intended solely for investigational use by experts qualified
by scientific training and experience to investigate the safety and
efficacy of drugs. Such regulations may, within the discretion of the
Secretary, among other conditions relating to the protection of the
public health, provide for conditioning the exemption under clause (3)
of this subsection upon --
(1) the submission to the Secretary, before any clinical testing of a
new drug is undertaken, of reports, by the manufacturer or the sponsor
of the investigation of such drug, of preclinical tests (including tests
on animals) of such drug adequate to justify the proposed clinical
testing;
(2) the manufacturer or the sponsor of the investigation of a new
drug proposed to be distributed to investigators for clinical testing
obtaining a signed agreement from each of such investigators that
patients to whom the drug is administered will be under his personal
supervision, or under the supervision of investigators responsible to
him, and that he will not supply such drug to any other investigator, or
to clinics, for administration to human beings; and
(3) the establishment and maintenance of such records, and the making
of such reports to the Secretary, by the manufacturer or the sponsor of
the investigation of such drug, of data (including but not limited to
analytical reports by investigators) obtained as the result of such
investigational use of such drug, as the Secretary finds will enable him
to evaluate the safety and effectiveness of such drug in the event of
the filing of an application for certification or release pursuant to
subsection (a) of this section.
Such regulations shall provide that such exemption shall be
conditioned upon the manufacturer, or the sponsor of the investigation,
requiring that experts using such drugs for investigational purposes
certify to such manufacturer or sponsor that they will inform any human
beings to whom such drugs, or any controls used in connection therewith,
are being administered, or their representatives, that such drugs are
being used for investigational purposes and will obtain the consent of
such human beings or their representatives, except where they deem it
not feasible or, in their professional judgment, contrary to the best
interests of such human beings. Nothing in this subsection shall be
construed to require any clinical investigator to submit directly to the
Secretary reports on the investigational use of drugs.
(e) Exempted new drugs subject to section 355 of this title; request
for certification of exempted drug; determination of compliance with
sections 351(b) and 352(g) of this title
No drug which is subject to this section shall be deemed to be
subject to any provision of section 355 of this title except a new drug
exempted from the requirements of this section and of section 352(l) of
this title pursuant to regulations promulgated by the Secretary:
Provided, That, for purposes of section 355 of this title, the initial
request for certification, as thereafter duly amended, pursuant to this
section, of a new drug so exempted shall be considered a part of the
application filed pursuant to section 355(b) of this title with respect
to the person filing such request and to such drug as of the date of the
exemption. Compliance of any drug subject to section 352(l) of this
title or this section with sections 351(b) and 352(g) of this title
shall be determined by the application of the standards of strength,
quality, and purity, the tests and methods of assay, and the
requirements of packaging and labeling, respectively, prescribed by
regulations promulgated under this section.
(f) Filing of petitions; contents; notice; answer; public
hearing; orders
Any interested person may file with the Secretary a petition
proposing the issuance, amendment, or repeal of any regulation
contemplated by this section. The petition shall set forth the proposal
in general terms and shall state reasonable grounds therefor. The
Secretary shall give public notice of the proposal and an opportunity
for all interested persons to present their views thereon, orally or in
writing, and as soon as practicable thereafter shall make public his
action upon such proposal. At any time prior to the thirtieth day after
such action is made public any interested person may file objections to
such action, specifying with particularity the changes desired, stating
reasonable grounds therefor, and requesting a public hearing upon such
objections. The Secretary shall thereupon, after due notice, hold such
public hearing. As soon as practicable after completion of the hearing,
the Secretary shall by order make public his action on such objections.
The Secretary shall base his order only on substantial evidence of
record at the hearing and shall set forth as part of the order detailed
findings of fact on which the order is based. The order shall be
subject to the provisions of section 371(f) and (g) of this title.
(g) Records and reports; professional ethics and interests of
patients; examination of data; access to records
(1) Every person engaged in manufacturing, compounding, or processing
any drug within the purview of this section with respect to which a
certificate or release has been issued pursuant to this section shall
establish and maintain such records, and make such reports to the
Secretary, of data relating to clinical experience and other data or
information, received or otherwise obtained by such person with respect
to such drug, as the Secretary may by general regulation, or by order
with respect to such certification or release, prescribe on the basis of
a finding that such records and reports are necessary in order to enable
the Secretary to make, or to facilitate, a determination as to whether
such certification or release should be rescinded or whether any
regulation issued under this section should be amended or repealed:
Provided, however, That regulations and orders issued under this
subsection and under clause (3) of subsection (d) of this section shall
have due regard for the professional ethics of the medical profession
and the interests of patients and shall provide, where the Secretary
deems it to be appropriate, for the examination, upon request, by the
persons to whom such regulations or orders are applicable, of similar
information received or otherwise obtained by the Secretary.
(2) Every person required under this section to maintain records, and
every person having charge or custody thereof, shall, upon request of an
officer or employee designated by the Secretary, permit such officer or
employee at all reasonable times to have access to and copy and verify
such records.
(h) Issuance of regulations; conditions; amendment or repeal of
regulations; effective date; procedure; lack of substantial evidence
In the case of a drug for which, on the day immediately preceding May
1, 1963, a prior approval of an application under section 355 of this
title had not been withdrawn under section 355(e) of this title, the
initial issuance of regulations providing for certification or exemption
of such drug under this section shall, with respect to the conditions of
use prescribed, recommended, or suggested in the labeling covered by
such application, not be conditioned upon an affirmative finding of the
efficacy of such drug. Any subsequent amendment or repeal of such
regulations so as no longer to provide for such certification or
exemption on the ground of a lack of efficacy of such drug for use under
such conditions of use may be effected only on or after May 1, 1963,
which would be applicable to such drug under such conditions of use if
such drug were subject to section 355(e) of this title, and then only if
(1) such amendment or repeal is made in accordance with the procedure
specified in subsection (f) of this section (except that such amendment
or repeal may be initiated either by a proposal of the Secretary or by a
petition of any interested person) and (2) the Secretary finds, on the
basis of new information with respect to such drug evaluated together
with the information before him when the application under section 355
of this title became effective or was approved, that there is a lack of
substantial evidence (as defined in section 355(d) of this title) that
the drug has the effect it purports or is represented to have under such
conditions of use.
(June 25, 1938, ch. 675, 507, as added July 6, 1945, ch. 281, 3, 59
Stat. 463, and amended Mar. 10, 1947, ch. 16, 3, 61 Stat. 12; July 13,
1949, ch. 305, 2, 63 Stat. 409; 1953 Reorg. Plan No. 1, 5, eff. Apr.
11, 1953, 18 F.R. 2053, 67 Stat. 631; Aug. 5, 1953, ch. 334, 2, 67
Stat. 389; Oct. 10, 1962, Pub. L. 87-781, title I, 105(a), (b), (d)-(
f), 106(a), (b), 76 Stat. 785, 786, 787; July 13, 1968, Pub. L.
90-399, 105(b), 82 Stat. 352; Oct. 17, 1979, Pub. L. 96-88, title V,
509(b), 93 Stat. 695.)
1968 -- Subsec. (a). Pub. L. 90-399 inserted ''(except drugs for use
in animals other than man)'' after ''drugs'' in first sentence.
1962 -- Subsec. (a). Pub. L. 87-781, 105(a), (b), inserted
definition of ''antibiotic drug'' and substituted ''bacitracin, or any
other antibiotic drug'' for ''or bacitracin''.
Subsec. (c). Pub. L. 87-781, 105(d), required the Secretary to
consider, among other relevant factors, whether such drug or class of
drugs is manufactured by anyone who has, or shall have, produced 50
consecutive batches in compliance with the regulations for
certification, within a period of not more than 18 months, or whether it
is manufactured by anyone who has otherwise demonstrated such
consistency in production as the Secretary determines is adequate to
insure the safety and efficacy thereof, and provided that an exempted
manufacturer may still obtain certification of a batch or batches of a
drug if he applies for and meets the requirements, and that nothing in
this chapter shall be deemed to prevent a truthful statement in labeling
or advertising of whether or not the product has been certified or
exempted from the requirement of certification.
Subsec. (d). Pub. L. 87-781, 106(b), provided that the regulations
may condition the exemption under cl. (3) of this subsection upon the
submission of reports of preclinical tests to justify the proposed
clinical testing, upon the obtaining by the manufacturer or sponsor of
the investigation of a new drug of a signed agreement from each of the
investigators that patients to whom the drug is administered will be
under his supervision, or under investigators responsible to him, and
that he will not supply such drug to any other investigator, or to
clinics, for administration to human beings, or upon the establishment
and maintenance of records and reports of data obtained by the
investigational use of such drug, as the Secretary finds will enable him
to evaluate the safety and effectiveness of such drug, and that the
regulations shall condition an exemption upon the manufacturer or
sponsor of the investigation requiring that experts using such drugs
certify that they will inform humans to whom such drugs or any controls
connected therewith are administered, or their representatives, and will
obtain the consent of such people where feasible and not against the
best interests of such people, and that reports on the investigational
use of drugs are not required to be submitted directly to the Secretary.
Subsec. (e). Pub. L. 87-781, 105(e), subjected new drugs, exempted
from the requirements of this section and of section 352(l) of this
title to section 355 of this title, and provided that for purposes of
said section 355, the initial request for certification, as thereafter
amended, pursuant to this section, shall be considered a part of the
application filed pursuant to section 355(b) of this title with respect
to the person filing, and to the drug in question as of the date of the
exemption.
Subsec. (g). Pub. L. 87-781, 106(a), added subsec. (g).
Subsec. (h). Pub. L. 87-781, 105(f), added subsec. (h).
1953 -- Act Aug. 5, 1953, 2(a), substituted ''chlortetracycline''
for ''aureomycin'' in section catchline.
Subsec. (a). Act Aug. 5, 1953, 2(b), substituted
''chlortetracycline'' for ''aureomycin''.
1949 -- Act July 13, 1949, 2(a), inserted ''aureomycin,
chloramphenicol, or bacitracin'' in section catchline.
Subsec. (a). Act July 13, 1949, 2(b), inserted '', aureomycin,
chloramphenicol, or bacitracin'' after ''streptomycin''.
1947 -- Act Mar. 10, 1947, inserted ''or streptomycin'' after
''penicillin'' in section catchline.
Subsec. (a). Act Mar. 10, 1947, inserted ''or streptomycin'' after
''penicillin'' in first sentence.
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in subsec. (a) pursuant
to section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions note
under section 360b of this title.
Amendment by Pub. L. 87-781 effective on first day of seventh
calendar month following October 1962, see section 107 of Pub. L.
87-781, set out as a note under section 321 of this title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
title 42 section 1396r-8.
21 USC 358. Authority to designate official names
TITLE 21 -- FOOD AND DRUGS
(a) Necessity or desirability; use in official compendiums;
infringement of trademarks
The Secretary may designate an official name for any drug or device
if he determines that such action is necessary or desirable in the
interest of usefulness and simplicity. Any official name designated
under this section for any drug or device shall be the only official
name of that drug or device used in any official compendium published
after such name has been prescribed or for any other purpose of this
chapter. In no event, however, shall the Secretary establish an
official name so as to infringe a valid trademark.
(b) Review of names in official compendiums
Within a reasonable time after October 10, 1962, and at such other
times as he may deem necessary, the Secretary shall cause a review to be
made of the official names by which drugs are identified in the official
United States Pharmacopoeia, the official Homoeopathic Pharmacopoeia of
the United States, and the official National Formulary, and all
supplements thereto, and at such times as he may deem necessary shall
cause a review to be made of the official names by which devices are
identified in any official compendium (and all supplements thereto) to
determine whether revision of any of those names is necessary or
desirable in the interest of usefulness and simplicity.
(c) Determinations of complexity, usefulness, multiplicity, or lack
of name; designation by Secretary
Whenever he determines after any such review that (1) any such
official name is unduly complex or is not useful for any other reason,
(2) two or more official names have been applied to a single drug or
device, or to two or more drugs which are identical in chemical
structure and pharmacological action and which are substantially
identical in strength, quality, and purity, or to two or more devices
which are substantially equivalent in design and purpose or (3) no
official name has been applied to a medically useful drug or device, he
shall transmit in writing to the compiler of each official compendium in
which that drug or drugs or device are identified and recognized his
request for the recommendation of a single official name for such drug
or drugs or device which will have usefulness and simplicity. Whenever
such a single official name has not been recommended within one hundred
and eighty days after such request, or the Secretary determines that any
name so recommended is not useful for any reason, he shall designate a
single official name for such drug or drugs or device. Whenever he
determines that the name so recommended is useful, he shall designate
that name as the official name of such drug or drugs or device. Such
designation shall be made as a regulation upon public notice and in
accordance with the procedure set forth in section 553 of title 5.
(d) Revised official names; compilation, publication, and public
distribution of listings
After each such review, and at such other times as the Secretary may
determine to be necessary or desirable, the Secretary shall cause to be
compiled, published, and publicly distributed a list which shall list
all revised official names of drugs or devices designated under this
section and shall contain such descriptive and explanatory matter as the
Secretary may determine to be required for the effective use of those
names.
(e) Request by compiler of official compendium for designation of
name
Upon a request in writing by any compiler of an official compendium
that the Secretary exercise the authority granted to him under
subsection (a) of this section, he shall upon public notice and in
accordance with the procedure set forth in section 553 of title 5
designate the official name of the drug or device for which the request
is made.
(June 25, 1938, ch. 675, 508, as added Oct. 10, 1962, Pub. L.
87-781, title I, 111(a), 76 Stat. 789, and amended May 28, 1976, Pub.
L. 94-295, 5(b), 90 Stat. 581.)
In subsecs. (c) and (e), ''section 553 of title 5'' substituted for
''section 4 of the Administrative Procedure Act (5 U.S.C. 1003)'' on
authority of Pub. L. 89-554, 7(b), Sept. 6, 1966, 80 Stat. 631, the
first section of which enacted Title 5, Government Organization and
Employees.
1976 -- Subsec. (a). Pub. L. 94-295 substituted ''drug or device''
for ''drug'' wherever appearing.
Subsec. (b). Pub. L. 94-295 substituted ''National Formulary, and all
supplements thereto, and at such times as he may deem necessary shall
cause a review to be made of the official names by which devices are
identified in any official compendium (and all supplements thereto)''
for ''National Formulary, and all supplements thereto,''.
Subsec. (c)(2). Pub. L. 94-295 inserted ''or device'' after ''single
drug'', and ''or to two or more devices which are substantially
equivalent in design and purpose'' after ''purity,''.
Subsec. (c)(3). Pub. L. 94-295 inserted ''or device'' after ''useful
drug'' and after ''drug or drugs'' wherever appearing.
Subsec. (d). Pub. L. 94-295 inserted ''or devices'' after ''drugs''.
Subsec. (e). Pub. L. 94-295 substituted ''drug or device'' for
''drug''.
Section 111(b) of Pub. L. 87-781 provided that: ''This section
(enacting this section) shall take effect on the date of its enactment
(Oct. 10, 1962).''
21 USC 359. Nonapplicability of subchapter to cosmetics
TITLE 21 -- FOOD AND DRUGS
This subchapter, as amended by the Drug Amendments of 1962, shall not
apply to any cosmetic unless such cosmetic is also a drug or device or
component thereof.
(June 25, 1938, ch. 675, 509, as added Oct. 10, 1962, Pub. L.
87-781, title I, 113, 76 Stat. 791.)
This subchapter, as amended by the Drug Amendments of 1962, referred
to in text, means the amendment of this subchapter by Pub. L. 87-781
which enacted sections 358 to 360 of this title, amended sections 351 to
353, 355, and 357 of this title, and enacted provisions set out as notes
under sections 352, 355, 358, and 360 of this title.
The Drug Amendments of 1962, referred to in text, is Pub. L.
87-781, Oct. 10, 1962, 76 Stat. 780, as amended. For complete
classification of this Act to the Code, see Short Title of 1962
Amendment note set out under section 301 of this title and Tables.
21 USC 360. Registration of producers of drugs or devices
TITLE 21 -- FOOD AND DRUGS
(a) Definitions
As used in this section --
(1) the term ''manufacture, preparation, propagation, compounding, or
processing'' shall include repackaging or otherwise changing the
container, wrapper, or labeling of any drug package or device package in
furtherance of the distribution of the drug or device from the original
place of manufacture to the person who makes final delivery or sale to
the ultimate consumer or user; and
(2) the term ''name'' shall include in the case of a partnership the
name of each partner and, in the case of a corporation, the name of each
corporate officer and director, and the State of incorporation.
(b) Annual registration
On or before December 31 of each year every person who owns or
operates any establishment in any State engaged in the manufacture,
preparation, propagation, compounding, or processing of a drug or drugs
or a device or devices shall register with the Secretary his name,
places of business, and all such establishments.
(c) New producers
Every person upon first engaging in the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs or a device
or devices in any establishment which he owns or operates in any State
shall immediately register with the Secretary his name, place of
business, and such establishment.
(d) Additional establishments
Every person duly registered in accordance with the foregoing
subsections of this section shall immediately register with the
Secretary any additional establishment which he owns or operates in any
State and in which he begins the manufacture, preparation, propagation,
compounding, or processing of a drug or drugs or a device or devices.
(e) Registration number; uniform system for identification of
devices intended for human use
The Secretary may assign a registration number to any person or any
establishment registered in accordance with this section. The Secretary
may also assign a listing number to each drug or class of drugs listed
under subsection (j) of this section. Any number assigned pursuant to
the preceding sentence shall be the same as that assigned pursuant to
the National Drug Code. The Secretary may by regulation prescribe a
uniform system for the identification of devices intended for human use
and may require that persons who are required to list such devices
pursuant to subsection (j) of this section shall list such devices in
accordance with such system.
(f) Availability of registrations for inspection
The Secretary shall make available for inspection, to any person so
requesting, any registration filed pursuant to this section; except
that any list submitted pursuant to paragraph (3) of subsection (j) of
this section and the information accompanying any list or notice filed
under paragraph (1) or (2) of that subsection shall be exempt from such
inspection unless the Secretary finds that such an exemption would be
inconsistent with protection of the public health.
(g) Exclusions from application of section
The foregoing subsections of this section shall not apply to --
(1) pharmacies which maintain establishments in conformance with any
applicable local laws regulating the practice of pharmacy and medicine
and which are regularly engaged in dispensing prescription drugs or
devices, upon prescriptions of practitioners licensed to administer such
drugs or devices to patients under the care of such practitioners in the
course of their professional practice, and which do not manufacture,
prepare, propagate, compound, or process drugs or devices for sale other
than in the regular course of their business of dispensing or selling
drugs or devices at retail;
(2) practitioners licensed by law to prescribe or administer drugs or
devices and who manufacture, prepare, propagate, compound, or process
drugs or devices solely for use in the course of their professional
practice;
(3) persons who manufacture, prepare, propagate, compound, or process
drugs or devices solely for use in research, teaching, or chemical
analysis and not for sale;
(4) such other classes of persons as the Secretary may by regulation
exempt from the application of this section upon a finding that
registration by such classes of persons in accordance with this section
is not necessary for the protection of the public health.
(h) Inspection of premises
Every establishment in any State registered with the Secretary
pursuant to this section shall be subject to inspection pursuant to
section 374 of this title and every such establishment engaged in the
manufacture, propagation, compounding, or processing of a drug or drugs
or of a device or devices classified in class II or III shall be so
inspected by one or more officers or employees duly designated by the
Secretary at least once in the two-year period beginning with the date
of registration of such establishment pursuant to this section and at
least once in every successive two-year period thereafter.
(i) Foreign establishments
Any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of a
drug or drugs, or a device or devices, shall be permitted to register
under this section pursuant to regulations promulgated by the Secretary.
Such regulations shall require such establishment to provide the
information required by subsection (j) of this section and shall require
such establishment to provide the information required by subsection (j)
of this section in the case of a device or devices and shall include
provisions for registration of any such establishment upon condition
that adequate and effective means are available, by arrangement with the
government of such foreign country or otherwise, to enable the Secretary
to determine from time to time whether drugs or devices manufactured,
prepared, propagated, compounded, or processed in such establishment, if
imported or offered for import into the United States, shall be refused
admission on any of the grounds set forth in section 381(a) of this
title.
(j) Filing of lists of drugs and devices manufactured, prepared,
propagated and compounded by registrants; statements; accompanying
disclosures
(1) Every person who registers with the Secretary under subsection
(b), (c), or (d) of this section shall, at the time of registration
under any such subsection, file with the Secretary a list of all drugs
and a list of all devices and a brief statement of the basis for
believing that each device included in the list is a device rather than
a drug (with each drug and device in each list listed by its established
name (as defined in section 352(e) of this title) and by any proprietary
name) which are being manufactured, prepared, propagated, compounded, or
processed by him for commercial distribution and which he has not
included in any list of drugs or devices filed by him with the Secretary
under this paragraph or paragraph (2) before such time of registration.
Such list shall be prepared in such form and manner as the Secretary may
prescribe and shall be accompanied by --
(A) in the case of a drug contained in the applicable list and
subject to sections 355, 356, 357, or 360b of this title, or a device
intended for human use contained in the applicable list with respect to
which a performance standard has been established under section 360d of
this title or which is subject to section 360e of this title, a
reference to the authority for the marketing of such drug or device and
a copy of all labeling for such drug or device;
(B) in the case of any other drug or device contained in an
applicable list --
(i) which drug is subject to section 353(b)(1) of this title, or
which device is a restricted device, a copy of all labeling for such
drug or device, a representative sampling of advertisements for such
drug or device, and, upon request made by the Secretary for good cause,
a copy of all advertisements for a particular drug product or device, or
(ii) which drug is not subject to section 353(b)(1) of this title or
which device is not a restricted device, the label and package insert
for such drug or device and a representative sampling of any other
labeling for such drug or device;
(C) in the case of any drug contained in an applicable list which is
described in subparagraph (B), a quantitative listing of its active
ingredient or ingredients, except that with respect to a particular drug
product the Secretary may require the submission of a quantitative
listing of all ingredients if he finds that such submission is necessary
to carry out the purposes of this chapter; and
(D) if the registrant filing a list has determined that a particular
drug product or device contained in such list is not subject to section
355, 356, 357, or 360b of this title, or the particular device contained
in such list is not subject to a performance standard established under
section 360d of this title or to section 360e of this title or is not a
restricted device a brief statement of the basis upon which the
registrant made such determination if the Secretary requests such a
statement with respect to that particular drug product or device.
(2) Each person who registers with the Secretary under this section
shall report to the Secretary once during the month of June of each year
and once during the month of December of each year the following
information:
(A) A list of each drug or device introduced by the registrant for
commercial distribution which has not been included in any list
previously filed by him with the Secretary under this subparagraph or
paragraph (1) of this subsection. A list under this subparagraph shall
list a drug or device by its established name (as defined in section
352(e) of this title), and by any proprietary name it may have and shall
be accompanied by the other information required by paragraph (1).
(B) If since the date the registrant last made a report under this
paragraph (or if he has not made a report under this paragraph, since
February 1, 1973) he has discontinued the manufacture, preparation,
propagation, compounding, or processing for commercial distribution of a
drug or device included in a list filed by him under subparagraph (A) or
paragraph (1); notice of such discontinuance, the date of such
discontinuance, and the identity (by established name (as defined in
section 352(e) of this title) and by any proprietary name) of such drug
or device.
(C) If since the date the registrant reported pursuant to
subparagraph (B) a notice of discontinuance he has resumed the
manufacture, preparation, propagation, compounding, or processing for
commercial distribution of the drug or device with respect to which such
notice of discontinuance was reported; notice of such resumption, the
date of such resumption, the identity of such drug or device (each by
established name (as defined in section 352(e) of this title) and by any
proprietary name), and the other information required by paragraph (1),
unless the registrant has previously reported such resumption to the
Secretary pursuant to this subparagraph.
(D) Any material change in any information previously submitted
pursuant to this paragraph or paragraph (1).
(3) The Secretary may also require each registrant under this section
to submit a list of each drug product which (A) the registrant is
manufacturing, preparing, propagating, compounding, or processing for
commercial distribution, and (B) contains a particular ingredient. The
Secretary may not require the submission of such a list unless he has
made a finding that the submission of such a list is necessary to carry
out the purposes of this chapter.
(k) Report preceding introduction of devices into interstate commerce
Each person who is required to register under this section and who
proposes to begin the introduction or delivery for introduction into
interstate commerce for commercial distribution of a device intended for
human use shall, at least ninety days before making such introduction or
delivery, report to the Secretary (in such form and manner as the
Secretary shall by regulation prescribe) --
(1) the class in which the device is classified under section 360c of
this title or if such person determines that the device is not
classified under such section, a statement of that determination and the
basis for such person's determination that the device is or is not so
classified, and
(2) action taken by such person to comply with requirements under
section 360d or 360e of this title which are applicable to the device.
(June 25, 1938, ch. 675, 510, as added Oct. 10, 1962, Pub. L.
87-781, title III, 302, 76 Stat. 794, and amended July 15, 1965, Pub.
L. 89-74, 4, 79 Stat. 231; Oct. 27, 1970, Pub. L. 91-513, title II,
701(e), 84 Stat. 1282; Aug. 16, 1972, Pub. L. 92-387, 3, 4(a)-(c), 86
Stat. 560-562; May 28, 1976, Pub. L. 94-295, 4(a), 90 Stat. 579.)
1976 -- Subsec. (a)(1). Pub. L. 94-295, 4(a)(2), substituted ''drug
package or device package'' for ''drug package'', ''distribution of the
drug or device'' for ''distribution of the drug'', and ''ultimate
consumer or user'' for ''ultimate consumer''.
Subsecs. (b) to (d). Pub. L. 94-295, 4(a)(3), inserted ''or a device
or devices'' after ''drug or drugs''.
Subsec. (e). Pub. L. 94-295, 4(a)(4), authorized the Secretary to
prescribe by regulation a uniform system for the identification of
devices intended for human use and authorized him, in addition, to
require that persons who are required to list devices pursuant to
subsec. (j) also list such devices in accordance with the system.
Subsec. (g)(1) to (3). Pub. L. 94-295, 4(a)(5), substituted ''drugs
or devices'' for ''drugs''.
Subsec. (h). Pub. L. 94-295, 4(a)(6), inserted reference to
establishments engaged in the manufacture, propagation, compounding, or
processing of a drug or drugs or of a device or devices classified in
class II or III.
Subsec. (i). Pub. L. 94-295, 4(a)(7), inserted reference to devices
and inserted requirement that regulations require establishments to
provide the information required by subsection (j) of this section in
the case of a device or devices.
Subsec. (j)(1). Pub. L. 94-295, 4(a)(8)(A), in introductory
provisions substituted ''a list of all drugs and a list of all devices
and a brief statement of the basis for believing that each device
included in the list is a device rather than a drug (with each drug and
device in each list listed by its established name'' for ''a list of all
drugs (by established name'' and ''drugs or devices filed'' for ''drugs
filed''.
Subsec. (j)(1)(A). Pub. L. 94-295, 4(a)(8)(B), substituted ''the
applicable list'' for ''such list'', inserted ''or a device intended for
human use contained in the applicable list with respect to which a
performance standard has been established under section 360d of this
title or which is subject to section 360e of this title,'' after ''360b
of this title,'', and substituted ''such drug or device'' for ''such
drug'' wherever appearing.
Subsec. (j)(1)(B). Pub. L. 94-295, 4(a)(8)(C), in introductory
provisions substituted ''drug or device contained in an applicable
list'' for ''drug contained in such list''.
Subsec. (j)(1)(B)(i). Pub. L. 94-295, 4(a)(8)(D), substituted ''which
drug is subject to section 353(b)(1) of this title, or which device is a
restricted device, a copy of all labeling for such drug or device, a
representative sampling of advertisements for such drug or device, and,
upon request made by the Secretary for good cause, a copy of all
advertisements for a particular drug product or device, or'' for ''which
is subject to section 353(b)(1) of this title, a copy of all labeling
for such drug, a representative sampling of advertisements for such
drug, and, upon request made by the Secretary for good cause, a copy of
all advertisements for a particular drug product, or''.
Subsec. (j)(1)(B)(ii). Pub. L. 94-295, 4(a)(8)(E), substituted
''which drug is not subject to section 353(b)(1) of this title or which
device is not a restricted device, the label and package insert for such
drug or device and a representative sampling of any other labeling for
such drug or device'' for ''which is not subject to section 353(b)( 1)
of this title, the label and package insert for such drug and a
representative sampling of any other labeling for such drug''.
Subsec. (j)(1)(C). Pub. L. 94-295, 4(a)(8)(F), substituted ''an
applicable list'' for ''such list''.
Subsec. (j)(1)(D). Pub. L. 94-295, 4(a)(8)(G), substituted ''a list''
for ''the list'', inserted ''or the particular device contained in such
list is not subject to a performance standard established under section
360d of this title or to section 360e of this title or is not a
restricted device'' after ''or 360b of this title,'', and substituted
''particular drug product or device'' for ''particular drug product''
wherever appearing.
Subsec. (j)(2). Pub. L. 94-295, 4(a)(8)(H), substituted ''drug or
''device'' for ''drug'' in subpars. (A), (B), and (C), and substituted
''(each by established name'' for ''(by established name'' in subpar.
(C).
Subsec. (k). Pub. L. 94-295, 4(a)(9), added subsec. (k).
1972 -- Subsec. (e). Pub. L. 92-387, 4(a), inserted provision that
the Secretary may assign a listing number to each drug or class of drugs
listed under subsec. (j).
Subsec. (f). Pub. L. 92-387, 4(b), inserted exception that the list
submitted under subsec. (j)(3) and information submitted under subsec.
(j)(1), (2) shall be exempt from inspection unless the Secretary
determines otherwise.
Subsec. (i). Pub. L. 92-387, 4(c), inserted provision that the
regulations shall require such establishment to provide the information
required by subsec. (j).
Subsec. (j). Pub. L. 92-387, 3, added subsec. (j).
1970 -- Subsec. (a). Pub. L. 91-513 struck out provisions defining
the wholesaling, jobbing, or distributing of depressant or stimulant
drugs.
Subsec. (b). Pub. L. 91-513 struck out provisions covering
establishments engaged in the wholesaling, jobbing, or distributing of
depressant or stimulant drugs and the inclusion of the fact of such
activity in the annual registration.
Subsec. (c). Pub. L. 91-513 struck out provisions covering new
registrations of persons first engaging in the wholesaling, jobbing, or
distributing of depressant or stimulant drugs and the inclusion of the
fact of such activity in the registration.
Subsec. (d). Pub. L. 91-513 struck out number designation ''(1)''
preceding first sentence, struck out portion of such redesignated
provisions covering the wholesaling, jobbing, or distributing of
depressant or stimulant drugs, and struck out par. (2) covering the
filing of supplemental registration whenever a person not previously
engaged or involved with depressant or stimulant drugs goes into the
manufacturing, preparation, or processing thereof.
1965 -- Pub. L. 89-74, 4(e), included certain wholesalers in section
catchline.
Subsec. (a)(2), (3). Pub. L. 89-74, 4(a), added par. (2) and
redesignated former par. (2) as (3).
Subsecs. (b), (c). Pub. L. 89-74, 4(b), (c), inserted ''or in the
wholesaling, jobbing, or distributing of any depressant or stimulant
drug'' after ''drug or drugs'' and inserted requirement that
establishment indicate activity in depressant or stimulant drugs at time
of registration.
Subsec. (d). Pub. L. 89-74 4(d), designated existing provisions as
par. (1), inserted ''or the wholesaling, jobbing, or distributing of
any depressant or stimulant drug'' and the requirement that the
additional establishment indicate activity in depressant or stimulant
drugs at time of registration, and added par. (2).
Section 5 of Pub. L. 92-387 provided that: ''The amendments made by
this Act (amending this section and sections 331 and 335 of this title
and enacting provisions set out below) shall take effect on the first
day of the sixth month beginning after the date of enactment of this Act
(Aug. 16, 1972).''
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of Pub.
L. 91-513, set out as an Effective Date note under section 801 of this
title.
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, subject to
registration with Secretary of names, places of business,
establishments, and other prescribed information prior to Feb. 1, 1966,
see section 11 of Pub. L. 89-74, set out as a note under section 321 of
this title.
Amendment by Pub. L. 91-513 not to affect or abate any prosecutions
for any violation of law or any civil seizures or forfeitures and
injunctive proceedings commenced prior to the effective date of such
amendment, and all administrative proceedings pending before the Bureau
of Narcotics and Dangerous Drugs (now the Drug Enforcement
Administration) on Oct. 27, 1970, to be continued and brought to final
determination in accord with laws and regulations in effect prior to
Oct. 27, 1970, see section 702 of Pub. L. 91-513, set out as a note
under section 321 of this title.
Section 301 of Pub. L. 87-781 provided that: ''The Congress hereby
finds and declares that in order to make regulation of interstate
commerce in drugs effective, it is necessary to provide for registration
and inspection of all establishments in which drugs are manufactured,
prepared, propagated, compounded, or processed; that the products of
all such establishments are likely to enter the channels of interstate
commerce and directly affect such commerce; and that the regulation of
interstate commerce in drugs without provision for registration and
inspection of establishments that may be engaged only in intrastate
commerce in such drugs would discriminate against and depress interstate
commerce in such drugs, and adversely burden, obstruct, and affect such
interstate commerce.''
Section 2 of Pub. L. 92-387 provided that: ''The Federal Government
which is responsible for regulating drugs has no ready means of
determining what drugs are actually being manufactured or packed by
establishments registered under the Federal Food, Drug, and Cosmetic Act
(this chapter) except by periodic inspection of such registered
establishments. Knowledge of which particular drugs are being
manufactured or packed by each registered establishment would
substantially assist in the enforcement of Federal laws requiring that
such drugs be pure, safe, effective, and properly labeled. Information
on the discontinuance of a particular drug could serve to alleviate the
burden of reviewing and implementing enforcement actions against drugs
which, although commercially discontinued, remain active for regulatory
purposes. Information on the type and number of different drugs being
manufactured or packed by drug establishments could permit more
effective and timely regulation by the agencies of the Federal
Government responsible for regulating drugs, including identification of
which drugs in interstate commerce are subject to section 505 or 507
(section 355 or 357 of this title), or to other provisions of the
Federal Food, Drug, and Cosmetic Act.''
Section 303 of Pub. L. 87-781 provided that any person who, on the
day immediately preceding Oct. 10, 1962, owned or operated an
establishment which manufactured or processed drugs, registered before
the first day of the seventh month following October, 1962, would be
deemed to be registered in accordance with subsec. (b) of this section
for the calendar year 1962 and if registered within this period and
effected in 1963, be deemed in compliance for that calendar year.
21 USC 360a. Repealed. Pub. L. 91-513, title II, 701(a), Oct. 27, 1970,
84 Stat. 1281
TITLE 21 -- FOOD AND DRUGS
Section, act June 25, 1938, ch. 675, 511, as added July 15, 1965,
Pub. L. 89-74, 3(b), 79 Stat. 227, and amended Oct. 24, 1968, Pub.
L. 90-639, 2(a), 82 Stat. 1361, regulated the manufacture, compounding,
and processing of depressant and stimulant drugs and their sale,
delivery, disposal, possession, and recordkeeping activities connected
therewith. See section 801 et seq. of this title.
Repeal by Pub. L. 91-513 effective on first day of seventh calendar
month that begins after Oct. 26, 1970, see section 704 of Pub. L.
91-513, set out as an Effective Date note under section 801 of this
title.
Repeal not to affect or abate any prosecutions for violation of law
or any civil seizures or forfeitures and injunctive proceedings
commenced prior to the effective date of such repeal, and all
administrative proceedings pending before the Bureau of Narcotics and
Dangerous Drugs (now Drug Enforcement Administration) on Oct. 27, 1970,
to be continued and brought to final determination in accord with laws
and regulations in effect prior to Oct. 27, 1970, see section 702 of
Pub. L. 91-513, set out as a note under section 321 of this title.
21 USC 360b. New animal drugs
TITLE 21 -- FOOD AND DRUGS
(a) Unsafe new animal drugs and animal feed containing such drugs;
conditions of safety; exemption of drugs for research
(1) A new animal drug shall, with respect to any particular use or
intended use of such drug, be deemed unsafe for the purposes of section
351(a)(5) and section 342(a)(2)(D) of this title unless --
(A) there is in effect an approval of an application filed pursuant
to subsection (b) of this section with respect to such use or intended
use of such drug, and
(B) such drug, its labeling, and such use conform to such approved
application.
A new animal drug shall also be deemed unsafe for such purposes in
the event of removal from the establishment of a manufacturer, packer,
or distributor of such drug for use in the manufacture of animal feed in
any State unless at the time of such removal such manufacturer, packer,
or distributor has an unrevoked written statement from the consignee of
such drug, or notice from the Secretary, to the effect that, with
respect to the use of such drug in animal feed, such consignee --
(i) is the holder of an approved application under subsection (m) of
this section; or
(ii) will, if the consignee is not a user of the drug, ship such drug
only to a holder of an approved application under subsection (m) of this
section.
(2) An animal feed bearing or containing a new animal drug shall,
with respect to any particular use or intended use of such animal feed,
be deemed unsafe for the purposes of section 351(a)(6) of this title
unless --
(A) there is in effect an approval of an application filed pursuant
to subsection (b) of this section with respect to such drugs, as used in
such animal feed,
(B) there is in effect an approval of an application pursuant to
subsection (m)(1) of this section with respect to such animal feed, and
(C) such animal feed, its labeling, and such use conform to the
conditions and indications of use published pursuant to subsection (i)
of this section and to the application with respect thereto approved
under subsection (m) of this section.
(3) A new animal drug or an animal feed bearing or containing a new
animal drug shall not be deemed unsafe for the purposes of section 351(
a)(5) or (6) of this title if such article is for investigational use
and conforms to the terms of an exemption in effect with respect thereto
under subsection (j) of this section.
(b) Filing application for uses of new animal drug; contents;
patent information; abbreviated application
(1) Any person may file with the Secretary an application with
respect to any intended use or uses of a new animal drug. Such person
shall submit to the Secretary as a part of the application (A) full
reports of investigations which have been made to show whether or not
such drug is safe and effective for use; (B) a full list of the
articles used as components of such drug; (C) a full statement of the
composition of such drug; (D) a full description of the methods used
in, and the facilities and controls used for, the manufacture,
processing, and packing of such drug; (E) such samples of such drug and
of the articles used as components thereof, of any animal feed for use
in or on which such drug is intended, and of the edible portions or
products (before or after slaughter) of animals to which such drug
(directly or in or on animal feed) is intended to be administered, as
the Secretary may require; (F) specimens of the labeling proposed to be
used for such drug, or in case such drug is intended for use in animal
feed, proposed labeling appropriate for such use, and specimens of the
labeling for the drug to be manufactured, packed, or distributed by the
applicant; (G) a description of practicable methods for determining the
quantity, if any, of such drug in or on food, and any substance formed
in or on food, because of its use; and (H) the proposed tolerance or
withdrawal period or other use restrictions for such drug if any
tolerance or withdrawal period or other use restrictions are required in
order to assure that the proposed use of such drug will be safe. The
applicant shall file with the application the patent number and the
expiration date of any patent which claims the new animal drug for which
the applicant filed the application or which claims a method of using
such drug and with respect to which a claim of patent infringement could
reasonably be asserted if a person not licensed by the owner engaged in
the manufacture, use, or sale of the drug. If an application is filed
under this subsection for a drug and a patent which claims such drug or
a method of using such drug is issued after the filing date but before
approval of the application, the applicant shall amend the application
to include the information required by the preceding sentence. Upon
approval of the application, the Secretary shall publish information
submitted under the two preceding sentences.
(2) Any person may file with the Secretary an abbreviated application
for the approval of a new animal drug. An abbreviated application shall
contain the information required by subsection (n) of this section.
(c) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order; abbreviated
applications; withdrawal periods; effective date of approval;
relationship to other applications; withdrawal or suspension of
approval; bioequivalence; filing of additional patent information
(1) Within one hundred and eighty days after the filing of an
application pursuant to subsection (b) of this section, or such
additional period as may be agreed upon by the Secretary and the
applicant, the Secretary shall either (A) issue an order approving the
application if he then finds that none of the grounds for denying
approval specified in subsection (d) of this section applies, or (B)
give the applicant notice of an opportunity for a hearing before the
Secretary under subsection (d) of this section on the question whether
such application is approvable. If the applicant elects to accept the
opportunity for a hearing by written request within thirty days after
such notice, such hearing shall commence not more than ninety days after
the expiration of such thirty days unless the Secretary and the
applicant otherwise agree. Any such hearing shall thereafter be
conducted on an expedited basis and the Secretary's order thereon shall
be issued within ninety days after the date fixed by the Secretary for
filing final briefs.
(2)(A) Subject to subparagraph (C), the Secretary shall approve an
abbreviated application for a drug unless the Secretary finds --
(i) the methods used in, or the facilities and controls used for, the
manufacture, processing, and packing of the drug are inadequate to
assure and preserve its identity, strength, quality, and purity;
(ii) the conditions of use prescribed, recommended, or suggested in
the proposed labeling are not reasonably certain to be followed in
practice or, except as provided /1/ subparagraph (B), information
submitted with the application is insufficient to show that each of the
proposed conditions of use or similar limitations (whether in the
labeling or published pursuant to subsection (i) of this section) have
been previously approved for the approved new animal drug referred to in
the application;
(iii) information submitted with the application is insufficient to
show that the active ingredients are the same as those of the approved
new animal drug referred to in the application;
(iv)(I) if the application is for a drug whose active ingredients,
route of administration, dosage form, strength, or use with other animal
drugs in animal feed is the same as the active ingredients, route of
administration, dosage form, strength, or use with other animal drugs in
animal feed of the approved new animal drug referred to in the
application, information submitted in the application is insufficient to
show that the active ingredients, route of administration, dosage form,
strength, or use with other animal drugs in animal feed is the same as
that of the approved new animal drug, or
(II) if the application is for a drug whose active ingredients, route
of administration, dosage form, strength, or use with other animal drugs
in animal feed is different from that of the approved new animal drug
referred to in the application, no petition to file an application for
the drug with the different active ingredients, route of administration,
dosage form, strength, or use with other animal drugs in animal feed was
approved under subsection (n)(3) of this section;
(v) if the application was filed pursuant to the approval of a
petition under subsection (n)(3) of this section, the application did
not contain the information required by the Secretary respecting the
active ingredients, route of administration, dosage form, strength, or
use with other animal drugs in animal feed which is not the same;
(vi) information submitted in the application is insufficient to show
that the drug is bioequivalent to the approved new animal drug referred
to in the application, or if the application is filed under a petition
approved pursuant to subsection (n)(3) of this section, information
submitted in the application is insufficient to show that the active
ingredients of the new animal drug are of the same pharmacological or
therapeutic class as the pharmacological or therapeutic class of the
approved new animal drug and that the new animal drug can be expected to
have the same therapeutic effect as the approved new animal drug when
used in accordance with the labeling;
(vii) information submitted in the application is insufficient to
show that the labeling proposed for the drug is the same as the labeling
approved for the approved new animal drug referred to in the application
except for changes required because of differences approved under a
petition filed under subsection (n)(3) of this section, because of a
different withdrawal period, or because the drug and the approved new
animal drug are produced or distributed by different manufacturers;
(viii) information submitted in the application or any other
information available to the Secretary shows that (I) the inactive
ingredients of the drug are unsafe for use under the conditions
prescribed, recommended, or suggested in the labeling proposed for the
drug, (II) the composition of the drug is unsafe under such conditions
because of the type or quantity of inactive ingredients included or the
manner in which the inactive ingredients are included, or (III) in the
case of a drug for food producing animals, the inactive ingredients of
the drug or its composition may be unsafe with respect to human food
safety;
(ix) the approval under subsection (b)(1) of this section of the
approved new animal drug referred to in the application filed under
subsection (b)(2) of this section has been withdrawn or suspended for
grounds described in paragraph (1) of subsection (e) of this section,
the Secretary has published a notice of a hearing to withdraw approval
of the approved new animal drug for such grounds, the approval under
this paragraph of the new animal drug for which the application under
subsection (b)(2) of this section was filed has been withdrawn or
suspended under subparagraph (G) for such grounds, or the Secretary has
determined that the approved new animal drug has been withdrawn from
sale for safety or effectiveness reasons;
(x) the application does not meet any other requirement of subsection
(n) of this section; or
(xi) the application contains an untrue statement of material fact.
(B) If the Secretary finds that a new animal drug for which an
application is submitted under subsection (b)(2) of this section is
bioequivalent to the approved new animal drug referred to in such
application and that residues of the new animal drug are consistent with
the tolerances established for such approved new animal drug but at a
withdrawal period which is different than the withdrawal period approved
for such approved new animal drug, the Secretary may establish, on the
basis of information submitted, such different withdrawal period as the
withdrawal period for the new animal drug for purposes of the approval
of such application for such drug.
(C) Within 180 days of the initial receipt of an application under
subsection (b)(2) of this section or within such additional period as
may be agreed upon by the Secretary and the applicant, the Secretary
shall approve or disapprove the application.
(D) The approval of an application filed under subsection (b)(2) of
this section shall be made effective on the last applicable date
determined under the following:
(i) If the applicant only made a certification described in clause
(i) or (ii) of subsection (n)(1)(G) of this section or in both such
clauses, the approval may be made effective immediately.
(ii) If the applicant made a certification described in clause (iii)
of subsection (n)(1)(G) of this section, the approval may be made
effective on the date certified under clause (iii).
(iii) If the applicant made a certification described in clause (iv)
of subsection (n)(1)(G) of this section, the approval shall be made
effective immediately unless an action is brought for infringement of a
patent which is the subject of the certification before the expiration
of 45 days from the date the notice provided under subsection (n)(2)(
B)(i) of this section is received. If such an action is brought before
the expiration of such days, the approval shall be made effective upon
the expiration of the 30 month period beginning on the date of the
receipt of the notice provided under subsection (n)(2)(B) of this
section or such shorter or longer period as the court may order because
either party to the action failed to reasonably cooperate in expediting
the action, except that if before the expiration of such period --
(I) the court decides that such patent is invalid or not infringed,
the approval shall be made effective on the date of the court decision,
(II) the court decides that such patent has been infringed, the
approval shall be made effective on such date as the court orders under
section 271(e)(4)(A) of title 35, or
(III) the court grants a preliminary injunction prohibiting the
applicant from engaging in the commercial manufacture or sale of the
drug until the court decides the issues of patent validity and
infringement and if the court decides that such patent is invalid or not
infringed, the approval shall be made effective on the date of such
court decision.
In such an action, each of the parties shall reasonably cooperate in
expediting the action. Until the expiration of 45 days from the date
the notice made under subsection (n)(2)(B) of this section is received,
no action may be brought under section 2201 of title 28 for a
declaratory judgment with respect to the patent. Any action brought
under section 2201 of title 28 shall be brought in the judicial district
where the defendant has its principal place of business or a regular and
established place of business.
(iv) If the application contains a certification described in clause
(iv) of subsection (n)(1)(G) of this section and is for a drug for which
a previous application has been filed under this subsection containing
such a certification, the application shall be made effective not
earlier than 180 days after --
(I) the date the Secretary receives notice from the applicant under
the previous application of the first commercial marketing of the drug
under the previous application, or
(II) the date of a decision of a court in an action described in
subclause (III) holding the patent which is the subject of the
certification to be invalid or not infringed,
whichever is earlier.
(E) If the Secretary decides to disapprove an application, the
Secretary shall give the applicant notice of an opportunity for a
hearing before the Secretary on the question of whether such application
is approvable. If the applicant elects to accept the opportunity for
hearing by written request within 30 days after such notice, such
hearing shall commence not more than 90 days after the expiration of
such 30 days unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an expedited basis and
the Secretary's order thereon shall be issued within 90 days after the
date fixed by the Secretary for filing final briefs.
(F)(i) If an application submitted under subsection (b)(1) of this
section for a drug, no active ingredient (including any ester or salt of
the active ingredient) of which has been approved in any other
application under subsection (b)(1) of this section, is approved after
November 16, 1988, no application may be submitted under subsection
(b)(2) of this section which refers to the drug for which the subsection
(b)(1) application was submitted before the expiration of 5 years from
the date of the approval of the application under subsection (b)(1) of
this section, except that such an application may be submitted under
subsection (b)(2) of this section after the expiration of 4 years from
the date of the approval of the subsection (b)(1) application if it
contains a certification of patent invalidity or noninfringement
described in clause (iv) of subsection (n)(1)(G) of this section. The
approval of such an application shall be made effective in accordance
with subparagraph (B) except that, if an action for patent infringement
is commenced during the one-year period beginning 48 months after the
date of the approval of the subsection (b) application, the 30 month
period referred to in subparagraph (C)( iii) /2/ shall be extended by
such amount of time (if any) which is required for seven and one-half
years to have elapsed from the date of approval of the subsection (b)
application.
(ii) If an application submitted under subsection (b)(1) of this
section for a drug, which includes an active ingredient (including any
ester or salt of the active ingredient) that has been approved in
another application approved under such subsection, is approved after
November 16, 1988, and if such application contains reports of new
clinical or field investigations (other than bioequivalence or residue
studies) and, in the case of food producing animals, human food safety
studies (other than bioequivalence or residue studies) essential to the
approval of the application and conducted or sponsored by the applicant,
the Secretary may not make the approval of an application submitted
under subsection (b)(2) of this section for the conditions of approval
of such drug in the subsection (b)(1) application effective before the
expiration of 3 years from the date of the approval of the application
under subsection (b)(1) of this section for such drug.
(iii) If a supplement to an application approved under subsection
(b)(1) of this section is approved after November 16, 1988, and the
supplement contains reports of new clinical or field investigations
(other than bioequivalence or residue studies) and, in the case of food
producing animals, human food safety studies (other than bioequivalence
or residue studies) essential to the approval of the supplement and
conducted or sponsored by the person submitting the supplement, the
Secretary may not make the approval of an application submitted under
subsection (b)(2) of this section for a change approved in the
supplement effective before the expiration of 3 years from the date of
the approval of the supplement.
(iv) An applicant under subsection (b)(1) of this section who comes
within the provisions of clause (i) of this subparagraph as a result of
an application which seeks approval for a use solely in non-food
producing animals, may elect, within 10 days of receiving such approval,
to waive clause (i) of this subparagraph, in which event the limitation
on approval of applications submitted under subsection (b)( 2) of this
section set forth in clause (ii) of this subparagraph shall be
applicable to the subsection (b)(1) application.
(v) If an application (including any supplement to a new animal drug
application) submitted under subsection (b)(1) of this section for a new
animal drug for a food-producing animal use, which includes an active
ingredient (including any ester or salt of the active ingredient) which
has been the subject of a waiver under subparagraph (B)(iv) is approved
after November 16, 1988, and if the application contains reports of
clinical or field investigations or human food safety studies (other
than bioequivalence or residue studies) essential to the new approval of
the application and conducted or sponsored by the applicant, the
Secretary may not make the approval of an application (including any
supplement to such application) submitted under subsection (b)(2) of
this section for the new conditions of approval of such drug in the
subsection (b)(1) application effective before the expiration of five
years from the date of approval of the application under subsection
(b)(1) of this section for such drug. The provisions of this paragraph
shall apply only to the first approval for a food-producing animal use
for the same applicant after the waiver under subparagraph (B)(iv).
(G) If an approved application submitted under subsection (b)(2) of
this section for a new animal drug refers to a drug the approval of
which was withdrawn or suspended for grounds described in paragraph (1)
or (2) of subsection (e) of this section or was withdrawn or suspended
under this subparagraph or which, as determined by the Secretary, has
been withdrawn from sale for safety or effectiveness reasons, the
approval of the drug under this paragraph shall be withdrawn or
suspended --
(i) for the same period as the withdrawal or suspension under
subsection (e) of this section or this subparagraph, or
(ii) if the approved new animal drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier, the period ending
on the date the Secretary determines that the withdrawal from sale is
not for safety or effectiveness reasons.
(H) For purposes of this paragraph:
(i) The term ''bioequivalence'' means the rate and extent to which
the active ingredient or therapeutic ingredient is absorbed from a new
animal drug and becomes available at the site of drug action.
(ii) A new animal drug shall be considered to be bioequivalent to the
approved new animal drug referred to in its application under subsection
(n) of this section if --
(I) the rate and extent of absorption of the drug do not show a
significant difference from the rate and extent of absorption of the
approved new animal drug referred to in the application when
administered at the same dose of the active ingredient under similar
experimental conditions in either a single dose or multiple doses;
(II) the extent of absorption of the drug does not show a significant
difference from the extent of absorption of the approved new animal drug
referred to in the application when administered at the same dose of the
active ingredient under similar experimental conditions in either a
single dose or multiple doses and the difference from the approved new
animal drug in the rate of absorption of the drug is intentional, is
reflected in its proposed labeling, is not essential to the attainment
of effective drug concentrations in use, and is considered
scientifically insignificant for the drug in attaining the intended
purposes of its use and preserving human food safety; or
(III) in any case in which the Secretary determines that the
measurement of the rate and extent of absorption or excretion of the new
animal drug in biological fluids is inappropriate or impractical, an
appropriate acute pharmacological effects test or other test of the new
animal drug and, when deemed scientifically necessary, of the approved
new animal drug referred to in the application in the species to be
tested or in an appropriate animal model does not show a significant
difference between the new animal drug and such approved new animal drug
when administered at the same dose under similar experimental
conditions.
If the approved new animal drug referred to in the application for a
new animal drug under subsection (n) of this section is approved for use
in more than one animal species, the bioequivalency information
described in subclause /3/ (I), (II), and (III) shall be obtained for
one species, or if the Secretary deems appropriate based on scientific
principles, shall be obtained for more than one species. The Secretary
may prescribe the dose to be used in determining bioequivalency under
subclause (I), (II), or (III). To assure that the residues of the new
animal drug will be consistent with the established tolerances for the
approved new animal drug referred to in the application under subsection
(b)(2) of this section upon the expiration of the withdrawal period
contained in the application for the new animal drug, the Secretary
shall require bioequivalency data or residue depletion studies of the
new animal drug or such other data or studies as the Secretary considers
appropriate based on scientific principles. If the Secretary requires
one or more residue studies under the preceding sentence, the Secretary
may not require that the assay methodology used to determine the
withdrawal period of the new animal drug be more rigorous than the
methodology used to determine the withdrawal period for the approved new
animal drug referred to in the application. If such studies are
required and if the approved new animal drug, referred to in the
application for the new animal drug for which such studies are required,
is approved for use in more than one animal species, such studies shall
be conducted for one species, or if the Secretary deems appropriate
based on scientific principles, shall be conducted for more than one
species.
(3) If the patent information described in subsection (b)(1) of this
section could not be filed with the submission of an application under
subsection (b)(1) of this section because the application was filed
before the patent information was required under subsection (b)(1) of
this section or a patent was issued after the application was approved
under such subsection, the holder of an approved application shall file
with the Secretary the patent number and the expiration date of any
patent which claims the new animal drug for which the application was
filed or which claims a method of using such drug and with respect to
which a claim of patent infringement could reasonably be asserted if a
person not licensed by the owner engaged in the manufacture, use, or
sale of the drug. If the holder of an approved application could not
file patent information under subsection (b)(1) of this section because
it was not required at the time the application was approved, the holder
shall file such information under this subsection not later than 30 days
after November 16, 1988, and if the holder of an approved application
could not file patent information under subsection (b)(1) of this
section because no patent had been issued when an application was filed
or approved, the holder shall file such information under this
subsection not later than 30 days after the date the patent involved is
issued. Upon the submission of patent information under this subsection,
the Secretary shall publish it.
(d) Grounds for refusing application; approval of application;
factors; ''substantial evidence'' defined
(1) If the Secretary finds, after due notice to the applicant in
accordance with subsection (c) of this section and giving him an
opportunity for a hearing, in accordance with said subsection, that --
(A) the investigations, reports of which are required to be submitted
to the Secretary pursuant to subsection (b) of this section, do not
include adequate tests by all methods reasonably applicable to show
whether or not such drug is safe for use under the conditions
prescribed, recommended, or suggested in the proposed labeling thereof;
(B) the results of such tests show that such drug is unsafe for use
under such conditions or do not show that such drug is safe for use
under such conditions;
(C) the methods used in, and the facilities and controls used for,
the manufacture, processing, and packing of such drug are inadequate to
preserve its identity, strength, quality, and purity;
(D) upon the basis of the information submitted to him as part of the
application, or upon the basis of any other information before him with
respect to such drug, he has insufficient information to determine
whether such drug is safe for use under such conditions;
(E) evaluated on the basis of the information submitted to him as
part of the application and any other information before him with
respect to such drug, there is a lack of substantial evidence that the
drug will have the effect it purports or is represented to have under
the conditions of use prescribed, recommended, or suggested in the
proposed labeling thereof;
(F) upon the basis of the information submitted to him as part of the
application or any other information before him with respect to such
drug, the tolerance limitation proposed, if any, exceeds that reasonably
required to accomplish the physical or other technical effect for which
the drug is intended;
(G) the application failed to contain the patent information
prescribed by subsection (b)(1) of this section;
(H) based on a fair evaluation of all material facts, such labeling
is false or misleading in any particular; or
(I) such drug induces cancer when ingested by man or animal or, after
tests which are appropriate for the evaluation of the safety of such
drug, induces cancer in man or animal, except that the foregoing
provisions of this subparagraph shall not apply with respect to such
drug if the Secretary finds that, under the conditions of use specified
in proposed labeling and reasonably certain to be followed in practice
(i) such drug will not adversely affect the animals for which it is
intended, and (ii) no residue of such drug will be found (by methods of
examination prescribed or approved by the Secretary by regulations,
which regulations shall not be subject to subsections (c), (d), and (h)
of this section), in any edible portion of such animals after slaughter
or in any food yielded by or derived from the living animals;
he shall issue an order refusing to approve the application. If,
after such notice and opportunity for hearings, the Secretary finds that
subparagraphs (A) through (G) /4/ do not apply, he shall issue an order
approving the application.
(2) In determining whether such drug is safe for use under the
conditions prescribed, recommended, or suggested in the proposed
labeling thereof, the Secretary shall consider, among other relevant
factors, (A) the probable consumption of such drug and of any substance
formed in or on food because of the use of such drug, (B) the cumulative
effect on man or animal of such drug, taking into account any chemically
or pharmacologically related substance, (C) safety factors which in the
opinion of experts, qualified by scientific training and experience to
evaluate the safety of such drugs, are appropriate for the use of animal
experimentation data, and (D) whether the conditions of use prescribed,
recommended, or suggested in the proposed labeling are reasonably
certain to be followed in practice. Any order issued under this
subsection refusing to approve an application shall state the findings
upon which it is based.
(3) As used in this subsection and subsection (e) of this section,
the term ''substantial evidence'' means evidence consisting of adequate
and well-controlled investigations, including field investigation, by
experts qualified by scientific training and experience to evaluate the
effectiveness of the drug involved, on the basis of which it could
fairly and reasonably be concluded by such experts that the drug will
have the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the labeling
or proposed labeling thereof.
(e) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to health of man or animals
(1) The Secretary shall, after due notice and opportunity for hearing
to the applicant, issue an order withdrawing approval of an application
filed pursuant to subsection (b) of this section with respect to any new
animal drug if the Secretary finds --
(A) that experience or scientific data show that such drug is unsafe
for use under the conditions of use upon the basis of which the
application was approved;
(B) that new evidence not contained in such application or not
available to the Secretary until after such application was approved, or
tests by new methods, or tests by methods not deemed reasonably
applicable when such application was approved, evaluated together with
the evidence available to the Secretary when the application was
approved, shows that such drug is not shown to be safe for use under the
conditions of use upon the basis of which the application was approved
or that subparagraph (I) of paragraph (1) of subsection (d) of this
section applies to such drug;
(C) on the basis of new information before him with respect to such
drug, evaluated together with the evidence available to him when the
application was approved, that there is a lack of substantial evidence
that such drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or suggested
in the labeling thereof;
(D) the patent information prescribed by subsection (c)(3) of this
section was not filed within 30 days after the receipt of written notice
from the Secretary specifying the failure to file such information;
(E) that the application contains any untrue statement of a material
fact; or
(F) that the applicant has made any changes from the standpoint of
safety or effectiveness beyond the variations provided for in the
application unless he has supplemented the application by filing with
the Secretary adequate information respecting all such changes and
unless there is in effect an approval of the supplemental application.
The supplemental application shall be treated in the same manner as the
original application.
If the Secretary (or in his absence the officer acting as Secretary)
finds that there is an imminent hazard to the health of man or of the
animals for which such drug is intended, he may suspend the approval of
such application immediately, and give the applicant prompt notice of
his action and afford the applicant the opportunity for an expedited
hearing under this subsection; but the authority conferred by this
sentence to suspend the approval of an application shall not be
delegated.
(2) The Secretary may also, after due notice and opportunity for
hearing to the applicant, issue an order withdrawing the approval of an
application with respect to any new animal drug under this section if
the Secretary finds --
(A) that the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately failed
to maintain such records or to make required reports in accordance with
a regulation or order under subsection (1) of this section, or the
applicant has refused to permit access to, or copying or verification
of, such records as required by paragraph (2) of such subsection;
(B) that on the basis of new information before him, evaluated
together with the evidence before him when the application was approved,
the methods used in, or the facilities and controls used for, the
manufacture, processing, and packing of such drug are inadequate to
assure and preserve its identity, strength, quality, and purity and were
not made adequate within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of; or
(C) that on the basis of new information before him, evaluated
together with the evidence before him when the application was approved,
the labeling of such drug, based on a fair evaluation of all material
facts, is false or misleading in any particular and was not corrected
within a reasonable time after receipt of written notice from the
Secretary specifying the matter complained of.
(3) Any order under this subsection shall state the findings upon
which it is based.
(f) Revocation of order refusing, withdrawing or suspending approval
of application
Whenever the Secretary finds that the facts so require, he shall
revoke any previous order under subsection (d), (e), or (m) of this
section refusing, withdrawing, or suspending approval of an application
and shall approve such application or reinstate such approval, as may be
appropriate.
(g) Service of orders
Orders of the Secretary issued under this section (other than orders
issuing, amending, or repealing regulations) shall be served (1) in
person by any officer or employee of the department designated by the
Secretary or (2) by mailing the order by registered mail or by certified
mail addressed to the applicant or respondent at his last known address
in the records of the Secretary.
(h) Appeal from order
An appeal may be taken by the applicant from an order of the
Secretary refusing or withdrawing approval of an application filed under
subsection (b) or (m) of this section. The provisions of subsection (h)
of section 355 of this title shall govern any such appeal.
(i) Publication in Federal Register; effective date and revocation
or suspension of regulation
When a new animal drug application filed pursuant to subsection (b)
of this section is approved, the Secretary shall by notice, which upon
publication shall be effective as a regulation, publish in the Federal
Register the name and address of the applicant and the conditions and
indications of use of the new animal drug covered by such application,
including any tolerance and withdrawal period or other use restrictions
and, if such new animal drug is intended for use in animal feed,
appropriate purposes and conditions of use (including special labeling
requirements) applicable to any animal feed for use in which such drug
is approved, and such other information, upon the basis of which such
application was approved, as the Secretary deems necessary to assure the
safe and effective use of such drug. Upon withdrawal of approval of
such new animal drug application or upon its suspension, the Secretary
shall forthwith revoke or suspend, as the case may be, the regulation
published pursuant to this subsection (i) insofar as it is based on the
approval of such application.
(j) Exemption of drugs for research; discretionary and mandatory
conditions
To the extent consistent with the public health, the Secretary shall
promulgate regulations for exempting from the operation of this section
new animal drugs, and animal feeds bearing or containing new animal
drugs, intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and
effectiveness of animal drugs. Such regulations may, in the discretion
of the Secretary, among other conditions relating to the protection of
the public health, provide for conditioning such exemption upon the
establishment and maintenance of such records, and the making of such
reports to the Secretary, by the manufacturer or the sponsor of the
investigation of such article, of data (including but not limited to
analytical reports by investigators) obtained as a result of such
investigational use of such article, as the Secretary finds will enable
him to evaluate the safety and effectiveness of such article in the
event of the filing of an application pursuant to this section. Such
regulations, among other things, shall set forth the conditions (if any)
upon which animals treated with such articles, and any products of such
animals (before or after slaughter), may be marketed for food use.
(k) Food containing new animal drug considered unadulterated while
approval of application for such drug is effective
While approval of an application for a new animal drug is effective,
a food shall not, by reason of bearing or containing such drug or any
substance formed in or on the food because of its use in accordance with
such application (including the conditions and indications of use
prescribed pursuant to subsection (i) of this section), be considered
adulterated within the meaning of clause (1) of section 342(a) of this
title.
(l) Records and reports; required information; regulations and
orders; examination of data; access to records
(1) In the case of any new animal drug for which an approval of an
application filed pursuant to subsection (b) of this section is in
effect, the applicant shall establish and maintain such records, and
make such reports to the Secretary, of data relating to experience and
other data or information, received or otherwise obtained by such
applicant with respect to such drug, or with respect to animal feeds
bearing or containing such drug, as the Secretary may by general
regulation, or by order with respect to such application, prescribe on
the basis of a finding that such records and reports are necessary in
order to enable the Secretary to determine, or facilitate a
determination, whether there is or may be ground for invoking subsection
(e) or subsection (m)(4) of this section. Such regulation or order
shall provide, where the Secretary deems it to be appropriate, for the
examination, upon request, by the persons to whom such regulation or
order is applicable, of similar information received or otherwise
obtained by the Secretary.
(2) Every person required under this subsection to maintain records,
and every person in charge or custody thereof, shall, upon request of an
officer or employee designated by the Secretary, permit such officer or
employee at all reasonable times to have access to and copy and verify
such records.
(m)(1) Filing application for uses of animal feed containing new
animal drug; contents
Any person may file with the Secretary an application with respect to
any intended use or uses of an animal feed bearing or containing a new
animal drug. Such person shall submit to the Secretary as part of the
application (A) a full statement of the composition of such animal feed,
(B) an identification of the regulation or regulations (relating to the
new animal drug or drugs to be used in such feed), published pursuant to
subsection (i) of this section, on which he relies as a basis for
approval of his application with respect to the use of such drug in such
feed, (C) a full description of the methods used in, and the facilities
and controls used for, the manufacture, processing, and packing of such
animal feed, (D) specimens of the labeling proposed to be used for such
animal feed, and (E) if so requested by the Secretary, samples of such
animal feed or components thereof.
(2) Period for approval of application; period for, notice, and
expedition of hearing; period for issuance of order
Within ninety days after the filing of an application pursuant to
paragraph (1) of this subsection, or such additional period as may be
agreed upon by the Secretary and the applicant, the Secretary shall
either (A) issue an order approving the application if he then finds
that none of the grounds for denying approval specified in paragraph (3)
applies, or (B) give the applicant notice of an opportunity for a
hearing before the Secretary under paragraph (3) on the question whether
such application is approvable. The procedure governing such a hearing
shall be the procedure set forth in the last two sentences of subsection
(c) of this section.
(3) Grounds for refusing application; approval of application;
approval effective during existence of subsection (i) regulation
If the Secretary, after due notice to the applicant in accordance
with paragraph (2) and giving him an opportunity for a hearing in
accordance with such paragraph, finds, on the basis of information
submitted to him as part of the application or on the basis of any other
information before him --
(A) that there is not in effect a regulation under subsection (i) of
this section (identified in such application) on the basis of which such
application may be approved;
(B) that such animal feed (including the proposed use of any new
animal drug therein or thereon) does not conform to an applicable
regulation published pursuant to subsection (i) of this section referred
to in the application, or that the purposes and conditions or
indications of use prescribed, recommended, or suggested in the labeling
of such feed do not conform to the applicable purposes and conditions or
indications of use (including warnings) published pursuant to subsection
(i) of this section or such labeling omits or fails to conform to other
applicable information published pursuant to subsection (i) of this
section;
(C) that the methods used in, and the facilities and controls used
for, the manufacture, processing, and packing of such animal feed are
inadequate to preserve the identity, strength, quality, and purity of
the new animal drug therein; or
(D) that, based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular;
he shall issue an order refusing to approve the application. If,
after such notice and opportunity for hearing, the Secretary finds that
subparagraphs (A) through (D) do not apply, he shall issue an order
approving the application. An order under this subsection approving an
application with respect to an animal feed bearing or containing a new
animal drug shall be effective only while there is in effect a
regulation pursuant to subsection (i) of this section, on the basis of
which such application (or a supplement thereto) was approved, relating
to the use of such drug in or on such feed.
(4) Withdrawal of approval; grounds; immediate suspension upon
finding imminent hazard to health of man or animals
(A) The Secretary shall, after due notice and opportunity for hearing
to the applicant, issue an order withdrawing approval of an application
with respect to any animal feed under this subsection if the Secretary
finds --
(i) that the application contains any untrue statement of a material
fact; or
(ii) that the applicant has made any changes from the standpoint of
safety or effectiveness beyond the variations provided for in the
application unless he has supplemented the application by filing with
the Secretary adequate information respecting all such changes and
unless there is in effect an approval of the supplemental application.
The supplemental application shall be treated in the same manner as the
original application.
If the Secretary (or in his absence the officer acting as Secretary)
finds that there is an imminent hazard to the health of man or of the
animals for which such animal feed is intended, he may suspend the
approval of such application immediately, and give the applicant prompt
notice of his action and afford the applicant the opportunity for an
expedited hearing under this subsection; but the authority conferred by
this sentence shall not be delegated.
(B) The Secretary may also, after due notice and opportunity for
hearing to the applicant, issue an order withdrawing the approval of an
application with respect to any animal feed under this subsection if the
Secretary finds --
(i) that the applicant has failed to establish a system for
maintaining required records, or has repeatedly or deliberately failed
to maintain such records or to make required reports in accordance with
a regulation or order under paragraph (5)(A) of this subsection, or the
applicant has refused to permit access to, or copying or verification
of, such records as required by subparagraph (B) of such paragraph;
(ii) that on the basis of new information before him, evaluated
together with the evidence before him when such application was
approved, the methods used in, or the facilities and controls used for,
the manufacture, processing, and packing of such animal feed are
inadequate to assure and preserve the identity, strength, quality, and
purity of the new animal drug therein, and were not made adequate within
a reasonable time after receipt of written notice from the Secretary,
specifying the matter complained of; or
(iii) that on the basis of new information before him, evaluated
together with the evidence before him when the application was approved,
the labeling of such animal feed, based on a fair evaluation of all
material facts, is false or misleading in any particular and was not
corrected within a reasonable time after receipt of written notice from
the Secretary specifying the matter complained of.
(C) Any order under paragraph (4) of this subsection shall state the
findings upon which it is based.
(5) Records and reports; regulations and orders; access to records
In the case of an animal feed for which an approval of an application
filed pursuant to this subsection is in effect --
(A) the applicant shall establish and maintain such records, and make
such reports to the Secretary, or (at the option of the Secretary) to
the appropriate person or persons holding an approved application filed
under subsection (b) of this section, as the Secretary may by general
regulation, or by order with respect to such application, prescribe on
the basis of a finding that such records and reports are necessary in
order to enable the Secretary to determine, or facilitate a
determination, whether there is or may be ground for invoking subsection
(e) of this section or paragraph (4) of this subsection.
(B) every person required under this subsection to maintain records,
and every person in charge or custody thereof, shall, upon request of an
officer or employee designated by the Secretary, permit such officer or
employee at all reasonable times to have access to and copy and verify
such records.
(n) Abbreviated applications for new animal drugs; contents, filing,
etc.; lists of approved drugs
(1) An abbreviated application for a new animal drug shall contain --
(A)(i) except as provided in clause (ii), information to show that
the conditions of use or similar limitations (whether in the labeling or
published pursuant to subsection (i) of this section) prescribed,
recommended, or suggested in the labeling proposed for the new animal
drug have been previously approved for a new animal drug listed under
paragraph (4) (hereinafter in this subsection referred to as an
''approved new animal drug''), and
(ii) information to show that the withdrawal period at which residues
of the new animal drug will be consistent with the tolerances
established for the approved new animal drug is the same as the
withdrawal period previously established for the approved new animal
drug or, if the withdrawal period is proposed to be different,
information showing that the residues of the new animal drug at the
proposed different withdrawal period will be consistent with the
tolerances established for the approved new animal drug;
(B)(i) information to show that the active ingredients of the new
animal drug are the same as those of the approved new animal drug, and
(ii) if the approved new animal drug has more than one active
ingredient, and if one of the active ingredients of the new animal drug
is different from one of the active ingredients of the approved new
animal drug and the application is filed pursuant to the approval of a
petition filed under paragraph (3) --
(I) information to show that the other active ingredients of the new
animal drug are the same as the active ingredients of the approved new
animal drug,
(II) information to show either that the different active ingredient
is an active ingredient of another approved new animal drug or of an
animal drug which does not meet the requirements of section 321(w) of
this title, and
(III) such other information respecting the different active
ingredients as the Secretary may require;
(C)(i) if the approved new animal drug is permitted to be used with
one or more animal drugs in animal feed, information to show that the
proposed uses of the new animal drug with other animal drugs in animal
feed are the same as the uses of the approved new animal drug, and
(ii) if the approved new animal drug is permitted to be used with one
or more other animal drugs in animal feed, and one of the other animal
drugs proposed for use with the new animal drug in animal feed is
different from one of the other animal drugs permitted to be used in
animal feed with the approved new animal drug, and the application is
filed pursuant to the approval of a petition filed under paragraph (3)
--
(I) information to show either that the different animal drug
proposed for use with the approved new animal drug in animal feed is an
approved new animal drug permitted to be used in animal feed or does not
meet the requirements of section 321(w) of this title when used with
another animal drug in animal feed,
(II) information to show that other animal drugs proposed for use
with the new animal drug in animal feed are the same as the other animal
drugs permitted to be used with the approved new animal drug, and
(III) such other information respecting the different animal drug or
combination with respect to which the petition was filed as the
Secretary may require,
(D) information to show that the route of administration, the dosage
form, and the strength of the new animal drug are the same as those of
the approved new animal drug or, if the route of administration, the
dosage form, or the strength of the new animal drug is different and the
application is filed pursuant to the approval of a petition filed under
paragraph (3), such information respecting the route of administration,
dosage form, or strength with respect to which the petition was filed as
the Secretary may require;
(E) information to show that the new animal drug is bioequivalent to
the approved new animal drug, except that if the application is filed
pursuant to the approval of a petition filed under paragraph (3) for the
purposes described in subparagraph (B) or (C), information to show that
the active ingredients of the new animal drug are of the same
pharmacological or therapeutic class as the pharmacological or
therapeutic class of the approved new animal drug and that the new
animal drug can be expected to have the same therapeutic effect as the
approved new animal drug when used in accordance with the labeling;
(F) information to show that the labeling proposed for the new animal
drug is the same as the labeling approved for the approved new animal
drug except for changes required because of differences approved under a
petition filed under paragraph (3), because of a different withdrawal
period, or because the new animal drug and the approved new animal drug
are produced or distributed by different manufacturers;
(G) the items specified in clauses (B) through (F) of subsection
(b)(1) of this section;
(H) a certification, in the opinion of the applicant and to the best
of his knowledge, with respect to each patent which claims the approved
new animal drug or which claims a use for such approved new animal drug
for which the applicant is seeking approval under this subsection and
for which information is required to be filed under subsection (b)(1) or
(c)(3) of this section --
(i) that such patent information has not been filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will expire, or
(iv) that such patent is invalid or will not be infringed by the
manufacture, use, or sale of the new animal drug for which the
application is filed; and
(I) if with respect to the approved new animal drug information was
filed under subsection (b)(1) or (c)(3) of this section for a method of
use patent which does not claim a use for which the applicant is seeking
approval of an application under subsection (c)(2) of this section, a
statement that the method of use patent does not claim such a use.
The Secretary may not require that an abbreviated application contain
information in addition to that required by subparagraphs (A) through
(H).
(2)(A) An applicant who makes a certification described in paragraph
(1)(G)(iv) shall include in the application a statement that the
applicant will give the notice required by subparagraph (B) to --
(i) each owner of the patent which is the subject of the
certification or the representative of such owner designated to receive
such notice, and
(ii) the holder of the approved application under subsection (c)(1)
of this section for the drug which is claimed by the patent or a use of
which is claimed by the patent or the representative of such holder
designated to receive such notice.
(B) The notice referred to in subparagraph (A) shall state that an
application, which contains data from bioequivalence studies, has been
filed under this subsection for the drug with respect to which the
certification is made to obtain approval to engage in the commercial
manufacture, use, or sale of such drug before the expiration of the
patent referred to in the certification. Such notice shall include a
detailed statement of the factual and legal basis of the applicant's
opinion that the patent is not valid or will not be infringed.
(C) If an application is amended to include a certification described
in paragraph (1)(G)(iv), the notice required by subparagraph (B) shall
be given when the amended application is filed.
(3) If a person wants to submit an abbreviated application for a new
animal drug --
(A) whose active ingredients, route of administration, dosage form,
or strength differ from that of an approved new animal drug, or
(B) whose use with other animal drugs in animal feed differs from
that of an approved new animal drug,
such person shall submit a petition to the Secretary seeking
permission to file such an application. The Secretary shall approve a
petition for a new animal drug unless the Secretary finds that --
(C) investigations must be conducted to show the safety and
effectiveness, in animals to be treated with the drug, of the active
ingredients, route of administration, dosage form, strength, or use with
other animal drugs in animal feed which differ from the approved new
animal drug, or
(D) investigations must be conducted to show the safety for human
consumption of any residues in food resulting from the proposed active
ingredients, route of administration, dosage form, strength, or use with
other animal drugs in animal feed for the new animal drug which is
different from the active ingredients, route of administration, dosage
form, strength, or use with other animal drugs in animal feed of the
approved new animal drug.
The Secretary shall approve or disapprove a petition submitted under
this paragraph within 90 days of the date the petition is submitted.
(4)(A)(i) Within 60 days of November 16, 1988, the Secretary shall
publish and make available to the public a list in alphabetical order of
the official and proprietary name of each new animal drug which has been
approved for safety and effectiveness before November 16, 1988.
(ii) Every 30 days after the publication of the first list under
clause (i) the Secretary shall revise the list to include each new
animal drug which has been approved for safety and effectiveness under
subsection (c) of this section during the 30 day period.
(iii) When patent information submitted under subsection (b)(1) or
(c)(3) of this section respecting a new animal drug included on the list
is to be published by the Secretary, the Secretary shall, in revisions
made under clause (ii), include such information for such drug.
(B) A new animal drug approved for safety and effectiveness before
November 16, 1988, or approved for safety and effectiveness under
subsection (c) of this section shall, for purposes of this subsection,
be considered to have been published under subparagraph (A) on the date
of its approval or November 16, 1988, whichever is later.
(C) If the approval of a new animal drug was withdrawn or suspended
under subsection (c)(2)(G) of this section or for grounds described in
subsection (e) of this section or if the Secretary determines that a
drug has been withdrawn from sale for safety or effectiveness reasons,
it may not be published in the list under subparagraph (A) or, if the
withdrawal or suspension occurred after its publication in such list, it
shall be immediately removed from such list --
(i) for the same period as the withdrawal or suspension under
subsection (c)(2)(G) or (e) of this section, or
(ii) if the listed drug has been withdrawn from sale, for the period
of withdrawal from sale or, if earlier, the period ending on the date
the Secretary determines that the withdrawal from sale is not for safety
or effectiveness reasons.
A notice of the removal shall be published in the Federal Register.
(5) If an application contains the information required by clauses
(A), (G), and (H) of subsection (b)(1) of this section and such
information --
(A) is relied on by the applicant for the approval of the
application, and
(B) is not information derived either from investigations, studies,
or tests conducted by or for the applicant or for which the applicant
had obtained a right of reference or use from the person by or for whom
the investigations, studies, or tests were conducted,
such application shall be considered to be an application filed under
subsection (b)(2) of this section.
(o) ''Patent'' defined
For purposes of this section, the term ''patent'' means a patent
issued by the Patent and Trademark Office of the Department of Commerce.
(p) Safety and effectiveness data
(1) Safety and effectiveness data and information which has been
submitted in an application filed under subsection (b)(1) of this
section for a drug and which has not previously been disclosed to the
public shall be made available to the public, upon request, unless
extraordinary circumstances are shown --
(A) if no work is being or will be undertaken to have the application
approved,
(B) if the Secretary has determined that the application is not
approvable and all legal appeals have been exhausted,
(C) if approval of the application under subsection (c) of this
section is withdrawn and all legal appeals have been exhausted,
(D) if the Secretary has determined that such drug is not a new drug,
or
(E) upon the effective date of the approval of the first application
filed under subsection (b)(2) of this section which refers to such drug
or upon the date upon which the approval of an application filed under
subsection (b)(2) of this section which refers to such drug could be
made effective if such an application had been filed.
(2) Any request for data and information pursuant to paragraph (1)
shall include a verified statement by the person making the request that
any data or information received under such paragraph shall not be
disclosed by such person to any other person --
(A) for the purpose of, or as part of a plan, scheme, or device for,
obtaining the right to make, use, or market, or making, using, or
marketing, outside the United States, the drug identified in the
application filed under subsection (b)(1) of this section, and
(B) without obtaining from any person to whom the data and
information are disclosed an identical verified statement, a copy of
which is to be provided by such person to the Secretary, which meets the
requirements of this paragraph.
(June 25, 1938, ch. 675, 512, as added July 13, 1968, Pub. L.
90-399, 101(b), 82 Stat. 343, and amended Nov. 16, 1988, Pub. L.
100-670, title I, 101, 102, 104, 107(a)(2), 102 Stat. 3971, 3981, 3982,
3984; Aug. 17, 1991, Pub. L. 102-108, 2(e), 105 Stat. 550.)
1991 -- Subsec. (e)(1)(B). Pub. L. 102-108 substituted ''(I)'' for
''(H)''.
1988 -- Subsec. (a)(1)(C). Pub. L. 100-670, 107(a)(2), struck out
subpar. (C) which read as follows: ''in the case of a new animal drug
subject to subsection (n) of this section and not exempted therefrom by
regulations it is from a batch with respect to which a certificate or
release issued pursuant to subsection (n) of this section is in effect
with respect to such drug.''
Subsec. (b). Pub. L. 100-670, 101(a), 102(a), designated existing
provisions as par. (1), redesignated cls. (1) to (8) as cls. (A) to
(H), respectively, added par. (2), and inserted provisions at end of
par. (1) which require applicant to file with application, patent
number and expiration date of any patent which claims new animal drug,
to amend application to include such information if patent which claims
such drug or method of using such drug is issued after filing date but
before approval of application, and to publish such information upon
approval.
Subsec. (c). Pub. L. 100-670, 101(c), 102(b)(1), designated existing
provisions as par. (1), redesignated cls. (1) and (2) as cls. (A) and
(B), respectively, and added pars. (2) and (3).
Subsec. (d)(1). Pub. L. 100-670, 102(b)(3), substituted ''(G)'' for
''(H)'' in last sentence.
Subsec. (d)(1)(G) to (I). Pub. L. 100-670, 102(b)(2), added subpar.
(G) and redesignated former subpars. (G) and (H) as (H) and (I),
respectively.
Subsec. (e)(1)(D) to (F). Pub. L. 100-670, 102(b)(4), added subpar.
(D) and redesignated former subpars. (D) and (E) as (E) and (F),
respectively.
Subsecs. (n) to (p). Pub. L. 100-670, 101(b), added subsecs. (n) to
(p) and struck out former subsec. (n) which related to certification of
new drugs containing penicillin, streptomycin, chlortetracycline,
chloramphenicol, or bacitracin, and release prior to certification.
Section 108 of Pub. L. 100-670 provided that: ''The Secretary of
Health and Human Services may not make an approval of an application
submitted under section 512(b)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(b)(2)) effective before January 1, 1991.''
Section 108 of Pub. L. 90-399 provided that:
''(a) Except as otherwise provided in this section, the amendments
made by the foregoing sections (see Short Title of 1968 Amendment note
set out under section 301 of this title) shall take effect on the first
day of the thirteenth calendar month which begins after the date of
enactment of this Act (July 13, 1968).
''(b)(1) As used in this subsection, the term 'effective date' means
the effective date specified in subsection (a) of this section; the
term 'basic Act' means the Federal Food, Drug, and Cosmetic Act (this
chapter); and other terms used both in this section and the basic Act
shall have the same meaning as they have, or had, at the time referred
to in the context, under the basic Act.
''(2) Any approval, prior to the effective date, of a new animal drug
or of an animal feed bearing or containing a new animal drug, whether
granted by approval of a new-drug application, master file, antibiotic
regulation, or food additive regulations, shall continue in effect, and
shall be subject to change in accordance with the provisions of the
basic Act as amended by this Act (see Short Title of 1968 Amendment note
set out under section 301 of this title).
''(3) In the case of any drug (other than a drug subject to section
512(n) of the basic Act as amended by this Act) (subsection (n) of this
section) intended for use in animals other than man which, on October 9,
1962, (A) was commercially used or sold in the United States, (B) was
not a new drug as defined by section 201(p) of the basic Act (section
321(p) of this title) as then in force, and (C) was not covered by an
effective application under section 505 of that Act (section 355 of this
title), the words 'effectiveness' and 'effective' contained in section
201(w) as added by this Act to the basic Act (section 321(w) of this
title) shall not apply to such drug when intended solely for use under
conditions prescribed, recommended, or suggested in labeling with
respect to such drug on that day.
''(4) Regulations providing for fees (and advance deposits to cover
fees) which on the day preceding the effective date applicable under
subsection (a) of this section were in effect pursuant to section 507 of
the basic Act (section 357 of this title) shall, except as the Secretary
may otherwise prescribe, be deemed to apply also under section 512(n) of
the basic Act (subsection (n) of this section), and appropriations of
fees (and of advance deposits to cover fees) available for the purposes
specified in such section 507 (section 357 of this title) as in effect
prior to the effective date shall also be available for the purposes
specified in section 512(n) (subsection (n) of this section), including
preparatory work or proceedings prior to that date.''
Section 103 of Pub. L. 100-670 provided that:
''(a) General Rule. -- The Secretary of Health and Human Services
shall promulgate, in accordance with the notice and comment requirements
of section 553 of title 5, United States Code, such regulations as may
be necessary for the administration of section 512 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b), as amended by sections 101
through 103 of this title, within one year of the date of enactment of
this Act (Nov. 16, 1988).
''(b) Transition. -- During the period beginning 60 days after the
date of enactment of this Act (Nov. 16, 1988) and ending on the date
regulations promulgated under subsection (a) take effect, abbreviated
new animal drug applications may be submitted in accordance with the
provisions of section 314.55 and part 320 of title 21 of the Code of
Federal Regulations and shall be considered as suitable for any drug
which has been approved for safety and effectiveness under section 512(
c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c))
before the date of enactment of this Act. If any such provision of
section 314.55 or part 320 is inconsistent with the requirements of
section 512 of the Federal Food, Drug, and Cosmetic Act (as amended by
this title), the Secretary shall consider the application under the
applicable requirements of section 512 (as so amended).''
Section 106 of Pub. L. 100-670 provided that: ''Notwithstanding
section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.
C. 360b(b)(2)), the Secretary of Health and Human Services may not
approve an abbreviated application submitted under such section for a
new animal drug which is primarily manufactured using recombinant DNA,
recombinant RNA, hybridoma technology, or other processes involving site
specific genetic manipulation techniques.''
section 2201; title 35 sections 156, 271.
/1/ So in original. Probably should be followed by ''in''.
/2/ So in original. Probably should be subparagraph ''(D)(iii)''.
/3/ So in original. Probably should be ''subclauses''.
/4/ So in original. Probably should be ''(I)''.
21 USC 360c. Classification of devices intended for human use
TITLE 21 -- FOOD AND DRUGS
(a) Classes of devices
(1) There are established the following classes of devices intended
for human use:
(A) Class I, General Controls. --
(i) A device for which the controls authorized by or under section
351, 352, 360, 360f, 360h, 360i, or 360j of this title or any
combination of such sections are sufficient to provide reasonable
assurance of the safety and effectiveness of the device.
(ii) A device for which insufficient information exists to determine
that the controls referred to in clause (i) are sufficient to provide
reasonable assurance of the safety and effectiveness of the device or to
establish special controls to provide such assurance, but because it --
(I) is not purported or represented to be for a use in supporting or
sustaining human life or for a use which is of substantial importance in
preventing impairment of human health, and
(II) does not present a potential unreasonable risk of illness or
injury,
is to be regulated by the controls referred to in clause (i).
(B) Class II, Special Controls. -- A device which cannot be
classified as a class I device because the general controls by
themselves are insufficient to provide reasonable assurance of the
safety and effectiveness of the device, and for which there is
sufficient information to establish special controls to provide such
assurance, including the promulgation of performance standards,
postmarket surveillance, patient registries, development and
dissemination of guidelines (including guidelines for the submission of
clinical data in premarket notification submissions in accordance with
section 360(k) of this title), recommendations, and other appropriate
actions as the Secretary deems necessary to provide such assurance. For
a device that is purported or represented to be for a use in supporting
or sustaining human life, the Secretary shall examine and identify the
special controls, if any, that are necessary to provide adequate
assurance of safety and effectiveness and describe how such controls
provide such assurance.
(C) Class III, Premarket Approval. -- A device which because --
(i) it (I) cannot be classified as a class I device because
insufficient information exists to determine that the application of
general controls are sufficient to provide reasonable assurance of the
safety and effectiveness of the device, and (II) cannot be classified as
a class II device because insufficient information exists to determine
that the special controls described in subparagraph (B) would provide
reasonable assurance of its safety and effectiveness, and
(ii)(I) is purported or represented to be for a use in supporting or
sustaining human life or for a use which is of substantial importance in
preventing impairment of human health, or
(II) presents a potential unreasonable risk of illness or injury,
is to be subject, in accordance with section 360e of this title, to
premarket approval to provide reasonable assurance of its safety and
effectiveness.
If there is not sufficient information to establish a performance
standard for a device to provide reasonable assurance of its safety and
effectiveness, the Secretary may conduct such activities as may be
necessary to develop or obtain such information.
(2) For purposes of this section and sections 360d and 360e of this
title, the safety and effectiveness of a device are to be determined --
(A) with respect to the persons for whose use the device is
represented or intended,
(B) with respect to the conditons of use prescribed, recommended, or
suggested in the labeling of the device, and
(C) weighing any probable benefit to health from the use of the
device against any probable risk of injury or illness from such use.
(3)(A) Except as authorized by subparagraph (B), the effectiveness of
a device is, for purposes of this section and sections 360d and 360e of
this title, to be determined, in accordance with regulations promulgated
by the Secretary, on the basis of well-controlled investigations,
including clinical investigations where appropriate, by experts
qualified by training and experience to evaluate the effectiveness of
the device, from which investigations it can fairly and responsibly be
concluded by qualified experts that the device will have the effect it
purports or is represented to have under the conditions of use
prescribed, recommended, or suggested in the labeling of the device.
(B) If the Secretary determines that there exists valid scientific
evidence (other than evidence derived from investigations described in
subparagraph (A)) --
(i) which is sufficient to determine the effectiveness of a device,
and
(ii) from which it can fairly and responsibly be concluded by
qualified experts that the device will have the effect it purports or is
represented to have under the conditions of use prescribed, recommended,
or suggested in the labeling of the device,
then, for purposes of this section and sections 360d and 360e of this
title, the Secretary may authorize the effectiveness of the device to be
determined on the basis of such evidence.
(b) Classification panels
(1) For purposes of --
(A) determining which devices intended for human use should be
subject to the requirements of general controls, performance standards,
or premarket approval, and
(B) providing notice to the manufacturers and importers of such
devices to enable them to prepare for the application of such
requirements to devices manufactured or imported by them,
the Secretary shall classify all such devices (other than devices
classified by subsection (f) of this section) into the classes
established by subsection (a) of this section. For the purpose of
securing recommendations with respect to the classification of devices,
the Secretary shall establish panels of experts or use panels of experts
established before May 28, 1976, or both. Section 14 of the Federal
Advisory Committee Act shall not apply to the duration of a panel
established under this paragraph.
(2) The Secretary shall appoint to each panel established under
paragraph (1) persons who are qualified by training and experience to
evaluate the safety and effectiveness of the devices to be referred to
the panel and who, to the extent feasible, possess skill in the use of,
or experience in the development, manufacture, or utilization of, such
devices. The Secretary shall make appointments to each panel so that
each panel shall consist of members with adequately diversified
expertise in such fields as clinical and administrative medicine,
engineering, biological and physical sciences, and other related
professions. In addition, each panel shall include as nonvoting members
a representative of consumer interests and a representative of interests
of the device manufacturing industry. Scientific, trade, and consumer
organizations shall be afforded an opportunity to nominate individuals
for appointment to the panels. No individual who is in the regular
full-time employ of the United States and engaged in the administration
of this chapter may be a member of any panel. The Secretary shall
designate one of the members of each panel to serve as chairman thereof.
(3) Panel members (other than officers or employees of the United
States), while attending meetings or conferences of a panel or otherwise
engaged in its business, shall be entitled to receive compensation at
rates to be fixed by the Secretary, but not at rates exceeding the daily
equivalent of the rate in effect for grade GS-18 of the General
Schedule, for each day so engaged, including traveltime; and while so
serving away from their homes or regular places of business each member
may be allowed travel expenses (including per diem in lieu of
subsistence) as authorized by section 5703(b) /1/ of title 5, for
persons in the Government service employed intermittently.
(4) The Secretary shall furnish each panel with adequate clerical and
other necessary assistance.
(c) Classification panel organization and operation
(1) The Secretary shall organize the panels according to the various
fields of clinical medicine and fundamental sciences in which devices
intended for human use are used. The Secretary shall refer a device to
be classified under this section to an appropriate panel established or
authorized to be used under subsection (b) of this section for its
review and for its recommendation respecting the classification of the
device. The Secretary shall by regulation prescribe the procedure to be
followed by the panels in making their reviews and recommendations. In
making their reviews of devices, the panels, to the maximum extent
practicable, shall provide an opportunity for interested persons to
submit data and views on the classification of the devices.
(2)(A) Upon completion of a panel's review of a device referred to it
under paragraph (1), the panel shall, subject to subparagraphs (B) and
(C), submit to the Secretary its recommendation for the classification
of the device. Any such recommendation shall (i) contain (I) a summary
of the reasons for the recommendation, (II) a summary of the data upon
which the recommendation is based, and (III) an identification of the
risks to health (if any) presented by the device with respect to which
the recommendation is made, and (ii) to the extent practicable, include
a recommendation for the assignment of a priority for the application of
the requirements of section 360d or 360e of this title to a device
recommended to be classified in class II or class III.
(B) A recommendation of a panel for the classification of a device in
class I shall include a recommendation as to whether the device should
be exempted from the requirements of section 360, 360i, or 360j( f) of
this title.
(C) In the case of a device which has been referred under paragraph
(1) to a panel, and which --
(i) is intended to be implanted in the human body or is purported or
represented to be for a use in supporting or sustaining human life, and
(ii)(I) has been introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976, or
(II) is within a type of device which was so introduced or delivered
before such date and is substantially equivalent to another device
within that type,
such panel shall recommend to the Secretary that the device be
classified in class III unless the panel determines that classification
of the device in such class is not necessary to provide reasonable
assurance of its safety and effectiveness. If a panel does not
recommend that such a device be classified in class III, it shall in its
recommendation to the Secretary for the classification of the device set
forth the reasons for not recommending classification of the device in
such class.
(3) The panels shall submit to the Secretary within one year of the
date funds are first appropriated for the implementation of this section
their recommendations respecting all devices of a type introduced or
delivered for introduction into interstate commerce for commercial
distribution before May 28, 1976.
(d) Panel recommendation; publication; priorities
(1) Upon receipt of a recommendation from a panel respecting a
device, the Secretary shall publish in the Federal Register the panel's
recommendation and a proposed regulation classifying such device and
shall provide interested persons an opportunity to submit comments on
such recommendation and the proposed regulation. After reviewing such
comments, the Secretary shall, subject to paragraph (2), by regulation
classify such device.
(2)(A) A regulation under paragraph (1) classifying a device in class
I shall prescribe which, if any, of the requirements of section 360,
360i, or 360j(f) of this title shall not apply to the device. A
regulation which makes a requirement of section 360, 360i, or 360j(f) of
this title inapplicable to a device shall be accompanied by a statement
of the reasons of the Secretary for making such requirement
inapplicable.
(B) A device described in subsection (c)(2)(C) of this section shall
be classified in class III unless the Secretary determines that
classification of the device in such class is not necessary to provide
reasonable assurance of its safety and effectiveness. A proposed
regulation under paragraph (1) classifying such a device in a class
other than class III shall be accompanied by a full statement of the
reasons of the Secretary (and supporting documentation and data) for not
classifying such device in such class and an identification of the risks
to health (if any) presented by such device.
(3) In the case of devices classified in class II and devices
classified under this subsection in class III and described in section
360e(b)(1) of this title the Secretary may establish priorities which,
in his discretion, shall be used in applying sections 360d and 360e of
this title, as appropriate, to such devices.
(e) Classification changes
(1) Based on new information respecting a device, the Secretary may,
upon his own initiative or upon petition of an interested person, by
regulation (A) change such device's classification, and (B) revoke,
because of the change in classification, any regulation or requirement
in effect under section 360d or 360e of this title with respect to such
device. In the promulgation of such a regulation respecting a device's
classification, the Secretary may secure from the panel to which the
device was last referred pursuant to subsection (c) of this section a
recommendation respecting the proposed change in the device's
classification and shall publish in the Federal Register any
recommendation submitted to the Secretary by the panel respecting such
change. A regulation under this subsection changing the classification
of a device from class III to class II may provide that such
classification shall not take effect until the effective date of a
performance standard established under section 360d of this title for
such device.
(2) By regulation promulgated under paragraph (1), the Secretary may
change the classification of a device from class III --
(A) to class II if the Secretary determines that special controls
would provide reasonable assurance of the safety and effectiveness of
the device and that general controls would not provide reasonable
assurance of the safety and effectiveness of the device, or
(B) to class I if the Secretary determines that general controls
would provide reasonable assurance of the safety and effectiveness of
the device.
(f) Initial classification and reclassification of certain devices
(1) Any device intended for human use which was not introduced or
delivered for introduction into interstate commerce for commercial
distribution before May 28, 1976, is classified in class III unless --
(A) the device --
(i) is within a type of device (I) which was introduced or delivered
for introduction into interstate commerce for commercial distribution
before such date and which is to be classified pursuant to subsection
(b) of this section, or (II) which was not so introduced or delivered
before such date and has been classified in class I or II, and
(ii) is substantially equivalent to another device within such type,
or
(B) the Secretary in response to a petition submitted under paragraph
(2) has classified such device in class I or II.
A device classified in class III under this paragraph shall be
classified in that class until the effective date of an order of the
Secretary under paragraph (2) classifying the device in class I or II.
(2)(A) The Secretary may initiate the reclassification of a device
classified into class III under paragraph (1) of this subsection or the
manufacturer or importer of a device classified under paragraph (1) may
petition the Secretary (in such form and manner as he shall prescribe)
for the issuance of an order classifying the device in class I or class
II. Within thirty days of the filing of such a petition, the Secretary
shall notify the petitioner of any deficiencies in the petition which
prevent the Secretary from making a decision on the petition.
(B)(i) Upon determining that a petition does not contain any
deficiency which prevents the Secretary from making a decision on the
petition, the Secretary may for good cause shown refer the petition to
an appropriate panel established or authorized to be used under
subsection (b) of this section. A panel to which such a petition has
been referred shall not later than ninety days after the referral of the
petition make a recommendation to the Secretary respecting approval or
denial of the petition. Any such recommendation shall contain (I) a
summary of the reasons for the recommendation, (II) a summary of the
data upon which the recommendation is based, and (III) an identification
of the risks to health (if any) presented by the device with respect to
which the petition was filed. In the case of a petition for a device
which is intended to be implanted in the human body or which is
purported or represented to be for a use in supporting or sustaining
human life, the panel shall recommend that the petition be denied unless
the panel determines that the classification in class III of the device
is not necessary to provide reasonable assurance of its safety and
effectiveness. If the panel recommends that such petition be approved,
it shall in its recommendation to the Secretary set forth its reasons
for such recommendation.
(ii) The requirements of paragraphs (1) and (2) of subsection (c) of
this section (relating to opportunities for submission of data and views
and recommendations respecting priorities and exemptions from sections
360, 360i, and 360j(f) of this title) shall apply with respect to
consideration by panels of petitions submitted under subparagraph (A).
(C)(i) Within ninety days from the date the Secretary receives the
recommendation of a panel respecting a petition (but not later than 210
days after the filing of such petition) the Secretary shall by order
deny or approve the petition. If the Secretary approves the petition,
the Secretary shall order the classification of the device into class I
or class II in accordance with the criteria prescribed by subsection
(a)(1)(A) or (a)(1)(B) of this section. In the case of a petition for a
device which is intended to be implanted in the human body or which is
purported or represented to be for a use in supporting or sustaining
human life, the Secretary shall deny the petition unless the Secretary
determines that the classification in class III of the device is not
necessary to provide reasonable assurance of its safety and
effectiveness. An order approving such petition shall be accompanied by
a full statement of the reasons of the Secretary (and supporting
documentation and data) for approving the petition and an identification
of the risks to health (if any) presented by the device to which such
order applies.
(ii) The requirements of paragraphs (1) and (2)(A) of subsection (d)
of this section (relating to publication of recommendations, opportunity
for submission of comments, and exemption from sections 360, 360i, and
360j(f) of this title) shall apply with respect to action by the
Secretary on petitions submitted under subparagraph (A).
(3) If a manufacturer reports to the Secretary under section 360(k)
of this title that a device is substantially equivalent to another
device --
(i) which the Secretary has classified as a class III device under
subsection (b) of this section,
(ii) which was introduced or delivered for introduction into
interstate commerce for commercial distribution before December 1, 1990,
and
(iii) for which no final regulation requiring premarket approval has
been promulgated under section 360e(b) of this title,
the manufacturer shall certify to the Secretary that the manufacturer
has conducted a reasonable search of all information known or otherwise
available to the manufacturer respecting such other device and has
included in the report under section 360(k) of this title a summary of
and a citation to all adverse safety and effectiveness data respecting
such other device and respecting the device for which the 360(k) report
is being made and which has not been submitted to the Secretary under
section 360i of this title. The Secretary may require the manufacturer
to submit the adverse safety and effectiveness data described in the
report.
(g) Information
Within sixty days of the receipt of a written request of any person
for information respecting the class in which a device has been
classified or the requirements applicable to a device under this
chapter, the Secretary shall provide such person a written statement of
the classification (if any) of such device and the requirements of this
chapter applicable to the device.
(h) Definitions
For purposes of this section and sections 351, 360, 360d, 360e, 360f,
360i, and 360j of this title
(1) a reference to ''general controls'' is a reference to the
controls authorized by or under sections 351, 352, 360, 360f, 360h,
360i, and 360j of this title,
(2) a reference to ''class I'', ''class II'', or ''class III'' is a
reference to a class of medical devices described in subparagraph (A),
(B), or (C) of subsection (a)(1) of this section, and
(3) a reference to a ''panel under section 360c of this title'' is a
reference to a panel established or authorized to be used under this
section.
(i) Substantial equivalence
(1)(A) For purposes of determinations of substantial equivalence
under subsection (f) of this section and section 360j(l) of this title,
the term ''substantially equivalent'' or ''substantial equivalence''
means, with respect to a device being compared to a predicate device,
that the device has the same intended use as the predicate device and
that the Secretary by order has found that the device --
(i) has the same technological characteristics as the predicate
device, or
(ii)(I) has different technological characteristics and the
information submitted that the device is substantially equivalent to the
predicate device contains information, including clinical data if deemed
necessary by the Secretary, that demonstrates that the device is as safe
and effective as a legally marketed device, and (II) does not raise
different questions of safety and efficacy than the predicate device.
(B) For purposes of subparagraph (A), the term ''different
technological characteristics'' means, with respect to a device being
compared to a predicate device, that there is a significant change in
the materials, design, energy source, or other features of the device
from those of the predicate device.
(2) A device may not be found to be substantially equivalent to a
predicate device that has been removed from the market at the initiative
of the Secretary or that has been determined to be misbranded or
adulterated by a judicial order.
(3)(A) As part of a submission under section 360(k) of this title
respecting a device, the person required to file a premarket
notification under such section shall provide an adequate summary of any
information respecting safety and effectiveness or state that such
information will be made available upon request by any person.
(B) Any summary under subparagraph (A) respecting a device shall
contain detailed information regarding data concerning adverse health
effects and shall be made available to the public by the Secretary
within 30 days of the issuance of a determination that such device is
substantially equivalent to another device.
(June 25, 1938, ch. 675, 513, as added May 28, 1976, Pub. L. 94-295,
2, 90 Stat. 540, and amended Nov. 28, 1990, Pub. L. 101-629,
4(a), 5(a)-(c)(1), (3), 12(a), 18(a), 104 Stat. 4515, 4517, 4518,
4523, 4528.)
The Federal Advisory Committee Act, referred to in subsec. (b)(1), is
Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is set
out in the Appendix to Title 5, Government Organization and Employees.
Section 5703 of title 5, referred to in subsec. (b)(3), was amended
generally by Pub. L. 94-22, 4, May 19, 1975, 89 Stat. 85, and, as so
amended, does not contain a subsec. (b).
1990 -- Subsec. (a)(1)(A)(ii). Pub. L. 101-629, 5(a)(1), substituted
''or to establish special controls'' for ''or to establish a performance
standard''.
Subsec. (a)(1)(B). Pub. L. 101-629, 5(a)(2), amended subpar. (B)
generally. Prior to amendment, subpar. (B) read as follows: ''Class
II, Performance Standards. -- A device which cannot be classified as a
class I device because the controls authorized by or under sections 351,
352, 360, 360f, 360h, 360i, and 360j of this title by themselves are
insufficient to provide reasonable assurance of the safety and
effectiveness of the device, for which there is sufficient information
to establish a performance standard to provide such assurance, and for
which it is therefore necessary to establish for the device a
performance standard under section 360d of this title to provide
reasonable assurance of its safety and effectiveness.''
Subsec. (a)(1)(C)(i). Pub. L. 101-629, 5(a)(3), amended cl. (i)
generally. Prior to amendment, cl. (i) read as follows: ''it (I)
cannot be classified as a class I device because insufficient
information exists to determine that the controls authorized by or under
sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title are
sufficient to provide reasonable assurance of the safety and
effectiveness of the device and (II) cannot be classified as a class II
device because insufficient information exists for the establishment of
a performance standard to provide reasonable assurance of its safety and
effectiveness, and''.
Subsec. (e). Pub. L. 101-629, 5(b), designated existing provisions as
par. (1), redesignated cls. (1) and (2) as (A) and (B), respectively,
and added par. (2).
Subsec. (f). Pub. L. 101-629, 5(c)(3), inserted ''and
reclassification'' before ''of'' in heading.
Subsec. (f)(2)(A). Pub. L. 101-629, 5(c)(1), substituted ''The
Secretary may initiate the reclassification of a device classified into
class III under paragraph (1) of this subsection or the manufacturer''
for ''The manufacturer''.
Subsec. (f)(2)(B)(i). Pub. L. 101-629, 18(a), substituted ''the
Secretary may for good cause shown'' for ''the Secretary shall''.
Subsec. (f)(3). Pub. L. 101-629, 4(a), added par. (3).
Subsec. (i). Pub. L. 101-629, 12(a), added subsec. (i).
Pub. L. 94-295, 1(a), May 28, 1976, 90 Stat. 539, provided that:
''This Act (enacting sections 360c to 360k, 379, and 379a of this title
and section 3512 of Title 42, The Public Health and Welfare, and
amending sections 321, 331, 334, 351, 352, 358, 360, 374, 376, and 381
of this title and section 55 of Title 15, Commerce and Trade) may be
cited as the 'Medical Device Amendments of 1976'.''
Section 12(b) of Pub. L. 101-629 provided that: ''Within 12 months
of the date of the enactment of this Act (Nov. 28, 1990), the Secretary
of Health and Human Services shall issue regulations establishing the
requirements of the summaries under section 513(i)(3) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)(3)), as added by the
amendment made by subsection (a).''
Section 4(b)(3) of Pub. L. 101-629 provided that:
''(A) Notwithstanding section 520(l)(5) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j(l)(5)), the Secretary of Health and
Human Services shall not retain any daily wear soft or daily wear
nonhydrophilic plastic contact lens in class III under such Act (this
chapter) unless the Secretary finds that it meets the criteria set forth
in section 513(a)(1)(C) of such Act (21 U.S.C. 360c(a)(1)(C)). The
finding and the grounds for the finding shall be published in the
Federal Register. For any such lens, the Secretary shall make the
determination respecting reclassification required in section 520(l)(
5)(B) of such Act within 24 months of the date of the enactment of this
paragraph (Nov. 28, 1990).
''(B) The Secretary of Health and Human Services may by notice
published in the Federal Register extend the two-year period prescribed
by subparagraph (A) for a lens for an additional period not to exceed
one year.
''(C)(i) Before classifying a lens in class II pursuant to
subparagraph (A), the Secretary of Health and Human Services shall
pursuant to section 513(a)(1)(B) of such Act assure that appropriate
regulatory safeguards are in effect which provide reasonable assurance
of the safety and effectiveness of such lens, including clinical and
preclinical data if deemed necessary by the Secretary.
''(ii) Prior to classifying a lens in class I pursuant to
subparagraph (A), the Secretary shall assure that appropriate regulatory
safeguards are in effect which provide reasonable assurance of the
safety and effectiveness of such lens, including clinical and
preclinical data if deemed necessary by the Secretary.
''(D) Notwithstanding section 520(l)(5) of such Act, if the Secretary
of Health and Human Services has not made the finding and published the
finding required by subparagraph (A) within 36 months of the date of the
enactment of this subparagraph (Nov. 28, 1990), the Secretary shall
issue an order placing the lens in class II.
''(E) Any person adversely affected by a final regulation under this
paragraph revising the classification of a lens may challenge the
revision of the classification of such lens only by filing a petition
under section 513(e) for a classification change.''
References in laws to the rates of pay for GS-16, 17, or 18, or to
maximum rates of pay under the General Schedule, to be considered
references to rates payable under specified sections of Title 5,
Government Organization and Employees, see section 529 (title I, 101(
c)(1)) of Pub. L. 101-509, set out in a note under section 5376 of
Title 5.
/1/ See References in Text note below.
21 USC 360d. Performance standards
TITLE 21 -- FOOD AND DRUGS
(a) Reasonable assurance of safe and effective performance; periodic
evaluation
(1) The special controls required by section 360c(a)(1)(B) of this
title shall include performance standards for a class II device if the
Secretary determines that a performance standard is necessary to provide
reasonable assurance of the safety and effectiveness of the device. A
class III device may also be considered a class II device for purposes
of establishing a standard for the device under this section if the
device has been reclassified as a class II device under a regulation
under section 360c(e) of this title but such regulation provides that
the reclassification is not to take effect until the effective date of
such a standard for the device.
(2) A performance standard established under this section for a
device --
(A) shall include provisions to provide reasonable assurance of its
safe and effective performance;
(B) shall, where necessary to provide reasonable assurance of its
safe and effective performance, include --
(i) provisions respecting the construction, components, ingredients,
and properties of the device and its compatibility with power systems
and connections to such systems,
(ii) provisions for the testing (on a sample basis or, if necessary,
on an individual basis) of the device or, if it is determined that no
other more practicable means are available to the Secretary to assure
the conformity of the device to the standard, provisions for the testing
(on a sample basis or, if necessary, on an individual basis) by the
Secretary or by another person at the direction of the Secretary,
(iii) provisions for the measurement of the performance
characteristics of the device,
(iv) provisions requiring that the results of each or of certain of
the tests of the device required to be made under clause (ii) show that
the device is in conformity with the portions of the standard for which
the test or tests were required, and
(v) a provision requiring that the sale and distribution of the
device be restricted but only to the extent that the sale and
distribution of a device may be restricted under a regulation under
section 360j(e) of this title; and
(C) shall, where appropriate, require the use and prescribe the form
and content of labeling for the proper installation, maintenance,
operation, and use of the device.
(3) The Secretary shall provide for periodic evaluation of
performance standards established under this section to determine if
such standards should be changed to reflect new medical, scientific, or
other technological data.
(4) In carrying out his duties under this section, the Secretary
shall, to the maximum extent practicable --
(A) use personnel, facilities, and other technical support available
in other Federal agencies,
(B) consult with other Federal agencies concerned with
standard-setting and other nationally or internationally recognized
standard-setting entities, and
(C) invite appropriate participation, through joint or other
conferences, workshops, or other means, by informed persons
representative of scientific, professional, industry, or consumer
organizations who in his judgment can make a significant contribution.
(b) Establishment of a standard
(1)(A) The Secretary shall publish in the Federal Register a notice
of proposed rulemaking for the establishment, amendment, or revocation
of any performance standard for a device.
(B) A notice of proposed rulemaking for the establishment or
amendment of a performance standard for a device shall --
(i) set forth a finding with supporting justification that the
performance standard is appropriate and necessary to provide reasonable
assurance of the safety and effectiveness of the device,
(ii) set forth proposed findings with respect to the risk of illness
or injury that the performance standard is intended to reduce or
eliminate,
(iii) invite interested persons to submit to the Secretary, within 30
days of the publication of the notice, requests for changes in the
classification of the device pursuant to section 360c(e) of this title
based on new information relevant to the classification, and
(iv) invite interested persons to submit an existing performance
standard for the device, including a draft or proposed performance
standard, for consideration by the Secretary.
(C) A notice of proposed rulemaking for the revocation of a
performance standard shall set forth a finding with supporting
justification that the performance standard is no longer necessary to
provide reasonable assurance of the safety and effectiveness of a
device.
(D) The Secretary shall provide for a comment period of not less than
60 days.
(2) If, after publication of a notice in accordance with paragraph
(1), the Secretary receives a request for a change in the classification
of the device, the Secretary shall, within 60 days of the publication of
the notice, after consultation with the appropriate panel under section
360c of this title, either deny the request or give notice of an intent
to initiate such change under section 360c(e) of this title.
(3)(A) After the expiration of the period for comment on a notice of
proposed rulemaking published under paragraph (1) respecting a
performance standard and after consideration of such comments and any
report from an advisory committee under paragraph (5), the Secretary
shall (i) promulgate a regulation establishing a performance standard
and publish in the Federal Register findings on the matters referred to
in paragraph (1), or (ii) publish a notice terminating the proceeding
for the development of the standard together with the reasons for such
termination. If a notice of termination is published, the Secretary
shall (unless such notice is issued because the device is a banned
device under section 360f of this title) initiate a proceeding under
section 360c(e) of this title to reclassify the device subject to the
proceeding terminated by such notice.
(B) A regulation establishing a performance standard shall set forth
the date or dates upon which the standard shall take effect, but no such
regulation may take effect before one year after the date of its
publication unless (i) the Secretary determines that an earlier
effective date is necessary for the protection of the public health and
safety, or (ii) such standard has been established for a device which,
effective upon the effective date of the standard, has been reclassified
from class III to class II. Such date or dates shall be established so
as to minimize, consistent with the public health and safety, economic
loss to, and disruption or dislocation of, domestic and international
trade.
(4)(A) The Secretary, upon his own initiative or upon petition of an
interested person may by regulation, promulgated in accordance with the
requirements of paragraphs (1), (2), and (3)(B) of this subsection,
amend or revoke a performance standard.
(B) The Secretary may declare a proposed amendment of a performance
standard to be effective on and after its publication in the Federal
Register and until the effective date of any final action taken on such
amendment if he determines that making it so effective is in the public
interest. A proposed amendment of a performance standard made so
effective under the preceding sentence may not prohibit, during the
period in which it is so effective, the introduction or delivery for
introduction into interstate commerce of a device which conforms to such
standard without the change or changes provided by such proposed
amendment.
(5)(A) The Secretary --
(i) may on his own initiative refer a proposed regulation for the
establishment, amendment, or revocation of a performance standard, or
(ii) shall, upon the request of an interested person which
demonstrates good cause for referral and which is made before the
expiration of the period for submission of comments on such proposed
regulation refer such proposed regulation,
to an advisory committee of experts, established pursuant to
subparagraph (B), for a report and recommendation with respect to any
matter involved in the proposed regulation which requires the exercise
of scientific judgment. If a proposed regulation is referred under this
subparagraph to an advisory committee, the Secretary shall provide the
advisory committee with the data and information on which such proposed
regulation is based. The advisory committee shall, within sixty days of
the referral of a proposed regulation and after independent study of the
data and information furnished to it by the Secretary and other data and
information before it, submit to the Secretary a report and
recommendation respecting such regulation, together with all underlying
data and information and a statement of the reason or basis for the
recommendation. A copy of such report and recommendation shall be made
public by the Secretary.
(B) The Secretary shall establish advisory committees (which may not
be panels under section 360c of this title) to receive referrals under
subparagraph (A). The Secretary shall appoint as members of any such
advisory committee persons qualified in the subject matter to be
referred to the committee and of appropriately diversified professional
background, except that the Secretary may not appoint to such a
committee any individual who is in the regular full-time employ of the
United States and engaged in the administration of this chapter. Each
such committee shall include as nonvoting members a representative of
consumer interests and a representative of interests of the device
manufacturing industry. Members of an advisory committee who are not
officers or employees of the United States, while attending conferences
or meetings of their committee or otherwise serving at the request of
the Secretary, shall be entitled to receive compensation at rates to be
fixed by the Secretary, which rates may not exceed the daily equivalent
of the rate in effect for grade GS-18 of the General Schedule, for each
day (including traveltime) they are so engaged; and while so serving
away from their homes or regular places of business each member may be
allowed travel expenses, including per diem in lieu of subsistence, as
authorized by section 5703 of title 5 for persons in the Government
service employed intermittently. The Secretary shall designate one of
the members of each advisory committee to serve as chairman thereof.
The Secretary shall furnish each advisory committee with clerical and
other assistance, and shall by regulation prescribe the procedures to be
followed by each such committee in acting on referrals made under
subparagraph (A).
(June 25, 1938, ch. 675, 514, as added May 28, 1976, Pub. L. 94-295,
2, 90 Stat. 546, and amended Oct. 8, 1976, Pub. L. 94-460, title III,
304, 90 Stat. 1960; Nov. 28, 1990, Pub. L. 101-629, 6( a), (b)(1), 18(
b), 104 Stat. 4519, 4528.)
1990 -- Subsec. (a)(1). Pub. L. 101-629, 6(a)(1), substituted ''The
special controls required by section 360c(a)(1)(B) of this title shall
include performance standards for a class II device if the Secretary
determines that a performance standard is necessary to provide
reasonable assurance of the safety and effectiveness of the device.''
for ''The Secretary may by regulation, promulgated in accordance with
this section, establish a performance standard for a class II device.''
Subsec. (b). Pub. L. 101-629, 6(a)(2), (3), redesignated subsec. (g)
as (b) and struck out former subsec. (b) which read as follows:
''(1) A proceeding for the development of a performance standard for
a device shall be initiated by the Secretary by the publication in the
Federal Register of notice of the opportunity to submit to the Secretary
a request (within fifteen days of the date of the publication of the
notice) for a change in the classification of the device based on new
information relevant to its classification.
''(2) If, after publication of a notice pursuant to paragraph (1) the
Secretary receives a request for a change in the device's
classification, he shall, within sixty days of the publication of such
notice and after consultation with the appropriate panel under section
360c of this title, by order published in the Federal Register, either
deny the request for change in classification or give notice of his
intent to initiate such a change under section 360c(e) of this title.''
Subsec. (b)(1), (2). Pub. L. 101-629, 6(a)(4), amended pars. (1) and
(2) generally. Prior to amendment, pars. (1) and (2) read as follows:
''(1)(A) After publication pursuant to subsection (c) of this section
of a notice respecting a performance standard for a device, the
Secretary shall either --
''(i) publish, in the Federal Register in a notice of proposed
rulemaking, a proposed performance standard for the device (I) developed
by an offeror under such notice and accepted by the Secretary, (II)
developed under subsection (c)(4) of this section, (III) accepted by the
Secretary under subsection (d) of this section, or (IV) developed by him
under subsection (f) of this section, or
''(ii) issue a notice in the Federal Register that the proceeding is
terminated together with the reasons for such termination.
''(B) If the Secretary issues under subparagraph (A)(ii) a notice of
termination of a proceeding to establish a performance standard for a
device, he shall (unless such notice is issued because the device is a
banned device under section 360f of this title) initiate a proceeding
under section 360c(e) of this title to reclassify the device subject to
the proceeding terminated by such notice.
''(2) A notice of proposed rulemaking for the establishment of a
performance standard for a device published under paragraph (1)(A)(i)
shall set forth proposed findings with respect to the degree of the risk
of illness or injury designed to be eliminated or reduced by the
proposed standard and the benefit to the public from the device.''
Subsec. (b)(3)(A)(i). Pub. L. 101-629, 6(b)(1)(A), substituted
''paragraph (1)'' for ''paragraph (2)''.
Subsec. (b)(4)(A). Pub. L. 101-629, 6(b)(1)(B), substituted
''paragraphs (1), (2), and (3)(B)'' for ''paragraphs (2) and (3)(B)''.
Subsec. (b)(4)(B). Pub. L. 101-629, 18(b)(1), which directed the
amendment of par. (3)(B) by striking out '', after affording all
interested persons an opportunity for an informal hearing,'' was
executed by striking out that language after ''if he determines'' in
par. (4)(B), to reflect the probable intent of Congress.
Subsec. (b)(5)(A)(ii). Pub. L. 101-629, 18(b)(2), which directed the
amendment of par. (4)(A)(ii) by substituting ''which demonstrates good
cause for referral and which is made before the expiration of the period
for submission of comments on such proposed regulation refer such
proposed regulation,'' for ''unless'' and all that follows in cl. (ii),
was executed by substituting the new language for ''unless the Secretary
finds the request to be without good cause or the request is made after
the expiration of the period for submission of comments on such proposed
regulation refer such proposed regulation,'' in par. (5)( A)(ii), to
reflect the probable intent of Congress.
Subsecs. (c) to (f). Pub. L. 101-629, 6(a)(2), struck out subsec.
(c) relating to invitations for standards, subsec. (d) relating to
acceptance of certain existing standards, subsec. (e) relating to
acceptance of offers to develop standards, and subsec. (f) relating to
development of standards by the Secretary after publication of notice
inviting submissions or offers of standards.
Subsec. (g). Pub. L. 101-629, 6(a)(3), redesignated subsec. (g) as
(b).
1976 -- Subsec. (a). Pub. L. 94-460 redesignated pars. (4) and (5)
as (3) and (4), respectively. Section as originally enacted contained
no par. (3).
References in laws to the rates of pay for GS-16, 17, or 18, or to
maximum rates of pay under the General Schedule, to be considered
references to rates payable under specified sections of Title 5,
Government Organization and Employees, see section 529 (title I, 101(
c)(1)) of Pub. L. 101-509, set out in a note under section 5376 of
Title 5.
Advisory committees in existence on Jan. 5, 1973, to terminate not
later than the expiration of the 2-year period following Jan. 5, 1973,
and advisory committees established after Jan. 5, 1973, to terminate
not later than the expiration of the 2-year period beginning on the date
of their establishment, unless in the case of a committee established by
the President or an officer of the Federal Government, such committee is
renewed by appropriate action prior to the expiration of such 2-year
period, or in the case of a committee established by Congress, its
duration is otherwise provided by law. See section 14 of Pub. L.
92-463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title
5, Government Organization and Employees.
21 USC 360e. Premarket approval
TITLE 21 -- FOOD AND DRUGS
(a) General requirement
A class III device --
(1) which is subject to a regulation promulgated under subsection (b)
of this section; or
(2) which is a class III device because of section 360c(f) of this
title,
is required to have, unless exempt under section 360j(g) of this
title, an approval under this section of an application for premarket
approval.
(b) Regulation to require premarket approval
(1) In the case of a class III device which --
(A) was introduced or delivered for introduction into interstate
commerce for commercial distribution before May 28, 1976; or
(B) is (i) of a type so introduced or delivered, and (ii) is
substantially equivalent to another device within that type,
the Secretary shall by regulation, promulgated in accordance with
this subsection, require that such device have an approval under this
section of an application for premarket approval.
(2)(A) A proceeding for the promulgation of a regulation under
paragraph (1) respecting a device shall be initiated by the publication
in the Federal Register of a notice of proposed rulemaking. Such notice
shall contain --
(i) the proposed regulation;
(ii) proposed findings with respect to the degree of risk of illness
or injury designed to be eliminated or reduced by requiring the device
to have an approved application for premarket approval and the benefit
to the public from use of the device;
(iii) opportunity for the submission of comments on the proposed
regulation and the proposed findings; and
(iv) opportunity to request a change in the classification of the
device based on new information relevant to the classification of the
device.
(B) If, within fifteen days after publication of a notice under
subparagraph (A), the Secretary receives a request for a change in the
classification of a device, he shall, within sixty days of the
publication of such notice and after consultation with the appropriate
panel under section 360c of this title, by order published in the
Federal Register, either deny the request for change in classification
or give notice of his intent to initiate such a change under section
360c(e) of this title.
(3) After the expiration of the period for comment on a proposed
regulation and proposed findings published under paragraph (2) and after
consideration of comments submitted on such proposed regulation and
findings, the Secretary shall (A) promulgate such regulation and publish
in the Federal Register findings on the matters referred to in paragraph
(2)(A)(ii), or (B) publish a notice terminating the proceeding for the
promulgation of the regulation together with the reasons for such
termination. If a notice of termination is published, the Secretary
shall (unless such notice is issued because the device is a banned
device under section 360f of this title) initiate a proceeding under
section 360c(e) of this title to reclassify the device subject to the
proceeding terminated by such notice.
(4) The Secretary, upon his own initiative or upon petition of an
interested person, may by regulation amend or revoke any regulation
promulgated under this subsection. A regulation to amend or revoke a
regulation under this subsection shall be promulgated in accordance with
the requirements prescribed by this subsection for the promulgation of
the regulation to be amended or revoked.
(c) Application for premarket approval
(1) Any person may file with the Secretary an application for
premarket approval for a class III device. Such an application for a
device shall contain --
(A) full reports of all information, published or known to or which
should reasonably be known to the applicant, concerning investigations
which have been made to show whether or not such device is safe and
effective;
(B) a full statement of the components, ingredients, and properties
and of the principle or principles of operation, of such device;
(C) a full description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and, when relevant,
packing and installation of, such device;
(D) an identifying reference to any performance standard under
section 360d of this title which would be applicable to any aspect of
such device if it were a class II device, and either adequate
information to show that such aspect of such device fully meets such
performance standard or adequate information to justify any deviation
from such standard;
(E) such samples of such device and of components thereof as the
Secretary may reasonably require, except that where the submission of
such samples is impracticable or unduly burdensome, the requirement of
this subparagraph may be met by the submission of complete information
concerning the location of one or more such devices readily available
for examination and testing;
(F) specimens of the labeling proposed to be used for such device;
and
(G) such other information relevant to the subject matter of the
application as the Secretary, with the concurrence of the appropriate
panel under section 360c of this title, may require.
(2) Upon receipt of an application meeting the requirements set forth
in paragraph (1), the Secretary --
(A) may on the Secretary's own initiative refer such application, or
(B) shall, upon the request of an applicant unless the Secretary
finds that the information in the application which would be reviewed by
a panel substantially duplicates information which has previously been
reviewed by a panel appointed under section 360c of this title,
refer such application to the appropriate panel under section 360c of
this title for study and for submission (within such period as he may
establish) of a report and recommendation respecting approval of the
application, together with all underlying data and the reasons or basis
for the recommendation.
(d) Action on application for premarket approval
(1)(A) As promptly as possible, but in no event later than one
hundred and eighty days after the receipt of an application under
subsection (c) of this section (except as provided in section 360j(l)(
3)(D)(ii) of this title or unless, in accordance with subparagraph (B)(
i), an additional period as agreed upon by the Secretary and the
applicant), the Secretary, after considering the report and
recommendation submitted under paragraph (2) of such subsection, shall
--
(i) issue an order approving the application if he finds that none of
the grounds for denying approval specified in paragraph (2) of this
subsection applies; or
(ii) deny approval of the application if he finds (and sets forth the
basis for such finding as part of or accompanying such denial) that one
or more grounds for denial specified in paragraph (2) of this subsection
apply.
(B)(i) The Secretary may not enter into an agreement to extend the
period in which to take action with respect to an application submitted
for a device subject to a regulation promulgated under subsection (b) of
this section unless he finds that the continued availability of the
device is necessary for the public health.
(ii) An order approving an application for a device may require as a
condition to such approval that the sale and distribution of the device
be restricted but only to the extent that the sale and distribution of a
device may be restricted under a regulation under section 360j(e) of
this title.
(2) The Secretary shall deny approval of an application for a device
if, upon the basis of the information submitted to the Secretary as part
of the application and any other information before him with respect to
such device, the Secretary finds that --
(A) there is a lack of a showing of reasonable assurance that such
device is safe under the conditions of use prescribed, recommended, or
suggested in the proposed labeling thereof;
(B) there is a lack of a showing of reasonable assurance that the
device is effective under the conditions of use prescribed, recommended,
or suggested in the proposed labeling thereof;
(C) the methods used in, or the facilities or controls used for, the
manufacture, processing, packing, or installation of such device do not
conform to the requirements of section 360j(f) of this title;
(D) based on a fair evaluation of all material facts, the proposed
labeling is false or misleading in any particular; or
(E) such device is not shown to conform in all respects to a
performance standard in effect under section 360d of this title
compliance with which is a condition to approval of the application and
there is a lack of adequate information to justify the deviation from
such standard.
Any denial of an application shall, insofar as the Secretary
determines to be practicable, be accompanied by a statement informing
the applicant of the measures required to place such application in
approvable form (which measures may include further research by the
applicant in accordance with one or more protocols prescribed by the
Secretary).
(3) An applicant whose application has been denied approval may, by
petition filed on or before the thirtieth day after the date upon which
he receives notice of such denial, obtain review thereof in accordance
with either paragraph (1) or (2) of subsection (g) of this section, and
any interested person may obtain review, in accordance with paragraph
(1) or (2) of subsection (g) of this section, of an order of the
Secretary approving an application.
(e) Withdrawal and temporary suspension of approval of application
(1) The Secretary shall, upon obtaining, where appropriate, advice on
scientific matters from a panel or panels under section 360c of this
title, and after due notice and opportunity for informal hearing to the
holder of an approved application for a device, issue an order
withdrawing approval of the application if the Secretary finds --
(A) that such device is unsafe or ineffective under the conditions of
use prescribed, recommended, or suggested in the labeling thereof;
(B) on the basis of new information before him with respect to such
device, evaluated together with the evidence available to him when the
application was approved, that there is a lack of a showing of
reasonable assurance that the device is safe or effective under the
conditions of use prescribed, recommended, or suggested in the labeling
thereof;
(C) that the application contained or was accompanied by an untrue
statement of a material fact;
(D) that the applicant (i) has failed to establish a system for
maintaining records, or has repeatedly or deliberately failed to
maintain records or to make reports, required by an applicable
regulation under section 360i(a) of this title, (ii) has refused to
permit access to, or copying or verification of, such records as
required by section 374 of this title, or (iii) has not complied with
the requirements of section 360 of this title;
(E) on the basis of new information before him with respect to such
device, evaluated together with the evidence before him when the
application was approved, that the methods used in, or the facilities
and controls used for, the manufacture, processing, packing, or
installation of such device do not conform with the requirements of
section 360j(f) of this title and were not brought into conformity with
such requirements within a reasonable time after receipt of written
notice from the Secretary of nonconformity;
(F) on the basis of new information before him, evaluated together
with the evidence before him when the application was approved, that the
labeling of such device, based on a fair evaluation of all material
facts, is false or misleading in any particular and was not corrected
within a reasonable time after receipt of written notice from the
Secretary of such fact; or
(G) on the basis of new information before him, evaluated together
with the evidence before him when the application was approved, that
such device is not shown to conform in all respects to a performance
standard which is in effect under section 360d of this title compliance
with which was a condition to approval of the application and that there
is a lack of adequate information to justify the deviation from such
standard.
(2) The holder of an application subject to an order issued under
paragraph (1) withdrawing approval of the application may, by petition
filed on or before the thirtieth day after the date upon which he
receives notice of such withdrawal, obtain review thereof in accordance
with either paragraph (1) or (2) of subsection (g) of this section.
(3) If, after providing an opportunity for an informal hearing, the
Secretary determines there is reasonable probability that the
continuation of distribution of a device under an approved application
would cause serious, adverse health consequences or death, the Secretary
shall by order temporarily suspend the approval of the application
approved under this section. If the Secretary issues such an order, the
Secretary shall proceed expeditiously under paragraph (1) to withdraw
such application.
(f) Product development protocol
(1) In the case of a class III device which is required to have an
approval of an application submitted under subsection (c) of this
section, such device shall be considered as having such an approval if a
notice of completion of testing conducted in accordance with a product
development protocol approved under paragraph (4) has been declared
completed under paragraph (6).
(2) Any person may submit to the Secretary a proposed product
development protocol with respect to a device. Such a protocol shall be
accompanied by data supporting it. If, within thirty days of the
receipt of such a protocol, the Secretary determines that it appears to
be appropriate to apply the requirements of this subsection to the
device with respect to which the protocol is submitted, he shall refer
the proposed protocol to the appropriate panel under section 360c of
this title for its recommendation respecting approval of the protocol.
(3) A proposed product development protocol for a device may be
approved only if --
(A) the Secretary determines that it is appropriate to apply the
requirements of this subsection to the device in lieu of the requirement
of approval of an application submitted under subsection (c) of this
section; and
(B) the Secretary determines that the proposed protocol provides --
(i) a description of the device and the changes which may be made in
the device,
(ii) a description of the preclinical trials (if any) of the device
and a specification of (I) the results from such trials to be required
before the commencement of clinical trials of the device, and (II) any
permissible variations in preclinical trials and the results therefrom,
(iii) a description of the clinical trials (if any) of the device and
a specification of (I) the results from such trials to be required
before the filing of a notice of completion of the requirements of the
protocol, and (II) any permissible variations in such trials and the
results therefrom,
(iv) a description of the methods to be used in, and the facilities
and controls to be used for, the manufacture, processing, and, when
relevant, packing and installation of the device,
(v) an identifying reference to any performance standard under
section 360d of this title to be applicable to any aspect of such
device,
(vi) if appropriate, specimens of the labeling proposed to be used
for such device,
(vii) such other information relevant to the subject matter of the
protocol as the Secretary, with the concurrence of the appropriate panel
or panels under section 360c of this title, may require, and
(viii) a requirement for submission of progress reports and, when
completed, records of the trials conducted under the protocol which
records are adequate to show compliance with the protocol.
(4) The Secretary shall approve or disapprove a proposed product
development protocol submitted under paragraph (2) within one hundred
and twenty days of its receipt unless an additional period is agreed
upon by the Secretary and the person who submitted the protocol.
Approval of a protocol or denial of approval of a protocol is final
agency action subject to judicial review under chapter 7 of title 5.
(5) At any time after a product development protocol for a device has
been approved pursuant to paragraph (4), the person for whom the
protocol was approved may submit a notice of completion --
(A) stating (i) his determination that the requirements of the
protocol have been fulfilled and that, to the best of his knowledge,
there is no reason bearing on safety or effectiveness why the notice of
completion should not become effective, and (ii) the data and other
information upon which such determination was made, and
(B) setting forth the results of the trials required by the protocol
and all the information required by subsection (c)(1) of this section.
(6)(A) The Secretary may, after providing the person who has an
approved protocol and opportunity for an informal hearing and at any
time prior to receipt of notice of completion of such protocol, issue a
final order to revoke such protocol if he finds that --
(i) such person has failed substantially to comply with the
requirements of the protocol,
(ii) the results of the trials obtained under the protocol differ so
substantially from the results required by the protocol that further
trials cannot be justified, or
(iii) the results of the trials conducted under the protocol or
available new information do not demonstrate that the device tested
under the protocol does not present an unreasonable risk to health and
safety.
(B) After the receipt of a notice of completion of an approved
protocol the Secretary shall, within the ninety-day period beginning on
the date such notice is received, by order either declare the protocol
completed or declare it not completed. An order declaring a protocol
not completed may take effect only after the Secretary has provided the
person who has the protocol opportunity for an informal hearing on the
order. Such an order may be issued only if the Secretary finds --
(i) such person has failed substantially to comply with the
requirements of the protocol,
(ii) the results of the trials obtained under the protocol differ
substantially from the results required by the protocol, or
(iii) there is a lack of a showing of reasonable assurance of the
safety and effectiveness of the device under the conditions of use
prescribed, recommended, or suggested in the proposed labeling thereof.
(C) A final order issued under subparagraph (A) or (B) shall be in
writing and shall contain the reasons to support the conclusions
thereof.
(7) At any time after a notice of completion has become effective,
the Secretary may issue an order (after due notice and opportunity for
an informal hearing to the person for whom the notice is effective)
revoking the approval of a device provided by a notice of completion
which has become effective as provided in subparagraph (B) if he finds
that any of the grounds listed in subparagraphs (A) through (G) of
subsection (e)(1) of this section apply. Each reference in such
subparagraphs to an application shall be considered for purposes of this
paragraph as a reference to a protocol and the notice of completion of
such protocol, and each reference to the time when an application was
approved shall be considered for purposes of this paragraph as a
reference to the time when a notice of completion took effect.
(8) A person who has an approved protocol subject to an order issued
under paragraph (6)(A) revoking such protocol, a person who has an
approved protocol with respect to which an order under paragraph (6)(B)
was issued declaring that the protocol had not been completed, or a
person subject to an order issued under paragraph (7) revoking the
approval of a device may, by petition filed on or before the thirtieth
day after the date upon which he receives notice of such order, obtain
review thereof in accordance with either paragraph (1) or (2) of
subsection (g) of this section.
(g) Review
(1) Upon petition for review of --
(A) an order under subsection (d) of this section approving or
denying approval of an application or an order under subsection (e) of
this section withdrawing approval of an application, or
(B) an order under subsection (f)(6)(A) of this section revoking an
approved protocol, under subsection (f)(6)(B) of this section declaring
that an approved protocol has not been completed, or under subsection
(f)(7) of this section revoking the approval of a device,
the Secretary shall, unless he finds the petition to be without good
cause or unless a petition for review of such order has been submitted
under paragraph (2), hold a hearing, in accordance with section 554 of
title 5, on the order. The panel or panels which considered the
application, protocol, or device subject to such order shall designate a
member to appear and testify at any such hearing upon request of the
Secretary, the petitioner, or the officer conducting the hearing, but
this requirement does not preclude any other member of the panel or
panels from appearing and testifying at any such hearing. Upon
completion of such hearing and after considering the record established
in such hearing, the Secretary shall issue an order either affirming the
order subject to the hearing or reversing such order and, as
appropriate, approving or denying approval of the application,
reinstating the application's approval, approving the protocol, or
placing in effect a notice of completion.
(2)(A) Upon petition for review of --
(i) an order under subsection (d) of this section approving or
denying approval of an application or an order under subsection (e) of
this section withdrawing approval of an application, or
(ii) an order under subsection (f)(6)(A) of this section revoking an
approved protocol, under subsection (f)(6)(B) of this section declaring
that an approved protocol has not been completed, or under subsection
(f)(7) of this section revoking the approval of a device,
the Secretary shall refer the application or protocol subject to the
order and the basis for the order to an advisory committee of experts
established pursuant to subparagraph (B) for a report and recommendation
with respect to the order. The advisory committee shall, after
independent study of the data and information furnished to it by the
Secretary and other data and information before it, submit to the
Secretary a report and recommendation, together with all underlying data
and information and a statement of the reasons or basis for the
recommendation. A copy of such report shall be promptly supplied by the
Secretary to any person who petitioned for such referral to the advisory
committee.
(B) The Secretary shall establish advisory committees (which may not
be panels under section 360c of this title) to receive referrals under
subparagraph (A). The Secretary shall appoint as members of any such
advisory committee persons qualified in the subject matter to be
referred to the committee and of appropriately diversified professional
backgrounds, except that the Secretary may not appoint to such a
committee any individual who is in the regular full-time employ of the
United States and engaged in the administration of this chapter.
Members of an advisory committee (other than officers or employees of
the United States), while attending conferences or meetings of their
committee or otherwise serving at the request of the Secretary, shall be
entitled to receive compensation at rates to be fixed by the Secretary,
which rates may not exceed the daily equivalent for grade GS-18 of the
General Schedule for each day (including traveltime) they are so
engaged; and while so serving away from their homes or regular places
of business each member may be allowed travel expenses, including per
diem in lieu of subsistence, as authorized by section 5703 of title 5
for persons in the Government service employed intermittently. The
Secretary shall designate the chairman of an advisory committee from its
members. The Secretary shall furnish each advisory committee with
clerical and other assistance, and shall by regulation prescribe the
procedures to be followed by each such committee in acting on referrals
made under subparagraph (A).
(C) The Secretary shall make public the report and recommendation
made by an advisory committee with respect to an application and shall
by order, stating the reasons therefor, either affirm the order referred
to the advisory committee or reverse such order and, if appropriate,
approve or deny approval of the application, reinstate the application's
approval, approve the protocol, or place in effect a notice of
completion.
(h) Service of orders
Orders of the Secretary under this section shall be served (1) in
person by any officer or employee of the department designated by the
Secretary, or (2) by mailing the order by registered mail or certified
mail addressed to the applicant at his last known address in the records
of the Secretary.
(i) Revision
(1) Before December 1, 1995, the Secretary shall by order require
manufacturers of devices, which were introduced or delivered for
introduction into interstate commerce for commercial distribution before
May 28, 1976, and which are subject to revision of classification under
paragraph (2), to submit to the Secretary a summary of and citation to
any information known or otherwise available to the manufacturer
respecting such devices, including adverse safety or effectiveness
information which has not been submitted under section 360i of this
title. The Secretary may require the manufacturer to submit the adverse
safety or effectiveness data for which a summary and citation were
submitted, if such data are available to the manufacturer.
(2) After the issuance of an order under paragraph (1) but before
December 1, 1995, the Secretary shall publish a regulation in the
Federal Register for each device --
(A) which the Secretary has classified as a class III device, and
(B) for which no final regulation has been promulgated under
subsection (b) of this section,
revising the classification of the device so that the device is
classified into class I or class II, unless the regulation requires the
device to remain in class III. In determining whether to revise the
classification of a device or to require a device to remain in class
III, the Secretary shall apply the criteria set forth in section 360c(
a) of this title. Before the publication of a regulation requiring a
device to remain in class III or revising its classification, the
Secretary shall publish a proposed regulation respecting the
classification of a device under this paragraph and provide reasonable
opportunity for the submission of comments on any such regulation. No
regulation requiring a device to remain in class III or revising its
classification may take effect before the expiration of 90 days from the
date of its publication in the Federal Register as a proposed
regulation.
(3) The Secretary shall, as promptly as is reasonably achievable, but
not later than 12 months after the effective date of the regulation
requiring a device to remain in class III, establish a schedule for the
promulgation of a subsection (b) of this section regulation for each
device which is subject to the regulation requiring the device to remain
in class III.
(June 25, 1938, ch. 675, 515, as added May 28, 1976, Pub. L. 94-295,
2, 90 Stat. 552, and amended Nov. 28, 1990, Pub. L. 101-629,
4(b)(1), 9(a), 18(c), 104 Stat. 4515, 4521, 4528.)
1990 -- Subsec. (c)(2). Pub. L. 101-629, 18(c), substituted ''the
Secretary -- '' for ''the Secretary shall'' and added subpars. (A) and
(B).
Subsec. (e). Pub. L. 101-629, 9(a)(2), inserted ''and temporary
suspension'' after ''Withdrawal'' in heading.
Subsec. (e)(3). Pub. L. 101-629, 9(a)(1), added par. (3).
Subsec. (i). Pub. L. 101-629, 4(b)(1), added subsec. (i).
Advisory committees in existence on Jan. 5, 1973, to terminate not
later than the expiration of the 2-year period following Jan. 5, 1973,
and advisory committees established after Jan. 5, 1973, to terminate
not later than the expiration of the 2-year period beginning on the date
of their establishment, unless in the case of a committee established by
the President or an officer of the Federal Government, such committee is
renewed by appropriate action prior to the expiration of such 2-year
period, or in the case of a committee established by Congress, its
duration is otherwise provided by law. See section 14 of Pub. L.
92-463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title
5, Government Organization and Employees.
References in laws to the rates of pay for GS-16, 17, or 18, or to
maximum rates of pay under the General Schedule, to be considered
references to rates payable under specified sections of Title 5,
Government Organization and Employees, see section 529 (title I, 101(
c)(1)) of Pub. L. 101-509, set out in a note under section 5376 of
Title 5.
section 156.
21 USC 360f. Banned devices
TITLE 21 -- FOOD AND DRUGS
(a) General rule
Whenever the Secretary finds, on the basis of all available data and
information, that --
(1) a device intended for human use presents substantial deception or
an unreasonable and substantial risk of illness or injury; and
(2) in the case of substantial deception or an unreasonable and
substantial risk of illness or injury which the Secretary determined
could be corrected or eliminated by labeling or change in labeling and
with respect to which the Secretary provided written notice to the
manufacturer specifying the deception or risk of illness or injury, the
labeling or change in labeling to correct the deception or eliminate or
reduce such risk, and the period within which such labeling or change in
labeling was to be done, such labeling or change in labeling was not
done within such period;
he may initiate a proceeding to promulgate a regulation to make such
device a banned device.
(b) Special effective date
The Secretary may declare a proposed regulation under subsection (a)
of this section to be effective upon its publication in the Federal
Register and until the effective date of any final action taken
respecting such regulation if (1) he determines, on the basis of all
available data and information, that the deception or risk of illness or
injury associated with the use of the device which is subject to the
regulation presents an unreasonable, direct, and substantial danger to
the health of individuals, and (2) before the date of the publication of
such regulation, the Secretary notifies the manufacturer of such device
that such regulation is to be made so effective. If the Secretary makes
a proposed regulation so effective, he shall, as expeditiously as
possible, give interested persons prompt notice of his action under this
subsection, provide reasonable opportunity for an informal hearing on
the proposed regulation, and either affirm, modify, or revoke such
proposed regulation.
(June 25, 1938, ch. 675, 516, as added May 28, 1976, Pub. L. 94-295,
2, 90 Stat. 560, and amended Nov. 28, 1990, Pub. L. 101-629, 18(d), 104
Stat. 4529.)
1990 -- Subsec. (a). Pub. L. 101-629 struck out ''and after
consultation with the appropriate panel or panels under section 360c of
this title'' after ''data and information'' in introductory provisions
and struck out at end ''The Secretary shall afford all interested
persons opportunity for an informal hearing on a regulation proposed
under this subsection.''
21 USC 360g. Judicial review
TITLE 21 -- FOOD AND DRUGS
(a) Petition; record
Not later than thirty days after --
(1) the promulgation of a regulation under section 360c of this title
classifying a device in class I or changing the classification of a
device to class I or an order under subsection (f)(2) of such section
reclassifying a device or denying a petition for reclassification of a
device,
(2) the promulgation of a regulation under section 360d of this title
establishing, amending, or revoking a performance standard for a device,
(3) the issuance of an order under section 360d(b)(2) or 360e(b)(2)(
B) of this title denying a request for reclassification of a device,
(4) the promulgation of a regulation under paragraph (3) of section
360e(b) of this title requiring a device to have an approval of a
premarket application, a regulation under paragraph (4) of that section
amending or revoking a regulation under paragraph (3), or an order
pursuant to section 360e(g)(1) or 360e(g)(2)(C) of this title,
(5) the promulgation of a regulation under section 360f of this title
(other than a proposed regulation made effective under subsection (b) of
such section upon the regulation's publication) making a device a banned
device,
(6) the issuance of an order under section 360j(f)(2) of this title,
(7) an order under section 360j(g)(4) of this title disapproving an
application for an exemption of a device for investigational use or an
order under section 360j(g)(5) of this title withdrawing such an
exemption for a device,
(8) an order pursuant to section 360c(i) of this title,
(9) a regulation under section 360e(i)(2) or 360j(l)(5)(B) of this
title, or
(10) an order under section 360j(c)(4)(B) of this title,
any person adversely affected by such regulation or order may file a
petition with the United States Court of Appeals for the District of
Columbia or for the circuit wherein such person resides or has his
principal place of business for judicial review of such regulation or
order. A copy of the petition shall be transmitted by the clerk of the
court to the Secretary or other officer designated by him for that
purpose. The Secretary shall file in the court the record of the
proceedings on which the Secretary based his regulation or order as
provided in section 2112 of title 28. For purposes of this section, the
term ''record'' means all notices and other matter published in the
Federal Register with respect to the regulation or order reviewed, all
information submitted to the Secretary with respect to such regulation
or order, proceedings of any panel or advisory committee with respect to
such regulation or order, any hearing held with respect to such
regulation or order, and any other information identified by the
Secretary, in the administrative proceeding held with respect to such
regulation or order, as being relevant to such regulation or order.
(b) Additional data, views, and arguments
If the petitioner applies to the court for leave to adduce additional
data, views, or arguments respecting the regulation or order being
reviewed and shows to the satisfaction of the court that such additional
data, views, or arguments are material and that there were reasonable
grounds for the petitioner's failure to adduce such data, views, or
arguments in the proceedings before the Secretary, the court may order
the Secretary to provide additional opportunity for the oral
presentation of data, views, or arguments and for written submissions.
The Secretary may modify his findings, or make new findings by reason of
the additional data, views, or arguments so taken and shall file with
the court such modified or new findings, and his recommendation, if any,
for the modification or setting aside of the regulation or order being
reviewed, with the return of such additional data, views, or arguments.
(c) Standard for review
Upon the filing of the petition under subsection (a) of this section
for judicial review of a regulation or order, the court shall have
jurisdiction to review the regulation or order in accordance with
chapter 7 of title 5 and to grant appropriate relief, including interim
relief, as provided in such chapter. A regulation described in
paragraph (2) or (5) of subsection (a) of this section and an order
issued after the review provided by section 360e(g) of this title shall
not be affirmed if it is found to be unsupported by substantial evidence
on the record taken as a whole.
(d) Finality of judgments
The judgment of the court affirming or setting aside, in whole or in
part, any regulation or order shall be final, subject to review by the
Supreme Court of the United States upon certiorari or certification, as
provided in section 1254 of title 28.
(e) Remedies
The remedies provided for in this section shall be in addition to and
not in lieu of any other remedies provided by law.
(f) Statement of reasons
To facilitate judicial review under this section or under any other
provision of law of a regulation or order issued under section 360c,
360d, 360e, 360f, 360h, 360i, 360j, or 360k of this title each such
regulation or order shall contain a statement of the reasons for its
issuance and the basis, in the record of the proceedings held in
connection with its issuance, for its issuance.
(June 25, 1938, ch. 675, 517, as added May 28, 1976, Pub. L. 94-295,
2, 90 Stat. 560, and amended Nov. 28, 1990, Pub. L. 101-629, 13, 104
Stat. 4524.)
1990 -- Subsec. (a)(8) to (10). Pub. L. 101-629 added pars. (8) to
(10).
21 USC 360h. Notification and other remedies
TITLE 21 -- FOOD AND DRUGS
(a) Notification
If the Secretary determines that --
(1) a device intended for human use which is introduced or delivered
for introduction into interstate commerce for commercial distribution
presents an unreasonable risk of substantial harm to the public health,
and
(2) notification under this subsection is necessary to eliminate the
unreasonable risk of such harm and no more practicable means is
available under the provisions of this chapter (other than this section)
to eliminate such risk,
the Secretary may issue such order as may be necessary to assure that
adequate notification is provided in an appropriate form, by the persons
and means best suited under the circumstances involved, to all health
professionals who prescribe or use the device and to any other person
(including manufacturers, importers, distributors, retailers, and device
users) who should properly receive such notification in order to
eliminate such risk. An order under this subsection shall require that
the individuals subject to the risk with respect to which the order is
to be issued be included in the persons to be notified of the risk
unless the Secretary determines that notice to such individuals would
present a greater danger to the health of such individuals than no such
notification. If the Secretary makes such a determination with respect
to such individuals, the order shall require that the health
professionals who prescribe or use the device provide for the
notification of the individuals whom the health professionals treated
with the device of the risk presented by the device and of any action
which may be taken by or on behalf of such individuals to eliminate or
reduce such risk. Before issuing an order under this subsection, the
Secretary shall consult with the persons who are to give notice under
the order.
(b) Repair, replacement, or refund
(1)(A) If, after affording opportunity for an informal hearing, the
Secretary determines that --
(i) a device intended for human use which is introduced or delivered
for introduction into interstate commerce for commercial distribution
presents an unreasonable risk of substantial harm to the public health,
(ii) there are reasonable grounds to believe that the device was not
properly designed and manufactured with reference to the state of the
art as it existed at the time of its design and manufacture,
(iii) there are reasonable grounds to believe that the unreasonable
risk was not caused by failure of a person other than a manufacturer,
importer, distributor, or retailer of the device to exercise due care in
the installation, maintenance, repair, or use of the device, and
(iv) the notification authorized by subsection (a) of this section
would not by itself be sufficient to eliminate the unreasonable risk and
action described in paragraph (2) of this subsection is necessary to
eliminate such risk,
the Secretary may order the manufacturer, importer, or any
distributor of such device, or any combination of such persons, to
submit to him within a reasonable time a plan for taking one or more of
the actions described in paragraph (2). An order issued under the
preceding sentence which is directed to more than one person shall
specify which person may decide which action shall be taken under such
plan and the person specified shall be the person who the Secretary
determines bears the principal, ultimate financial responsibility for
action taken under the plan unless the Secretary cannot determine who
bears such responsibility or the Secretary determines that the
protection of the public health requires that such decision be made by a
person (including a device user or health professional) other than the
person he determines bears such responsibility.
(B) The Secretary shall approve a plan submitted pursuant to an order
issued under subparagraph (A) unless he determines (after affording
opportunity for an informal hearing) that the action or actions to be
taken under the plan or the manner in which such action or actions are
to be taken under the plan will not assure that the unreasonable risk
with respect to which such order was issued will be eliminated. If the
Secretary disapproves a plan, he shall order a revised plan to be
submitted to him within a reasonable time. If the Secretary determines
(after affording opportunity for an informal hearing) that the revised
plan is unsatisfactory or if no revised plan or no initial plan has been
submitted to the Secretary within the prescribed time, the Secretary
shall (i) prescribe a plan to be carried out by the person or persons to
whom the order issued under subparagraph (A) was directed, or (ii) after
affording an opportunity for an informal hearing, by order prescribe a
plan to be carried out by a person who is a manufacturer, importer,
distributor, or retailer of the device with respect to which the order
was issued but to whom the order under subparagraph (A) was not
directed.
(2) The actions which may be taken under a plan submitted under an
order issued under paragraph (1) are as follows:
(A) To repair the device so that it does not present the unreasonable
risk of substantial harm with respect to which the order under paragraph
(1) was issued.
(B) To replace the device with a like or equivalent device which is
in conformity with all applicable requirements of this chapter.
(C) To refund the purchase price of the device (less a reasonable
allowance for use if such device has been in the possession of the
device user for one year or more --
(i) at the time of notification ordered under subsection (a) of this
section, or
(ii) at the time the device user receives actual notice of the
unreasonable risk with respect to which the order was issued under
paragraph (1),
whichever first occurs).
(3) No charge shall be made to any person (other than a manufacturer,
importer, distributor or retailer) for availing himself of any remedy,
described in paragraph (2) and provided under an order issued under
paragraph (1), and the person subject to the order shall reimburse each
person (other than a manufacturer, importer, distributor, or retailer)
who is entitled to such a remedy for any reasonable and foreseeable
expenses actually incurred by such person in availing himself of such
remedy.
(c) Reimbursement
An order issued under subsection (b) of this section with respect to
a device may require any person who is a manufacturer, importer,
distributor, or retailer of the device to reimburse any other person who
is a manufacturer, importer, distributor, or retailer of such device for
such other person's expenses actually incurred in connection with
carrying out the order if the Secretary determines such reimbursement is
required for the protection of the public health. Any such requirement
shall not affect any rights or obligations under any contract to which
the person receiving reimbursement or the person making such
reimbursement is a party.
(d) Effect on other liability
Compliance with an order issued under this section shall not relieve
any person from liability under Federal or State law. In awarding
damages for economic loss in an action brought for the enforcement of
any such liability, the value to the plaintiff in such action of any
remedy provided him under such order shall be taken into account.
(e) Recall authority
(1) If the Secretary finds that there is a reasonable probability
that a device intended for human use would cause serious, adverse health
consequences or death, the Secretary shall issue an order requiring the
appropriate person (including the manufacturers, importers,
distributors, or retailers of the device) --
(A) to immediately cease distribution of such device, and
(B) to immediately notify health professionals and device user
facilities of the order and to instruct such professionals and
facilities to cease use of such device.
The order shall provide the person subject to the order with an
opportunity for an informal hearing, to be held not later than 10 days
after the date of the issuance of the order, on the actions required by
the order and on whether the order should be amended to require a recall
of such device. If, after providing an opportunity for such a hearing,
the Secretary determines that inadequate grounds exist to support the
actions required by the order, the Secretary shall vacate the order.
(2)(A) If, after providing an opportunity for an informal hearing
under paragraph (1), the Secretary determines that the order should be
amended to include a recall of the device with respect to which the
order was issued, the Secretary shall, except as provided in
subparagraphs (B) and (C), amend the order to require a recall. The
Secretary shall specify a timetable in which the device recall will
occur and shall require periodic reports to the Secretary describing the
progress of the recall.
(B) An amended order under subparagraph (A) --
(i) shall --
(I) not include recall of a device from individuals, and
(II) not include recall of a device from device user facilities if
the Secretary determines that the risk of recalling such device from the
facilities presents a greater health risk than the health risk of not
recalling the device from use, and
(ii) shall provide for notice to individuals subject to the risks
associated with the use of such device.
In providing the notice required by clause (ii), the Secretary may
use the assistance of health professionals who prescribed or used such a
device for individuals. If a significant number of such individuals
cannot be identified, the Secretary shall notify such individuals
pursuant to section 375(b) of this title.
(3) The remedy provided by this subsection shall be in addition to
remedies provided by subsections (a), (b), and (c) of this section.
(June 25, 1938, ch. 675, 518, as added May 28, 1976, Pub. L. 94-295,
2, 90 Stat. 562, and amended Nov. 28, 1990, Pub. L. 101-629, 8, 104
Stat. 4520.)
1990 -- Subsec. (e). Pub. L. 101-629 added subsec. (e).
21 USC 360i. Records and reports on devices
TITLE 21 -- FOOD AND DRUGS
(a) General rule
Every person who is a manufacturer, importer, or distributor of a
device intended for human use shall establish and maintain such records,
make such reports, and provide such information, as the Secretary may by
regulation reasonably require to assure that such device is not
adulterated or misbranded and to otherwise assure its safety and
effectiveness. Regulations prescribed under the preceding sentence --
(1) shall not impose requirements unduly burdensome to a device
manufacturer, importer, or distributor taking into account his cost of
complying with such requirements and the need for the protection of the
public health and the implementation of this chapter;
(2) which prescribe the procedure for making requests for reports or
information shall require that each request made under such regulations
for submission of a report or information to the Secretary state the
reason or purpose for such request and identify to the fullest extent
practicable such report or information;
(3) which require submission of a report or information to the
Secretary shall state the reason or purpose for the submission of such
report or information and identify to the fullest extent practicable
such report or information;
(4) may not require that the identity of any patient be disclosed in
records, reports, or information required under this subsection unless
required for the medical welfare of an individual, to determine the
safety or effectiveness of a device, or to verify a record, report, or
information submitted under this chapter;
(5) may not require a manufacturer, importer, or distributor of a
class I device to --
(A) maintain for such a device records respecting information not in
the possession of the manufacturer, importer, or distributor, or
(B) to submit for such a device to the Secretary any report or
information --
(i) not in the possession of the manufacturer, importer, or
distributor, or
(ii) on a periodic basis,
unless such report or information is necessary to determine if the
device should be reclassified or if the device is adulterated or
misbranded; and
(6) shall require distributors who submit such reports to submit
copies of the reports to the manufacturer of the device for which the
report was made.
In prescribing such regulations, the Secretary shall have due regard
for the professional ethics of the medical profession and the interests
of patients. The prohibitions of paragraph (4) of this subsection
continue to apply to records, reports, and information concerning any
individual who has been a patient, irrespective of whether or when he
ceases to be a patient.
(b) User reports
(1)(A) Whenever a device user facility receives or otherwise becomes
aware of information that reasonably suggests that there is a
probability that a device has caused or contributed to the death of a
patient of the facility, the facility shall, as soon as practicable but
not later than 10 working days after becoming aware of the information,
report the information to the Secretary and, if the identity of the
manufacturer is known, to the manufacturer of the device. In the case
of deaths, the Secretary may by regulation prescribe a shorter period
for the reporting of such information.
(B) Whenever a device user facility receives or otherwise becomes
aware of information that reasonably suggests that there is a
probability that a device has caused or contributed to the serious
illness of, or serious injury to, a patient of the facility, the
facility shall, as soon as practicable but not later than 10 working
days after becoming aware of the information, report the information to
the manufacturer of the device or to the Secretary if the identity of
the manufacturer is not known.
(C) Each device user facility shall submit to the Secretary on a
semi-annual basis a summary of the reports made under subparagraphs (A)
and (B). Such summary shall be submitted on January 1 and July 1 of
each year. The summary shall be in such form and contain such
information from such reports as the Secretary may require and shall
include --
(i) sufficient information to identify the facility which made the
reports for which the summary is submitted,
(ii) in the case of any product which was the subject of a report,
the product name, serial number, and model number,
(iii) the name and the address of the manufacturer of such device,
and
(iv) a brief description of the event reported to the manufacturer.
The Secretary may by regulation alter the frequency and timing of
reports required by this subparagraph.
(D) For purposes of subparagraphs (A), (B), and (C), a device user
facility shall be treated as having received or otherwise become aware
of information with respect to a device of that facility when medical
personnel who are employed by or otherwise formally affiliated with the
facility receive or otherwise become aware of information with respect
to that device in the course of their duties.
(2) The Secretary may not disclose the identity of a device user
facility which makes a report under paragraph (1) except in connection
with --
(A) an action brought to enforce section 331(q) of this title,
(B) a communication to a manufacturer of a device which is the
subject of a report under paragraph (1), or
(C) a disclosure required under subsection (a) of this section.
This paragraph does not prohibit the Secretary from disclosing the
identity of a device user facility making a report under paragraph (1)
or any information in such a report to employees of the Department of
Health and Human Services, to the Department of Justice, or to the duly
authorized committees and subcommittees of the Congress.
(3) No report made under paragraph (1) by --
(A) a device user facility,
(B) an individual who is employed by or otherwise formally affiliated
with such a facility, or
(C) a physician who is not required to make such a report,
shall be admissible into evidence or otherwise used in any civil
action involving private parties unless the facility, individual, or
physician who made the report had knowledge of the falsity of the
information contained in the report.
(4) A report made under paragraph (1) does not affect any obligation
of a manufacturer who receives the report to file a report as required
under subsection (a) of this section.
(5) For purposes of this subsection:
(A) The term ''device user facility'' means a hospital, ambulatory
surgical facility, nursing home, or outpatient treatment facility which
is not a physician's office. The Secretary may by regulation include an
outpatient diagnostic facility which is not a physician's office in such
term.
(B) The terms ''serious illness'' and ''serious injury'' mean illness
or injury, respectively, that --
(i) is life threatening,
(ii) results in permanent impairment of a body function or permanent
damage to a body structure, or
(iii) necessitates immediate medical or surgical intervention to
preclude permanent impairment of a body function or permanent damage to
a body structure.
(c) Persons exempt
Subsection (a) of this section shall not apply to --
(1) any practitioner who is licensed by law to prescribe or
administer devices intended for use in humans and who manufactures or
imports devices solely for use in the course of his professional
practice;
(2) any person who manufactures or imports devices intended for use
in humans solely for such person's use in research or teaching and not
for sale (including any person who uses a device under an exemption
granted under section 360j(g) of this title); and
(3) any other class of persons as the Secretary may by regulation
exempt from subsection (a) of this section upon a finding that
compliance with the requirements of such subsection by such class with
respect to a device is not necessary to (A) assure that a device is not
adulterated or misbranded or (B) otherwise to assure its safety and
effectiveness.
(d) Certification
Each manufacturer, importer, and distributor required to make reports
under subsection (a) of this section shall submit to the Secretary
annually a statement certifying that --
(1) the manufacturer, importer, or distributor did file a certain
number of such reports, or
(2) the manufacturer, importer, or distributor did not file any
report under subsection (a) of this section.
(e) Device tracking
Every person who registers under section 360 of this title and is
engaged in the manufacture of --
(1) a device the failure of which would be reasonably likely to have
serious adverse health consequences and which is (A) a permanently
implantable device, or (B) a life sustaining or life supporting device
used outside a device user facility, or
(2) any other device which the Secretary may designate,
shall adopt a method of device tracking.
(f) Report of removals and corrections
(1) Except as provided in paragraph (2), the Secretary shall by
regulation require a manufacturer, importer, or distributor of a device
to report promptly to the Secretary any correction or removal of a
device undertaken by such manufacturer, importer, or distributor if the
removal or correction was undertaken --
(A) to reduce a risk to health posed by the device, or
(B) to remedy a violation of this chapter caused by the device which
may present a risk to health.
A manufacturer, importer, or distributor of a device who undertakes a
correction or removal of a device which is not required to be reported
under this paragraph shall keep a record of such correction or removal.
(2) No report of the corrective action or removal of a device may be
required under paragraph (1) if a report of the corrective action or
removal is required and has been submitted under subsection (a) of this
section.
(3) For purposes of paragraphs (1) and (2), the terms ''correction''
and ''removal'' do not include routine servicing.
(June 25, 1938, ch. 675, 519, as added May 28, 1976, Pub. L. 94-295,
2, 90 Stat. 564, and amended Nov. 28, 1990, Pub. L. 101-629,
2(a), 3(a)(1), (b)(1), 7, 104 Stat. 4511, 4513, 4514, 4520.)
1990 -- Subsec. (a)(6). Pub. L. 101-629, 3(a)(1), added par. (6).
Subsecs. (b), (c). Pub. L. 101-629, 2(a), added subsec. (b) and
redesignated former subsec. (b) as (c).
Subsecs. (d), (e). Pub. L. 101-629, 3(b)(1), added subsecs. (d) and
(e).
Subsec. (f). Pub. L. 101-629, 7, added subsec. (f).
Section 2(c) of Pub. L. 101-629 provided that: ''Section 519(b) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(b)), as added
by the amendment made by subsection (a), shall take effect --
''(1) upon the effective date of regulations promulgated under
subsection (b) (set out below), or
''(2) upon the expiration of 12 months from the date of the enactment
of this Act (Nov. 28, 1990),
whichever occurs first.''
Section 3(a)(2) of Pub. L. 101-629 provided that: ''Section 519(
a)(6) (21 U.S.C. 360i(a)(6)), as added by the amendment made by
paragraph (1), shall take effect upon the effective date of final
regulations under subsection (c) (set out below).''
Section 3(b)(3) of Pub. L. 101-629 provided that: ''Section 519(e)
(21 U.S.C. 360i(e)), as added by the amendment made by paragraph (1),
shall take effect upon the effective date of final regulations under
subsection (c) (set out below).''
Section 2(b) of Pub. L. 101-629 provided that: ''The Secretary of
Health and Human Services shall promulgate regulations to implement
section 519(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360i(b)), as added by the amendment made by subsection (a) (including a
definition of the summary required by paragraph (1)(C) of such section)
not later than 12 months after the date of enactment of this Act (Nov.
28, 1990). In promulgating the regulations, the Secretary shall
minimize the administrative burdens on device user facilities consistent
with the need to assure adequate information.''
Section 3(c) of Pub. L. 101-629 provided that:
''(1)(A) Not later than 9 months after the date of the enactment of
this Act (Nov. 28, 1990), the Secretary of Health and Human Services
shall issue proposed regulations --
''(i) to require distributors of devices to establish and maintain
records and to make reports (including reports required by part 803 of
title 21 of the Code of Federal Regulations) under section 519(a)(6) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(a)(6)), and
''(ii) to implement section 519(e) of such Act.
The Secretary may exempt from regulations described in clause (i)
classes of distributors of class I and class II devices from whom
reports are not necessary for the protection of the public health.
''(B) Regulations under subparagraph (A) shall --
''(i) require appropriate methods for maintenance of records to
ensure that patients who receive devices can be provided the
notification required by such Act (this chapter),
''(ii) require that manufacturers adopt effective methods of tracking
devices,
''(iii) take into account the position of distributors in the device
distribution process, and
''(iv) include such other requirements as the Secretary deems
necessary for the adoption of an effective user tracking program under
section 519(e) of such Act.
''(2) Not later than 18 months after the date of the enactment of
this Act, the Secretary shall issue final regulations to implement
sections 519(a)(6) and 519(e) of the Federal Food, Drug, and Cosmetic
Act. If the Secretary does not promulgate such final regulations upon
the expiration of such 18 months, the Congress finds that there is good
cause for the proposed regulations to be considered as the final
regulations without response to comment because the implementation of
sections 519(a)(6) and 519(e) of such Act are essential to protect the
health of patients who use such devices. Consequently, in such event,
the proposed regulations issued under paragraph (1) shall become final
regulations as of the expiration of such 18 months. There shall be
promptly published in the Federal Register notice of the new status of
the proposed regulations.''
Section 2(d) of Pub. L. 101-629 provided that: ''During the
18-month period beginning on the date of the enactment of this Act (Nov.
28, 1990), the Secretary of Health and Human Services shall inform
device user facilities (as defined in section 519(b)(5)(A) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(b)(5)(A))) and
manufacturers and distributors of devices respecting the requirements of
section 519(b) of such Act. Additionally, the Secretary, to the extent
practicable, shall provide persons subject to the requirements of such
section assistance in the form of publications regarding such
requirements.''
User Facilities; Actions by Manufacturers; Cost
Effectiveness; Recommendations
Section 2(e) of Pub. L. 101-629 provided that: ''Not more than 36
months after the date of the enactment of this Act (Nov. 28, 1990), the
Comptroller General of the United States shall conduct a study of --
''(1) the compliance by device user facilities (as defined in section
519(b)(5)(A) of the Federal Food, Drug, and Cosmetic Act (21 U. S.C.
360i(b)(5)(A))) with the requirements of section 519(b) of such Act,
''(2) the actions taken by the manufacturers of devices in response
to reports made to them under such section,
''(3) the cost effectiveness of such requirements and their
implementation, and
''(4) any recommendations for improvements to such requirements.
The Comptroller General shall complete the study and submit a report
on the study not later than 45 months from the date of the enactment of
this Act. The report shall be submitted to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Labor and
Human Resources of the Senate and to the Secretary of Health and Human
Services.''
Section 2(f) of Pub. L. 101-629 provided that: ''Not later than 36
months after the date of enactment of this Act (Nov. 28, 1990), the
Secretary of Health and Human Services shall prepare and submit to the
appropriate committees of Congress a report that contains an evaluation
of the requirements of section 519(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360i(b)). In preparing the report, the Secretary
shall consult with individuals and organizations with an interest in
health care and consumer issues. At a minimum, the report shall contain
--
''(1) an evaluation of the safety benefits of the requirements,
''(2) an evaluation of the burdens placed on the Food and Drug
Administration and on device user facilities by the requirements,
''(3) an evaluation of the cost-effectiveness of the requirements,
and
''(4) recommendations for legislative reform.''
21 USC 360j. General provisions respecting control of devices intended
for human use
TITLE 21 -- FOOD AND DRUGS
(a) General rule
Any requirement authorized by or under section 351, 352, 360, or 360i
of this title applicable to a device intended for human use shall apply
to such device until the applicability of the requirement to the device
has been changed by action taken under section 360c, 360d, or 360e of
this title or under subsection (g) of this section, and any requirement
established by or under section 351, 352, 360, or 360i of this title
which is inconsistent with a requirement imposed on such device under
section 360d or 360e of this title or under subsection (g) of this
section shall not apply to such device.
(b) Custom devices
Sections 360d and 360e of this title do not apply to any device
which, in order to comply with the order of an individual physician or
dentist (or any other specially qualified person designated under
regulations promulgated by the Secretary after an opportunity for an
oral hearing) necessarily deviates from an otherwise applicable
performance standard or requirement prescribed by or under section 360e
of this title if (1) the device is not generally available in finished
form for purchase or for dispensing upon prescription and is not offered
through labeling or advertising by the manufacturer, importer, or
distributor thereof for commercial distribution, and (2) such device --
(A)(i) is intended for use by an individual patient named in such
order of such physician or dentist (or other specially qualified person
so designated) and is to be made in a specific form for such patient, or
(ii) is intended to meet the special needs of such physician or
dentist (or other specially qualified person so designated) in the
course of the professional practice of such physician or dentist (or
other specially qualified person so designated), and
(B) is not generally available to or generally used by other
physicians or dentists (or other specially qualified persons so
designated).
(c) Trade secrets
Any information reported to or otherwise obtained by the Secretary or
his representative under section 360c, 360d, 360e, 360f, 360h, 360i, or
374 of this title or under subsection (f) or (g) of this section which
is exempt from disclosure pursuant to subsection (a) of section 552 of
title 5 by reason of subsection (b)(4) of such section shall be
considered confidential and shall not be disclosed and may not be used
by the Secretary as the basis for the reclassification of a device from
class III to class II or class I or as the basis for the establishment
or amendment of a performance standard under section 360d of this title
for a device reclassified from class III to class II, except (1) in
accordance with subsection (h) of this section, and (2) that such
information may be disclosed to other officers or employees concerned
with carrying out this chapter or when relevant in any proceeding under
this chapter (other than section 360c or 360d of this title).
(d) Notices and findings
Each notice of proposed rulemaking under section 360c, 360d, 360e,
360f, 360h, or 360i of this title, or under this section, any other
notice which is published in the Federal Register with respect to any
other action taken under any such section and which states the reasons
for such action, and each publication of findings required to be made in
connection with rulemaking under any such section shall set forth --
(1) the manner in which interested persons may examine data and other
information on which the notice or findings is based, and
(2) the period within which interested persons may present their
comments on the notice or findings (including the need therefor) orally
or in writing, which period shall be at least sixty days but may not
exceed ninety days unless the time is extended by the Secretary by a
notice published in the Federal Register stating good cause therefor.
(e) Restricted devices
(1) The Secretary may by regulation require that a device be
restricted to sale, distribution, or use --
(A) only upon the written or oral authorization of a practitioner
licensed by law to administer or use such device, or
(B) upon such other conditions as the Secretary may prescribe in such
regulation,
if, because of its potentiality for harmful effect or the collateral
measures necessary to its use, the Secretary determines that there
cannot otherwise be reasonable assurance of its safety and
effectiveness. No condition prescribed under subparagraph (B) may
restrict the use of a device to persons with specific training or
experience in its use or to persons for use in certain facilities unless
the Secretary determines that such a restriction is required for the
safe and effective use of the device. No such condition may exclude a
person from using a device solely because the person does not have the
training or experience to make him eligible for certification by a
certifying board recognized by the American Board of Medical Specialties
or has not been certified by such a Board. A device subject to a
regulation under this subsection is a restricted device.
(2) The label of a restricted device shall bear such appropriate
statements of the restrictions required by a regulation under paragraph
(1) as the Secretary may in such regulation prescribe.
(f) Good manufacturing practice requirements
(1)(A) The Secretary may, in accordance with subparagraph (B),
prescribe regulations requiring that the methods used in, and the
facilities and controls used for, the manufacture, pre-production design
validation (including a process to assess the performance of a device
but not including an evaluation of the safety or effectiveness of a
device), packing, storage, and installation of a device conform to
current good manufacturing practice, as prescribed in such regulations,
to assure that the device will be safe and effective and otherwise in
compliance with this chapter.
(B) Before the Secretary may promulgate any regulation under
subparagraph (A) he shall --
(i) afford the advisory committee established under paragraph (3) an
opportunity to submit recommendations to him with respect to the
regulation proposed to be promulgated, and
(ii) afford opportunity for an oral hearing.
The Secretary shall provide the advisory committee a reasonable time
to make its recommendation with respect to proposed regulations under
subparagraph (A).
(2)(A) Any person subject to any requirement prescribed by
regulations under paragraph (1) may petition the Secretary for an
exemption or variance from such requirement. Such a petition shall be
submitted to the Secretary in such form and manner as he shall prescribe
and shall --
(i) in the case of a petition for an exemption from a requirement,
set forth the basis for the petitioner's determination that compliance
with the requirement is not required to assure that the device will be
safe and effective and otherwise in compliance with this chapter,
(ii) in the case of a petition for a variance from a requirement, set
forth the methods proposed to be used in, and the facilities and
controls proposed to be used for, the manufacture, packing, storage, and
installation of the device in lieu of the methods, facilities, and
controls prescribed by the requirement, and
(iii) contain such other information as the Secretary shall
prescribe.
(B) The Secretary may refer to the advisory committee established
under paragraph (3) any petition submitted under subparagraph (A). The
advisory committee shall report its recommendations to the Secretary
with respect to a petition referred to it within sixty days of the date
of the petition's referral. Within sixty days after --
(i) the date the petition was submitted to the Secretary under
subparagraph (A), or
(ii) if the petition was referred to an advisory committee, the
expiration of the sixty-day period beginning on the date the petition
was referred to the advisory committee,
whichever occurs later, the Secretary shall by order either deny the
petition or approve it.
(C) The Secretary may approve --
(i) a petition for an exemption for a device from a requirement if he
determines that compliance with such requirement is not required to
assure that the device will be safe and effective and otherwise in
compliance with this chapter, and
(ii) a petition for a variance for a device from a requirement if he
determines that the methods to be used in, and the facilities and
controls to be used for, the manufacture, packing, storage, and
installation of the device in lieu of the methods, controls, and
facilities prescribed by the requirement are sufficient to assure that
the device will be safe and effective and otherwise in compliance with
this chapter.
An order of the Secretary approving a petition for a variance shall
prescribe such conditions respecting the methods used in, and the
facilities and controls used for, the manufacture, packing, storage, and
installation of the device to be granted the variance under the petition
as may be necessary to assure that the device will be safe and effective
and otherwise in compliance with this chapter.
(D) After the issuance of an order under subparagraph (B) respecting
a petition, the petitioner shall have an opportunity for an informal
hearing on such order.
(3) The Secretary shall establish an advisory committee for the
purpose of advising and making recommendations to him with respect to
regulations proposed to be promulgated under paragraph (1)(A) and the
approval or disapproval of petitions submitted under paragraph (2). The
advisory committee shall be composed of nine members as follows:
(A) Three of the members shall be appointed from persons who are
officers or employees of any State or local government or of the Federal
Government.
(B) Two of the members shall be appointed from persons who are
representative of interests of the device manufacturing industry; two
of the members shall be appointed from persons who are representative of
the interests of physicians and other health professionals; and two of
the members shall be representative of the interests of the general
public.
Members of the advisory committee who are not officers or employees
of the United States, while attending conferences or meetings of the
committee or otherwise engaged in its business, shall be entitled to
receive compensation at rates to be fixed by the Secretary, which rates
may not exceed the daily equivalent of the rate in effect for grade
GS-18 of the General Schedule, for each day (including traveltime) they
are so engaged; and while so serving away from their homes or regular
places of business each member may be allowed travel expenses, including
per diem in lieu of subsistence, as authorized by section 5703 of title
5 for persons in the Government service employed intermittently. The
Secretary shall designate one of the members of the advisory committee
to serve as its chairman. The Secretary shall furnish the advisory
committee with clerical and other assistance. Section 14 of the Federal
Advisory Committee Act shall not apply with respect to the duration of
the advisory committee established under this paragraph.
(g) Exemption for devices for investigational use
(1) It is the purpose of this subsection to encourage, to the extent
consistent with the protection of the public health and safety and with
ethical standards, the discovery and development of useful devices
intended for human use and to that end to maintain optimum freedom for
scientific investigators in their pursuit of that purpose.
(2)(A) The Secretary shall, within the one hundred and twenty-day
period beginning on May 28, 1976, by regulation prescribe procedures and
conditions under which devices intended for human use may upon
application be granted an exemption from the requirements of section
352, 360, 360d, 360e, 360f, 360i, or 376 of this title or subsection (e)
or (f) of this section or from any combination of such requirements to
permit the investigational use of such devices by experts qualified by
scientific training and experience to investigate the safety and
effectiveness of such devices.
(B) The conditions prescribed pursuant to subparagraph (A) shall
include the following:
(i) A requirement that an application be submitted to the Secretary
before an exemption may be granted and that the application be submitted
in such form and manner as the Secretary shall specify.
(ii) A requirement that the person applying for an exemption for a
device assure the establishment and maintenance of such records, and the
making of such reports to the Secretary of data obtained as a result of
the investigational use of the device during the exemption, as the
Secretary determines will enable him to assure compliance with such
conditions, review the progress of the investigation, and evaluate the
safety and effectiveness of the device.
(iii) Such other requirements as the Secretary may determine to be
necessary for the protection of the public health and safety.
(C) Procedures and conditions prescribed pursuant to subparagraph (A)
for an exemption may appropriately vary depending on (i) the scope and
duration of clinical testing to be conducted under such exemption, (ii)
the number of human subjects that are to be involved in such testing,
(iii) the need to permit changes to be made in the device subject to the
exemption during testing conducted in accordance with a clinical testing
plan required under paragraph (3)(A), and (iv) whether the clinical
testing of such device is for the purpose of developing data to obtain
approval for the commercial distribution of such device.
(3) Procedures and conditions prescribed pursuant to paragraph (2)(
A) shall require, as a condition to the exemption of any device to be
the subject of testing involving human subjects, that the person
applying for the exemption --
(A) submit a plan for any proposed clinical testing of the device and
a report of prior investigations of the device (including, where
appropriate, tests on animals) adequate to justify the proposed clinical
testing --
(i) to the local institutional review committee which has been
established in accordance with regulations of the Secretary to supervise
clinical testing of devices in the facilities where the proposed
clinical testing is to be conducted, or
(ii) to the Secretary, if --
(I) no such committee exists, or
(II) the Secretary finds that the process of review by such committee
is inadequate (whether or not the plan for such testing has been
approved by such committee),
for review for adequacy to justify the commencement of such testing;
and, unless the plan and report are submitted to the Secretary, submit
to the Secretary a summary of the plan and a report of prior
investigations of the device (including, where appropriate, tests on
animals);
(B) promptly notify the Secretary (under such circumstances and in
such manner as the Secretary prescribes) of approval by a local
institutional review committee of any clinical testing plan submitted to
it in accordance with subparagraph (A);
(C) in the case of a device to be distributed to investigators for
testing, obtain signed agreements from each of such investigators that
any testing of the device involving human subjects will be under such
investigator's supervision and in accordance with subparagraph (D) and
submit such agreements to the Secretary; and
(D) assure that informed consent will be obtained from each human
subject (or his representative) of proposed clinical testing involving
such device, except where subject to such conditions as the Secretary
may prescribe, the investigator conducting or supervising the proposed
clinical testing of the device determines in writing that there exists a
life threatening situation involving the human subject of such testing
which necessitates the use of such device and it is not feasible to
obtain informed consent from the subject and there is not sufficient
time to obtain such consent from his representative.
The determination required by subparagraph (D) shall be concurred in
by a licensed physician who is not involved in the testing of the human
subject with respect to which such determination is made unless
immediate use of the device is required to save the life of the human
subject of such testing and there is not sufficient time to obtain such
concurrence.
(4)(A) An application, submitted in accordance with the procedures
prescribed by regulations under paragraph (2), for an exemption for a
device (other than an exemption from section 360f of this title) shall
be deemed approved on the thirtieth day after the submission of the
application to the Secretary unless on or before such day the Secretary
by order disapproves the application and notifies the applicant of the
disapproval of the application.
(B) The Secretary may disapprove an application only if he finds that
the investigation with respect to which the application is submitted
does not conform to procedures and conditions prescribed under
regulations under paragraph (2). Such a notification shall contain the
order of disapproval and a complete statement of the reasons for the
Secretary's disapproval of the application and afford the applicant
opportunity for an informal hearing on the disapproval order.
(5) The Secretary may by order withdraw an exemption granted under
this subsection for a device if the Secretary determines that the
conditions applicable to the device under this subsection for such
exemption are not met. Such an order may be issued only after
opportunity for an informal hearing, except that such an order may be
issued before the provision of an opportunity for an informal hearing if
the Secretary determines that the continuation of testing under the
exemption with respect to which the order is to be issued will result in
an unreasonable risk to the public health.
(h) Release of information respecting safety and effectiveness
(1) The Secretary shall promulgate regulations under which a detailed
summary of information respecting the safety and effectiveness of a
device which information was submitted to the Secretary and which was
the basis for --
(A) an order under section 360e(d)(1)(A) of this title approving an
application for premarket approval for the device or denying approval of
such an application or an order under section 360e(e) of this title
withdrawing approval of such an application for the device,
(B) an order under section 360e(f)(6)(A) of this title revoking an
approved protocol for the device, an order under section 360e(f)(6)(B)
of this title declaring a protocol for the device completed or not
completed, or an order under section 360e(f)(7) of this title revoking
the approval of the device, or
(C) an order approving an application under subsection (g) of this
section for an exemption for the device from section 360f of this title
or an order disapproving, or withdrawing approval of, an application for
an exemption under such subsection for the device,
shall be made available to the public upon issuance of the order.
Summaries of information made available pursuant to this paragraph
respecting a device shall include information respecting any adverse
effects on health of the device.
(2) The Secretary shall promulgate regulations under which each
advisory committee established under section 360e(g)(2)(B) of this title
shall make available to the public a detailed summary of information
respecting the safety and effectiveness of a device which information
was submitted to the advisory committee and which was the basis for its
recommendation to the Secretary made pursuant to section 360e(g)(2)(A)
of this title. A summary of information upon which such a
recommendation is based shall be made available pursuant to this
paragraph only after the issuance of the order with respect to which the
recommendation was made and each summary shall include information
respecting any adverse effect on health of the device subject to such
order.
(3) Except as provided in paragraph (4), any information respecting a
device which is made available pursuant to paragraph (1) or (2) of this
subsection (A) may not be used to establish the safety or effectiveness
of another device for purposes of this chapter by any person other than
the person who submitted the information so made available, and (B)
shall be made available subject to subsection (c) of this section.
(4)(A) Any information contained in an application for premarket
approval filed with the Secretary pursuant to section 360e(c) of this
title, including clinical and preclinical tests or studies, but
excluding descriptions of methods of manufacture and product
composition, that demonstrates the safety and effectiveness of a device
shall be available 1 year after the original application for the fourth
device of a kind has been approved by the Secretary, for use by the
Secretary in approving devices, or determining whether a product
development protocol has been completed, under section 360e of this
title, establishing a performance standard under section 360d of this
title, and reclassifying devices under subsections (e) and (f) of
section 360c of this title, and subsection (l)(2) of this section. The
Secretary shall deem devices that incorporate the same technologies,
have the same principles of operation, and are intended for the same use
or uses to be within a kind of device.
(B) The Secretary, contemporaneously with the approval of the fourth
device of a kind, shall publish an order in the Federal Register
identifying the four devices of a kind that have been approved under
section 360e of this title and the date on which the data contained in
premarket approval applications for the devices will be available to the
Secretary for use, as described in subparagraph (A).
(C) The publicly available detailed summaries of information
respecting the safety and effectiveness of devices required by paragraph
(1)(A) shall be available for use by the Secretary as the evidentiary
basis for the regulatory action described in subparagraph (A).
(D)(i) This paragraph shall become effective --
(I) on November 15, 1990, for devices for which four devices of a
kind were approved on or before December 31, 1987, and
(II) on November 15, 1991, for devices not described in subclause
(I).
(ii) For each device described in clause (i)(I), the Secretary shall
publish a notice in the Federal Register setting forth the date, which
shall be not earlier than 1 year after the date of the notice, that data
identified in subparagraph (A) shall be available for the use of the
Secretary.
(E)(i) Except as provided in clause (ii), the approval date of a
device, for purposes of this paragraph, shall be the date of the letter
of the Secretary to the applicant approving a device under section 360e
of this title and permitting the applicant to commercially distribute
the device.
(ii) For each device described in subparagraph (D)(i)(II) for which
the original application for a fourth device of a kind is approved by
the Secretary before November 1, 1991, the approval date of the fourth
device of a kind shall be deemed to be November 15, 1991.
(F) Any challenge to an order under subparagraph (B) shall be made
not later than 30 days after the date of the Federal Register notice
referred to in such subparagraph.
(i) Proceedings of advisory panels and committees
Each panel under section 360c of this title and each advisory
committee established under section 360d(b)(5)(B) or 360e(g) of this
title or under subsection (f) of this section shall make and maintain a
transcript of any proceeding of the panel or committee. Each such panel
and committee shall delete from any transcript made pursuant to this
subsection information which under subsection (c) of this section is to
be considered confidential.
(j) Traceability
Except as provided in section 360i(e) of this title, no regulation
under this chapter may impose on a type or class of device requirements
for the traceability of such type or class of device unless such
requirements are necessary to assure the protection of the public
health.
(k) Research and development
The Secretary may enter into contracts for research, testing, and
demonstrations respecting devices and may obtain devices for research,
testing, and demonstration purposes without regard to section 3324(a)
and (b) of title 31 and section 5 of title 41.
(l) Transitional provisions for devices considered as new drugs or
antibiotic drugs
(1) Any device intended for human use --
(A) for which on May 28, 1976 (hereinafter in this subsection
referred to as the ''enactment date'') an approval of an application
submitted under section 355(b) of this title was in effect;
(B) for which such an application was filed on or before the
enactment date and with respect to which application no order of
approval or refusing to approve had been issued on such date under
subsection (c) or (d) of such section;
(C) for which on the enactment date an exemption under subsection (i)
of such section was in effect;
(D) which is within a type of device described in subparagraph (A),
(B), or (C) and is substantially equivalent to another device within
that type;
(E) which the Secretary in a notice published in the Federal Register
before the enactment date has declared to be a new drug subject to
section 355 of this title; or
(F) with respect to which on the enactment date an action is pending
in a United States court under section 332, 333, or 334 of this title
for an alleged violation of a provision of section 331 of this title
which enforces a requirement of section 355 of this title or for an
alleged violation of section 355(a) of this title,
is classified in class III unless the Secretary in response to a
petition submitted under paragraph (2) has classified such device in
class I or II.
(2) The Secretary may initiate the reclassification of a device
classified into class III under paragraph (1) of this subsection or the
manufacturer or importer of a device classified under paragraph (1) may
petition the Secretary (in such form and manner as he shall prescribe)
for the issuance of an order classifying the device in class I or class
II. Within thirty days of the filing of such a petition, the Secretary
shall notify the petitioner of any deficiencies in the petition which
prevent the Secretary from making a decision on the petition. Except as
provided in paragraph (3)(D)(ii), within one hundred and eighty days
after the filing of a petition under this paragraph, the Secretary
shall, after consultation with the appropriate panel under section 360c
of this title, by order either deny the petition or order the
classification, in accordance with the criteria prescribed by section
360c(a)(1)(A) of this title or 360c(a)(1)(B) of this title, of the
device in class I or class II.
(3)(A) In the case of a device which is described in paragraph (1)(
A) and which is in class III --
(i) such device shall on the enactment date be considered a device
with an approved application under section 360e of this title, and
(ii) the requirements applicable to such device before the enactment
date under section 355 of this title shall continue to apply to such
device until changed by the Secretary as authorized by this chapter.
(B) In the case of a device which is described in paragraph (1)(B)
and which is in class III, an application for such device shall be
considered as having been filed under section 360e of this title on the
enactment date. The period in which the Secretary shall act on such
application in accordance with section 360e(d)(1) of this title shall be
one hundred and eighty days from the enactment date (or such greater
period as the Secretary and the applicant may agree upon after the
Secretary has made the finding required by section 360e(d)(1)(B)(i) of
this title) less the number of days in the period beginning on the date
an application for such device was filed under section 355 of this title
and ending on the enactment date. After the expiration of such period
such device is required, unless exempt under subsection (g) of this
section, to have in effect an approved application under section 360e of
this title.
(C) A device which is described in paragraph (1)(C) and which is in
class III shall be considered a new drug until the expiration of the
ninety-day period beginning on the date of the promulgation of
regulations under subsection (g) of this section. After the expiration
of such period such device is required, unless exempt under subsection
(g) of this section, to have in effect an approved application under
section 360e of this title.
(D)(i) Except as provided in clauses (ii) and (iii), a device which
is described in subparagraph (D), (E), or (F) of paragraph (1) and which
is in class III is required, unless exempt under subsection (g) of this
section, to have on and after sixty days after the enactment date in
effect an approved application under section 360e of this title.
(ii) If --
(I) a petition is filed under paragraph (2) for a device described in
subparagraph (D), (E), or (F) of paragraph (1), or
(II) an application for premarket approval is filed under section
360e of this title for such a device,
within the sixty-day period beginning on the enactment date (or
within such greater period as the Secretary, after making the finding
required under section 360e(d)(1)(B) of this title, and the petitioner
or applicant may agree upon), the Secretary shall act on such petition
or application in accordance with paragraph (2) or section 360e of this
title except that the period within which the Secretary must act on the
petition or application shall be within the one hundred and twenty-day
period beginning on the date the petition or application is filed. If
such a petition or application is filed within such sixty-day (or
greater) period, clause (i) of this subparagraph shall not apply to such
device before the expiration of such one hundred and twenty-day period,
or if such petition is denied or such application is denied approval,
before the date of such denial, whichever occurs first.
(iii) In the case of a device which is described in subparagraph (E)
of paragraph (1), which the Secretary in a notice published in the
Federal Register after March 31, 1976, declared to be a new drug subject
to section 355 of this title, and which is in class III --
(I) the device shall, after eighteen months after the enactment date,
have in effect an approved application under section 360e of this title
unless exempt under subsection (g) of this section, and
(II) the Secretary may, during the period beginning one hundred and
eighty days after the enactment date and ending eighteen months after
such date, restrict the use of the device to investigational use by
experts qualified by scientific training and experience to investigate
the safety and effectiveness of such device, and to investigational use
in accordance with the requirements applicable under regulations under
subsection (g) of this section to investigational use of devices granted
an exemption under such subsection.
If the requirements under subsection (g) of this section are made
applicable to the investigational use of such a device, they shall be
made applicable in such a manner that the device shall be made
reasonably available to physicians meeting appropriate qualifications
prescribed by the Secretary.
(4) Any device intended for human use which on the enactment date was
subject to the requirements of section 357 of this title shall be
subject to such requirements as follows:
(A) In the case of such a device which is classified into class I,
such requirements shall apply to such device until the effective date of
the regulation classifying the device into such class.
(B) In the case of such a device which is classified into class II,
such requirements shall apply to such device until the effective date of
a performance standard applicable to the device under section 360d of
this title.
(C) In the case of such a device which is classified into class III,
such requirements shall apply to such device until the date on which the
device is required to have in effect an approved application under
section 360e of this title.
(5)(A) Before December 1, 1991, the Secretary shall by order require
manufacturers of devices described in paragraph (1), which are subject
to revision of classification under subparagraph (B), to submit to the
Secretary a summary of and citation to any information known or
otherwise available to the manufacturers respecting the devices,
including adverse safety or effectiveness information which has not been
submitted under section 360i of this title. The Secretary may require a
manufacturer to submit the adverse safety or effectiveness data for
which a summary and citation were submitted, if such data are available
to the manufacturer.
(B) Except as provided in subparagraph (C), after the issuance of an
order under subparagraph (A) but before December 1, 1992, the Secretary
shall publish a regulation in the Federal Register for each device which
is classified in class III under paragraph (1) revising the
classification of the device so that the device is classified into class
I or class II, unless the regulation requires the device to remain in
class III. In determining whether to revise the classification of a
device or to require a device to remain in class III, the Secretary
shall apply the criteria set forth in section 360c( a) of this title.
Before the publication of a regulation requiring a device to remain in
class III or revising its classification, the Secretary shall publish a
proposed regulation respecting the classification of a device under this
subparagraph and provide an opportunity for the submission of comments
on any such regulation. No regulation under this subparagraph requiring
a device to remain in class III or revising its classification may take
effect before the expiration of 90 days from the date of the publication
in the Federal Register of the proposed regulation.
(C) The Secretary may by notice published in the Federal Register
extend the period prescribed by subparagraph (B) for a device for an
additional period not to exceed 1 year.
(m) Humanitarian device exemption
(1) To the extent consistent with the protection of the public health
and safety and with ethical standards, it is the purpose of this
subsection to encourage the discovery and use of devices intended to
benefit patients in the treatment and diagnosis of diseases or
conditions that affect fewer than 4,000 individuals in the United
States.
(2) The Secretary may grant a request for an exemption from the
effectiveness requirements of sections 360d and 360e of this title for a
device for which the Secretary finds that --
(A) the device is designed to treat or diagnose a disease or
condition that affects fewer than 4,000 individuals in the United
States,
(B) the device would not be available to a person with a disease or
condition referred to in subparagraph (A) unless the Secretary grants
such an exemption and there is no comparable device, other than under
this exemption, available to treat or diagnose such disease or
condition, and
(C) the device will not expose patients to an unreasonable or
significant risk of illness or injury and the probable benefit to health
from the use of the device outweighs the risk of injury or illness from
its use, taking into account the probable risks and benefits of
currently available devices or alternative forms of treatment.
(3) No person granted an exemption under paragraph (2) with respect
to a device may sell the device for an amount that exceeds the costs of
research and development, fabrication, and distribution of the device.
(4) Devices granted an exemption under paragraph (2) may only be used
--
(A) in facilities that have established, in accordance with
regulations of the Secretary, a local institutional review committee to
supervise clinical testing of devices in the facilities, and
(B) if, before the use of a device, an institutional review committee
approves the use in the treatment or diagnosis of a disease or condition
referred to in paragraph (2)(A).
(5) An exemption under paragraph (2) shall be for a term of 18 months
and may only be initially granted in the 5-year period beginning on the
date regulations under paragraph (6) take effect. The Secretary may
extend such an exemption for a period of 18 months if the Secretary is
able to make the findings set forth in paragraph (2) and if the
applicant supplies information demonstrating compliance with paragraph
(3). An exemption may be extended more than once and may be extended
after the expiration of such 5-year period.
(6) Within one year of November 28, 1990, the Secretary shall issue
regulations to implement this subsection.
(June 25, 1938, ch. 675, 520, as added May 28, 1976, Pub. L. 94-295,
2, 90 Stat. 565, and amended Nov. 28, 1990, Pub. L. 101-629,
3(b)(2), 4(b)(2), 5(c)(2), 6(b)(2), 11, 14(a), 18(e), (f), 104 Stat.
4514, 4516, 4518, 4519, 4522, 4524, 4529.)
The Federal Advisory Committee Act, referred to in subsec. (f)(3), is
Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is set
out in the Appendix to Title 5, Government Organization and Employees.
In subsec. (k), ''section 3324(a) and (b) of title 31'' substituted
for reference to section 3648 of the Revised Statutes (31 U.S.C. 529) on
authority of Pub. L. 97-258, 4(b), Sept. 13, 1982, 96 Stat. 1067, the
first section of which enacted Title 31, Money and Finance.
1990 -- Subsec. (c). Pub. L. 101-629, 11(1), substituted ''from
class III to class II or class I'' for ''under section 360c of this
title from class III to class II'' and inserted ''(1) in accordance with
subsection (h) of this section, and (2)'' after ''except''.
Subsec. (f)(1)(A). Pub. L. 101-629, 18(e), inserted ''pre-production
design validation (including a process to assess the performance of a
device but not including an evaluation of the safety or effectiveness of
a device),'' after ''manufacture,''.
Subsec. (h)(3). Pub. L. 101-629, 11(2)(A), substituted ''Except as
provided in paragraph (4), any'' for ''Any''.
Subsec. (h)(4). Pub. L. 101-629, 11(2)(B), added par. (4).
Subsec. (i). Pub. L. 101-629, 6(b)(2), substituted ''section 360d(
b)(5)(B)'' for ''section 360d(g)(5)(B)''.
Subsec. (j). Pub. L. 101-629, 3(b)(2), substituted ''Except as
provided in section 360i(e) of this title, no'' for ''No''.
Subsec. (l)(2). Pub. L. 101-629, 18(f), struck out ''and after
affording the petitioner an opportunity for an informal hearing'' after
''under this paragraph''.
Pub. L. 101-629, 5(c)(2), substituted ''The Secretary may initiate
the reclassification of a device classified into class III under
paragraph (1) of this subsection or the manufacturer'' for ''The
manufacturer''.
Subsec. (l)(5). Pub. L. 101-629, 4(b)(2), added par. (5).
Subsec. (m). Pub. L. 101-629, 14(a), added subsec. (m).
Section 14(b) of Pub. L. 101-629 provided that: ''Subsection (m) of
section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360j(m)), as added by the amendment made by subsection (a), shall take
effect on the effective date of the regulations issued by the Secretary
under paragraph (6) of such subsection.''
Section 14(c) of Pub. L. 101-629 provided that: ''Within 4 years
after the issuance of regulations under section 520(m)(6) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)), as added by the
amendment made by subsection (a), the Secretary of Health and Human
Services shall report to the Congress (1) on the types of devices
exempted under such section, (2) an evaluation of the effects of such
section, and (3) a recommendation on extension of the section.''
References in laws to the rates of pay for GS-16, 17, or 18, or to
maximum rates of pay under the General Schedule, to be considered
references to rates payable under specified sections of Title 5,
Government Organization and Employees, see section 529 (title I, 101(
c)(1)) of Pub. L. 101-509, set out in a note under section 5376 of
Title 5.
21 USC 360k. State and local requirements respecting devices
TITLE 21 -- FOOD AND DRUGS
(a) General rule
Except as provided in subsection (b) of this section, no State or
political subdivision of a State may establish or continue in effect
with respect to a device intended for human use any requirement --
(1) which is different from, or in addition to, any requirement
applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to
any other matter included in a requirement applicable to the device
under this chapter.
(b) Exempt requirements
Upon application of a State or a political subdivision thereof, the
Secretary may, by regulation promulgated after notice and opportunity
for an oral hearing, exempt from subsection (a) of this section, under
such conditions as may be prescribed in such regulation, a requirement
of such State or political subdivision applicable to a device intended
for human use if --
(1) the requirement is more stringent than a requirement under this
chapter which would be applicable to the device if an exemption were not
in effect under this subsection; or
(2) the requirement --
(A) is required by compelling local conditions, and
(B) compliance with the requirement would not cause the device to be
in violation of any applicable requirement under this chapter.
(June 25, 1938, ch. 675, 521, as added May 28, 1976, Pub. L. 94-295,
2, 90 Stat. 574.)
21 USC 360l. Postmarket surveillance
TITLE 21 -- FOOD AND DRUGS
(a) In general
(1) Required surveillance
The Secretary shall require a manufacturer to conduct postmarket
surveillance for any device of the manufacturer first introduced or
delivered for introduction into interstate commerce after January 1,
1991, that --
(A) is a permanent implant the failure of which may cause serious,
adverse health consequences or death,
(B) is intended for a use in supporting or sustaining human life, or
(C) potentially presents a serious risk to human health.
(2) Discretionary surveillance
The Secretary may require a manufacturer to conduct postmarket
surveillance for a device of the manufacturer if the Secretary
determines that postmarket surveillance of the device is necessary to
protect the public health or to provide safety or effectiveness data for
the device.
(b) Surveillance approval
Each manufacturer required to conduct a surveillance of a device
under subsection (a) of this section shall, within 30 days of the first
introduction or delivery for introduction of such device into interstate
commerce submit, for the approval of the Secretary, a protocol for the
required surveillance. The Secretary, within 60 days of the receipt of
such protocol, shall determine if the principal investigator proposed to
be used in the surveillance has sufficient qualifications and experience
to conduct such surveillance and if such protocol will result in
collection of useful data or other information necessary to protect the
public health and to provide safety and effectiveness information for
the device. The Secretary may not approve such a protocol until it has
been reviewed by an appropriately qualified scientific and technical
review committee established by the Secretary.
(June 25, 1938, ch. 675, 522, as added Nov. 28, 1990, Pub. L.
101-629, 10, 104 Stat. 4521.)
21 USC Part B -- Drugs for Rare Diseases or Conditions
TITLE 21 -- FOOD AND DRUGS
21 USC 360aa. Recommendations for investigations of drugs for rare
diseases or conditions
TITLE 21 -- FOOD AND DRUGS
(a) Request by sponsor; response by Secretary
The sponsor of a drug for a disease or condition which is rare in the
States may request the Secretary to provide written recommendations for
the non-clinical and clinical investigations which must be conducted
with the drug before --
(1) it may be approved for such disease or condition under section
355 of this title,
(2) if the drug is an antibiotic, it may be certified for such
disease or condition under section 357 of this title, or
(3) if the drug is a biological product, it may be licensed for such
disease or condition under section 262 of title 42.
If the Secretary has reason to believe that a drug for which a
request is made under this section is a drug for a disease or condition
which is rare in the States, the Secretary shall provide the person
making the request written recommendations for the non-clinical and
clinical investigations which the Secretary believes, on the basis of
information available to the Secretary at the time of the request under
this section, would be necessary for approval of such drug for such
disease or condition under section 355 of this title, certification of
such drug for such disease or condition under section 357 of this title,
or licensing of such drug for such disease or condition under section
262 of title 42.
(b) Regulations
The Secretary shall by regulation promulgate procedures for the
implementation of subsection (a) of this section.
(June 25, 1938, ch. 675, 525, as added Jan. 4, 1983, Pub. L. 97-414,
2(a), 96 Stat. 2049, and amended Aug. 15, 1985, Pub. L. 99-91, 3(a)(1),
99 Stat. 387.)
1985 -- Subsec. (a). Pub. L. 99-91 struck out ''or'' at end of par.
(1), inserted par. (2), redesignated former par. (2) as (3) and struck
out ''before'' after ''product,'', and in last sentence inserted
provisions relating to certification of such drug for disease or
condition under section 357 of this title and substituted ''licensing of
such drug for such disease or condition under section 262 of title 42''
for ''licensing under section 262 of title 42 for such disease or
condition''.
Section 8 of Pub. L. 99-91 provided that:
''(a) General Rule. -- Except as provided in subsection (b), this Act
and the amendments made by this Act (amending this section, sections
360bb, 360cc, and 360ee of this title, and sections 295g-1 and 6022 of
Title 42, The Public Health and Welfare, and enacting provisions set out
as notes under section 301 of this title and section 236 of Title 42)
shall take effect October 1, 1985.
''(b) Exception. -- The amendments made by sections 2, 3, and 6(a)
(amending this section and sections 360bb and 360cc of this title) shall
take effect on the date of the enactment of this Act (Aug. 15, 1985).
The amendment made by section 6(b) (amending section 6022 of Title 42)
shall take effect October 19, 1984. The amendments made by section 7
(amending section 295g-1 of Title 42) shall take effect October 1, 1984
and shall cease to be in effect after September 30, 1985.''
Pub. L. 100-290, 3(d), Apr. 18, 1988, 102 Stat. 91, provided that:
''The Secretary of Health and Human Services shall conduct a study to
determine whether the application of subchapter B of chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aa et seq.) (relating
to drugs for rare diseases and conditions) and section 28 of the
Internal Revenue Code of 1986 (26 U.S.C. 28) (relating to tax credit) to
medical devices or medical foods for rare diseases or conditions or to
both is needed to encourage the development of such devices and foods.
The Secretary shall report the results of the study to the Committee on
Energy and Commerce of the House of Representatives and the Committee on
Labor and Human Resources of the Senate not later than one year after
the date of the enactment of this Act (Apr. 18, 1988). For purposes of
this section, the term 'rare diseases or conditions' has the meaning
prescribed by section 5 of the Orphan Drug Act (21 U.S.C. 360ee).''
Section 1(b) of Pub. L. 97-414 provided that: ''The Congress finds
that --
''(1) there are many diseases and conditions, such as Huntington's
disease, myoclonus, ALS (Lou Gehrig's disease), Tourette syndrome, and
muscular dystrophy which affect such small numbers of individuals
residing in the United States that the diseases and conditions are
considered rare in the United States;
''(2) adequate drugs for many of such diseases and conditions have
not been developed;
''(3) drugs for these diseases and conditions are commonly referred
to as 'orphan drugs';
''(4) because so few individuals are affected by any one rare disease
or condition, a pharmaceutical company which develops an orphan drug may
reasonably expect the drug to generate relatively small sales in
comparison to the cost of developing the drug and consequently to incur
a financial loss;
''(5) there is reason to believe that some promising orphan drugs
will not be developed unless changes are made in the applicable Federal
laws to reduce the costs of developing such drugs and to provide
financial incentives to develop such drugs; and
''(6) it is in the public interest to provide such changes and
incentives for the development of orphan drugs.''
21 USC 360bb. Designation of drugs for rare diseases or conditions
TITLE 21 -- FOOD AND DRUGS
(a) Request by sponsor; preconditions; ''rare disease or
condition'' defined
(1) The manufacturer or the sponsor of a drug may request the
Secretary to designate the drug as a drug for a rare disease or
condition. A request for designation of a drug shall be made before the
submission of an application under section 355(b) of this title for the
drug, the submission of an application for certification of the drug
under section 357 of this title, or the submission of an application for
licensing of the drug under section 262 of title 42. If the Secretary
finds that a drug for which a request is submitted under this subsection
is being or will be investigated for a rare disease or condition and --
(A) if an application for such drug is approved under section 355 of
this title,
(B) if a certification for such drug is issued under section 357 of
this title, or
(C) if a license for such drug is issued under section 262 of title
42,
the approval, certification, or license would be for use for such
disease or condition, the Secretary shall designate the drug as a drug
for such disease or condition. A request for a designation of a drug
under this subsection shall contain the consent of the applicant to
notice being given by the Secretary under subsection (b) of this section
respecting the designation of the drug.
(2) For purposes of paragraph (1), the term ''rare disease or
condition'' means any disease or condition which (A) affects less than
200,000 persons in the United States, or (B) affects more than 200,000
in the United States and for which there is no reasonable expectation
that the cost of developing and making available in the United States a
drug for such disease or condition will be recovered from sales in the
United States of such drug. Determinations under the preceding sentence
with respect to any drug shall be made on the basis of the facts and
circumstances as of the date the request for designation of the drug
under this subsection is made.
(b) Notification of discontinuance of drug or application as
condition
A designation of a drug under subsection (a) of this section shall be
subject to the condition that --
(1) if an application was approved for the drug under section 355(b)
of this title, a certificate was issued for the drug under section 357
of this title, or a license was issued for the drug under section 262 of
title 42, the manufacturer of the drug will notify the Secretary of any
discontinuance of the production of the drug at least one year before
discontinuance, and
(2) if an application has not been approved for the drug under
section 355(b) of this title, a certificate has not been issued for the
drug under section 357 of this title, or a license has not been issued
for the drug under section 262 of title 42 and if preclinical
investigations or investigations under section 355(i) of this title are
being conducted with the drug, the manufacturer or sponsor of the drug
will notify the Secretary of any decision to discontinue active pursuit
of approval of an application under section 355(b) of this title,
approval of an application for certification under section 357 of this
title, or approval of a license under section 262 of title 42.
(c) Notice to public
Notice respecting the designation of a drug under subsection (a) of
this section shall be made available to the public.
(d) Regulations
The Secretary shall by regulation promulgate procedures for the
implementation of subsection (a) of this section.
(June 25, 1938, ch. 675, 526, as added Jan. 4, 1983, Pub. L. 97-414,
2(a), 96 Stat. 2050, and amended Oct. 30, 1984, Pub. L. 98-551, 4(a), 98
Stat. 2817; Aug. 15, 1985, Pub. L. 99-91, 3(a)(2), 99 Stat. 387; Apr.
18, 1988, Pub. L. 100-290, 2, 102 Stat. 90.)
1988 -- Subsec. (a)(1). Pub. L. 100-290, 2(a), inserted after first
sentence ''A request for designation of a drug shall be made before the
submission of an application under section 355(b) of this title for the
drug, the submission of an application for certification of the drug
under section 357 of this title, or the submission of an application for
licensing of the drug under section 262 of title 42.''
Subsecs. (b) to (d). Pub. L. 100-290, 2(b), added subsec. (b) and
redesignated former subsecs. (b) and (c) as (c) and (d), respectively.
1985 -- Subsec. (a)(1). Pub. L. 99-91 struck out ''or'' at end of
subpar. (A), struck out subpar. (B) and substituted subpars. (B) and
(C), and inserted '', certification,'' after ''approval''.
1984 -- Subsec. (a)(2). Pub. L. 98-551 substituted ''which (A)
affects less than 200,000 persons in the United States, or (B) affects
more than 200,000 in the United States and for which'' for ''which
occurs so infrequently in the United States that''.
Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section 8(
b) of Pub. L. 99-91, set out as a note under section 360aa of this
title.
section 236.
21 USC 360cc. Protection for drugs for rare diseases or conditions
TITLE 21 -- FOOD AND DRUGS
(a) Exclusive approval, certification, or license
Except as provided in subsection (b) of this section, if the
Secretary --
(1) approves an application filed pursuant to section 355 of this
title,
(2) issues a certification under section 357 of this title, or
(3) issues a license under section 262 of title 42
for a drug designated under section 360bb of this title for a rare
disease or condition, the Secretary may not approve another application
under section 355 of this title, issue another certification under
section 357 of this title, or issue another license under section 262 of
title 42 for such drug for such disease or condition for a person who is
not the holder of such approved application, of such certification, or
of such license until the expiration of seven years from the date of the
approval of the approved application, the issuance of the certification,
or the issuance of the license. Section 355(c)( 2) of this title does
not apply to the refusal to approve an application under the preceding
sentence.
(b) Exceptions
If an application filed pursuant to section 355 of this title is
approved for a drug designated under section 360bb of this title for a
rare disease or condition, if a certification is issued under section
357 of this title for such a drug, or if a license is issued under
section 262 of title 42 for such a drug, the Secretary may, during the
seven-year period beginning on the date of the application approval, of
the issuance of the certification under section 357 of this title, or of
the issuance of the license, approve another application under section
355 of this title, issue another certification under section 357 of this
title,, /1/ or issue a license under section 262 of title 42, for such
drug for such disease or condition for a person who is not the holder of
such approved application, of such certification, or of such license if
--
(1) The /2/ Secretary finds, after providing the holder notice and
opportunity for the submission of views, that in such period the holder
of the approved application, of such certification, or of the license
cannot assure the availability of sufficient quantities of the drug to
meet the needs of persons with the disease or condition for which the
drug was designated; or
(2) such holder provides the Secretary in writing the consent of such
holder for the approval of other applications, issuance of other
certifications, or the issuance of other licenses before the expiration
of such seven-year period.
(June 25, 1938, ch. 675, 527, as added Jan. 4, 1983, Pub. L. 97-414,
2(a), 96 Stat. 2050, and amended Sept. 24, 1984, Pub. L. 98-417, title
I, 102(b)(6), 98 Stat. 1593; Aug. 15, 1985, Pub. L. 99-91, 2, 3(a)(3),
99 Stat. 387, 388.)
1985 -- Pub. L. 99-91, 2(3), struck out ''unpatented'' before
''drugs'' in section catchline.
Subsec. (a). Pub. L. 99-91, 2(1), 3(a)(3)(A)-(D), struck out ''or''
at end of par. (1), added par. (2), redesignated former par. (2) as
(3), struck out ''and for which a United States Letter of Patent may not
be issued'' after ''rare disease or condition'', inserted in first
sentence '', issue another certification under section 357 of this
title,'' after ''section 355 of this title'' the second time it
appeared, inserted '', of such certification,'' after ''holder of such
approved application'', and inserted '', the issuance of the
certification,'' after ''approval of the approved application''.
Subsec. (b). Pub. L. 99-91, 2(2), 3(a)(3)(E)-(K), struck out ''and if
a United States Letter of Patent may not be issued for the drug'' after
''such a drug'', substituted '', if a certification is issued under
section 357 of this title for such a drug, or if a license'' for ''or a
license'', inserted '', of the issuance of the certification under
section 357 of this title,'' after ''application approval'', struck out
'', if the drug is a biological product,'' before ''issue a license'',
inserted '', issue another certification under section 357 of this
title,'' after ''section 355 of this title'', inserted '', of such
certification,'' after ''holder of such approved application'', inserted
'', of such certification,'' after ''application'' in par. (1), and
inserted '', issuance of other certifications,'' after ''other
applications'' in par. (2).
1984 -- Subsecs. (a), (b). Pub. L. 98-417 substituted ''section
355'' for ''section 355(b)'' wherever appearing.
Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section 8(
b) of Pub. L. 99-91, set out as a note under section 360aa of this
title.
/1/ So in original.
/2/ So in original. Probably should not be capitalized.
21 USC 360dd. Open protocols for investigations of drugs for rare
diseases or conditions
TITLE 21 -- FOOD AND DRUGS
If a drug is designated under section 360bb of this title as a drug
for a rare disease or condition and if notice of a claimed exemption
under section 355(i) of this title or regulations issued thereunder is
filed for such drug, the Secretary shall encourage the sponsor of such
drug to design protocols for clinical investigations of the drug which
may be conducted under the exemption to permit the addition to the
investigations of persons with the disease or condition who need the
drug to treat the disease or condition and who cannot be satisfactorily
treated by available alternative drugs.
(June 25, 1938, ch. 675, 528, as added Jan. 4, 1983, Pub. L. 97-414,
2(a), 96 Stat. 2051.)
21 USC 360ee. Grants and contracts for development of drugs for rare
diseases and conditions
TITLE 21 -- FOOD AND DRUGS
(a) Authority of Secretary
The Secretary may make grants to and enter into contracts with public
and private entities and individuals to assist in (1) defraying the
costs of qualified testing expenses incurred in connection with the
development of drugs for rare diseases and conditions, (2) defraying the
costs of developing medical devices for rare diseases or conditions, and
(3) defraying the costs of developing medical foods for rare diseases or
conditions.
(b) Definitions
For purposes of subsection (a) of this section:
(1) The term ''qualified testing'' means --
(A) human clinical testing --
(i) which is carried out under an exemption for a drug for a rare
disease or condition under section 355(i) of this title (or regulations
issued under such section); and
(ii) which occurs after the date such drug is designated under
section 360bb of this title and before the date on which an application
with respect to such drug is submitted under section 355(b) or 357 of
this title or under section 262 of title 42; and
(B) preclinical testing involving a drug for a rare disease or
condition which occurs after the date such drug is designated under
section 360bb of this title and before the date on which an application
with respect to such drug is submitted under section 355(b) or 357 of
this title or under section 262 of title 42.
(2) The term ''rare disease or condition'' means (1) in the case of a
drug, any disease or condition which (A) affects less than 200,000
persons in the United States, or (B) affects more than 200,000 in the
United States and for which there is no reasonable expectation that the
cost of developing and making available in the United States a drug for
such disease or condition will be recovered from sales in the United
States of such drug, (2) in the case of a medical device, any disease or
condition that occurs so infrequently in the United States that there is
no reasonable expectation that a medical device for such disease or
condition will be developed without assistance under subsection (a) of
this section, and (3) in the case of a medical food, any disease or
condition that occurs so infrequently in the United States that there is
no reasonable expectation that a medical food for such disease or
condition will be developed without assistance under subsection (a) of
this section. Determinations under the preceding sentence with respect
to any drug shall be made on the basis of the facts and circumstances as
of the date the request for designation of the drug under section 360bb
of this title is made.
(3) The term ''medical food'' means a food which is formulated to be
consumed or administered enterally under the supervision of a physician
and which is intended for the specific dietary management of a disease
or condition for which distinctive nutritional requirements, based on
recognized scientific principles, are established by medical evaluation.
(c) Authorization of appropriations
For grants and contracts under subsection (a) of this section there
are authorized to be appropriated $10,000,000 for fiscal year 1988,
$12,000,000 for fiscal year 1989, /1/ $14,000,000 for fiscal year 1990.
(Pub. L. 97-414, 5, Jan. 4, 1983, 96 Stat. 2056; Pub. L. 98-551, 4(
b), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91, 5, Aug. 15, 1985, 99
Stat. 391; Pub. L. 100-290, 3(a)-(c), Apr. 18, 1988, 102 Stat. 90, 91.)
Section was enacted as part of the Orphan Drug Act, and not as part
of the Federal Food, Drug, and Cosmetic Act which comprises this
chapter.
1988 -- Subsec. (a). Pub. L. 100-290, 3(a)(1), (b)(1), inserted
''(1)'' after ''assist in'' and added cls. (2) and (3).
Subsec. (b)(2). Pub. L. 100-290, 3(a)(2), (b)(2), inserted ''(1) in
the case of a drug,'' after ''means'', added cls. (2) and (3), and
substituted ''under section 360bb of this title'' for ''under this
subsection'' in last sentence.
Subsec. (b)(3). Pub. L. 100-290, 3(b)(3), added par. (3).
Subsec. (c). Pub. L. 100-290, 3(c), amended subsec. (c) generally.
Prior to amendment, subsec. (c) read as follows: ''For grants and
contracts under subsection (a) of this section there are authorized to
be appropriated $4,000,000 for fiscal year 1986, $4,000,000 for fiscal
year 1987, and $4,000,000 for fiscal year 1988.''
1985 -- Subsec. (a). Pub. L. 99-91, 5(a)(1), struck out ''clinical''
before ''testing''.
Subsec. (b)(1). Pub. L. 99-91, 5(a)(2), substituted provisions
defining ''qualified testing'' for provisions defining ''qualified
clinical testing''.
Subsec. (c). Pub. L. 99-91, 5(b), substituted provisions authorizing
appropriations for fiscal years 1986 to 1988, for provisions authorizing
appropriations for fiscal years 1983 and the two succeeding fiscal
years.
1984 -- Subsec. (b)(2). Pub. L. 98-551 substituted ''which (A)
affects less than 200,000 persons in the United States, or (B) affects
more than 200,000 in the United States and for which'' for ''which
occurs so infrequently in the United States that''.
Amendment by Pub. L. 99-91 effective Oct. 1, 1985, see section 8(
a) of Pub. L. 99-91, set out as a note under section 360aa of this
title.
title 42 section 236.
/1/ So in original. Probably should be followed by ''and''.
21 USC Part C -- Electronic Product Radiation Control
TITLE 21 -- FOOD AND DRUGS
This part was classified to subpart 3 ( 263b et seq.) of part F of
subchapter II of chapter 6A of Title 42, The Public Health and Welfare,
prior to its renumbering by Pub. L. 101-629, 19(a)(4), Nov. 28, 1990,
104 Stat. 4530.
21 USC 360gg. Repealed. Pub. L. 101-629, 19(a)(3), Nov. 28, 1990, 104
Stat. 4530
TITLE 21 -- FOOD AND DRUGS
Section, act June 25, 1938, ch. 675, 530, formerly act July 1, 1944,
ch. 373, title III, 354, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1173; renumbered 530 of act June 25, 1938, and amended
Nov. 28, 1990, Pub. L. 101-629, 19(a)(1)(B), (4), 104 Stat. 4529,
4530, set forth Congressional declaration of purpose.
Section was classified to section 263b of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
21 USC 360hh. Definitions
TITLE 21 -- FOOD AND DRUGS
As used in this part --
(1) the term ''electronic product radiation'' means --
(A) any ionizing or non-ionizing electromagnetic or particulate
radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from
an electronic product as the result of the operation of an electronic
circuit in such product;
(2) the term ''electronic product'' means (A) any manufactured or
assembled product which, when in operation, (i) contains or acts as part
of an electronic circuit and (ii) emits (or in the absence of effective
shielding or other controls would emit) electronic product radiation, or
(B) any manufactured or assembled article which is intended for use as a
component, part, or accessory of a product described in clause (A) and
which when in operation emits (or in the absence of effective shielding
or other controls would emit) such radiation;
(3) the term ''manufacturer'' means any person engaged in the
business of manufacturing, assembling, or importing of electronic
products;
(4) the term ''commerce'' means (A) commerce between any place in any
State and any place outside thereof; and (B) commerce wholly within the
District of Columbia; and
(5) the term ''State'' includes the District of Columbia, the
Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin
Islands, Guam, and American Samoa.
(June 25, 1938, ch. 675, 531, formerly act July 1, 1944, ch. 373,
title III, 531, formerly 355, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1174, and amended Oct. 12, 1976, Pub. L. 94-484, title
IX, 905(b)(1), 90 Stat. 2325; renumbered 531 and amended Nov. 28, 1990,
Pub. L. 101-629, 19(a)(1)(B), (3), (4), 104 Stat. 4529, 4530.)
Section was classified to section 263c of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263c of
Title 42, The Public Health and Welfare, as this section.
Pub. L. 101-629, 19(a)(1)(B), substituted ''this part'' for ''this
subpart'' in introductory provisions.
1976 -- Par. (5). Pub. L. 94-484 defined ''State'' to include
Northern Mariana Islands.
For short title of Pub. L. 90-602, which enacted provisions now
comprising this part ( 360gg to 360ss), as the ''Radiaition Control for
Health and Safety Act of 1968'', see section 1 of Pub. L. 90-602, set
out as a Short Title of 1968 Amendments note under section 301 of this
title.
Section 19(c) of Pub. L. 101-629 provided that: ''The transfer of
subpart 3 of part F of title III of the Public Health Service Act (42
U.S.C. 263b et seq.) to the Federal Food, Drug, and Cosmetic Act (this
chapter) does not change the application of the requirements of such
subpart and such Act to electronic products which were in effect on the
date of the enactment of this Act (Nov. 28, 1990).''
Section 3 of Pub. L. 90-602, as amended Pub. L. 96-88, title V,
509(b), Oct. 17, 1979, 93 Stat. 695, provided that: ''As used in the
amendments made by section 2 of this Act (enacting provisions now
comprising sections 360gg to 360ss of this title), except when otherwise
specified, the term 'Secretary' means the Secretary of Health and Human
Services, and the term 'Department' means the Department of Health and
Human Services.''
Section 4 of Pub. L. 90-602 provided that: ''The amendments made by
section 2 of this Act (enacting provisions now comprising sections 360gg
to 360ss of this title) shall not be construed as superseding or
limiting the functions, under any other provision of law, of any officer
or agency of the United States.''
21 USC 360ii. Program of control
TITLE 21 -- FOOD AND DRUGS
(a) Establishment
The Secretary shall establish and carry out an electronic product
radiation control program designed to protect the public health and
safety from electronic product radiation. As a part of such program, he
shall --
(1) pursuant to section 360kk of this title, develop and administer
performance standards for electronic products;
(2) plan, conduct, coordinate, and support research, development,
training, and operational activities to minimize the emissions of and
the exposure of people to, unnecessary electronic product radiation;
(3) maintain liaison with and receive information from other Federal
and State departments and agencies with related interests, professional
organizations, industry, industry and labor associations, and other
organizations on present and future potential electronic product
radiation;
(4) study and evaluate emissions of, and conditions of exposure to,
electronic product radiation and intense magnetic fields;
(5) develop, test, and evaluate the effectiveness of procedures and
techniques for minimizing exposure to electronic product radiation; and
(6) consult and maintain liaison with the Secretary of Commerce, the
Secretary of Defense, the Secretary of Labor, the Atomic Energy
Commission, and other appropriate Federal departments and agencies on
(A) techniques, equipment, and programs for testing and evaluating
electronic product radiation, and (B) the development of performance
standards pursuant to section 360kk of this title to control such
radiation emissions.
(b) Powers of Secretary
In carrying out the purposes of subsection (a) of this section, the
Secretary is authorized to --
(1)(A) collect and make available, through publications and other
appropriate means, the results of, and other information concerning,
research and studies relating to the nature and extent of the hazards
and control of electronic product radiation; and (B) make such
recommendations relating to such hazards and control as he considers
appropriate;
(2) make grants to public and private agencies, organizations, and
institutions, and to individuals for the purposes stated in paragraphs
(2), (4), and (5) of subsection (a) of this section;
(3) contract with public or private agencies, institutions, and
organizations, and with individuals, without regard to section 3324 of
title 31 and section 5 of title 41; and
(4) procure (by negotiation or otherwise) electronic products for
research and testing purposes, and sell or otherwise dispose of such
products.
(c) Record keeping
(1) Each recipient of assistance under this part pursuant to grants
or contracts entered into under other than competitive bidding
procedures shall keep such records as the Secretary shall prescribe,
including records which fully disclose the amount and disposition by
such recipient of the proceeds of such assistance, the total cost of the
project or undertaking in connection with which such assistance is given
or used, and the amount of that portion of the cost of the project or
undertaking supplied by other sources, and such other records as will
facilitate an effective audit.
(2) The Secretary and the Comptroller General of the United States,
or any of their duly authorized representatives, shall have access for
the purpose of audit and examination to any books, documents, papers,
and records of the recipients that are pertinent to the grants or
contracts entered into under this part under other than competitive
bidding procedures.
(June 25, 1938, ch. 675, 532, formerly act July 1, 1944, ch. 373,
title III, 532, formerly 356, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1174, and renumbered 532 and amended Nov. 28, 1990, Pub.
L. 101-629, 19(a)(1)(B), (2)(A), (3), (4), 104 Stat. 4529, 4530.)
Section was classified to section 263d of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263d of
Title 42, The Public Health and Welfare, as this section.
Subsec. (a)(1), (6). Pub. L. 101-629, 19(a)(2)(A)(i), substituted
''section 360kk'' for ''section 263f''.
Subsec. (b)(3). Pub. L. 101-629, 19(a)(2)(A)(ii), substituted
reference to section 3324 of title 31 for reference to section 3648 of
the Revised Statutes (31 U.S.C. 529).
Subsec. (c)(1), (2). Pub. L. 101-629, 19(a)(1)(B), substituted
''this part'' for ''this subpart''.
Atomic Energy Commission abolished and functions transferred by
sections 5814 and 5841 of Title 42, The Public Health and Welfare. See
also Transfer of Functions notes set out under those sections.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law or any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
21 USC 360jj. Studies by Secretary
TITLE 21 -- FOOD AND DRUGS
(a) Report to Congress
The Secretary shall conduct the following studies, and shall make a
report or reports of the results of such studies to the Congress on or
before January 1, 1970, and from time to time thereafter as he may find
necessary, together with such recommendations for legislation as he may
deem appropriate:
(1) A study of present State and Federal control of health hazards
from electronic product radiation and other types of ionizing radiation,
which study shall include, but not be limited to --
(A) control of health hazards from radioactive materials other than
materials regulated under the Atomic Energy Act of 1954 (42 U.S.C. 2011
et seq.);
(B) any gaps and inconsistencies in present controls;
(C) the need for controlling the sale of certain used electronic
products, particularly antiquated X-ray equipment, without upgrading
such products to meet the standards for new products or separate
standards for used products;
(D) measures to assure consistent and effective control of the
aforementioned health hazards;
(E) measures to strengthen radiological health programs of State
governments; and
(F) the feasibility of authorizing the Secretary to enter into
arrangements with individual States or groups of States to define their
respective functions and responsibilities for the control of electronic
product radiation and other ionizing radiation;
(2) A study to determine the necessity for the development of
standards for the use of nonmedical electronic products for commercial
and industrial purposes; and
(3) A study of the development of practicable procedures for the
detection and measurement of electronic product radiation which may be
emitted from electronic products manufactured or imported prior to the
effective date of any applicable standard established pursuant to this
part.
(b) Participation of other Federal agencies
In carrying out these studies, the Secretary shall invite the
participation of other Federal departments and agencies having related
responsibilities and interests, State governments -- particularly those
of States which regulate radioactive materials under section 274 of the
Atomic Energy Act of 1954, as amended (42 U.S.C. 2021), and interested
professional, labor, and industrial organizations. Upon request from
congressional committees interested in these studies, the Secretary
shall keep these committees currently informed as to the progress of the
studies and shall permit the committees to send observers to meetings of
the study groups.
(c) Organization of studies and participation
The Secretary or his designee shall organize the studies and the
participation of the invited participants as he deems best. Any dissent
from the findings and recommendations of the Secretary shall be included
in the report if so requested by the dissenter.
(June 25, 1938, ch. 675, 533, formerly act July 1, 1944, ch. 373,
title III, 533, formerly 357, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1176, and renumbered 533 and amended Nov. 28, 1990, Pub.
L. 101-629, 19(a)(1)(B), (3), (4), 104 Stat. 4529, 4530.)
The Atomic Energy Act of 1954, referred to in subsec. (a)(1)(A), is
act Aug. 30, 1954, ch. 1073, 1, 68 Stat. 921, as amended, which is
classified generally to chapter 23 ( 2011 et seq.) of Title 42, The
Public Health and Welfare. For complete classification of this Act to
the Code, see Short Title note set out under section 2011 of Title 42
and Tables.
Section was classified to section 263e of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263e of
Title 42, The Public Health and Welfare, as this section.
Subsec. (a)(3). Pub. L. 101-629, 19(a)(1)(B), substituted ''this
part'' for ''this subpart''.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law of any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
21 USC 360kk. Performance standards for electronic products
TITLE 21 -- FOOD AND DRUGS
(a) Promulgation of regulations
(1) The Secretary shall by regulation prescribe performance standards
for electronic products to control the emission of electronic product
radiation from such products if he determines that such standards are
necessary for the protection of the public health and safety. Such
standards may include provisions for the testing of such products and
the measurement of their electronic product radiation emissions, may
require the attachment of warning signs and labels, and may require the
provision of instructions for the installation, operation, and use of
such products. Such standards may be prescribed from time to time
whenever such determinations are made, but the first of such standards
shall be prescribed prior to January 1, 1970. In the development of
such standards, the Secretary shall consult with Federal and State
departments and agencies having related responsibilities or interests
and with appropriate professional organizations and interested persons,
including representatives of industries and labor organizations which
would be affected by such standards, and shall give consideration to --
(A) the latest available scientific and medical data in the field of
electronic product radiation;
(B) the standards currently recommended by (i) other Federal agencies
having responsibilities relating to the control and measurement of
electronic product radiation, and (ii) public or private groups having
an expertise in the field of electronic product radiation;
(C) the reasonableness and technical feasibility of such standards as
applied to a particular electronic product;
(D) the adaptability of such standards to the need for uniformity and
reliability of testing and measuring procedures and equipment; and
(E) in the case of a component, or accessory described in paragraph
(2)(B) of section 360hh of this title, the performance of such article
in the manufactured or assembled product for which it is designed.
(2) The Secretary may prescribe different and individual performance
standards, to the extent appropriate and feasible, for different
electronic products so as to recognize their different operating
characteristics and uses.
(3) The performance standards prescribed under this section shall not
apply to any electronic product which is intended solely for export if
(A) such product and the outside of any shipping container used in the
export of such product are labeled or tagged to show that such product
is intended for export, and (B) such product meets all the applicable
requirements of the country to which such product is intended for
export.
(4) The Secretary may by regulation amend or revoke any performance
standard prescribed under this section.
(5) The Secretary may exempt from the provisions of this section any
electronic product intended for use by departments or agencies of the
United States provided such department or agency has prescribed
procurement specifications governing emissions of electronic product
radiation and provided further that such product is of a type used
solely or predominantly by departments or agencies of the United States.
(b) Administrative procedure
The provisions of subchapter II of chapter 5 of title 5 (relating to
the administrative procedure for rulemaking), and of chapter 7 of title
5 (relating to judicial review), shall apply with respect to any
regulation prescribing, amending, or revoking any standard prescribed
under this section.
(c) Publication in Federal Register
Each regulation prescribing, amending, or revoking a standard shall
specify the date on which it shall take effect which, in the case of any
regulation prescribing, or amending any standard, may not be sooner than
one year or not later than two years after the date on which such
regulation is issued, unless the Secretary finds, for good cause shown,
that an earlier or later effective date is in the public interest and
publishes in the Federal Register his reason for such finding, in which
case such earlier or later date shall apply.
(d) Judicial review
(1) In a case of actual controversy as to the validity of any
regulation issued under this section prescribing, amending, or revoking
a performance standard, any person who will be adversely affected by
such regulation when it is effective may at any time prior to the
sixtieth day after such regulation is issued file a petition with the
United States court of appeals for the circuit wherein such person
resides or has his principal place of business, for a judicial review of
such regulation. A copy of the petition shall be forthwith transmitted
by the clerk of the court to the Secretary or other officer designated
by him for that purpose. The Secretary thereupon shall file in the
court the record of the proceedings on which the Secretary based the
regulation, as provided in section 2112 of title 28.
(2) If the petitioner applies to the court for leave to adduce
additional evidence, and shows to the satisfaction of the court that
such additional evidence is material and that there were reasonable
grounds for the failure to adduce such evidence in the proceeding before
the Secretary, the court may order such additional evidence (and
evidence in rebuttal thereof) to be taken before the Secretary, and to
be adduced upon the hearing, in such manner and upon such terms and
conditions as to the court may seem proper. The Secretary may modify
his findings, or make new findings, by reason of the additional evidence
so taken, and he shall file such modified or new findings, and his
recommendations, if any, for the modification or setting aside of his
original regulation, with the return of such additional evidence.
(3) Upon the filing of the petition referred to in paragraph (1) of
this subsection, the court shall have jurisdiction to review the
regulation in accordance with chapter 7 of title 5 and to grant
appropriate relief as provided in such chapter.
(4) The judgment of the court affirming or setting aside, in whole or
in part, any such regulation of the Secretary shall be final, subject to
review by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28.
(5) Any action instituted under this subsection shall survive,
notwithstanding any change in the person occupying the office of
Secretary or any vacancy in such office.
(6) The remedies provided for in this subsection shall be in addition
to and not substitution for any other remedies provided by law.
(e) Availability of record
A certified copy of the transcript of the record and administrative
proceedings under this section shall be furnished by the Secretary to
any interested party at his request, and payment of the costs thereof,
and shall be admissible in any criminal, exclusion of imports, or other
proceeding arising under or in respect of this part irrespective of
whether proceedings with respect to the regulation have previously been
initiated or become final under this section.
(f) Technical Electronic Product Radiation Safety Standards Committee
(1)(A) The Secretary shall establish a Technical Electronic Product
Radiation Safety Standards Committee (hereafter in this part referred to
as the ''Committee'') which he shall consult before prescribing any
standard under this section. The Committee shall be appointed by the
Secretary, after consultation with public and private agencies concerned
with the technical aspect of electronic product radiation safety, and
shall be composed of fifteen members each of whom shall be technically
qualified by training and experience in one or more fields of science or
engineering applicable to electronic product radiation safety, as
follows:
(i) Five members shall be selected from governmental agencies,
including State and Federal Governments;
(ii) Five members shall be selected from the affected industries
after consultation with industry representatives; and
(iii) Five members shall be selected from the general public, of
which at least one shall be a representative of organized labor.
(B) The Committee may propose electronic product radiation safety
standards to the Secretary for his consideration. All proceedings of
the Committee shall be recorded and the record of each such proceeding
shall be available for public inspection.
(2) Payments to members of the Committee who are not officers or
employees of the United States pursuant to subsection (c) of section 210
of title 42 /1/ shall not render members of the Committee officers or
employees of the United States for any purpose.
(g) Review and evaluation
The Secretary shall review and evaluate on a continuing basis testing
programs carried out by industry to assure the adequacy of safeguards
against hazardous electronic product radiation and to assure that
electronic products comply with standards prescribed under this section.
(h) Product certification
Every manufacturer of an electronic product to which is applicable a
standard in effect under this section shall furnish to the distributor
or dealer at the time of delivery of such product, in the form of a
label or tag permanently affixed to such product or in such manner as
approved by the Secretary, the certification that such product conforms
to all applicable standards under this section. Such certification
shall be based upon a test, in accordance with such standard, of the
individual article to which it is attached or upon a testing program
which is in accord with good manufacturing practice and which has not
been disapproved by the Secretary (in such manner as he shall prescribe
by regulation) on the grounds that it does not assure the adequacy of
safeguards against hazardous electronic product radiation or that it
does not assure that electronic products comply with the standards
prescribed under this section.
(June 25, 1938, ch. 675, 534, formerly act July 1, 1944, ch. 373,
title III, 534, formerly 358, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1177, and amended Oct. 30, 1970, Pub. L. 91-515, title
VI, 601(b)(2), (3), 84 Stat. 1311; renumbered 534 and amended Nov. 28,
1990, Pub. L. 101-629, 19(a)(1)(B), (2)(B), (3), (4), 104 Stat. 4529,
4530.)
Section 210 of title 42, referred to in subsec. (f)(2), was in the
original ''section 208 of this Act'' and has been translated as reading
''section 208 of the Public Health Service Act'' to reflect the probable
intent of Congress and the transfer of this section from the Public
Health Service Act by Pub. L. 101-629.
Section was classified to section 263f of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263f of
Title 42, The Public Health and Welfare, as this section.
Subsec. (a)(1)(E). Pub. L. 101-629, 19(a)(2)(B), substituted
''section 360hh'' for ''section 263c''.
Subsecs. (e), (f)(1)(A). Pub. L. 101-629, 19(a)(1)(B), substituted
''this part'' for ''this subpart''.
1970 -- Subsec. (f)(2). Pub. L. 91-515 struck out provisions related
to payment of compensation and travel expenses of members of the
Committee who are not officers or employees of the United States, and
substituted ''to members of the Committee who are not officers or
employees of the United States pursuant to subsection (c) of section 210
of title 42'' for ''under this subsection''.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law of any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
/1/ See References in Text note below.
21 USC 360ll. Notification of defects in and repair or replacement of
electronic products
TITLE 21 -- FOOD AND DRUGS
(a) Notification; exemption
(1) Every manufacturer of electronic products who discovers that an
electronic product produced, assembled, or imported by him has a defect
which relates to the safety of use of such product by reason of the
emission of electronic product radiation, or that an electronic product
produced, assembled, or imported by him on or after the effective date
of an applicable standard prescribed pursuant to section 360kk of this
title fails to comply with such standard, shall immediately notify the
Secretary of such defect or failure to comply if such product has left
the place of manufacture and shall (except as authorized by paragraph
(2)) with reasonable promptness furnish notification of such defect or
failure to the persons (where known to the manufacturer) specified in
subsection (b) of this section.
(2) If, in the opinion of such manufacturer, the defect or failure to
comply is not such as to create a significant risk of injury, including
genetic injury, to any person, he may, at the time of giving notice to
the Secretary of such defect or failure to comply, apply to the
Secretary for an exemption from the requirement of notice to the persons
specified in subsection (b) of this section. If such application states
reasonable grounds for such exemption, the Secretary shall afford such
manufacturer an opportunity to present his views and evidence in support
of the application, the burden of proof being on the manufacturer. If,
after such presentation, the Secretary is satisfied that such defect or
failure to comply is not such as to create a significant risk of injury,
including genetic injury, to any person, he shall exempt such
manufacturer from the requirement of notice to the persons specified in
subsection (b) of this section and from the requirements of repair or
replacement imposed by subsection (f) of this section.
(b) Method of notification
The notification (other than to the Secretary) required by paragraph
(1) of subsection (a) of this section shall be accomplished --
(1) by certified mail to the first purchaser of such product for
purposes other than resale, and to any subsequent transferee of such
product; and
(2) by certified mail or other more expeditious means to the dealers
or distributors of such manufacturer to whom such product was delivered.
(c) Requisite elements of notification
The notifications required by paragraph (1) of subsection (a) of this
section shall contain a clear description of such defect or failure to
comply with an applicable standard, an evaluation of the hazard
reasonably related to such defect or failure to comply, and a statement
of the measures to be taken to repair such defect. In the case of a
notification to a person referred to in subsection (b) of this section,
the notification shall also advise the person of his rights under
subsection (f) of this section.
(d) Copies to Secretary of communications by manufacturers to dealers
or distributors regarding defects
Every manufacturer of electronic products shall furnish to the
Secretary a true or representative copy of all notices, bulletins, and
other communications to the dealers or distributors of such manufacturer
or to purchasers (or subsequent transferees) of electronic products of
such manufacturer regarding any such defect in such product or any such
failure to comply with a standard applicable to such product. The
Secretary shall disclose to the public so much of the information
contained in such notice or other information obtained under section
360nn of this title as he deems will assist in carrying out the purposes
of this part, but he shall not disclose any information which contains
or relates to a trade secret or other matter referred to in section 1905
of title 18 unless he determines that it is necessary to carry out the
purposes of this part.
(e) Notice from Secretary to manufacturer of defects or failure to
comply with standards
If through testing, inspection, investigation, or research carried
out pursuant to this part, or examination of reports submitted pursuant
to section 360nn of this title, or otherwise, the Secretary determines
that any electronic product --
(1) does not comply with an applicable standard prescribed pursuant
to section 360kk of this title; or
(2) contains a defect which relates to the safety of use of such
product by reason of the emission of electronic product radiation;
he shall immediately notify the manufacturer of such product of such
defect or failure to comply. The notice shall contain the findings of
the Secretary and shall include all information upon which the findings
are based. The Secretary shall afford such manufacturer an opportunity
to present his views and evidence in support thereof, to establish that
there is no failure of compliance or that the alleged defect does not
exist or does not relate to safety of use of the product by reason of
the emission of such radiation hazard. If after such presentation by
the manufacturer the Secretary determines that such product does not
comply with an applicable standard prescribed pursuant to section 360kk
of this title, or that it contains a defect which relates to the safety
of use of such product by reason of the emission of electronic product
radiation, the Secretary shall direct the manufacturer to furnish the
notification specified in subsection (c) of this section to the persons
specified in paragraphs (1) and (2) of subsection (b) of this section
(where known to the manufacturer), unless the manufacturer has applied
for an exemption from the requirement of such notification on the ground
specified in paragraph (2) of subsection (a) of this section and the
Secretary is satisfied that such noncompliance or defect is not such as
to create a significant risk of injury, including genetic injury, to any
person.
(f) Correction of defects
If any electronic product is found under subsection (a) or (e) of
this section to fail to comply with an applicable standard prescribed
under this part or to have a defect which relates to the safety of use
of such product, and the notification specified in subsection (c) of
this section is required to be furnished on account of such failure or
defect, the manufacturer of such product shall (1) without charge, bring
such product into conformity with such standard or remedy such defect
and provide reimbursement for any expenses for transportation of such
product incurred in connection with having such product brought into
conformity or having such defect remedied, (2) replace such product with
a like or equivalent product which complies with each applicable
standard prescribed under this part and which has no defect relating to
the safety of its use, or (3) make a refund of the cost of such product.
The manufacturer shall take the action required by this subsection in
such manner, and with respect to such persons, as the Secretary by
regulations shall prescribe.
(g) Effective date
This section shall not apply to any electronic product that was
manufactured before October 18, 1968.
(June 25, 1938, ch. 675, 535, formerly act July 1, 1944, ch. 373,
title III, 535, formerly 359, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1180, and renumbered 535 and amended Nov. 28, 1990, Pub.
L. 101-629, 19(a)(1)(B), (2)(C), (3), (4), 104 Stat. 4529, 4530.)
Section was classified to section 263g of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263g of
Title 42, The Public Health and Welfare, as this section.
Subsec. (a)(1). Pub. L. 101-629, 19(a)(2)(C)(i), substituted
''section 360kk'' for ''section 263f''.
Subsec. (d). Pub. L. 101-629, 19(a)(1)(B), (2)(C)(ii), substituted
''section 360nn'' for ''section 263i'' and ''this part'' for ''this
subpart'' in two places.
Subsec. (e). Pub. L. 101-629, 19(a)(1)(B), (2)(C), substituted ''this
part'' for ''this subpart'' and ''section 360nn'' for ''section 263i''
in introductory provisions and ''section 360kk'' for ''section 263f'' in
par. (1) and concluding provisions.
Subsec. (f). Pub. L. 101-629, 19(a)(1)(B), substituted ''this part''
for ''this subpart'' in two places.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law of any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
21 USC 360mm. Imports
TITLE 21 -- FOOD AND DRUGS
(a) Refusal of admission to noncomplying electronic products
Any electronic product offered for importation into the United States
which fails to comply with an applicable standard prescribed under this
part, or to which is not affixed a certification in the form of a label
or tag in conformity with section 360kk(h) of this title shall be
refused admission into the United States. The Secretary of the Treasury
shall deliver to the Secretary of Health and Human Services, upon the
latter's request, samples of electronic products which are being
imported or offered for import into the United States, giving notice
thereof to the owner or consignee, who may have a hearing before the
Secretary of Health and Human Services. If it appears from an
examination of such samples or otherwise that any electronic product
fails to comply with applicable standards prescribed pursuant to section
360kk of this title, then, unless subsection (b) of this section applies
and is complied with, (1) such electronic product shall be refused
admission, and (2) the Secretary of the Treasury shall cause the
destruction of such electronic product unless such article is exported,
under regulations prescribed by the Secretary of the Treasury, within 90
days after the date of notice of refusal of admission or within such
additional time as may be permitted by such regulations.
(b) Bond
If it appears to the Secretary of Health and Human Services that any
electronic product refused admission pursuant to subsection (a) of this
section can be brought into compliance with applicable standards
prescribed pursuant to section 360kk of this title, final determination
as to admission of such electronic product may be deferred upon filing
of timely written application by the owner or consignee and the
execution by him of a good and sufficient bond providing for the payment
of such liquidated damages in the event of default as the Secretary of
Health and Human Services may by regulation prescribe. If such
application is filed and such bond is executed the Secretary of Health
and Human Services may, in accordance with rules prescribed by him,
permit the applicant to perform such operations with respect to such
electronic product as may be specified in the notice of permission.
(c) Liability of owner or consignee for expenses connected with
refusal of admission
All expenses (including travel, per diem or subsistence, and salaries
of officers or employees of the United States) in connection with the
destruction provided for in subsection (a) of this section and the
supervision of operations provided for in subsection (b) of this
section, and all expenses in connection with the storage, cartage, or
labor with respect to any electronic product refused admission pursuant
to subsection (a) of this section, shall be paid by the owner or
consignee, and, in event of default, shall constitute a lien against any
future importations made by such owner or consignee.
(d) Designation of agent for purposes of service
It shall be the duty of every manufacturer offering an electronic
product for importation into the United States to designate in writing
an agent upon whom service of all administrative and judicial processes,
notices, orders, decisions, and requirements may be made for and on
behalf of said manufacturer, and to file such designation with the
Secretary, which designation may from time to time be changed by like
writing, similarly filed. Service of all administrative and judicial
processes, notices, orders, decisions, and requirements may be made upon
said manufacturer by service upon such designated agent at his office or
usual place of residence with like effect as if made personally upon
said manufacturer, and in default of such designation of such agent,
service of process, notice, order, requirement, or decision in any
proceeding before the Secretary or in any judicial proceeding for
enforcement of this part or any standards prescribed pursuant to this
part may be made by posting such process, notice, order, requirement, or
decision in the Office of the Secretary or in a place designated by him
by regulation.
(June 25, 1938, ch. 675, 536, formerly act July 1, 1944, ch. 373,
title III, 536, formerly 360, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1181, and amended Oct. 17, 1979, Pub. L. 96-88, title V,
509(b), 93 Stat. 695; renumbered 536 and amended Nov. 28, 1990, Pub.
L. 101-629, 19(a)(1)(B), (2)(D), (3), (4), 104 Stat. 4529, 4530.)
Section was classified to section 263h of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263h of
Title 42, The Public Health and Welfare, as this section.
Subsec. (a). Pub. L. 101-629, 19(a)(1)(B), (2)(D), substituted ''this
part'' for ''this subpart'', ''section 360kk(h)'' for ''section
263f(h)'', and ''section 360kk'' for ''section 263f''.
Subsec. (b). Pub. L. 101-629, 19(a)(2)(D), substituted ''section
360kk'' for ''section 263f''.
Subsec. (d). Pub. L. 101-629, 19(a)(1)(B), substituted ''this part''
for ''this subpart'' in two places.
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in subsecs. (a) and (b)
pursuant to section 509(b) of Pub. L. 96-88 which is classified to
section 3508(b) of Title 20, Education.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law of any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
21 USC 360nn. Inspection, records, and reports
TITLE 21 -- FOOD AND DRUGS
(a) Inspection of premises
If the Secretary finds for good cause that the methods, tests, or
programs related to electronic product radiation safety in a particular
factory, warehouse, or establishment in which electronic products are
manufactured or held, may not be adequate or reliable, officers or
employees duly designated by the Secretary, upon presenting appropriate
credentials and a written notice to the owner, operator, or agent in
charge, are thereafter authorized (1) to enter, at reasonable times, any
area in such factory, warehouse, or establishment in which the
manufacturer's tests (or testing programs) required by section 360kk(h)
of this title are carried out, and (2) to inspect, at reasonable times
and within reasonable limits and in a reasonable manner, the facilities
and procedures within such area which are related to electronic product
radiation safety. Each such inspection shall be commenced and completed
with reasonable promptness. In addition to other grounds upon which
good cause may be found for purposes of this subsection, good cause will
be considered to exist in any case where the manufacturer has introduced
into commerce any electronic product which does not comply with an
applicable standard prescribed under this part and with respect to which
no exemption from the notification requirements has been granted by the
Secretary under section 360ll(a)( 2) or 360ll(e) of this title.
(b) Record keeping
Every manufacturer of electronic products shall establish and
maintain such records (including testing records), make such reports,
and provide such information, as the Secretary may reasonably require to
enable him to determine whether such manufacturer has acted or is acting
in compliance with this part and standards prescribed pursuant to this
part and shall, upon request of an officer or employee duly designated
by the Secretary, permit such officer or employee to inspect appropriate
books, papers, records, and documents relevant to determining whether
such manufacturer has acted or is acting in compliance with standards
prescribed pursuant to this part.
(c) Disclosure of technical data
Every manufacturer of electronic products shall provide to the
Secretary such performance data and other technical data related to
safety as may be required to carry out the purposes of this part. The
Secretary is authorized to require the manufacturer to give such
notification of such performance and technical data at the time of
original purchase to the ultimate purchaser of the electronic product,
as he determines necessary to carry out the purposes of this part after
consulting with the affected industry.
(d) Public nature of reports
Accident and investigation reports made under this part by any
officer, employee, or agent of the Secretary shall be available for use
in any civil, criminal, or other judicial proceeding arising out of such
accident. Any such officer, employee, or agent may be required to
testify in such proceedings as to the facts developed in such
investigations. Any such report shall be made available to the public
in a manner which need not identify individuals. All reports on
research projects, demonstration projects, and other related activities
shall be public information.
(e) Trade secrets
The Secretary or his representative shall not disclose any
information reported to or otherwise obtained by him, pursuant to
subsection (a) or (b) of this section, which concerns any information
which contains or relates to a trade secret or other matter referred to
in section 1905 of title 18, except that such information may be
disclosed to other officers or employees of the Department and of other
agencies concerned with carrying out this part or when relevant in any
proceeding under this part. Nothing in this section shall authorize the
withholding of information by the Secretary, or by any officers or
employees under his control, from the duly authorized committees of the
Congress.
(f) Information required to identify and locate first purchasers of
electronic products
The Secretary may by regulation (1) require dealers and distributors
of electronic products, to which there are applicable standards
prescribed under this part and the retail prices of which is not less
than $50, to furnish manufacturers of such products such information as
may be necessary to identify and locate, for purposes of section 360ll
of this title, the first purchasers of such products for purposes other
than resale, and (2) require manufacturers to preserve such information.
Any regulation establishing a requirement pursuant to clause (1) of the
preceding sentence shall (A) authorize such dealers and distributors to
elect, in lieu of immediately furnishing such information to the
manufacturer, to hold and preserve such information until advised by the
manufacturer or Secretary that such information is needed by the
manufacturer for purposes of section 360ll of this title, and (B)
provide that the dealer or distributor shall, upon making such election,
give prompt notice of such election (together with information
identifying the notifier and the product) to the manufacturer and shall,
when advised by the manufacturer or Secretary, of the need therefor for
the purposes of section 360ll of this title, immediately furnish the
manufacturer with the required information. If a dealer or distributor
discontinues the dealing in or distribution of electronic products, he
shall turn the information over to the manufacturer. Any manufacturer
receiving information pursuant to this subsection concerning first
purchasers of products for purposes other than resale shall treat it as
confidential and may use it only if necessary for the purpose of
notifying persons pursuant to section 360ll(a) of this title.
(June 25, 1938, ch. 675, 537, formerly act July 1, 1944, ch. 373,
title III, 537, formerly 360A, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1182; renumbered 537 and amended Nov. 28, 1990, Pub. L.
101-629, 19(a)(1)(B), (2)(E), (3), (4), 104 Stat. 4529, 4530.)
Section was classified to section 263i of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263i of
Title 42, The Public Health and Welfare, as this section.
Subsec. (a). Pub. L. 101-629, 19(a)(1)(B), (2)(E), substituted
''section 360kk(h)'' for ''section 263f(h)'', ''this part'' for ''this
subpart'', and ''section 360ll(a)(2) or 360ll(e)'' for ''section 263g(
a)(2) or 263g(e)''.
Subsecs. (b) to (e). Pub. L. 101-629, 19(a)(1)(B), substituted
''this part'' for ''this subpart'' wherever appearing.
Subsec. (f). Pub. L. 101-629, 19(a)(1)(B), (2)(E)(ii), substituted
''this part'' for ''this subpart'', ''section 360ll'' for ''section
263g'' in three places, and ''section 360ll(a)'' for ''section 263g(
a)''.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law of any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
21 USC 360oo. Prohibited acts
TITLE 21 -- FOOD AND DRUGS
(a) It shall be unlawful --
(1) for any manufacturer to introduce, or to deliver for
introduction, into commerce, or to import into the United States, any
electronic product which does not comply with an applicable standard
prescribed pursuant to section 360kk of this title;
(2) for any person to fail to furnish any notification or other
material or information required by section 360ll or 360nn of this
title; or to fail to comply with the requirements of section 360ll(f)
of this title;
(3) for any person to fail or to refuse to establish or maintain
records required by this part or to permit access by the Secretary or
any of his duly authorized representatives to, or the copying of, such
records, or to permit entry or inspection, as required by or pursuant to
section 360nn of this title;
(4) for any person to fail or to refuse to make any report required
pursuant to section 360nn(b) of this title or to furnish or preserve any
information required pursuant to section 360nn(f) of this title; or
(5) for any person (A) to fail to issue a certification as required
by section 360kk(h) of this title, or (B) to issue such a certification
when such certification is not based upon a test or testing program
meeting the requirements of section 360kk(h) of this title or when the
issuer, in the exercise of due care, would have reason to know that such
certification is false or misleading in a material respect.
(b) The Secretary may exempt any electronic product, or class
thereof, from all or part of subsection (a) of this section, upon such
conditions as he may find necessary to protect the public health or
welfare, for the purpose of research, investigations, studies,
demonstrations, or training, or for reasons of national security.
(June 25, 1938, ch. 675, 538, formerly act July 1, 1944, ch. 373,
title III, 538, formerly 360B, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1184, and renumbered 538 and amended Nov. 28, 1990, Pub.
L. 101-629, 19(a)(1)(B), (2)(F), (3), (4), 104 Stat. 4529, 4530.)
Section was classified to section 263j of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263j of
Title 42, The Public Health and Welfare, as this section.
Subsec. (a)(1). Pub. L. 101-629, 19(a)(2)(F)(i), substituted
''section 360kk'' for ''section 263f''.
Subsec. (a)(2). Pub. L. 101-629, 19(a)(2)(F)(ii), (iii), substituted
''section 360ll or 360nn'' for ''section 263g or 263i'' and ''section
360ll(f)'' for ''section 263g(f)''.
Subsec. (a)(3). Pub. L. 101-629, 19(a)(1)(B), (2)(F)(iii),
substituted ''this part'' for ''this subpart'' and ''section 360nn'' for
''section 263i''.
Subsec. (a)(4). Pub. L. 101-629, 19(a)(2)(F)(iii), substituted
''section 360nn(b)'' for ''section 263i(b)'' and ''section 360nn(f)''
for ''section 263i(f)''.
Subsec. (a)(5). Pub. L. 101-629, 19(a)(2)(F)(i), substituted
''section 360kk(h)'' for ''section 263f(h)'' in two places.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law of any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
21 USC 360pp. Enforcement
TITLE 21 -- FOOD AND DRUGS
(a) Jurisdiction of courts
The district courts of the United States shall have jurisdiction, for
cause shown, to restrain violations of section 360oo of this title and
to restrain dealers and distributors of electronic products from selling
or otherwise disposing of electronic products which do not conform to an
applicable standard prescribed pursuant to section 360kk of this title
except when such products are disposed of by returning them to the
distributor or manufacturer from whom they were obtained. The district
courts of the United States shall also have jurisdiction in accordance
with section 1355 of title 28 to enforce the provisions of subsection
(b) of this section.
(b) Penalties
(1) Any person who violates section 360oo of this title shall be
subject to a civil penalty of not more than $1,000. For purposes of
this subsection, any such violation shall with respect to each
electronic product involved, or with respect to each act or omission
made unlawful by section 360oo of this title, constitute a separate
violation, except that the maximum civil penalty imposed on any person
under this subsection for any related series of violations shall not
exceed $300,000.
(2) Any such civil penalty may on application be remitted or
mitigated by the Secretary. In determining the amount of such penalty,
or whether it should be remitted or mitigated and in what amount, the
appropriateness of such penalty to the size of the business of the
person charged and the gravity of the violation shall be considered.
The amount of such penalty, when finally determined, may be deducted
from any sums owing by the United States to the person charged.
(c) Venue; process
Actions under subsections (a) and (b) of this section may be brought
in the district court of the United States for the district wherein any
act or omission or transaction constituting the violation occurred, or
in such court for the district where the defendant is found or transacts
business, and process in such cases may be served in any other district
of which the defendant is an inhabitant or wherever the defendant may be
found.
(d) Warnings
Nothing in this part shall be construed as requiring the Secretary to
report for the institution of proceedings minor violations of this part
whenever he believes that the public interest will be adequately served
by a suitable written notice or warning.
(e) Compliance with regulations
Except as provided in the first sentence of section 360ss of this
title, compliance with this part or any regulations issued thereunder
shall not relieve any person from liability at common law or under
statutory law.
(f) Additional remedies
The remedies provided for in this part shall be in addition to and
not in substitution for any other remedies provided by law.
(June 25, 1938, ch. 675, 539, formerly act July 1, 1944, ch. 373,
title III, 539, formerly 360C, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1184, and renumbered 539 and amended Nov. 28, 1990, Pub.
L. 101-629, 19(a)(1)(B), (2)(G), (3), (4), 104 Stat. 4529, 4530.)
Section was classified to section 263k of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263k of
Title 42, The Public Health and Welfare, as this section.
Subsec. (a). Pub. L. 101-629, 19(a)(2)(G)(i), (ii), substituted
''section 360oo'' for ''section 263j'' and ''section 360kk'' for
''section 263f''.
Subsec. (b)(1). Pub. L. 101-629, 19(a)(2)(G)(ii), substituted
''section 360oo'' for ''section 263j'' in two places.
Subsec. (d). Pub. L. 101-629, 19(a)(1)(B), substituted ''this part''
for ''this subpart'' in two places.
Subsec. (e). Pub. L. 101-629, 19(a)(1)(B), (2)(G)(iii), substituted
''section 360ss'' for ''section 263n'' and ''this part'' for ''this
subpart''.
Subsec. (f). Pub. L. 101-629, 19(a)(1)(B), substituted ''this part''
for ''this subpart''.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law of any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
21 USC 360qq. Annual report
TITLE 21 -- FOOD AND DRUGS
(a) The Secretary shall prepare and submit to the President for
transmittal to the Congress on or before April 1 of each year a
comprehensive report on the administration of this part for the
preceding calendar year. Such report shall include --
(1) a thorough appraisal (including statistical analyses, estimates,
and long-term projections) of the incidence of biological injury and
effects, including genetic effects, to the population resulting from
exposure to electronic product radiation, with a breakdown, insofar as
practicable, among the various sources of such radiation;
(2) a list of Federal electronic product radiation control standards
prescribed or in effect in such year, with identification of standards
newly prescribed during such year;
(3) an evaluation of the degree of observance of applicable
standards, including a list of enforcement actions, court decisions, and
compromises of alleged violations by location and company name;
(4) a summary of outstanding problems confronting the administration
of this part in order of priority;
(5) an analysis and evaluation of research activities completed as a
result of Government and private sponsorship, and technological progress
for safety achieved during such year;
(6) a list, with a brief statement of the issues, of completed or
pending judicial actions under this part;
(7) the extent to which technical information was disseminated to the
scientific, commercial, and labor community and consumer-oriented
information was made available to the public; and
(8) the extent of cooperation between Government officials and
representatives of industry and other interested parties in the
implementation of this part including a log or summary of meetings held
between Government officials and representatives of industry and other
interested parties.
(b) The report required by subsection (a) of this section shall
contain such recommendations for additional legislation as the Secretary
deems necessary to promote cooperation among the several States in the
improvement of electronic product radiation control and to strengthen
the national electronic product radiation control program.
(June 25, 1938, ch. 675, 540, formerly act July 1, 1944, ch. 373,
title III, 540, formerly 360D, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1185, and renumbered 540 and amended Nov. 28, 1990, Pub.
L. 101-629, 19(a)(1)(B), (3), (4), 104 Stat. 4529, 4530.)
Section was classified to section 263l of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263l of
Title 42, The Public Health and Welfare, as this section.
Subsec. (a). Pub. L. 101-629, 19(a)(1)(B), substituted ''this part''
for ''this subpart'' wherever appearing.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law of any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
21 USC 360rr. Federal-State cooperation
TITLE 21 -- FOOD AND DRUGS
The Secretary is authorized (1) to accept from State and local
authorities engaged in activities related to health or safety or
consumer protection, on a reimbursable basis or otherwise, any
assistance in the administration and enforcement of this part which he
may request and which they may be able and willing to provide and, if so
agreed, may pay in advance or otherwise for the reasonable cost of such
assistance, and (2) he may, for the purpose of conducting examinations,
investigations, and inspections, commission any officer or employee of
any such authority as an officer of the Department.
(June 25, 1938, ch. 675, 541, formerly act July 1, 1944, ch. 373,
title III, 541, formerly 360E, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1186, and renumbered 541 and amended Nov. 28, 1990, Pub.
L. 101-629, 19(a)(1)(B), (3), (4), 104 Stat. 4529, 4530.)
Section was classified to section 263m of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263m of
Title 42, The Public Health and Welfare, as this section.
Pub. L. 101-629, 19(a)(1)(B), substituted ''this part'' for ''this
subpart''.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law of any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
21 USC 360ss. State standards
TITLE 21 -- FOOD AND DRUGS
Whenever any standard prescribed pursuant to section 360kk of this
title with respect to an aspect of performance of an electronic product
is in effect, no State or political subdivision of a State shall have
any authority either to establish, or to continue in effect, any
standard which is applicable to the same aspect of performance of such
product and which is not identical to the Federal standard. Nothing in
this part shall be construed to prevent the Federal Government or the
government of any State or political subdivision thereof from
establishing a requirement with respect to emission of radiation from
electronic products procured for its own use if such requirement imposes
a more restrictive standard than that required to comply with the
otherwise applicable Federal standard.
(June 25, 1938, ch. 675, 542, formerly act July 1, 1944, ch. 373,
title III, 542, formerly 360F, as added Oct. 18, 1968, Pub. L. 90-602,
2(3), 82 Stat. 1186, and renumbered 542 and amended Nov. 28, 1990, Pub.
L. 101-629, 19(a)(1)(B), (2)(H), (3), (4), 104 Stat. 4529, 4530.)
Section was classified to section 263n of Title 42, The Public Health
and Welfare, prior to renumbering by Pub. L. 101-629.
1990 -- Pub. L. 101-629, 19(a)(3), (4), renumbered section 263n of
Title 42, The Public Health and Welfare, as this section.
Pub. L. 101-629, 19(a)(1)(B), (2)(H), substituted ''section 360kk''
for ''section 263f'' and ''this part'' for ''this subpart''.
Enactment of this section not to be construed to supersede or limit
the functions under any other provision of law of any officer or agency
of the United States, see section 4 of Pub. L. 90-602, set out as a
note under section 360hh of this title.
21 USC SUBCHAPTER VI -- COSMETICS
TITLE 21 -- FOOD AND DRUGS
21 USC 361. Adulterated cosmetics
TITLE 21 -- FOOD AND DRUGS
A cosmetic shall be deemed to be adulterated --
(a) If it bears or contains any poisonous or deleterious substance
which may render it injurious to users under the conditions of use
prescribed in the labeling thereof, or under such conditions of use as
are customary or usual: Provided, That this provision shall not apply
to coal-tar hair dye, the label of which bears the following legend
conspicuously displayed thereon: ''Caution -- This product contains
ingredients which may cause skin irritation on certain individuals and a
preliminary test according to accompanying directions should first be
made. This product must not be used for dyeing the eyelashes or
eyebrows; to do so may cause blindness.'', and the labeling of which
bears adequate directions for such preliminary testing. For the
purposes of this subsection and subsection (e) of this section the term
''hair dye'' shall not include eyelash dyes or eyebrow dyes.
(b) If it consists in whole or in part of any filthy, putrid, or
decomposed substance.
(c) If it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health.
(d) If its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health.
(e) If it is not a hair dye and it is, or it bears or contains, a
color additive which is unsafe within the meaning of section 376(a) of
this title.
(June 25, 1938, ch. 675, 601, 52 Stat. 1054; July 12, 1960, Pub. L.
86-618, title I, 102(c)(1), 74 Stat. 398.)
1960 -- Subsec. (e). Pub. L. 86-618 substituted ''and it is, or it
bears or contains, a color additive which is unsafe within the meaning
of section 376(a) of this title'' for ''and it bears or contains a
coal-tar color other than one from a batch that has been certified in
accordance with regulations as provided by section 364 of this title''.
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Subsec. (e) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,
53 Stat. 853, set out as an Effective Date; Postponement in Certain
Cases note under section 301 of this title.
Section effective twelve months after June 25, 1938, except subsec.
(a), which, with certain exceptions, became effective on June 25, 1938,
see section 902(a) of act June 25, 1938, set out as a note under section
301 of this title.
21 USC 362. Misbranded cosmetics
TITLE 21 -- FOOD AND DRUGS
A cosmetic shall be deemed to be misbranded --
(a) If its labeling is false or misleading in any particular.
(b) If in package form unless it bears a label containing (1) the
name and place of business of the manufacturer, packer, or distributor;
and (2) an accurate statement of the quantity of the contents in terms
of weight, measure, or numerical count: Provided, That under clause (2)
of this subsection reasonable variations shall be permitted, and
exemptions as to small packages shall be established, by regulations
prescribed by the Secretary.
(c) If any word, statement, or other information required by or under
authority of this chapter to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with
other words, statements, designs, or devices, in the labeling) and in
such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.
(d) If its container is so made, formed, or filled as to be
misleading.
(e) If it is a color additive, unless its packaging and labeling are
in conformity with such packaging and labeling requirements, applicable
to such color additive, as may be contained in regulations issued under
section 376 of this title. This subsection shall not apply to packages
of color additives which, with respect to their use for cosmetics, are
marketed and intended for use only in or on hair dyes (as defined in the
last sentence of section 361(a) of this title).
(f) If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 1472 or 1473 of title 15.
(June 25, 1938, ch. 675, 602, 52 Stat. 1054; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; July 12,
1960, Pub. L. 86-618, title I, 102(c)(2), 74 Stat. 398; Dec. 30, 1970,
Pub. L. 91-601, 6(f), formerly 7(f), 84 Stat. 1673, renumbered Aug. 13,
1981, Pub. L. 97-35, title XII, 1205(c), 95 Stat. 716.)
1970 -- Subsec. (f). Pub. L. 91-601 added subsec. (f).
1960 -- Subsec. (e). Pub. L. 86-618 added subsec. (e).
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no sooner
than 180 days or later than one year from date regulations are final, or
an earlier date published in Federal Register, see section 8 of Pub. L.
91-601, set out as an Effective Date note under section 1471 of Title
15, Commerce and Trade.
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Subsec. (b) effective Jan. 1, 1940, and such subsection effective
July 1, 1940, as provided by regulations for certain lithographed
labeling and containers bearing certain labeling, see act June 23, 1939,
ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in
Certain Cases note under section 301 of this title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 363. Regulations making exemptions
TITLE 21 -- FOOD AND DRUGS
The Secretary shall promulgate regulations exempting from any
labeling requirement of this chapter cosmetics which are, in accordance
with the practice of the trade, to be processed, labeled, or repacked in
substantial quantities at establishments other than those where
originally processed or packed, on condition that such cosmetics are not
adulterated or misbranded under the provisions of this chapter upon
removal from such processing, labeling, or repacking establishment.
(June 25, 1938, ch. 675, 603, 52 Stat. 1054; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 364. Repealed. Pub. L. 86-618, title I, 103(a)(3), July 12,
1960, 74 Stat. 398
TITLE 21 -- FOOD AND DRUGS
Section, act June 25, 1938, ch. 675, 604, 52 Stat. 1055, required
Secretary to promulgate regulations for listing of coal-tar colors for
cosmetics. See section 376 of this title.
Repeal effective July 12, 1960, subject to the provisions of section
203 of Pub. L. 86-618, see section 202 of Pub. L. 86-618, set out as
an Effective Date of 1960 Amendment note under section 376 of this
title.
21 USC SUBCHAPTER VII -- GENERAL ADMINISTRATIVE PROVISIONS
TITLE 21 -- FOOD AND DRUGS
21 USC 371. Regulations and hearings
TITLE 21 -- FOOD AND DRUGS
(a) Authority to promulgate regulations
The authority to promulgate regulations for the efficient enforcement
of this chapter, except as otherwise provided in this section, is vested
in the Secretary.
(b) Regulations for imports and exports
The Secretary of the Treasury and the Secretary of Health and Human
Services shall jointly prescribe regulations for the efficient
enforcement of the provisions of section 381 of this title, except as
otherwise provided therein. Such regulations shall be promulgated in
such manner and take effect at such time, after due notice, as the
Secretary of Health and Human Services shall determine.
(c) Conduct of hearings
Hearings authorized or required by this chapter shall be conducted by
the Secretary of Health and Human Services or such officer or employee
as he may designate for the purpose.
(d) Effectiveness of definitions and standards of identity
The definitions and standards of identity promulgated in accordance
with the provisions of this chapter shall be effective for the purposes
of the enforcement of this chapter, notwithstanding such definitions and
standards as may be contained in other laws of the United States and
regulations promulgated thereunder.
(e) Procedure for establishment
(1) Any action for the issuance, amendment, or repeal of any
regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or (h)
of this title, and any action for the amendment or repeal of any
definition and standard of identity under section 341 of this title for
any dairy product (including products regulated under parts 131, 133 and
135 of title 21, Code of Federal Regulations) or maple sirup (regulated
under section 168.140 of title 21, Code of Federal Regulations) shall be
begun by a proposal made (A) by the Secretary on his own initiative, or
(B) by petition of any interested person, showing reasonable grounds
therefor, filed with the Secretary. The Secretary shall publish such
proposal and shall afford all interested persons an opportunity to
present their views thereon, orally or in writing. As soon as
practicable thereafter, the Secretary shall by order act upon such
proposal and shall make such order public. Except as provided in
paragraph (2) of this subsection, the order shall become effective at
such time as may be specified therein, but not prior to the day
following the last day on which objections may be filed under such
paragraph.
(2) On or before the thirtieth day after the date on which an order
entered under paragraph (1) of this subsection is made public, any
person who will be adversely affected by such order if placed in effect
may file objections thereto with the Secretary, specifying with
particularity the provisions of the order deemed objectionable, stating
the grounds therefor, and requesting a public hearing upon such
objections. Until final action upon such objections is taken by the
Secretary under paragraph (3) of this subsection, the filing of such
objections shall operate to stay the effectiveness of those provisions
of the order to which the objections are made. As soon as practicable
after the time for filing objections has expired the Secretary shall
publish a notice in the Federal Register specifying those parts of the
order which have been stayed by the filing of objections and, if no
objections have been filed, stating that fact.
(3) As soon as practicable after such request for a public hearing,
the Secretary, after due notice, shall hold such a public hearing for
the purpose of receiving evidence relevant and material to the issues
raised by such objections. At the hearing, any interested person may be
heard in person or by representative. As soon as practicable after
completion of the hearing, the Secretary shall by order act upon such
objections and make such order public. Such order shall be based only
on substantial evidence of record at such hearing and shall set forth,
as part of the order, detailed findings of fact on which the order is
based. The Secretary shall specify in the order the date on which it
shall take effect, except that it shall not be made to take effect prior
to the ninetieth day after its publication unless the Secretary finds
that emergency conditions exist necessitating an earlier effective date,
in which event the Secretary shall specify in the order his findings as
to such conditions.
(f) Review of order
(1) In a case of actual controversy as to the validity of any order
under subsection (e) of this section, any person who will be adversely
affected by such order if placed in effect may at any time prior to the
ninetieth day after such order is issued file a petition with the United
States court of appeals for the circuit wherein such person resides or
has his principal place of business, for a judicial review of such
order. A copy of the petition shall be forthwith transmitted by the
clerk of the court to the Secretary or other officer designated by him
for that purpose. The Secretary thereupon shall file in the court the
record of the proceedings on which the Secretary based his order, as
provided in section 2112 of title 28.
(2) If the petitioner applies to the court for leave to adduce
additional evidence, and shows to the satisfaction of the court that
such additional evidence is material and that there were reasonable
grounds for the failure to adduce such evidence in the proceeding before
the Secretary, the court may order such additional evidence (and
evidence in rebuttal thereof) to be taken before the Secretary, and to
be adduced upon the hearing, in such manner and upon such terms and
conditions as to the court may seem proper. The Secretary may modify
his findings as to the facts, or make new findings, by reason of the
additional evidence so taken, and he shall file such modified or new
findings, and his recommendation, if any, for the modification or
setting aside of his original order, with the return of such additional
evidence.
(3) Upon the filing of the petition referred to in paragraph (1) of
this subsection, the court shall have jurisdiction to affirm the order,
or to set it aside in whole or in part, temporarily or permanently. If
the order of the Secretary refuses to issue, amend, or repeal a
regulation and such order is not in accordance with law the court shall
by its judgment order the Secretary to take action, with respect to such
regulation, in accordance with law. The findings of the Secretary as to
the facts, if supported by substantial evidence, shall be conclusive.
(4) The judgment of the court affirming or setting aside, in whole or
in part, any such order of the Secretary shall be final, subject to
review by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28.
(5) Any action instituted under this subsection shall survive
notwithstanding any change in the person occupying the office of
Secretary or any vacancy in such office.
(6) The remedies provided for in this subsection shall be in addition
to and not in substitution for any other remedies provided by law.
(g) Copies of records of hearings
A certified copy of the transcript of the record and proceedings
under subsection (e) of this section shall be furnished by the Secretary
to any interested party at his request, and payment of the costs
thereof, and shall be admissible in any criminal, libel for
condemnation, exclusion of imports, or other proceeding arising under or
in respect to this chapter, irrespective of whether proceedings with
respect to the order have previously been instituted or become final
under subsection (f) of this section.
(June 25, 1938, ch. 675, 701, 52 Stat. 1055; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; June 25, 1948,
ch. 646, 32, 62 Stat. 991; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; Apr. 15, 1954, ch. 143, 2, 68 Stat.
55; Aug. 1, 1956, ch. 861, 2, 70 Stat. 919; Aug. 28, 1958, Pub. L.
85-791, 21, 72 Stat. 948; July 12, 1960, Pub. L. 86-618, title I, 103(
a)(4), 74 Stat. 398; Oct. 17, 1979, Pub. L. 96-88, title V, 509(b), 93
Stat. 695; Nov. 8, 1990, Pub. L. 101-535, 8, 104 Stat. 2365.)
In subsec. (f)(4), ''section 1254 of title 28'' substituted for
''sections 239 and 240 of the Judicial Code, as amended'' on authority
of act June 25, 1948, ch. 646, 62 Stat. 869, the first section of
which enacted Title 28, Judiciary and Judicial Procedure.
1990 -- Subsec. (e)(1). Pub. L. 101-535 substituted ''Any action for
the issuance, amendment, or repeal of any regulation under section
343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and any
action for the amendment or repeal of any definition and standard of
identity under section 341 of this title for any dairy product
(including products regulated under parts 131, 133 and 135 of title 21,
Code of Federal Regulations) or maple sirup (regulated under section
168.140 of title 21, Code of Federal Regulations)'' for ''Any action for
the issuance, amendment, or repeal of any regulation under section 341,
343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title''.
1960 -- Subsec. (e). Pub. L. 86-618 substituted ''section 341, 343(
j), 344(a), 346, 351(b), or 352(d) or (h), of this title'' for ''section
341, 343(j), 344(a), 346(a) or (b), 351(b), 352(d) or (h), 354 or 364 of
this title''.
1958 -- Subsec. (f)(1). Pub. L. 85-791, 21(a), substituted
provisions requiring transmission of a copy of the petition by clerk to
Secretary, and filing of the record by Secretary, for provisions which
permitted service of summons and petition any place in United States and
required Secretary to certify and file transcript of the proceedings and
record upon service.
Subsec. (f)(3). Pub. L. 85-791, 21(b), inserted ''Upon the filing of
the petition referred to in paragraph (1) of this subsection''.
1956 -- Subsec. (e). Act Aug. 1, 1956, simplified procedures
governing prescribing of regulations under certain provisions of this
chapter.
1954 -- Subsec. (e). Act Apr. 15, 1954, struck out reference to
section 341 of this title, before ''343(j)'', such section 341 now
containing its own provisions with respect to hearings regarding the
establishment of food standards.
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in subsecs. (b) and (c)
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
Circuit Court of Appeals of the United States changed to United
States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub.
L. 86-618, set out as a note under section 376 of this title.
Savings clause of act Aug. 1, 1956, see note set out under section
341 of this title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Amendments by Pub. L. 101-535 not to be construed to alter the
authority of the Secretary of Health and Human Services and the
Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),
and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see
section 9 of Pub. L. 101-535, set out as a note under section 343 of
this title.
Provisions of this chapter in effect prior to Apr. 15, 1954, as
applicable with respect to hearings begun prior to such date under
subsection (e) of this section, regarding food standards, see Savings
Provisions note set out under section 341 of this title.
Admiralty and maritime rules of practice (which included libel
procedures) were superseded, and civil and admiralty procedures in
United States district courts were unified, effective July 1, 1966, see
rule 1 and Supplemental Rules for Certain Admiralty and Maritime Claims,
Title 28, Appendix, Judiciary and Judicial Procedure.
Pesticide chemical regulations, see section 346a of this title.
1455, 1474.
21 USC 372. Examinations and investigations
TITLE 21 -- FOOD AND DRUGS
(a) Authority to conduct
The Secretary is authorized to conduct examinations and
investigations for the purposes of this chapter through officers and
employees of the Department or through any health, food, or drug officer
or employee of any State, Territory, or political subdivision thereof,
duly commissioned by the Secretary as an officer of the Department. In
the case of food packed in the Commonwealth of Puerto Rico or a
Territory the Secretary shall attempt to make inspection of such food at
the first point of entry within the United States when, in his opinion
and with due regard to the enforcement of all the provisions of this
chapter, the facilities at his disposal will permit of such inspection.
For the purposes of this subsection the term ''United States'' means the
States and the District of Columbia.
(b) Availability to owner of part of analysis samples
Where a sample of a food, drug, or cosmetic is collected for analysis
under this chapter the Secretary shall, upon request, provide a part of
such official sample for examination or analysis by any person named on
the label of the article, or the owner thereof, or his attorney or
agent; except that the Secretary is authorized, by regulations, to make
such reasonable exceptions from, and impose such reasonable terms and
conditions relating to, the operation of this subsection as he finds
necessary for the proper administration of the provisions of this
chapter.
(c) Records of other departments and agencies
For purposes of enforcement of this chapter, records of any
department or independent establishment in the executive branch of the
Government shall be open to inspection by any official of the Department
duly authorized by the Secretary to make such inspection.
(d) Information on patents for drugs
The Secretary is authorized and directed, upon request from the
Commissioner of Patents and Trademarks, to furnish full and complete
information with respect to such questions relating to drugs as the
Commissioner may submit concerning any patent application. The
Secretary is further authorized, upon receipt of any such request, to
conduct or cause to be conducted, such research as may be required.
(e) Powers of enforcement personnel
Any officer or employee of the Department designated by the Secretary
to conduct examinations, investigations, or inspections under this
chapter relating to counterfeit drugs may, when so authorized by the
Secretary --
(1) carry firearms;
(2) execute and serve search warrants and arrest warrants;
(3) execute seizure by process issued pursuant to libel under section
334 of this title;
(4) make arrests without warrant for offenses under this chapter with
respect to such drugs if the offense is committed in his presence or, in
the case of a felony, if he has probable cause to believe that the
person so arrested has committed, or is committing, such offense; and
(5) make, prior to the institution of libel proceedings under section
334(a)(2) of this title, seizures of drugs or containers or of
equipment, punches, dies, plates, stones, labeling, or other things, if
they are, or he has reasonable grounds to believe that they are, subject
to seizure and condemnation under such section 334(a)(2). In the event
of seizure pursuant to this paragraph (5), libel proceedings under
section 334(a)(2) of this title shall be instituted promptly and the
property seized be placed under the jurisdiction of the court.
(June 25, 1938, ch. 675, 702, 52 Stat. 1056; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct.
10, 1962, Pub. L. 87-781, title III, 307(b), 308, 76 Stat. 796; July
15, 1965, Pub. L. 89-74, 8(a), 79 Stat. 234; Oct. 27, 1970, Pub. L.
91-513, title II, 701(f), 84 Stat. 1282; Jan. 2, 1975, Pub. L. 93-596,
3, 88 Stat. 1949.)
1970 -- Subsec. (e). Pub. L. 91-513 struck out reference to
depressant or stimulant drugs.
1965 -- Subsec. (e). Pub. L. 89-74 added subsec. (e).
1962 -- Subsec. (a). Pub. L. 87-781, 307(b), inserted ''the
Commonwealth of Puerto Rico or'' before ''a Territory the Secretary''.
Subsec. (d). Pub. L. 87-781, 308, added subsec. (d).
''Commissioner of Patents and Trademarks'' substituted for
''Commissioner of Patents'' in subsec. (d) pursuant to section 3 of
Pub. L. 93-596, set out as a note under section 1 of Title 35, Patents.
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of Pub.
L. 91-513, set out as an Effective Date note under section 801 of this
title.
Amendment by Pub. L. 89-74 effective July 15, 1965, see section 11
of Pub. L. 89-74, set out as a note under section 321 of this title.
Amendment by Pub. L. 91-513 not to affect or abate any prosecutions
for any violation of law or any civil seizures or forfeitures and
injunctive proceedings commenced prior to the effective date of such
amendment, and all administrative proceedings pending before the Bureau
of Narcotics and Dangerous Drugs (now Drug Enforcement Administration)
on Oct. 27, 1970, to be continued and brought to final determination in
accord with laws and regulations in effect prior to Oct. 27, 1970, see
section 702 of Pub. L. 91-513, set out as a note under section 321 of
this title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Admiralty and maritime rules of practice (which included libel
procedures) were superseded, and civil and admiralty procedures in
United States district courts were unified, effective July 1, 1966, see
rule 1 and Supplemental Rules for Certain Admiralty and Maritime Claims,
Title 28, Appendix, Judiciary and Judicial Procedure.
21 USC 372a. Examination of sea food on request of packer; marking
food with results; fees; penalties
TITLE 21 -- FOOD AND DRUGS
The Secretary of Health and Human Services, upon application of any
packer of any sea food for shipment or sale within the jurisdiction of
this chapter, may, at his discretion, designate inspectors to examine
and inspect such food and the production, packing, and labeling thereof.
If on such examination and inspection compliance is found with the
provisions of this chapter and regulations promulgated thereunder, the
applicant shall be authorized or required to mark the food as provided
by regulation to show such compliance. Services under this section
shall be rendered only upon payment by the applicant of fees fixed by
regulation in such amounts as may be necessary to provide, equip, and
maintain an adequate and efficient inspection service. Receipts from
such fees shall be covered into the Treasury and shall be available to
the Secretary of Health and Human Services for expenditures incurred in
carrying out the purposes of this section, including expenditures for
salaries of additional inspectors when necessary to supplement the
number of inspectors for whose salaries Congress has appropriated. The
Secretary is authorized to promulgate regulations governing the sanitary
and other conditions under which the service herein provided shall be
granted and maintained, and for otherwise carrying out the purposes of
this section. Any person who forges, counterfeits, simulates, or
falsely represents, or without proper authority uses any mark, stamp,
tag, label, or other identification devices authorized or required by
the provisions of this section or regulations thereunder, shall be
guilty of a misdemeanor, and shall on conviction thereof be subject to
imprisonment for not more than one year or a fine of not less than
$1,000 nor more than $5,000, or both such imprisonment and fine.
(June 25, 1938, ch. 675, 702A, formerly June 30, 1906, ch. 3915, 10A,
as added June 22, 1934, ch. 712, 48 Stat. 1204, amended Aug. 27, 1935,
ch. 739, 49 Stat. 871; June 25, 1938, ch. 675, 902(a), 52 Stat. 1059;
1940 Reorg. Plan No. IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat.
1237, renumbered July 12, 1943, ch. 221, title II, 57 Stat. 500, and
amended 1953 Reorg. Plan No. 1, 5, eff. Apr. 11, 1953, 18 F. R. 2053,
67 Stat. 631; Oct. 17, 1979, Pub. L. 96-88, title V, 509(b), 93 Stat.
695.)
Section, which formerly was not a part of the Federal Food, Drug, and
Cosmetic Act, originally was classified to section 14a of this title.
Section 902(a) of act June 25, 1938, set out as an Effective Date note
under section 301 of this title, provided that the section should remain
in force and effect and be applicable to the provisions of this chapter.
Act July 12, 1943, renumbered this section as 702A of the Federal Food,
Drug, and Cosmetic Act.
''Secretary of Health and Human Services'' substituted in text for
''Secretary of Health, Education, and Welfare'' pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 373. Records of interstate shipment
TITLE 21 -- FOOD AND DRUGS
For the purpose of enforcing the provisions of this chapter, carriers
engaged in interstate commerce, and persons receiving food, drugs,
devices, or cosmetics in interstate commerce or holding such articles so
received, shall, upon the request of an officer or employee duly
designated by the Secretary, permit such officer or employee, at
reasonable times, to have access to and to copy all records showing the
movement in interstate commerce of any food, drug, device, or cosmetic,
or the holding thereof during or after such movement, and the quantity,
shipper, and consignee thereof; and it shall be unlawful for any such
carrier or person to fail to permit such access to and copying of any
such record so requested when such request is accompanied by a statement
in writing specifying the nature or kind of food, drug, device, or
cosmetic to which such request relates: Provided, That evidence
obtained under this section, or any evidence which is directly or
indirectly derived from such evidence, shall not be used in a criminal
prosecution of the person from whom obtained: Provided further, That
carriers shall not be subject to the other provisions of this chapter by
reason of their receipt, carriage, holding, or delivery of food, drugs,
devices, or cosmetics in the usual course of business as carriers.
(June 25, 1938, ch. 675, 703, 52 Stat. 1057; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct.
15, 1970, Pub. L. 91-452, title II, 230, 84 Stat. 930.)
1970 -- Pub. L. 91-452 inserted '', or any evidence which is
directly or indirectly derived from such evidence,'' after ''under this
section''.
Amendment by Pub. L. 91-452 effective on sixtieth day following Oct.
15, 1970, and not to affect any immunity to which any individual is
entitled under this section by reason of any testimony given before
sixtieth day following Oct. 15, 1970, see section 260 of Pub. L.
91-452, set out as an Effective Date; Savings Provision note under
section 6001 of Title 18, Crimes and Criminal Procedure.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Immunity of witnesses, see section 6001 et seq. of Title 18, Crimes
and Criminal Procedure.
21 USC 374. Inspection
TITLE 21 -- FOOD AND DRUGS
(a) Right of agents to enter; scope of inspection; notice;
promptness; exclusions
(1) For purposes of enforcement of this chapter, officers or
employees duly designated by the Secretary, upon presenting appropriate
credentials and a written notice to the owner, operator, or agent in
charge, are authorized (A) to enter, at reasonable times, any factory,
warehouse, or establishment in which food, drugs, devices, or cosmetics
are manufactured, processed, packed, or held, for introduction into
interstate commerce or after such introduction, or to enter any vehicle
being used to transport or hold such food, drugs, devices, or cosmetics
in interstate commerce; and (B) to inspect, at reasonable times and
within reasonable limits and in a reasonable manner, such factory,
warehouse, establishment, or vehicle and all pertinent equipment,
finished and unfinished materials; /1/ containers, and labeling
therein. In the case of any factory, warehouse, establishment, or
consulting laboratory in which prescription drugs or restricted devices
are manufactured, processed, packed, or held, the inspection shall
extend to all things therein (including records, files, papers,
processes, controls, and facilities) bearing on whether prescription
drugs or restricted devices which are adulterated or misbranded within
the meaning of this chapter, or which may not be manufactured,
introduced into interstate commerce, or sold, or offered for sale by
reason of any provision of this chapter, have been or are being
manufactured, processed, packed, transported, or held in any such place,
or otherwise bearing on violation of this chapter. No inspection
authorized by the preceding sentence or by paragraph (3) shall extend to
financial data, sales data other than shipment data, pricing data,
personnel data (other than data as to qualification of technical and
professional personnel performing functions subject to this chapter),
and research data (other than data relating to new drugs, antibiotic
drugs, and devices and subject to reporting and inspection under
regulations lawfully issued pursuant to section 355(i) or (j), /2/
section 357(d) or (g), section 360i, or 360j(g) of this title, and data
relating to other drugs or devices which in the case of a new drug would
be subject to reporting or inspection under lawful regulations issued
pursuant to section 355(j) of this title). A separate notice shall be
given for each such inspection, but a notice shall not be required for
each entry made during the period covered by the inspection. Each such
inspection shall be commenced and completed with reasonable promptness.
(2) The provisions of the second sentence of paragraph (1) shall not
apply to --
(A) pharmacies which maintain establishments in conformance with any
applicable local laws regulating the practice of pharmacy and medicine
and which are regularly engaged in dispensing prescription drugs or
devices, upon prescriptions of practitioners licensed to administer such
drugs or devices to patients under the care of such practitioners in the
course of their professional practice, and which do not, either through
a subsidiary or otherwise, manufacture, prepare, propagate, compound, or
process drugs or devices for sale other than in the regular course of
their business of dispensing or selling drugs or devices at retail;
(B) practitioners licensed by law to prescribe or administer drugs,
or prescribe or use devices, as the case may be, and who manufacture,
prepare, propagate, compound, or process drugs, or manufacture or
process devices, solely for use in the course of their professional
practice;
(C) persons who manufacture, prepare, propagate, compound, or process
drugs or manufacture or process devices, solely for use in research,
teaching, or chemical analysis and not for sale;
(D) such other classes of persons as the Secretary may by regulation
exempt from the application of this section upon a finding that
inspection as applied to such classes of persons in accordance with this
section is not necessary for the protection of the public health.
(3) An officer or employee making an inspection under paragraph (1)
for purposes of enforcing the requirements of section 350a of this title
applicable to infant formulas shall be permitted, at all reasonable
times, to have access to and to copy and verify any records --
(A) bearing on whether the infant formula manufactured or held in the
facility inspected meets the requirements of section 350a of this title,
or
(B) required to be maintained under section 350a of this title.
(b) Written report to owner; copy to Secretary
Upon completion of any such inspection of a factory, warehouse,
consulting laboratory, or other establishment, and prior to leaving the
premises, the officer or employee making the inspection shall give to
the owner, operator, or agent in charge a report in writing setting
forth any conditions or practices observed by him which, in his
judgment, indicate that any food, drug, device, or cosmetic in such
establishment (1) consists in whole or in part of any filthy, putrid, or
decomposed substance, or (2) has been prepared, packed, or held under
insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health. A copy
of such report shall be sent promptly to the Secretary.
(c) Receipt for samples taken
If the officer or employee making any such inspection of a factory,
warehouse, or other establishment has obtained any sample in the course
of the inspection, upon completion of the inspection and prior to
leaving the premises he shall give to the owner, operator, or agent in
charge a receipt describing the samples obtained.
(d) Analysis of samples furnished owner
Whenever in the course of any such inspection of a factory or other
establishment where food is manufactured, processed, or packed, the
officer or employee making the inspection obtains a sample of any such
food, and an analysis is made of such sample for the purpose of
ascertaining whether such food consists in whole or in part of any
filthy, putrid, or decomposed substance, or is otherwise unfit for food,
a copy of the results of such analysis shall be furnished promptly to
the owner, operator, or agent in charge.
(e) Accessibility of records
Every person required under section 360i or 360j(g) of this title to
maintain records and every person who is in charge or custody of such
records shall, upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable times to
have access to, and to copy and verify, such records.
(June 25, 1938, ch. 675, 704, 52 Stat. 1057; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Aug. 7,
1953, ch. 350, 1, 67 Stat. 476; Oct. 10, 1962, Pub. L. 87-781, title
II, 201(a), (b), 76 Stat. 792, 793; May 28, 1976, Pub. L. 94-295, 6, 90
Stat. 581; Sept. 26, 1980, Pub. L. 96-359, 4, 94 Stat. 1193.)
Section 355(j) of this title, referred to in subsec. (a)(1), was
redesignated section 355(k) of this title by Pub. L. 98-417, title I,
101, Sept. 24, 1984, 98 Stat. 1585.
1980 -- Subsec. (a)(1). Pub. L. 96-359, 4(1), (2), restructured
first five sentences of former subsec. (a) as par. (1) and, as so
restructured, inserted reference to paragraph (3) and substituted
''(A)'' and ''(B)'' for ''(1)'' and ''(2)'', respectively.
Subsec. (a)(2). Pub. L. 96-359, 4(3), redesignated sixth sentence of
former subsec. (a) as par. (2) and, as so redesignated, substituted
reference to second sentence of paragraph (1) for reference to former
second sentence of this subsection, and ''(A)'', ''(B)'', ''(C)'', and
''(D)'', for ''(1)'', ''(2)'', ''(3)'', and ''(4)'', respectively.
Subsec. (a)(3). Pub. L. 96-359, 4(4), added par. (3).
1976 -- Subsec. (a). Pub. L. 94-295, 6(a)-(c), expanded existing
provisions to encompass medical devices by inserting references to
factories, warehouses, establishments, and consulting laboratories in
which restricted devices are manufactured, processed, packed, or held,
inspections relating to devices, reporting and inspection regulations
issued pursuant to sections 360i and 360j(g) of this title, and the
manufacture and processing of devices.
Subsec. (e). Pub. L. 94-295, 6(d), added subsec. (e).
1962 -- Subsec. (a). Pub. L. 87-781, 201(a), extended the
inspection, where prescription drugs are manufactured, processed,
packed, or held, to all things bearing on whether adulterated or
misbranded drugs, or any which may not be manufactured, introduced in
interstate commerce, or sold or offered for sale under any provision of
this chapter, have been or are being manufactured, processed, packed,
transported or held in any such place, or otherwise bearing on violation
of this chapter, but excluded from such inspection, data concerning
finance, sales other than shipment, pricing, personnel other than
qualifications of technical and professional personnel, research other
than relating to new drugs subject to reporting, provided that
provisions of second sentence of this subsection shall be inapplicable
to pharmacies, practitioners and other persons enumerated in pars. (1)
to (4), and struck out ''are held'' before ''after such introduction''.
Subsec. (b). Pub. L. 87-781, 201(b), inserted ''consulting
laboratory'' after ''warehouse''.
1953 -- Act Aug. 7, 1953, designated existing provisions as subsec.
(a) and amended them by substituting provisions permitting entry and
inspection upon presentation of appropriate credentials and a written
notice to the owner, operator, or agent in charge for provisions which
authorized entry and inspection only after making a request and
obtaining permission from the owner, operator, or custodian, and
inserting provisions requiring a separate written notice for each
inspection but not for each entry made during the period covered by the
inspection, and directing that the inspection shall be conducted within
reasonable limits, in a reasonable manner and completed with reasonable
promptness, and added subsecs. (b) to (d).
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
203 of Pub. L. 87-781, set out as a note under section 332 of this
title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
Section 201(d) of Pub. L. 87-781 provided that: ''Nothing in the
amendments made by subsections (a) and (b) of this section (amending
this section) shall be construed to negate or derogate from any
authority of the Secretary existing prior to the enactment of this Act
(Oct. 10, 1962).''
/1/ So in original. Probably should be a comma.
/2/ See References in Text note below.
21 USC 375. Publicity
TITLE 21 -- FOOD AND DRUGS
(a) Reports
The Secretary shall cause to be published from time to time reports
summarizing all judgments, decrees, and court orders which have been
rendered under this chapter, including the nature of the charge and the
disposition thereof.
(b) Information regarding certain goods
The Secretary may also cause to be disseminated information regarding
food, drugs, devices, or cosmetics in situations involving, in the
opinion of the Secretary, imminent danger to health or gross deception
of the consumer. Nothing in this section shall be construed to prohibit
the Secretary from collecting, reporting, and illustrating the results
of the investigations of the Department.
(June 25, 1938, ch. 675, 705, 52 Stat. 1057; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 376. Listing and certification of color additives for foods,
drugs, devices, and cosmetics
TITLE 21 -- FOOD AND DRUGS
(a) Unsafe color additives
A color additive shall, with respect to any particular use (for which
it is being used or intended to be used or is represented as suitable)
in or on food or drugs or devices or cosmetics, be deemed unsafe for the
purposes of the application of section 342(c), 351(a)( 4), or 361(e) of
this title, as the case may be, unless --
(1)(A) there is in effect, and such additive and such use are in
conformity with, a regulation issued under subsection (b) of this
section listing such additive for such use, including any provision of
such regulation prescribing the conditions under which such additive may
be safely used, and (B) such additive either (i) is from a batch
certified, in accordance with regulations issued pursuant to subsection
(c) of this section, for such use, or (ii) has, with respect to such
use, been exempted by the Secretary from the requirement of
certification; or
(2) such additive and such use thereof conform to the terms of an
exemption which is in effect pursuant to subsection (f) of this section.
While there are in effect regulations under subsections (b) and (c)
of this section relating to a color additive or an exemption pursuant to
subsection (f) of this section with respect to such additive, an article
shall not, by reason of bearing or containing such additive in all
respects in accordance with such regulations or such exemption, be
considered adulterated within the meaning of clause (1) of section 342(
a) of this title if such article is a food, or within the meaning of
section 361(a) of this title if such article is a cosmetic other than a
hair dye (as defined in the last sentence of section 361(a) of this
title). A color additive for use in or on a device shall be subject to
this section only if the color additive comes in direct contact with the
body of man or other animals for a significant period of time. The
Secretary may by regulation designate the uses of color additives in or
on devices which are subject to this section.
(b) Listing of colors; regulations; issuance, amendment or repeal;
referral to advisory committee; report and recommendations;
appointment and compensation of advisory committee
(1) The Secretary shall, by regulation, provide for separately
listing color additives for use in or on food, color additives for use
in or on drugs, or devices, and color additives for use in or on
cosmetics, if and to the extent that such additives are suitable and
safe for any such use when employed in accordance with such regulations.
(2)(A) Such regulations may list any color additive for use generally
in or on food, or in or on drugs or devices, or in or on cosmetics, if
the Secretary finds that such additive is suitable and may safely be
employed for such general use.
(B) If the data before the Secretary do not establish that the
additive satisfies the requirements for listing such additive on the
applicable list pursuant to subparagraph (A) of this paragraph, or if
the proposal is for listing such additive for a more limited use or
uses, such regulations may list such additive only for any more limited
use or uses for which it is suitable and may safely be employed.
(3) Such regulations shall, to the extent deemed necessary by the
Secretary to assure the safety of the use or uses for which a particular
color additive is listed, prescribe the conditions under which such
additive may be safely employed for such use or uses (including, but not
limited to, specifications, hereafter in this section referred to as
tolerance limitations, as to the maximum quantity or quantities which
may be used or permitted to remain in or on the article or articles in
or on which it is used; specifications as to the manner in which such
additive may be added to or used in or on such article or articles; and
directions or other labeling or packaging requirements for such
additive).
(4) The Secretary shall not list a color additive under this section
for a proposed use unless the data before him establish that such use,
under the conditions of use specified in the regulations, will be safe:
Provided, however, That a color additive shall be deemed to be suitable
and safe for the purpose of listing under this subsection for use
generally in or on food, while there is in effect a published finding of
the Secretary declaring such substance exempt from the term ''food
additive'' because of its being generally recognized by qualified
experts as safe for its intended use, as provided in section 321(s) of
this title.
(5)(A) In determining, for the purposes of this section, whether a
proposed use of a color additive is safe, the Secretary shall consider,
among other relevant factors --
(i) the probable consumption of, or other relevant exposure from, the
additive and of any substance formed in or on food, drugs or devices, or
cosmetics because of the use of the additive;
(ii) the cumulative effect, if any, of such additive in the diet of
man or animals, taking into account the same or any chemically or
pharmacologically related substance or substances in such diet;
(iii) safety factors which, in the opinion of experts qualified by
scientific training and experience to evaluate the safety of color
additives for the use or uses for which the additive is proposed to be
listed, are generally recognized as appropriate for the use of animal
experimentation data; and
(iv) the availability of any needed practicable methods of analysis
for determining the identity and quantity of (I) the pure dye and all
intermediates and other impurities contained in such color additive,
(II) such additive in or on any article of food, drug or device, or
cosmetic, and (III) any substance formed in or on such article because
of the use of such additive.
(B) A color additive (i) shall be deemed unsafe, and shall not be
listed, for any use which will or may result in ingestion of all or part
of such additive, if the additive is found by the Secretary to induce
cancer when ingested by man or animal, or if it is found by the
Secretary, after tests which are appropriate for the evaluation of the
safety of additives for use in food, to induce cancer in man or animal,
and (ii) shall be deemed unsafe, and shall not be listed, for any use
which will not result in ingestion of any part of such additive, if,
after tests which are appropriate for the evaluation of the safety of
additives for such use, or after other relevant exposure of man or
animal to such additive, it is found by the Secretary to induce cancer
in man or animal: Provided, That clause (i) of this subparagraph (B)
shall not apply with respect to the use of a color additive as an
ingredient of feed for animals which are raised for food production, if
the Secretary finds that, under the conditions of use and feeding
specified in proposed labeling and reasonably certain to be followed in
practice, such additive will not adversely affect the animals for which
such feed is intended, and that no residue of the additive will be found
(by methods of examination prescribed or approved by the Secretary by
regulations, which regulations shall not be subject to subsection (d) of
this section) in any edible portion of such animals after slaughter or
in any food yielded by or derived from the living animal.
(C)(i) In any proceeding for the issuance, amendment, or repeal of a
regulation listing a color additive, whether commenced by a proposal of
the Secretary on his own initiative or by a proposal contained in a
petition, the petitioner, or any other person who will be adversely
affected by such proposal or by the Secretary's order issued in
accordance with paragraph (1) of section 371(e) of this title if placed
in effect, may request, within the time specified in this subparagraph,
that the petition or order thereon, or the Secretary's proposal, be
referred to an advisory committee for a report and recommendations with
respect to any matter arising under subparagraph (B) of this paragraph,
which is involved in such proposal or order and which requires the
exercise of scientific judgment. Upon such request, or if the Secretary
within such time deems such a referral necessary, the Secretary shall
forthwith appoint an advisory committee under subparagraph (D) of this
paragraph and shall refer to it, together with all the data before him,
such matter arising under subparagraph (B) for study thereof and for a
report and recommendations on such matter. A person who has filed a
petition or who has requested the referral of a matter to an advisory
committee pursuant to this subparagraph (C), as well as representatives
of the Department of Health and Human Services, shall have the right to
consult with such advisory committee in connection with the matter
referred to it. The request for referral under this subparagraph, or
the Secretary's referral on his own initiative, may be made at any time
before, or within thirty days after, publication of an order of the
Secretary acting upon the petition or proposal.
(ii) Within sixty days after the date of such referral, or within an
additional thirty days if the committee deems such additional time
necessary, the committee shall, after independent study of the data
furnished to it by the Secretary and other data before it, certify to
the Secretary a report and recommendations, together with all underlying
data and a statement of the reasons or basis for the recommendations. A
copy of the foregoing shall be promptly supplied by the Secretary to any
person who has filed a petition, or who has requested such referral to
the advisory committee. Within thirty days after such certification,
and after giving due consideration to all data then before him,
including such report, recommendations, underlying data, and statement,
and to any prior order issued by him in connection with such matter, the
Secretary shall by order confirm or modify any order theretofore issued
or, if no such prior order has been issued, shall by order act upon the
petition or other proposal.
(iii) Where --
(I) by reason of subparagraph (B) of this paragraph, the Secretary
has initiated a proposal to remove from listing a color additive
previously listed pursuant to this section; and
(II) a request has been made for referral of such proposal to an
advisory committee;
the Secretary may not act by order on such proposal until the
advisory committee has made a report and recommendations to him under
clause (ii) of this subparagraph and he has considered such
recommendations, unless the Secretary finds that emergency conditions
exist necessitating the issuance of an order notwithstanding this
clause.
(D) The advisory committee referred to in subparagraph (C) of this
paragraph shall be composed of experts selected by the National Academy
of Sciences, qualified in the subject matter referred to the committee
and of adequately diversified professional background, except that in
the event of the inability or refusal of the National Academy of
Sciences to act, the Secretary shall select the members of the
committee. The size of the committee shall be determined by the
Secretary. Members of any advisory committee established under this
chapter, while attending conferences or meetings of their committees or
otherwise serving at the request of the Secretary, shall be entitled to
receive compensation at rates to be fixed by the Secretary but at rates
not exceeding the daily equivalent of the rate specified at the time of
such service for grade GS-18 of the General Schedule, including
traveltime; and while away from their homes or regular places of
business they may be allowed travel expenses, including per diem in lieu
of subsistence, as authorized by section 5703(b) /1/ of title 5 for
persons in the Government service employed intermittently. The members
shall not be subject to any other provisions of law regarding the
appointment and compensation of employees of the United States. The
Secretary shall furnish the committee with adequate clerical and other
assistance, and shall by rules and regulations prescribe the procedure
to be followed by the committee.
(6) The Secretary shall not list a color additive under this
subsection for a proposed use if the data before him show that such
proposed use would promote deception of the consumer in violation of
this chapter or would otherwise result in misbranding or adulteration
within the meaning of this chapter.
(7) If, in the judgment of the Secretary, a tolerance limitation is
required in order to assure that a proposed use of a color additive will
be safe, the Secretary --
(A) shall not list the additive for such use if he finds that the
data before him do not establish that such additive, if used within a
safe tolerance limitation, would achieve the intended physical or other
technical effect; and
(B) shall not fix such tolerance limitation at a level higher than he
finds to be reasonably required to accomplish the intended physical or
other technical effect.
(8) If, having regard to the aggregate quantity of color additive
likely to be consumed in the diet or to be applied to the human body,
the Secretary finds that the data before him fail to show that it would
be safe and otherwise permissible to list a color additive (or
pharmacologically related color additives) for all the uses proposed
therefor and at the levels of concentration proposed, the Secretary
shall, in determining for which use or uses such additive (or such
related additives) shall be or remain listed, or how the aggregate
allowable safe tolerance for such additive or additives shall be
allocated by him among the uses under consideration, take into account,
among other relevant factors (and subject to the paramount criterion of
safety), (A) the relative marketability of the articles involved as
affected by the proposed uses of the color additive (or of such related
additives) in or on such articles, and the relative dependence of the
industries concerned on such uses; (B) the relative aggregate amounts
of such color additive which he estimates would be consumed in the diet
or applied to the human body by reason of the various uses and levels of
concentration proposed; and (C) the availability, if any, of other
color additives suitable and safe for one or more of the uses proposed.
(c) Certification of colors
The Secretary shall further, by regulation, provide (1) for the
certification, with safe diluents or without diluents, of batches of
color additives listed pursuant to subsection (b) of this section and
conforming to the requirements for such additives established by
regulations under such subsection and this subsection, and (2) for
exemption from the requirement of certification in the case of any such
additive, or any listing or use thereof, for which he finds such
requirement not to be necessary in the interest of the protection of the
public health: Provided, That, with respect to any use in or on food
for which a listed color additive is deemed to be safe by reason of the
proviso to paragraph (4) of subsection (b), the requirement of
certification shall be deemed not to be necessary in the interest of
public health protection.
(d) Procedure for issuance, amendment, or repeal of regulations
The provisions of section 371(e), (f), and (g) of this title shall,
subject to the provisions of subparagraph (c) of subsection (b)(5) of
this section, apply to and in all respects govern proceedings for the
issuance, amendment, or repeal of regulations under subsection (b) or
(c) of this section (including judicial review of the Secretary's action
in such proceedings) and the admissibility of transcripts of the record
of such proceedings in other proceedings, except that --
(1) if the proceeding is commenced by the filing of a petition,
notice of the proposal made by the petition shall be published in
general terms by the Secretary within thirty days after such filing, and
the Secretary's order (required by paragraph (1) of section 371(e) of
this title) acting upon such proposal shall, in the absence of prior
referral (or request for referral) to an advisory committee, be issued
within ninety days after the date of such filing, except that the
Secretary may (prior to such ninetieth day), by written notice to the
petitioner, extend such ninety-day period to such time (not more than
one hundred and eighty days after the date of filing of the petiton) as
the Secretary deems necessary to enable him to study and investigate the
petition;
(2) any report, recommendations, underlying data, and reasons
certified to the Secretary by an advisory committee appointed pursuant
to subparagraph (D) of subsection (b)(5) of this section, shall be made
a part of the record of any hearing if relevant and material, subject to
the provisions of section 556(d) of title 5. The advisory committee
shall designate a member to appear and testify at any such hearing with
respect to the report and recommendations of such committee upon request
of the Secretary, the petitioner, or the officer conducting the hearing,
but this shall not preclude any other member of the advisory committee
from appearing and testifying at such hearing;
(3) the Secretary's order after public hearing (acting upon
objections filed to an order made prior to hearing) shall be subject to
the requirements of section 348(f)(2) of this title; and
(4) the scope of judicial review of such order shall be in accordance
with the fourth sentence of paragraph (2), and with the provisions of
paragraph (3), of section 348(g) of this title.
(e) Fees
The admitting to listing and certification of color additives, in
accordance with regulations prescribed under this chapter, shall be
performed only upon payment of such fees, which shall be specified in
such regulations, as may be necessary to provide, maintain, and equip an
adequate service for such purposes.
(f) Exemptions
The Secretary shall by regulations (issued without regard to
subsection (d) of this section) provide for exempting from the
requirements of this section any color additive or any specific type of
use thereof, and any article of food, drug, or device, or cosmetic
bearing or containing such additive, intended solely for investigational
use by qualified experts when in his opinion such exemption is
consistent with the public health.
(June 25, 1938, ch. 675, 706, 52 Stat. 1058; July 12, 1960, Pub. L.
86-618, title I, 103(b), 74 Stat. 399; Oct. 10, 1962, Pub. L. 87-781,
title I, 104(f)(2), 76 Stat. 785; Oct. 30, 1970, Pub. L. 91-515, title
VI, 601(d)(2), 84 Stat. 1311; May 28, 1976, Pub. L. 94-295, 9(a), 90
Stat. 583; Oct. 17, 1979, Pub. L. 96-88, title V, 509(b), 93 Stat.
695.)
Section 5703 of title 5, referred to in subsec. (b)(5)(D), was
amended generally by Pub. L. 94-22, 4, May 19, 1975, 89 Stat. 85, and,
as so amended, does not contain a subsec. (b).
In subsec. (d)(2), ''section 556(d) of title 5'' substituted for
''section 7(c) of the Administrative Procedure Act (5 U.S.C., sec.
1006(c))'' on authority of Pub. L. 89-554, 7(b), Sept. 6, 1966, 80
Stat. 631, the first section of which enacted Title 5, Government
Organization and Employees.
1976 -- Subsec. (a). Pub. L. 94-295, 9(a)(2), (3), inserted
reference to devices and inserted provisions directing that color
additives for use in or on devices be subject to this section only if
the color additives come in direct contact with the body of man or other
animals for a significant period of time and authorizing the Secretary
to designate by regulation the uses of color additives in or on devices
which are subject to this section.
Subsec. (b). Pub. L. 94-295, 9(a)(1), (2), substituted ''drug or
device'' for ''drug'' and ''drugs or devices'' for ''drugs'' wherever
appearing.
Subsec. (f). Pub. L. 94-295, 9(a)(1), substituted ''drug or device''
for ''drug''.
1970 -- Subsec. (b)(5)(D). Pub. L. 91-515 substituted provisions
authorizing members of an advisory committee to receive compensation at
rates fixed by the Secretary, with a specific maximum amount, and travel
expenses, including per diem in lieu of subsistence, as authorized by
section 5703(b) of Title 5, for provisions authorizing such members to
receive as compensation a reasonable per diem for time actually spent on
committee work, and necessary traveling and subsistence expenses while
serving away from their places of residence.
1962 -- Subsec. (b)(5)(B). Pub. L. 87-781 provided that clause (i)
of this subparagraph shall not apply to a color additive in feed of
animals raised for food production, if under the conditions of use
specified in proposed labeling, and which conditions are reasonably
certain to be followed in practice, such additive will not adversely
affect the animals and no residue will be found in any edible portion of
such animal after slaughter or in any food from the living animal.
1960 -- Pub. L. 86-618 amended section generally. Prior to
amendment, section read as follows: ''The admitting to listing and
certification of coal-tar colors, in accordance with regulations
prescribed under this chapter, shall be performed only upon payment of
such fees, which shall be specified in such regulations, as may be
necessary to provide, maintain, and equip an adequate service for such
purposes.''
''Department of Health and Human Services'' substituted for
''Department of Health, Education, and Welfare'' in subsec. (b)(5)(C)(
i) pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
107 of Pub. L. 87-781, set out as a note under section 321 of this
title.
Title II of Pub. L. 86-618 provided that:
''Sec. 201. (Definitions.) As used in this title, the term 'basic
Act' means the Federal Food, Drug, and Cosmetic Act (this chapter); the
term 'enactment date' means the date of enactment of this Act (July 12,
1960); and other terms, insofar as also used in the basic Act (whether
before or after enactment of this Act) shall have the same meaning as
they have, or had when in effect, under the basic Act.
''Sec. 202. (Effective Date.) This Act (amending this section and
sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371 of
this title and repealing sections 354 and 364 of this title) shall,
subject to the provisions of section 203, take effect on the enactment
date (July 12, 1960).
''Sec. 203. (Provisional Listings of Commercially Established
Colors.) (a)(1) The purpose of this section is to make possible, on an
interim basis for a reasonable period, through provisional listings, the
use of commercially established color additives to the extent consistent
with the public health, pending the completion of the scientific
investigations needed as a basis for making determinations as to listing
of such additives under the basic Act as amended by this Act. A
provisional listing (including a deemed provisional listing) of a color
additive under this section for any use shall, unless sooner terminated
or expiring under the provisions of this section, expire (A) on the
closing date (as defined in paragraph (2) of this subsection) or (B) on
the effective date of a listing of such additive for such use under
section 706 of the basic Act, (this section), whichever date first
occurs.
''(2) For the purposes of this section, the term 'closing date' means
(A) the last day of the two and one-half year period beginning on the
enactment date (July 12, 1960) or (B), with respect to a particular
provisional listing (or deemed provisional listing) of a color additive
or use thereof, such later closing date as the Secretary may from time
to time establish pursuant to the authority of this paragraph. The
Secretary may by regulation, upon application of an interested person or
on his own initiative, from time to time postpone the original closing
date with respect to a provisional listing (or deemed provisional
listing) under this section of a specified color additive, or of a
specified use or uses of such additive, for such period or periods as he
finds necessary to carry out the purpose of this section, if in the
Secretary's judgment such action is consistent with the objective of
carrying to completion in good faith, as soon as reasonably practicable,
the scientific investigations necessary for making a determination as to
listing such additive, or such specified use or uses thereof, under
section 706 of the basic Act (this section). The Secretary may
terminate a postponement of the closing date at any time if he finds
that such postponement should not have been granted, or that by reason
of a change in circumstances the basis for such postponement no longer
exists, or that there has been a failure to comply with a requirement
for submission of progress reports or with other conditions attached to
such postponement.
''(b) Subject to the other provisions of this section --
''(1) any color additive which, on the day preceding the enactment
date (July 12, 1960), was listed and certifiable for any use or uses
under section 406(b), 504, or 604 (section 346(b), 354, or 364 of this
title), or under the third proviso of section 402(c) (section 342(c) of
this title), of the basic Act, and of which a batch or batches had been
certified for such use or uses prior to the enactment date (July 12,
1960), and
''(2) any color additive which was commercially used or sold prior to
the enactment date (July 12, 1960) for any use or uses in or on any
food, drug, or cosmetic, and which either, (A), on the day preceding the
enactment date (July 12, 1960), was not a material within the purview of
any of the provisions of the basic Act enumerated in paragraph (1) of
this subsection, or (B) is the color additive known as synthetic
beta-carotene,
shall, beginning on the enactment date (July 12, 1960), be deemed to
be provisionally listed under this section as a color additive for such
use or uses.
''(c) Upon request of any person, the Secretary, by regulations
issued under subsection (d), shall without delay, if on the basis of the
data before him he deems such action consistent with the protection of
the public health, provisionally list a material as a color additive for
any use for which it was listed, and for which a batch or batches of
such material had been certified, under section 406(b), 504, or 604 of
the basic Act (section 346(b), 354, or 364 of this title) prior to the
enactment date (July 12, 1960), although such color was no longer listed
and certifiable for such use under such sections on the day preceding
the enactment date. Such provisional listing shall take effect on the
date of publication.
''(d)(1) The Secretary shall, by regulations issued or amended from
time to time under this section --
''(A) insofar as practicable promulgate and keep current a list or
lists of the color additives, and of the particular uses thereof, which
he finds are deemed provisionally listed under subsection (b), and the
presence of a color additive on such a list with respect to a particular
use shall, in any proceeding under the basic Act, be conclusive evidence
that such provisional listing is in effect;
''(B) provide for the provisional listing of the color additives and
particular uses thereof specified in subsection (c);
''(C) provide, with respect to particular uses for which color
additives are or are deemed to be provisionally listed, such temporary
tolerance limitations (including such limitations at zero level) and
other conditions of use and labeling or packaging requirements, if any,
as in his judgment are necessary to protect the public health pending
listing under section 706 of the basic Act (this section);
''(D) provide for the certification of batches of such color
additives (with or without diluents) for the uses for which they are so
listed or deemed to be listed under this section, except that such an
additive which is a color additive deemed provisionally listed under
subsection (b)(2) of this section shall be deemed exempt from the
requirement of such certification while not subject to a tolerance
limitation; and
''(E) provide for the termination of a provisional listing (or deemed
provisional listing) of a color additive or particular use thereof
forthwith whenever in his judgment such action is necessary to protect
the public health.
''(2)(A) Except as provided in subparagraph (C) of this paragraph,
regulations under this section shall, from time to time, be issued,
amended, or repealed by the Secretary without regard to the requirements
of the basic Act (subsec. (e) of this section), but for the purposes of
the application of section 706(e) of the basic Act (relating to fees)
and of determining the availability of appropriations of fees (and of
advance deposits to cover fees), proceedings, regulations, and
certifications under this section shall be deemed to be proceedings,
regulations, and certifications under such section 706 (this section).
Regulations providing for fees (and advance deposits to cover fees),
which on the day preceding the enactment date (July 12, 1960) were in
effect pursuant to section 706 of the basic Act (this section), shall be
deemed to be regulations under such section 706 (this section) as
amended by this Act, and appropriations of fees (and advance deposits)
available for the purposes specified in such section 706 as in effect
prior to the enactment date (July 12, 1960) shall be available for the
purposes specified in such section 706 (this section) as so amended.
''(B) If the Secretary, by regulation --
''(i) has terminated a provisional listing (or deemed provisional
listing) of a color additive or particular use thereof pursuant to
paragraph (1)(E) of this subsection; or
''(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of this
subsection, initially established or rendered more restrictive a
tolerance limitation or other restriction or requirement with respect to
a provisional listing (or deemed provisional listing) which listing had
become effective prior to such action,
any person adversely affected by such action may, prior to the
expiration of the period specified in clause (A) of subsection (a)(2) of
this section, file with the Secretary a petition for amendment of such
regulation so as to revoke or modify such action of the Secretary, but
the filing of such petition shall not operate to stay or suspend the
effectiveness of such action. Such petition shall, in accordance with
regulations, set forth the proposed amendment and shall contain data (or
refer to data which are before the Secretary or of which he will take
official notice), which show that the revocation or modification
proposed is consistent with the protection of the public health. The
Secretary shall, after publishing such proposal and affording all
interested persons an opportunity to present their views thereon orally
or in writing, act upon such proposal by published order.
''(C) Any person adversely affected by an order entered under
subparagraph (B) of this paragraph may, within thirty days after its
publication, file objections thereto with the Secretary, specifying with
particularity the provisions of the order deemed objectionable, stating
reasonable grounds for such objections, and requesting a public hearing
upon such objections. The Secretary shall hold a public hearing on such
objections and shall, on the basis of the evidence adduced at such
hearing, act on such objections by published order. Such order may
reinstate a terminated provisional listing, or increase or dispense with
a previously established temporary tolerance limitation, or make less
restrictive any other limitation established by him under paragraph (1)
or (3) of this subsection, only if in his judgment the evidence so
adduced shows that such action will be consistent with the protection of
the public health. An order entered under this subparagraph shall be
subject to judicial review in accordance with section 701(f) of the
basic Act (section 371(f) of this title) except that the findings and
order of the Secretary shall be sustained only if based upon a fair
evaluation of the entire record at such hearing. No stay or suspension
of such order shall be ordered by the court pending conclusion of such
judicial review.
''(D) On and after the enactment date (July 12, 1960), regulations,
provisional listings, and certifications (or exemptions from
certification) in effect under this section shall, for the purpose of
determining whether an article is adulterated or misbranded within the
meaning of the basic Act by reason of its being, bearing, or containing
a color additive, have the same effect as would regulations, listings,
and certifications (or exemptions from certification) under section 706
of the basic Act (this section). A regulation, provisional listing or
termination thereof, tolerance limitation, or certification or exemption
therefrom, under this section shall not be the basis for any presumption
or inference in any proceeding under section 706 (b) or (c) of the basic
Act (subsec. (b) or (c) of this section).
''(3) For the purpose of enabling the Secretary to carry out his
functions under paragraphs (1)(A) and (C) of this subsection with
respect to color additives deemed provisionally listed, he shall, as
soon as practicable after enactment of this Act (July 12, 1960), afford
by public notice a reasonable opportunity to interested persons to
submit data relevant thereto. If the data so submitted or otherwise
before him do not, in his judgment, establish a reliable basis for
including such a color additive or particular use or uses thereof in a
list or lists promulgated under paragraph (1)(A), or for determining the
prevailing level or levels of use thereof prior to the enactment date
(July 12, 1960) with a view to prescribing a temporary tolerance or
tolerances for such use or uses under paragraph (1)(C), the Secretary
shall establish a temporary tolerance limitation at zero level for such
use or uses until such time as he finds that it would not be
inconsistent with the protection of the public health to increase or
dispense with such temporary tolerance limitation.
''Sec. 204. (Effect on Meat Inspection and Poultry Products
Inspection Acts.) Nothing in this Act (amending sections 321, 331, 333,
342, 343, 346, 351, 352, 361, 362, 371, and 376 of this title and
repealing sections 354 and 364 of this title) shall be construed to
exempt any meat or meat food product, poultry or poultry product, or any
person from any requirement imposed by or pursuant to the Meat
Inspection Act of March 4, 1907, 34 Stat. 1260, as amended or extended
(21 U.S.C. 71 and the following) (see section 601 et seq. of this title)
or the Poultry Products Inspection Act (21 U.S.C. 451 and the
following).''
This section was made ''immediately effective'' by act May 2, 1939,
ch. 107, title I, 1, 53 Stat. 631.
Advisory committees in existence on Jan. 5, 1973, to terminate not
later than the expiration of the 2-year period following Jan. 5, 1973,
and advisory committees established after Jan. 5, 1973, to terminate
not later than the expiration of the 2-year period beginning on the date
of their establishment, unless in the case of a committee established by
the President or an officer of the Federal Government, such committee is
renewed by appropriate action prior to the expiration of such 2-year
period, or in the case of a committee established by Congress, its
duration is otherwise provided by law. See section 14 of Pub. L.
92-463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title
5, Government Organization and Employees.
References in laws to the rates of pay for GS-16, 17, or 18, or to
maximum rates of pay under the General Schedule, to be considered
references to rates payable under specified sections of Title 5,
Government Organization and Employees, see section 529 (title I, 101(
c)(1)) of Pub. L. 101-509, set out in a note under section 5376 of
Title 5.
/1/ See References in Text note below.
21 USC 377. Revision of United States Pharmacopoeia; development of
analysis and mechanical and physical tests
TITLE 21 -- FOOD AND DRUGS
The Secretary, in carrying into effect the provisions of this
chapter, is authorized on and after July 12, 1943, to cooperate with
associations and scientific societies in the revision of the United
States Pharmacopoeia and in the development of methods of analysis and
mechanical and physical tests necessary to carry out the work of the
Food and Drug Administration.
(July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan
No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)
Section was enacted as part of the Labor-Federal Security
Appropriation Act, 1944, and not as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 378. Advertising of foods
TITLE 21 -- FOOD AND DRUGS
(a) Determination of misbranding; notification of Federal Trade
Commission by Secretary; contents
(1) Except as provided in subsection (c) of this section, before the
Secretary may initiate any action under subchapter III of this chapter
--
(A) with respect to any food which the Secretary determines is
misbranded under section 343(a)(2) of this title because of its
advertising, or
(B) with respect to a food's advertising which the Secretary
determines causes the food to be so misbranded,
the Secretary shall, in accordance with paragraph (2), notify in
writing the Federal Trade Commission of the action the Secretary
proposes to take respecting such food or advertising.
(2) The notice required by paragraph (1) shall --
(A) contain (i) a description of the action the Secretary proposes to
take and of the advertising which the Secretary has determined causes a
food to be misbranded, (ii) a statement of the reasons for the
Secretary's determination that such advertising has caused such food to
be misbranded, and
(B) be accompanied by the records, documents, and other written
materials which the Secretary determines supports his determination that
such food is misbranded because of such advertising.
(b) Action by Federal Trade Commission precluding action by
Secretary; exception
(1) If the Secretary notifies the Federal Trade Commission under
subsection (a) of this section of action proposed to be taken under
subchapter III of this chapter with respect to a food or food
advertising and the Commission notifies the Secretary in writing, within
the 30-day period beginning on the date of the receipt of such notice,
that --
(A) it has initiated under the Federal Trade Commission Act (15 U.S.
C. 41 et seq.) an investigation of such advertising to determine if it
is prohibited by such Act or any order or rule under such Act,
(B) it has commenced (or intends to commence) a civil action under
section 5, 13, or 19 (15 U.S.C. 45, 53, or 57b) with respect to such
advertising or the Attorney General has commenced (or intends to
commence) a civil action under section 5 (15 U.S.C. 45) with respect to
such advertising,
(C) it has issued and served (or intends to issue and serve) a
complaint under section 5(b) of such Act (15 U.S.C. 45(b)) respecting
such advertising, or
(D) pursuant to section 16(b) of such Act (15 U.S.C. 56(b)) it has
made a certification to the Attorney General respecting such
advertising,
the Secretary may not, except as provided by paragraph (2), initiate
the action described in the Secretary's notice to the Federal Trade
Commission.
(2) If, before the expiration of the 60-day period beginning on the
date the Secretary receives a notice described in paragraph (1) from the
Federal Trade Commission in response to a notice of the Secretary under
subsection (a) of this section --
(A) the Commission or the Attorney General does not commence a civil
action described in subparagraph (B) of paragraph (1) of this subsection
respecting the advertising described in the Secretary's notice,
(B) the Commission does not issue and serve a complaint described in
subparagraph (C) of such paragraph respecting such advertising, or
(C) the Commission does not (as described in subparagraph (D) of such
paragraph) make a certification to the Attorney General respecting such
advertising, or, if the Commission does make such a certification to the
Attorney General respecting such advertising, the Attorney General,
before the expiration of such period, does not cause appropriate
criminal proceedings to be brought against such advertising,
the Secretary may, after the expiration of such period, initiate the
action described in the notice to the Commission pursuant to subsection
(a) of this section. The Commission shall promptly notify the Secretary
of the commencement by the Commission of such a civil action, the
issuance and service by it of such a complaint, or the causing by the
Attorney General of criminal proceedings to be brought against such
advertising.
(c) Secretary's determination of imminent hazard to health as
suspending applicability of provisions
The requirements of subsections (a) and (b) of this section do not
apply with respect to action under subchapter III of this chapter with
respect to any food or food advertising if the Secretary determines that
such action is required to eliminate an imminent hazard to health.
(d) Coordination of action by Secretary with Federal Trade Commission
For the purpose of avoiding unnecessary duplication, the Secretary
shall coordinate any action taken under subchapter III of this chapter
because of advertising which the Secretary determines causes a food to
be misbranded with any action of the Federal Trade Commission under the
Federal Trade Commission Act (15 U.S.C. 41 et seq.) with respect to such
advertising.
(June 25, 1938, ch. 675, 707, as added Apr. 22, 1976, Pub. L.
94-278, title V, 502(b), 90 Stat. 412.)
The Federal Trade Commission Act, referred to in subsecs. (b) and
(d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, as amended, which
is classified generally to subchapter I ( 41 et seq.) of chapter 2 of
Title 15, Commerce and Trade. For complete classification of this Act
to the Code, see section 58 of Title 15 and Tables.
21 USC 379. Confidential information
TITLE 21 -- FOOD AND DRUGS
The Secretary may provide any information which is exempt from
disclosure pursuant to subsection (a) of section 552 of title 5 by
reason of subsection (b)(4) of such section to a person other than an
officer or employee of the Department if the Secretary determines such
other person requires the information in connection with an activity
which is undertaken under contract with the Secretary, which relates to
the administration of this chapter, and with respect to which the
Secretary (or an officer or employee of the Department) is not
prohibited from using such information. The Secretary shall require as
a condition to the provision of information under this section that the
person receiving it take such security precautions respecting the
information as the Secretary may by regulation prescribe.
(June 25, 1938, ch. 675, 708, as added May 28, 1976, Pub. L. 94-295,
8, 90 Stat. 582.)
21 USC 379a. Presumption of existence of jurisdiction
TITLE 21 -- FOOD AND DRUGS
In any action to enforce the requirements of this chapter respecting
a device the connection with interstate commerce required for
jurisdiction in such action shall be presumed to exist.
(June 25, 1938, ch. 675, 709, as added May 28, 1976, Pub. L. 94-295,
8, 90 Stat. 583.)
21 USC 379b. Consolidated administrative and laboratory facility
TITLE 21 -- FOOD AND DRUGS
(a) Authority
The Secretary, in consultation with the Administrator of the General
Services Administration, shall enter into contracts for the design,
construction, and operation of a consolidated Food and Drug
Administration administrative and laboratory facility.
(b) Awarding of contract
The Secretary shall solicit contract proposals under subsection (a)
of this section from interested parties. In awarding contracts under
such subsection, the Secretary shall review such proposals and give
priority to those alternatives that are the most cost effective for the
Federal Government and that allow for the use of donated land, federally
owned property, or lease-purchase arrangements. A contract under this
subsection shall not be entered into unless such contract results in a
net cost savings to the Federal Government over the duration of the
contract, as compared to the Government purchase price including
borrowing by the Secretary of the Treasury.
(c) Donations
In carrying out this section, the Secretary shall have the power, in
connection with real property, buildings, and facilities, to accept on
behalf of the Food and Drug Administration gifts or donations of
services or property, real or personal, as the Secretary determines to
be necessary.
(d) Authorization of appropriations
There are authorized to be appropriated to carry out this section
$100,000,000 for fiscal year 1991, and such sums as may be necessary for
each of the subsequent fiscal years, to remain available until expended.
(June 25, 1938, ch. 675, 710, as added Nov. 28, 1990, Pub. L.
101-635, title I, 101, 104 Stat. 4583.)
21 USC 379c. Recovery and retention of fees for freedom of information
requests
TITLE 21 -- FOOD AND DRUGS
(a) In general
The Secretary, acting through the Commissioner of Food and Drugs, may
--
(1) set and charge fees, in accordance with section 552(a)(4)(A) of
title 5, to recover all reasonable costs incurred in processing requests
made under section 552 of title 5 for records obtained or created under
this chapter or any other Federal law for which responsibility for
administration has been delegated to the Commissioner by the Secretary;
(2) retain all fees charged for such requests; and
(3) establish an accounting system and procedures to control receipts
and expenditures of fees received under this section.
(b) Use of fees
The Secretary and the Commissioner of Food and Drugs shall not use
fees received under this section for any purpose other than funding the
processing of requests described in subsection (a)(1) of this section.
Such fees shall not be used to reduce the amount of funds made to carry
out other provisions of this chapter.
(c) Waiver of fees
Nothing in this section shall supersede the right of a requester to
obtain a waiver of fees pursuant to section 552(a)(4)(A) of title 5.
(June 25, 1938, ch. 675, 711, as added Nov. 28, 1990, Pub. L.
101-635, title II, 201, 104 Stat. 4584.)
21 USC 379d. Automation of Food and Drug Administration
TITLE 21 -- FOOD AND DRUGS
(a) In general
The Secretary, acting through the Commissioner of Food and Drugs,
shall automate appropriate activities of the Food and Drug
Administration to ensure timely review of activities regulated under
this chapter.
(b) Authorization of appropriations
There are authorized to be appropriated each fiscal year such sums as
are necessary to carry out this section.
(June 25, 1938, ch. 675, 712, as added Nov. 28, 1990, Pub. L.
101-635, title IV, 401, 104 Stat. 4585.)
21 USC SUBCHAPTER VIII -- IMPORTS AND EXPORTS
TITLE 21 -- FOOD AND DRUGS
21 USC 381. Imports and exports
TITLE 21 -- FOOD AND DRUGS
(a) Imports; list of registered foreign establishments; samples
from unregistered foreign establishments; examination and refusal of
admission
The Secretary of the Treasury shall deliver to the Secretary of
Health and Human Services, upon his request, samples of food, drugs,
devices, and cosmetics which are being imported or offered for import
into the United States, giving notice thereof to the owner or consignee,
who may appear before the Secretary of Health and Human Services and
have the right to introduce testimony. The Secretary of Health and
Human Services shall furnish to the Secretary of the Treasury a list of
establishments registered pursuant to section 360(i) of this title and
shall request that if any drugs and devices manufactured, prepared,
propagated, compounded, or processed in an establishment not so
registered are imported or offered for import into the United States,
samples of such drugs and devices be delivered to the Secretary of
Health and Human Services, with notice of such delivery to the owner or
consignee, who may appear before the Secretary of Health and Human
Services and have the right to introduce testimony. If it appears from
the examination of such samples or otherwise that (1) such article has
been manufactured, processed, or packed under insanitary conditions or,
in the case of a device, the methods used in, or the facilities or
controls used for, the manufacture, packing, storage, or installation of
the device do not conform to the requirements of section 360j(f) of this
title, or (2) such article is forbidden or restricted in sale in the
country in which it was produced or from which it was exported, or (3)
such article is adulterated, misbranded, or in violation of section 355
of this title, then such article shall be refused admission, except as
provided in subsection (b) of this section. The Secretary of the
Treasury shall cause the destruction of any such article refused
admission unless such article is exported, under regulations prescribed
by the Secretary of the Treasury, within ninety days of the date of
notice of such refusal or within such additional time as may be
permitted pursuant to such regulations. Clause (2) of the third
sentence of this subsection shall not be construed to prohibit the
admission of narcotic drugs the importation of which is permitted under
the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.).
(b) Disposition of refused articles
Pending decision as to the admission of an article being imported or
offered for import, the Secretary of the Treasury may authorize delivery
of such article to the owner or consignee upon the execution by him of a
good and sufficient bond providing for the payment of such liquidated
damages in the event of default as may be required pursuant to
regulations of the Secretary of the Treasury. If it appears to the
Secretary of Health and Human Services that an article included within
the provisions of clause (3) of subsection (a) of this section can, by
relabeling or other action, be brought into compliance with this chapter
or rendered other than a food, drug, device, or cosmetic, final
determination as to admission of such article may be deferred and, upon
filing of timely written application by the owner or consignee and the
execution by him of a bond as provided in the preceding provisions of
this subsection, the Secretary of Health and Human Services may, in
accordance with regulations, authorize the applicant to perform such
relabeling or other action specified in such authorization (including
destruction or export of rejected articles or portions thereof, as may
be specified in the Secretary's authorization). All such relabeling or
other action pursuant to such authorization shall in accordance with
regulations be under the supervision of an officer or employee of the
Department of Health and Human Services designated by the Secretary of
Health and Human Services, or an officer or employee of the Department
of the Treasury designated by the Secretary of the Treasury.
(c) Charges concerning refused articles
All expenses (including travel, per diem or subsistence, and salaries
of officers or employees of the United States) in connection with the
destruction provided for in subsection (a) of this section and the
supervision of the relabeling or other action authorized under the
provisions of subsection (b) of this section, the amount of such
expenses to be determined in accordance with regulations, and all
expenses in connection with the storage, cartage, or labor with respect
to any article refused admission under subsection (a) of this section,
shall be paid by the owner or consignee and, in default of such payment,
shall constitute a lien against any future importations made by such
owner or consignee.
(d) Reimportation
(1) Except as provided in paragraph (2), no drug subject to section
353(b) of this title which is manufactured in a State and exported may
be imported into the United States unless the drug is imported by the
person who manufactured the drug.
(2) The Secretary may authorize the importation of a drug the
importation of which is prohibited by paragraph (1) if the drug is
required for emergency medical care.
(e) Exports
(1) A food, drug, device, or cosmetic intended for export shall not
be deemed to be adulterated or misbranded under this chapter if it --
(A) accords to the specifications of the foreign purchaser,
(B) is not in conflict with the laws of the country to which it is
intended for export,
(C) is labeled on the outside of the shipping package that it is
intended for export, and
(D) is not sold or offered for sale in domestic commerce.
This paragraph does not authorize the exportation of any new animal
drug, or an animal feed bearing or containing a new animal drug, which
is unsafe within the meaning of section 360b of this title.
(2) Paragraph (1) does not apply to any device --
(A) which does not comply with an applicable requirement of section
360d or 360e of this title,
(B) which under section 360j(g) of this title is exempt from either
such section, or
(C) which is a banned device under section 360f of this title,
unless, in addition to the requirements of paragraph (1), the
Secretary has determined that the exportation of the device is not
contrary to public health and safety and has the approval of the country
to which it is intended for export.
(June 25, 1938, ch. 675, 801, 52 Stat. 1058; 1940 Reorg. Plan No.
IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; Oct. 18, 1949,
ch. 696, 1-3, 63 Stat. 882; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; Oct. 10, 1962, Pub. L. 87-781, title
III, 306, 76 Stat. 796; July 13, 1968, Pub. L. 90-399, 106, 82 Stat.
353; Oct. 27, 1970, Pub. L. 91-513, title II, 701(h), 84 Stat. 1282;
May 28, 1976, Pub. L. 94-295, 3(f), 4(b)(3), 90 Stat. 578, 580; Oct.
17, 1979, Pub. L. 96-88, title V, 509(b), 93 Stat. 695; Apr. 22, 1988,
Pub. L. 100-293, 3, 102 Stat. 96.)
The Controlled Substances Import and Export Act, referred to in
subsec. (a), is title III of Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
1285, as amended, which is classified principally to subchapter II ( 951
et seq.) of chapter 13 of this title. For complete classification of
this Act to the Code, see Short Title note set out under section 951 of
this title and Tables.
1988 -- Subsecs. (d), (e). Pub. L. 100-293 added subsec. (d) and
redesignated former subsec. (d) as (e).
1976 -- Subsec. (a). Pub. L. 94-295, 3(f)(2), 4(b)(3), expanded
provisions requiring the Secretary of Health, Education, and Welfare to
request that the Secretary of the Treasury deliver to the Secretary of
Health, Education, and Welfare items imported or offered for import into
the United States that were manufactured, prepared, propagated,
compounded, or processed in non-registered establishments by extending
the provisions to include devices imported or offered for import, and,
in cl. (1), inserted reference to devices which were manufactured,
packed, stored, or installed using methods, facilities, or controls not
conforming to the requirements of section 360j(f) of this title.
Subsec. (d). Pub. L. 94-295, 3(f)(1), designated existing provisions
as par. (1) and added par. (2).
1970 -- Subsec. (a). Pub. L. 91-513 substituted ''Clause (2) of the
third sentence of this subsection'' for ''This subsection'' and ''the
Controlled Substances Import and Export Act'' for ''section 173 of this
title'' in provisions prohibiting a construction of subsec. (a) which
might rule out the admission of narcotic drugs expressly permitted under
the named statute.
1968 -- Subsec. (d). Pub. L. 90-399 provided that nothing in subsec.
(d) shall authorize the exportation of any new animal drug, or an
animal feed bearing or containing a new animal drug, which is unsafe
within the meaning of section 360b of this title.
1962 -- Subsec. (a). Pub. L. 87-781 inserted provisions requiring
the Secretary of Health, Education, and Welfare to furnish the Secretary
of the Treasury a list of establishments registered under section 360(i)
of this title, and to request that samples of any drugs from any
establishments not so registered be delivered to the Secretary of
Health, Education, and Welfare, with notice of delivery to the consignee
who may appear before the Secretary to testify.
1949 -- Subsec. (a). Act Oct. 18, 1949, 1, inserted before period
at end of second sentence '', except as provided in subsection (b) of
this section. The Secretary of the Treasury shall cause the destruction
of any such article refused admission unless such article is exported,
under regulations prescribed by the Secretary of the Treasury within
ninety days of the notice of such refusal or within such additional time
as may be permitted pursuant to such regulations''.
Subsec. (b). Act Oct. 18, 1949, 2, provided for express statutory
authority for the long-standing administrative practice of releasing
imported articles that do not comply with the requirements of the law so
that they may be relabeled or given appropriate treatment to bring them
into compliance.
Subsec. (c). Act Oct. 18, 1949, 3, charged all costs, including
salaries and travel and subsistence expenses of officers and employees,
against importers.
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in subsecs. (a) and
(b), and ''Department of Health and Human Services'' substituted for
''Department of Health, Education, and Welfare'' in subsec. (b),
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
Amendment by Pub. L. 100-293 effective upon expiration of 90 days
after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out as a
note under section 353 of this title.
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of Pub.
L. 91-513, set out as an Effective Date note under section 801 of this
title.
Amendment of subsec. (d) by Pub. L. 90-399 effective on first day
of thirteenth calendar month after July 13, 1968, see section 108(a) of
Pub. L. 90-399, set out as an Effective Date and Transitional
Provisions note under section 360b of this title.
Amendment by Pub. L. 91-513 not to affect or abate any prosecutions
for violation of law or any civil seizure or forfeitures and injunctive
proceedings commenced prior to the effective date of such amendment, and
all administrative proceedings pending before the Bureau of Narcotic and
Dangerous Drugs (now Drug Enforcement Administration) on Oct. 27, 1970,
to be continued and brought to final determination in accord with laws
and regulations in effect prior to Oct. 27, 1970, see section 702 of
Pub. L. 91-513, set out as a note under section 321 of this title.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare (now Health and Human
Services), and of Food and Drug Administration to Federal Security
Agency, see note set out under section 41 of this title.
21 USC 382. Exports of certain unapproved products
TITLE 21 -- FOOD AND DRUGS
(a) Drugs intended for human or animal use which require approval or
licensing
A drug (including a biological product) intended for human or animal
use --
(1) which --
(A) requires approval by the Secretary under section 355 of this
title or section 360b of this title, or
(B) requires licensing by the Secretary under section 262 of title 42
or by the Secretary of Agriculture under the Act of March 4, 1913 (21
U.S.C. 151 et seq.) (known as the Virus Serum Toxin Act),
before it may be introduced or delivered for introduction into
interstate commerce to a country, and
(2) which does not have such approval or license, which is not exempt
from such sections or Act, and which is introduced or delivered for
introduction into interstate commerce to a country,
is adulterated, misbranded, and in violation of such sections or Act
unless the export of the drug is authorized under subsection (b) of this
section.
(b) Conditions for export; active pursuit of drug approval or
licensing; application for export, contents, approval or disapproval;
list of eligible countries for export; criteria for list change
(1) A drug (including a biological product) may, upon approval of an
application submitted under paragraph (3), be exported if --
(A) the drug contains the same active ingredient as a --
(i) new drug --
(I) which has an exemption under section 355(i) of this title, and
(II) for which approval is actively being pursued by the person who
has the exemption,
(ii) biological product for human use --
(I) which has an exemption under section 355(i) of this title, and
(II) for which licensing of the biological product under section 262
of title 42 is actively being pursued by the person who has the
exemption,
(iii) biological product for animal use --
(I) for which authority has been granted under the Virus-Serum Toxin
Act (21 U.S.C. 151 et seq.) for the preparation of an experimental drug
product, and
(II) for which the licensing of the biological product under such Act
is actively being pursued by the person who has the authority, or
(iv) new animal drug --
(I) which has an exemption under section 360b(j) of this title, and
(II) for which approval is actively being pursued by the person who
has the exemption,
(B) except as provided in paragraph (2), the drug is exported to a
country which is listed under paragraph (4) and in which the drug is
approved and has not been withdrawn from sale,
(C) an application for the drug under section 355 or 360b of this
title, section 262 of title 42, or the Virus-Serum Toxin Act (21 U.S.C.
151 et seq.) has not been disapproved by an order of the Secretary under
section 355(d) or 360b(d) of this title or section 262 of title 42 or by
the Secretary of Agriculture in the case of an application under the
Virus-Serum Toxin Act,
(D) the drug is manufactured, processed, packaged, and held in
conformity with current good manufacturing practice and is not
adulterated under paragraph /1/ (a)(1), (a)(2)(A), (a)(3), (c), or (d)
of section 351 of this title,
(E) the outside of the shipping package is labeled with the following
statement: ''This drug may be sold or offered for sale only in the
following countries: '', the blank space being filled with a list of
the countries to which export of the drug is authorized under this
subsection,
(F) the drug is not the subject of a notice by the Secretary or the
Secretary of Agriculture of a determination that the manufacture of the
drug in the United States for export to a country is contrary to the
public health and safety of the United States,
(G) the requirements of subparagraphs (A) through (D) of section
381(d)(1) of this title have been met.
The Secretary shall determine that an applicant is actively pursuing
the approval or licensing of a drug if the applicant has demonstrated
that degree of attention and continuous directed effort as may
reasonably be expected from, and are ordinarily exercised by, a person
before approval or licensing of a drug, such as the preparation for and
the conduct of preclinical or clinical investigations, the analysis of
the results of such investigations, conferences on such investigations
with government officials, and the preparation of an application of
approval or licensing for the drug.
(2) The Secretary may permit the export of a drug under paragraph (1)
to a country which is listed under paragraph (4) and in which the drug
is not approved if the drug is exported to such country solely for the
purpose of further export to a country listed in paragraph (4) in which
the drug is approved.
(3)(A) Any person may apply to have a drug exported under paragraph
(1). Such an application shall be filed at least 90 days before the
date the applicant proposes to export the drug for which the application
is submitted. Before the expiration of 10 days from the date of the
submission of such an application, the Secretary shall publish a notice
in the Federal Register which identifies the applicant under such
application, the drug proposed to be exported under such application,
and the country to which the drug is proposed to be exported.
(B) An application for the export of a drug shall --
(i) identify the drug to be exported,
(ii) list each country to which the drug is to be exported and list
the persons in each such country to which the drug is to be exported,
(iii) contain a certification by the applicant that --
(I) the applicant will export the drug only to a country which is
listed in paragraph (4) and in which the drug is approved unless the
drug is authorized to be exported under paragraph (2) and will export
only those quantities of the drug which may reasonably be sold in each
country to which it is to be exported,
(II) the drug is approved by each country to which it is to be
exported unless the drug is authorized to be exported under paragraph
(2) and the drug has not been withdrawn from sale in such country,
(III) the drug meets the requirements of paragraph (1)(D),
(IV) the drug will be labeled in accordance with paragraph (1)(E),
and
(V) the drug meets the requirements of paragraphs (1)(C) and (1)(G),
(iv) contain a certification by the holder of the exemption or
authority for such drug described in paragraph (1)(A) that the holder
will actively pursue the approval or licensing of the drug,
(v) identify the exemption or authority for an experimental drug
product in effect for such drug under the laws referred to in paragraph
(1)(A),
(vi) identify the establishments in which the drug is manufactured,
and
(vii) include a written agreement from each importer to whom the drug
is to be exported from the United States that such importer will not
export the drug to a country which is not listed under paragraph (4) and
will provide notice to the applicant of any knowledge of an export of
the drug to such a country by any person and will maintain records of
the drug wholesale distributors to which the drug is sold.
(C)(i) Before the expiration of 30 days after the date an application
is submitted to the Secretary, the Secretary shall review the
application to determine if the application meets the requirements of
clauses (i), (ii), (iv), (v), (vi), and (vii) of subparagraph (B) and
contains the certifications described in clauses (iii) (other than the
certification required by clause (iii)(II)) and (iv). If the Secretary
determines that the application meets such requirements and contains
such certifications the Secretary shall conditionally approve the
application. An application which is so conditionally approved shall be
finally approved within 5 days of the submission of the certification
required by clause (iii)(II).
(ii) If the Secretary proposes to disapprove an application, the
Secretary shall provide the applicant with a written statement
specifying --
(I) the deficiencies which the applicant must correct in order to
enable the Secretary to approve the application, and
(II) that the applicant has 60 days after receiving the statement to
correct such deficiencies.
(D) If the holder of an application approved under subparagraph (C)
for the export of a drug intends to export such drug to a country listed
in paragraph (4) which is not listed in such application, such holder
shall submit an amendment to such application to the Secretary not later
than 30 days before the date of the proposed export to such country
identifying the country to which the holder intends to export such drug
and containing information sufficient to show that the drug is approved
by such country and has not been withdrawn from sale in such country.
The Secretary shall approve or disapprove the export of such drug to
such country within 15 days of the receipt of the notice required by
this subparagraph.
(4)(A) The countries to which a drug may be exported under paragraph
(1) are --
(i) Australia,
(ii) Austria,
(iii) Belgium,
(iv) Canada,
(v) Denmark,
(vi) Federal Republic of Germany,
(vii) Finland,
(viii) France,
(ix) Iceland,
(x) Ireland,
(xi) Italy,
(xii) Japan,
(xiii) Luxembourg,
(xiv) The Netherlands,
(xv) New Zealand,
(xvi) Norway,
(xvii) Portugal,
(xviii) Spain,
(xix) Sweden,
(xx) Switzerland, and
(xxi) The United Kingdom,
(B) Changes in the list contained in subparagraph (A) shall be based
on the following criteria:
(i) Statutory or regulatory requirements which require the review of
drugs for safety and effectiveness by an entity of the government of
such country and which authorize the approval of only those drugs which
have been determined to be safe and effective by experts employed by or
acting on behalf of such entity and qualified by scientific training and
experience to evaluate the safety and effectiveness of drugs on the
basis of adequate and well-controlled investigations, including clinical
investigations, conducted by experts qualified by scientific training
and experience to evaluate the safety and effectiveness of drugs.
(ii) Statutory or regulatory requirements that the methods used in,
and the facilities and controls used for, the manufacture, processing,
and packing of drugs in the country are adequate to preserve their
identity, quality, purity, and strength.
(iii) Statutory or regulatory requirements for the reporting of
adverse reactions to drugs and procedures to withdraw approval and
remove drugs found not to be safe or effective.
(iv) Statutory or regulatory requirements that the labeling and
promotion of drugs must be in accordance with the approval of the drug.
(c) Report to Secretary by holder of approved application; events
requiring report; annual report to Secretary on pursuit of approval of
drug
(1) The holder of an approved application under subsection (b) of
this section authorizing the export of a drug shall report to the
Secretary --
(A) any withdrawal of an approval of the drug by any country to which
it has been exported,
(B) any withdrawal of the drug from sale in any such country,
(C) the withdrawal of an application by the holder under section 355
or 360b of this title, section 262 of title 42, or the Virus-Serum Toxin
Act (21 U.S.C. 151 et seq.), and
(D) the receipt of any credible information indicating that the drug
is being or may have been exported from a country listed under
subsection (b)(4) of this section to a country which is not listed under
such subsection.
The reporting of an event described in subparagraph (A), (B), or (C)
shall be made within 15 days of the occurrence of the event and the
reporting of the receipt of information under subparagraph (D) shall be
made within 15 days of the receipt of such information.
(2) The holder of an approved application under subsection (b) of
this section authorizing the export of a drug shall report annually to
the Secretary after the date of the approval of the application of the
actions taken by the holder in pursuit of the approval of such drug
during the year reported on. Not later than 90 days from the date of
the receipt of a report under this paragraph the Secretary shall
determine if the holder is actively pursuing the approval of such drug.
(d) Export of drug under approved application prohibited
A drug authorized to be exported to a country under an application
approved under subsection (b) of this section may not be exported to
such country if --
(1) an approval of such drug is withdrawn by such country,
(2) the drug is withdrawn from sale in such country,
(3) the Secretary issues an order refusing to approve an application
of the holder of such application under section 355 or 360b of this
title, section 262 of title 42, or the Virus-Serum Toxin Act (21 U.S.C.
151 et seq.), or
(4) an application for such drug under such section or Act is
withdrawn or if an exemption for such drug under section 355(i) or
360b(j) of this title or the authority granted for such drug to prepare
an experimental drug product under the Virus-Serum Toxin Act (21 U.S.C.
151 et seq.) is withdrawn and no application for approval of such drug
has been submitted under section 355 or 360b of this title, section 262
of title 42, or the Virus-Serum Toxin Act.
(e) Determination by Secretary of noncompliance, failure of active
pursuit of drug approval, imminent hazard of drug to public health, or
exportation of drug to noneligible country; notices and hearings;
prohibition on exportation of drug
(1) If the Secretary determines that --
(A) a drug for which an application was approved under subsection (b)
of this section no longer complies with subparagraphs (A), (D), (E), and
(G) of paragraph (1) of such subsection or with paragraph (2) of such
subsection or the holder of such application has not made the reports
required by subsection (c) of this section, or
(B) the manufacture of a drug in the United States for export is
contrary to the public health and safety of the United States and an
application for the export of such drug has been approved under
subsection (b) of this section,
then before taking action against the holder of an application for
which a determination was made under subparagraph (A) or (B), the
Secretary shall notify the holder in writing of the determination and
provide the holder 30 days to take such action as may be required so
that the Secretary would be unable to make such determination. When the
Secretary takes action against such holder because of such a
determination, the Secretary shall provide the holder a written
statement specifying the reasons for such determination and provide the
person, on request, an opportunity for an informal hearing with respect
to such determination.
(2) If the Secretary determines that the approval of a drug is not
being actively pursued as required by subsection (b)(1)(A) of this
section, the Secretary shall give the holder of the application
authorizing the export of such drug 60 days to assure that actions are
taken to actively pursue such approval. During the 60-day period the
Secretary shall give the holder an opportunity for an informal hearing
on the determination of the Secretary. If upon the expiration of such
60-day period the Secretary determines that approval of such drug is not
being actively pursued, the Secretary shall prohibit the export of such
drug.
(3)(A) If at any time the Secretary, or in the absence of the
Secretary the individual acting as the Secretary, determines that --
(i) the holder of an approved application under subsection (b) of
this section is exporting a drug from the United States to an importer,
(ii) such importer is exporting the drug to a country which is not
listed under subsection (b)(4) of this section, and
(iii) such export presents an imminent hazard to the public health in
such country,
the Secretary shall immediately prohibit the export of the drug to
such importer, give the person exporting the drug from the United States
prompt notice of the determination, and afford such person an
opportunity for an expedited hearing.
(B) The authority conferred by subparagraph (A) shall not be
delegated by the Secretary. A determination by the Secretary under
subparagraph (A) may not be stayed pending final action by a reviewing
court.
(4)(A) If the Secretary, or in the absence of the Secretary the
individual acting as the Secretary, determines that the holder of an
approved application under subsection (b) of this section is exporting a
drug to a country which is not listed under subsection (b)(4) of this
section and that the export of the drug presents an imminent hazard, the
Secretary shall immediately prohibit the export of the drug to such
country, give the holder prompt notice of the determination, and afford
the holder an opportunity for an expedited hearing.
(B) The authority conferred by subparagraph (A) shall not be
delegated by the Secretary. A determination by the Secretary under
subparagraph (A) may not be stayed pending final action by a reviewing
court.
(5) If the Secretary receives credible evidence that the holder of an
application approved under subsection (b) of this section is exporting a
drug to a country which is not listed under subsection (b)( 4) of this
section, the Secretary shall give the holder 60 days to provide
information to the Secretary respecting such evidence and shall provide
the holder an opportunity for an informal hearing on such evidence.
Upon the expiration of such 60 days the Secretary shall prohibit the
export of such drug to such country if the Secretary determines that the
holder of the application is exporting the drug to a country which is
not listed under subsection (b)(4) of this section.
(6) If the Secretary receives credible evidence that an importer is
exporting a drug to a country which is not listed under subsection (b)(
4) of this section, the Secretary shall notify the holder of the
application authorizing the export of such drug of such evidence and
shall require the holder to investigate the export by such importer and
to report to the Secretary within 14 days of the receipt of such notice
the findings of the holder. If the Secretary determines that the
importer has exported a drug to such a country, the Secretary shall
prohibit such holder from exporting such drug to the importer unless the
Secretary determines that the export by the importer was unintentional.
(f) Drugs used in prevention or treatment of tropical disease
(1) A drug (including a biological product) which is to be used in
the prevention or treatment of a tropical disease may, upon approval of
an application submitted under paragraph (2), be exported if --
(A) the Secretary finds, based on credible scientific evidence,
including clinical investigations, that the drug is safe and effective
in the country to which it is to be exported in the prevention or
treatment of a tropical disease in such country,
(B) the drug is manufactured, processed, packaged, and held in
conformity with current good manufacturing practice and is not
adulterated under paragraph /2/ (a)(1), (a)(2)(A), (a)(3), (c), or (d)
of section 351 of this title,
(C) the outside of the shipping package is labeled with the following
statement: ''This drug may be sold or offered for sale only in the
following countries: '', the blank space being filled with a list of
the countries to which export of the drug is authorized under this
subsection,
(D) the drug is not the subject of a notice by the Secretary or the
Secretary of Agriculture of a determination that the manufacture of the
drug in the United States for export to a country is contrary to the
public health and safety of the United States, and
(E) the requirements of subparagraphs (A) through (D) of section
381(d)(1) of this title have been met.
(2) Any person may apply to have a drug exported under paragraph (1).
The application shall --
(A) describe the drug to be exported,
(B) list each country to which the drug is to be exported,
(C) contain a certification by the applicant that the drug will not
be exported to a country for which the Secretary cannot make a finding
described in paragraph (1)(A),
(D) identify the establishments in which the drug is manufactured,
and
(E) demonstrate to the Secretary that the drug meets the requirements
of paragraph (1).
(3) The holder of an approved application for the export of a drug
under this subsection shall report to the Secretary --
(A) the receipt of any information indicating that the drug is being
or may have been exported from a country for which the Secretary made a
finding under paragraph (1)(A) to a country for which the Secretary
cannot make such a finding, and
(B) the receipt of any information indicating any adverse reactions
to such drug.
(4)(A) If the Secretary determines that --
(i) a drug for which an application is approved under paragraph (2)
does not continue to meet the requirements of paragraph (1),
(ii) the holder of such application has not made the report required
by paragraph (3), or
(iii) the manufacture of such drug in the United States for export is
contrary to the public health and safety of the United States and an
application for the export of such drug has been approved under
paragraph (2),
then before taking action against the holder of an application for
which a determination was made under clause (i), (ii), or (iii), the
Secretary shall notify the holder in writing of the determination and
provide the holder 30 days to take such action as may be required so
that the Secretary would be unable to make such determination. When the
Secretary takes action against such holder because of such a
determination, the Secretary shall provide the holder a written
statement specifying the reasons for such determination and provide the
person, on request, an opportunity for an informal hearing with respect
to such determination.
(B) If at any time the Secretary, or in the absence of the Secretary
the individual acting as the Secretary, determines that --
(i) the holder of an approved application under paragraph (2) is
exporting a drug from the United States to an importer,
(ii) such importer is exporting the drug to a country for which the
Secretary cannot make a finding under paragraph (1)(A), and
(iii) such export presents an imminent hazard to the public health in
such country,
the Secretary shall immediately prohibit the export of the drug to
such importer, give the person exporting the drug from the United States
prompt notice of the determination, and afford such person an
opportunity for an expedited hearing. A determination by the Secretary
under this subparagraph may not be stayed pending final action by a
reviewing court. The authority conferred by this subparagraph shall not
be delegated by the Secretary.
(C) If the Secretary, or in the absence of the Secretary the
individual acting as the Secretary, determines that the holder of an
approved application under paragraph (2) is exporting a drug to a
country for which the Secretary cannot make a finding under paragraph
(1)(A), and that the export of the drug presents an imminent hazard, the
Secretary shall immediately prohibit the export of the drug to such
country, give the holder prompt notice of the determination, and afford
the holder an opportunity for an expedited hearing. A determination by
the Secretary under this subparagraph may not be stayed pending final
action by a reviewing court. The authority conferred by this
subparagraph shall not be delegated by the Secretary.
(D) If the Secretary receives credible evidence that the holder of an
application approved under paragraph (2) is exporting a drug to a
country for which the Secretary cannot make a finding under paragraph
(1)(A), the Secretary shall give the holder 60 days to provide
information to the Secretary respecting such evidence and shall provide
the holder an opportunity for an informal hearing on such evidence.
Upon the expiration of such 60 days the Secretary shall prohibit the
export of such drug to such country if the Secretary determines the
holder is exporting the drug to a country for which the Secretary cannot
make a finding under paragraph (1)(A).
(E) If the Secretary receives credible evidence that an importer is
exporting a drug to a country for which the Secretary cannot make a
finding under paragraph (1)(A), the Secretary shall notify the holder of
the application authorizing the export of such drug of such evidence and
shall require the holder to investigate the export by such importer and
to report to the Secretary within 14 days of the receipt of such notice
the findings of the holder. If the Secretary determines that the
importer has exported a drug to such a country, the Secretary shall
prohibit such holder from exporting such drug to the importer unless the
Secretary determines that the export by the importer was unintentional.
(g) Reference to Secretary and holder of application
For purposes of this section --
(1) a reference to the Secretary shall in the case of a biological
product which is required to be licensed under the Virus-Serum Toxin Act
(21 U.S.C. 151 et seq.) be considered to be a reference to the Secretary
of Agriculture, and
(2) a reference in paragraph (3), (4), (5), or (6) of subsection (e)
of this section and in subparagraph (B), (C), (D), or (E) of subsection
(f)(4) of this section to the holder of an application shall be
considered a reference to any person which is under common control with
holder, is controlled by the holder, controls the holder, is owned by
the holder, or owns the holder.
(June 25, 1938, ch. 675, 802, as added Nov. 14, 1986, Pub. L.
99-660, title I, 102(2), 100 Stat. 3743.)
Act of March 4, 1913 (known as the Virus Serum Toxin Act), referred
to in subsecs. (a)(1)(B), (b)(1)(A)(iii)(I), (C), (c)(1)(C), (d)(3),
(4), and (g)(1), is act Mar. 4, 1913, ch. 145, 37 Stat. 828, as
amended, which is classified generally to chapter 5 ( 151 et seq.) of
this title. For complete classification of this Act to the Code, see
Short Title note set out under section 151 of this title and Tables.
/1/ So in original. Probably should be ''subsection''.
/2/ So in original. Probably should be ''subsection''.
21 USC 383. Office of International Relations
TITLE 21 -- FOOD AND DRUGS
(a) There is established in the Department of Health and Human
Services an Office of International Relations.
(b) In carrying out the functions of the office under subsection (a)
of this section, the Secretary may enter into agreements with foreign
countries to facilitate commerce in devices between the United States
and such countries consistent with the requirements of this chapter. In
such agreements, the Secretary shall encourage the mutual recognition of
--
(1) good manufacturing practice regulations promulgated under section
360j(f) of this title, and
(2) other regulations and testing protocols as the Secretary
determines to be appropriate.
(June 25, 1938, ch. 675, 803, as added Nov. 28, 1990, Pub. L.
101-629, 15(a), 104 Stat. 4525.)
Section 15(b) of Pub. L. 101-629 provided that: ''Not later than 2
years after the date of the enactment of this Act (Nov. 28, 1990), the
Secretary of Health and Human Services shall prepare and submit to the
appropriate committees of Congress a report on the activities of the
Office of International Relations under section 803 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 383), added by subsection (a).''
21 USC SUBCHAPTER IX -- MISCELLANEOUS
TITLE 21 -- FOOD AND DRUGS
21 USC 391. Separability clause
TITLE 21 -- FOOD AND DRUGS
If any provision of this chapter is declared unconstitutional, or the
applicability thereof to any person or circumstances is held invalid,
the constitutionality of the remainder of the chapter and the
applicability thereof to other persons and circumstances shall not be
affected thereby.
(June 25, 1938, ch. 675, 901, 52 Stat. 1059.)
21 USC 392. Exemption of meats and meat food products
TITLE 21 -- FOOD AND DRUGS
(a) Law determinative of exemption
Meats and meat food products shall be exempt from the provisions of
this chapter to the extent of the application or the extension thereto
of the Meat Inspection Act, approved March 4, 1907, as amended (21 U.S.
C. 601 et seq.).
(b) Laws unaffected
Nothing contained in this chapter shall be construed as in any way
affecting, modifying, repealing, or superseding the provisions of
section 351 of Public Health Service Act (42 U.S.C. 262) (relating to
viruses, serums, toxins, and analogous products applicable to man); the
virus, serum, toxin, and analogous products provisions, applicable to
domestic animals, of the Act of Congress approved March 4, 1913 (21 U.
S.C. 151 et seq.); the Filled Cheese Act of June 6, 1896 (U.S.C., 1934
ed., title 26, ch. 10), the Filled Milk Act of March 4, 1923 (21 U.S.C.
61 et seq.); or the Import Milk Act of February 15, 1927 (21 U. S.C.
141 et seq.).
(June 25, 1938, ch. 675, 902(b), (c), 52 Stat. 1059; July 13, 1968,
Pub. L. 90-399, 107, 82 Stat. 353.)
The Meat Inspection Act, approved March 4, 1907, as amended, referred
to in subsec. (a), is act Mar. 4, 1907, ch. 2907, titles I to IV, as
added Dec. 15, 1967, Pub. L. 90-201, 81 Stat. 584, which are
classified generally to subchapters I to IV ( 601 et seq.) of chapter 12
of this title. For complete classification of this Act to the Code, see
Short Title note set out under section 601 of this title and Tables.
Act of March 4, 1913, referred to in subsec. (b), is act Mar. 4,
1913, ch. 145, 37 Stat. 828, as amended. The provisions of such act
relating to viruses, etc., applicable to domestic animals, popularly
known as the Virus-Serum-Toxin Act, are classified generally to chapter
5 ( 151 et seq.) of this title. For complete classification of this Act
to the Code, see Short Title note set out under section 151 of this
title and Tables.
The Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26,
ch. 10), referred to in subsec. (b), is act June 6, 1896, ch. 337, 29
Stat. 253, as amended, which had been classified to chapter 10 ( 1000
et seq.) of Title 26, Internal Revenue, and included as chapter 17 (
2350 et seq.) of Title 26, Internal Revenue Code of 1939. Such chapter
17 was covered by section 4831 et seq. of Title 26, Internal Revenue
Code, prior to the repeal of section 4831 et seq. of Title 26 by Pub.
L. 93-490, 3(a)(1), Oct. 26, 1974, 88 Stat. 1466.
The Filled Milk Act of March 4, 1923, referred to in subsec. (b), is
act Mar. 4, 1923, ch. 262, 42 Stat. 1486, as amended, which is
classified generally to chapter 3 ( 61 et seq.) of this title. For
complete classification of this Act to the Code, see Short Title note
set out under section 61 of this title and Tables.
The Import Milk Act of February 15, 1927, referred to in subsec.
(b), is act Feb. 15, 1927, ch. 155, 44 Stat. 1101, as amended, which
is classified generally to subchapter IV ( 141 et seq.) of chapter 4 of
this title. For complete classification of this Act to the Code, see
Short Title note set out under section 141 of this title and Tables.
Subsecs. (a) and (b) of this section comprise respectively subsecs.
(b) and (c) of section 902 of act June 25, 1938. Subsecs. (a) and (d)
of section 902 of act June 25, 1938, which prescribed the effective date
of this chapter and made appropriations available, are set out as notes
under section 301 of this title and this section, respectively.
1968 -- Subsec. (b). Pub. L. 90-399 substituted ''section 262 of
title 42 (relating to viruses, serums, toxins, and analogous products
applicable to man)'' for ''the virus serum, and toxin Act of July 1,
1902'' and inserted reference to ''the virus, serum, toxin, and
analogous products provisions, applicable to domestic animals, of the
Act of Congress approved March 4, 1913''.
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions note
under section 360b of this title.
Section 902(d) of act June 25, 1938, provided that: ''In order to
carry out the provisions of this Act which take effect (see section
902(a) of act June 25, 1938, set out as an Effective Date note under
section 301 of this title) prior to the repeal of the Food and Drugs Act
of June 30, 1906, as amended (sections 1 to 15 of this title),
appropriations available for the enforcement of such Act of June 30,
1906, are also authorized to be made available to carry out such
provisions.''
21 USC 393. Food and Drug Administration
TITLE 21 -- FOOD AND DRUGS
(a) In general
There is established in the Department of Health and Human Services
the Food and Drug Administration (hereinafter in this section referred
to as the ''Administration'').
(b) Commissioner
(1) Appointment
There shall be in the Administration a Commissioner of Food and Drugs
(hereinafter in this section referred to as the ''Commissioner'') who
shall be appointed by the President by and with the advice and consent
of the Senate.
(2) General powers
The Secretary, through the Commissioner, shall be responsible for
executing this chapter and for --
(A) providing overall direction to the Food and Drug Administration
and establishing and implementing general policies respecting the
management and operation of programs and activities of the Food and Drug
Administration;
(B) coordinating and overseeing the operation of all administrative
entities within the Administration;
(C) research relating to foods, drugs, cosmetics, and devices in
carrying out this chapter;
(D) conducting educational and public information programs relating
to the responsibilities of the Food and Drug Administration; and
(E) performing such other functions as the Secretary may prescribe.
(c) Technical and scientific review groups
The Secretary through the Commissioner of Food and Drugs may, without
regard to the provisions of title 5 governing appointments in the
competitive service and without regard to the provisions of chapter 51
and subchapter III of chapter 53 of such title relating to
classification and General Schedule pay rates, establish such technical
and scientific review groups as are needed to carry out the functions of
the Administration, including functions under this chapter, and appoint
and pay the members of such groups, except that officers and employees
of the United States shall not receive additional compensation for
service as members of such groups.
(June 25, 1938, ch. 675, 903, as added Nov. 4, 1988, Pub. L.
100-607, title V, 503(a), 102 Stat. 3121, and amended Nov. 18, 1988,
Pub. L. 100-690, title II, 2631, 102 Stat. 4244.)
The provisions of title 5 governing appointments in the competitive
service, referred to in subsec. (c), are classified generally to
section 3301 et seq. of Title 5, Government Organization and Employees.
Another section 903 of the Federal Food, Drug, and Cosmetic Act is
classified to section 394 of this title.
1988 -- Subsec. (b)(2). Pub. L. 100-690 substituted ''shall be
responsible for executing this chapter and for ''shall be responsible''.
Section 503(c) of title V of Pub. L. 100-607 provided that:
''(1) Except as provided in paragraph (2), the amendments made by
this title (enacting this section and amending sections 5315 and 5316 of
Title 5, Government Organization and Employees) shall take effect on the
date of enactment of this Act (Nov. 4, 1988).
''(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 393(b)(1)) (as added by subsection (a) of this section) shall
apply to the appointments of Commissioners of Food and Drugs made after
the date of enactment of this Act.''
Section 502 of Pub. L. 100-607 provided that: ''Congress finds that
--
''(1) the public health has been effectively protected by the
presence of the Food and Drug Administration during the last eighty
years;
''(2) the presence and importance of the Food and Drug Administration
must be guaranteed; and
''(3) the independence and integrity of the Food and Drug
Administration need to be enhanced in order to ensure the continuing
protection of the public health.''
21 USC 394. Scientific review groups
TITLE 21 -- FOOD AND DRUGS
Without regard to the provisions of title 5 governing appointments in
the competitive service and without regard to the provisions of chapter
51 and subchapter III of chapter 53 of such title relating to
classification and General Schedule pay rates, the Commissioner of Food
and Drugs may --
(1) establish such technical and scientific review groups as are
needed to carry out the functions of the Food and Drug Administration
(including functions prescribed under this chapter); and
(2) appoint and pay the members of such groups, except that officers
and employees of the United States shall not receive additional
compensation for service as members of such groups.
(June 25, 1938, ch. 675, 903, as added Nov. 28, 1990, Pub. L.
101-635, title III, 301, 104 Stat. 4584.)
The provisions of title 5 governing appointments in the competitive
service, referred to in text, are classified generally to section 3301
et seq. of Title 5, Government Organization and Employees.
Another section 903 of the Federal Food, Drug, and Cosmetic Act is
classified to section 393 of this title.
21 USC CHAPTER 10 -- POULTRY AND POULTRY PRODUCTS INSPECTION
TITLE 21 -- FOOD AND DRUGS
Sec.
451. Congressional statement of findings.
452. Congressional declaration of policy.
453. Definitions.
454. Federal and State cooperation in development and administration
of State poultry product inspection programs.
(a) State laws; planning, technical and financial assistance;
advisory committees.
(b) Appropriate State agency; performance of functions by
subordinate governmental unit.
(c) Intrastate activities; designation of State for regulation;
publication of designation; exempted operations; termination of
designation; review of operations in nondesignated States; annual
report.
(d) ''State'' defined.
455. Inspection in official establishments.
(a) Ante mortem inspection.
(b) Post mortem inspection; quarantine, segregation, and
reinspection.
(c) Condemnation; appeal; reprocessing.
456. Operation of premises, facilities and equipment.
(a) Sanitary practices.
(b) Refusal of inspection.
457. Labeling and container standards.
(a) Requirements for shipping containers and immediate containers;
nonconsumer packaged carcasses.
(b) Labeling requirements; definitions and standards of identity or
composition or articles and standards of fill of container; standards
consistent with Federal Food, Drug, and Cosmetic Act; consistency
between Federal and State standards.
(c) Use of trade names; false or misleading marking or labeling;
misleading form or size of container.
(d) Withholding use of false or misleading mark, label, or container
size or form; modification; hearing; conclusiveness of determination;
appeal.
458. Prohibited acts.
459. Compliance by all establishments.
460. Miscellaneous activities subject to regulation.
(a) Prohibition of inspection of articles not intended for use as
human food; denaturation or other identification prior to distribution
in commerce; inedible articles.
(b) Recordkeeping requirements; persons liable; scope of
disclosure; access to places of business; examination of records,
facilities, and inventories; copies; samples.
(c) Registration of business, name of person, and trade names.
(d) Regulation of transactions, transportation, or importation of
dead, dying, disabled or diseased poultry or carcasses to prevent use as
human food.
(e) Federal provisions applicable to State or Territorial business
transactions of a local nature and not subject to local authority.
461. Offenses and punishment.
(a) Violations; liability of agents, employees, and employers.
(b) Liability of carrier.
(c) Assaulting, resisting, or impeding certain persons; murder;
punishments.
462. Reporting of violations; notice; opportunity to present
views.
463. Rules and regulations.
(a) Storage and handling of poultry products; violation of
regulations.
(b) Other necessary rules and regulations.
(c) Oral presentation of views.
464. Exemptions.
(a) Persons exempted.
(b) Territorial exemption.
(c) Personal slaughtering; custom slaughtering; name and address of
the poultry producer or processor in lieu of other labeling
requirements; small enterprises; slaughterers or processors of
specified number of turkeys; poultry producers raising poultry on own
farms.
(d) Pizzas containing poultry products.
(e) Applicability of adulteration and misbranding provisions to
articles exempted from inspection.
(f) Suspension or termination of exemption.
465. Limitations upon entry of poultry products and other materials
into official establishments.
466. Imports.
(a) Compliance with standards and regulations; status after
importation.
(b) Rules and regulations; destruction and exportation of refused
imports.
(c) Storage, cartage and labor charges for imports refused admission.
(d) Domestic standards and processing facilities applicable;
enforcement.
467. Inspection services.
(a) Refusal or withdrawal; hearing; business unfitness based upon
certain convictions; persons responsibly connected with the business.
(b) Hearing to determine validity of withdrawal or refusal of
inspection services; continuation of withdrawal or refusal.
(c) Finality and conclusiveness of determination; judicial review;
record.
467a. Administrative detention; duration; pending judicial
proceedings; notification of government authorities; release; removal
of official marks.
467b. Seizure and condemnation.
(a) Proceedings in rem; libel of information; jurisdiction;
disposal by destruction or sale; proceeds into the Treasury; sales
restrictions; bonds; court costs and fees, storage, and other expenses
against claimants; jury trial; United States as plaintiff.
(b) Condemnation or seizure under other provisions unaffected.
467c. Federal court jurisdiction of enforcement and injunction
proceedings and other kinds of cases; limitations; United States as
plaintiff; subpenas.
467d. Administration and enforcement; applicability of penalty
provisions; conduct of inquiries; power and jurisdiction of courts.
467e. Non-Federal jurisdiction of federally regulated matters;
prohibition of additional or different requirements for establishments
with inspection services and as to marking, labeling, packaging, and
ingredients; recordkeeping and related requirements; concurrent
jurisdiction over distribution for human food purposes of adulterated or
misbranded and imported articles; other matters.
467f. Federal Food, Drug, and Cosmetic Act applications.
(a) Exemptions; authorities under food, drug, and cosmetic
provisions unaffected.
(b) Enforcement proceedings; detainer authority of representatives
of Secretary of Health and Human Services.
468. Cost of inspection; overtime.
469. Authorization of appropriations.
470. Reports to Congress.
title 7 sections 138f, 6519.
21 USC 451. Congressional statement of findings
TITLE 21 -- FOOD AND DRUGS
Poultry and poultry products are an important source of the Nation's
total supply of food. They are consumed throughout the Nation and the
major portion thereof moves in interstate or foreign commerce. It is
essential in the public interest that the health and welfare of
consumers be protected by assuring that poultry products distributed to
them are wholesome, not adulterated, and properly marked, labeled, and
packaged. Unwholesome, adulterated, or misbranded poultry products
impair the effective regulation of poultry products in interstate or
foreign commerce, are injurious to the public welfare, destroy markets
for wholesome, not adulterated, and properly labeled and packaged
poultry products, and result in sundry losses to poultry producers and
processors of poultry and poultry products, as well as injury to
consumers. It is hereby found that all articles and poultry which are
regulated under this chapter are either in interstate or foreign
commerce or substantially affect such commerce, and that regulation by
the Secretary of Agriculture and cooperation by the States and other
jurisdictions as contemplated by this chapter are appropriate to prevent
and eliminate burdens upon such commerce, to effectively regulate such
commerce, and to protect the health and welfare of consumers.
(Pub. L. 85-172, 2, Aug. 28, 1957, 71 Stat. 441; Pub. L. 90-492, 2,
Aug. 18, 1968, 82 Stat. 791.)
1968 -- Pub. L. 90-492 inserted provisions stating it to be
necessary that the health and welfare of consumers be protected by
assuring that poultry products distributed to them are wholesome, not
adulterated, and properly marked, labeled, and packaged, provisions that
misbranded poultry products impair the effective regulation of poultry
products and destroy markets for wholesome, not adulterated, and
properly labeled and packaged poultry products, and result in sundry
losses to poultry producers and processors of poultry and poultry
products, as well as injury to consumers, and provisions that all
articles and poultry which are regulated by this chapter are either in
interstate or foreign commerce or substantially affect such commerce and
that regulation by the Secretary of Agriculture and cooperation by the
states and other jurisdictions as contemplated by this chapter are
appropriate to serve the specified aims, and struck out provisions that
all poultry and poultry products which have or are required to have
inspection under this chapter are either in the current of interstate or
foreign commerce or directly affect such commerce, provisions that that
part entering directly into the current of interstate or foreign
commerce cannot be effectively inspected and regulated without also
inspecting and regulating all poultry and poultry products in the same
establishment, and provisions authorizing the Secretary to designate
major consuming areas.
Section 20 of Pub. L. 90-492 provided that: ''This Act (see Short
Title of 1968 Amendment note below) shall become effective upon
enactment (Aug. 18, 1968) except as provided in paragraphs (a) through
(c):
''(a) The provisions of subparagraphs (a)(2)(A) and (a)(3) of section
9 of the Poultry Products Inspection Act, as amended by section 9 of
this Act (section 458(a)(2)(A) and (a)(3) of this title), shall become
effective upon the expiration of sixty days after enactment hereof (Aug.
18, 1968).
''(b) Section 14 of this Act, amending section 15 of the Poultry
Products Inspection Act (section 464 of this title), shall become
effective upon the expiration of sixty days after enactment hereof (Aug.
18, 1968).
''(c) Paragraph 11(d) of the Poultry Products Inspection Act, as
added by section 11 of this Act (section 460(d) of this title), shall
become effective upon the expiration of sixty days after enactment
hereof (Aug. 18, 1968).''
Section 29, formerly section 22, of Pub. L. 85-172, as renumbered by
Pub. L. 90-492, 17, Aug. 18, 1968, 82 Stat. 805, provided that:
''This Act (this chapter) shall take effect upon enactment (Aug. 28,
1957), except that no person shall be subject to the provisions of this
Act (this chapter) prior to January 1, 1959, unless such person after
January 1, 1958, applies for and receives inspection for poultry or
poultry products in accordance with the provisions of this Act (this
chapter) and pursuant to regulations promulgated by the Secretary
hereunder, in any establishment processing poultry or poultry products
in commerce or in a designated major consuming area. Any person who
voluntarily applies for and receives such inspection after January 1,
1958, shall be subject, on and after the date he commences to receive
such inspection, to all of the provisions and penalties provided for in
this Act (this chapter) with respect to all poultry or poultry products
handled in the establishment for which such said application for
inspection is made.''
Section 1 of Pub. L. 90-492 provided: ''That this Act (enacting
sections 467a to 467f and 470 of this title, amending this section and
sections 452 to 461, 463 to 465, and 467 of this title, and enacting
provisions set out as notes under this section) may be cited as the
'Wholesome Poultry Products Act'.''
Section 1 of Pub. L. 85-172 provided: ''That this Act (enacting
this chapter and provisions set out as notes under this section) may be
cited as the 'Poultry Products Inspection Act'.''
Section 19 of Pub. L. 90-492 provided that: ''If any provisions of
this Act or of the amendments made hereby (see Short Title of 1968
Amendment note above) or the application thereof to any person or
circumstances is held invalid, the validity of the remainder of the Act
and the remaining amendments and of the application of such provision to
other persons and circumstances shall not be affected thereby.''
Section 28, formerly section 21, of Pub. L. 85-172, as renumbered by
Pub. L. 90-492, 17, Aug. 18, 1968, 82 Stat. 805, provided that: ''If
any provision of this Act (this chapter) or the application thereof to
any person or circumstances is held invalid, the validity of the
remainder of the Act and of the application of such provision to other
persons and circumstances shall not be affected thereby.''
Pub. L. 85-929, 7, Sept. 6, 1958, 72 Stat. 1789, provided that:
''Nothing in this Act (amending sections 321, 331, 342, 346, and 348 of
this title and section 210 of Title 42, The Public Health and Welfare,
and enacting provisions set out as notes under sections 321 and 342 of
this title) shall be construed to exempt any meat or meat food product
or any person from any requirement imposed by or pursuant to the Poultry
Products Inspection Act (21 U.S.C. 451 and the following) (this chapter)
or the Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended
and extended (21 U.S.C. 71 and the following) (see section 601 et seq.
of this title).''
21 USC 452. Congressional declaration of policy
TITLE 21 -- FOOD AND DRUGS
It is hereby declared to be the policy of the Congress to provide for
the inspection of poultry and poultry products and otherwise regulate
the processing and distribution of such articles as hereinafter
prescribed to prevent the movement or sale in interstate or foreign
commerce of, or the burdening of such commerce by, poultry products
which are adulterated or misbranded. It is the intent of Congress that
when poultry and poultry products are condemned because of disease, the
reason for condemnation in such instances shall be supported by
scientific fact, information, or criteria, and such condemnation under
this chapter shall be achieved through uniform inspection standards and
uniform applications thereof.
(Pub. L. 85-172, 3, Aug. 28, 1957, 71 Stat. 441; Pub. L. 90-492, 3,
Aug. 18, 1968, 82 Stat. 792.)
1968 -- Pub. L. 90-492 inserted provisions declaring the policy of
Congress to be to otherwise regulate the processing and distribution of
poultry and poultry products as hereinafter prescribed so as to prevent
the movement or sale in interstate commerce of, or the burdening of such
commerce by poultry products which are adulterated or misbranded, and
provisions that declared the policy of Congress to be that condemnation
of diseased poultry and poultry products shall be achieved through
uniform inspection standards and supported by scientific fact or
criteria, and struck out provisions that declared the policy of Congress
to be to provide for inspection by the inspection service to prevent the
movement in interstate commerce or foreign commerce or in a designated
major consuming area of poultry products which are unwholesome,
adulterated, or otherwise unfit for human food.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
21 USC 453. Definitions
TITLE 21 -- FOOD AND DRUGS
For purposes of this chapter --
(a) The term ''commerce'' means commerce between any State, any
territory, or the District of Columbia, and any place outside thereof;
or within any territory not organized with a legislative body, or the
District of Columbia.
(b) Except as otherwise provided in this chapter, the term ''State''
means any State of the United States and the Commonwealth of Puerto
Rico.
(c) The term ''territory'' means Guam, the Virgin Islands of the
United States, American Samoa, and any other territory or possession of
the United States, excluding the Canal Zone.
(d) The term ''United States'' means the States, the District of
Columbia, and the territories of the United States.
(e) The term ''poultry'' means any domesticated bird, whether live or
dead.
(f) The term ''poultry product'' means any poultry carcass, or part
thereof; or any product which is made wholly or in part from any
poultry carcass or part thereof, excepting products which contain
poultry ingredients only in a relatively small proportion or
historically have not been considered by consumers as products of the
poultry food industry, and which are exempted by the Secretary from
definition as a poultry product under such conditions as the Secretary
may prescribe to assure that the poultry ingredients in such products
are not adulterated and that such products are not represented as
poultry products.
(g) The term ''adulterated'' shall apply to any poultry product under
one or more of the following circumstances:
(1) if it bears or contains any poisonous or deleterious substance
which may render it injurious to health; but in case the substance is
not an added substance, such article shall not be considered adulterated
under this clause if the quantity of such substance in or on such
article does not ordinarily render it injurious to health;
(2)(A) if it bears or contains (by reason of administration of any
substance to the live poultry or otherwise) any added poisonous or added
deleterious substance (other than one which is (i) a pesticide chemical
in or on a raw agricultural commodity; (ii) a food additive; or (iii)
a color additive) which may, in the judgment of the Secretary, make such
article unfit for human food;
(B) if it is, in whole or in part, a raw agricultural commodity and
such commodity bears or contains a pesticide chemical which is unsafe
within the meaning of section 346a of this title;
(C) if it bears or contains any food additive which is unsafe within
the meaning of section 348 of this title;
(D) if it bears or contains any color additive which is unsafe within
the meaning of section 376 of this title: Provided, That an article
which is not otherwise deemed adulterated under clause (B), (C), or (D)
shall nevertheless be deemed adulterated if use of the pesticide
chemical, food additive, or color additive in or on such article is
prohibited by regulations of the Secretary in official establishments;
(3) if it consists in whole or in part of any filthy, putrid, or
decomposed substance or is for any other reason unsound, unhealthful,
unwholesome, or otherwise unfit for human food;
(4) if it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health;
(5) if it is, in whole or in part, the product of any poultry which
has died otherwise than by slaughter;
(6) if its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health;
(7) if it has been intentionally subjected to radiation, unless the
use of the radiation was in conformity with a regulation or exemption in
effect pursuant to section 348 of this title;
(8) if any valuable constituent has been in whole or in part omitted
or abstracted therefrom; or if any substance has been substituted,
wholly or in part therefor; or if damage or inferiority has been
concealed in any manner; or if any substance has been added thereto or
mixed or packed therewith so as to increase its bulk or weight, or
reduce its quality or strength, or make it appear better or of greater
value than it is.
(h) The term ''misbranded'' shall apply to any poultry product under
one or more of the following circumstances:
(1) if its labeling is false or misleading in any particular;
(2) if it is offered for sale under the name of another food;
(3) if it is an imitation of another food, unless its label bears, in
type of uniform size and prominence, the word ''imitation'' and
immediately thereafter, the name of the food imitated;
(4) if its container is so made, formed, or filled as to be
misleading;
(5) unless it bears a label showing (A) the name and the place of
business of the manufacturer, packer, or distributor; and (B) an
accurate statement of the quantity of the product in terms of weight,
measure, or numerical count: Provided, That under clause (B) of this
subparagraph (5), reasonable variations may be permitted, and exemptions
as to small packages or articles not in packages or other containers may
be established by regulations prescribed by the Secretary;
(6) if any word, statement, or other information required by or under
authority of this chapter to appear on the label or other labeling is
not prominently placed thereon with such conspicuousness (as compared
with other words, statements, designs, or devices, in the labeling) and
in such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use;
(7) if it purports to be or is represented as a food for which a
definition and standard of identity or composition has been prescribed
by regulations of the Secretary under section 457 of this title unless
(A) it conforms to such definition and standard, and (B) its label bears
the name of the food specified in the definition and standard and,
insofar as may be required by such regulations, the common names of
optional ingredients (other than spices, flavoring, and coloring)
present in such food;
(8) if it purports to be or is represented as a food for which a
standard or standards of fill of container have been prescribed by
regulations of the Secretary under section 457 of this title, and it
falls below the standard to fill of container applicable thereto, unless
its label bears, in such manner and form as such regulations specify, a
statement that it falls below such standard;
(9) if it is not subject to the provisions of subparagraph (7),
unless its label bears (A) the common or usual name of the food, if any
there be, and (B) in case it is fabricated from two or more ingredients,
the common or usual name of each such ingredient; except that spices,
flavorings, and colorings may, when authorized by the Secretary, be
designated as spices, flavorings, and colorings without naming each:
Provided, That to the extent that compliance with the requirements of
clause (B) of this subparagraph (9) is impracticable or results in
deception or unfair competition, exemptions shall be established by
regulations promulgated by the Secretary;
(10) if it purports to be or is represented for special dietary uses
unless its label bears such information concerning its vitamin, mineral,
and other dietary properties as the Secretary, after consultation with
the Secretary of Health and Human Services, determines to be, and by
regulations prescribes as, necessary in order fully to inform purchasers
as to its value for such uses;
(11) if it bears or contains any artificial flavoring, artificial
coloring, or chemical preservative unless it bears labeling stating that
fact: Provided, That, to the extent that compliance with the
requirements of this subparagraph (11) is impracticable, exemptions
shall be established by regulations promulgated by the Secretary; or
(12) if it fails to bear on its containers, and in the case of
nonconsumer packaged carcasses (if the Secretary so requires) directly
thereon, as the Secretary may by regulations prescribe, the official
inspection legend and official establishment number of the establishment
where the article was processed, and, unrestricted by any of the
foregoing, such other information as the Secretary may require in such
regulations to assure that it will not have false or misleading labeling
and that the public will be informed of the manner of handling required
to maintain the article in a wholesome condition.
(i) The term ''Secretary'' means the Secretary of Agriculture or his
delegate.
(j) The term ''person'' means any individual, partnership,
corporation, association, or other business unit.
(k) The term ''inspector'' means: (1) an employee or official of the
United States Government authorized by the Secretary to inspect poultry
and poultry products under the authority of this chapter, or (2) any
employee or official of the government of any State or territory or the
District of Columbia authorized by the Secretary to inspect poultry and
poultry products under authority of this chapter, under an agreement
entered into between the Secretary and the appropriate State or other
agency.
(l) The term ''official mark'' means the official inspection legend
or any other symbol prescribed by regulation of the Secretary to
identify the status of any article or poultry under this chapter.
(m) The term ''official inspection legend'' means any symbol
prescribed by regulations of the Secretary showing that an article was
inspected for wholesomeness in accordance with this chapter.
(n) The term ''official certificate'' means any certificate
prescribed by regulations of the Secretary for issuance by an inspector
or other person performing official functions under this chapter.
(o) The term ''official device'' means any device prescribed or
authorized by the Secretary for use in applying any official mark.
(p) The term ''official establishment'' means any establishment as
determined by the Secretary at which inspection of the slaughter of
poultry, or the processing of poultry products, is maintained under the
authority of this chapter.
(q) The term ''inspection service'' means the official Government
service within the Department of Agriculture designated by the Secretary
as having the responsibility for carrying out the provisions of this
chapter.
(r) The term ''container'' or ''package'' includes any box, can, tin,
cloth, plastic, or other receptacle, wrapper, or cover.
(s) The term ''label'' means a display of written, printed, or
graphic matter upon any article or the immediate container (not
including packaged liners) of any article; and the term ''labeling''
means all labels and other written, printed, or graphic matter (1) upon
any article or any of its containers or wrappers, or (2) accompanying
such article.
(t) The term ''shipping container'' means any container used or
intended for use in packaging the product packed in an immediate
container.
(u) The term ''immediate container'' includes any consumer package;
or any other container in which poultry products, not consumer packaged,
are packed.
(v) The term ''capable of use as human food'' shall apply to any
carcass, or part or product of a carcass, of any poultry, unless it is
denatured or otherwise identified as required by regulations prescribed
by the Secretary to deter its use as human foods, or it is naturally
inedible by humans.
(w) The term ''processed'' means slaughtered, canned, salted,
stuffed, rendered, boned, cut up, or otherwise manufactured or
processed.
(x) The term ''Federal Food, Drug, and Cosmetic Act'' means the Act
so entitled, approved June 25, 1938 (52 Stat. 1040) (21 U.S.C. 301 et
seq.), and Acts amendatory thereof or supplementary thereto.
(y) The terms ''pesticide chemical,'' ''food additive'', ''color
additive'', and ''raw agricultural commodity'' shall have the same
meanings for purposes of this chapter as under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).
(z) The term ''poultry products broker'' means any person engaged in
the business of buying or selling poultry products on commission, or
otherwise negotiating purchases or sales of such articles other than for
his own account or as an employee of another person.
(aa) The term ''renderer'' means any person engaged in the business
of rendering carcasses, or parts or products of the carcasses, of
poultry, except rendering conducted under inspection or exemption under
this chapter.
(bb) The term ''animal food manufacturer'' means any person engaged
in the business of manufacturing or processing animal food derived
wholly or in part from carcasses, or parts or products of the carcasses,
of poultry.
(Pub. L. 85-172, 4, Aug. 28, 1957, 71 Stat. 441; Pub. L. 87-498,
June 25, 1962, 76 Stat. 110; Pub. L. 90-492, 4, Aug. 18, 1968, 82 Stat.
792; Pub. L. 96-88, title V, 509(b), Oct. 17, 1979, 93 Stat. 695.)
The Federal Food, Drug, and Cosmetic Act, referred to in pars. (x)
and (y), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 ( 301 et seq.) of this title.
For complete classification of this Act to the Code, see section 301 of
this title and Tables.
1968 -- Pub. L. 90-492 inserted definitions of ''State'',
''territory'', ''United States'', ''misbranded'', ''official mark'',
''official inspection legend'', ''official certificate'', ''official
device'', ''capable of use as human food'', ''processed'', ''Federal
Food, Drug, and Cosmetic Act'', ''pesticide chemical'', ''poultry
products broker'', ''renderer'', and ''animal food manufacturer'',
revised definitions of ''commerce'', ''poultry'', ''poultry product'',
''adulterated'', ''Secretary'', ''inspector'', ''container'' or
''package'', ''label'', and ''immediate container'', reenacted without
change definitions of ''person'', ''official establishment'',
''inspection service'', and ''shipping container'', and deleted
definition of ''wholesome'', ''unwholesome'', and ''official inspection
mark''.
1962 -- Par. (a). Pub. L. 87-498 struck out references to
Territories or possessions, and inserted definition of ''State''.
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in par. (h)(10)
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
2602.
21 USC 454. Federal and State cooperation in development and
administration of State poultry product inspection programs
TITLE 21 -- FOOD AND DRUGS
(a) State laws; planning, technical and financial assistance;
advisory committees
It is the policy of the Congress to protect the consuming public from
poultry products that are adulterated or misbranded and to assist in
efforts by State and other government agencies to accomplish this
objective. In furtherance of this policy --
(1) The Secretary is authorized, whenever he determines that it would
effectuate the purposes of this chapter, to cooperate with the
appropriate State agency in developing and administering a State poultry
product inspection program in any State which has enacted a mandatory
State poultry product inspection law that imposes ante mortem and post
mortem inspection, reinspection and sanitation requirements that are at
least equal to those under this chapter, with respect to all or certain
classes of persons engaged in the State in slaughtering poultry or
processing poultry products for use as human food solely for
distribution within such State.
(2) The Secretary is further authorized, whenever he determines that
it would effectuate the purposes of this chapter, to cooperate with
appropriate State agencies in developing and administering State
programs under State laws containing authorities at least equal to those
provided in section 460 of this title; and to cooperate with other
agencies of the United States in carrying out any provisions of this
chapter. In carrying out the provisions of this chapter, the Secretary
may conduct such examinations, investigations, and inspections as he
determines practicable through any officer or employee of any State or
Territory or the District of Columbia commissioned by the Secretary for
such purpose.
(3) Cooperation with State agencies under this section may include
furnishing to the appropriate State agency (i) advisory assistance in
planning and otherwise developing an adequate State program under the
State law; and (ii) technical and laboratory assistance and training
(including necessary curricular and instructional materials and
equipment), and financial and other aid for administration of such a
program. The amount to be contributed to any State by the Secretary
under this section from Federal funds for any year shall not exceed 50
per centum of the estimated total cost of the cooperative program; and
the Federal funds shall be allocated among the States desiring to
cooperate on an equitable basis. Such cooperation and payment shall be
contingent at all times upon the administration of the State program in
a manner which the Secretary, in consultation with the appropriate
advisory committee appointed under subparagraph (4), deems adequate to
effectuate the purposes of this section.
(4) The Secretary may appoint advisory committees consisting of such
representatives of appropriate State agencies as the Secretary and the
State agencies may designate to consult with him concerning State and
Federal programs with respect to poultry product inspection and other
matters within the scope of this chapter, including evaluating State
programs for purposes of this chapter, and obtaining better coordination
and more uniformity among the State programs and between the Federal and
State programs and adequate protection of consumers.
(b) Appropriate State agency; performance of functions by
subordinate governmental unit
The appropriate State agency with which the Secretary may cooperate
under this chapter shall be a single agency in the State which is
primarily responsible for the coordination of the State programs having
objectives similar to those under this chapter. When the State program
includes performance of certain functions by a municipality or other
subordinate governmental unit, such unit shall be deemed to be a part of
the State agency for purposes of this section.
(c) Intrastate activities; designation of State for regulation;
publication of designation; exempted operations; termination of
designation; review of operations in nondesignated States; annual
report
(1) If the Secretary has reason to believe, by thirty days prior to
the expiration of two years after August 18, 1968, that a State has
failed to develop or is not enforcing, with respect to all
establishments within its jurisdiction (except those that would be
exempted from Federal inspection under subparagraph (2) of this
paragraph (c)) at which poultry are slaughtered, or poultry products are
processed for use as human food, solely for distribution within such
State, and the products of such establishments, requirements at least
equal to those imposed under sections 451 to 453, 455 to 459, 461 to
467d of this title, he shall promptly notify the Governor of the State
of this fact. If the Secretary determines, after consultation with the
Governor of the State, or representative selected by him, that such
requirements have not been developed and activated, he shall promptly
after the expiration of such two-year period designate such State as one
in which the provisions of said sections of this chapter shall apply to
operations and transactions wholly within such State: Provided, That if
the Secretary has reason to believe that the State will activate such
requirements within one additional year, he may delay such designation
for said period, and not designate the State, if he determines at the
end of the year that the State then has such requirements in effective
operation. The Secretary shall publish any such designation in the
Federal Register and, upon the expiration of thirty days after such
publication, the provisions of said sections of this chapter shall apply
to operations and transactions and to persons engaged therein in the
State to the same extent and in the same manner as if such operations
and transactions were conducted in or for commerce. However,
notwithstanding any other provision of this section, if the Secretary
determines that any establishment within a State is producing
adulterated poultry products for distribution within such State which
would clearly endanger the public health he shall notify the Governor of
the State and the appropriate advisory committee provided for by
subparagraph (a)(4) of this section of such fact for effective action
under State or local law. If the State does not take action to prevent
such endangering of the public health within a reasonable time after
such notice, as determined by the Secretary, in light of the risk to
public health, the Secretary may forthwith designate any such
establishment as subject to the provisions of said sections of this
chapter, and thereupon the establishment and operator thereof shall be
subject to such provisions as though engaged in commerce until such time
as the Secretary determines that such State has developed and will
enforce requirements at least equal to those imposed under said
sections.
(2) The provisions of this chapter requiring inspection of the
slaughter of poultry and the processing of poultry products shall not
apply to operations of types traditionally and usually conducted at
retail stores and restaurants, when conducted at any retail store or
restaurant or similar retail-type establishment for sale in normal
retail quantities or service of such articles to consumers at such
establishments if such establishment are subject to such inspection
provisions only under this paragraph (c). For the purposes of this
subparagraph, operations conducted at a restaurant central kitchen
facility shall be considered as being conducted at a restaurant if the
restaurant central kitchen prepares poultry products that are ready to
eat when they leave such facility and are served in meals or as entrees
only to customers at restaurants owned or operated by the same person
owning or operating such facility: Provided, That such facility shall
be subject to the provisions of section 460(b) of this title: Provided
further, That the facility may be subject to the inspection requirements
of this chapter for as long as the Secretary deems necessary, if the
Secretary determines that the sanitary conditions or practices of the
facility or the processing procedures or methods at the facility are
such that any of its poultry products are rendered adulterated.
(3) Whenever the Secretary determines that any State designated under
this paragraph (c) has developed and will enforce State poultry products
inspection requirements at least equal to those imposed under the
aforesaid sections of this chapter, with respect to the operations and
transactions within such State which are regulated under subparagraph
(1) of this paragraph (c), he shall terminate the designation of such
State under this paragraph (c), but this shall not preclude the
subsequent redesignation of the State at any time upon thirty days'
notice to the Governor and publication in the Federal Register in
accordance with this paragraph, and any State may be designated upon
such notice and publication, at any time after the period specified in
this paragraph whether or not the State has theretofore been designated,
upon the Secretary determining that it is not effectively enforcing
requirements at least equal to those imposed under said sections.
(4) The Secretary shall promptly upon August 18, 1968, and
periodically thereafter, but at least annually, review the requirements,
including the enforcement thereof, of the several States not designated
under this paragraph (c), with respect to the slaughter, and the
processing, storage, handling, and distribution of poultry products, and
inspection of such operations, and annually report thereon to the
Committee on Agriculture of the House of Representatives and the
Committee on Agriculture, Nutrition, and Forestry of the Senate in the
report required in section 470 of this title.
(d) ''State'' defined
As used in this section, the term ''State'' means any State
(including the Commonwealth of Puerto Rico) or organized territory.
(Pub. L. 85-172, 5, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90-492, 5,
Aug. 18, 1968, 82 Stat. 796; S. Res. 4, Feb. 4, 1977; Pub. L. 98-487,
2, Oct. 17, 1984, 98 Stat. 2264.)
In par. (c)(1), (4), ''August 18, 1968'' substituted for ''enactment
of the Wholesome Poultry Products Act''.
1984 -- Par. (c)(2). Pub. L. 98-487 inserted provisions relating to
operations conducted at a restaurant central kitchen facility.
1968 -- Pub. L. 90-492 substituted provisions authorizing the
Secretary to cooperate with the appropriate state agency in the
development and administration of state poultry product inspection
programs in those states having mandatory poultry product inspection
laws and those states having laws at least equal to the provisions of
section 460 of this title, provisions authorizing planning, technical
and financial assistance and the appointment of advisory committees,
provisions designating the appropriate state agency with which the
Secretary may cooperate, provisions authorizing the Secretary to
designate states as subject to the regulatory provisions of this chapter
when the requirements of the specified section have not been complied
with or when the specified intrastate activities are present, provisions
exempting from the requirements of this chapter operations of the types
traditionally and usually conducted at retail stores and restaurants,
provisions authorizing the Secretary to terminate the aforementioned
designation of states as subject to the regulatory provisions of this
chapter, and provisions authorizing the Secretary to review the
operations in nondesignated states and make an annual report thereon,
for provisions authorizing the Secretary, upon application by any
appropriate state or local official or agency or by any appropriate
local poultry industry group and after public hearing, to designate
major consuming areas as subject to the regulatory provisions of this
chapter where the Secretary finds that poultry or poultry products are
handled or consumed in such volume as to affect, burden or obstruct the
movement of inspected poultry products in interstate commerce.
Committee on Agriculture and Forestry of the Senate abolished and
replaced by Committee on Agriculture, Nutrition, and Forestry of the
Senate, effective Feb. 11, 1977. See Rule XXV of Standing Rules of the
Senate, as amended by Senate Resolution 4 (popularly cited as the
''Committee System Reorganization Amendments of 1977''), approved Feb.
4, 1977.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
21 USC 455. Inspection in official establishments
TITLE 21 -- FOOD AND DRUGS
(a) Ante mortem inspection
For the purpose of preventing the entry into or flow or movement in
commerce of, or the burdening of commerce by, any poultry product which
is capable of use as human food and is adulterated, the Secretary shall,
where and to the extent considered by him necessary, cause to be made by
inspectors ante mortem inspection of poultry in each official
establishment processing poultry or poultry products for commerce or
otherwise subject to inspection under this chapter.
(b) Post mortem inspection; quarantine, segregation, and
reinspection
The Secretary, whenever processing operations are being conducted,
shall cause to be made by inspectors post mortem inspection of the
carcass of each bird processed, and at any time such quarantine,
segregation, and reinspection as he deems necessary of poultry and
poultry products capable of use as human food in each official
establishment processing such poultry or poultry products for commerce
or otherwise subject to inspection under this chapter.
(c) Condemnation; appeal; reprocessing
All poultry carcasses and parts thereof and other poultry products
found to be adulterated shall be condemned and shall, if no appeal be
taken from such determination of condemnation, be destroyed for human
food purposes under the supervision of an inspector: Provided, That
carcasses, parts, and products, which may by reprocessing be made not
adulterated, need not be so condemned and destroyed if so reprocessed
under the supervision of an inspector and thereafter found to be not
adulterated. If an appeal be taken from such determination, the
carcasses, parts, or products shall be appropriately marked and
segregated pending completion of an appeal inspection, which appeal
shall be at the cost of the appellant if the Secretary determines that
the appeal is frivolous. If the determination of condemnation is
sustained the carcasses, parts, and products shall be destroyed for
human food purposes under the supervision of an inspector.
(Pub. L. 85-172, 6, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90-492, 6,
Aug. 18, 1968, 82 Stat. 798.)
1968 -- Par. (a). Pub. L. 90-492, 6(a), substituted ''of, or the
burdening of commerce by, any poultry product which is capable of use as
human food and is adulterated,'' for ''or a designated major consuming
area of any poultry product which is unwholesome or adulterated,''
''each official establishment'' for ''any official establishment'', and
''otherwise subject to inspection under this chapter'' for ''in, or for
marketing in a designated city or area''.
Par. (b). Pub. L. 90-492, 6(b), substituted ''segregation, and
reinspection'' for ''segregation, reinspection'', and ''otherwise
subject to inspection under this chapter'' for ''in, or for marketing in
a designated city or area'', and inserted ''capable of use as human
food'' after ''necessary of poultry and poultry products''.
Par. (c). Pub. L. 90-492, 6(c), inserted ''other'' before ''poultry
products'', and substituted ''to be adulterated'' for ''to be
unwholesome or adulterated'', ''made not adulterated'' for ''made not
unwholesome and not adulterated'', and ''to be not adulterated'' for
''to be not unwholesome and not adulterated''.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
21 USC 456. Operation of premises, facilities and equipment
TITLE 21 -- FOOD AND DRUGS
(a) Sanitary practices
Each official establishment slaughtering poultry or processing
poultry products for commerce or otherwise subject to inspection under
this chapter shall have such premises, facilities, and equipment, and be
operated in accordance with such sanitary practices, as are required by
regulations promulgated by the Secretary for the purpose of preventing
the entry into or flow or movement in commerce or burdensome effect upon
commerce, of poultry products which are adulterated.
(b) Refusal of inspection
The Secretary shall refuse to render inspection to any establishment
whose premises, facilities, or equipment, or the operation thereof, fail
to meet the requirements of this section.
(Pub. L. 85-172, 7, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90-492, 7,
Aug. 18, 1968, 82 Stat. 799.)
1968 -- Par. (a). Pub. L. 90-492 substituted ''otherwise subject to
inspection under this chapter'' for ''in or for marketing in a
designated major consuming area'', ''burdensome effect upon commerce''
for ''in a designated major consuming area'', and ''which are
adulterated'' for ''which are unwholesome or adulterated''.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
21 USC 457. Labeling and container standards
TITLE 21 -- FOOD AND DRUGS
(a) Requirements for shipping containers and immediate containers;
nonconsumer packaged carcasses
All poultry products inspected at any official establishment under
the authority of this chapter and found to be not adulterated, shall at
the time they leave the establishment bear, in distinctly legible form,
on their shipping containers and immediate containers as the Secretary
may require, the information required under paragraph (h) of section 453
of this title. In addition, the Secretary whenever he determines such
action is practicable and necessary for the protection of the public,
may require nonconsumer packaged carcasses at the time they leave the
establishment to bear directly thereon in distinctly legible form any
information required under such paragraph (h).
(b) Labeling requirements; definitions and standards of identity or
composition or articles and standards of fill of container; standards
consistent with Federal Food, Drug, and Cosmetic Act; consistency
between Federal and State standards
The Secretary, whenever he determines such action is necessary for
the protection of the public, may prescribe: (1) the styles and sizes
of type to be used with respect to material required to be incorporated
in labeling to avoid false or misleading labeling in marketing and
labeling any articles or poultry subject to this chapter; (2)
definitions and standards of identity or composition or articles subject
to this chapter and standards of fill of container for such articles not
inconsistent with any such standards established under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and there shall be
consultation between the Secretary and the Secretary of Health and Human
Services prior to the issuance of such standards under either Act
relating to articles subject to this chapter to avoid inconsistency in
such standards and possible impairment of the coordinated effective
administration of this chapter and the Federal Food, Drug, and Cosmetic
Act. There shall also be consultation between the Secretary and an
appropriate advisory committee provided for in section 454 of this
title, prior to the issuance of such standards under this chapter, to
avoid, insofar as feasible, inconsistency between Federal and State
standards.
(c) Use of trade names; false or misleading marking or labeling;
misleading form or size of container
No article subject to this chapter shall be sold or offered for sale
by any person in commerce, under any name or other marking or labeling
which is false or misleading, or in any container of a misleading form
or size, but established trade names and other marking and labeling and
containers which are not false or misleading and which are approved by
the Secretary are permitted.
(d) Withholding use of false or misleading mark, label, or container
size or form; modification; hearing; conclusiveness of determination;
appeal
If the Secretary has reason to believe that any marking or labeling
or the size or form of any container in use or proposed for use with
respect to any article subject to this chapter is false or misleading in
any particular, he may direct that such use be withheld unless the
marking, labeling, or container is modified in such manner as he may
prescribe so that it will not be false or misleading. If the person
using or proposing to use the marketing, labeling, or container does not
accept the determination of the Secretary, such person may request a
hearing, but the use of the marking, labeling, or container shall, if
the Secretary so directs, be withheld pending hearing and final
determination by the Secretary. Any such determination by the Secretary
shall be conclusive unless, within thirty days after receipt of notice
of such final determination, the person adversely affected thereby
appeals to the United States Court of Appeals for the circuit in which
such person has its principal place of business or to the United States
Court of Appeals for the District of Columbia Circuit. The provisions
of section 194 of title 7 shall be applicable to appeals taken under
this section.
(Pub. L. 85-172, 8, Aug. 28, 1957, 71 Stat. 444; Pub. L. 90-492, 8,
Aug. 18, 1968, 82 Stat. 799; Pub. L. 96-88, title V, 509(b), Oct. 17,
1979, 93 Stat. 695.)
The Federal Food, Drug, and Cosmetic Act, referred to in par. (b), is
act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
classified generally to chapter 9 ( 301 et seq.) of this title. For
complete classification of this Act to the Code, see section 301 of this
title and Tables.
1968 -- Par. (a). Pub. L. 90-492 substituted provisions requiring
shipping containers and immediate containers, as the Secretary may
order, to bear the information required under section 453(h) of this
title, and provisions, whenever the Secretary determines such action to
be practicable and necessary, requiring nonconsumer packaged carcasses
at the time they leave the official establishment to bear the
information required under the aforementioned section, for provisions
requiring shipping containers to bear the official mark and the approved
plant number of the official establishment in which the contents were
processed, provisions requiring immediate containers to bear the
official inspection mark, the name of the product, a statement of
ingredients, the net weight or other appropriate measure of the
contents, the name and address of the processor, and the approved plant
number of the official establishment in which the contents were
processed, and provisions authorizing the Secretary to make reasonable
variations and grant exemptions from the foregoing labeling
requirements.
Par. (b). Pub. L. 90-492 added par. (b). Provisions of former par.
(b) were redesignated as pars. (c) and (d).
Par. (c). Pub. L. 90-492 redesignated part of provisions of former
par. (b) as (c) and made changes in phraseology.
Par. (d). Pub. L. 90-492 redesignated part of provisions of former
par. (b) as (d) and extended the authority of the Secretary to withhold
from use products which have false or misleading markings or containers.
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in par. (b) pursuant to
section 509(b) of Pub. L. 96-88, which is classified to section 3508(b)
of Title 20, Education.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
21 USC 458. Prohibited acts
TITLE 21 -- FOOD AND DRUGS
(a) No person shall --
(1) slaughter any poultry or process any poultry products which are
capable of use as human food at any establishment processing any such
articles for commerce, except in compliance with the requirements of
this chapter;
(2) sell, transport, offer for sale or transportation, or receive for
transportation, in commerce, (A) any poultry products which are capable
of use as human food and are adulterated or misbranded at the time of
such sale, transportation, offer for sale or transportation, or receipt
for transportation; or (B) any poultry products required to be
inspected under this chapter unless they have been so inspected and
passed;
(3) do, with respect to any poultry products which are capable of use
as human food, any act while they are being transported in commerce or
held for sale after such transportation, which is intended to cause or
has the effect of causing such products to be adulterated or misbranded;
(4) sell, transport, offer for sale or transportation, or receive for
transportation, in commerce or from an official establishment, any
slaughtered poultry from which the blood, feathers, feet, head, or
viscera have not been removed in accordance with regulations promulgated
by the Secretary, except as may be authorized by regulations of the
Secretary;
(5) use to his own advantage, or reveal other than to the authorized
representatives of the United States Government or any State or other
government in their official capacity, or as ordered by a court in any
judicial proceedings, any information acquired under the authority of
this chapter concerning any matter which is entitled to protection as a
trade secret.
(b) No brand manufacturer, printer, or other person shall cast,
print, lithograph, or otherwise make any device containing any official
mark or simulation thereof, or any label bearing any such mark or
simulation, or any form of official certificate or simulation thereof,
except as authorized by the Secretary.
(c) No person shall --
(1) forge any official device, mark, or certificate;
(2) without authorization from the Secretary use any official device,
mark, or certificate, or simulation thereof, or alter, detach, deface,
or destroy any official device, mark, or certificate;
(3) contrary to the regulations prescribed by the Secretary, fail to
use, or to detach, deface, or destroy any official device, mark, or
certificate;
(4) knowingly possess, without promptly notifying the Secretary or
his representative, any official device or any counterfeit, simulated,
forged, or improperly altered official certificate or any device or
label or any carcass of any poultry, or part or product thereof, bearing
any counterfeit, simulated, forged, or improperly altered official mark;
(5) knowingly make any false statement in any shipper's certificate
or other nonofficial or official certificate provided for in the
regulations prescribed by the Secretary; or
(6) knowingly represent that any article has been inspected and
passed, or exempted, under this chapter when, in fact, it has
respectively, not been so inspected and passed, or exempted.
(Pub. L. 85-172, 9, Aug. 28, 1957, 71 Stat. 445; Pub. L. 90-492, 9,
Aug. 18, 1968, 82 Stat. 800.)
1968 -- Pub. L. 90-492 made revisions in form and phraseology, added
to the enumerated prohibited acts slaughtering poultry or processing any
poultry products capable of use as human food, except in compliance with
the requirements of this chapter, selling and transporting adulterated
or misbranded poultry products or uninspected poultry products,
adulterating or misbranding poultry products while they are being
transported in commerce or held for sale after such transportation,
treating carcasses not in accordance with regulations promulgated by the
Secretary, possessing, without notifying the Secretary, any official
device or any counterfeit, simulated, etc., official certificate, or any
device or label bearing any counterfeit, simulated, etc., official mark,
and making false representations and statements, and clarified
application to brand manufacturers and printers of existing provisions
prohibiting the counterfeiting of official marks, labels, or
certificates.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, except that
amendment of pars. (a)(2)(A) and (a)(3) effective upon the expiration
of sixty days after Aug. 18, 1968, see section 20 of Pub. L. 90-492,
set out as a note under section 451 of this title.
21 USC 459. Compliance by all establishments
TITLE 21 -- FOOD AND DRUGS
No establishment processing poultry or poultry products for commerce
otherwise subject to this chapter shall process any poultry or poultry
product except in compliance with the requirements of this chapter.
(Pub. L. 85-172, 10, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90-492,
10, Aug. 18, 1968, 82 Stat. 801.)
1968 -- Pub. L. 90-492 substituted ''otherwise subject to this
chapter'' for ''in or for marketing in a designated major consuming
area''.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
21 USC 460. Miscellaneous activities subject to regulation
TITLE 21 -- FOOD AND DRUGS
(a) Prohibition of inspection of articles not intended for use as
human food; denaturation or other identification prior to distribution
in commerce; inedible articles
Inspection shall not be provided under this chapter at any
establishment for the slaughter of poultry or the processing of any
carcasses or parts or products of poultry, which are not intended for
use as human food, but such articles shall, prior to their offer for
sale or transportation in commerce, unless naturally inedible by humans,
be denatured or otherwise identified as prescribed by regulations of the
Secretary to deter their use for human food. No person shall buy, sell,
transport, or offer for sale or transportation, or receive for
transportation, in commerce, or import, any poultry carcasses or parts
or products thereof which are not intended for use as human food unless
they are denatured or otherwise identified as required by the
regulations of the Secretary or are naturally inedible by humans.
(b) Recordkeeping requirements; persons liable; scope of
disclosure; access to places of business; examination of records,
facilities, and inventories; copies; samples
The following classes of persons shall, for such period of time as
the Secretary may by regulations prescribe, not to exceed two years
unless otherwise directed by the Secretary for good cause shown, keep
such records as are properly necessary for the effective enforcement of
this chapter in order to insure against adulterated or misbranded
poultry products for the American consumer; and all persons subject to
such requirements shall, at all reasonable times, upon notice by a duly
authorized representative of the Secretary, afford such representative
access to their places of business and opportunity to examine the
facilities, inventory, and records thereof, to copy all such records,
and to take reasonable samples of their inventory upon payment of the
fair market value therefor --
(1) Any person that engages in the business of slaughtering any
poultry or processing, freezing, packaging, or labeling any carcasses,
or parts or products of carcasses, of any poultry, for commerce, for use
as human food or animal food;
(2) Any person that engages in the business of buying or selling (as
poultry products brokers, wholesalers or otherwise), or transporting, in
commerce, or storing in or for commerce, or importing, any carcasses, or
parts or products of carcasses, of any poultry;
(3) Any person that engages in business, in or for commerce, as a
renderer, or engages in the business of buying, selling, or
transporting, in commerce, or importing, any dead, dying, disabled, or
diseased poultry or parts of the carcasses of any poultry that died
otherwise than by slaughter.
(c) Registration of business, name of person, and trade names
No person shall engage in business, in or for commerce, as a poultry
products broker, renderer, or animal food manufacturer, or engage in
business in commerce as a wholesaler of any carcasses, or parts or
products of the carcasses, of any poultry, whether intended for human
food or other purposes, or engage in business as a public warehouseman
storing any such articles in or for commerce, or engage in the business
of buying, selling, or transporting in commerce, or importing, any dead,
dying, disabled, or diseased poultry, or parts of the carcasses of any
poultry that died otherwise than by slaughter, unless when required by
regulations of the Secretary, he has registered with the Secretary his
name, and the address of each place of business at which, and all trade
names under which, he conducts such business.
(d) Regulation of transactions, transportation, or importation of
dead, dying, disabled or diseased poultry or carcasses to prevent use as
human food
No person engaged in the business of buying, selling, or transporting
in commerce, or importing, dead, dying, disabled, or diseased poultry,
or any parts of the carcasses of any poultry that died otherwise than by
slaughter, shall buy, sell, transport, offer for sale or transportation,
or receive for transportation, in commerce, or import, any dead, dying,
disabled, or diseased poultry or parts of the carcasses of any poultry
that died otherwise than by slaughter, unless such transaction,
transportation or importation is made in accordance with such
regulations as the Secretary may prescribe to assure that such poultry,
or the unwholesome parts or products thereof, will be prevented from
being used for human food.
(e) Federal provisions applicable to State or Territorial business
transactions of a local nature and not subject to local authority
The authority conferred on the Secretary by paragraph (b), (c), or
(d) of this section with respect to persons engaged in the specified
kinds of business in or for commerce may be exercised with respect to
persons engaged, in any State or organized territory, in such kinds of
business but not in or for commerce, whenever the Secretary determines,
after consultation with an appropriate advisory committee provided for
in section 454 of this title, that the State or territory does not have
at least equal authority under its laws or such authority is not
exercised in a manner to effectuate the purposes of this chapter,
including the State or territory providing for the Secretary or his
representative being afforded access to such places of business and the
facilities, inventories, and records thereof, and the taking of
reasonable samples, where he determines necessary in carrying out his
responsibilities under this chapter; and in such case the provisions of
paragraph (b), (c), or (d) of this section, respectively, shall apply to
such persons to the same extent and in the same manner as if they were
engaged in such business in or for commerce and the transactions
involved were in commerce.
(Pub. L. 85-172, 11, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90-492,
11, Aug. 18, 1968, 82 Stat. 801.)
1968 -- Pub. L. 90-492 designated existing provisions as par. (b),
added pars. (a), and (c) to (e), and in par. (b), as so designated,
extended the types of persons required to maintain records necessary for
the enforcement of this chapter, required such persons to give
representatives of the Secretary access to their places of business, and
opportunity to examine records, facilities, and inventories and to copy
records and take inventory samples upon payment.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, except that
par. (d) effective upon the expiration of sixty days after Aug. 18,
1968, see section 20 of Pub. L. 90-492, set out as a note under section
451 of this title.
21 USC 461. Offenses and punishment
TITLE 21 -- FOOD AND DRUGS
(a) Violations; liability of agents, employees, and employers
Any person who violates the provisions of section 458, 459, 460, 463,
or 466 of this title shall be fined not more than $1,000 or imprisoned
not more than one year, or both; but if such violation involves intent
to defraud, or any distribution or attempted distribution of an article
that is adulterated (except as defined in section 453(g)(8) of this
title), such person shall be fined not more than $10,000 or imprisoned
not more than three years, or both. When construing or enforcing the
provisions of said sections the act, omission, or failure of any person
acting for or employed by any individual, partnership, corporation, or
association within the scope of his employment or office shall in every
case be deemed the act, omission, or failure of such individual,
partnership, corporation, or association, as well as of such person.
(b) Liability of carrier
No carrier shall be subject to the penalties of this chapter, other
than the penalties for violation of section 460 of this title, by reason
of his receipt, carriage, holding, or delivery, in the usual course of
business, as a carrier, of poultry or poultry products, owned by another
person unless the carrier has knowledge, or is in possession of facts
which would cause a reasonable person to believe that such poultry or
poultry products were not inspected or marked in accordance with the
provisions of this chapter or were otherwise not eligible for
transportation under this chapter or unless the carrier refuses to
furnish on request of a representative of the Secretary the name and
address of the person from whom he received such poultry or poultry
products, and copies of all documents, if any there be, pertaining to
the delivery of the poultry or poultry products to such carrier.
(c) Assaulting, resisting, or impeding certain persons; murder;
punishments
Any person who forcibly assaults, resists, opposes, impedes,
intimidates, or interferes with any person while engaged in or on
account of the performance of his official duties under this chapter
shall be fined not more than $5,000 or imprisoned not more than three
years, or both. Whoever, in the commission of any such acts, uses a
deadly or dangerous weapon, shall be fined not more than $10,000 or
imprisoned not more than ten years, or both. Whoever kills any person
while engaged in or on account of the performance of his official duties
under this chapter shall be punished as provided under sections 1111 and
1114 of title 18.
(Pub. L. 85-172, 12, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90-492,
12, Aug. 18, 1968, 82 Stat. 802.)
1968 -- Par. (a). Pub. L. 90-492, 12(a), inserted reference to
violations of section 463 of this title, and substituted provisions that
violators of the enumerated sections shall be fined not more than $1,000
or imprisoned not more than one year, or both, but that in cases
involving intent to defraud, or any distribution or attempt to
distribute adulterated articles, except as defined in section 453(g) of
this title, the violators shall be fined not more than $10,000 or
imprisoned not more than three years, or both, for provisions that
violators shall be guilty of a misdemeanor and subject to imprisonment
for not more than six months or a fine of not more than $3,000, or both,
with increased fines and imprisonment for any subsequent violations.
Par. (b). Pub. L. 90-492, 12(b), substituted ''of poultry'' for ''of
slaughtered poultry'', ''such poultry'' for ''such slaughtered
poultry'', and ''otherwise not eligible'' for ''not otherwise
eligible'', and inserted provision that no carrier shall be subject to
punishment unless the carrier refuses to furnish the name and address of
the person from whom he received such poultry or poultry products, and
copies of any documents pertaining to the delivery of the poultry or
poultry products to such carrier.
Par. (c). Pub. L. 90-492, 12(c), added par. (c).
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
21 USC 462. Reporting of violations; notice; opportunity to present
views
TITLE 21 -- FOOD AND DRUGS
Before any violation of this chapter is reported by the Secretary to
any United States attorney for institution of a criminal proceeding, the
person against whom such proceeding is contemplated shall be given
reasonable notice of the alleged violation and opportunity to present
his views orally or in writing with regard to such contemplated
proceeding. Nothing in this chapter shall be construed as requiring the
Secretary to report for criminal prosecution violations of this chapter
whenever he believes that the public interest will be adequately served
and compliance with the chapter obtained by a suitable writtdn notice or
warning.
(Pub. L. 85-172, 13, Aug. 28, 1957, 71 Stat. 447.)
21 USC 463. Rules and regulations
TITLE 21 -- FOOD AND DRUGS
(a) Storage and handling of poultry products; violation of
regulations
The Secretary may by regulations prescribe conditions under which
poultry products capable of use as human food, shall be stored or
otherwise handled by any person engaged in the business of buying,
selling, freezing, storing, or transporting, in or for commerce, or
importing, such articles, whenever the Secretary deems such action
necessary to assure that such articles will not be adulterated or
misbranded when delivered to the consumer. Violation of any such
regulation is prohibited.
(b) Other necessary rules and regulations
The Secretary shall promulgate such other rules and regulations as
are necessary to carry out the provisions of this chapter.
(c) Oral presentation of views
In applying the provisions of section 553(c) of title 5 to proposed
rule making under this chapter, an opportunity for the oral presentation
of views shall be accorded all interested persons.
(Pub. L. 85-172, 14, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90-492,
13, Aug. 18, 1968, 82 Stat. 803.)
1968 -- Pub. L. 90-492 designated existing provisions as par. (b),
added pars. (a) and (c), and in par. (b), as so designated,
substituted ''such other rules'' for ''such rules''.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
21 USC 464. Exemptions
TITLE 21 -- FOOD AND DRUGS
(a) Persons exempted
The Secretary shall, by regulation and under such conditions as to
sanitary standards, practices, and procedures as he may prescribe,
exempt from specific provisions of this chapter --
(1) retail dealers with respect to poultry products sold directly to
consumers in individual retail stores, if the only processing operation
performed by such retail dealers is the cutting up of poultry products
on the premises where such sales to consumers are made;
(2) for such period of time as the Secretary determines that it would
be impracticable to provide inspection and the exemption will aid in the
effective administration of this chapter, any person engaged in the
processing of poultry or poultry products for commerce and the poultry
or poultry products processed by such person: Provided, however, That
no such exemption shall continue in effect on and after January 1, 1970;
and
(3) persons slaughtering, processing, or otherwise handling poultry
or poultry products which have been or are to be processed as required
by recognized religious dietary laws, to the extent that the Secretary
determines necessary to avoid conflict with such requirements while
still effectuating the purposes of this chapter.
(b) Territorial exemption
The Secretary may, under such sanitary conditions as he may by
regulations prescribe, exempt from the inspection requirements of this
chapter the slaughter of poultry, and the processing of poultry
products, by any person in any Territory not organized with a
legislative body, solely for distribution within such Territory, when
the Secretary determines that it is impracticable to provide such
inspection within the limits of funds appropriated for administration of
this chapter and that such exemption will aid in the effective
administration of this chapter.
(c) Personal slaughtering; custom slaughtering; name and address of
the poultry producer or processor in lieu of other labeling
requirements; small enterprises; slaughterers or processors of
specified number of turkeys; poultry producers raising poultry on own
farms
(1) The Secretary shall, by regulation and under such conditions,
including sanitary standards, practices, and procedures, as he may
prescribe, exempt from specific provisions of this chapter --
(A) the slaughtering by any person of poultry of his own raising, and
the processing by him and transportation in commerce of the poultry
products exclusively for use by him and members of his household and his
nonpaying guests and employees;
(B) the custom slaughter by any person of poultry delivered by the
owner thereof for such slaughter, and the processing by such slaughterer
and transportation in commerce of the poultry products exclusively for
use, in the household of such owner, by him and members of his household
and his nonpaying guests and employees: Provided, That such custom
slaughterer does not engage in the business of buying or selling any
poultry products capable of use as human food;
(C) the slaughtering and processing of poultry products in any State
or Territory or the District of Columbia by any poultry producer on his
own premises with respect to sound and healthy poultry raised on his
premises and the distribution by any person solely within such
jurisdiction of the poultry products derived from such operations, if,
in lieu of other labeling requirements, such poultry products are
identified with the name and address of such poultry producer, and if
they are not otherwise misbranded, and are sound, clean, and fit for
human food when so distributed; and
(D) the slaughtering of sound and healthy poultry or the processing
of poultry products of such poultry in any State or territory or the
District of Columbia by any poultry producer or other person for
distribution by him solely within such jurisdiction directly to
household consumers, restaurants, hotels, and boarding houses, for use
in their own dining rooms, or in the preparation of meals for sales
direct to consumers, if, in lieu of other labeling requirements, such
poultry products are identified with the name and address of the
processor, and if they are not otherwise misbranded and are sound,
clean, and fit for human food when distributed by such processor.
The exemptions provided for in clauses (C) and (D) above shall not
apply if the poultry producer or other person engages in the current
calendar year in the business of buying or selling any poultry or
poultry products other than as specified in such clauses.
(2) In addition to the specific exemptions provided herein, the
Secretary shall, when he determines that the protection of consumers
from adulterated or misbranded poultry products will not be impaired by
such action, provide by regulation, consistent with subparagraph (3),
for the exemption of the operation and products of small enterprises
(including poultry producers), not exempted under subparagraph (1),
which are engaged in any State or Territory or the District of Columbia
in slaughtering and/or cutting up poultry for distribution as carcasses
or parts thereof solely for distribution within such jurisdiction, from
such provisions of this chapter as he deems appropriate, while still
protecting the public from adulterated or misbranded products, under
such conditions, including sanitary requirements, as he shall prescribe
to effectuate the purposes of this chapter.
(3) No exemption under subparagraph (1)(C) or (D) or subparagraph (2)
shall apply to any poultry producer or other person who, in the current
calendar year --
(A) slaughters or processes the products of more than 20,000 poultry;
or
(B) slaughters or processes the products of poultry at a facility
used for slaughtering or processing of the products of poultry by any
other poultry producer or person.
Notwithstanding clause (B), the Secretary may grant such exemption to
any poultry producer or other person if the Secretary determines, upon
application of such poultry producer or other person, that granting such
exemption will not impair effectuating the purposes of this chapter.
(4) The provisions of this chapter shall not apply to poultry
producers with respect to poultry of their own raising on their own
farms if (i) such producers slaughter not more than 1,000 poultry during
the calendar year for which this exemption is being determined; (ii)
such poultry producers do not engage in buying or selling poultry
products other than those produced from poultry raised on their own
farms; and (iii) none of such poultry moves in commerce (as defined in
section 453(a) of this title).
(d) Pizzas containing poultry products
(1) Under such terms and conditions as the Secretary shall prescribe
through rules and regulations issued under this section that may be
necessary to ensure food safety and protect public health such as
special handling procedures, the Secretary shall exempt pizzas
containing a poultry product from the inspection requirements of this
chapter if --
(A) the poultry product components of the pizzas have been prepared,
inspected, and passed in a cured or cooked form as ready-to-eat in
compliance with the requirements of this chapter; and
(B) the pizzas are to be served in public or private nonprofit
institutions.
(2) The Secretary may withdraw or modify any exemption under this
subsection whenever the Secretary determines such action is necessary to
ensure food safety and to protect public health. The Secretary may
reinstate or further modify any exemption withdrawn or modified under
this subsection.
(e) Applicability of adulteration and misbranding provisions to
articles exempted from inspection
The adulteration and misbranding provisions of this chapter, other
than the requirement of the inspection legend, shall apply to articles
which are exempted from inspection under this section, except as
otherwise specified under paragraphs (a) and (d).
(f) Suspension or termination of exemption
The Secretary may by order suspend or terminate any exemption under
this section with respect to any person whenever he finds that such
action will aid in effectuating the purposes of this chapter.
(Pub. L. 85-172, 15, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90-492,
14, Aug. 18, 1968, 82 Stat. 803; Pub. L. 97-206, June 30, 1982, 96
Stat. 136; Pub. L. 102-237, title X, 1016(b), Dec. 13, 1991, 105 Stat.
1903.)
1991 -- Subsecs. (d) to (f). Pub. L. 102-237 added subsec. (d),
redesignated former subsec. (d) as (e) and substituted ''(d)'' for
''(c)'', and redesignated former subsec. (e) as (f).
1982 -- Par. (c)(3). Pub. L. 97-206, 1, substituted provisions that
no exemption would be given to persons who during the current calendar
year either slaughter or process the products of more than 20,000
poultry, or slaughter or process such poultry at a facility of another
poultry producer or person, but that, in the latter case, the Secretary
may grant the exemption upon application of such poultry producer or
person if granting such exemption would not impair the purposes of this
chapter, for provisions that an exemption would not be granted to those
who slaughter or process the products of more than 5,000 turkeys or an
equivalent number of poultry of all species in the current calendar year
(four birds of other species being deemed equivalent of one turkey).
Par. (c)(4)(i). Pub. L. 97-206, 2, substituted ''1,000 poultry during
the calendar year for which this exemption is being determined'' for
''250 turkeys, or not more than an equivalent number of birds of all
species during the calendar year for which this exemption is being
determined (four birds of other species being deemed the equivalent of
one turkey)''.
1968 -- Par. (a). Pub. L. 90-492, 14(a), (b), redesignated subpars.
(2) to (4) as (1) to (3), respectively, and in subpar. (2), as so
redesignated, substituted ''January 1, 1970'' for ''July 1, 1960''.
Former subpar. (1), which exempted poultry producers with respect to
poultry of their own raising on their own farms which they sold directly
to household consumers, hotels, etc., for use in their own dining rooms
or in the preparation of meals for sales direct to consumers only,
provided that such producers did not engage in buying or selling poultry
products other than those produced from poultry raised on their own
farms, was struck out.
Pars. (b) to (e). Pub. L. 90-492, 14(c), added pars. (b) to (d) and
redesignated former par. (b) as (e).
Amendment by Pub. L. 90-492 effective upon the expiration of sixty
days after Aug. 18, 1968, see section 20(b) of Pub. L. 90-492, set out
as a note under section 451 of this title.
Section 1016(c) of Pub. L. 102-237 provided that: ''No later than
August 1, 1992, the Secretary of Agriculture shall issue final rules,
through prior notice and comment rulemaking procedures, to implement the
exemption authorized by section 23(c) of the Federal Meat Inspection Act
(21 U.S.C. 623(c)) (as added by subsection (a)) and the exemption
authorized by section 15(d) of the Poultry Products Inspection Act (21
U.S.C. 464(d)) (as added by subsection (b)). Prior to the issuance of
the final rules, the Secretary shall hold at least one public hearing
examining the public health and food safety issues raised by the
granting of each of the exemptions.''
Section 1016(d) of Pub. L. 102-237 provided that:
''(1) In general. -- Not later than 24 months after the date of
enactment of this Act (Dec. 13, 1991), the Secretary of Agriculture, in
consultation with the National Academy of Sciences, shall conduct --
''(A) a study to develop criteria for, and evaluate, present and
future inspection exemptions for meat food products and poultry products
under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the
Poultry Products Inspection Act (21 U.S.C. 451 et seq.), respectively,
which shall examine the potential effect on consumers, on the affected
industries, on public health and food safety, on the role of the
Department of Agriculture, and the scientific basis for the exemptions;
and
''(B) a study of the appropriateness of granting an exemption from
the requirements of the Federal Meat Inspection Act or the Poultry
Products Inspection Act, as appropriate, for wholesale meat outlets
selling to hotels, restaurants, or other similar institutional users
provided that the processing of meat by the outlets is limited to
cutting, slicing, grinding, or repackaging into smaller quantities.
''(2) Results. -- On completion of each study required under
paragraph (1), the Secretary shall provide the results of the study to
the Committee on Agriculture of the House of Representatives and the
Committee on Agriculture, Nutrition, and Forestry of the Senate.''
21 USC 465. Limitations upon entry of poultry products and other
materials into official establishments
TITLE 21 -- FOOD AND DRUGS
The Secretary may limit the entry of poultry products and other
materials into any official establishment, under such conditions as he
may prescribe to assure that allowing the entry of such articles into
such inspected establishments will be consistent with the purposes of
this chapter.
(Pub. L. 85-172, 16, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90-492,
15, Aug. 18, 1968, 82 Stat. 805.)
1968 -- Pub. L. 90-492 substituted provisions authorizing the
Secretary to limit the entry of poultry products and other materials
into any official establishment for provisions that any person
distributing unwholesome or adulterated exempted poultry or poultry
products intended for human consumption shall be guilty of a misdemeanor
and subject to penalties upon conviction thereof.
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
21 USC 466. Imports
TITLE 21 -- FOOD AND DRUGS
(a) Compliance with standards and regulations; status after
importation
No slaughtered poultry, or parts or products thereof, of any kind
shall be imported into the United States unless they are healthful,
wholesome, fit for human food, not adulterated, and contain no dye,
chemical, preservative, or ingredient which renders them unhealthful,
unwholesome, adulterated, or unfit for human food and unless they also
comply with the rules and regulations made by the Secretary of
Agriculture to assure that imported poultry or poultry products comply
with the standards provided for in this chapter. All imported,
slaughtered poultry, or parts or products thereof, shall after entry
into the United States in compliance with such rules and regulations be
deemed and treated as domestic slaughtered poultry, or parts or products
thereof, within the meaning and subject to the provisions of this
chapter and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.), and Acts amendatory of, supplemental to, or in substitution for
such chapter and Act.
(b) Rules and regulations; destruction and exportation of refused
imports
The Secretary of Agriculture is authorized to make rules and
regulations to carry out the purposes of this section and in such rules
and regulations the Secretary of Agriculture may prescribe the terms and
conditions for the destruction of all slaughtered poultry, or parts or
products thereof, offered for entry and refused admission into the
United States unless such slaughtered poultry, or parts or products
thereof, be exported by the consignee within the time fixed therefor in
such rules and regulations.
(c) Storage, cartage and labor charges for imports refused admission
All charges for storage, cartage, and labor with respect to any
product which is refused admission pursuant to this section shall be
paid by the owner or consignee, and in default of such payment shall
constitute a lien against any other products imported thereafter by or
for such owner or consignee.
(d) Domestic standards and processing facilities applicable;
enforcement
(1) Notwithstanding any other provision of law, all poultry, or parts
or products thereof, capable of use as human food offered for
importation into the United States shall --
(A) be subject to the same inspection, sanitary, quality, species
verification, and residue standards applied to products produced in the
United States; and
(B) have been processed in facilities and under conditions that are
the same as those under which similar products are processed in the
United States.
(2) Any such imported poultry article that does not meet such
standards shall not be permitted entry into the United States.
(3) The Secretary shall enforce this subsection through --
(A) random inspections for such species verification and for
residues; and
(B) random sampling and testing of internal organs and fat of
carcasses for residues at the point of slaughter by the exporting
country, in accordance with methods approved by the Secretary.
(Pub. L. 85-172, 17, Aug. 28, 1957, 71 Stat. 448; Pub. L. 99-198,
title XVII, 1701(a), Dec. 23, 1985, 99 Stat. 1633.)
The Federal Food, Drug, and Cosmetic Act, referred to in par. (a), is
act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
classified generally to chapter 9 ( 301 et seq.) of this title. For
complete classification of this Act to the Code, see section 301 of this
title and Tables.
1985 -- Par. (d). Pub. L. 99-198 added par. (d).
Section 1701(b) of Pub. L. 99-198 proved that: ''The amendment made
by this section (amending this section) shall become effective 6 months
after the date of enactment of this Act (Dec. 23, 1985).''
21 USC 467. Inspection services
TITLE 21 -- FOOD AND DRUGS
(a) Refusal or withdrawal; hearing; business unfitness based upon
certain convictions; persons responsibly connected with the business
The Secretary may (for such period, or indefinitely, as he deems
necessary to effectuate the purposes of this chapter) refuse to provide,
or withdraw, inspection service under this chapter with respect to any
establishment if he determines, after opportunity for a hearing is
accorded to the applicant for, or recipient of, such service, that such
applicant or recipient is unfit to engage in any business requiring
inspection upon this chapter because the applicant or recipient or
anyone responsibly connected with the applicant or recipient, has been
convicted, in any Federal or State court, within the previous ten years
of (1) any felony or more than one misdemeanor under any law based upon
the acquiring, handling, or distributing of adulterated, mislabeled, or
deceptively packaged food or fraud in connection with transactions in
food; or (2) any felony, involving fraud, bribery, extortion, or any
other act or circumstances indicating a lack of the integrity needed for
the conduct of operations affecting the public health. For the purpose
of this paragraph a person shall be deemed to be responsibly connected
with the business if he was a partner, officer, director, holder, or
owner of 10 per centum or more of its voting stock or employee in a
managerial or executive capacity.
(b) Hearing to determine validity of withdrawal or refusal of
inspection services; continuation of withdrawal or refusal
Upon the withdrawal of inspection service from any official
establishment for failure to destroy condemned poultry products as
required under section 455 of this title, or other failure of an
official establishment to comply with the requirements as to premises,
facilities, or equipment, or the operation thereof, as provided in
section 456 of this title, or the refusal of inspection service to any
applicant therefor because of failure to comply with any requirements
under section 456 of this title, the applicant for, or recipient of, the
service shall, upon request, be afforded opportunity for a hearing with
respect to the merits or validity of such action; but such withdrawal
or refusal shall continue in effect unless otherwise ordered by the
Secretary.
(c) Finality and conclusiveness of determination; judicial review;
record
The determination and order of the Secretary when made after
opportunity for hearing, with respect to withdrawal or refusal of
inspection service under this chapter shall be final and conclusive
unless the affected applicant for, or recipient of, inspection service
files application for judicial review within thirty days after the
effective date of such order in the United States Court of Appeals as
provided in section 457 of this title. Judicial review of any such
order shall be upon the record upon which the determination and order
are based. The provisions of section 194 of title 7 shall be applicable
to appeals taken under this section.
(Pub. L. 85-172, 18, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90-492,
16, Aug. 18, 1968, 82 Stat. 805.)
1968 -- Par. (a). Pub. L. 90-492 substituted provisions authorizing
the Secretary to refuse or withdraw inspection services subsequent to a
hearing determining that the applicant or recipient is unfit to engage
in any business requiring inspection under this chapter based upon the
specified considerations, for provisions granting the Secretary
exclusive jurisdiction within the scope of this chapter and exempting
poultry and poultry products from the provisions of the Federal Food,
Drug, and Cosmetic Act, as amended, to the extent of the application or
the extension thereof of the provisions of this chapter.
Par. (b). Pub. L. 90-492 substituted provisions granting a hearing,
upon request by the applicant or recipient, to determine the merits and
validity of the withdrawal or refusal of inspection services and
continuing such withdrawal or refusal in effect, unless otherwise
ordered by the Secretary, for provisions authorizing the Secretary to
cooperate with other branches of government and with State agencies and
to conduct examinations, investigations, and inspections through any
officer or employee of a State commissioned by the Secretary for such
purpose.
Par. (c). Pub. L. 90-492 added par. (c).
Amendment by Pub. L. 90-492 effective Aug. 18, 1968, see section 20
of Pub. L. 90-492, set out as a note under section 451 of this title.
21 USC 467a. Administrative detention; duration; pending judicial
proceedings; notification of government authorities; release; removal
of official marks
TITLE 21 -- FOOD AND DRUGS
Whenever any poultry product, or any product exempted from the
definition of a poultry product, or any dead, dying, disabled, or
diseased poultry is found by any authorized representative of the
Secretary upon any premises where it is held for purposes of, or during
or after distribution in, commerce or otherwise subject to this chapter,
and there is reason to believe that any such article is adulterated or
misbranded and is capable of use as human food, or that it has not been
inspected, in violation of the provisions of this chapter or of any
other Federal law or the laws of any State or Territory, or the District
of Columbia, or that it has been or is intended to be, distributed in
violation of any such provisions, it may be detained by such
representative for a period not to exceed twenty days, pending action
under section 467b of this title or notification of any Federal, State,
or other governmental authorities having jurisdiction over such article
or poultry, and shall not be moved by any person, from the place at
which it is located when so detained, until released by such
representative. All official marks may be required by such
representative to be removed from such article or poultry before it is
released unless it appears to the satisfaction of the Secretary that the
article or poultry is eligible to retain such marks.
(Pub. L. 85-172, 19, as added Pub. L. 90-492, 17, Aug. 18, 1968, 82
Stat. 805.)
21 USC 467b. Seizure and condemnation
TITLE 21 -- FOOD AND DRUGS
(a) Proceedings in rem; libel of information; jurisdiction;
disposal by destruction or sale; proceeds into the Treasury; sales
restrictions; bonds; court costs and fees, storage, and other expenses
against claimants; jury trial; United States as plaintiff
(1) Any poultry product, or any dead, dying, disabled, or diseased
poultry, that is being transported in commerce or otherwise subject to
this chapter, or is held for sale in the United States after such
transportation, and that (A) is or has been processed, sold,
transported, or otherwise distributed or offered or received for
distribution in violation of this chapter, or (B) is capable of use as
human food and is adulterated or misbranded, or (C) in any other way is
in violation of this chapter, shall be liable to be proceeded against
and seized and condemned, at any time, on a libel of information in any
United States district court or other proper court as provided in
section 467c of this title within the jurisdiction of which the article
or poultry is found.
(2) If the article or poultry is condemned it shall, after entry of
the decree, (A) be distributed in accordance with paragraph (5), or (B)
be disposed of by destruction or sale as the court may direct and the
proceeds, if sold, less the court costs and fees, and storage and other
proper expenses, shall be paid into the Treasury of the United States,
but the article or poultry shall not be sold contrary to the provisions
of this chapter, or the laws of the jurisdiction in which it is sold:
Provided, That upon the execution and delivery of a good and sufficient
bond conditioned that the article or poultry shall not be sold or
otherwise disposed of contrary to the provisions of this chapter, or the
laws of the jurisdiction in which disposal is made, the court may direct
that such article or poultry be delivered to the owner thereof subject
to such supervision by authorized representatives of the Secretary as is
necessary to insure compliance with the applicable laws.
(3) When a decree of condemnation is entered against the article or
poultry and it is released under bond, or destroyed, court costs and
fees, and storage and other proper expenses shall be awarded against the
person, if any, intervening as claimant of the article or poultry.
(4) The proceedings in such libel cases shall conform, as nearly as
may be, to the proceedings in admiralty, except that either party may
demand trial by jury of any issue of fact joined in any case, and all
such proceedings shall be at the suit of and in the name of the United
States.
(5)(A) An article that is condemned under paragraph (1) may as the
court may direct, after entry of the decree, be distributed without
charge to nonprofit, private entities or to Federal, State, or local
government entities engaged in the distribution of food without charge
to individuals, if such article --
(i) is capable of use as a human food;
(ii) has been inspected under this chapter and found to be wholesome
and not to be adulterated within the meaning of paragraphs (1) through
(7) of section 453(g) of this title and a determination is made at the
time of the entry of the decree that such article is wholesome and not
so adulterated; and
(iii) is plainly marked ''Not for Sale'' on such article or its
container.
(B) The United States may not be held legally responsible for any
article that is distributed under subparagraph (A) to a nonprofit,
private entity or to a Federal, State, or local government entity, if
such article --
(i) was found after inspection under this chapter to be wholesome and
not adulterated within the meaning of paragraphs (1) through (7) of
section 453(g) of this title and a determination was made at the time of
the entry of the decree that such article was wholesome and not so
adulterated; and
(ii) was plainly marked ''Not for Sale'' on such article or its
container.
(C) The person from whom such article was seized and condemned may
not be held legally responsible for such article, if such article --
(i) was found after inspection under this chapter to be wholesome and
not adulterated within the meaning of paragraphs (1) through (7) of
section 453(g) of this title and a determination was made at the time of
entry of the decree that such article was wholesome and not so
adulterated; and
(ii) was plainly marked ''Not for Sale'' on such article or its
container.
(b) Condemnation or seizure under other provisions unaffected
The provisions of this section shall in no way derogate from
authority for condemnation or seizure conferred by other provisions of
this chapter, or other laws.
(Pub. L. 85-172, 20, as added Pub. L. 90-492, 17, Aug. 18, 1968, 82
Stat. 806, and amended Pub. L. 101-205, 2, Dec. 7, 1989, 103 Stat.
1830.)
1989 -- Subsec. (a). Pub. L. 101-205 designated first sentence as
par. (1) and redesignated cls. (1) to (3) as cls. (A) to (C),
respectively, designated second sentence as par. (2) and inserted ''(A)
be distributed in accordance with paragraph (5), or (B)'' after ''entry
of the decree,'', designated third and fourth sentences as pars. (3)
and (4), respectively, and added par. (5).
Admiralty and maritime rules of practice (which included libel
procedures) were superseded, and civil and admiralty procedures in
United States district courts were unified, effective July 1, 1966, see
rule 1 and Supplemental Rules for Certain Admiralty and Maritime Claims,
Title 28, Appendix, Judiciary and Judicial Procedure.
21 USC 467c. Federal court jurisdiction of enforcement and injunction
proceedings and other kinds of cases; limitations; United States as
plaintiff; subpenas
TITLE 21 -- FOOD AND DRUGS
The United States district courts, the District Court of Guam, the
District Court of the Virgin Islands, the highest court of American
Samoa, and the United States courts of the other territories, are vested
with jurisdiction specifically to enforce, and to prevent and restrain
violations of, this chapter, and shall have jurisdiction in all other
kinds of cases arising under this chapter, except as provided in section
457(d) or 467 of this title. All proceedings for the enforcement or to
restrain violations of this chapter shall be by and in the name of the
United States. Subpenas for witnesses who are required to attend a
court of the United States, in any district, may run into any other
district in any such proceeding.
(Pub. L. 85-172, 21, as added Pub. L. 90-492, 17, Aug. 18, 1968, 82
Stat. 806.)
21 USC 467d. Administration and enforcement; applicability of penalty
provisions; conduct of inquiries; power and jurisdiction of courts
TITLE 21 -- FOOD AND DRUGS
For the efficient administration and enforcement of this chapter, the
provision (including penalties) of sections 46, 48, 49 and 50 of title
15 (except paragraphs (c) through (h) of section 46 and the last
paragraph of section 49 /1/ of title 15), and the provisions of section
409(l) /1/ of title 47, are made applicable to the jurisdiction, powers,
and duties of the Secretary in administering and enforcing the
provisions of this chapter and to any person with respect to whom such
authority is exercised. The Secretary, in person or by such agents as
he may designate, may prosecute any inquiry necessary to his duties
under this chapter in any part of the United States, and the powers
conferred by said sections 49 and 50 of title 15 on the district courts
of the United States may be exercised for the purposes of this chapter
by any court designated in section 467c of this title.
(Pub. L. 85-172, 22, as added Pub. L. 90-492, 17, Aug. 18, 1968, 82
Stat. 807.)
The last paragraph of section 49 of title 15, and the provisions of
section 409(l) of title 47, referred to in text, which related to
immunity of witnesses, were repealed by sections 211 and 242,
respectively, of Pub. L. 91-452, Oct. 15, 1970, title II, 84 Stat.
929, 930. For provisions relating to immunity of witnesses, see section
6001 et seq. of Title 18, Crimes and Criminal Procedure.
/1/ See References in Text note below.
21 USC 467e. Non-Federal jurisdiction of federally regulated matters;
prohibition of additional or different requirements for establishments
with inspection services and as to marking, labeling, packaging, and
ingredients; recordkeeping and related requirements; concurrent
jurisdiction over distribution for human food purposes of adulterated or
misbranded and imported articles; other matters
TITLE 21 -- FOOD AND DRUGS
Requirements within the scope of this chapter with respect to
premises, facilities and operations of any official establishment which
are in addition to, or different than those made under this chapter may
not be imposed by any State or Territory or the District of Columbia,
except that any such jurisdiction may impose recordkeeping and other
requirements within the scope of paragraph (b) of section 460 of this
title, if consistent therewith, with respect to any such establishment.
Marking, labeling, packaging, or ingredient requirements (or storage or
handling requirements found by the Secretary to unduly interfere with
the free flow of poultry products in commerce) in addition to, or
different than, those made under this chapter may not be imposed by any
State or Territory or the District of Columbia with respect to articles
prepared at any official establishment in accordance with the
requirements under this chapter, but any State or Territory or the
District of Columbia may, consistent with the requirements under this
chapter exercise concurrent jurisdiction with the Secretary over
articles required to be inspected under this chapter for the purpose of
preventing the distribution for human food purposes of any such articles
which are adulterated or misbranded and are outside of such an
establishment, or, in the case of imported articles which are not at
such an establishment, after their entry into the United States. This
chapter shall not preclude any State or Territory or the District of
Columbia from making requirement or taking other action, consistent with
this chapter, with respect to any other matters regulated under this
chapter.
(Pub. L. 85-172, 23, as added Pub. L. 90-492, 17, Aug. 18, 1968, 82
Stat. 807.)
21 USC 467f. Federal Food, Drug, and Cosmetic Act applications
TITLE 21 -- FOOD AND DRUGS
(a) Exemptions; authorities under food, drug, and cosmetic
provisions unaffected
Poultry and poultry products shall be exempt from the provisions of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et. seq.) to the
extent of the application or extension thereto of the provisions of this
chapter, except that the provisions of this chapter shall not derogate
from any authority conferred by the Federal Food, Drug, and Cosmetic Act
prior to August 18, 1968.
(b) Enforcement proceedings; detainer authority of representatives
of Secretary of Health and Human Services
The detainer authority conferred by section 467a of this title shall
apply to any authorized representative of the Secretary of Health and
Human Services for purposes of the enforcement of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) with respect to any
poultry carcass, or part or product thereof, that is outside any
official establishment, and for such purposes the first reference to the
Secretary in section 467a of this title shall be deemed to refer to the
Secretary of Health, Education, and Welfare.
(Pub. L. 85-172, 24, as added Pub. L. 90-492, 17, Aug. 18, 1968, 82
Stat. 807, and amended Pub. L. 96-88, title V, 509(b), Oct. 17, 1979, 93
Stat. 695.)
The Federal Food, Drug, and Cosmetic Act, referred to in text, is act
June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified
generally to chapter 9 ( 301 et seq.) of this title. For complete
classification of this Act to the Code, see section 301 of this title
and Tables.
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in par. (b) pursuant to
section 509(b) of Pub. L. 96-88, which is classified to section 3508(b)
of Title 20, Education.
21 USC 468. Cost of inspection; overtime
TITLE 21 -- FOOD AND DRUGS
The cost of inspection rendered under the requirements of this
chapter, shall be borne by the United States, except that the cost of
overtime and holiday work performed in establishments subject to the
provisions of this chapter at such rates as the Secretary may determine
shall be borne by such establishments. Sums received by the Secretary
in reimbursement for sums paid out by him for such premium pay work
shall be available without fiscal year limitation to carry out the
purposes of this section.
(Pub. L. 85-172, 25, formerly 19, Aug. 28, 1957, 71 Stat. 448,
renumbered Pub. L. 90-492, 17, Aug. 18, 1968, 82 Stat. 805.)
21 USC 469. Authorization of appropriations
TITLE 21 -- FOOD AND DRUGS
There is authorized to be appropriated such sums as are necessary to
carry out the provisions of this chapter.
(Pub. L. 85-172, 26, formerly 20, Aug. 28, 1957, 71 Stat. 449,
renumbered Pub. L. 90-492, 17, Aug. 18, 1968, 82 Stat. 805.)
21 USC 470. Reports to Congress
TITLE 21 -- FOOD AND DRUGS
The Secretary shall annually report to the Committee on Agriculture
of the House of Representatives and the Committee on Agriculture,
Nutrition, and Forestry of the Senate with respect to the slaughter of
poultry subject to this chapter, and the preparation, storage, handling,
and distribution of poultry parts, poultry products, and inspection of
establishments operated in connection therewith, including the
operations under and the effectiveness of this chapter.
(Pub. L. 85-172, 27, as added Pub. L. 90-492, 17, Aug. 18, 1968, 82
Stat. 807, and amended S. Res. 4, Feb. 4, 1977.)
Committee on Agriculture and Forestry of the Senate abolished and
replaced by Committee on Agriculture, Nutrition, and Forestry of the
Senate, effective Feb. 11, 1977. See Rule XXV of Standing Rules of the
Senate, as amended by Senate Resolution 4 (popularly cited as the
''Committee System Reorganization Amendments of 1977''), approved Feb.
4, 1977.
21 USC CHAPTER 11 -- MANUFACTURE OF NARCOTIC DRUGS
TITLE 21 -- FOOD AND DRUGS
21 USC 501 to 517. Repealed. Pub. L. 91-513, title III, 1101(a)( 10),
Oct. 27, 1970, 84 Stat. 1292
TITLE 21 -- FOOD AND DRUGS
Sections, Pub. L. 86-429, Apr. 22, 1960, 74 Stat. 55, provided for
licensing and control of the manufacture of all narcotic drugs and was
known as the ''Narcotic Manufacturing Act of 1960''. Sections 1 to 3
and 5 to 22 of said Pub. L. 86-429 were classified respectively to
sections 501, 501 notes, and 502 to 517 of this title. Section 4 of
Pub. L. 86-429 was classified to sections 4702, 4731, and 4731 note of
Title 26, Internal Revenue Code. See section 801 et seq. of this
title.
Repeal effective on first day of seventh calendar month that begins
after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513, set out as
a note under section 951 of this title. For provisions postponing such
effective date if the Attorney General postpones the effective date of
section 826 of this title, see section 1105(c) of Pub. L. 91-513, set
out as an Effective Date note under section 951 of this title.
Prosecutions for any violation of law occurring, and civil seizures
or forfeitures and injunctive proceedings commenced, prior to the
effective date of repeal of these sections by section 1101 of Pub. L.
91-513 not to be affected or abated by reason thereof, see section 1103
of Pub. L. 91-513, set out as a note under sections 171 to 174 of this
title.
21 USC CHAPTER 12 -- MEAT INSPECTION
TITLE 21 -- FOOD AND DRUGS
AND MISBRANDING
Sec.
601. Definitions.
602. Congressional statement of findings.
603. Inspection of meat and meat food products.
(a) Examination of animals before slaughtering; diseased animals
slaughtered separately and carcasses examined.
(b) Humane methods of slaughter.
604. Post mortem examination of carcasses and marking or labeling;
destruction of carcasses condemned; reinspection.
605. Examination of carcasses brought into slaughtering or packing
establishments, and of meat food products issued from and returned
thereto; conditions for entry.
606. Examination and inspection of meat food products.
(a) Authority of Secretary; manner and frequency of inspections.
(b) Marking, stamping, etc., of inspected food; destruction of
condemned food.
(c) Access to food processing establishments.
(d) Exceptions for meat and food products destined for export to
foreign country.
607. Labeling, marking, and container requirements.
(a) Labeling receptacles or coverings of meat or meat food products
inspected and passed; supervision by inspectors.
(b) Information on articles or containers; legible form.
(c) Labeling: type styles and sizes; definitions and standards of
identity or composition; standards of fill of container; consistency
of Federal and Federal-State standards.
(d) Sales under false or misleading name, other marking or labeling
or in containers of misleading form or size; trade names, and other
marking, labeling, and containers approved by Secretary.
(e) Use withholding directive respecting false or misleading marking,
labeling, or container; modification of false or misleading matter;
hearing; withholding use pending proceedings; finality of Secretary's
action; judicial review; application of section 194 of title 7.
608. Sanitary inspection and regulation of slaughtering and packing
establishments; rejection of adulterated meat or meat food products.
609. Examination of animals and food products thereof, slaughtered
and prepared during nighttime.
610. Prohibited acts.
(a) Slaughtering animals or preparation of articles capable of use as
human food.
(b) Humane methods of slaughter.
(c) Sales, transportation, and other transactions.
(d) Adulteration or misbranding.
611. Devices, marks, labels, and certificates; simulations.
(a) Devices to be made under authorization of Secretary.
(b) Other misconduct.
612. Inspection of animals for export.
613. Inspectors of animals for export; certificates of condition.
614. Clearance prohibited to vessel carrying animals for export
without inspector's certificate.
615. Inspection of carcasses, meat of which is intended for export.
616. Inspectors of carcasses, etc., meat of which is intended for
export; certificates of condition.
617. Clearance prohibited to vessel carrying meat for export without
inspector's certificate.
618. Delivery of inspectors' certificates, and of copies.
619. Marking, labeling, or other identification of kinds of animals
of articles' derivation; separate establishments for preparation and
slaughtering activities.
620. Imports.
(a) Adulteration or misbranding prohibition; compliance with
inspection, building construction standards, and other provisions;
humane methods of slaughter; treatment as domestic articles subject to
this chapter and food, drug, and cosmetic provisions; marking and
labeling; personal consumption exemption.
(b) Terms and conditions for destruction.
(c) Payment of storage, cartage, and labor charges by owner or
consignee; liens.
(d) Prohibition.
(e) Reports to Congressional committees.
(f) Inspection and other standards; applicability, enforcement,
etc.; certifications.
(g) Administration of animal drugs or antibiotics; terms and
conditions; entry order violations.
(h) Reciprocal meat inspection requirement.
621. Inspectors to make examinations provided for; appointment;
duties; regulations.
622. Bribery of or gifts to inspectors or other officers and
acceptance of gifts.
623. Exemptions from inspection requirements.
(a) Personal slaughtering and custom slaughtering for personal,
household, guest, and employee uses.
(b) Territorial exemption; refusal, withdrawal, or modification.
(c) Pizzas containing meat food products.
(d) Adulteration and misbranding provisions applicable to
inspection-free articles.
624. Storage and handling regulations; violations; exemption of
establishments subject to non-Federal jurisdiction.
641. Prohibition of subchapter I inspection of articles not intended
for use as human food; denaturation or other identification prior to
distribution in commerce; inedible articles.
642. Recordkeeping requirements.
(a) Classes of persons bound; scope of disclosure; access to places
of business; examination of records, facilities, and inventories;
copies; samples.
(b) Period of maintenance.
643. Registration of business, name of person, and trade names.
644. Regulation of transactions, transportation, or importation of
4-D animals to prevent use as human food.
645. Federal provisions applicable to State or Territorial business
transactions of a local nature and not subject to local authority.
661. Federal and State cooperation.
(a) Congressional statement of policy.
(1)
Development and administration of State meat inspection program equal
to subchapter I ante and post mortem inspection, reinspection, and
sanitation requirements.
(2)
Development and administration of State program with authorities
equal to subchapter II authorities; cooperation with Federal agencies.
(3)
Scope of cooperation: advisory assistance, technical and laboratory
assistance and training, and financial and other aid; limitation on
amount; equitable allocation of Federal funds; adequacy of State
program to obtain Federal cooperation and payments.
(4)
Advisory committees.
(b) Single State agency; subordinate governmental unit as part of
State agency.
(c) State meat inspection requirements.
(1)
Notice to Governor of nondevelopment or nonenforcement; designation
of State as subject to subchapters I and IV; delay and revocation of
designation; publication in Federal Register; notice of production of
adulterated meat or meat food products; designation of State.
(2)
Exemptions of retail stores, restaurants, and similar retail-type
establishments; operations conducted at a restaurant central kitchen
facility.
(3)
Termination of designation of State upon development and enforcement
of minimum requirements; redesignation; designation for nonenforcement
of minimum requirements: notice and publication in Federal Register.
(4)
Periodic review; report to Congressional committees.
(d) ''State'' defined.
671. Inspection services.
(a) Refusal or withdrawal; hearing; business unfitness based upon
certain convictions.
(b) Order enjoining presence of controlling person at establishment;
duration of order.
(c) Judicial review of orders.
(d) Civil action for withdrawal of inspection services or prevention
of operational control by responsibly connected persons.
(e) Temporary withdrawal of inspection services to ensure safety of
employees.
(f) Withdrawal of inspection services under other provisions.
(g) Persons responsibly connected with business.
(h) Conclusiveness of Secretarial order; judicial review.
672. Administrative detentions; duration; pending judicial
proceedings; notification of governmental authorities; release.
673. Seizure and condemnation.
(a) Proceedings in rem; libel of information; jurisdiction;
disposal by destruction or sale; proceeds into the Treasury; sales
restrictions; bond; court costs and fees, storage, and other expenses
against claimants; proceedings in admiralty; jury trial; United
States as plaintiff.
(b) Condemnation or seizure under other provisions unaffected.
674. Federal court jurisdiction of enforcement and injunction
proceedings and other kinds of cases; limitations of section 607(e) of
this title.
675. Assaulting, resisting, or impeding certain persons; murder;
protection of such persons.
676. Violations.
(a) Misdemeanors; felonies: intent to defraud and distribution of
adulterated articles; good faith.
(b) Minor violations; written notice of warning of criminal and
civil proceedings.
(c) Notice of criminal prosecution.
677. Other Federal laws applicable for administration and
enforcement of chapter; location of inquiries; jurisdiction of Federal
courts.
678. Non-Federal jurisdiction of federally regulated matters;
prohibition of additional or different requirements for establishments
with inspection services and as to marking, labeling, packaging, and
ingredients; recordkeeping and related requirements; concurrent
jurisdiction over distribution for human food purposes of adulterated or
misbranded and imported articles; other matters.
679. Application of Federal Food, Drug, and Cosmetic Act.
(a) Authorities under food, drug, and cosmetic provisions unaffected.
(b) Enforcement proceedings; detainer authority of representatives
of Secretary of Health and Human Services.
680. Authorization of appropriations.
691. Reports to Congressional committees.
692. Inspection extended to reindeer.
693. Inspection of dairy products for export.
694. Authorization of appropriations.
695. Payment of cost of meat-inspection service; exception.
21 USC SUBCHAPTER I -- INSPECTION REQUIREMENTS; ADULTERATION AND
MISBRANDING
TITLE 21 -- FOOD AND DRUGS
21 USC 601. Definitions
TITLE 21 -- FOOD AND DRUGS
As used in this chapter, except as otherwise specified, the following
terms shall have the meanings stated below:
(a) The term ''Secretary'' means the Secretary of Agriculture of the
United States or his delegate.
(b) The term ''firm'' means any partnership, association, or other
unincorporated business organization.
(c) The term ''meat broker'' means any person, firm, or corporation
engaged in the business of buying or selling carcasses, parts of
carcasses, meat, or meat food products of cattle, sheep, swine, goats,
horses, mules, or other equines on commission, or otherwise negotiating
purchases or sales of such articles other than for his own account or as
an employee of another person, firm, or corporation.
(d) The term ''renderer'' means any person, firm, or corporation
engaged in the business of rendering carcasses or parts or products of
the carcasses, of cattle, sheep, swine, goats, horses, mules, or other
equines, except rendering conducted under inspection or exemption under
this subchapter.
(e) The term ''animal food manufacturer'' means any person, firm, or
corporation engaged in the business of manufacturing or processing
animal food derived wholly or in part from carcasses, or parts of
products of the carcasses, of cattle, sheep, swine, goats, horses,
mules, or other equines.
(f) The term ''State'' means any State of the United States and the
Commonwealth of Puerto Rico.
(g) The term ''Territory'' means Guam, the Virgin Islands of the
United States, American Samoa, and any other territory or possession of
the United States, excluding the Canal Zone.
(h) The term ''commerce'' means commerce between any State, any
Territory, or the District of Columbia, and any place outside thereof;
or within any Territory not organized with a legislative body, or the
District of Columbia.
(i) The term ''United States'' means the States, the District of
Columbia, and the Territories of the United States.
(j) The term ''meat food product'' means any product capable of use
as human food which is made wholly or in part from any meat or other
portion of the carcass of any cattle, sheep, swine, or goats, excepting
products which contain meat or other portions of such carcasses only in
a relatively small proportion or historically have not been considered
by consumers as products of the meat food industry, and which are
exempted from definition as a meat food product by the Secretary under
such conditions as he may prescribe to assure that the meat or other
portions of such carcasses contained in such product are not adulterated
and that such products are not represented as meat food products. This
term as applied to food products of equines shall have a meaning
comparable to that provided in this paragraph with respect to cattle,
sheep, swine, and goats.
(k) The term ''capable of use as human food'' shall apply to any
carcass, or part or product of a carcass, of any animal, unless it is
denatured or otherwise identified as required by regulations prescribed
by the Secretary to deter its use as human food, or it is naturally
inedible by humans.
(l) The term ''prepared'' means slaughtered, canned, salted,
rendered, boned, cut up, or otherwise manufactured or processed.
(m) The term ''adulterated'' shall apply to any carcass, part
thereof, meat or meat food product under one or more of the following
circumstances:
(1) if it bears or contains any poisonous or deleterious substance
which may render it injurious to health; but in case the substance is
not an added substance, such article shall not be considered adulterated
under this clause if the quantity of such substance in or on such
article does not ordinarily render it injurious to health;
(2)(A) if it bears or contains (by reason of administration of any
substance to the live animal or otherwise) any added poisonous or added
deleterious substance (other than one which is (i) a pesticide chemical
in or on a raw agricultural commodity; (ii) a food additive; or (iii)
a color additive) which may, in the judgment of the Secretary, make such
article unfit for human food;
(B) if it is, in whole or in part, a raw agricultural commodity and
such commodity bears or contains a pesticide chemical which is unsafe
within the meaning of section 346a of this title,
(C) if it bears or contains any food additive which is unsafe within
the meaning of section 348 of this title,
(D) if it bears or contains any color additive which is unsafe within
the meaning of section 376 of this title: Provided, That an article
which is not adulterated under clause (B), (C), or (D) shall
nevertheless be deemed adulterated if use of the pesticide chemical,
food additive, or color additive in or on such article is prohibited by
regulations of the Secretary in establishments at which inspection is
maintained under this subchapter;
(3) if it consists in whole or in part of any filthy, putrid, or
decomposed substance or is for any other reason unsound, unhealthful,
unwholesome, or otherwise unfit for human food;
(4) if it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health;
(5) if it is, in whole or in part, the product of an animal which has
died otherwise than by slaughter;
(6) if its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health;
(7) if it has been intentionally subjected to radiation, unless the
use of the radiation was in conformity with a regulation or exemption in
effect pursuant to section 348 of this title;
(8) if any valuable constituent has been in whole or in part omitted
or abstracted therefrom; or if any substance has been substituted,
wholly or in part therefor; or if damage or inferiority has been
concealed in any manner; or if any substance has been added thereto or
mixed or packed therewith so as to increase its bulk or weight, or
reduce its quality or strength, or make it appear better or of greater
value than it is; or
(9) if it is margarine containing animal fat and any of the raw
material used therein consisted in whole or in part of any filthy,
putrid, or decomposed substance.
(n) The term ''misbranded'' shall apply to any carcass, part thereof,
meat or meat food product under one or more of the following
circumstances:
(1) if its labeling is false or misleading in any particular;
(2) if it is offered for sale under the name of another food;
(3) if it is an imitation of another food, unless its label bears, in
type of uniform size and prominence, the word ''imitation'' and
immediately thereafter, the name of the food imitated;
(4) if its container is so made, formed, or filled as to be
misleading;
(5) if in a package or other container unless it bears a label
showing (A) the name and place of business of the manufacturer, packer,
or distributor; and (B) an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical count: Provided,
That under clause (B) of this subparagraph (5), reasonable variations
may be permitted, and exemptions as to small packages may be
established, by regulations prescribed by the Secretary;
(6) if any word, statement, or other information required by or under
authority of this chapter to appear on the label or other labeling is
not prominently placed thereon with such conspicuousness (as compared
with other words, statements, designs, or devices, in the labeling) and
in such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use;
(7) if it purports to be or is represented as a food for which a
definition and standard of identity or composition has been prescribed
by regulations of the Secretary under section 607 of this title unless
(A) it conforms to such definition and standard, and (B) its label bears
the name of the food specified in the definition and standard and,
insofar as may be required by such regulations, the common names of
optional ingredients (other than spices, flavoring, and coloring)
present in such food;
(8) if it purports to be or is represented as a food for which a
standard or standards of fill of container have been prescribed by
regulations of the Secretary under section 607 of this title, and it
falls below the standard of fill of container applicable thereto, unless
its label bears, in such manner and form as such regulations specify, a
statement that it falls below such standard;
(9) if it is not subject to the provisions of subparagraph (7),
unless its label bears (A) the common or usual name of the food, if any
there be, and (B) in case it is fabricated from two or more ingredients,
the common or usual name of each such ingredient; except that spices,
flavorings, and colorings may, when authorized by the Secretary, be
designated as spices, flavorings, and colorings without naming each:
Provided, That to the extent that compliance with the requirements of
clause (B) of this subparagraph (9) is impracticable, or results in
deception or unfair competition, exemptions shall be established by
regulations promulgated by the Secretary;
(10) if it purports to be or is represented for special dietary uses,
unless its label bears such information concerning its vitamin, mineral,
and other dietary properties as the Secretary, after consultation with
the Secretary of Health and Human Services, determines to be, and by
regulations prescribes as, necessary in order fully to inform purchasers
as to its value for such uses;
(11) if it bears or contains any artificial flavoring, artificial
coloring, or chemical preservative, unless it bears labeling stating
that fact: Provided, That, to the extent that compliance with the
requirements of this subparagraph (11) is impracticable, exemptions
shall be established by regulations promulgated by the Secretary; or
(12) if it fails to bear, directly thereon or on its container, as
the Secretary may by regulations prescribe, the inspection legend and,
unrestricted by any of the foregoing, such other information as the
Secretary may require in such regulations to assure that it will not
have false or misleading labeling and that the public will be informed
of the manner of handling required to maintain the article in a
wholesome condition.
(o) The term ''label'' means a display of written, printed, or
graphic matter upon the immediate container (not including package
liners) of any article.
(p) The term ''labeling'' means all labels and other written,
printed, or graphic matter (1) upon any article or any of its containers
or wrappers, or (2) accompanying such article.
(q) The term ''Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.)'' means the Act so entitled, approved June 25, 1938 (52 Stat.
1040), and Acts amendatory thereof or supplementary thereto.
(r) The terms ''pesticide chemical,'' ''food additive,'' ''color
additive,'' and ''raw agricultural commodity'' shall have the same
meanings for purposes of this chapter as under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).
(s) The term ''official mark'' means the official inspection legend
or any other symbol prescribed by regulations of the Secretary to
identify the status of any article or animal under this chapter.
(t) The term ''official inspection legend'' means any symbol
prescribed by regulations of the Secretary showing that an article was
inspected and passed in accordance with this chapter.
(u) The term ''official certificate'' means any certificate
prescribed by regulations of the Secretary for issuance by an inspector
or other person performing official functions under this chapter.
(v) The term ''official device'' means any device prescribed or
authorized by the Secretary for use in applying any official mark.
(Mar. 4, 1907, ch. 2907, title I, 1, as added Dec. 15, 1967, Pub. L.
90-201, 2, 81 Stat. 584, and amended Oct. 17, 1979, Pub. L. 96-88, title
V, 509(b), 93 Stat. 695.)
The Federal Food, Drug, and Cosmetic Act, referred to in pars. (q)
and (r), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 ( 301 et seq.) of this title.
For complete classification of this Act to the Code, see section 301 of
this title and Tables.
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in par. (n)(10)
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
Section 20 of Pub. L. 90-201 provided that: ''This Act (see Short
Title note below) shall become effective upon enactment (Dec. 15, 1967)
except as provided in paragraphs (a) through (d):
''(a) The provisions of paragraph (b)(1) and (c) of section 10 and
the provisions of section 20 of the Federal Meat Inspection Act, as
amended by sections 7 and 10 of this Act (sections 610 and 620 of this
title), and the provisions of section 18 of this Act repealing paragraph
(b) of section 306 of the Tariff Act of 1930 (section 1306(b) of Title
19, Customs Duties), shall become effective upon the expiration of sixty
days after enactment (Dec. 15, 1967), hereof.
''(b) The provisions of title I of the Federal Meat Inspection Act,
as amended by this Act (this subchapter), shall become effective with
respect to equines (other than horses) and their carcasses and parts
thereof, meat, and meat food products thereof upon the expiration of
sixty days after enactment (Dec. 15, 1967) hereof.
''(c) Section 11 of this Act, amending section 23, of the Federal
Meat Inspection Act (section 623 of this title), shall become effective
upon the expiration of sixty days after enactment hereof (Dec. 15,
1967).
''(d) Section 204 of the Federal Meat Inspection Act, as added by
section 14 of this Act (section 644 of this title), shall become
effective upon the expiration of sixty days after enactment hereof (Dec.
15, 1967).''
Pub. L. 99-641, title IV, 401, Nov. 10, 1986, 100 Stat. 3567,
provided that: ''This title (amending sections 606, 609, 621, 671, and
676 of this title and enacting provisions set out as notes under
sections 606, 609, 621, 671, and 676 of this title) may be cited as the
'Processed Products Inspection Improvement Act of 1986'.''
Pub. L. 95-445, 1, Oct. 10, 1978, 92 Stat. 1069, provided: ''That
this Act (amending sections 603, 610, and 620 of this title and sections
1902 and 1904 of Title 7, Agriculture, repealing sections 1903 and 1905
of Title 7, and enacting provisions set out as notes under sections 601
and 603 of this title) may be cited as the 'Humane Methods of Slaughter
Act of 1978'.''
Section 1 of Pub. L. 90-201 provided in part: ''That this Act
(enacting this section and sections 602, 624, 641 to 645, 661, 671 to
680, and 691 of this title, amending sections 603 to 623 of this title,
repealing section 96 of this title and section 1306(b) of Title 19,
Customs Duties, and enacting provisions set out as notes under this
section) may be cited as the 'Wholesome Meat Act'.''
Section 1 of Pub. L. 90-201 provided in part that the provisions of
act Mar. 4, 1907, as amended, classified to subchapters I to IV of this
chapter, are designated as the ''Federal Meat Inspection Act''.
Section 19 of Pub. L. 90-201 provided that: ''If any provision of
this Act or of the amendments made hereby (see Short Title note above)
or the application thereof to any person or circumstances is held
invalid, the validity of the remainder of the Act and the remaining
amendments (see Short Title note above) and of the application of such
provision to other persons and circumstances shall not be affected
thereby.''
21 USC 602. Congressional statement of findings
TITLE 21 -- FOOD AND DRUGS
Meat and meat food products are an important source of the Nation's
total supply of food. They are consumed throughout the Nation and the
major portion thereof moves in interstate or foreign commerce. It is
essential in the public interest that the health and welfare of
consumers be protected by assuring that meat and meat food products
distributed to them are wholesome, not adulterated, and properly marked,
labeled, and packaged. Unwholesome, adulterated, or misbranded meat or
meat food products impair the effective regulation of meat and meat food
products in interstate or foreign commerce, are injurious to the public
welfare, destroy markets for wholesome, not adulterated, and properly
labeled and packaged meat and meat food products, and result in sundry
losses to livestock producers and processors of meat and meat food
products, as well as injury to consumers. The unwholesome, adulterated,
mislabeled, or deceptively packaged articles can be sold at lower prices
and compete unfairly with the wholesome, not adulterated, and properly
labeled and packaged articles, to the detriment of consumers and the
public generally. It is hereby found that all articles and animals
which are regulated under this chapter are either in interstate or
foreign commerce or substantially affect such commerce, and that
regulation by the Secretary and cooperation by the States and other
jurisdictions as contemplated by this chapter are appropriate to prevent
and eliminate burdens upon such commerce, to effectively regulate such
commerce, and to protect the health and welfare of consumers.
(Mar. 4, 1907, ch. 2907, title I, 2, as added Dec. 15, 1967, Pub. L.
90-201, 2, 81 Stat. 587.)
21 USC 603. Inspection of meat and meat food products
TITLE 21 -- FOOD AND DRUGS
(a) Examination of animals before slaughtering; diseased animals
slaughtered separately and carcasses examined
For the purpose of preventing the use in commerce of meat and meat
food products which are adulterated, the Secretary shall cause to be
made, by inspectors appointed for that purpose, an examination and
inspection of all cattle, sheep, swine, goats, horses, mules, and other
equines before they shall be allowed to enter into any slaughtering,
packing, meat-canning, rendering, or similar establishment, in which
they are to be slaughtered and the meat and meat food products thereof
are to be used in commerce; and all cattle, sheep, swine, goats,
horses, mules, and other equines found on such inspection to show
symptoms of disease shall be set apart and slaughtered separately from
all other cattle, sheep, swine, goats, horses, mules, or other equines,
and when so slaughtered the carcasses of said cattle, sheep, swine,
goats, horses, mules, or other equines shall be subject to a careful
examination and inspection, all as provided by the rules and regulations
to be prescribed by the Secretary, as provided for in this subchapter.
(b) Humane methods of slaughter
For the purpose of preventing the inhumane slaughtering of livestock,
the Secretary shall cause to be made, by inspectors appointed for that
purpose, an examination and inspection of the method by which cattle,
sheep, swine, goats, horses, mules, and other equines are slaughtered
and handled in connection with slaughter in the slaughtering
establishments inspected under this chapter. The Secretary may refuse
to provide inspection to a new slaughtering establishment or may cause
inspection to be temporarily suspended at a slaughtering establishment
if the Secretary finds that any cattle, sheep, swine, goats, horses,
mules, or other equines have been slaughtered or handled in connection
with slaughter at such establishment by any method not in accordance
with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901-1906)
until the establishment furnishes assurances satisfactory to the
Secretary that all slaughtering and handling in connection with
slaughter of livestock shall be in accordance with such a method.
(Mar. 4, 1907, ch. 2907, title I, 3, formerly 1st par., 34 Stat.
1260, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3, 12(
a), (b), 81 Stat. 584, 588, 592; Oct. 10, 1978, Pub. L. 95-445, 2, 92
Stat. 1069.)
Act of August 27, 1958, referred to in subsec. (b), is Pub. L.
85-765, Aug. 27, 1958, 72 Stat. 862, as amended, which is classified
generally to chapter 48 ( 1901 et seq.) of Title 7, Agriculture. For
complete classification of this Act to the Code, see Tables.
Sections 1903 and 1905 of Title 7, included within reference to Act
of August 27, 1958, were repealed by Pub. L. 95-445, 5(b), Oct. 10,
1978, 92 Stat. 1069, effective as set forth in section 7 of Pub. L.
95-445, set out as an Effective Date of 1978 Amendment note below.
Section was formerly classified to section 71 of this title.
1978 -- Pub. L. 95-445 designated existing provisions as subsec.
(a) and added subsec. (b).
1967 -- Pub. L. 90-201, 3, 12(a), (b), struck out ''interstate or
foreign'' before ''commerce'' in two places, substituted ''Secretary
shall'' for ''Secretary, at his discretion, may'', and struck out ''of
Agriculture'' after ''Secretary'', included horses, mules, and other
equines, and horses, mules, or other equines in the list of animals, and
substituted ''adulterated'' for ''unsound, unhealthful, unwholesome, or
otherwise unfit for human food'', respectively.
Section 7 of Pub. L. 95-445 provided that: ''The provisions of this
Act (see Short Title of 1978 Amendment note set out under section 601 of
this title) shall become effective one year after the date of enactment
(Oct. 10, 1978). However, such provisions shall not apply to a person,
firm, or corporation for such additional period of time, not to exceed
eighteen months, as may be determined by the Secretary, if the
Secretary, upon application, finds that compliance with the provisions
of this Act on its effective date would cause undue hardship on such
person, firm, or corporation.''
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
Section 6 of Pub. L. 95-445 provided that: ''Nothing in this Act
(see Short Title of 1978 Amendment note set out under section 601 of
this title) shall be construed to prohibit, abridge, or in any way
hinder the religious freedom of any person or group. Notwithstanding
any other provision of this Act, in order to protect freedom of
religion, ritual slaughter and the handling or other preparation of
livestock for ritual slaughter are exempted from the terms of this Act.
For the purposes of this section the term 'ritual slaughter' means
slaughter in accordance with section 2(b) of the Act of August 27, 1958
(72 Stat. 862; 7 U.S.C. 1902(b)).''
21 USC 604. Post mortem examination of carcasses and marking or
labeling; destruction of carcasses condemned; reinspection
TITLE 21 -- FOOD AND DRUGS
For the purposes hereinbefore set forth the Secretary shall cause to
be made by inspectors appointed for that purpose a post mortem
examination and inspection of the carcasses and parts thereof of all
cattle, sheep, swine, goats, horses, mules, and other equines to be
prepared at any slaughtering, meat-canning, salting, packing, rendering,
or similar establishment in any State, Territory, or the District of
Columbia as articles of commerce which are capable of use as human food;
and the carcasses and parts thereof of all such animals found to be not
adulterated shall be marked, stamped, tagged, or labeled as ''Inspected
and passed''; and said inspectors shall label, mark, stamp, or tag as
''Inspected and condemned'' all carcasses and parts thereof of animals
found to be adulterated; and all carcasses and parts thereof thus
inspected and condemned shall be destroyed for food purposes by the said
establishment in the presence of an inspector, and the Secretary may
remove inspectors from any such establishment which fails to so destroy
any such condemned carcass or part thereof, and said inspectors, after
said first inspection, shall, when they deem it necessary, reinspect
said carcasses or parts thereof to determine whether since the first
inspection the same have become adulterated, and if any carcass or any
part thereof shall, upon examination and inspection subsequent to the
first examination and inspection, be found to be adulterated, it shall
be destroyed for food purposes by the said establishment in the presence
of an inspector, and the Secretary may remove inspectors from any
establishment which fails to so destroy any such condemned carcass or
part thereof.
(Mar. 4, 1907, ch. 2907, title I, 4, formerly 2nd par., 34 Stat.
1260, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3, 4,
12(a)-(d), 81 Stat. 584, 588, 592.)
Section was formerly classified to section 72 of this title.
1967 -- Pub. L. 90-201, 3, 4, 12(a)-(d), struck out ''interstate or
foreign'' before ''commerce'' and ''of Agriculture'' after ''Secretary''
in three places; struck out ''for human consumption'' before ''at any
slaughtering'' and ''for transportation or sale'' after ''District of
Columbia'' and inserted ''which are capable of use as human food'' after
''commerce''; included horses, mules, and other equines in the list of
animals; substituted ''adulterated'' for ''unsound, unhealthful,
unwholesome, or otherwise unfit for human food'' after '''Inspected and
condemned,' all carcasses and parts thereof of animals found to be'' and
before '', it shall be destroyed''; substituted ''not adulterated'' for
''sound, healthful, wholesome, and fit for human food''; and
substituted ''adulterated'' for ''unsound, unhealthful, unwholesome, or
in any way unfit for human food'' before ''and if any carcass'',
respectively.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 605. Examination of carcasses brought into slaughtering or
packing establishments, and of meat food products issued from and
returned thereto; conditions for entry
TITLE 21 -- FOOD AND DRUGS
The foregoing provisions shall apply to all carcasses or parts of
carcasses of cattle, sheep, swine, goats, horses, mules, and other
equines or the meat or meat products thereof which may be brought into
any slaughtering, meat-canning, salting, packing, rendering, or similar
establishment, and such examination and inspection shall be had before
the said carcasses or parts thereof shall be allowed to enter into any
department wherein the same are to be treated and prepared for meat food
products; and the foregoing provisions shall also apply to all such
products, which, after having been issued from any slaughtering,
meat-canning, salting, packing, rendering, or similar establishment,
shall be returned to the same or to any similar establishment where such
inspection is maintained. The Secretary may limit the entry of
carcasses, parts of carcasses, meat and meat food products, and other
materials into any establishment at which inspection under this
subchapter is maintained, under such conditions as he may prescribe to
assure that allowing the entry of such articles into such inspected
establishments will be consistent with the purposes of this chapter.
(Mar. 4, 1907, ch. 2907, title I, 5, formerly 3rd par., 34 Stat.
1261, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 5, 12(
a), 81 Stat. 584, 588, 592.)
Section was formerly classified to section 73 of this title.
1967 -- Pub. L. 90-201, 5, 12(a), limited entry of articles into
establishments under such prescribed conditions as would be consistent
with the purpose of this chapter and included horses, mules, and other
equines in the list of animals, respectively.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 606. Examination and inspection of meat food products
TITLE 21 -- FOOD AND DRUGS
(a) Authority of Secretary; manner and frequency of inspections
(1) For the purposes set forth in the preceding provisions of this
chapter, the Secretary shall cause to be made, by inspectors appointed
for that purpose, an examination and inspection of meat food products
prepared for commerce in any slaughtering, meat-canning, salting,
packing, rendering, or similar establishment.
(2) Such examination and inspection shall be conducted with such
frequency and in such manner as the Secretary considers necessary, as
provided in rules and regulations issued by the Secretary, taking into
account such factors as the Secretary considers to be appropriate,
including --
(A) the nature and frequency of the processing operations at such
establishment;
(B) the adequacy and reliability of the processing controls and
sanitary procedures at such establishment; and
(C) the history of compliance with inspection requirements in effect
under this chapter, by the operator of such establishment or anyone
responsibly connected with the business (as described in section 671(g)
of this title) that operates such establishment.
(b) Marking, stamping, etc., of inspected food; destruction of
condemned food
(1) All such products found by any of such inspectors and by the
operator of such establishment to be not adulterated shall be marked,
stamped, tagged, or labeled as ''Inspected and passed''.
(2) All such products found by any of such inspectors or by the
operator of such establishment to be adulterated shall be marked,
stamped, tagged, or labeled as ''Inspected and condemned''. Each such
condemned product shall be destroyed for human food purposes. The
Secretary may suspend inspection at, and remove inspectors from, any
establishment that fails to so condemn adulterated meat food products or
fails to so destroy condemned meat food products.
(c) Access to food processing establishments
For purposes of any examination and inspection, such inspectors shall
have access to every part of an establishment at all times, by day or
night, and without regard to whether such establishment is operated.
(d) Exceptions for meat and food products destined for export to
foreign country
Notwithstanding the preceding provisions of this section, subject to
the rules and regulations of the Secretary the provisions of this
section in regard to preservatives shall not apply to meat food products
for export to any foreign country and which are prepared or packed
according to the specifications or directions of the foreign purchaser,
when no substance is used in the preparation or packing thereof in
conflict with the laws of the foreign country to which said article is
to be exported; but if said article shall be in fact sold or offered
for sale for domestic use or consumption then this proviso shall not
exempt said article from the operation of all the other provisions of
this chapter.
(Mar. 4, 1907, ch. 2907, title I, 6, formerly 4th par., 34 Stat.
1261, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3, 12(
e), 81 Stat. 584, 588, 592; Nov. 10, 1986, Pub. L. 99-641, title IV,
403(a), 100 Stat. 3567.)
Section was formerly classified to section 74 of this title.
1986 -- Pub. L. 99-641 temporarily added subsecs. (a) to (c) and
struck out former undesignated provisions which read as follows: ''For
the purposes hereinbefore set forth the Secretary shall cause to be
made, by inspectors appointed for that purpose, an examination and
inspection of all meat food products prepared for commerce in any
slaughtering, meat-canning, salting, packing, rendering, or similar
establishment, and for the purposes of any examination and inspection
and inspectors shall have access at all times, by day or night, whether
the establishment be operated or not, to every part of said
establishment; and said inspectors shall mark, stamp, tag, or label as
'Inspected and passed' all such products found to be not adulterated;
and said inspectors shall label, mark, stamp, or tag as 'Inspected and
condemned' all such products found adulterated, and all such condemned
meat food products shall be destroyed for food purposes, as hereinbefore
provided, and the Secretary may remove inspectors from any establishment
which fails to so destroy such condemned meat food products: Provided,
That'', designated remaining provisions as subsec. (d), and inserted
''Notwithstanding the preceding provisions of this section,''. See
Effective and Termination Dates of 1986 Amendment note below.
1967 -- Pub. L. 90-201, 3, 12(e), struck out ''interstate or
foreign'' before ''commerce'' and ''of Agriculture'' after ''Secretary''
in three places, and substituted ''not adulterated'' for ''sound,
healthful, and wholesome, and which contains no dyes, chemicals,
preservatives, or ingredients which render such meat or meat food
products unsound, unhealthful, unwholesome, or unfit for human food''
and ''adulterated'' for ''unsound, unhealthful, and unwholesome, or
which contain dyes, chemicals, preservatives, or ingredients which
render such meat or meat food products unsound, unhealthful,
unwholesome, or unfit for human food,'' respectively.
Section 403(a) of Pub. L. 99-641 provided in part that the amendment
of this section by Pub. L. 99-641 is effective only during the 6-year
period beginning Nov. 10, 1986.
Section 408 of title IV of Pub. L. 99-641 provided that:
''(a) General Effective Date. -- Except as provided in subsection (b)
of this section, this title and the amendments made by this title
(amending sections 606, 609, 621, 671, and 676 of this title and
enacting provisions set out as notes under sections 606, 609, 621, 671,
and 676 of this title) shall become effective on the date of the
enactment of this Act (Nov. 10, 1986).
''(b) Temporary Application of Existing Law. -- Sections 6, 9, and 21
of the Federal Meat Inspection Act (21 U.S.C. 606, 609, and 621), as in
effect immediately before the date of the enactment of this Act (Nov.
10, 1986), shall apply with respect to establishments until the
Secretary of Agriculture first issues rules and regulations to implement
the amendments made by section 403(a) (amending this section).''
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
Section 404 of Pub. L. 99-641 provided that: ''The expiration date
provisions of section 403 (enacting provisions set out as notes under
this section and sections 609, 621, 671, and 676 of this title) shall
not have the effect of releasing or extinguishing any penalty,
forfeiture, or liability incurred under the Federal Meat Inspection Act
(21 U.S.C. 601 et seq.), as amended by section 403 (amending this
section and sections 609, 621, 671, and 676 of this title), or under the
rules or regulations issued under such Act.''
Section 403(e) of Pub. L. 99-641 provided that: ''The amendments
made by this section (amending this section and sections 609, 621, 671,
and 676 of this title) shall not be construed to authorize the Secretary
of Agriculture to refuse to provide inspection under the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.) at an establishment solely
because such establishment does not participate in a total plant
quality-control program.''
Section 405 of Pub. L. 99-641 provided that: ''It is the sense of
Congress that the Secretary of Agriculture should --
''(1) carry out a program to detect residues in livestock that are
subject to inspection under title I of the Federal Meat Inspection Act
(21 U.S.C. 601 et seq.); and
''(2) evaluate the feasibility of, and develop, a program that would
enable the Secretary to trace any particular livestock that are subject
to inspection under title I of the Federal Meat Inspection Act, in order
to identify the producer of such livestock.''
Section 406 of Pub. L. 99-641 provided that: ''Not later than 1
year after the date of the enactment of this Act (Nov. 10, 1986), and
annually thereafter, the Secretary of Agriculture shall submit to the
Committee on Agriculture of the House of Representatives and the
Committee on Agriculture, Nutrition, and Forestry of the Senate a report
describing --
''(1) any action proposed or taken by the Secretary to implement the
amendments made by section 403 (amending this section and sections 609,
621, 671, and 676 of this title);
''(2) any action proposed or taken by the Secretary to carry out a
program to detect residues in livestock that are subject to inspection
under title I of the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.);
''(3) any action proposed or taken by the Secretary to evaluate the
feasibility of, and develop, a program that would enable the Secretary
to trace any particular livestock that are subject to inspection under
such title, in order to identify the producer of such livestock; and
''(4) any personnel action proposed or taken by the Secretary as a
result of the amendments made by section 403 and any effort made by the
Secretary to minimize any adverse economic effect of such amendments on
employees of the Department of Agriculture.''
Section 407 of Pub. L. 99-641 provided that: ''It is the sense of
Congress that, not later than 6 years after the date of the enactment of
this Act (Nov. 10, 1986), Congress shall --
''(1) evaluate the operation and effects of the amendments made by
section 403 (amending this section and sections 609, 621, 671, and 676
of this title), for the purpose of determining whether to extend or
modify the operation of such amendments; and
''(2) enact such legislation as may be necessary to efficiently and
effectively carry out the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.).''
21 USC 607. Labeling, marking, and container requirements
TITLE 21 -- FOOD AND DRUGS
(a) Labeling receptacles or coverings of meat or meat food products
inspected and passed; supervision by inspectors
When any meat or meat food product prepared for commerce which has
been inspected as hereinbefore provided and marked ''Inspected and
passed'' shall be placed or packed in any can, pot, tin, canvas, or
other receptacle or covering in any establishment where inspection under
the provisions of this chapter is maintained, the person, firm, or
corporation preparing said product shall cause a label to be attached to
said can, pot, tin, canvas, or other receptacle or covering, under the
supervision of an inspector, which label shall state that the contents
thereof have been ''inspected and passed'' under the provisions of this
chapter; and no inspection and examination of meat or meat food
products deposited or inclosed in cans, tins, pots, canvas, or other
receptacle or covering in any establishment where inspection under the
provisions of this chapter is maintained shall be deemed to be complete
until such meat or meat food products have been sealed or inclosed in
said can, tin, pot, canvas, or other receptacle or covering under the
supervision of an inspector.
(b) Information on articles or containers; legible form
All carcasses, parts of carcasses, meat and meat food products
inspected at any establishment under the authority of this subchapter
and found to be not adulterated, shall at the time they leave the
establishment bear, in distinctly legible form, directly thereon or on
their containers, as the Secretary may require, the information required
under paragraph (n) of section 601 of this title.
(c) Labeling: type styles and sizes; definitions and standards of
identity or composition; standards of fill of container; consistency
of Federal and Federal-State standards
The Secretary, whenever he determines such action is necessary for
the protection of the public, may prescribe: (1) the styles and sizes
of type to be used with respect to material required to be incorporated
in labeling to avoid false or misleading labeling in marketing and
labeling any articles or animals subject to this subchapter or
subchapter II of this chapter; (2) definitions and standards of
identity or composition for articles subject to this subchapter and
standards of fill of container for such articles not inconsistent with
any such standards established under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), and there shall be consultation
between the Secretary and the Secretary of Health and Human Services
prior to the issuance of such standards under either Act relating to
articles subject to this chapter to avoid inconsistency in such
standards and possible impairment of the coordinated effective
administration of these Acts. There shall also be consultation between
the Secretary and an appropriate advisory committee provided for in
section 661 of this title, prior to the issuance of such standards under
this chapter, to avoid, insofar as feasible, inconsistency between
Federal and State standards.
(d) Sales under false or misleading name, other marking or labeling
or in containers of misleading form or size; trade names, and other
marking, labeling, and containers approved by Secretary
No article subject to this subchapter shall be sold or offered for
sale by any person, firm, or corporation, in commerce, under any name or
other marking or labeling which is false or misleading, or in any
container of a misleading form or size, but established trade names and
other marking and labeling and containers which are not false or
misleading and which are approved by the Secretary are permitted.
(e) Use withholding directive respecting false or misleading marking,
labeling, or container; modification of false or misleading matter;
hearing; withholding use pending proceedings; finality of Secretary's
action; judicial review; application of section 194 of title 7
If the Secretary has reason to believe that any marking or labeling
or the size or form of any container in use or proposed for use with
respect to any article subject to this subchapter is false or misleading
in any particular, he may direct that such use be withheld unless the
marking, labeling, or container is modified in such manner as he may
prescribe so that it will not be false or misleading. If the person,
firm, or corporation using or proposing to use the marking, labeling or
container does not accept the determination of the Secretary, such
person, firm, or corporation may request a hearing, but the use of the
marking, labeling, or container shall, if the Secretary so directs, be
withheld pending hearing and final determination by the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
thirty days after receipt of notice of such final determination, the
person, firm, or corporation adversely affected thereby appeals to the
United States court of appeals for the circuit in which such person,
firm, or corporation has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
The provisions of section 194 of title 7 shall be applicable to appeals
taken under this section.
(Mar. 4, 1907, ch. 2907, title I, 7, formerly 5th par., 34 Stat.
1262, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3(a), 6,
81 Stat. 584, 588; Oct. 17, 1979, Pub. L. 96-88, title V, 509(b), 93
Stat. 695.)
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(c)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 ( 301 et seq.) of this title.
For complete classification of this Act to the Code, see section 301 of
this title and Tables.
Either Act and these Acts, referred to in subsec. (c)(2), mean the
Federal Meat Inspection Act and the Federal Food, Drug, and Cosmetic
Act. The Federal Meat Inspection Act is act Mar. 4, 1907, ch. 2907,
titles I to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81 Stat. 584,
and amended, which are classified generally to subchapters I to IV ( 601
et seq.), respectively, of this chapter. For complete classification of
this Act to the Code, see Short Title note under section 601 of this
title and Tables.
Section was formerly classified to section 75 of this title.
1967 -- Subsec. (a). Pub. L. 90-201, 3(a), 6(a), (b), struck out
''interstate or foreign'' before ''commerce'' and provisions prohibiting
sales of meat or meat food products in interstate or foreign commerce
under any false or deceptive names and permitting trade names or names
which are usual to such products and are not false and deceptive and are
approved by the Secretary of Agriculture, now incorporated in subsec.
(d), and designated remaining provisions as subsecs. (a), respectively.
Subsecs. (b) to (e). Pub. L. 90-201, 6(c), added subsecs. (b) to
(e).
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in subsec. (c)(2)
pursuant to section 509(b) of Pub. L. 96-88, which is classified to
section 3508(b) of Title 20, Education.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
Federal Food, Drug, and Cosmetic Act defined, see section 601 of this
title.
21 USC 608. Sanitary inspection and regulation of slaughtering and
packing establishments; rejection of adulterated meat or meat food
products
TITLE 21 -- FOOD AND DRUGS
The Secretary shall cause to be made, by experts in sanitation or by
other competent inspectors, such inspection of all slaughtering, meat
canning, salting, packing, rendering, or similar establishments in which
cattle, sheep, swine, goats, horses, mules and other equines are
slaughtered and the meat and meat food products thereof are prepared for
commerce as may be necessary to inform himself concerning the sanitary
conditions of the same, and to prescribe the rules and regulations of
sanitation under which such establishments shall be maintained; and
where the sanitary conditions of any such establishment are such that
the meat or meat food products are rendered adulterated, he shall refuse
to allow said meat or meat food products to be labeled, marked, stamped
or tagged as ''inspected and passed.''
(Mar. 4, 1907, ch. 2907, title I, 8, formerly 6th par., 34 Stat.
1262, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3, 12(
a), (f), 81 Stat. 584, 588, 592.)
Section was formerly classified to section 76 of this title.
1967 -- Pub. L. 90-201, 3, 12(a), (f), struck out ''interstate or
foreign'' before ''commerce'' and ''of Agriculture'' after
''Secretary'', included horses, mules, and other equines in the list of
animals, and substituted ''adulterated'' for ''unclean, unsound,
unhealthful, unwholesome, or otherwise unfit for human food'',
respectively.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 609. Examination of animals and food products thereof,
slaughtered and prepared during nighttime
TITLE 21 -- FOOD AND DRUGS
The Secretary shall cause an examination and inspection of all
cattle, sheep, swine, goats, horses, mules and other equines, and,
except as provided in section 606 of this title, the food products
thereof, slaughtered and prepared in the establishments hereinbefore
described for the purposes of commerce to be made during the nighttime
as well as during the daytime when the slaughtering of said cattle,
sheep, swine, goats, horses, mules, and other equines, or the
preparation of said food products is conducted during the nighttime.
(Mar. 4, 1907, ch. 2907, title I, 9, formerly 7th par., 34 Stat.
1262, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3, 12(
a), 81 Stat. 584, 588, 592; Nov. 10, 1986, Pub. L. 99-641, title IV,
403(d)(1), 100 Stat. 3570.)
Section was formerly classified to section 77 of this title.
1986 -- Pub. L. 99-641 temporarily inserted '', except as provided
in section 606 of this title,'' after first reference to ''other
equines, and''. See Effective and Termination Dates of 1986 Amendment
note below.
1967 -- Pub. L. 90-201, 3, 12(a), struck out ''interstate or
foreign'' before ''commerce'' and ''of Agriculture'' after ''Secretary''
and included horses, mules, and other equines in the list of animals,
respectively.
Section 403(d)(1) of Pub. L. 99-641 provided that the amendment made
by that section is effective only during the 6-year period beginning
Nov. 10, 1986.
Amendment by Pub. L. 99-641 effective Nov. 10, 1986, except that
this section as in effect immediately before Nov. 10, 1986, applies
with respect to establishments until the Secretary of Agriculture first
issues rules and regulations to implement the amendments made by section
403(a) of Pub. L. 99-641 to section 606 of this title, see section 408
of Pub. L. 99-641, set out as a note under section 606 of this title.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
For provisions relating to construction and effect of temporary
amendments by section 403 of Pub. L. 99-641, see sections 403(e) and
404 of Pub. L. 99-641, set out as notes entitled ''Inspection Services
for Establishments Not Participating in Total Plant Quality-Control
Program'' and ''Savings Provision'', respectively, under section 606 of
this title.
21 USC 610. Prohibited acts
TITLE 21 -- FOOD AND DRUGS
No person, firm, or corporation shall, with respect to any cattle,
sheep, swine, goats, horses, mules, or other equines, or any carcasses,
parts of carcasses, meat or meat food products of any such animals --
(a) Slaughtering animals or preparation of articles capable of use as
human food
slaughter any such animals or prepare any such articles which are
capable of use as human food at any establishment preparing any such
articles for commerce, except in compliance with the requirements of
this chapter;
(b) Humane methods of slaughter
slaughter or handle in connection with slaughter any such animals in
any manner not in accordance with the Act of August 27, 1958 (72 Stat.
862; 7 U.S.C. 1901-1906);
(c) Sales, transportation, and other transactions
sell, transport, offer for sale or transportation, or receive for
transportation, in commerce, (1) any such articles which (A) are capable
of use as human food and (B) are adulterated or misbranded at the time
of such sale, transportation, offer for sale or transportation, or
receipt for transportation; or (2) any articles required to be
inspected under this subchapter unless they have been so inspected and
passed;
(d) Adulteration or misbranding
do, with respect to any such articles which are capable of use as
human food, any act while they are being transported in commerce or held
for sale after such transportation, which is intended to cause or has
the effect of causing such articles to be adulterated or misbranded.
(Mar. 4, 1907, ch. 2907, title I, 10, formerly 8th par., 34 Stat.
1262, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 7, 81
Stat. 584, 589; Oct. 10, 1978, Pub. L. 95-445, 3, 92 Stat. 1069.)
Act of August 27, 1958, referred to in subsec. (b), is Pub. L.
85-765, Aug. 27, 1958, 72 Stat. 862, as amended, which is classified
generally to chapter 48 ( 1901 et seq.) of Title 7, Agriculture. For
complete classification of this Act to the Code, see Tables.
Sections 1903 and 1905 of Title 7, included within reference to Act
of August 27, 1958, were repealed by Pub. L. 95-445, 5(b), Oct. 10,
1978, 92 Stat. 1069, effective as set forth in section 7 of Pub. L.
95-445, set out as an Effective Date of 1978 Amendment note under
section 603 of this title.
Section was formerly classified to section 78 of this title.
1978 -- Subsecs. (b) to (d). Pub. L. 95-445 added subsec. (b) and
redesignated former subsecs. (b) and (c) as (c) and (d), respectively.
1967 -- Pub. L. 90-201, 7, included the list of animals and
prohibited, except in compliance with requirements of this chapter,
slaughtering animals or preparation of articles capable of use as human
food, sales, transportation, and other transactions, and acts of
adulteration or misbranding, incorporating in subsec. (b)(2) existing
prohibition on distributions in interstate or foreign commerce of
noninspected articles.
Amendment by Pub. L. 95-445 effective one year after Oct. 10, 1978,
and an additional eighteen month period thereafter in hardship cases,
see section 7 of Pub. L. 95-445, set out as an Effective Date of 1978
Amendment note under section 603 of this title.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
subsecs. (b)(1) and (c) of this section effective upon expiration of
sixty days after Dec. 15, 1967, see section 20(a) of Pub. L. 90-201,
set out as an Effective Date note under section 601 of this title.
21 USC 611. Devices, marks, labels, and certificates; simulations
TITLE 21 -- FOOD AND DRUGS
(a) Devices to be made under authorization of Secretary
No brand manufacturer, printer, or other person, firm, or corporation
shall cast, print, lithograph, or otherwise make any device containing
any official mark or simulation thereof, or any label bearing any such
mark or simulation, or any form of official certificate or simulation
thereof, except as authorized by the Secretary.
(b) Other misconduct
No person, firm, or corporation shall --
(1) forge any official device, mark, or certificate;
(2) without authorization from the Secretary use any official device,
mark, or certificate, or simulation thereof, or alter, detach, deface,
or destroy any official device, mark, or certificate;
(3) contrary to the regulations prescribed by the Secretary, fail to
use, or to detach, deface, or destroy any official device, mark, or
certificate;
(4) knowingly possess, without promptly notifying the Secretary or
his representative, any official device or any counterfeit, simulated,
forged, or improperly altered official certificate or any device or
label or any carcass of any animal, or part or product thereof, bearing
any counterfeit, simulated, forged, or improperly altered official mark;
(5) knowingly make any false statement in any shipper's certificate
or other nonofficial or official certificate provided for in the
regulations prescribed by the Secretary; or
(6) knowingly represent that any article has been inspected and
passed, or exempted, under this chapter when, in fact, it has,
respectively, not been so inspected and passed, or exempted.
(Mar. 4, 1907, ch. 2907, title I, 11, formerly 9th par., 34 Stat.
1263, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 8, 81
Stat. 584, 589.)
Section was formerly classified to section 79 of this title.
1967 -- Pub. L. 90-201, 8, clarified application to brand
manufacturers and printers of existing prohibition against
counterfeiting official marks, labels or certificates, the provisions
with respect to forgery, unauthorized use or failure to use official
marks, or similar items, and similar offenses, and existing prohibitions
with respect to false statements in official or nonofficial
certificates, and added restriction upon possession of official devices,
or devices, labels, meat, or other articles bearing counterfeit official
marks, counterfeit official certificates, or similar items, and
prohibition against false representations.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 612. Inspection of animals for export
TITLE 21 -- FOOD AND DRUGS
The Secretary shall cause to be made a careful inspection of all
cattle, sheep, swine, goats, horses, mules, and other equines intended
and offered for export to foreign countries at such times and places,
and in such manner as he may deem proper, to ascertain whether such
cattle, sheep, swine, goats, horses, mules, and other equines are free
from disease.
(Mar. 4, 1907, ch. 2907, title I, 12, formerly 10th par., 34 Stat.
1263, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3(b),
12(a), 81 Stat. 584, 588, 592.)
Section was formerly classified to section 80 of this title.
1967 -- Pub. L. 90-201, 3(b), 12(a), struck out ''of Agriculture''
after ''Secretary'' and included horses, mules, and other equines in the
list of animals, respectively.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
title 16 section 1540.
21 USC 613. Inspectors of animals for export; certificates of
condition
TITLE 21 -- FOOD AND DRUGS
For the purpose of section 612 of this title the Secretary may
appoint inspectors who shall be authorized to give an official
certificate clearly stating the condition in which such cattle, sheep,
swine, goats, horses, mules, and other equines are found.
(Mar. 4, 1907, ch. 2907, title I, 13, formerly 11th par., 34 Stat.
1263, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3(b),
12(a), 81 Stat. 584, 588, 592.)
Section was formerly classified to section 81 of this title.
1967 -- Pub. L. 90-201, 3(b), 12(a), struck out ''of Agriculture''
after ''Secretary'', and included horses, mules, and other equines in
the list of animals.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 614. Clearance prohibited to vessel carrying animals for export
without inspector's certificate
TITLE 21 -- FOOD AND DRUGS
No clearance shall be given to any vessel having on board cattle,
sheep, swine, goats, horses, mules, or other equines for export to a
foreign country until the owner or shipper of such cattle, sheep, swine,
goats, horses, mules, or other equines has a certificate from the
inspector authorized to be appointed, stating that the said cattle,
sheep, swine, goats, horses, mules, or other equines are sound and
healthy, or unless the Secretary shall have waived the requirement of
such certificate for export to the particular country to which such
cattle, sheep, swine, goats, horses, mules, or other equines are to be
exported.
(Mar. 4, 1907, ch. 2907, title I, 14, formerly 12th par., 34 Stat.
1263, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3(b),
12(a), 81 Stat. 584, 588, 592.)
Section was formerly classified to section 82 of this title.
1967 -- Pub. L. 90-201, 3(b), 12(a), struck out ''of Agriculture''
after ''Secretary'' and included horses, mules, or other equines in the
list of animals, respectively.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 615. Inspection of carcasses, meat of which is intended for
export
TITLE 21 -- FOOD AND DRUGS
The Secretary shall also cause to be made a careful inspection of the
carcasses and parts thereof of all cattle, sheep, swine, goats, horses,
mules, and other equines, the meat of which, fresh, salted, canned,
corned, packed, cured, or otherwise prepared, is intended and offered
for export to any foreign country, at such times and places and in such
manner as he may deem proper.
(Mar. 4, 1907, ch. 2907, title I, 15, formerly 13th par., 34 Stat.
1263, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3(b),
12(a), 81 Stat. 584, 588, 592.)
Section was formerly classified to section 83 of this title.
1967 -- Pub. L. 90-201, 3(b), 12(a), struck out ''of Agriculture''
after ''Secretary'' and included horses, mules, and other equines in the
list of animals, respectively.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 616. Inspectors of carcasses, etc., meat of which is intended
for export; certificates of condition
TITLE 21 -- FOOD AND DRUGS
For the purpose of section 615 of this title the Secretary may
appoint inspectors who shall be authorized to give an official
certificate stating the condition in which said cattle, sheep, swine,
goats, horses, mules, or other equines, and the meat thereof, are found.
(Mar. 4, 1907, ch. 2907, title I, 16, formerly 14th par., 34 Stat.
1263, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3(b),
12(a), 81 Stat. 584, 588, 592.)
Section was formerly classified to section 84 of this title.
1967 -- Pub. L. 90-201, 3(b), 12(a), struck out ''of Agriculture''
after ''Secretary'', and included horses, mules, or other equines in the
list of animals.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 617. Clearance prohibited to vessel carrying meat for export
without inspector's certificate
TITLE 21 -- FOOD AND DRUGS
No clearance shall be given to any vessel having on board any fresh,
salted, canned, corned, or packed beef, mutton, pork, goat or equine
meat for export to and sale in a foreign country from any port in the
United States, until the owner or shipper thereof shall obtain from an
inspector appointed under the provisions of this chapter a certificate
that the said cattle, sheep, swine, goats, horses, mules, and other
equines were sound and healthy at the time of inspection, and that their
meat is sound and wholesome, unless the Secretary shall have waived the
requirements of such certificate for the country to which said cattle,
sheep, swine, goats, horses, mules, and other equines or meats are to be
exported.
(Mar. 4, 1907, ch. 2907, title I, 17, formerly 15th par., 34 Stat.
1263, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3(b),
12(a), (g), 81 Stat. 584, 588, 592.)
Section was formerly classified to section 85 of this title.
1967 -- Pub. L. 90-201, 3(b), 12(a), (g), struck out ''of
Agriculture'' after ''Secretary'', included horses, mules, and other
equines in the list of animals, and substituted ''goat or equine meat''
for ''or goat meat, being the meat of animals killed after March 4,
1907, or except as hereinbefore provided'', respectively.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 618. Delivery of inspectors' certificates, and of copies
TITLE 21 -- FOOD AND DRUGS
The inspectors provided for under this subchapter shall be authorized
to give official certificates of the condition of the cattle, sheep,
swine, goats, horses, mules, and other equines, their carcasses and
products as described in this subchapter; and one copy of every
certificate granted under the provisions of this chapter shall be filed
in the Department of Agriculture, another copy shall be delivered to the
owner or shipper, and when the cattle, sheep, swine, goats, horses,
mules, and other equines, or their carcasses and products are sent
abroad, a third copy shall be delivered to the chief officer of the
vessel on which the shipment shall be made.
(Mar. 4, 1907, ch. 2907, title I, 18, formerly 16th par., 34 Stat.
1263, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 12(a),
(h), 81 Stat. 584, 592.)
''Provided for under this subchapter'', and ''described in this
subchapter'' was in the original ''provided for herein'' and ''herein
described'', respectively.
Section was formerly classified to section 86 of this title.
1967 -- Pub. L. 90-201, 12(a), (h), included horses, mules, and
other equines in the list of animals and struck out ''sound and
wholesome'' before ''conditions'', respectively.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 619. Marking, labeling, or other identification of kinds of
animals of articles' derivation; separate establishments for
preparation and slaughtering activities
TITLE 21 -- FOOD AND DRUGS
No person, firm, or corporation shall sell, transport, offer for sale
or transportation, or receive for transportation, in commerce, any
carcasses of horses, mules, or other equines or parts of such carcasses,
or the meat or meat food products thereof, unless they are plainly and
conspicuously marked or labeled or otherwise identified as required by
regulations prescribed by the Secretary to show the kinds of animals
from which they were derived. When required by the Secretary, with
respect to establishments at which inspection is maintained under this
subchapter, such animals and their carcasses, parts thereof, meat and
meat food products shall be prepared in establishment separate from
those in which cattle, sheep, swine, or goats are slaughtered or their
carcasses, parts thereof, meat or meat food products are prepared.
(Mar. 4, 1907, ch. 2907, title I, 19, formerly 17th par., 34 Stat.
1264, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 9, 81
Stat. 584, 590.)
Section was formerly classified to section 87 of this title.
1967 -- Pub. L. 90-201, 9, substituted provisions for marking,
labeling, or other identification of kinds of animals whence the
articles are derived and for separate establishments for preparation and
slaughtering activities for prohibition against transportation or sale
of meat or meat food products without complying with inspection
provisions. See section 610(b) of this title.
Amendment by Pub. L, 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration, of sixty days after Dec. 15, 1967, see section 20(b)
of Pub. L. 90-201, set out as an Effective Date note under section 601
of this title.
21 USC 620. Imports
TITLE 21 -- FOOD AND DRUGS
(a) Adulteration or misbranding prohibition; compliance with
inspection, building construction standards, and other provisions;
humane methods of slaughter; treatment as domestic articles subject to
this chapter and food, drug, and cosmetic provisions; marking and
labeling; personal consumption exemption
No carcasses, parts of carcasses, meat or meat food products of
cattle, sheep, swine, goats, horses, mules, or other equines which are
capable of use as human food, shall be imported into the United States
if such articles are adulterated or misbranded and unless they comply
with all the inspection, building, construction standards, and all other
provisions of this chapter and regulations issued thereunder applicable
to such articles in commerce within the United States. No such
carcasses, parts of carcasses, meat or meat food products shall be
imported into the United States unless the livestock from which they
were produced was slaughtered and handled in connection with slaughter
in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C.
1901-1906). All such imported articles shall, upon entry into the United
States, be deemed and treated as domestic articles subject to the other
provisions of this chapter and the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.): Provided, That they shall be marked and
labeled as required by such regulations for imported articles: Provided
further, That nothing in this section shall apply to any individual who
purchases meat or meat products outside the United States for his own
consumption except that the total amount of such meat or meat products
shall not exceed fifty pounds.
(b) Terms and conditions for destruction
The Secretary may prescribe the terms and conditions for the
destruction of all such articles which are imported contrary to this
section, unless (1) they are exported by the consignee within the time
fixed therefor by the Secretary, or (2) in the case of articles which
are not in compliance with the chapter solely because of misbranding,
such articles are brought into compliance with the chapter under
supervision of authorized representatives of the Secretary.
(c) Payment of storage, cartage, and labor charges by owner or
consignee; liens
All charges for storage, cartage, and labor with respect to any
article which is imported contrary to this section shall be paid by the
owner or consignee, and in default of such payment shall constitute a
lien against such article and any other article thereafter imported
under this chapter by or for such owner or consignee.
(d) Prohibition
The knowing importation of any article contrary to this section is
prohibited.
(e) Reports to Congressional committees
Not later than March 1 of each year the Secretary shall submit to the
Committee on Agriculture of the House of Representatives and the
Committee on Agriculture, Nutrition, and Forestry of the Senate a
comprehensive and detailed written report with respect to the
administration of this section during the immediately preceding calendar
year. Such report shall include, but shall not be limited to --
(1) a certification by the Secretary that foreign plants exporting
carcasses or meat or meat products referred to in subsection (a) of this
section have complied with requirements at least equal to all the
inspection, building construction standards, and all other provisions of
this chapter and regulations issued thereunder;
(2) the names and locations of plants authorized or permitted to have
imported into the United States therefrom carcasses or meat or meat
products referred to in subsection (a) of this section;
(3) the number of inspectors employed by the Department of
Agriculture in the calendar year concerned who were assigned to inspect
plants referred to in paragraph (e)(2) hereof and the frequency with
which each such plant was inspected by such inspectors;
(4) the number of inspectors licensed by each country from which any
imports subject to the provisions of this section were imported who were
assigned, during the calendar year concerned, to inspect such imports
and the facilities in which such imports were handled and the frequency
and effectiveness of such inspections;
(5) the total volume of carcasses or meat or meat products referred
to in subsection (a) of this section which was imported into the United
States during the calendar year concerned from each country, including a
separate itemization of the volume of each major category of such
imports from each country during such year, and a detailed report of
rejections of plants and products because of failure to meet appropriate
standards prescribed by this chapter; and
(6) the name of each foreign country that applies standards for the
importation of meat articles from the United States that are described
in subsection (h)(2) of this section.
(f) Inspection and other standards; applicability, enforcement,
etc.; certifications
Notwithstanding any other provision of law, all carcasses, parts of
carcasses, meat, and meat food products of cattle, sheep, swine, goats,
horses, mules, or other equines, capable of use as human food, offered
for importation into the United States shall be subject to the
inspection, sanitary, quality, species verification, and residue
standards applied to products produced in the United States. Any such
imported meat articles that do not meet such standards shall not be
permitted entry in to the United States. The Secretary shall enforce
this provision through (1) the imposition of random inspections for such
species verification and for residues, and (2) random sampling and
testing of internal organs and fat of the carcasses for residues at the
point of slaughter by the exporting country in accordance with methods
approved by the Secretary. Each foreign country from which such meat
articles are offered for importation into the United States shall obtain
a certification issued by the Secretary stating that the country
maintains a program using reliable analytical methods to ensure
compliance with the United States standards for residues in such meat
articles. No such meat article shall be permitted entry into the United
States from a country for which the Secretary has not issued such
certification. The Secretary shall periodically review such
certifications and shall revoke any certification if the Secretary
determines that the country involved is not maintaining a program that
uses reliable analytical methods to ensure compliance with United States
standards for residues in such meat articles. The consideration of any
application for a certification under this subsection and the review of
any such certification, by the Secretary, shall include the inspection
of individual establishments to ensure that the inspection program of
the foreign country involved is meeting such United States standards.
(g) Administration of animal drugs or antibiotics; terms and
conditions; entry order violations
The Secretary may prescribe terms and conditions under which cattle,
sheep, swine, goats, horses, mules, and other equines that have been
administered an animal drug or antibiotic banned for use in the United
States may be imported for slaughter and human consumption. No person
shall enter cattle, sheep, swine, goats, horses, mules, and other
equines into the United States in violation of any order issued under
this subsection by the Secretary.
(h) Reciprocal meat inspection requirement
(1) As used in this subsection:
(A) The term ''meat articles'' means carcasses, meat and meat food
products of cattle, sheep, swine, goats, horses, mules, or other
equines, that are capable of use as human food.
(B) The term ''standards'' means inspection, building construction,
sanitary, quality, species verification, residue, and other standards
that are applicable to meat articles.
(2) On request of the Committee on Agriculture or the Committee on
Ways and Means of the House of Representatives or the Committee on
Agriculture, Nutrition, and Forestry or the Committee on Finance of the
Senate, or at the initiative of the Secretary, the Secretary shall, as
soon as practicable, determine whether a particular foreign country
applies standards for the importation of meat articles from the United
States that are not related to public health concerns about end-product
quality that can be substantiated by reliable analytical methods.
(3) If the Secretary determines that a foreign country applies
standards described in paragraph (2) --
(A) the Secretary shall consult with the United States Trade
Representative; and
(B) within 30 days after the determination of the Secretary under
paragraph (2), the Secretary and the United States Trade Representative
shall recommend to the President whether action should be taken under
paragraph (4).
(4) Within 30 days after receiving a recommendation for action under
paragraph (3), the President shall, if and for such time as the
President considers appropriate, prohibit imports into the United States
of any meat articles produced in such foreign country unless it is
determined that the meat articles produced in that country meet the
standards applicable to meat articles in commerce within the United
States.
(5) The action authorized under paragraph (4) may be used instead of,
or in addition to, any other action taken under any other law.
(Mar. 4, 1907, ch. 2907, title I, 20, formerly 18th par., 34 Stat.
1264, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 10, 81
Stat. 584, 590; S. Res. 4, Feb. 4, 1977; Oct. 10, 1978, Pub. L.
95-445, 4, 92 Stat. 1069; Dec. 22, 1981, Pub. L. 97-98, title XI, 1122,
95 Stat. 1273; Dec. 23, 1985, Pub. L. 99-198, title XVII, 1702, 99
Stat. 1634; Aug. 23, 1988, Pub. L. 100-418, title IV, 4604, 102 Stat.
1408.)
Act of August 27, 1958, referred to in subsec. (a), is Pub. L.
85-765, Aug. 27, 1958, 72 Stat. 862, as amended, which is classified
generally to chapter 48 ( 1901 et seq.) of Title 7, Agriculture. For
complete classification of this Act to the Code, see Tables.
Sections 1903 and 1905 of Title 7, included within reference to Act
of August 27, 1958, were repealed by Pub. L. 95-445, 5(b), Oct. 10,
1978, 92 Stat. 1069, effective as set forth in section 7 of Pub. L.
95-445, set out as an Effective Date of 1978 Amendment note under
section 603 of this title.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(a), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which
is classified generally to chapter 9 ( 301 et seq.) of this title. For
complete classification of this act to the Code, see section 301 of this
title and Tables.
Section was formerly classified to section 88 of this title.
1988 -- Subsec. (e)(6). Pub. L. 100-418, 4604(b), added par. (6).
Subsec. (h). Pub. L. 100-418, 4604(a), added subsec. (h).
1985 -- Subsec. (f). Pub. L. 99-198, 1702(a), struck out provision
which had made this subsection effective six months after Dec. 22,
1981, and inserted provisions requiring that each foreign country from
which meat articles are offered for importation into the United States
obtain a certification issued by the Secretary stating that the country
maintains a program using reliable analytical methods to ensure
compliance with the United States standards for residues in such meat
articles, that no meat article be permitted entry into the United States
from a country for which the Secretary has not issued such
certification, that the Secretary periodically review such
certifications and revoke any certification if the Secretary determines
that the country involved is not maintaining a program that uses
reliable analytical methods to ensure compliance with United States
standards for residues in such meat articles, and that the consideration
of any application for a certification under this subsection and the
review of any such certification, by the Secretary, include the
inspection of individual establishments to ensure that the inspection
program of the foreign country involved is meeting such United States
standards.
Subsec. (g). Pub. L. 99-198, 1702(b), added subsec. (g).
1981 -- Subsec. (f). Pub. L. 97-98 added subsec. (f).
1978 -- Subsec. (a). Pub. L. 95-445 prohibited imports which do not
comply with humane methods of slaughter.
1967 -- Pub. L. 90-201, 10, substituted imported articles provisions
for penalty provisions deeming offenses as misdemeanors and punishable
by fine of $10,000 or imprisonment for two years or both. See section
676(a) of this title.
Committee on Agriculture and Forestry of the Senate abolished and
replaced by Committee on Agriculture, Nutrition, and Forestry of the
Senate, effective Feb. 11, 1977. See Rule XXV of Standing Rules of the
Senate, as amended by Senate Resolution 4 (popularly cited as the
''Committee System Reorganization Amendments of 1977''), approved Feb.
4, 1977.
Amendment by Pub. L. 97-98 effective Dec. 22, 1981, see section
1801 of Pub. L. 97-98, set out as an Effective Date note under section
4301 of Title 7, Agriculture.
Amendment by Pub. L. 95-445 effective one year after Oct. 10, 1978,
and an additional eighteen-month period thereafter in hardship cases,
see section 7 of Pub. L. 95-445, set out as a note under section 603 of
this title.
Amendment by Pub. L. 90-201 effective upon expiration of sixty days
after Dec. 15, 1967, see section 20(a) of Pub. L. 90-201, set out as
an Effective Date note under section 601 of this title.
Federal Food, Drug, and Cosmetic Act defined, see section 601 of this
title.
21 USC 621. Inspectors to make examinations provided for; appointment;
duties; regulations
TITLE 21 -- FOOD AND DRUGS
The Secretary shall appoint from time to time inspectors to make
examination and inspection of all cattle, sheep, swine, goats, horses,
mules, and other equines, inspection of which is hereby provided for and
of all carcasses and parts thereof, and of all meats thereof, and of
meat food products thereof, and of the sanitary conditions of all
establishments in which such meat and meat food products hereinbefore
described are prepared; and said inspectors shall refuse to stamp,
mark, tag, or label any carcass or any part thereof, or meat food
product therefrom, prepared in any establishment hereinbefore mentioned,
until the same shall have actually been inspected and found to be not
adulterated; and shall perform such other duties as are provided by
this chapter and by the rules and regulations to be prescribed by said
Secretary; and said Secretary shall, from time to time, make such rules
and regulations as are necessary for the efficient execution of the
provisions of this chapter, and all inspections and examinations made
under this chapter, shall be such and made in such manner as described
in the rules and regulations prescribed by said Secretary not
inconsistent with provisions of this chapter.
(Mar. 4, 1907, ch. 2907, title I, 21, formerly 19th par., 34 Stat.
1264, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3(b),
12(a), (i), 81 Stat. 584, 588, 592, 593; Nov. 10, 1986, Pub. L.
99-641, title IV, 403(d)(2), 100 Stat. 3570.)
Section was formerly classified to section 89 of this title.
1986 -- Pub. L. 99-641 temporarily substituted ''thereof, and of
meat food products'' for ''and meat food products'', which substitution
was made for the first such reference as the probable intent of
Congress. See Effective and Termination Dates of 1986 Amendment note
below.
1967 -- Pub. L. 90-201, 3(b), 12(a), (i), struck out ''of
Agriculture'' after ''Secretary'' in four places, included horses,
mules, and other equines in the list of animals, and substituted ''not
adulterated'' for ''sound, healthful, wholesome, and fit for human food,
and to contain no dyes, chemicals, preservatives, or ingredients which
render such meat food product unsound, unhealthful, unwholesome, or
unfit for human food; and to have been prepared under proper sanitary
conditions, hereinbefore provided for'', respectively.
Section 403(d)(2) of Pub. L. 99-641 provided that the amendment made
by that section is effective only during the 6-year period beginning on
Nov. 10, 1986.
Amendment by Pub. L. 99-641 effective Nov. 10, 1986, except that
this section as in effect immediately before Nov. 10, 1986, applies
with respect to establishments until the Secretary of Agriculture first
issues rules and regulations to implement the amendments made by section
403(a) of Pub. L. 99-641 to section 606 of this title, see section 408
of Pub. L. 99-641, set out as a note under section 606 of this title.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiraton of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
For provisions relating to construction and effect of temporary
amendments by section 403 of Pub. L. 99-641, see sections 403(e) and
404 of Pub. L. 99-641, set out as notes entitled ''Inspection Services
for Establishments Not Participating in Total Plant Quality-Control
Program'' and ''Savings Provision'', respectively, under section 606 of
this title.
21 USC 622. Bribery of or gifts to inspectors or other officers and
acceptance of gifts
TITLE 21 -- FOOD AND DRUGS
Any person, firm, or corporation, or any agent or employee of any
person, firm, or corporation, who shall give, pay, or offer, directly or
indirectly, to any inspector, deputy inspector, chief inspector, or any
other officer or employee of the United States authorized to perform any
of the duties prescribed by this chapter or by the rules and regulations
of the Secretary any money or other thing of value, with intent to
influence said inspector, deputy inspector, chief inspector, or other
officer or employee of the United States in the discharge of any duty
provided for in this chapter, shall be deemed guilty of a felony, and,
upon conviction thereof, shall be punished by a fine not less than
$5,000 nor more than $10,000 and by imprisonment not less than one year
nor more than three years; and any inspector, deputy inspector, chief
inspector, or other officer or employee of the United States authorized
to perform any of the duties prescribed by this chapter who shall accept
any money, gift, or other thing of value from any person, firm, or
corporation, or officers, agents, or employees thereof, given with
intent to influence his official action, or who shall receive or accept
from any person, firm, or corporation engaged in commerce any gift,
money, or other thing of value, given with any purpose or intent
whatsoever, shall be deemed guilty of a felony and shall, upon
conviction thereof, be summarily discharged from office and shall be
punished by a fine not less than $1,000 nor more than $10,000 and by
imprisonment not less than one year nor more than three years.
(Mar. 4, 1907, ch. 2907, title I, 22, formerly 20th par., 34 Stat.
1264, renumbered and amended Dec. 15, 1967, Pub. L. 90-201, 1, 3, 81
Stat. 584, 588.)
Section was formerly classified to section 90 of this title.
1967 -- Pub. L. 90-201, 3, struck out ''interstate or foreign''
before ''commerce'' and ''of Agriculture'' after ''Secretary''.
Amendment by Pub. L. 90-201 effective Dec. 15, 1967, except that
with respect to equines (other than horses) and their carcasses and
parts thereof, meat, and meat food products thereof, amendment effective
upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of
Pub. L. 90-201, set out as an Effective Date note under section 601 of
this title.
21 USC 623. Exemptions from inspection requirements
TITLE 21 -- FOOD AND DRUGS
(a) Personal slaughtering and custom slaughtering for personal,
household, guest, and employee uses
The provisions of this subchapter requiring inspection of the
slaughter of animals and the preparation of the carcasses, parts
thereof, meat and meat food products at establishments conducting such
operations for commerce shall not apply to the slaughtering by any
person of animals of his own raising, and the preparation by him and
transportation in commerce of the carcasses, parts thereof, meat and
meat food products of such animals exclusively for use by him and
members of his household and his nonpaying guests and employees; nor to
the custom slaughter by any person, firm, or corporation of cattle,
sheep, swine or goats delivered by the owner thereof for such slaughter,
and the preparation by such slaughterer and transportation in commerce
of the carcasses, parts thereof, meat and meat food products of such
animals, exclusively for use, in the household of such owner, by him and
members of his household and his nonpaying guests and employees; nor to
the custom preparation by any person, firm, or corporation of carcasses,
parts thereof, meat or meat food products, derived from the slaughter by
any person of cattle, sheep, swine, or goats of his own raising, or from
game animals, delivered by the owner thereof for such custom
preparation, and transportation in commerce of such custom prepared
articles, exclusively for use in the household of such owner, by him and
members of his household and his nonpaying guests and employees:
Provided, That in cases where such person, firm, or corporation engages
in such custom operations at an establishment at which inspection under
this subchapter is maintained, the Secretary may exempt from such
inspection at such establishment any animals slaughtered or any meat or
meat food products otherwise prepared on such custom basis: Provided
further, That custom operations at any establishment shall be exempt
from inspection requirements as provided by this section only if the
establishment complies with regulations which the Secretary is hereby
authorized to promulgate to assure that any carcasses, parts thereof,
meat or meat food products wherever handled on a custom basis, or any
containers or packages containing such articles, are separated at all
times from carcasses, parts thereof, meat or meat food products prepared
for sale, and that all such articles prepared on a custom basis, or any
containers or packages containing such articles, are plainly marked
''Not for Sale'' immediately after being prepared and kept so identified
until delivered to the owner and that the establishment conducting the
custom operation is maintained and operated in a sanitary manner.
(b) Territorial exemption; refusal, withdrawal, or modification
The Secretary may, under such sanitary conditions as he may by
regulations prescribe, exempt from the inspection requirements of this
subchapter the slaughter of animals, and the preparation of carcasses,
parts thereof, meat and meat food products, by any person, firm, or
corporation in any Territory not organized with a legislative body
solely for distribution within such Territory when the Secretary
determines that it is impracticable to provide such inspection within
the limits of funds appropriated for administration of this chapter and
that such exemption will otherwise facilitate enforcement of this
chapter. The Secretary may refuse, withdraw, or modify any exemption
under this subsection in his discretion whenever he determines such
action is necessary to effectuate the purposes of this chapter.
(c) Pizzas containing meat food products
(1) Under such terms and conditions as the Secretary shall prescribe
through rules and regulations issued under section 624 of this title
that may be necessary to ensure food safety and protect public health
such as special handling procedures, the Secretary shall exempt pizzas
containing a meat food product from the inspection requirements of this
chapter if --
(A) the meat food product components of the pizzas have been
prepared, inspected, and passed in a cured or cooked form as
ready-to-eat in compliance with the requirements of this chapter; and
(B) the pizzas are to be served in public or private nonprofit
institutions.
(2) The Secretary may withdraw or modify any exemption under this
subsection whenever the Secretary determines such action is necessary to
ensure food safety and to protect public health. The Secretary may
reinstate or further modify any exemption withdrawn or modified under
this subsection.
(d) Adulteration and misbranding provisions applicable to
inspection-free articles
The adulteration and misbranding provisions of this subchapter, other
than the requirement of the inspection legend, shall apply to articles
which are exempted from inspection or not required to be inspected under
this section.
(Mar. 4, 1907, ch. 2907, title I, 23, formerly 21st, 22nd pars., 34
Stat. 1265; June 29, 1938, ch. 810, 52 Stat. 1235; renumbered and
amended Dec. 15, 1967, Pub. L. 90-201, 1, 11, 81 Stat. 584, 591; July
18, 1970, Pub. L. 91-342, 84 Stat. 438; Dec. 13, 1991, Pub. L.
102-237, title X, 1016(a), 105 Stat. 1902.)
Section was formerly classified to sections 91 and 92 of this title.
1991 -- Subsecs. (c), (d). Pub. L. 102-237 added subsec. (c) and
redesignated former subsec. (c) as (d).
1970 -- Subsec. (a). Pub. L. 91-342 changed proviso so as to permit
custom slaughterers to conduct a separate inspected meat business,
continued the exemption for owners to slaughter and process their own
animals for their own use, authorized the Secretary to exempt custom
slaughtering and processing performed by an inspected establishment, and
required that custom slaughtered articles be clearly marked ''not for
sale''.
1967 -- Pub. L. 90-201, 11, substituted provisions for personal,
custom, and territorial slaughtering exemptions and for application of
adulteration and misbranding provisions to inspection-free articles for
farmer definition and retail butcher and retail dealer exemption
provisions.
1938 -- Act June 29, 1948, amended section generally.
Amendment by Pub. L. 90-201 effective upon expiration of sixty days
after Dec. 15, 1967, see section 20(c) of Pub. L. 90-201, set out as
an Effective Date note under section 601 of this title.
Secretary to issue final rules no later than Aug. 1, 1992, to
implement exemption authorized by subsec. (c) of this section, see
section 1016(c) of Pub. L. 102-237, set out as a note under section 464
of this title.
21 USC 624. Storage and handling regulations; violations; exemption
of establishments subject to non-Federal jurisdiction
TITLE 21 -- FOOD AND DRUGS
The Secretary may by regulations prescribe conditions under which
carcasses, parts of carcasses, meat, and meat food products of cattld,
sheep, swine, goats, horses, mules, or other equines, capable of use as
human food, shall be stored or otherwise handled by any person, firm, or
corporation engaged in the business of buying, selling, freezing,
storing, or transporting, in or for commerce, or importing, such
articles, whenever the Secretary deems such action necessary to assure
that such articles will not be adulterated or misbranded when delivered
to the consumer. Violation of any such regulation is prohibited.
However, such regulations shall not apply to the storage or handling of
such articles at any retail store or other establishment in any State or
organized Territory that would be subject to this section only because
of purchases in commerce, if the storage and handling of such articles
at such establishment is regulated under the laws of the State or
Territory in which such establishment is located, in a manner which the
Secretary, after consultation with the appropriate advisory committee
provided for in section 661 of this title, determines is adequate to
effectuate the purposes of this section.
(Mar. 4, 1907, ch. 2907, title I, 24, as added Dec. 15, 1967, Pub.
L. 90-201, 13, 81 Stat. 593.)
21 USC SUBCHAPTER II -- MEAT PROCESSORS AND RELATED INDUSTRIES
TITLE 21 -- FOOD AND DRUGS
21 USC 641. Prohibition of subchapter I inspection of articles not
intended for use as human food; denaturation or other identification
prior to distribution in commerce; inedible articles
TITLE 21 -- FOOD AND DRUGS
Inspection shall not be provided under subchapter I of this chapter
at any establishment for the slaughter of cattle, sheep, swine, goats,
horses, mules, or other equines, or the preparation of any carcasses or
parts or products of such animals, which are not intended for use as
human food, but such articles shall, prior to their offer for sale or
transportation in commerce, unless naturally inedible by humans, be
denatured or otherwise identified as prescribed by regulations of the
Secretary to deter their use for human food. No person, firm, or
corporation shall buy, sell, transport, or offer for sale or
transportation, or receive for transportation, in commerce, or import,
any carcasses, parts thereof, meat or meat food products of any such
animals, which are not intended for use as human food unless they are
denatured or otherwise identified as required by the regulations of the
Secretary or are naturally inedible by humans.
(Mar. 4, 1907, ch. 2907, title II, 201, as added Dec. 15, 1967, Pub.
L. 90-201, 14, 81 Stat. 593.)
Subchapter effective Dec. 15, 1967, see section 20 of Pub. L.
90-201, set out as a note under section 601 of this title.
21 USC 642. Recordkeeping requirements
TITLE 21 -- FOOD AND DRUGS
(a) Classes of persons bound; scope of disclosure; access to places
of business; examination of records, facilities, and inventories;
copies; samples
The following classes of persons, firms, and corporations shall keep
such records as will fully and correctly disclose all transactions
involved in their businesses; and all persons, firms, and corporations
subject to such requirements shall, at all reasonable times upon notice
by a duly authorized representative of the Secretary, afford such
representative access to their places of business and opportunity to
examine the facilities, inventory, and records thereof, to copy all such
records, and to take reasonable samples of their inventory upon payment
of the fair market value therefor --
(1) Any persons, firms, or corporations that engage, for commerce, in
the business of slaughtering any cattle, sheep, swine, goats, horses,
mules, or other equines, or preparing, freezing, packaging, or labeling
any carcasses, or parts or products of carcasses, of any such animals,
for use as human food or animal food;
(2) Any persons, firms, or corporations that engage in the business
of buying or selling (as meat brokers, wholesalers or otherwise), or
transporting in commerce, or storing in or for commerce, or importing,
any carcasses, or parts or products of carcasses, of any such animals;
(3) Any persons, firms, or corporations that engage in business, in
or for commerce, as renderers, or engage in the business of buying,
selling, or transporting, in commerce, or importing, any dead, dying,
disabled, or diseased cattle, sheep, swine, goats, horses, mules, or
other equines, or parts of the carcasses of any such animals that died
otherwise than by slaughter.
(b) Period of maintenance
Any record required to be maintained by this section shall be
maintained for such period of time as the Secretary may by regulations
prescribe.
(Mar. 4, 1907, ch. 2907, title II, 202, as added Dec. 15, 1967, Pub.
L. 90-201, 14, 81 Stat. 593.)
21 USC 643. Registration of business, name of person, and trade names
TITLE 21 -- FOOD AND DRUGS
No person, firm, or corporation shall engage in business, in or for
commerce, as a meat broker, renderer, or animal food manufacturer, or
engage in business in commerce as a wholesaler of any carcasses, or
parts or products of the carcasses, of any cattle, sheep, swine, goats,
horses, mules, or other equines, whether intended for human food or
other purposes, or engage in business as a public warehouseman storing
any such articles in or for commerce, or engage in the business of
buying, selling, or transporting in commerce, or importing, any dead,
dying, disabled, or diseased animals of the specified kinds, or parts of
the carcasses of any such animals that died otherwise than by slaughter,
unless, when required by regulations of the Secretary, he has registered
with the Secretary his name, and the address of each place of business
at which, and all trade names under which, he conducts such business.
(Mar. 4, 1907, ch. 2907, title II, 203, as added Dec. 15, 1967, Pub.
L. 90-201, 14, 81 Stat. 594.)
21 USC 644. Regulation of transactions, transportation, or importation
of 4-D animals to prevent use as human food
TITLE 21 -- FOOD AND DRUGS
No person, firm, or corporation engaged in the business of buying,
selling, or transporting in commerce, or importing, dead, dying,
disabled, or diseased animals, or any parts of the carcasses of any
animals that died otherwise than by slaughter, shall buy, sell,
transport, offer for sale or transportation, or receive for
transportation, in commerce, or import, any dead, dying, disabled, or
diseased cattle, sheep, swine, goats, horses, mules or other equines, or
parts of the carcasses of any such animals that died otherwise than by
slaughter, unless such transaction, transportation or importation is
made in accordance with such regulations as the Secretary may prescribe
to assure that such animals, or the unwholesome parts or products
thereof, will be prevented from being used for human food purposes.
(Mar. 4, 1907, ch. 2907, title II, 204, as added Dec. 15, 1967, Pub.
L. 90-201, 14, 81 Stat. 594.)
21 USC 645. Federal provisions applicable to State or Territorial
business transactions of a local nature and not subject to local
authority
TITLE 21 -- FOOD AND DRUGS
The authority conferred on the Secretary by section 642, 643, or 644
of this title with respect to persons, firms, and corporations engaged
in the specified kinds of business in or for commerce may be exercised
with respect to persons, firms, or corporations engaged, in any State or
organized Territory, in such kinds of business but not in or for
commerce, whenever the Secretary determines, after consultation with an
appropriate advisory committee provided for in section 661 of this
title, that the State or territory does not have at least equal
authority under its laws or such authority is not exercised in a manner
to effectuate the purposes of this chapter including the State providing
for the Secretary or his representative being afforded access to such
places of business and the facilities, inventories, and records thereof,
and the taking of reasonable samples, where he determines necessary in
carrying out his responsibilities under this chapter; and in such case
the provisions of section 642, 643, or 644 of this title, respectively,
shall apply to such persons, firms, and corporations to the same extent
and in the same manner as if they were engaged in such business in or
for commerce and the transactions involved were in commerce.
(Mar. 4, 1907, ch. 2907, title II, 205, as added Dec. 15, 1967, Pub.
L. 90-201, 14, 81 Stat. 594.)
21 USC SUBCHAPTER III -- FEDERAL AND STATE COOPERATION
TITLE 21 -- FOOD AND DRUGS
21 USC 661. Federal and State cooperation
TITLE 21 -- FOOD AND DRUGS
(a) Congressional statement of policy
It is the policy of the Congress to protect the consuming public from
meat and meat food products that are adulterated or misbranded and to
assist in efforts by State and other Government agencies to accomplish
this objective. In furtherance of this policy --
(1) Development and administration of State meat inspection program
equal to subchapter I ante and post mortem inspection, reinspection, and
sanitation requirements
The Secretary is authorized, whenever he determines that it would
effectuate the purposes of this chapter, to cooperate with the
appropriate State agency in developing and administering a State meat
inspection program in any State which has enacted a State meat
inspection law that imposes mandatory ante mortem and post mortem
inspection, reinspection and sanitation requirements that are at least
equal to those under subchapter I of this chapter, with respect to all
or certain classes of persons engaged in the State in slaughtering
cattle, sheep, swine, goats, or equines, or preparing the carcasses,
parts thereof, meat or meat food products, of any such animals for use
as human food solely for distribution within such State.
(2) Development and administration of State program with authorities
equal to subchapter II authorities; cooperation with Federal agencies
The Secretary is further authorized, whenever he determines that it
would effectuate the purposes of this chapter, to cooperate with
appropriate State agencies in developing and administering State
programs under State laws containing authorities at least equal to those
provided in subchapter II of this chapter; and to cooperate with other
agencies of the United States in carrying out any provisions of this
chapter.
(3) Scope of cooperation: advisory assistance, technical and
laboratory assistance and training, and financial and other aid;
limitation on amount; equitable allocation of Federal funds; adequacy
of State program to obtain Federal cooperation and payments
Cooperation with State agencies under this section may include
furnishing to the appropriate State agency (i) advisory assistance in
planning and otherwise developing an adequate State program under the
State law; and (ii) technical and laboratory assistance and training
(including necessary curricular and instructional materials and
equipment), and financial and other aid for administration of such a
program. The amount to be contributed to any State by the Secretary
under this section from Federal funds for any year shall not exceed 50
per centum of the estimated total cost of the cooperative program; and
the Federal funds shall be allocated among the States desiring to
cooperate on an equitable basis. Such cooperation and payment shall be
contingent at all times upon the administration of the State program in
a manner which the Secretary, in consultation with the appropriate
advisory committee appointed under paragraph (4), deems adequate to
effectuate the purposes of this section.
(4) Advisory committees
The Secretary may appoint advisory committees consisting of such
representatives of appropriate State agencies as the Secretary and the
State agencies may designate to consult with him concerning State and
Federal programs with respect to meat inspection and other matters
within the scope of this chapter, including evaluating State programs
for purposes of this chapter and obtaining better coordination and more
uniformity among the State programs and between the Federal and State
programs and adequate protection of consumers.
(b) Single State agency; subordinate governmental unit as part of
State agency
The appropriate State agency with which the Secretary may cooperate
under this chapter shall be a single agency in the State which is
primarily responsible for the coordination of the State programs having
objectives similar to those under this chapter. When the State program
includes performance of certain functions by a municipality or other
subordinate governmental unit, such unit shall be deemed to be a part of
the State agency for purposes of this section.
(c) State meat inspection requirements
(1) Notice to Governor of nondevelopment or nonenforcement;
designation of State as subject to subchapters I and IV; delay and
revocation of designation; publication in Federal Register; notice of
production of adulterated meat or meat food products; designation of
State
If the Secretary has reason to believe, by thirty days prior to the
expiration of two years after December 15, 1967, that a State has failed
to develop or is not enforcing, with respect to all establishments
within its jurisdiction (except those that would be exempted from
Federal inspection under subparagraph (2)) at which cattle, sheep,
swine, goats, or equines are slaughtered, or their carcasses, or parts
or products thereof, are prepared for use as human food, solely for
distribution within such State, and the products of such establishments,
requirements at least equal to those imposed under subchapter I and IV
of this chapter, he shall promptly notify the Governor of the State of
this fact. If the Secretary determines, after consultation with the
Governor of the State, or representative selected by him, that such
requirements have not been developed and activated, he shall promptly
after the expiration of such two-year period designate such State as one
in which the provisions of subchapters I and IV of this chapter shall
apply to operations and transactions wholly within such State:
Provided, That if the Secretary has reason to believe that the State
will activate such requirements within one additional year, he may delay
such designation for said period, and not designate the State, if he
determines at the end of the year that the State then has such
requirements in effective operation. The Secretary shall publish any
such designation in the Federal Register and, upon the expiration of
thirty days after such publication, the provisions of subchapters I and
IV shall apply to operations and transactions and to persons, firms, and
corporations engaged therein in the State to the same extent and in the
same manner as if such operations and transactions were conducted in or
for commerce. Thereafter, upon request of the Governor, the Secretary
shall revoke such designation if the Secretary determines that such
State has developed and will enforce requirements at least equal to
those imposed under subchapter I and subchapter IV of this chapter: And
provided further, That, notwithstanding any other provision of this
section, if the Secretary determines that any establishment within a
State is producing adulterated meat or meat food products for
distribution within such State which would clearly endanger the public
health he shall notify the Governor of the State and the appropriate
Advisory Committee provided by section 661 of this title of such fact
for effective action under State or local law. If the State does not
take action to prevent such endangering of the public health within a
reasonable time after such notice, as determined by the Secretary, in
light of the risk to public health, the Secretary may forthwith
designate any such establishment as subject to the provisions of
subchapters I and IV of this chapter, and thereupon the establishment
and operator thereof shall be subject to such provisions as though
engaged in commerce until such time as the Secretary determines that
such State has developed and will enforce requirements at least equal to
those imposed under subchapter I and subchapter IV of this chapter.
(2) Exemptions of retail stores, restaurants, and similar retail-type
establishments; operations conducted at a restaurant central kitchen
facility
The provisions of this chapter requiring inspection of the slaughter
of animals and the preparation of carcasses, parts thereof, meat and
meat food products shall not apply to operations of types traditionally
and usually conducted at retail stores and restaurants, when conducted
at any retail store or restaurant or similar retail-type establishment
for sale in normal retail quantities or service of such articles to
consumers at such establishments if such establishments are subject to
such inspection provisions only under this paragraph (c). For the
purposes of this subparagraph, operations conducted at a restaurant
central kitchen facility shall be considered as being conducted at a
restaurant if the restaurant central kitchen prepares meat or meat food
products that are ready to eat when they leave such facility and are
served in meals or as entrees only to customers at restaurants owned or
operated by the same person, firm, or corporation owning or operating
such facility: Provided, That such facility shall be subject to the
provisions of section 642 of this title: Provided further, That the
facility may be subject to the inspection requirements under subchapter
I of this chapter for as long as the Secretary deems necessary, if the
Secretary determines that the sanitary conditions or practices of the
facility or the processing procedures or methods at the facility are
such that any of its meat or meat food products are rendered
adulterated.
(3) Termination of designation of State upon development and
enforcement of minimum requirements; redesignation; designation for
nonenforcement of minimum requirements: notice and publication in
Federal Register
Whenever the Secretary determines that any State designated under
this paragraph (c) has developed and will enforce State meat inspection
requirements at least equal to those imposed under subchapters I and IV
of this chapter with respect to the operations and transactions within
such State which are regulated under paragraph (1), he shall terminate
the designation of such State under this paragraph (c), but this shall
not preclude the subsequent redesignation of the State at any time upon
thirty days notice to the Governor and publication in the Federal
Register in accordance with this paragraph, and any State may be
designated upon such notice and publication at any time after the period
specified in this paragraph whether or not the State has theretofore
been designated upon the Secretary determining that it is not
effectively enforcing requirements at least equal to those imposed under
subchapters I and IV of this chapter.
(4) Periodic review; report to Congressional committees
The Secretary shall promptly upon December 15, 1967, and periodically
thereafter, but at least annually, review the requirements, including
the enforcement thereof, of the several States not designated under this
paragraph (c), with respect to the slaughter, and the preparation,
storage, handling and distribution of carcasses, parts thereof, meat and
meat food products, of such animals, and inspection of such operations
and annually report thereon to the Committee on Agriculture of the House
of Representatives and the Committee on Agriculture, Nutrition, and
Forestry of the Senate in the report required under section 691 of this
title.
(d) ''State'' defined
As used in this section, the term ''State'' means any State
(including the Commonwealth of Puerto Rico) or organized Territory.
(Mar. 4, 1907, ch. 2907, title III 301, as added Dec. 15, 1967, Pub.
L. 90-201, 15, 81 Stat. 595, and amended S. Res. 4, Feb. 4, 1977; Oct.
17, 1984, Pub. L. 98-487, 1, 98 Stat. 2264.)
In subsec. (c)(1), (4), ''December 15, 1967'' substituted for
''enactment of the Wholesome Meat Act''.
1984 -- Subsec. (c)(2). Pub. L. 98-487 inserted provisions relating
to operations conducted at a restaurant central kitchen facility.
Committee on Agriculture and Forestry of the Senate abolished and
replaced by Committee on Agriculture, Nutrition, and Forestry of the
Senate, effective Feb. 11, 1977. See Rule XXV of Standing Rules of the
Senate, as amended by Senate Resolution 4 (popularly cited as the
''Committee System Reorganization Amendments of 1977''), approved Feb.
4, 1977.
Section effective Dec. 15, 1967, see section 20 of Pub. L. 90-201,
set out as a note under section 601 of this title.
Advisory committees in existence on Jan. 5, 1973, to terminate not
later than the expiration of the 2-year period following Jan. 5, 1973,
and advisory committees established after Jan. 5, 1973, to terminate
not later than the expiration of the 2-year period beginning on the date
of their establishment, unless in the case of a committee established by
the President or an officer of the Federal Government, such committee is
renewed by appropriate action prior to the expiration of such 2-year
period, or in the case of a committee established by Congress, its
duration is otherwise provided by law. See section 14 of Pub. L.
92-463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title
5, Government Organization and Employees.
21 USC SUBCHAPTER IV -- AUXILIARY PROVISIONS
TITLE 21 -- FOOD AND DRUGS
21 USC 671. Inspection services
TITLE 21 -- FOOD AND DRUGS
(a) Refusal or withdrawal; hearing; business unfitness based upon
certain convictions
The Secretary may (for such period, or indefinitely, as he deems
necessary to effectuate the purposes of this chapter) refuse to provide,
or withdraw, inspection service under subchapter I of this chapter with
respect to any establishment if he determines, after opportunity for a
hearing is accorded to the applicant for, or recipient of, such service,
that such applicant or recipient is unfit to engage in any business
requiring inspection under subchapter I because the applicant or
recipient, or anyone responsibly connected with the applicant or
recipient, has been convicted, in any Federal or State court, of (1)
more than one violation of any law, other than a felony, based upon the
acquiring, handling, or distributing of unwholesome, mislabeled, or
deceptively packaged food or upon fraud in connection with transactions
in food or (2) any felony.
(b) Order enjoining presence of controlling person at establishment;
duration of order
(1) On the request of the Secretary at the time of the sentencing of
an individual who is a person responsibly connected with any business
requiring inspection under subchapter I of this chapter and who is
convicted of a felony involving --
(A) the intentional adulteration of food (except as defined in
section 601(m)(8) of this title);
(B) the adulteration of food, as defined in section 601(m)(8) of this
title, with intent to defraud;
(C) bribery; or
(D) extortion;
the sentencing court shall issue a temporary order forbidding such
individual to exercise operational control of, or to be physically
present at, any establishment requiring inspection under subchapter I of
this chapter if the court finds that the exercise of operational control
by, or the presence of, such individual at any such establishment either
poses a direct and substantial threat to the public health or safety or,
if such individual is convicted of a felony described in subparagraph
(B), poses a clear likelihood of significant economic harm to consumers.
(2) Such order shall terminate --
(A) whenever the Secretary determines by order, after a hearing on
the record, whether such individual should exercise operational control
of, or be physically present at, any establishment requiring inspection
under subchapter I of this chapter, and judicial review, if any, of such
determination is completed; or
(B) 90 days after the issuance of such temporary order by the court
if the Secretary does not commence such hearing before the expiration of
such 90 days;
whichever occurs earlier.
(c) Judicial review of orders
Any determination and order of the Secretary issued under subsection
(a) or (b) of this section shall be conclusive and enforceable unless
the affected applicant for, or recipient of, inspection service or the
affected individual files, not later than 30 days after the effective
date of such order, a petition for review of such order in the United
States Court of Appeals for the District of Columbia Circuit or the
court of appeals for the circuit in which the relevant establishment is
doing business. Judicial review of such order shall be on the record on
which the determination and order are based.
(d) Civil action for withdrawal of inspection services or prevention
of operational control by responsibly connected persons
(1) Subject to paragraph (3), the Secretary may commence a civil
action in an appropriate court, as provided in section 674 of this
title, to withdraw inspection service under subchapter I of this chapter
with respect to any establishment or to prevent any individual
responsibly connected with any business requiring inspection under
subchapter I of this chapter from exercising operational control of, or
being present at, any establishment requiring inspection under
subchapter I of this chapter.
(2) If the court finds, on the basis of clear and convincing
evidence, that the recipient of inspection service or such individual
has repeatedly failed to comply with the requirements of this chapter,
or the rules and regulations issued under this chapter, in a manner that
poses a direct and substantial threat to the public health or safety,
the court shall issue an order --
(A) withdrawing inspection at such establishment; or
(B) forbidding such individual to exercise operational control of, or
to be physically present at, such establishment,
for such period as the court determines is necessary to carry out the
purposes of this chapter.
(3) Not less than 90 days, and not more than 450 days, before
commencing a civil action under paragraph (1), the Secretary shall
provide to each recipient of inspection service, and each individual
responsibly connected with the business, with respect to which such
action is commenced, a written notice that includes --
(A) a statement that the Secretary intends to commence such action;
(B) a comprehensive description of the violations of this chapter and
the regulations issued under this chapter alleged by the Secretary; and
(C) a description of the actions the Secretary considers necessary to
be taken by such recipient or such individual to comply with this
chapter and to eliminate the need to commence such civil action.
(e) Temporary withdrawal of inspection services to ensure safety of
employees
(1) The Secretary may temporarily withdraw inspection service under
subchapter I of this chapter with respect to any establishment for such
period as is necessary to ensure the safe and effective performance of
official duties under this chapter if the Secretary determines, after an
opportunity for a hearing on the record, that an officer, employee, or
agent of such establishment --
(A) threatened to forcibly assault;
(B) forcibly assaulted;
(C) forcibly intimidated; or
(D) forcibly interfered with,
an employee of the United States engaged in, or on account of, the
performance of any of such official duties.
(2)(A) Notwithstanding paragraph (1), the Secretary may temporarily
suspend inspection service under subchapter I of this chapter with
respect to any establishment, pending an expedited administrative
hearing on the record and judicial review of the order of the Secretary
based on such record, if the Secretary determines that temporary
suspension of such inspection service is necessary for the safety of any
employee who performs official duties under this chapter.
(B) If the Secretary receives, before or after temporarily suspending
such inspection service in accordance with subparagraph (A), adequate
written assurances from the recipient of inspection service, or the
individuals involved, that the conduct or circumstances that threatened
the safety of such employee will not continue or recur, the Secretary
may continue or restore such inspection service on condition that such
assurances are fulfilled.
(f) Withdrawal of inspection services under other provisions
This section shall not affect in any way other provisions of this
chapter for withdrawal of inspection services under subchapter I from
establishments failing to maintain sanitary conditions or to destroy
condemned carcasses, parts, meat or meat food products.
(g) Persons responsibly connected with business
For the purpose of this section a person shall be deemed to be
responsibly connected with the business if he was a partner, officer,
director, holder, or owner of 10 per centum or more of its voting stock
or employee in a managerial or executive capacity.
(h) Conclusiveness of Secretarial order; judicial review
Except as provided in subsection (e)(2) of this section, the
determination and order of the Secretary with respect thereto under
subsection (e) of this section shall be final and conclusive unless the
affected applicant for, or recipient of, inspection service files
application for judicial review within thirty days after the effective
date of such order in the appropriate court as provided in section 674
of this title. Judicial review of any such order shall be upon the
record upon which the determination and order are based.
(Mar. 4, 1907, ch. 2907, title IV, 401, as added Dec. 15, 1967, Pub.
L. 90-201, 16, 81 Stat. 597, and amended Nov. 10, 1986, Pub. L. 99-641,
title IV, 403(b), 100 Stat. 3568.)
1986 -- Subsec. (a). Pub. L. 99-641, 403(b)(1), (2)(B), (C),
temporarily designated provisions which related to authority to refuse
or withdraw inspection service as subsec. (a), struck out ''any felony,
or (2)'' after ''of (1)'', and inserted ''or (2) any felony'' after
''transactions in food''. See Effective and Termination Dates of 1986
Amendment note below.
Pub. L. 99-641, 403(b)(2)(A), which directed that subsec. (a) be
amended by substituting ''applicant for'' for ''applicant, for'', could
not be executed because ''applicant, for'' does not appear.
Subsecs. (b) to (e). Pub. L. 99-641, 403(b)(6), temporarily added
subsecs. (b) to (e). See Effective and Termination Dates of 1986
Amendment note below.
Subsecs. (f). Pub. L. 99-641, 403(b)(3), temporarily designated
provisions which related to other provisions for withdrawal of
inspection services as subsec. (f). See Effective and Termination Dates
of 1986 Amendment note below.
Subsec. (g). Pub. L. 99-641, 403(b)(4), temporarily designated
provisions which related to responsible connection with business as
subsec. (g). See Effective and Termination Dates of 1986 Amendment note
below.
Subsec. (h). Pub. L. 99-641, 403(b)(5), temporarily designated
provisions which related to finality of determination by Secretary and
to judicial review as subsec. (h), substituted ''Except as provided in
subsection (e)(2) of this section, the determination'' for ''The
determination'' and ''subsection (e) of this section'' for ''this
section''. See Effective and Termination Dates of 1986 Amendment note
below.
Section 403(b) of Pub. L. 99-641 provided that the amendment made by
that section is effective only during the 6-year period beginning Nov.
10, 1986.
Subchapter effective Dec. 15, 1967, see section 20 of Pub. L.
90-201, set out as a note under section 601 of this title.
For provisions relating to construction and effect of temporary
amendments by section 403 of Pub. L. 99-641, see sections 403(e) and
404 of Pub. L. 99-641, set out as notes entitled ''Inspection Services
for Establishments Not Participating in Total Plant Quality-Control
Program'' and ''Savings Provision'', respectively, under section 606 of
this title.
21 USC 672. Administrative detention; duration; pending judicial
proceedings; notification of governmental authorities; release
TITLE 21 -- FOOD AND DRUGS
Whenever any carcass, part of a carcass, meat or meat food product of
cattle, sheep, swine, goats, horses, mules, or other equines, or any
product exempted from the definition of a meat food product, or any
dead, dying, disabled, or diseased cattle, sheep, swine, goat, or equine
is found by any authorized representative of the Secretary upon any
premises where it is held for purposes of, or during or after
distribution in, commerce or otherwise subject to subchapter I or II of
this chapter, and there is reason to believe that any such article is
adulterated or misbranded and is capable of use as human food, or that
it has not been inspected, in violation of the provisions of subchapter
I of this chapter or of any other Federal law or the laws of any State
or Territory, or the District of Columbia, or that such article or
animal has been or is intended to be, distributed in violation of any
such provisions, it may be detained by such representative for a period
not to exceed twenty days, pending action under section 673 of this
title or notification of any Federal, State, or other governmental
authorities having jurisdiction over such article or animal, and shall
not be moved by any person, firm, or corporation from the place at which
it is located when so detained, until released by such representative.
All official marks may be required by such representative to be removed
from such article or animal before it is released unless it appears to
the satisfaction of the Secretary that the article or animal is eligible
to retain such marks.
(Mar. 4, 1907, ch. 2907, title IV, 402, as added Dec. 15, 1967, Pub.
L. 90-201, 16, 81 Stat. 598.)
21 USC 673. Seizure and condemnation
TITLE 21 -- FOOD AND DRUGS
(a) Proceedings in rem; libel of information; jurisdiction;
disposal by destruction or sale; proceeds into the Treasury; sales
restrictions; bond; court costs and fees, storage, and other expenses
against claimants; proceedings in admiralty; jury trial; United
States as plaintiff
(1) Any carcass, part of a carcass, meat or meat food product of
cattle, sheep, swine, goats, horses, mules or other equines, or any
dead, dying, disabled, or diseased cattle, sheep, swine, goat, or
equine, that is being transported in commerce or otherwise subject to
subchapter I or II of this chapter, or is held for sale in the United
States after such transportation, and that (A) is or has been prepared,
sold, transported, or otherwise distributed or offered or received for
distribution in violation of this chapter, or (B) is capable of use as
human food and is adulterated or misbranded, or (C) in any other way is
in violation of this chapter, shall be liable to be proceeded against
and seized and condemned, at any time, on a libel of information in any
United States district court or other proper court as provided in
section 674 of this title within the jurisdiction of which the article
or animal is found.
(2) If the article or animal is condemned it shall, after entry of
the decree, (A) be distributed in accordance with paragraph (5), or (B)
be disposed of by destruction or sale as the court may direct and the
proceeds, if sold, less the court costs and fees, and storage and other
proper expenses, shall be paid into the Treasury of the United States,
but the article or animal shall not be sold contrary to the provisions
of this chapter, or the laws of the jurisdiction in which it is sold:
Provided, That upon the execution and delivery of a good and sufficient
bond conditioned that the article or animal shall not be sold or
otherwise disposed of contrary to the provisions of this chapter, or the
laws of the jurisdiction in which disposal is made, the court may direct
that such article or animal be delivered to the owner thereof subject to
such supervision by authorized representatives of the Secretary as is
necessary to insure compliance with the applicable laws.
(3) When a decree of condemnation is entered against the article or
animal and it is released under bond, or destroyed, court costs and
fees, and storage and other proper expenses shall be awarded against the
person, if any, intervening as claimant of the article or animal.
(4) The proceedings in such libel cases shall conform, as nearly as
may be, to the proceedings in admiralty, except that either party may
demand trial by jury of any issue of fact joined in any case, and all
such proceedings shall be at the suit of and in the name of the United
States.
(5)(A) An article that is condemned under paragraph (1) may as the
court may direct, after entry of the decree, be distributed without
charge to nonprofit, private entities or to Federal, State, or local
government entities engaged in the distribution of food without charge
to individuals, if such article --
(i) has been inspected under this chapter and found to be wholesome
and not to be adulterated within the meaning of paragraphs (1) through
(7) and (9) of section 601(m) of this title and a determination is made
at the time of the entry of the decree that such article is wholesome
and not so adulterated; and
(ii) is plainly marked ''Not for Sale'' on such article or its
container.
(B) The United States may not be held legally responsible for any
article that is distributed under subparagraph (A) to a nonprofit,
private entity or to a Federal, State, or local government entity, if
such article --
(i) was found after inspection under this chapter to be wholesome and
not adulterated within the meaning of paragraphs (1) through (7) and (9)
of section 601(m) of this title and a determination was made at the time
of the entry of the decree that such article was wholesome and not so
adulterated; and
(ii) was plainly marked ''Not for Sale'' on such article or its
container.
(C) The person from whom such article was seized and condemned may
not be held legally responsible for such article, if such article --
(i) was found after inspection under this chapter to be wholesome and
not adulterated within the meaning of paragraphs (1) through (7) and (9)
of section 601(m) of this title and a determination was made at the time
of the entry of the decree that such article was wholesome and not so
adulterated; and
(ii) was plainly marked ''Not for Sale'' on such article or its
container.
(b) Condemnation or seizure under other provisions unaffected
The provisions of this section shall in no way derogate from
authority for condemnation or seizure conferred by other provisions of
this chapter, or other laws.
(Mar. 4, 1907, ch. 2907, title IV, 403, as added Dec. 15, 1967, Pub.
L. 90-201, 16, 81 Stat. 598, and amended Dec. 7, 1989, Pub. L. 101-205,
1, 103 Stat. 1829.)
1989 -- Subsec. (a). Pub. L. 101-205 designated first sentence as
par. (1) and redesignated cls. (1) to (3) as cls. (A) to (C),
respectively, designated second sentence as par. (2) and inserted ''(A)
to be distributed in accordance with paragraph (5), or (B)'' after
''entry of the decree,'', designated third and fourth sentences as pars.
(3) and (4), respectively, and added par. (5).
Admiralty and maritime rules of practice (which included libel
procedures) were superseded, and civil and admiralty procedures in
United States district courts were unified, effective July 1, 1966, see
rule 1 and Supplemental Rules for Certain Admiralty and Maritime Claims,
Title 28, Appendix, Judiciary and Judicial Procedure.
21 USC 674. Federal court jurisdiction of enforcement and injunction
proceedings and other kinds of cases; limitations of section 607(e) of
this title
TITLE 21 -- FOOD AND DRUGS
The United States district courts, the District Court of Guam, the
District Court of the Virgin Islands, the highest court of American
Samoa, and the United States courts of the other Territories, are vested
with jurisdiction specifically to enforce, and to prevent and restrain
violations of, this chapter, and shall have jurisdiction in all other
kinds of cases arising under this chapter, except as provided in section
607(e) of this title.
(Mar. 4, 1907, ch. 2907, title IV, 404, as added Dec. 15, 1967, Pub.
L. 90-201, 16, 81 Stat. 599.)
21 USC 675. Assaulting, resisting, or impeding certain persons;
murder; protection of such persons
TITLE 21 -- FOOD AND DRUGS
Any person who forcibly assaults, resists, opposes, impedes,
intimidates, or interferes with any person while engaged in or on
account of the performance of his official duties under this chapter
shall be fined not more than $5,000 or imprisoned not more than three
years, or both. Whoever, in the commission of any such acts, uses a
deadly or dangerous weapon, shall be fined not more than $10,000 or
imprisoned not more than ten years, or both. Whoever kills any person
while engaged in or on account of the performance of his official duties
under this chapter shall be punished as provided under sections 1111 and
1114 of title 18.
(Mar. 4, 1907, ch. 2907, title IV, 405, as added Dec. 15, 1967, Pub.
L. 90-201, 16, 81 Stat. 599.)
21 USC 676. Violations
TITLE 21 -- FOOD AND DRUGS
(a) Misdemeanors; felonies: intent to defraud and distribution of
adulterated articles; good faith
Any person, firm, or corporation who violates any provision of this
chapter for which no other criminal penalty is provided by this chapter
shall upon conviction be subject to imprisonment for not more than one
year, or a fine of not more than $1,000, or both such imprisonment and
fine; but if such violation involves intent to defraud, or any
distribution or attempted distribution of an article that is adulterated
(except as defined in section 601(m)(8) of this title), such person,
firm, or corporation shall be subject to imprisonment for not more than
three years or a fine of not more than $10,000, or both: Provided, That
no person, firm, or corporation, shall be subject to penalties under
this section for receiving for transportation any article or animal in
violation of this chapter if such receipt was made in good faith, unless
such person, firm, or corporation refuses to furnish on request of a
representative of the Secretary the name and address of the person from
whom he received such article or animal, and copies of all documents, if
any there be, pertaining to the delivery of the article or animal to
him.
(b) Minor violations; written notice of warning of criminal and
civil proceedings
Nothing in this chapter shall be construed as requiring the Secretary
to report for prosecution or for the institution of libel or injunction
proceedings, minor violations of this chapter whenever he believes that
the public interest will be adequately served by a suitable written
notice of warning. In determining whether the public interest could be
adequately served by a written notice of warning, the Secretary shall
take into account, among other factors --
(1) the compliance history of such establishment;
(2) the magnitude of the violation;
(3) whether compliance with this chapter would likely be obtained as
a result of such notice; and
(4) whether such violation is of a minor or technical nature.
(c) Notice of criminal prosecution
Unless the Secretary by regulation provides otherwise, before any
violation of this chapter is reported by the Secretary for prosecution
in a criminal proceeding, the Secretary shall give the person alleged to
have committed such violation --
(1) reasonable notice that the Secretary intends to report such
violation for prosecution; and
(2) an opportunity to present to the Secretary, orally or in writing,
views with respect to such proceeding.
(Mar. 4, 1907, ch. 2907, title IV, 406, as added Dec. 15, 1967, Pub.
L. 90-201, 16, 81 Stat. 599, and amended Nov. 10, 1986, Pub. L. 99-641,
title IV, 403(c), 100 Stat. 3570.)
1986 -- Subsec. (b). Pub. L. 99-641, 403(c)(1), temporarily inserted
provisions which related to factors required to be considered by
Secretary in determining whether public interest is served by written
notice of warning. See Effective and Termination Dates of 1986
Amendment note below.
Subsec. (c). Pub. L. 99-641, 403(c)(2), temporarily added subsec.
(c). See Effective and Termination Dates of 1986 Amendment note below.
Section 403(c) of Pub. L. 99-641 provided that the amendment made by
that section is effective only during the 6-year period beginning Nov.
10, 1986.
For provisions relating to construction and effect of temporary
amendments by section 403 of Pub. L. 99-641, see sections 403(e) and
404 of Pub. L. 99-641, set out as notes entitled ''Inspection Services
for Establishments Not Participating in Total Plant Quality-Control
Program'' and ''Savings Provision'', respectively, under section 606 of
this title.
Admiralty and maritime rules of practice (which included libel
procedures) were superseded, and civil and admiralty procedures in
United States district courts were unified, effective July 1, 1966, see
rule 1 and Supplemental Rules for Certain Admiralty and Maritime Claims,
Title 28, Appendix, Judiciary and Judicial Procedure.
21 USC 677. Other Federal laws applicable for administration and
enforcement of chapter; location of inquiries; jurisdiction of Federal
courts
TITLE 21 -- FOOD AND DRUGS
For the efficient administration and enforcement of this chapter, the
provisions (including penalties) of sections 46, 48, 49 and 50 of title
15 (except paragraphs (c) through (h) of section 46 and the last
paragraph of section 49 /1/ of title 15), and the provisions of section
409(l) /1/ of title 47; are made applicable to the jurisdiction,
powers, and duties of the Secretary in administering and enforcing the
provisions of this chapter and to any person, firm, or corporation with
respect to whom such authority is exercised. The Secretary, in person
or by such agents as he may designate, may prosecute any inquiry
necessary to his duties under this chapter in any part of the United
States, and the powers conferred by said sections 49 and 50 of title 15
on the district courts of the United States may be exercised for the
purposes of this chapter by any court designated in section 674 of this
title.
(Mar. 4, 1907, ch. 2907, title IV, 407, as added Dec. 15, 1967, Pub.
L. 90-201, 16, 81 Stat. 599.)
The last paragraph of section 49 of title 15, and the provisions of
section 409(l) of title 47, referred to in text, which related to
immunity of witnesses, were repealed by sections 211 and 242,
respectively, of Pub. L. 91-452, Oct. 15, 1970, title II, 84 Stat.
929, 930. For provisions relating to immunity of witnesses, see section
6001 et seq. of Title 18, Crimes and Criminal Procedure.
/1/ See References in Text note below.
21 USC 678. Non-Federal jurisdiction of federally regulated matters;
prohibition of additional or different requirements for establishments
with inspection services and as to marking, labeling, packaging, and
ingredients; recordkeeping and related requirements; concurrent
jurisdiction over distribution for human food purposes of adulterated or
misbranded and imported articles; other matters
TITLE 21 -- FOOD AND DRUGS
Requirements within the scope of this chapter with respect to
premises, facilities and operations of any establishment at which
inspection is provided under subchapter I of this chapter, which are in
addition to, or different than those made under this chapter may not be
imposed by any State or Territory or the District of Columbia, except
that any such jurisdiction may impose recordkeeping and other
requirements within the scope of section 642 of this title, if
consistent therewith, with respect to any such establishment. Marking,
labeling, packaging, or ingredient requirements in addition to, or
different than, those made under this chapter may not be imposed by any
State or Territory or the District of Columbia with respect to articles
prepared at any establishment under inspection in accordance with the
requirements under subchapter I of this chapter, but any State or
Territory or the District of Columbia may, consistent with the
requirements under this chapter, exercise concurrent jurisdiction with
the Secretary over articles required to be inspected under said
subchapter I, for the purpose of preventing the distribution for human
food purposes of any such articles which are adulterated or misbranded
and are outside of such an establishment, or, in the case of imported
articles which are not at such an establishment, after their entry into
the United States. This chapter shall not preclude any State or
Territory or the District of Columbia from making requirement /2/ or
taking other action, consistent with this chapter, with respect to any
other matters regulated under this chapter.
(Mar. 4, 1907, ch. 2907, title IV, 408, as added Dec. 15, 1967, Pub.
L. 90-201, 16, 81 Stat. 600.)
/2/ So in original. Probably should be ''requirements''.
21 USC 679. Application of Federal Food, Drug, and Cosmetic Act
TITLE 21 -- FOOD AND DRUGS
(a) Authorities under food, drug, and cosmetic provisions unaffected
Notwithstanding any other provisions of law, including section 902(
b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 392(a)), the
provisions of this chapter shall not derogate from any authority
conferred by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) prior to December 15, 1967.
(b) Enforcement proceedings; detainer authority of representatives
of Secretary of Health and Human Services
The detainer authority conferred by section 672 of this title shall
apply to any authorized representative of the Secretary of Health and
Human Services for purposes of the enforcement of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) with respect to any
carcass, part thereof, meat, or meat food product of cattle, sheep,
swine, goats, or equines that is outside any premises at which
inspection is being maintained under this chapter, and for such purposes
the first reference to the Secretary in section 672 of this title shall
be deemed to refer to the Secretary of Health and Human Services.
(Mar. 4, 1907, ch. 2907, title IV, 409, as added Dec. 15, 1967, Pub.
L. 90-201, 16, 81 Stat. 600, and amended Oct. 17, 1979, Pub. L. 96-88,
title V, 509(b), 93 Stat. 695.)
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(b), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which
is classified generally to chapter 9 ( 301 et seq.) of this title. For
complete classification of this Act to the Code, see section 301 of this
title and Tables.
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in subsec. (b) pursuant
to section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
Federal Food, Drug, and Cosmetic Act defined, see section 601 of this
title.
21 USC 680. Authorization of appropriations
TITLE 21 -- FOOD AND DRUGS
There are hereby authorized to be appropriated such sums as may be
necessary to carry out the provisions of this chapter.
(Mar. 4, 1907, ch. 2907, title IV, 410, as added Dec. 15, 1967, Pub.
L. 90-201, 16, 81 Stat. 600.)
21 USC SUBCHAPTER V -- MISCELLANEOUS PROVISIONS
TITLE 21 -- FOOD AND DRUGS
21 USC 691. Reports to Congressional committees
TITLE 21 -- FOOD AND DRUGS
The Secretary shall annually report to the Committee on Agriculture
of the House of Representatives and the Committee on Agriculture,
Nutrition, and Forestry of the Senate with respect to the slaughter of
animals subject to this Act, and the preparation, storage, handling and
distribution of carcasses, parts thereof, meat and meat food products,
of such animals, and inspection of establishments operated in connection
therewith, including the operations under and effectiveness of this Act.
(Pub. L. 90-201, 17, Dec. 15, 1967, 81 Stat. 600; S. Res. 4, Feb.
4, 1977.)
This Act, referred to in text, means Pub. L. 90-201, Dec. 15, 1967,
81 Stat. 584, as amended, known as the Wholesome Meat Act, which
enacted sections 601, 602, 624, 641 to 645, 661, 671 to 680, and 691 of
this title, amended sections 603 to 623 of this title, repealed section
96 of this title and section 1306(b) of Title 19, Customs Duties, and
enacted provisions set out as notes under section 601 of this title.
For complete classification of this Act to the Code, see Short Title
note set out under section 601 of this title and Tables.
Section was enacted as a part of the Wholesome Meat Act (see
References in Text note above) and not as a part of the Federal Meat
Inspection Act which is classified to subchapters I to IV of this
chapter.
Committee on Agriculture and Forestry of the Senate abolished and
replaced by Committee on Agriculture, Nutrition, and Forestry of the
Senate, effective Feb. 11, 1977. See Rule XXV of Standing Rules of the
Senate, as amended by Senate Resolution 4 (popularly cited as the
''Committee System Reorganization Amendments of 1977''), approved Feb.
4, 1977.
Section effective Dec. 15, 1967, see section 20 of Pub. L. 90-201,
set out as a note under section 601 of this title.
21 USC 692. Inspection extended to reindeer
TITLE 21 -- FOOD AND DRUGS
The provisions of the meat inspection law may be extended to the
inspection of reindeer.
(June 30, 1914, ch. 131, 38 Stat. 420.)
The meat inspection law, referred to in text, is classified generally
to this chapter. At the time of enactment, such reference probably
meant the Act of Mar. 4, 1907, ch. 2907, 34 Stat. 1260, as amended.
That Act (formerly classified to section 71 et seq. of this title), was
generally revised by Pub. L. 90-201, Dec. 15, 1967, 81 Stat. 584, and
is classified to this chapter. For complete classification of this Act
to the Code, see Tables.
Section was not enacted as part of the Federal Meat Inspection Act
which is classified to subchapters I to IV of this chapter.
Section was formerly classified to section 94 of this title.
21 USC 693. Inspection of dairy products for export
TITLE 21 -- FOOD AND DRUGS
The act of March 3, 1891, as amended, for the inspection of live
cattle and products thereof, shall be deemed to include dairy products
intended for exportation to any foreign country, and the Secretary of
Agriculture may apply, under rules and regulations to be prescribed by
him, the provisions of said act for inspection and certification
appropriate for ascertaining the purity and quality of such products,
and may cause the same to be so marked, stamped, or labeled as to secure
their identity and make known in the markets of foreign countries to
which they may be sent from the United States their purity, quality, and
grade; and all the provisions of said act relating to live cattle and
products thereof for export shall apply to dairy products so inspected
and certified.
(May 23, 1908, ch. 192, 35 Stat. 254.)
Act of March 3, 1891, referred to in text, is act Mar. 3, 1891, ch.
555, 26 Stat. 1089, which was superseded by act Mar. 4, 1907, ch.
2907, 34 Stat. 1260, as amended by act June 29, 1938, ch. 810, 52
Stat. 1235 (formerly classified to section 71 et seq. of this title).
Act Mar. 4, 1907, ch. 2907, was generally revised by Pub. L. 90-201,
Dec. 15, 1967, 81 Stat. 584, and is classified to this chapter.
Section was not enacted as part of the Federal Meat Inspection Act
which is classified to subchapters I to IV of this chapter.
Section was formerly classified to sections 94a and 132 of this
title.
21 USC 694. Authorization of appropriations
TITLE 21 -- FOOD AND DRUGS
Annual appropriations of the sum of $3,000,000 from the general fund
of the Treasury are authorized for the expenses of the inspection of
cattle, sheep, swine, and goats and the meat and meat food products
thereof which enter into interstate or foreign commerce and for all
expenses necessary to carry into effect the provisions of this Act
relating to meat inspection, including rent and the employment of labor
in Washington and elsewhere, for each year, and in addition there is
authorized to be appropriated such other sums as may be necessary in the
enforcement of the meat inspection laws.
(June 30, 1906, ch. 3913, 34 Stat. 679; June 26, 1934, ch. 756, 2,
48 Stat. 1225.)
This Act, referred to in text, is act June 30, 1906, ch. 3913, 34
Stat. 669, which made appropriations for the Department of Agriculture
for the fiscal year ending June 30, 1907.
Section 2 of act June 26, 1934, which was classified to section 725a
of former Title 31, Money and Finance, repealed the permanent
appropriation under the title ''Meat inspection, Bureau of Animal
Industry (fiscal year) (3-114)'' effective July 1, 1935, provided that
such portions of any Acts as make permanent appropriations to be
expended under such account are amended so as to authorize, in lieu
thereof, annual appropriations from the general fund of the Treasury in
identical terms and in such amounts as now provided by the laws
providing such permanent appropriations, and authorized, in addition
thereto, the appropriation of ''such other sums as may be necessary in
the enforcement of the meat inspection laws.'' In the original, the
parenthetical ''(U.S.C., title 21, secs. 71 to 96, inclusive)'' followed
the phrase ''meat inspection laws''. The ''meat inspection laws'' are
classified generally to this chapter.
Section was not enacted as part of the Federal Meat Inspection Act
which is classified to subchapters I to IV of this chapter.
Section was formerly classified to section 95 of this title.
21 USC 695. Payment of cost of meat-inspection service; exception
TITLE 21 -- FOOD AND DRUGS
The cost of inspection rendered on and after July 1, 1948, under the
requirements of laws relating to Federal inspection of meat and meat
food products shall be borne by the United States except the cost of
overtime pursuant to section 394 of title 7.
(June 5, 1948, ch. 423, 62 Stat. 344.)
Section was not enacted as part of the Federal Meat Inspection Act
which is classified to subchapters I to IV of this chapter.
Section was formerly classified to section 98 of this title.
21 USC
TITLE 21 -- FOOD AND DRUGS
21 USC CHAPTER 13 -- DRUG ABUSE PREVENTION AND CONTROL
TITLE 21 -- FOOD AND DRUGS
Sec.
801. Congressional findings and declarations: controlled
substances.
801a. Congressional findings and declarations: psychotropic
substances.
802. Definitions.
803. Repealed.
811. Authority and criteria for classification of substances.
(a) Rules and regulations of Attorney General; hearing.
(b) Evaluation of drugs and other substances.
(c) Factors determinative of control or removal from schedules.
(d) International treaties, conventions, and protocols requiring
control; procedures respecting changes in drug schedules of Convention
on Psychotropic Substances.
(e) Immediate precursors.
(f) Abuse potential.
(g) Exclusion of non-narcotic substances sold over the counter
without a prescription; dextromethorphan; exemption of substances
lacking abuse potential.
(h) Temporary scheduling to avoid imminent hazards to public safety.
812. Schedules of controlled substances.
(a) Establishment.
(b) Placement on schedules; findings required.
(c) Initial schedules of controlled substances.
(d) Repealed.
813. Treatment of controlled substance analogues.
821. Rules and regulations.
822. Persons required to register.
(a) Period of registration.
(b) Authorized activities.
(c) Exceptions.
(d) Waiver.
(e) Separate registration.
(f) Inspection.
823. Registration requirements.
(a) Manufacturers of controlled substances in schedule I or II.
(b) Distributors of controlled substances in schedule I or II.
(c) Limits of authorized activities.
(d) Manufacturers of controlled substances in schedule III, IV, or V.
(e) Distributors of controlled substances in schedule III, IV, or V.
(f) Research by practitioners; pharmacies; research applications;
construction of Article 7 of the Convention on Psychotropic Substances.
(g) Practitioners dispensing narcotic drugs for narcotic treatment;
annual registration; separate registration; qualifications.
824. Denial, revocation, or suspension of registration.
(a) Grounds.
(b) Limits of revocation or suspension.
(c) Service of show cause order; proceedings.
(d) Suspension of registration in cases of imminent danger.
(e) Suspension and revocation of quotas.
(f) Disposition of controlled substances.
(g) Seizure or placement under seal of controlled substances.
825. Labeling and packaging.
(a) Symbol.
(b) Unlawful distribution without identifying symbol.
(c) Warning on label.
(d) Containers to be securely sealed.
826. Production quotas for controlled substances.
(a) Establishment of total annual needs.
(b) Individual production quotas; revised quotas.
(c) Manufacturing quotas for registered manufacturers.
(d) Quotas for registrants who have not manufactured controlled
substance during one or more preceding years.
(e) Quota increases.
(f) Incidental production exception.
827. Records and reports of registrants.
(a) Inventory.
(b) Availability of records.
(c) Nonapplicability.
(d) Periodic reports to Attorney General.
(e) Reporting and recordkeeping requirements of drug conventions.
(f) Investigational uses of drugs; procedures.
(g) Change of address.
828. Order forms.
(a) Unlawful distribution of controlled substances.
(b) Nonapplicability of provisions.
(c) Preservation and availability.
(d) Issuance.
(e) Unlawful acts.
829. Prescriptions.
(a) Schedule II substances.
(b) Schedule III and IV substances.
(c) Schedule V substances.
(d) Non-prescription drugs with abuse potential.
830. Regulation of listed chemicals and certain machines.
(a) Record of regulated transactions.
(b) Reports to Attorney General.
(c) Confidentiality of information obtained by Attorney General;
non-disclosure exceptions.
841. Prohibited acts A.
(a) Unlawful acts.
(b) Penalties.
(c) Repealed.
(d) Offenses involving listed chemicals.
(e) Boobytraps on Federal property; penalties; ''boobytrap''
defined.
(f) Ten-year injunction as additional penalty.
(g) Wrongful distribution or possession of listed chemicals.
842. Prohibited acts B.
(a) Unlawful acts.
(b) Manufacture.
(c) Penalties.
843. Prohibited acts C.
(a) Unlawful acts.
(b) Communication facility.
(c) Penalties.
(d) Additional penalties.
844. Penalties for simple possession.
(a) Unlawful acts; penalties.
(b) Repealed.
(c) ''Drug or narcotic offense'' defined.
844a. Civil penalty for possession of small amounts of certain
controlled substances.
(a) In general.
(b) Income and net assets.
(c) Prior conviction.
(d) Limitation on number of assessments.
(e) Assessment.
(f) Compromise.
(g) Judicial review.
(h) Civil action.
(i) Limitation.
(j) Expungement procedures.
845 to 845b. Transferred.
846. Attempt and conspiracy.
847. Additional penalties.
848. Continuing criminal enterprise.
(a) Penalties; forfeitures.
(b) Life imprisonment for engaging in continuing criminal enterprise.
(c) ''Continuing criminal enterprise'' defined.
(d) Suspension of sentence and probation prohibited.
(e) Death penalty.
(g) Hearing required with respect to death penalty.
(h) Notice by Government in death penalty cases.
(i) Hearing before court or jury.
(j) Proof of aggravating and mitigating factors.
(k) Return of findings.
(l) Imposition of sentence.
(m) Mitigating factors.
(n) Aggravating factors for homicide.
(o) Right of defendant to justice without discrimination.
(p) Sentencing in capital cases in which death penalty is not sought
or imposed.
(q) Appeal in capital cases; counsel for financially unable
defendants.
(r) Refusal to participate by State and Federal correctional
employees.
849. Repealed.
850. Information for sentencing.
851. Proceedings to establish prior convictions.
(a) Information filed by United States Attorney.
(b) Affirmation or denial of previous conviction.
(c) Denial; written response; hearing.
(d) Imposition of sentence.
(e) Statute of limitations.
852. Application of treaties and other international agreements.
853. Criminal forfeitures.
(a) Property subject to criminal forfeiture.
(b) Meaning of term ''property''.
(c) Third party transfers.
(d) Rebuttable presumption.
(e) Protective orders.
(f) Warrant of seizure.
(g) Execution.
(h) Disposition of property.
(i) Authority of the Attorney General.
(j) Applicability of civil forfeiture provisions.
(k) Bar on intervention.
(l) Jurisdiction to enter orders.
(m) Depositions.
(n) Third party interests.
(o) Construction.
(p) Forfeiture of substitute property.
853a. Transferred.
854. Investment of illicit drug profits.
(a) Prohibition.
(b) Penalty.
(c) ''Enterprise'' defined.
(d) Construction.
855. Alternative fine.
856. Establishment of manufacturing operations.
857. Repealed.
858. Endangering human life while illegally manufacturing controlled
substance.
859. Distribution to persons under age twenty-one.
(a) First offense.
(b) Second offense.
860. Distribution or manufacturing in or near schools and colleges.
(a) Penalty.
(b) Second offenders.
(c) Suspension of sentence; probation; parole.
(d) Definitions.
861. Employment or use of persons under 18 years of age in drug
operations.
(a) Unlawful acts.
(b) Penalty for first offense.
(c) Penalty for subsequent offenses.
(d) Penalty for providing or distributing controlled substance to
underage person.
(e) Suspension of sentence; probation; parole.
(f) Distribution of controlled substance to pregnant individual.
862. Denial of Federal benefits to drug traffickers and possessors.
(a) Drug traffickers.
(b) Drug possessors.
(c) Suspension of period of ineligibility.
(d) Definitions.
(e) Inapplicability of this section to Government witnesses.
(f) Indian provision.
(g) Presidential report.
(h) Effective date.
863. Drug paraphernalia.
(a) In general.
(b) Penalties.
(c) Seizure and forfeiture.
(d) ''Drug paraphernalia'' defined.
(e) Matters considered in determination of what constitutes drug
paraphernalia.
(f) Exemptions.
871. Attorney General.
(a) Delegation of functions.
(b) Rules and regulations.
(c) Acceptance of devises, bequests, gifts, and donations.
872. Education and research programs of Attorney General.
(a) Authorization.
(b) Contracts.
(c) Identification of research populations; authorization to
withhold.
(d) Affect of treaties and other international agreements on
confidentiality.
(e) Use of controlled substances in research.
(f) Program to curtail diversion of precursor and essential
chemicals.
873. Cooperative arrangements.
(a) Cooperation of Attorney General with local, State, and Federal
agencies.
(b) Requests by Attorney General for assistance from Federal agencies
or instrumentalities.
(c) Descriptive and analytic reports by Attorney General to State
agencies of distribution patterns of schedule II substances having
highest rates of abuse.
(d) Grants by Attorney General.
874. Advisory committees.
875. Administrative hearings.
(a) Power of Attorney General.
(b) Procedures applicable.
876. Subpenas.
(a) Authorization of use by Attorney General.
(b) Service.
(c) Enforcement.
877. Judicial review.
878. Powers of enforcement personnel.
879. Search warrants.
880. Administrative inspections and warrants.
(a) ''Controlled premises'' defined.
(b) Grant of authority; scope of inspections.
(c) Situations not requiring warrants.
(d) Administrative inspection warrants; issuance; execution;
probable cause.
881. Forfeitures.
(a) Subject property.
(b) Seizure pursuant to Supplemental Rules for Certain Admiralty and
Maritime Claims issuance of warrant authorizing seizure.
(c) Custody of Attorney General.
(d) Other laws and proceedings applicable.
(e) Disposition of forfeited property.
(f) Forfeiture and destruction of schedule I and II substances.
(g) Plants.
(h) Vesting of title in United States.
(i) Stay of civil forfeiture proceedings.
(j) Venue.
(l) Agreement between Attorney General and Postal Service for
performance of functions.
881-1, 881a. Transferred.
882. Injunctions.
(a) Jurisdiction.
(b) Jury trial.
883. Enforcement proceedings.
884. Immunity and privilege.
(a) Refusal to testify.
(b) Order of United States district court.
(c) Request by United States attorney.
885. Burden of proof; liabilities.
(a) Exemptions and exceptions; presumption in simple possession
offenses.
(b) Registration and order forms.
(c) Use of vehicles, vessels, and aircraft.
(d) Immunity of Federal, State, local and other officials.
886. Payments and advances.
(a) Payment to informers.
(b) Reimbursement for purchase of controlled substances.
(c) Advance of funds for enforcement purposes.
(d) Drug Pollution Fund.
887. Coordination and consolidation of post-seizure administration.
888. Expedited procedures for seized conveyances.
(a) Petition for expedited decision; determination.
(b) Written notice of procedures.
(c) Complaint for forfeiture.
(d) Bond for release of conveyance.
889. Production control of controlled substances.
(a) Definitions.
(b) Persons ineligible for Federal agricultural program benefits.
(c) Regulations.
901. Severability.
902. Savings provisions.
903. Application of State law.
904. Payment of tort claims.
951. Definitions.
952. Importation of controlled substances.
(a) Controlled substances in schedule I or II and narcotic drugs in
schedule III, IV, or V; exceptions.
(b) Nonnarcotic controlled substances in schedule III, IV, or V.
(c) Coca leaves.
953. Exportation of controlled substances.
(a) Narcotic drugs in schedule I, II, III, or IV.
(b) Exception for exportation for special scientific purposes.
(c) Nonnarcotic controlled substances in schedule I or II.
(d) Exception for exportation for special scientific purposes.
(e) Nonnarcotic controlled substances in schedule III or IV;
controlled substances in schedule V.
954. Transshipment and in-transit shipment of controlled substances.
955. Possession on board vessels, etc., arriving in or departing
from United States.
955a to 955d. Transferred.
956. Exemption authority.
(a) Individual possessing controlled substance.
(b) Compound, mixture, or preparation.
957. Persons required to register.
(a) Coverage.
(b) Exemptions.
958. Registration requirements.
(a) Applicants to import or export controlled substances in schedule
I or II.
(b) Activity limited to specified substances.
(c) Applicants to import controlled substances in schedule III, IV,
or V or to export controlled substances in schedule III or IV.
(d) Denial of applications.
(e) Registration period.
(f) Rules and regulations.
(g) Scope of authorized activity.
(h) Separate registrations for each principal place of business.
(i) Emergency situations.
959. Possession, manufacture, or distribution of controlled
substance.
(a) Manufacture or distribution for purpose of unlawful importation.
(b) Possession, manufacture, or distribution by person on board
aircraft.
(c) Acts committed outside territorial jurisdiction of United States;
venue.
960. Prohibited acts A.
(a) Unlawful acts.
(b) Penalties.
(c) Repealed.
(d) Penalty for importation or exportation.
961. Prohibited acts B.
962. Second or subsequent offenses.
(a) Term of imprisonment and fine.
(b) Determination of status.
(c) Procedures applicable.
963. Attempt and conspiracy.
964. Additional penalties.
965. Applicability of part E of subchapter I.
966. Authority of Secretary of the Treasury.
967. Smuggling of controlled substances; investigations; oaths;
subpenas; witnesses; evidence; production of records; territorial
limits; fees and mileage of witnesses.
968. Service of subpena; proof of service.
969. Contempt proceedings.
970. Criminal forfeitures.
971. Notification, suspension of shipment, and penalties with
respect to importation and exportation of listed chemicals.
(a) Notification prior to transaction.
(b) Regular customers or suppliers.
(c) Suspension of importation or exportation; disqualification of
regular customers or suppliers; hearing.
title 22 sections 283s, 284k, 285p; title 28 section
524; title 42 section 2000e-2; title 46 App.
section 1903.
21 USC SUBCHAPTER I -- CONTROL AND ENFORCEMENT
TITLE 21 -- FOOD AND DRUGS
5110; title 16 section 559d; title 18 sections 924,
929, 981, 1864, 1956, 3142, 3554; title 20 sections
3192, 5421; title 22 sections 2708, 2714; title 23
section 159; title 28 section 524; title 29 section
706; title 40 section 304m; title 42 sections 242,
261, 3751, 12111, 12210.
21 USC Part A -- Introductory Provisions
TITLE 21 -- FOOD AND DRUGS
21 USC 801. Congressional findings and declarations: controlled
substances
TITLE 21 -- FOOD AND DRUGS
The Congress makes the following findings and declarations:
(1) Many of the drugs included within this subchapter have a useful
and legitimate medical purpose and are necessary to maintain the health
and general welfare of the American people.
(2) The illegal importation, manufacture, distribution, and
possession and improper use of controlled substances have a substantial
and detrimental effect on the health and general welfare of the American
people.
(3) A major portion of the traffic in controlled substances flows
through interstate and foreign commerce. Incidents of the traffic which
are not an integral part of the interstate or foreign flow, such as
manufacture, local distribution, and possession, nonetheless have a
substantial and direct effect upon interstate commerce because --
(A) after manufacture, many controlled substances are transported in
interstate commerce,
(B) controlled substances distributed locally usually have been
transported in interstate commerce immediately before their
distribution, and
(C) controlled substances possessed commonly flow through interstate
commerce immediately prior to such possession.
(4) Local distribution and possession of controlled substances
contribute to swelling the interstate traffic in such substances.
(5) Controlled substances manufactured and distributed intrastate
cannot be differentiated from controlled substances manufactured and
distributed interstate. Thus, it is not feasible to distinguish, in
terms of controls, between controlled substances manufactured and
distributed interstate and controlled substances manufactured and
distributed intrastate.
(6) Federal control of the intrastate incidents of the traffic in
controlled substances is essential to the effective control of the
interstate incidents of such traffic.
(7) The United States is a party to the Single Convention on Narcotic
Drugs, 1961, and other international conventions designed to establish
effective control over international and domestic traffic in controlled
substances.
(Pub. L. 91-513, title II, 101, Oct. 27, 1970, 84 Stat. 1242.)
This subchapter, referred to in par. (1), was in the original ''this
title'', meaning title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
1242, as amended, and is popularly known as the ''Controlled Substances
Act''. For complete classification of title II to the Code, see second
paragraph of Short Title note set out below and Tables.
Section 704 of title II of Pub. L. 91-513 provided that:
''(a) Except as otherwise provided in this section, this title (see
Short Title note below) shall become effective on the first day of the
seventh calendar month that begins after the day immediately preceding
the date of enactment (Oct. 27, 1970).
''(b) Parts A, B, E, and F of this title (Parts A, B, E, and F of
this subchapter), section 702 (set out as a note under section 321 of
this title), this section, and sections 705 through 709 (sections 901 to
904 of this title and note set out below), shall become effective upon
enactment (Oct. 27, 1970).
''(c) Sections 305 (relating to labels and labeling) (section 825 of
this title), and 306 (relating to manufacturing quotas) (section 826 of
this title) shall become effective on the date specified in subsection
(a) of this section, except that the Attorney General may by order
published in the Federal Register postpone the effective date of either
or both of these sections for such period as he may determine to be
necessary for the efficient administration of this title (see Short
Title note below).''
Pub. L. 101-647, title XIX, 1901, Nov. 29, 1990, 104 Stat. 4851,
provided that: ''This Act (probably means title XIX of Pub. L.
101-647, which amended sections 333, 802, 812, and 844 of this title and
section 290aa-6 of Title 42, The Public Health and Welfare, repealed
section 333a of this title, and enacted provisions set out as notes
under sections 802 and 829 of this title) may be cited as the 'Anabolic
Steroids Control Act of 1990'.''
Pub. L. 100-690, title VI, 6001, Nov. 18, 1988, 102 Stat. 4312,
provided that: ''This title (see Tables for classification) may be
cited as the 'Anti-Drug Abuse Amendments Act of 1988'.''
Pub. L. 100-690, title VI, 6051, Nov. 18, 1988, 102 Stat. 4312,
provided that: ''This subtitle (subtitle A ( 6051-6061) of title VI of
Pub. L. 100-690, enacting section 971 of this title, amending sections
802, 830, 841 to 843, 872, 876, 881, 960, and 961 of this title, and
enacting provisions set out as notes under sections 802 and 971 of this
title) may be cited as the 'Chemical Diversion and Trafficking Act of
1988'.''
Pub. L. 100-690, title VI, 6071, Nov. 18, 1988, 102 Stat. 4320,
provided that: ''This subtitle (subtitle B ( 6071-6080) of title VI of
Pub. L. 100-690, enacting sections 881-1, 887, and 1509 of this title,
amending section 881 of this title, section 1594 of Title 19, Customs
Duties, section 524 of Title 28, Judiciary and Judicial Procedure, and
section 782 of Title 49, Appendix, Transportation, and enacting
provisions set out as notes under section 881 of this title) may be
cited as the 'Asset Forfeiture Amendments Act of 1988'.''
Pub. L. 99-570, 1, Oct. 27, 1986, 100 Stat. 3207, provided that:
''This Act (see Tables for classification) may be cited as the
'Anti-Drug Abuse Act of 1986'.''
Pub. L. 99-570, title I, 1001, Oct. 27, 1986, 100 Stat. 3207-2,
provided that: ''This subtitle (subtitle A ( 1001-1009) of title I of
Pub. L. 99-570, amending sections 802, 841, 845, 845a, 848, 881, 960,
and 962 of this title, sections 3553 and 3583 of Title 18, Crimes and
Criminal Procedure, rule 35 of the Federal Rules of Criminal Procedure,
Title 18, Appendix, and section 994 of Title 28, Judiciary and Judicial
Procedure, and enacting provisions set out as notes under section 841 of
this title, sections 3553 and 3583 of Title 18, and rule 35 of the
Federal Rules of Criminal Procedure) may be cited as the 'Narcotics
Penalties and Enforcement Act of 1986'.''
Pub. L. 99-570, title I, 1051, Oct. 27, 1986, 100 Stat. 3207-8,
provided that: ''This subtitle (subtitle B ( 1051, 1052) of title I of
Pub. L. 99-570, amending section 844 of this title) may be cited as the
'Drug Possession Penalty Act of 1986'.''
Pub. L. 99-570, title I, 1101, Oct. 27, 1986, 100 Stat. 3207-10,
provided that: ''This subtitle (subtitle C ( 1101-1105) of title I of
Pub. L. 99-570, enacting section 845b of this title and amending
sections 841, 845, and 845a of this title) may be cited as the 'Juvenile
Drug Trafficking Act of 1986'.''
Pub. L. 99-570, title I, 1201, Oct. 27, 1986, 100 Stat. 3207-13,
provided that: ''This subtitle (subtitle E ( 1201-1204) of title I of
Pub. L. 99-570, enacting section 813 of this title and amending section
802 of this title) may be cited as the 'Controlled Substance Analogue
Enforcement Act of 1986'.''
Pub. L. 99-570, title I, 1251, Oct. 27, 1986, 100 Stat. 3207-14,
provided that: ''This subtitle (subtitle F ( 1251-1253) of title I of
Pub. L. 99-570, amending section 848 of this title) may be cited as the
'Continuing Drug Enterprises Act of 1986'.''
Pub. L. 99-570, title I, 1301, Oct. 27, 1986, 100 Stat. 3207-15,
provided that: ''This subtitle (subtitle G ( 1301, 1302) of title I of
Pub. L. 99-570, amending section 960 of this title) may be cited as the
'Controlled Substances Import and Export Penalties Enhancement Act of
1986'.''
Pub. L. 99-570, title I, 1821, Oct. 27, 1986, 100 Stat. 3207-51,
which provided that subtitle O ( 1821-1823) of title I of Pub. L.
99-570, enacting section 857 of this title and provisions set out as a
note under section 857 of this title, was to be cited as the ''Mail
Order Drug Paraphernalia Control Act'', was repealed by Pub. L.
101-647, title XXIV, 2401(d), Nov. 29, 1990, 104 Stat. 4859.
Pub. L. 99-570, title I, 1991, Oct. 27, 1986, 100 Stat. 3207-59,
provided that: ''This subtitle (subtitle U ( 1991, 1992) of title I of
Pub. L. 99-570, amending section 881 of this title) may be cited as the
'Federal Drug Law Enforcement Agent Protection Act of 1986'.''
Pub. L. 98-473, title II, 501, Oct. 12, 1984, 98 Stat. 2068,
provided that: ''This chapter (chapter V ( 501-525) of title II of Pub.
L. 98-473, enacting section 845a of this title, amending sections 802,
811, 812, 822-824, 827, 841, 843, 845, 873, 881, 952, 953, 957, 958,
960, and 962 of this title, and enacting provisions set out as a note
under this section) may be cited as the 'Controlled Substances Penalties
Amendments Act of 1984'.''
Pub. L. 98-473, title II, 506(a), Oct. 12, 1984, 98 Stat. 2070,
provided that: ''This part (part B of chapter V ( 506-525) of title II
of Pub. L. 98-473, amending sections 802, 811, 812, 822-824, 827, 843,
873, 881, 952, 953, 957, and 958 of this title) may be cited as the
'Dangerous Drug Diversion Control Act of 1984'.''
Pub. L. 95-633, 1, Nov. 10, 1978, 92 Stat. 3768, provided: ''That
this Act (enacting sections 801a, 830, and 852 of this title, amending
sections 352, 802, 811, 812, 823, 827, 841 to 843, 872, 881, 952, 953,
and 965 of this title and section 242a of Title 42, The Public Health
and Welfare, repealing section 830 of this title (effective Jan. 1,
1981), and enacting provisions set out as notes under sections 801a,
812, and 830 of this title) may be cited as the 'Psychotropic Substances
Act of 1978'.''
Pub. L. 93-281, 1, May 14, 1974, 88 Stat. 124, provided: ''That
this Act (amending sections 802, 823, 824, and 827 of this title) may be
cited as the 'Narcotic Addict Treatment Act of 1974'.''
Pub. L. 91-513, in the provisions preceding section 1 immediately
following the enacting clause, provided: ''That this Act (enacting this
chapter and sections 257a, 2688l-1, 2688n-1, and 3509 of Title 42, The
Public Health and Welfare, amending sections 162, 198a, 321, 331, 333,
334, 360, 372, and 381 of this title, sections 1114, 1952, and 4251 of
Title 18, Crimes and Criminal Procedure, sections 1584, 2078, 2079, and
2080 of Title 19, Customs Duties, sections 4901, 4905, 6808, 7012, 7103,
7326, 7607, 7609, 7641, 7651, and 7655 of Title 26, Internal Revenue
Code, section 2901 of Title 28, Judiciary and Judicial Procedure,
section 304m of Title 40, Public Buildings, Property, and Works,
sections 201, 225a, 242, 242a, 246, 257, 258, 259, 260, 261, 261a,
2688k, 2688l, 2688m, 2688n, 2688o, 2688r, and 3411 of Title 42, The
Public Health and Welfare, section 239a of former Title 46, Shipping,
and section 787 of Title 49, Appendix, Transportation, repealing
sections 171 to 174, 176 to 185, 188 to 188n, 191 to 193, 197, 198, 199,
360a, and 501 to 517 of this title, sections 1401 to 1407 and 3616 of
Title 18, sections 4701 to 4707, 4711 to 4716, 4721 to 4726, 4731 to
4736, 4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to 4776, 7237, 7238,
and 7491 of Title 26, sections 529a and 529g of former Title 31, Money
and Finance, and section 1421m of Title 48, Territories and Insular
Possessions, and enacting provisions set out as notes under this section
and sections 171, 321, 822, 951, and 957 of this title) may be cited as
the 'Comprehensive Drug Abuse Prevention and Control Act of 1970'.''
Section 100 of title II of Pub. L. 91-513 provided that: ''This
title (enacting this subchapter, repealing section 360a of this title,
amending sections 321, 331, 333, 334, 360, 372, and 381 of this title,
sections 1114 and 1952 of Title 18, Crimes and Criminal Procedure, and
section 242 of Title 42, The Public Health and Welfare, and enacting
provisions set out as notes under this section and sections 321 and 822
of this title) may be cited as the 'Controlled Substances Act'.''
Section 705 of title II of Pub. L. 91-513 provided that: ''Any
orders, rules, and regulations which have been promulgated under any law
affected by this title (see Short Title note above) and which are in
effect on the day preceding enactment of this title (Oct. 27, 1970)
shall continue in effect until modified, superseded, or repealed.''
Pub. L. 100-690, title II, 2405, Nov. 18, 1988, 102 Stat. 4231,
provided that:
''(a) Establishment of Task Force. -- There is established the Joint
Federal Task Force on Illegal Drug Laboratories (hereafter in this
section referred to as the 'Task Force').
''(b) Appointment and Membership of Task Force. -- The members of the
Task Force shall be appointed by the Administrators of the Environmental
Protection Agency and the Drug Enforcement Administration (hereafter in
this section referred to as the 'Administrators'). The Task Force shall
consist of at least 6 and not more than 20 members. Each Administrator
shall appoint one-half of the members as follows: (1) the Administrator
of the Environmental Protection Agency shall appoint members from among
Emergency Response Technicians and other appropriate employees of the
Agency; and (2) the Administrator of the Drug Enforcement
Administration shall appoint members from among Special Agents assigned
to field divisions and other appropriate employees of the
Administration.
''(c) Duties of Task Force. -- The Task Force shall formulate,
establish, and implement a program for the cleanup and disposal of
hazardous waste produced by illegal drug laboratories. In formulating
such program, the Task Force shall consider the following factors:
''(1) The volume of hazardous waste produced by illegal drug
laboratories.
''(2) The cost of cleaning up and disposing of hazardous waste
produced by illegal drug laboratories.
''(3) The effectiveness of the various methods of cleaning up and
disposing of hazardous waste produced by illegal drug laboratories.
''(4) The coordination of the efforts of the Environmental Protection
Agency and the Drug Enforcement Administration in cleaning up and
disposing of hazardous waste produced by illegal drug laboratories.
''(5) The dissemination of information to law enforcement agencies
that have responsibility for enforcement of drug laws.
''(d) Guidelines. -- The Task Force shall recommend to the
Administrators guidelines for cleanup of illegal drug laboratories to
protect the public health and environment. Not later than 180 days
after the date of the enactment of this subtitle (Nov. 18, 1988), the
Administrators shall formulate and publish such guidelines.
''(e) Demonstration Projects. --
''(1) The Attorney General shall make grants to, and enter into
contracts with, State and local governments for demonstration projects
to clean up and safely dispose of substances associated with illegal
drug laboratories which may present a danger to public health or the
environment.
''(2) The Attorney General may not under this subsection make a grant
or enter into a contract unless the applicant for such assistance agrees
to comply with the guidelines issued pursuant to subsection (d).
''(3) The Attorney General shall, through grant or contract, provide
for independent evaluations of the activities carried out pursuant to
this subsection and shall recommend appropriate legislation to the
Congress.
''(f) Funding. -- Of the amounts made available to carry out the
Controlled Substances Act (21 U.S.C. 801 et seq.) for fiscal year 1989,
not less than $5,000,000 shall be made available to carry out
subsections (d) and (e).
''(g) Reports. -- After consultation with the Task Force, the
Administrators shall --
''(1) transmit to the President and to each House of Congress not
later than 270 days after the date of the enactment of this subtitle
(Nov. 18, 1988) a report describing the program established by the Task
Force under subsection (c) (including an analysis of the factors
specified in paragraphs (1) through (5) of that subsection);
''(2) periodically transmit to the President and to each House of
Congress reports describing the implementation of the program
established by the Task Force under subsection (c) (including an
analysis of the factors specified in paragraphs (1) through (5) of that
subsection) and the progress made in the cleanup and disposal of
hazardous waste produced by illegal drug laboratories; and
''(3) transmit to each House of Congress a report describing the
findings made as a result of the evaluations referred to in subsection
(e)(3).''
Pub. L. 100-690, title VII, 7404, Nov. 18, 1988, 102 Stat. 4484,
provided that:
''(a) Interagency Agreement. -- The Secretary of Transportation and
the Secretary of the Treasury shall enter into an agreement for the
purpose of increasing the effectiveness of maritime drug interdiction
activities of the Coast Guard and the Customs Service in the Great Lakes
area.
''(b) Negotiations With Canada on Drug Enforcement Cooperation. --
The Secretary of State is encouraged to enter into negotiations with
appropriate officials of the Government of Canada for the purpose of
establishing an agreement between the United States and Canada which
provides for increased cooperation and sharing of information between
United States and Canadian law enforcement officials with respect to law
enforcement efforts conducted on the Great Lakes between the United
States and Canada.''
Pub. L. 100-180, div. A, title XII, 1241, Dec. 4, 1987, 101 Stat.
1162, provided that:
''(a) Study Requirement. -- The Comptroller General of the United
States shall conduct a comprehensive study regarding smuggling of
illegal drugs into the United States and the current capabilities of the
United States to deter such smuggling. In carrying out such study, the
Comptroller General shall --
''(1) assess the national security implications of the smuggling of
illegal drugs into the United States;
''(2) assess the magnitude, nature, and operational impact that
current resource limitations have on the drug smuggling interdiction
efforts of Federal law enforcement agencies and the capability of the
Department of Defense to respond to requests for assistance from those
law enforcement agencies;
''(3) assess the effect on military readiness, the costs that would
be incurred, the operational effects on military and civilian agencies,
the potential for improving drug interdiction operations, and the
methods for implementing increased drug law enforcement assistance by
the Department of Defense under section 825 of H.R. 1748 as passed the
House of Representatives on May 20, 1987, as if such section were
enacted into law and were to become effective on January 1, 1988;
''(4) assess results of a cooperative drug enforcement operation
between the United States Customs Service and National Guard units from
the States of Arizona, Utah, Missouri, and Wisconsin conducted along the
United States-Mexico border beginning on August 29, 1987, and include in
the assessment information relating to the cost of conducting the
operation, the personnel and equipment used in such operation, the
command and control relationships in such operation, and the legal
issues involved in such operation;
''(5) determine whether giving the Armed Forces a more direct, active
role in drug interdiction activities would enhance the morale and
readiness of the Armed Forces;
''(6) determine what assets are currently available to and under
consideration for the Department of Defense, the Department of
Transportation, the Department of Justice, and the Department of the
Treasury for the detection of airborne drug smugglers;
''(7) assess the current plan of the Customs Service for the
coordinated use of such assets;
''(8) determine the cost effectiveness and the capability of the
Customs Service to use effectively the information generated by the
systems employed by or planned for the Department of Defense, the Coast
Guard, and the Customs Service, respectively, to detect airborne drug
smugglers;
''(9) determine the availability of current and anticipated tracking,
pursuit, and apprehension resources to use the capabilities of such
systems; and
''(10) at a minimum, assess the detection capabilities of the
Over-the-Horizon Backscatter radar (OTH-B), ROTHR, aerostats, airships,
and the E-3A, E-2C, P-3, and P-3 Airborne Early Warning aircraft
(including any variant of the P-3 Airborne Early Warning aircraft).
''(b) Reports. -- (1) Not later than April 30, 1988, the Comptroller
General shall, as provided in paragraph (3), submit a report on the
results of the study required by subsection (a) with respect to the
elements of the study specified in paragraphs (1) through (5) of that
subsection.
''(2) As soon as practicable after the report under paragraph (1) is
submitted, and not later than March 31, 1989, the Comptroller General
shall, as provided in paragraph (3), submit a report on the results of
the study required by subsection (a) with respect to the elements of the
study specified in paragraphs (6) through (10) of that subsection.
''(3) The reports under paragraphs (1) and (2) shall be submitted to
--
''(A) the Committees on Armed Services, the Judiciary, Foreign
Relations, and Appropriations of the Senate;
''(B) the Committees on Armed Services, the Judiciary, Foreign
Affairs, and Appropriations of the House of Representatives;
''(C) the members of the Senate Caucus on International Narcotics
Control; and
''(D) the Select Committee on Narcotics Abuse and Control of the
House of Representatives.
''(4) The reports under this subsection shall be submitted in both
classified and unclassified forms and shall include such comments and
recommendations as the Comptroller General considers appropriate.''
Pub. L. 99-570, 3, Oct. 27, 1986, 100 Stat. 3207-1, provided that:
''Notwithstanding any other provision of this Act (see Tables for
classification), any spending authority and any credit authority
provided under this Act shall be effective for any fiscal year only to
such extent or in such amounts as are provided in appropriation Acts.
For purposes of this Act, the term 'spending authority' has the meaning
provided in section 401(c)(2) of the Congressional Budget Act of 1974 (2
U.S.C. 651(c)(2)) and the term 'credit authority' has the meaning
provided in section 3(10) of the Congresssional Budget Act of 1974 (2
U.S.C. 622(10)).''
Pub. L. 99-570, title III, 3001-3003, 3301, Oct. 27, 1986, 100 Stat.
3207-73, 3207-74, 3207-98, provided that:
''SEC. 3001. SHORT TITLE.
''This title (enacting section 379 of Title 10, Armed Forces,
sections 1590, 1628, 1629, and 2081 of Title 19, Customs Duties, and
section 312a of Title 47, Telegraphs, Telephones, and Radiotelegraphs,
amending section 959 of this title, sections 374 and 911 of Title 10,
sections 507, 1401, 1433, 1436, 1454, 1459, 1497, 1509, 1584 to 1586,
1594 to 1595a, 1613, 1613b, 1619, and 1622 of Title 19, section 5316 of
Title 31, Money and Finance, section 12109 of Title 46, Shipping,
sections 1901 to 1904 of Title 46, Appendix, Shipping, and sections
1401, 1472, 1474, and 1509 of Title 49, Appendix, Transportation,
repealing section 1460 of Title 19, enacting provisions set out as notes
under section 801 of this title, sections 371, 374, 525, and 9441 of
Title 10, sections 1613b and 1654 of Title 19, section 403 of Title 23,
Highways, section 1901 of Title 46, Appendix, section 11344 of Title 49,
and section 1509 of Title 49, Appendix, and repealing provisions set out
as a note under section 89 of Title 14, Coast Guard) may be cited as the
'National Drug Interdiction Improvement Act of 1986'.
''SEC. 3002. FINDINGS.
''The Congress hereby finds that --
''(1) a balanced, coordinated, multifaceted strategy for combating
the growing drug abuse and drug trafficking problem in the United States
is essential in order to stop the flow and abuse of drugs within our
borders;
''(2) a balanced, coordinated, multifaceted strategy for combating
the narcotics drug abuse and trafficking in the United States should
include --
''(A) increased investigations of large networks of drug smuggler
organizations;
''(B) source country drug eradication;
''(C) increased emphasis on stopping narcotics traffickers in
countries through which drugs are transshipped;
''(D) increased emphasis on drug education programs in the schools
and workplace;
''(E) increased Federal Government assistance to State and local
agencies, civic groups, school systems, and officials in their efforts
to combat the drug abuse and trafficking problem at the local level;
and
''(F) increased emphasis on the interdiction of drugs and drug
smugglers at the borders of the United States, in the air, at sea, and
on the land;
''(3) funds to support the interdiction of narcotics smugglers who
threaten the transport of drugs through the air, on the sea, and across
the land borders of the United States should be emphasized in the
Federal Government budget process to the same extent as the other
elements of a comprehensive antidrug effort are emphasized;
''(4) the Department of Defense and the use of its resources should
be an integral part of a comprehensive, natonal (national) drug
interdiction program;
''(5) the Federal Government civilian agencies engaged in drug
interdiction, particularly the United States Customs Service and the
Coast Guard, currently lack the aircraft, ships, radar, command,
control, communications, and intelligence (C3I) system, and manpower
resources necessary to mount a comprehensive attack on the narcotics
traffickers who threaten the United States;
''(6) the civilian drug interdiction agencies of the United States
are currently interdicting only a small percentage of the illegal, drug
smuggler penetrations in the United States every year;
''(7) the budgets for our civilian drug interdiction agencies,
primarily the United States Customs Service and the Coast Guard, have
not kept pace with those of the traditional investigative law
enforcement agencies of the Department of Justice; and
''(8) since the amendment of the Posse Comitatus Act (18 U.S.C.
1385) in 1981, the Department of Defense has assisted in the effort to
interdict drugs, but they can do more.
''SEC. 3003. PURPOSES.
''It is the purpose of this title --
''(1) to increase the level of funding and resources available to
civilian drug interdiction agencies of the Federal Government;
''(2) to increase the level of support from the Department of Defense
as consistent with the Posse Comitatus Act (18 U.S.C. 1385), for
interdiction of the narcotics traffickers before such traffickers
penetrate the borders of the United States; and
''(3) to improve other drug interdiction programs of the Federal
Government.
''SEC. 3301. ESTABLISHMENT OF A UNITED STATES-BAHAMAS DRUG
INTERDICTION TASK FORCE
''(a) Authorization of Appropriations. --
''(1) Establishment of a united states-bahamas drug interdiction task
force. -- (A) There is authorized to be established a United
States-Bahamas Drug Interdiction Task Force to be operated jointly by
the United States Government and the Government of the Bahamas.
''(B) The Secretary of State, the Commandant of the Coast Guard, the
Commissioner of Customs, the Attorney General, and the head of the
National Narcotics Border Interdiction System (NNBIS), shall upon
enactment of this Act (Oct. 27, 1986), immediately commence negotiations
with the Government of the Bahamas to enter into a detailed agreement
for the establishment and operation of a new drug interdiction task
force, including plans for (i) the joint operation and maintenance of
any drug interdiction assets authorized for the task force in this
section and section 3141 (see 19 U.S.C. 2075), and (ii) any training and
personnel enhancements authorized in this section and section 3141.
''(C) The Attorney General shall report to the appropriate committees
of Congress on a quarterly basis regarding the progress of the United
States- Bahamas Drug Interdiction Task Force.
''(2) Amounts authorized. -- There are authorized to be appropriated,
in addition to any other amounts authorized to be appropriated in this
title (see section 3001 of Pub. L. 99-570 set out above), $10,000,000
for the following:
''(A) $9,000,000 for 3 drug interdiction pursuit helicopters for use
primarily for operations of the United States-Bahamas Drug Interdiction
Task Force established under this section; and
''(B) $1,000,000 to enhance communications capabilities for the
operation of a United States- Bahamas Drug Interdiction Task Force
established under this section.
''(3) Coast guard-bahamas drug interdiction docking facility. -- (A)
There is authorized to be appropriated for acquisition, construction,
and improvements for the Coast Guard for fiscal year 1987, $5,000,000,
to be used for initial design engineering, and other activities for
construction of a drug interdiction docking facility in the Bahamas to
facilitate Coast Guard and Bahamian drug interdiction operations in and
through the Bahama Islands. Of the amounts authorized to be
appropriated in this subsection, such sums as may be necessary shall be
available for necessary communication and air support.
''(B) The Commandant of the Coast Guard shall use such amounts
appropriated pursuant to the authorization in this paragraph as may be
necessary to establish a repair, maintenance, and boat lift facility to
provide repair and maintenance services for both Coast Guard and
Bahamian marine drug interdiction equipment, vessels, and related
assets.
''(b) Concurrence by Secretary of State. -- Programs authorized by
this section may be carried out only with the concurrence of the
Secretary of State.''
Pub. L. 99-570, title IV, 4303, Oct. 27, 1986, 100 Stat. 3207-154,
provided that:
''(a) The Secretary of Labor shall collect such information as is
available on the incidence of drug abuse in the workplace and efforts to
assist workers, including counseling, rehabilitation and employee
assistance programs. The Secretary shall conduct such additional
research as is necessary to assess the impact and extent of drug abuse
and remediation efforts. The Secretary shall submit the findings of
such collection and research to the House Committee on Education and
Labor and the Senate Committee on Labor and Human Services no later than
two years from the date of enactment of this Act (Oct. 27, 1986).
''(b) There is authorized to be appropriated the aggregate sum of
$3,000,000 for fiscal years 1987 and 1988, to remain available until
expended, to enable the Secretary of Labor to carry out the purposes of
this section.''
Pub. L. 99-570, title IV, 4304, Oct. 27, 1986, 100 Stat. 3207-154,
provided that:
''(a) The Secretary of Education, the Secretary of Health and Human
Services, and the Secretary of Labor shall each designate an officer or
employee of the Departments of Education, Health and Human Services, and
Labor, respectively, to coordinate interagency drug abuse prevention
activities to prevent duplication of effort.
''(b) Within one year after enactment of this Act (Oct. 27, 1986), a
report shall be jointly submitted to the Congress by such Secretaries
concerning the extent to which States and localities have been able to
implement non-duplicative drug abuse prevention activities.''
Pub. L. 99-570, title VI, 6005, Oct. 27, 1986, 100 Stat. 3207-160,
as amended by Pub. L. 100-690, title II, 2058(c), Nov. 18, 1988, 102
Stat. 4214, provided that:
''(a) Study. -- The Secretary of Health and Human Services shall
contract with the Institute of Medicine of the National Academy of
Sciences to conduct a study of (1) the extent to which the cost of drug
abuse treatment is covered by private insurance, public programs, and
other sources of payment, and (2) the adequacy of such coverage for the
rehabilitation of drug abusers.
''(b) Report. -- Not later than 18 months after the execution of the
contract referred to in subsection (a), the Secretary of Health and
Human Services shall transmit to the Congress a report of the results of
the study conducted under subsection (a). The report shall include
recommendations of means to meet the needs identified in such study.''
Pub. L. 99-570, title VI, 6006, Oct. 27, 1986, 100 Stat. 3207-160,
provided that:
''(a) Findings. -- The Congress finds that --
''(1) drug and alcohol abuse are problems of grave concern and
consequence in American society;
''(2) over 500,000 individuals are known heroin addicts; 5 million
individuals use cocaine; and at least 7 million individuals regularly
use prescription drugs, mostly addictive ones, without medical
supervision;
''(3) 10 million adults and 3 million children and adolescents abuse
alcohol, and an additional 30 to 40 million people are adversely
affected because of close family ties to alcoholics;
''(4) the total cost of drug abuse to the Nation in 1983 was over
$60,000,000,000; and
''(5) the vast majority of health benefits plans provide only limited
coverage for treatment of drug and alcohol addiction, which is a fact
that can discourage the abuser from seeking treatment or, if the abuser
does seek treatment, can cause the abuser to face significant out of
pocket expenses for the treatment.
''(b) Sense of Congress. -- It is the sense of Congress that --
''(1) all employers providing health insurance policies should ensure
that the policies provide adequate coverage for treatment of drug and
alcohol addiction in recognition that the health consequences and costs
for individuals and society can be as formidable as those resulting from
other diseases and illnesses for which insurance coverage is much more
adequate; and
''(2) State insurance commissioners should encourage employers
providing health benefits plans to ensure that the policies provide more
adequate coverage for treatment of drug and alcohol addiction.''
Section 601 of Pub. L. 91-513, as amended by Pub. L. 92-13, May 14,
1971, 85 Stat. 37, provided that:
''(a) (Establishment; composition) There is established a commission
to be known as the Commission on Marihuana and Drug Abuse (hereafter in
this section referred to as the 'Commission'). The Commission shall be
composed of --
''(1) two Members of the Senate appointed by the President of the
Senate;
''(2) two Members of the House of Representatives appointed by the
Speaker of the House of Representatives; and
''(3) nine members appointed by the President of the United States.
At no time shall more than one of the members appointed under
paragraph (1), or more than one of the members appointed under paragraph
(2), or more than five of the members appointed under paragraph (3) be
members of the same political party.
''(b) (Chairman; Vice Chairman; compensation of members; meetings)
(1) The President shall designate one of the members of the Commission
as Chairman and one as Vice Chairman. Seven members of the Commission
shall constitute a quorum, but a lesser number may conduct hearings.
''(2) Members of the Commission who are Members of Congress or
full-time officers or employees of the United States shall serve without
additional compensation but shall be reimbursed for travel, subsistence,
and other necessary expenses incurred in the performance of the duties
vested in the Commission. Members of the Commission from private life
shall receive $100 per diem while engaged in the actual performance of
the duties vested in the Commission, plus reimbursement for travel,
subsistence, and other necessary expenses incurred in the performance of
such duties.
''(3) The Commission shall meet at the call of the Chairman or at the
call of a majority of the members thereof.
''(c) (Personnel; experts; information from departments and
agencies) (1) The Commission shall have the power to appoint and fix the
compensation of such personnel as it deems advisable, without regard to
the provisions of title 5, United States Code, governing appointments in
the competitive service, and the provisions of chapter 51 and subchapter
III of chapter 53 of such title, relating to classification and General
Schedule pay rates.
''(2) The Commission may procure, in accordance with the provisions
of section 3109 of title 5, United States Code, the temporary or
intermittent services of experts or consultants. Persons so employed
shall receive compensation at a rate to be fixed by the Commission, but
not in excess of $75 per diem, including traveltime. While away from his
home or regular place of business in the performance of services for the
Commission, any such person may be allowed travel expenses, including
per diem in lieu of subsistence, as authorized by section 5703(b) of
title 5, United States Code, for persons in the Government service
employed intermittently.
''(3) The Commission may secure directly from any department or
agency of the United States information necessary to enable it to carry
out its duties under this section. Upon request of the Chairman of the
Commission, such department or agency shall furnish such information to
the Commission.
''(d) (Marihuana study; report to the President and the Congress)
(1) The Commission shall conduct a study of marihuana including, but not
limited to, the following areas:
''(A) the extent of use of marihuana in the United States to include
its various sources of users, number of arrests, number of convictions,
amount of marihuana seized, type of user, nature of use;
''(B) an evaluation of the efficacy of existing marihuana laws;
''(C) a study of the pharmacology of marihuana and its immediate and
long-term effects, both physiological and psychological;
''(D) the relationship of marihuana use to aggressive behavior and
crime;
''(E) the relationship between marihuana and the use of other drugs;
and
''(F) the international control of marihuana.
''(2) Within one year after the date on which funds first become
available to carry out this section, the Commission shall submit to the
President and the Congress a comprehensive report on its study and
investigation under this subsection which shall include its
recommendations and such proposals for legislation and administrative
action as may be necessary to carry out its recommendations.
''(e) (Study and investigation of causes of drug abuse; report to
the President and the Congress; termination of Commission) The
Commission shall conduct a comprehensive study and investigation of the
causes of drug abuse and their relative significance. The Commission
shall submit to the President and the Congress such interim reports as
it deems advisable and shall within two years after the date on which
funds first become available to carry out this section submit to the
President and the Congress a final report which shall contain a detailed
statement of its findings and conclusions and also such recommendations
for legislation and administrative actions as it deems appropriate. The
Commission shall cease to exist sixty days after the final report is
submitted under this subsection.
''(f) (Limitation on expenditures) Total expenditures of the
Commission shall not exceed $4,000,000.''
Ex. Ord. No. 11599, June 17, 1971, 36 F.R. 11793, which established
the Special Action Office for Drug Abuse Prevention, was superseded.
See Prior Provisions notes set out under section 1111 of this title.
Ex. Ord. No. 11641, Jan. 28, 1972, 37 F.R. 2421, which established
the Office for Drug Abuse Law Enforcement, was revoked by Ex. Ord. No.
11727, July 6, 1973, 38 F.R. 18357, set out as a note under this
section.
Ex. Ord. No. 11676, July 27, 1972, 37 F.R. 15125, which established
the Office of National Narcotics Intelligence, was revoked by Ex. Ord.
No. 11727, July 6, 1973, 38 F.R. 18357, set out as a note under this
section.
Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, provided:
Reorganization Plan No. 2 of 1973 (set out in the Appendix to Title
5, Government Organization and Employees), which becomes effective on
July 1, 1973, among other things establishes a Drug Enforcement
Administration in the Department of Justice. In my message to the
Congress transmitting that plan, I stated that all functions of the
Office for Drug Abuse Law Enforcement (established pursuant to Executive
Order No. 11641 of January 28, 1972) and the Office of National
Narcotics Intelligence (established pursuant to Executive Order No.
11676 of July 27, 1972) would, together with other related functions, be
merged in the new Drug Enforcement Administration.
NOW, THEREFORE, by virtue of the authority vested in me by the
Constitution and laws of the United States, including section 5317 of
title 5 of the United States Code, as amended, it is hereby ordered as
follows:
Section 1. The Attorney General, to the extent permitted by law, is
authorized to coordinate all activities of executive branch departments
and agencies which are directly related to the enforcement of laws
respecting narcotics and dangerous drugs. Each department and agency of
the Federal Government shall, upon request and to the extent permitted
by law, assist the Attorney General in the performance of functions
assigned to him pursuant to this order, and the Attorney General may, in
carrying out those functions, utilize the services of any other
agencies, Federal and State, as may be available and appropriate.
Sec. 2. Executive Order No. 11641 of January 28, 1972, is revoked
and the Attorney General shall provide for the reassignment of the
functions of the Office for Drug Abuse Law Enforcement and for the
abolishment of that Office.
Sec. 3. Executive Order No. 11676 of July 27, 1972, is hereby
revoked and the Attorney General shall provide for the reassignment of
the functions of the Office of National Narcotics Intelligence and for
the abolishment of that Office.
Sec. 4. Section 1 of Executive Order No. 11708 of March 23, 1973, as
amended (set out as a note under section 5317 of Title 5, Government
Organization and Employees), placing certain positions in level IV of
the Executive Schedule is hereby further amended by deleting --
(1) ''(6) Director, Office for Drug Abuse Law Enforcement, Department
of Justice.''; and
(2) ''(7) Director, Office of National Narcotics Intelligence,
Department of Justice.''
Sec. 5. The Attorney General shall provide for the winding up of the
affairs of the two offices and for the reassignment of their functions.
Sec. 6. This order shall be effective as of July 1, 1973.
Richard Nixon.
21 USC 801a. Congressional findings and declarations: psychotropic
substances
TITLE 21 -- FOOD AND DRUGS
The Congress makes the following findings and declarations:
(1) The Congress has long recognized the danger involved in the
manufacture, distribution, and use of certain psychotropic substances
for nonscientific and nonmedical purposes, and has provided strong and
effective legislation to control illicit trafficking and to regulate
legitimate uses of psychotropic substances in this country. Abuse of
psychotropic substances has become a phenomenon common to many
countries, however, and is not confined to national borders. It is,
therefore, essential that the United States cooperate with other nations
in establishing effective controls over international traffic in such
substances.
(2) The United States has joined with other countries in executing an
international treaty, entitled the Convention on Psychotropic Substances
and signed at Vienna, Austria, on February 21, 1971, which is designed
to establish suitable controls over the manufacture, distribution,
transfer, and use of certain psychotropic substances. The Convention is
not self-executing, and the obligations of the United States thereunder
may only be performed pursuant to appropriate legislation. It is the
intent of the Congress that the amendments made by this Act, together
with existing law, will enable the United States to meet all of its
obligations under the Convention and that no further legislation will be
necessary for that purpose.
(3) In implementing the Convention on Psychotropic Substances, the
Congress intends that, consistent with the obligations of the United
States under the Convention, control of psychotropic substances in the
United States should be accomplished within the framework of the
procedures and criteria for classification of substances provided in the
Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U. S.C.
801 et seq.). This will insure that (A) the availability of psychotropic
substances to manufacturers, distributors, dispensers, and researchers
for useful and legitimate medical and scientific purposes will not be
unduly restricted; (B) nothing in the Convention will interfere with
bona fide research activities; and (C) nothing in the Convention will
interfere with ethical medical practice in this country as determined by
the Secretary of Health and Human Services on the basis of a consensus
of the views of the American medical and scientific community.
(Pub. L. 95-633, title I, 101, Nov. 10, 1978, 92 Stat. 3768; Pub.
L. 96-88, title V, 509(b), Oct. 17, 1979, 93 Stat. 695.)
This Act, referred to in par. (2), is Pub. L. 95-633, Nov. 10,
1978, 92 Stat. 2768, as amended, known as the Psychotropic Substances
Act of 1978, which enacted sections 801a, 830, and 852 of this title,
amended sections 352, 802, 811, 812, 823, 827, 841 to 843, 872, 881,
952, 953, and 965 of this title and section 242a of Title 42, The Public
Health and Welfare, repealed section 830 of this title effective Jan.
1, 1981, and enacted provisions set out as notes under sections 801,
801a, 812, and 830 of this title. For complete classification of this
Act to the Code, see Short Title of 1978 Amendment note set out under
section 801 of this title and Tables.
The Comprehensive Drug Abuse Prevention and Control Act of 1970,
referred to in par. (3), is Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
1236, as amended, which is classified principally to this chapter ( 801
et seq.). For complete classification of this Act to the Code, see Short
Title note set out under section 801 of this title and Tables.
Section was enacted as a part of the Psychotropic Substances Act of
1978, and not as a part of the Controlled Substances Act which comprises
this subchapter.
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in par. (3) pursuant to
section 509(b) of Pub. L. 96-88, which is classified to section 3508(b)
of Title 20, Education.
Section 112 of title I of Pub. L. 95-633 provided that: ''This
title (enacting this section and section 852 of this title, amending
sections 352, 802, 811, 812, 823, 827, 872, 952, and 953 of this title
and section 242a of Title 42, The Public Health and Welfare, and
enacting provisions set out as notes under sections 801 and 812 of this
title) and the amendments made by this title shall take effect on the
date the Convention on Psychotropic Substances, signed at Vienna,
Austria on February 21, 1971, enters into force in respect to the United
States.'' (The Convention entered into force in respect to the United
States on July 15, 1980.)
21 USC 802. Definitions
TITLE 21 -- FOOD AND DRUGS
As used in this subchapter:
(1) The term ''addict'' means any individual who habitually uses any
narcotic drug so as to endanger the public morals, health, safety, or
welfare, or who is so far addicted to the use of narcotic drugs as to
have lost the power of self-control with reference to his addiction.
(2) The term ''administer'' refers to the direct application of a
controlled substance to the body of a patient or research subject by --
(A) a practitioner (or, in his presence, by his authorized agent), or
(B) the patient or research subject at the direction and in the
presence of the practitioner,
whether such application be by injection, inhalation, ingestion, or
any other means.
(3) The term ''agent'' means an authorized person who acts on behalf
of or at the direction of a manufacturer, distributor, or dispenser;
except that such term does not include a common or contract carrier,
public warehouseman, or employee of the carrier or warehouseman, when
acting in the usual and lawful course of the carrier's or warehouseman's
business.
(4) The term ''Drug Enforcement Administration'' means the Drug
Enforcement Administration in the Department of Justice.
(5) The term ''control'' means to add a drug or other substance, or
immediate precursor, to a schedule under part B of this subchapter,
whether by transfer from another schedule or otherwise.
(6) The term ''controlled substance'' means a drug or other
substance, or immediate precursor, included in schedule I, II, III, IV,
or V of part B of this subchapter. The term does not include distilled
spirits, wine, malt beverages, or tobacco, as those terms are defined or
used in subtitle E of the Internal Revenue Code of 1986.
(7) The term ''counterfeit substance'' means a controlled substance
which, or the container or labeling of which, without authorization,
bears the trademark, trade name, or other identifying mark, imprint,
number, or device, or any likeness thereof, of a manufacturer,
distributor, or dispenser other than the person or persons who in fact
manufactured, distributed, or dispensed such substance and which thereby
falsely purports or is represented to be the product of, or to have been
distributed by, such other manufacturer, distributor, or dispenser.
(8) The terms ''deliver'' or ''delivery'' mean the actual,
constructive, or attempted transfer of a controlled substance or a
listed chemical, whether or not there exists an agency relationship.
(9) The term ''depressant or stimulant substance'' means --
(A) a drug which contains any quantity of (i) barbituric acid or any
of the salts of barbituric acid; or (ii) any derivative of barbituric
acid which has been designated by the Secretary as habit forming under
section 352(d) of this title; or
(B) a drug which contains any quantity of (i) amphetamine or any of
its optical isomers; (ii) any salt of amphetamine or any salt of an
optical isomer of amphetamine; or (iii) any substance which the
Attorney General, after investigation, has found to be, and by
regulation designated as, habit forming because of its stimulant effect
on the central nervous systems; or
(C) lysergic acid diethylamide; or
(D) any drug which contains any quantity of a substance which the
Attorney General, after investigation, has found to have, and by
regulation designated as having, a potential for abuse because of its
depressant or stimulant effect on the central nervous system or its
hallucinogenic effect.
(10) The term ''dispense'' means to deliver a controlled substance to
an ultimate user or research subject by, or pursuant to the lawful order
of, a practitioner, including the prescribing and administering of a
controlled substance and the packaging, labeling or compounding
necessary to prepare the substance for such delivery. The term
''dispenser'' means a practitioner who so delivers a controlled
substance to an ultimate user or research subject.
(11) The term ''distribute'' means to deliver (other than by
administering or dispensing) a controlled substance or a listed
chemical. The term ''distributor'' means a person who so delivers a
controlled substance or a listed chemical.
(12) The term ''drug'' has the meaning given that term by section
321(g)(1) of this title.
(13) The term ''felony'' means any Federal or State offense
classified by applicable Federal or State law as a felony.
(14) The term ''isomer'' means the optical isomer, except as used in
schedule I(c) and schedule II(a)(4). As used in schedule I(c), the term
''isomer'' means any optical, positional, or geometric isomer. As used
in schedule II(a)(4), the term ''isomer'' means any optical or geometric
isomer.
(15) The term ''manufacture'' means the production, preparation,
propagation, compounding, or processing of a drug or other substance,
either directly or indirectly or by extraction from substances of
natural origin, or independently by means of chemical synthesis or by a
combination of extraction and chemical synthesis, and includes any
packaging or repackaging of such substance or labeling or relabeling of
its container; except that such term does not include the preparation,
compounding, packaging, or labeling of a drug or other substance in
conformity with applicable State or local law by a practitioner as an
incident to his administration or dispensing of such drug or substance
in the course of his professional practice. The term ''manufacturer''
means a person who manufactures a drug or other substance.
(16) The term ''marihuana'' means all parts of the plant Cannabis
sativa L., whether growing or not; the seeds thereof; the resin
extracted from any part of such plant; and every compound, manufacture,
salt, derivative, mixture, or preparation of such plant, its seeds or
resin. Such term does not include the mature stalks of such plant,
fiber produced from such stalks, oil or cake made from the seeds of such
plant, any other compound, manufacture, salt, derivative, mixture, or
preparation of such mature stalks (except the resin extracted
therefrom), fiber, oil, or cake, or the sterilized seed of such plant
which is incapable of germination.
(17) The term ''narcotic drug'' means any of the following whether
produced directly or indirectly by extraction from substances of
vegetable origin, or independently by means of chemical synthesis, or by
a combination of extraction and chemical synthesis:
(A) Opium, opiates, derivatives of opium and opiates, including their
isomers, esters, ethers, salts, and salts of isomers, esters, and
ethers, whenever the existence of such isomers, esters, ethers, and
salts is possible within the specific chemical designation. Such term
does not include the isoquinoline alkaloids of opium.
(B) Poppy straw and concentrate of poppy straw.
(C) Coca leaves, except coca leaves and extracts of coca leaves from
which cocaine, ecgonine, and derivatives of ecgonine or their salts have
been removed.
(D) Cocaine, its salts, optical and geometric isomers, and salts of
isomers.
(E) Ecgonine, its derivatives, their salts, isomers, and salts of
isomers.
(F) Any compound, mixture, or preparation which contains any quantity
of any of the substances referred to in subparagraphs (A) through (E).
(18) The term ''opiate'' means any drug or other substance having an
addiction-forming or addiction-sustaining liability similar to morphine
or being capable of conversion into a drug having such addiction-forming
or addiction-sustaining liability.
(19) The term ''opium poppy'' means the plant of the species Papaver
somniferum L., except the seed thereof.
(20) The term ''poppy straw'' means all parts, except the seeds, of
the opium poppy, after mowing.
(21) The term ''practitioner'' means a physician, dentist,
veterinarian, scientific investigator, pharmacy, hospital, or other
person licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices or does research, to
distribute, dispense, conduct research with respect to, administer, or
use in teaching or chemical analysis, a controlled substance in the
course of professional practice or research.
(22) The term ''production'' includes the manufacture, planting,
cultivation, growing, or harvesting of a controlled substance.
(23) The term ''immediate precursor'' means a substance --
(A) which the Attorney General has found to be and by regulation
designated as being the principal compound used, or produced primarily
for use, in the manufacture of a controlled substance;
(B) which is an immediate chemical intermediary used or likely to be
used in the manufacture of such controlled substance; and
(C) the control of which is necessary to prevent, curtail, or limit
the manufacture of such controlled substance.
(24) The term ''Secretary'', unless the context otherwise indicates,
means the Secretary of Health and Human Services.
(25) The term ''serious bodily injury'' means bodily injury which
involves --
(A) a substantial risk of death;
(B) protracted and obvious disfigurement; or
(C) protracted loss or impairment of the function of a bodily member,
organ, or mental faculty.
(26) The term ''State'' means any State, territory, or possession of
the United States, the District of Columbia, the Commonwealth of Puerto
Rico, the Trust Territory of the Pacific Islands, and the Canal Zone.
(27) The term ''ultimate user'' means a person who has lawfully
obtained, and who possesses, a controlled substance for his own use or
for the use of a member of his household or for an animal owned by him
or by a member of his household.
(28) The term ''United States'', when used in a geographic sense,
means all places and waters, continental or insular, subject to the
jurisdiction of the United States.
(29) The term ''maintenance treatment'' means the dispensing, for a
period in excess of twenty-one days, of a narcotic drug in the treatment
of an individual for dependence upon heroin or other morphine-like
drugs.
(30) The term ''detoxification treatment'' means the dispensing, for
a period not in excess of one hundred and eighty days, of a narcotic
drug in decreasing doses to an individual in order to alleviate adverse
physiological or psychological effects incident to withdrawal from the
continuous or sustained use of a narcotic drug and as a method of
bringing the individual to a narcotic drug-free state within such
period.
(31) The term ''Convention on Psychotropic Substances'' means the
Convention on Psychotropic Substances signed at Vienna, Austria, on
February 21, 1971; and the term ''Single Convention on Narcotic Drugs''
means the Single Convention on Narcotic Drugs signed at New York, New
York, on March 30, 1961.
(32)(A) Except as provided in subparagraph (B), the term ''controlled
substance analogue'' means a substance --
(i) the chemical structure of which is substantially similar to the
chemical structure of a controlled substance in schedule I or II;
(ii) which has a stimulant, depressant, or hallucinogenic effect on
the central nervous system that is substantially similar to or greater
than the stimulant, depressant, or hallucinogenic effect on the central
nervous system of a controlled substance in schedule I or II; or
(iii) with respect to a particular person, which such person
represents or intends to have a stimulant, depressant, or hallucinogenic
effect on the central nervous system that is substantially similar to or
greater than the stimulant, depressant, or hallucinogenic effect on the
central nervous system of a controlled substance in schedule I or II.
(B) Such term does not include --
(i) a controlled substance;
(ii) any substance for which there is an approved new drug
application;
(iii) with respect to a particular person any substance, if an
exemption is in effect for investigational use, for that person, under
section 355 of this title to the extent conduct with respect to such
substance is pursuant to such exemption; or
(iv) any substance to the extent not intended for human consumption
before such an exemption takes effect with respect to that substance.
(33) The term ''listed chemical'' means any listed precursor chemical
or listed essential chemical.
(34) The term ''listed precursor chemical'' means a chemical
specified by regulation of the Attorney General as a chemical that is
used in manufacturing a controlled substance in violation of this
subchapter and is critical to the creation of the controlled substances,
and such term includes (until otherwise specified by regulation of the
Attorney General, as considered appropriate by the Attorney General or
upon petition to the Attorney General by any person) the following:
(A) Anthranilic acid and its salts.
(B) Benzyl cyanide.
(C) Ephedrine, its salts, optical isomers, and salts of optical
isomers.
(D) Ergonovine and its salts.
(E) Ergotamine and its salts.
(F) N-Acetylanthranilic acid and its salts.
(G) Norpseudoephedrine, its salts, optical isomers, and salts of
optical isomers.
(H) Phenylacetic acid and its salts.
(I) Phenylpropanolamine, its salts, optical isomers, and salts of
optical isomers.
(J) Piperidine and its salts.
(K) Pseudoephedrine, its salts, optical isomers, and salts of optical
isomers.
(L) 3,4-Methylenedioxyphenyl-2-propanone.
(M) Methylamine.
(N) Ethylamine.
(O) D-lysergic acid.
(P) Propionic anhydride.
(Q) Insosafrole.
(R) Safrole.
(S) Piperonal.
(T) N-Methylepherdrine. /1/
(U) N-ethylephedrine.
(V) N-methylpseudoephedrine.
(W) N-ethylpseudoephedrine.
(X) Hydriotic acid.
(Y) Any salt, optical isomer, or salt of an optical isomer of the
chemicals listed in subparagraphs (M) through (X) of this paragraph.
(35) The term ''listed essential chemical'' means a chemical
specified by regulation of the Attorney General as a chemical that is
used as a solvent, reagent, or catalyst in manufacturing a controlled
substance in violation of this subchapter, and such term includes (until
otherwise specified by regulation of the Attorney General, as considered
appropriate by the Attorney General or upon petition to the Attorney
General by any person) the following chemicals:
(A) Acetic anhydride.
(B) Acetone.
(C) Benzyl chloride.
(D) Ethyl ether.
(E) Repealed. Pub. L. 101-647, title XXIII, 2301(b), Nov. 29, 1990,
104 Stat. 4858.
(F) Potassium permanganate.
(G) 2-Butanone.
(H) Toluene.
(36) The term ''regular customer'' means, with respect to a regulated
person, a customer with whom the regulated person has an established
business relationship that is reported to the Attorney General.
(37) The term ''regular supplier'' means, with respect to a regulated
person, a supplier with whom the regulated person has an established
business relationship that is reported to the Attorney General.
(38) The term ''regulated person'' means a person who manufactures,
distributes, imports, or exports a listed chemical, a tableting machine,
or an encapsulating machine.
(39) The term ''regulated transaction'' means --
(A) a distribution, receipt, sale, importation or exportation of a
threshold amount, including a cumulative threshold amount for multiple
transactions (as determined by the Attorney General, in consultation
with the chemical industry and taking into consideration the quantities
normally used for lawful purposes), of a listed chemical, except that
such term does not include --
(i) a domestic lawful distribution in the usual course of business
between agents or employees of a single regulated person;
(ii) a delivery of a listed chemical to or by a common or contract
carrier for carriage in the lawful and usual course of the business of
the common or contract carrier, or to or by a warehouseman for storage
in the lawful and usual course of the business of the warehouseman,
except that if the carriage or storage is in connection with the
distribution, importation, or exportation of a listed chemical to a
third person, this clause does not relieve a distributor, importer, or
exporter from compliance with section 830 of this title;
(iii) any category of transaction specified by regulation of the
Attorney General as excluded from this definition as unnecessary for
enforcement of this subchapter or subchapter II of this chapter;
(iv) any transaction in a listed chemical that is contained in a drug
that may be marketed or distributed lawfully in the United States under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
(v) any transaction in a chemical mixture; and
(B) a distribution, importation, or exportation of a tableting
machine or encapsulating machine.
(40) The term ''chemical mixture'' means a combination of two or more
chemical substances, at least one of which is not a listed precursor
chemical or a listed essential chemical, except that such term does not
include any combination of a listed precursor chemical or a listed
essential chemical with another chemical that is present solely as an
impurity.
(41)(A) The term ''anabolic steroid'' means any drug or hormonal
substance, chemically and pharmacologically related to testosterone
(other than estrogens, progestins, and corticosteroids) that promotes
muscle growth, and includes --
(i) boldenone,
(ii) chlorotestosterone,
(iii) clostebol,
(iv) dehydrochlormethyltestosterone,
(v) dihydrotestosterone,
(vi) drostanolone,
(vii) ethylestrenol,
(viii) fluoxymesterone,
(ix) formebulone,
(x) mesterolone,
(xi) methandienone,
(xii) methandranone,
(xiii) methandriol,
(xiv) methandrostenolone,
(xv) methenolone,
(xvi) methyltestosterone,
(xvii) mibolerone,
(xviii) nandrolone,
(xix) norethandrolone,
(xx) oxandrolone,
(xxi) oxymesterone,
(xxii) oxymetholone,
(xxiii) stanolone,
(xxiv) stanozolol,
(xxv) testolactone,
(xxvi) testosterone,
(xxvii) trenbolone, and
(xxviii) any salt, ester, or isomer of a drug or substance described
or listed in this paragraph, if that salt, ester, or isomer promotes
muscle growth.
(B)(i) Except as provided in clause (ii), such term does not include
an anabolic steroid which is expressly intended for administration
through implants to cattle or other nonhuman species and which has been
approved by the Secretary of Health and Human Services for such
administration.
(ii) If any person prescribes, dispenses, or distributes such steroid
for human use, such person shall be considered to have prescribed,
dispensed, or distributed an anabolic steroid within the meaning of
subparagraph (A).
(Pub. L. 91-513, title II, 102, Oct. 27, 1970, 84 Stat. 1242; Pub.
L. 93-281, 2, May 14, 1974, 88 Stat. 124; Pub. L. 95-633, title I,
102(b), Nov. 10, 1978, 92 Stat. 3772; Pub. L. 96-88, title V, 509( b),
Oct. 17, 1979, 93 Stat. 695; Pub. L. 96-132, 16(a), Nov. 30, 1979, 93
Stat. 1049; Pub. L. 98-473, title II, 507(a), (b), Oct. 12, 1984, 98
Stat. 2071; Pub. L. 98-509, title III, 301(a), Oct. 19, 1984, 98 Stat.
2364; Pub. L. 99-514, 2, Oct. 22, 1986, 100 Stat. 2095; Pub. L.
99-570, title I, 1003(b), 1203, 1870, Oct. 27, 1986, 100 Stat. 3207-6,
3207-13, 3207-56; Pub. L. 99-646, 83, Nov. 10, 1986, 100 Stat. 3619;
Pub. L. 100-690, title VI, 6054, Nov. 18, 1988, 102 Stat. 4316; Pub.
L. 101-647, title XIX, 1902(b), title XXIII, 2301, title XXXV, 3599I,
Nov. 29, 1990, 104 Stat. 4852, 4858, 4932.)
This subchapter, referred to in introductory text and in par. (39)(
A)(iii), was in the original ''this title'', meaning title II of Pub.
L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as amended, and is popularly
known as the ''Controlled Substances Act''. For complete classification
of title II to the Code, see second paragraph of Short Title note set
out under section 801 of this title and Tables.
Schedules I, II, III, IV, and V, referred to in pars. (6), (14), and
(32)(A), are set out in section 812(c) of this title.
Subchapter II of this chapter, referred to in par. (39)(A)(iii), was
in the original ''title III'', meaning title III of Pub. L. 91-513,
Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter
II of this chapter. For classification of Part B, consisting of
sections 1101 to 1105 of title III, see Tables.
The Federal Food, Drug, and Cosmetic Act, referred to in par. (39)(
A)(iv), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 ( 301 et seq.) of this title.
For complete classification of this Act to the Code, see section 301 of
this title and Tables.
1990 -- Par. (32)(A). Pub. L. 101-647, 3599I, substituted ''the
stimulant'' for ''the stimulent'' in cl. (ii) and ''a stimulant'' for
''a stimulent'' in cl. (iii).
Par. (34)(M) to (Y). Pub. L. 101-647, 2301(a), added subpars. (M) to
(Y).
Par. (35)(E). Pub. L. 101-647, 2301(b), struck out subpar. (E)
''Hydriodic acid.''
Par. (41). Pub. L. 101-647, 1902(b), added par. (41).
1988 -- Par. (8). Pub. L. 100-690, 6054(1), inserted ''or a listed
chemical'' after ''a controlled substance''.
Par. (11). Pub. L. 100-690, 6054(2), inserted ''or a listed
chemical'' after ''a controlled substance'' in two places.
Pars. (33) to (40). Pub. L. 100-690, 6054(3), added pars. (33) to
(40).
1986 -- Par. (6). Pub. L. 99-514 substituted ''Internal Revenue Code
of 1986'' for ''Internal Revenue Code of 1954''.
Par. (14). Pub. L. 99-570, 1870, and Pub. L. 99-646 amended par.
(14) identically, substituting ''any optical'' for ''the optical'' in
second and third sentences.
Par. (25). Pub. L. 99-570, 1003(b)(1), added par. (25). Former par.
(25) redesignated (26).
Pars. (26) to (31). Pub. L. 99-570, 1003(b)(2), redesignated pars.
(25) to (30) as (26) to (31), respectively.
Par. (32). Pub. L. 99-570, 1203, added par. (32).
1984 -- Pars. (14) to (16). Pub. L. 98-473, 507(a), added par.
(14) and redesignated former pars. (14) to (16) as (15) to (17),
respectively.
Par. (17). Pub. L. 98-473, 507, redesignated former par. (16) as
(17), and expanded and revised definition of ''narcotic drug'',
including within term poppy straw, cocaine, and ecgonine. Former par.
(17) redesignated (18).
Pars. (18) to (28). Pub. L. 98-473, 507(a), redesignated former
pars. (17) to (27) as (18) to (28), respectively.
Par. (29). Pub. L. 98-509 which directed the substitution of ''one
hundred and eighty'' for ''twenty-one'' in par. (28), was executed to
par. (29) in view of the redesignation of par. (28) as par. (29) by
Pub. L. 98-473.
Pub. L. 98-473, 507(a), redesignated former par. (28) as (29).
Former par. (29) redesignated (30).
Par. (30). Pub. L. 98-473, 507(a), redesignated former par. (29) as
(30).
1979 -- Par. (4). Pub. L. 96-132 substituted provisions defining
''Drug Enforcement Administration'' for provisions defining ''Bureau of
Narcotics and Dangerous Drugs''.
1978 -- Par. (29). Pub. L. 95-633 added par. (29).
1974 -- Pars. (27), (28). Pub. L. 93-281 added pars. (27) and
(28).
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in par. (24) pursuant
to section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
Section 1902(d) of Pub. L. 101-647 provided that: ''This section
(amending this section and section 812 of this title and enacting
provisions set out as a note under section 829 of this title) and the
amendment made by this section shall take effect 90 days after the date
of enactment of this Act (Nov. 29, 1990).''
Section 6061 of title VI of Pub. L. 100-690 provided that: ''Except
as otherwise provided in this subtitle, this subtitle (subtitle A (
6051-6061) of title VI of Pub. L. 100-690, enacting section 971 of this
title, amending this section and sections 830, 841 to 843, 872, 876,
881, 960, and 961 of this title, and enacting provisions set out as
notes under this section and section 971 of this title) shall take
effect 120 days after the enactment of this Act (Nov. 18, 1988).''
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States (July 15,
1980), see section 112 of Pub. L. 95-633, set out as an Effective Date
note under section 801a of this title.
Section 301(b) of Pub. L. 98-509 provided that: ''The Secretary of
Health and Human Services shall, within ninety days of the date of the
enactment of this Act (Oct. 19, 1984), promulgate regulations for the
administration of section 102(28) of the Controlled Substances Act (21
U.S.C. 802(29)) as amended by subsection (a) and shall include in the
first report submitted under section 505(b) of the Public Health Service
Act (42 U.S.C. 290aa-4(b)) after the expiration of such ninety days the
findings of the Secretary with respect to the effect of the amendment
made by subsection (a).''
Section 1903 of Pub. L. 101-647 provided that:
''(a) Abuse Potential. -- The Attorney General, upon the
recommendation of the Secretary of Health and Human Services, may, by
regulation, exempt any compound, mixture, or preparation containing a
substance in paragraph (41) of section 102 of the Controlled Substances
Act (21 U.S.C. 802(41)) (as added by section 2 (1902) of this Act) from
the application of all or any part of the Controlled Substances Act (21
U.S.C. 801 et seq.) if, because of its concentration, preparation,
mixture or delivery system, it has no significant potential for abuse.
''(b) Drugs for Treatment of Rare Diseases. -- If the Attorney
General finds that a drug listed in paragraph (41) of section 102 of the
Controlled Substances Act (as added by section 2 (1902) of this Act) is
--
''(1) approved by the Food and Drug Administration as an accepted
treatment for a rare disease or condition, as defined in section 526 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb); and
''(2) does not have a significant potential for abuse, the Attorney
General may exempt such drug from any production regulations otherwise
issued under the Controlled Substances Act as may be necessary to ensure
adequate supplies of such drug for medical purposes.
''(c) Date of Issuance of Regulations. -- The Attorney General shall
issue regulations implementing this section not later than 45 days after
the date of enactment of this Act (Nov. 29, 1990), except that the
regulations required under section 3(a) (1903(a)) shall be issued not
later than 180 days after the date of enactment of this Act.''
2021; title 8 sections 1101, 1182, 1251; title 16
section 559b; title 18 sections 342, 842, 922, 924,
1791, 1952, 2118, 3142, 3563; title 19 sections 1401,
1584, 1607; title 22 section 2714; title 28 section
2901; title 29 section 1111; title 42 sections 201,
1437d, 1437f, 2000e-2, 2473c, 3411, 3602, 3607, 11851,
11905, 11924; title 45 section 431; title 46 section
2101; title 46 App. section 1903; title 49 App.
sections 787, 1401, 1422, 1425, 1429, 1434, 1472,
1618a, 2716, 2717.
/1/ So in original. Probably should be ''N-Methylephedrine.''
21 USC 803. Repealed. Pub. L. 95-137, 1(b), Oct. 18, 1977, 91 Stat.
1169
TITLE 21 -- FOOD AND DRUGS
Section, Pub. L. 91-513, title II, 103, Oct. 27, 1970, 84 Stat.
1245, authorized Bureau of Narcotics and Dangerous Drugs to add, during
fiscal year 1971, 300 agents, together with necessary supporting
personnel, and provided for appropriations of $6,000,000 to carry out
such addition.
21 USC Part B -- Authority To Control; Standards and Schedules
TITLE 21 -- FOOD AND DRUGS
21 USC 811. Authority and criteria for classification of substances
TITLE 21 -- FOOD AND DRUGS
(a) Rules and regulations of Attorney General; hearing
The Attorney General shall apply the provisions of this subchapter to
the controlled substances listed in the schedules established by section
812 of this title and to any other drug or other substance added to such
schedules under this subchapter. Except as provided in subsections (d)
and (e) of this section, the Attorney General may by rule --
(1) add to such a schedule or transfer between such schedules any
drug or other substance if he --
(A) finds that such drug or other substance has a potential for
abuse, and
(B) makes with respect to such drug or other substance the findings
prescribed by subsection (b) of section 812 of this title for the
schedule in which such drug is to be placed; or
(2) remove any drug or other substance from the schedules if he finds
that the drug or other substance does not meet the requirements for
inclusion in any schedule.
Rules of the Attorney General under this subsection shall be made on
the record after opportunity for a hearing pursuant to the rulemaking
procedures prescribed by subchapter II of chapter 5 of title 5.
Proceedings for the issuance, amendment, or repeal of such rules may be
initiated by the Attorney General (1) on his own motion, (2) at the
request of the Secretary, or (3) on the petition of any interested
party.
(b) Evaluation of drugs and other substances
The Attorney General shall, before initiating proceedings under
subsection (a) of this section to control a drug or other substance or
to remove a drug or other substance entirely from the schedules, and
after gathering the necessary data, request from the Secretary a
scientific and medical evaluation, and his recommendations, as to
whether such drug or other substance should be so controlled or removed
as a controlled substance. In making such evaluation and
recommendations, the Secretary shall consider the factors listed in
paragraphs (2), (3), (6), (7), and (8) of subsection (c) of this section
and any scientific or medical considerations involved in paragraphs (1),
(4), and (5) of such subsection. The recommendations of the Secretary
shall include recommendations with respect to the appropriate schedule,
if any, under which such drug or other substance should be listed. The
evaluation and the recommendations of the Secretary shall be made in
writing and submitted to the Attorney General within a reasonable time.
The recommendations of the Secretary to the Attorney General shall be
binding on the Attorney General as to such scientific and medical
matters, and if the Secretary recommends that a drug or other substance
not be controlled, the Attorney General shall not control the drug or
other substance. If the Attorney General determines that these facts and
all other relevant data constitute substantial evidence of potential for
abuse such as to warrant control or substantial evidence that the drug
or other substance should be removed entirely from the schedules, he
shall initiate proceedings for control or removal, as the case may be,
under subsection (a) of this section.
(c) Factors determinative of control or removal from schedules
In making any finding under subsection (a) of this section or under
subsection (b) of section 812 of this title, the Attorney General shall
consider the following factors with respect to each drug or other
substance proposed to be controlled or removed from the schedules:
(1) Its actual or relative potential for abuse.
(2) Scientific evidence of its pharmacological effect, if known.
(3) The state of current scientific knowledge regarding the drug or
other substance.
(4) Its history and current pattern of abuse.
(5) The scope, duration, and significance of abuse.
(6) What, if any, risk there is to the public health.
(7) Its psychic or physiological dependence liability.
(8) Whether the substance is an immediate precursor of a substance
already controlled under this subchapter.
(d) International treaties, conventions, and protocols requiring
control; procedures respecting changes in drug schedules of Convention
on Psychotropic Substances
(1) If control is required by United States obligations under
international treaties, conventions, or protocols in effect on October
27, 1970, the Attorney General shall issue an order controlling such
drug under the schedule he deems most appropriate to carry out such
obligations, without regard to the findings required by subsection (a)
of this section or section 812(b) of this title and without regard to
the procedures prescribed by subsections (a) and (b) of this section.
(2)(A) Whenever the Secretary of State receives notification from the
Secretary-General of the United Nations that information has been
transmitted by or to the World Health Organization, pursuant to article
2 of the Convention on Psychotropic Substances, which may justify adding
a drug or other substance to one of the schedules of the Convention,
transferring a drug or substance from one schedule to another, or
deleting it from the schedules, the Secretary of State shall immediately
transmit the notice to the Secretary of Health and Human Services who
shall publish it in the Federal Register and provide opportunity to
interested persons to submit to him comments respecting the scientific
and medical evaluations which he is to prepare respecting such drug or
substance. The Secretary of Health and Human Services shall prepare for
transmission through the Secretary of State to the World Health
Organization such medical and scientific evaluations as may be
appropriate regarding the possible action that could be proposed by the
World Health Organization respecting the drug or substance with respect
to which a notice was transmitted under this subparagraph.
(B) Whenever the Secretary of State receives information that the
Commission on Narcotic Drugs of the United Nations proposes to decide
whether to add a drug or other substance to one of the schedules of the
Convention, transfer a drug or substance from one schedule to another,
or delete it from the schedules, the Secretary of State shall transmit
timely notice to the Secretary of Health and Human Services of such
information who shall publish a summary of such information in the
Federal Register and provide opportunity to interested persons to submit
to him comments respecting the recommendation which he is to furnish,
pursuant to this subparagraph, respecting such proposal. The Secretary
of Health and Human Services shall evaluate the proposal and furnish a
recommendation to the Secretary of State which shall be binding on the
representative of the United States in discussions and negotiations
relating to the proposal.
(3) When the United States receives notification of a scheduling
decision pursuant to article 2 of the Convention on Psychotropic
Substances that a drug or other substance has been added or transferred
to a schedule specified in the notification or receives notification
(referred to in this subsection as a ''schedule notice'') that existing
legal controls applicable under this subchapter to a drug or substance
and the controls required by the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) do not meet the requirements of the schedule of
the Convention in which such drug or substance has been placed, the
Secretary of Health and Human Services after consultation with the
Attorney General, shall first determine whether existing legal controls
under this subchapter applicable to the drug or substance and the
controls required by the Federal Food, Drug, and Cosmetic Act, meet the
requirements of the schedule specified in the notification or schedule
notice and shall take the following action:
(A) If such requirements are met by such existing controls but the
Secretary of Health and Human Services nonetheless believes that more
stringent controls should be applied to the drug or substance, the
Secretary shall recommend to the Attorney General that he initiate
proceedings for scheduling the drug or substance, pursuant to
subsections (a) and (b) of this section, to apply to such controls.
(B) If such requirements are not met by such existing controls and
the Secretary of Health and Human Services concurs in the scheduling
decision or schedule notice transmitted by the notification, the
Secretary shall recommend to the Attorney General that he initiate
proceedings for scheduling the drug or substance under the appropriate
schedule pursuant to subsections (a) and (b) of this section.
(C) If such requirements are not met by such existing controls and
the Secretary of Health and Human Services does not concur in the
scheduling decision or schedule notice transmitted by the notification,
the Secretary shall --
(i) if he deems that additional controls are necessary to protect the
public health and safety, recommend to the Attorney General that he
initiate proceedings for scheduling the drug or substance pursuant to
subsections (a) and (b) of this section, to apply such additional
controls;
(ii) request the Secretary of State to transmit a notice of qualified
acceptance, within the period specified in the Convention, pursuant to
paragraph 7 of article 2 of the Convention, to the Secretary-General of
the United Nations;
(iii) request the Secretary of State to transmit a notice of
qualified acceptance as prescribed in clause (ii) and request the
Secretary of State to ask for a review by the Economic and Social
Council of the United Nations, in accordance with paragraph 8 of article
2 of the Convention, of the scheduling decision; or
(iv) in the case of a schedule notice, request the Secretary of State
to take appropriate action under the Convention to initiate proceedings
to remove the drug or substance from the schedules under the Convention
or to transfer the drug or substance to a schedule under the Convention
different from the one specified in the schedule notice.
(4)(A) If the Attorney General determines, after consultation with
the Secretary of Health and Human Services, that proceedings initiated
under recommendations made under paragraph /1/ (B) or (C)(i) of
paragraph (3) will not be completed within the time period required by
paragraph 7 of article 2 of the Convention, the Attorney General, after
consultation with the Secretary and after providing interested persons
opportunity to submit comments respecting the requirements of the
temporary order to be issued under this sentence, shall issue a
temporary order controlling the drug or substance under schedule IV or
V, whichever is most appropriate to carry out the minimum United States
obligations under paragraph 7 of article 2 of the Convention. As a part
of such order, the Attorney General shall, after consultation with the
Secretary, except such drug or substance from the application of any
provision of part C of this subchapter which he finds is not required to
carry out the United States obligations under paragraph 7 of article 2
of the Convention. In the case of proceedings initiated under
subparagraph (B) of paragraph (3), the Attorney General, concurrently
with the issuance of such order, shall request the Secretary of State to
transmit a notice of qualified acceptance to the Secretary-General of
the United Nations pursuant to paragraph 7 of article 2 of the
Convention. A temporary order issued under this subparagraph
controlling a drug or other substance subject to proceedings initiated
under subsections (a) and (b) of this section shall expire upon the
effective date of the application to the drug or substance of the
controls resulting from such proceedings.
(B) After a notice of qualified acceptance of a scheduling decision
with respect to a drug or other substance is transmitted to the
Secretary-General of the United Nations in accordance with clause (ii)
or (iii) of paragraph (3)(C) or after a request has been made under
clause (iv) of such paragraph with respect to a drug or substance
described in a schedule notice, the Attorney General, after consultation
with the Secretary of Health and Human Services and after providing
interested persons opportunity to submit comments respecting the
requirements of the order to be issued under this sentence, shall issue
an order controlling the drug or substance under schedule IV or V,
whichever is most appropriate to carry out the minimum United States
obligations under paragraph 7 of article 2 of the Convention in the case
of a drug or substance for which a notice of qualified acceptance was
transmitted or whichever the Attorney General determines is appropriate
in the case of a drug or substance described in a schedule notice. As a
part of such order, the Attorney General shall, after consultation with
the Secretary, except such drug or substance from the application of any
provision of part C of this subchapter which he finds is not required to
carry out the United States obligations under paragraph 7 of article 2
of the Convention. If, as a result of a review under paragraph 8 of
article 2 of the Convention of the scheduling decision with respect to
which a notice of qualified acceptance was transmitted in accordance
with clause (ii) or (iii) of paragraph (3)(C) --
(i) the decision is reversed, and
(ii) the drug or substance subject to such decision is not required
to be controlled under schedule IV or V to carry out the minimum United
States obligations under paragraph 7 of article 2 of the Convention,
the order issued under this subparagraph with respect to such drug or
substance shall expire upon receipt by the United States of the review
decision. If, as a result of action taken pursuant to action initiated
under a request transmitted under clause (iv) of paragraph (3)(C), the
drug or substance with respect to which such action was taken is not
required to be controlled under schedule IV or V, the order issued under
this paragraph with respect to such drug or substance shall expire upon
receipt by the United States of a notice of the action taken with
respect to such drug or substance under the Convention.
(C) An order issued under subparagraph (A) or (B) may be issued
without regard to the findings required by subsection (a) of this
section or by section 812(b) of this title and without regard to the
procedures prescribed by subsection (a) or (b) of this section.
(5) Nothing in the amendments made by the Psychotropic Substances Act
of 1978 or the regulations or orders promulgated thereunder shall be
construed to preclude requests by the Secretary of Health and Human
Services or the Attorney General through the Secretary of State,
pursuant to article 2 or other applicable provisions of the Convention,
for review of scheduling decisions under such Convention, based on new
or additional information.
(e) Immediate precursors
The Attorney General may, without regard to the findings required by
subsection (a) of this section or section 812(b) of this title and
without regard to the procedures prescribed by subsections (a) and (b)
of this section, place an immediate precursor in the same schedule in
which the controlled substance of which it is an immediate precursor is
placed or in any other schedule with a higher numerical designation. If
the Attorney General designates a substance as an immediate precursor
and places it in a schedule, other substances shall not be placed in a
schedule solely because they are its precursors.
(f) Abuse potential
If, at the time a new-drug application is submitted to the Secretary
for any drug having a stimulant, depressant, or hallucinogenic effect on
the central nervous system, it appears that such drug has an abuse
potential, such information shall be forwarded by the Secretary to the
Attorney General.
(g) Exclusion of non-narcotic substances sold over the counter
without a prescription; dextromethorphan; exemption of substances
lacking abuse potential
(1) The Attorney General shall by regulation exclude any non-narcotic
substance from a schedule if such substance may, under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), be lawfully sold over
the counter without a prescription.
(2) Dextromethorphan shall not be deemed to be included in any
schedule by reason of enactment of this subchapter unless controlled
after October 27, 1970 pursuant to the foregoing provisions of this
section.
(3) The Attorney General may, by regulation, exempt any compound,
mixture, or preparation containing a controlled substance from the
application of all or any part of this subchapter if he finds such
compound, mixture, or preparation meets the requirements of one of the
following categories:
(A) A mixture, or preparation containing a nonnarcotic controlled
substance, which mixture or preparation is approved for prescription
use, and which contains one or more other active ingredients which are
not listed in any schedule and which are included therein in such
combinations, quantity, proportion, or concentration as to vitiate the
potential for abuse.
(B) A compound, mixture, or preparation which contains any controlled
substance, which is not for administration to a human being or animal,
and which is packaged in such form or concentration, or with adulterants
or denaturants, so that as packaged it does not present any significant
potential for abuse.
(h) Temporary scheduling to avoid imminent hazards to public safety
(1) If the Attorney General finds that the scheduling of a substance
in schedule I on a temporary basis is necessary to avoid an imminent
hazard to the public safety, he may, by order and without regard to the
requirements of subsection (b) of this section relating to the Secretary
of Health and Human Services, schedule such substance in schedule I if
the substance is not listed in any other schedule in section 812 of this
title or if no exemption or approval is in effect for the substance
under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355). Such an order may not be issued before the expiration of thirty
days from --
(A) the date of the publication by the Attorney General of a notice
in the Federal Register of the intention to issue such order and the
grounds upon which such order is to be issued, and
(B) the date the Attorney General has transmitted the notice required
by paragraph (4).
(2) The scheduling of a substance under this subsection shall expire
at the end of one year from the date of the issuance of the order
scheduling such substance, except that the Attorney General may, during
the pendency of proceedings under subsection (a)(1) of this section with
respect to the substance, extend the temporary scheduling for up to six
months.
(3) When issuing an order under paragraph (1), the Attorney General
shall be required to consider, with respect to the finding of an
imminent hazard to the public safety, only those factors set forth in
paragraphs (4), (5), and (6) of subsection (c) of this section,
including actual abuse, diversion from legitimate channels, and
clandestine importation, manufacture, or distribution.
(4) The Attorney General shall transmit notice of an order proposed
to be issued under paragraph (1) to the Secretary of Health and Human
Services. In issuing an order under paragraph (1), the Attorney General
shall take into consideration any comments submitted by the Secretary in
response to a notice transmitted pursuant to this paragraph.
(5) An order issued under paragraph (1) with respect to a substance
shall be vacated upon the conclusion of a subsequent rulemaking
proceeding initiated under subsection (a) of this section with respect
to such substance.
(6) An order issued under paragraph (1) is not subject to judicial
review.
(Pub. L. 91-513, title II, 201, Oct. 27, 1970, 84 Stat. 1245; Pub.
L. 95-633, title I, 102(a), Nov. 10, 1978, 92 Stat. 3769; Pub. L.
96-88, title V, 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 98-473,
title II, 508, 509(a), Oct. 12, 1984, 98 Stat. 2071, 2072.)
This subchapter, referred to in subsecs. (a), (c)(8), (d)(3), (4)(
A), (B), and (g)(2), (3), was in the original ''this title'', meaning
title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as amended,
and is popularly known as the ''Controlled Substances Act''. For
complete classification of title II to the Code, see second paragraph of
Short Title note set out under section 801 of this title and Tables.
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
(d)(3) and (g)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 ( 301 et seq.) of
this title. For complete classification of this Act to the Code, see
section 301 of this title and Tables.
Schedules I, IV, and V, referred to in subsecs. (d)(4)(A), (B), and
(h)(1), are set out in section 812(c) of this title.
The Psychotropic Substances Act of 1978, referred to in subsec. (d)(
5), is Pub. L. 95-633, Nov. 10, 1978, 92 Stat. 3768, which enacted
sections 801a, 830, and 852 of this title, amended sections 352, 802,
811, 812, 823, 827, 841 to 843, 872, 881, 952, 953, and 965 of this
title and section 242a of Title 42, The Public Health and Welfare,
repealed section 830 of this title effective Jan. 1, 1981, and enacted
provisions set out as notes under sections 801, 801a, 812, and 830 of
this title. For complete classification of this Act to the Code, see
Short Title of 1978 Amendment note set out under section 801 of this
title and Tables.
1984 -- Subsec. (g)(3). Pub. L. 98-473, 509(a), added par. (3).
Subsec. (h). Pub. L. 98-473, 508, added subsec. (h).
1978 -- Subsec. (d). Pub. L. 95-633 designated existing provisions
as par. (1) and added pars. (2) to (5).
''Secretary of Health and Human Services'' substituted for
''Secretary of Health, Education, and Welfare'' in subsec. (d)(2), (3),
(4)(A), (B), (5) pursuant to section 509(b) of Pub. L. 96-88 which is
classified to section 3508(b) of Title 20, Education.
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States (July 15,
1980), see section 112 of Pub. L. 95-633, set out as an Effective Date
note under section 801a of this title.
/1/ So in original. Probably should be ''subparagraph''.
21 USC 812. Schedules of controlled substances
TITLE 21 -- FOOD AND DRUGS
(a) Establishment
There are established five schedules of controlled substances, to be
known as schedules I, II, III, IV, and V. Such schedules shall
initially consist of the substances listed in this section. The
schedules established by this section shall be updated and republished
on a semiannual basis during the two-year period beginning one year
after October 27, 1970, and shall be updated and republished on an
annual basis thereafter.
(b) Placement on schedules; findings required
Except where control is required by United States obligations under
an international treaty, convention, or protocol, in effect on October
27, 1970, and except in the case of an immediate precursor, a drug or
other substance may not be placed in any schedule unless the findings
required for such schedule are made with respect to such drug or other
substance. The findings required for each of the schedules are as
follows:
(1) Schedule I. --
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted medical use
in treatment in the United States.
(C) There is a lack of accepted safety for use of the drug or other
substance under medical supervision.
(2) Schedule II. --
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has a currently accepted medical use
in treatment in the United States or a currently accepted medical use
with severe restrictions.
(C) Abuse of the drug or other substances may lead to severe
psychological or physical dependence.
(3) Schedule III. --
(A) The drug or other substance has a potential for abuse less than
the drugs or other substances in schedules I and II.
(B) The drug or other substance has a currently accepted medical use
in treatment in the United States.
(C) Abuse of the drug or other substance may lead to moderate or low
physical dependence or high psychological dependence.
(4) Schedule IV. --
(A) The drug or other substance has a low potential for abuse
relative to the drugs or other substances in schedule III.
(B) The drug or other substance has a currently accepted medical use
in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical
dependence or psychological dependence relative to the drugs or other
substances in schedule III.
(5) Schedule V. --
(A) The drug or other substance has a low potential for abuse
relative to the drugs or other substances in schedule IV.
(B) The drug or other substance has a currently accepted medical use
in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited physical
dependence or psychological dependence relative to the drugs or other
substances in schedule IV.
(c) Initial schedules of controlled substances
Schedules I, II, III, IV, and V shall, unless and until amended
pursuant to section 811 of this title, consist of the following drugs or
other substances, by whatever official name, common or usual name,
chemical name, or brand name designated:
21 USC Schedule I
TITLE 21 -- FOOD AND DRUGS
(a) Unless specifically excepted or unless listed in another
schedule, any of the following opiates, including their isomers, esters,
ethers, salts, and salts of isomers, esters, and ethers, whenever the
existence of such isomers, esters, ethers, and salts is possible within
the specific chemical designation:
(1) Acetylmethadol.
(2) Allylprodine.
(3) Alphacetylmathadol.
(4) Alphameprodine.
(5) Alphamethadol.
(6) Benzethidine.
(7) Betacetylmethadol.
(8) Betameprodine.
(9) Betamethadol.
(10) Betaprodine.
(11) Clonitazene.
(12) Dextromoramide.
(13) Dextrorphan.
(14) Diampromide.
(15) Diethylthiambutene.
(16) Dimenoxadol.
(17) Dimepheptanol.
(18) Dimethylthiambutene.
(19) Dioxaphetyl butyrate.
(20) Dipipanone.
(21) Ethylmethylthiambutene.
(22) Etonitazene.
(23) Etoxeridine.
(24) Furethidine.
(25) Hydroxypethidine.
(26) Ketobemidone.
(27) Levomoramide.
(28) Levophenacylmorphan.
(29) Morpheridine.
(30) Noracymethadol.
(31) Norlevorphanol.
(32) Normethadone.
(33) Norpipanone.
(34) Phenadoxone.
(35) Phenampromide.
(36) Phenomorphan.
(37) Phenoperidine.
(38) Piritramide.
(39) Propheptazine.
(40) Properidine.
(41) Racemoramide.
(42) Trimeperidine.
(b) Unless specifically excepted or unless listed in another
schedule, any of the following opium derivatives, their salts, isomers,
and salt of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation:
(1) Acetorphine.
(2) Acetyldihydrocodeine.
(3) Benzylmorphine.
(4) Codeine methylbromide.
(5) Codeine-N-Oxide.
(6) Cyprenorphine.
(7) Desomorphine.
(8) Dihydromorphine.
(9) Etorphine.
(10) Heroin.
(11) Hydromorphinol.
(12) Methyldesorphine.
(13) Methylhydromorphine.
(14) Morphine methylbromide.
(15) Morphine methylsulfonate.
(16) Morphine-N-Oxide.
(17) Myrophine.
(18) Nicocodeine.
(19) Nicomorphine.
(20) Normorphine.
(21) Pholcodine.
(22) Thebacon.
(c) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation, which
contains any quantity of the following hallucinogenic substances, or
which contains any of their salts, isomers, and salts of isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible within the specific chemical designation:
(1) 3,4-methylenedioxy amphetamine.
(2) 5-methoxy-3,4-methylenedioxy amphetamine.
(3) 3,4,5-trimethoxy amphetamine.
(4) Bufotenine.
(5) Diethyltryptamine.
(6) Dimethyltryptamine.
(7) 4-methyl-2,5-diamethoxyamphetamine.
(8) Ibogaine.
(9) Lysergic acid diethylamide.
(10) Marihuana.
(11) Mescaline.
(12) Peyote.
(13) N-ethyl-3-piperidyl benzilate.
(14) N-methyl-3-piperidyl benzilate.
(15) Psilocybin.
(16) Psilocyn.
(17) Tetrahydrocannabinols.
21 USC Schedule II
TITLE 21 -- FOOD AND DRUGS
(a) Unless specifically excepted or unless listed in another
schedule, any of the following substances whether produced directly or
indirectly by extraction from substances of vegetable origin, or
independently by means of chemical synthesis, or by a combination of
extraction and chemical synthesis:
(1) Opium and opiate, and any salt, compound, derivative, or
preparation of opium or opiate.
(2) Any salt, compound, derivative, or preparation thereof which is
chemically equivalent or identical with any of the substances referred
to in clause (1), except that these substances shall not include the
isoquinoline alkaloids of opium.
(3) Opium poppy and poppy straw.
(4) coca /1/ leaves, except coca leaves and extracts of coca leaves
from which cocaine, ecgonine, and derivatives of ecgonine or their salts
have been removed; cocaine, its salts, optical and geometric isomers,
and salts of isomers; ecgonine, its derivatives, their salts, isomers,
and salts of isomers; or any compound, mixture, or preparation which
contains any quantity of any of the substances referred to in this
paragraph.
(b) Unless specifically excepted or unless listed in another
schedule, any of the following opiates, including their isomers, esters,
ethers, salts, and salts of isomers, esters and ethers, whenever the
existence of such isomers, esters, ethers, and salts is possible within
the specific chemical designation:
(1) Alphaprodine.
(2) Anileridine.
(3) Bezitramide.
(4) Dihydrocodeine.
(5) Diphenoxylate.
(6) Fentanyl.
(7) Isomethadone.
(8) Levomethorphan.
(9) Levorphanol.
(10) Metazocine.
(11) Methadone.
(12) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl
butane.
(13) Moramide-Intermediate, 2-methyl-3-morpholino-1,
1-diphenylpropane-carboxylic acid.
(14) Pethidine.
(15) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine.
(16) Pethidine-Intermediate-B,
ethyl-4-phenylpiperidine-4-carboxylate.
(17) Pethidine-Intermediate-C,
1-methyl-4-phenylpiperidine-4-carboxylic acid.
(18) Phenazocine.
(19) Piminodine.
(20) Racemethorphan.
(21) Racemorphan.
(c) Unless specifically excepted or unless listed in another
schedule, any injectable liquid which contains any quantity of
methamphetamine, including its salts, isomers, and salts of isomers.
/1/ So in original. Probably should be capitalized.
21 USC Schedule III
TITLE 21 -- FOOD AND DRUGS
(a) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation which contains
any quantity of the following substances having a stimulant effect on
the central nervous system:
(1) Amphetamine, its salts, optical isomers, and salts of its optical
isomers.
(2) Phenmetrazine and its salts.
(3) Any substance (except an injectable liquid) which contains any
quantity of methamphetamine, including its salts, isomers, and salts of
isomers.
(4) Methylphenidate.
(b) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation which contains
any quantity of the following substances having a depressant effect on
the central nervous system:
(1) Any substance which contains any quantity of a derivative of
barbituric acid, or any salt of a derivative of barbituric acid.
(2) Chorhexadol.
(3) Glutehimide.
(4) Lysergic acid.
(5) Lysergic acid amide.
(6) Methyprylon.
(7) Phencyclidine.
(8) Sulfondiethylmethane.
(9) Sulfonethylmethane.
(10) Sulfonmethane.
(c) Nalorphine.
(d) Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation containing
limited quantities of any of the following narcotic drugs, or any salts
thereof:
(1) Not more than 1.8 grams of codeine per 100 milliliters or not
more than 90 milligrams per dosage unit, with an equal or greater
quantity of an isoquinoline alkaloid of opium.
(2) Not more than 1.8 grams of codeine per 100 milliliters or not
more than 90 milligrams per dosage unit, with one or more active,
non-narcotic ingredients in recognized therapeutic amounts.
(3) Not more than 300 milligrams of dihydrocodeinone per 100
milliliters or not more than 15 milligrams per dosage unit, with a
fourfold or greater quantity of an isoquinoline alkaloid of opium.
(4) Not more than 300 milligrams of dihydrocodeinone per 100
milliliters or not more than 15 milligrams per dosage unit, with one or
more active, nonnarcotic ingredients in recognized therapeutic amounts.
(5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or
not more than 90 milligrams per dosage unit, with one or more active,
nonnarcotic ingredients in recognized therapeutic amounts.
(6) Not more than 300 milligrams of ethylmorphine per 100 milliliters
or not more than 15 milligrams per dosage unit, with one or more active,
nonnarcotic ingredients in recognized therapeutic amounts.
(7) Not more than 500 milligrams of opium per 100 milliliters or per
100 grams, or not more than 25 milligrams per dosage unit, with one or
more active, nonnarcotic ingredients in recognized therapeutic amounts.
(8) Not more than 50 milligrams of morphine per 100 milliliters or
per 100 grams with one or more active, nonnarcotic ingredients in
recognized therapeutic amounts.
(e) Anabolic steroids.
21 USC Schedule IV
TITLE 21 -- FOOD AND DRUGS
(1) Barbital.
(2) Chloral betaine.
(3) Chloral hydrate.
(4) Ethchlorvynol.
(5) Ethinamate.
(6) Methohexital.
(7) Meprobamate.
(8) Methylphenobarbital.
(9) Paraldehyde.
(10) Petrichloral.
(11) Phenobarbital.
21 USC Schedule V
TITLE 21 -- FOOD AND DRUGS
Any compound, mixture, or preparation containing any of the following
limited quantities of narcotic drugs, which shall include one or more
nonnarcotic active medicinal ingredients in sufficient proportion to
confer upon the compound, mixture, or preparation valuable medicinal
qualities other than those possessed by the narcotic drug alone:
(1) Not more than 200 milligrams of codeine per 100 milliliters or
per 100 grams.
(2) Not more than 100 milligrams of dihydrocodeine per 100
milliliters or per 100 grams.
(3) Not more than 100 milligrams of ethylmorphine per 100 milliliters
or per 100 grams.
(4) Not more than 2.5 milligrams of diphenoxylate and not less than
25 micrograms of atropine sulfate per dosage unit.
(5) Not more than 100 milligrams of opium per 100 milliliters or per
100 grams.
(Pub. L. 91-513, title II, 202, Oct. 27, 1970, 84 Stat. 1247; Pub.
L. 95-633, title I, 103, Nov. 10, 1978, 92 Stat. 3772; Pub. L. 98-473,
title II, 507(c), 509(b), Oct. 12, 1984, 98 Stat. 2071, 2072; Pub. L.
99-570, title I, 1867, Oct. 27, 1986, 100 Stat. 3207-55; Pub. L.
99-646, 84, Nov. 10, 1986, 100 Stat. 3619; Pub. L. 101-647, title XIX,
1902(a), Nov. 29, 1990, 104 Stat. 4851.)
1990 -- Subsec. (c). Pub. L. 101-647 added item (e) at end of
schedule III.
1986 -- Subsec. (c). Pub. L. 99-646 amended schedule II(a)(4)
generally. Prior to amendment, schedule II(a)(4) read as follows:
''Coca leaves (except coca leaves and extracts of coca leaves from which
cocaine, ecgonine, and derivatives of ecgonine or their salts have been
removed); cocaine, its salts, optical and geometric isomers, and salts
of isomers; and ecgonine, its derivatives, their salts, isomers, and
salts of isomers.''
Pub. L. 99-570 amended schedule II(a)(4) generally. Prior to
amendment, schedule II(a)(4) read as follows: ''Coca leaves and any
salt, compound, derivative, or preparation of coca leaves (including
cocaine and ecgonine and their salts, isomers, derivatives, and salts of
isomers and derivatives), and any salt, compound, derivative, or
preparation thereof which is chemically equivalent or identical with any
of these substances, except that the substances shall not include
decocainized coca leaves or extraction of coca leaves, which extractions
do not contain cocaine or ecgonine.''
1984 -- Subsec. (c). Pub. L. 98-473, 507(c), in schedule II(a)(4)
added applicability to cocaine and ecgonine and their salts, isomers,
etc.
Subsec. (d). Pub. L. 98-473, 509(b), struck out subsec. (d) which
related to authority of Attorney General to except stimulants or
depressants containing active medicinal ingredients.
1978 -- Subsec. (d)(3). Pub. L. 95-633 added cl. (3).
Amendment by Pub. L. 101-647 effective 90 days after Nov. 29, 1990,
see section 1902(d) of Pub. L. 101-647, set out as a note under section
802 of this title.
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States (July 15,
1980), see section 112 of Pub. L. 95-633, set out as an Effective Date
note under section 801a of this title.
Section 102(c) of Pub. L. 95-633 provided that: ''For the purpose
of carrying out the minimum United States obligations under paragraph 7
of article 2 of the Convention on Psychotropic Substances, signed at
Vienna, Austria, on February 21, 1971, with respect to pipradrol and SPA
(also known as (-)-1-dimethylamino-1,2-diphenylethane), the Attorney
General shall by order, made without regard to sections 201 and 202 of
the Controlled Substances Act (this section and section 811 of this
title), place such drugs in schedule IV of such Act (see subsec. (c) of
this section).''
Provision of section 102(c) of Pub. L. 95-633, set out above,
effective on the date the Convention on Psychotropic Substances enters
into force in the United States (July 15, 1980), see section 112 of Pub.
L. 95-633, set out as an Effective Date note under section 801a of this
title.
section 2484; title 29 sections 706, 2006; title 41
section 706; title 42 sections 12111, 12210.
21 USC 813. Treatment of controlled substance analogues
TITLE 21 -- FOOD AND DRUGS
A controlled substance analogue shall, to the extent intended for
human consumption, be treated, for the purposes of any Federal law as a
controlled substance in schedule I.
(Pub. L. 91-513, title II, 203, as added Pub. L. 99-570, title I,
1202, Oct. 27, 1986, 100 Stat. 3207-13, and amended Pub. L. 100-690,
title VI, 6470(c), Nov. 18, 1988, 102 Stat. 4378.)
Schedule I, referred to in text, is set out in section 812(c) of this
title.
1988 -- Pub. L. 100-690 substituted ''any Federal law'' for ''this
subchapter and subchapter II of this chapter''.
21 USC Part C -- Registration of Manufacturers, Distributors, and
Dispensers of Controlled Substances
TITLE 21 -- FOOD AND DRUGS
21 USC 821. Rules and regulations
TITLE 21 -- FOOD AND DRUGS
The Attorney General is authorized to promulgate rules and
regulations and to charge reasonable fees relating to the registration
and control of the manufacture, distribution, and dispensing of
controlled substances.
(Pub. L. 91-513, title II, 301, Oct. 27, 1970, 84 Stat. 1253.)
21 USC 822. Persons required to register
TITLE 21 -- FOOD AND DRUGS
(a) Period of registration
(1) Every person who manufactures or distributes any controlled
substance, or who proposes to engage in the manufacture or distribution
of any controlled substance, shall obtain annually a registration issued
by the Attorney General in accordance with the rules and regulations
promulgated by him.
(2) Every person who dispenses, or who proposes to dispense, any
controlled substance, shall obtain from the Attorney General a
registration issued in accordance with the rules and regulations
promulgated by him. The Attorney General shall, by regulation,
determine the period of such registrations. In no event, however, shall
such registrations be issued for less than one year nor for more than
three years.
(b) Authorized activities
Persons registered by the Attorney General under this subchapter to
manufacture, distribute, or dispense controlled substances are
authorized to possess, manufacture, distribute, or dispense such
substances (including any such activity in the conduct of research) to
the extent authorized by their registration and in conformity with the
other provisions of this subchapter.
(c) Exceptions
The following persons shall not be required to register and may
lawfully possess any controlled substance under this subchapter:
(1) An agent or employee of any registered manufacturer, distributor,
or dispenser of any controlled substance if such agent or employee is
acting in the usual course of his business or employment.
(2) A common or contract carrier or warehouseman, or an employee
thereof, whose possession of the controlled substance is in the usual
course of his business or employment.
(3) An ultimate user who possesses such substance for a purpose
specified in section 802(25) /1/ of this title.
(d) Waiver
The Attorney General may, by regulation, waive the requirement for
registration of certain manufacturers, distributors, or dispensers if he
finds it consistent with the public health and safety.
(e) Separate registration
A separate registration shall be required at each principal place of
business or professional practice where the applicant manufactures,
distributes, or dispenses controlled substances.
(f) Inspection
The Attorney General is authorized to inspect the establishment of a
registrant or applicant for registration in accordance with the rules
and regulations promulgated by him.
(Pub. L. 91-513, title II, 302, Oct. 27, 1970, 84 Stat. 1253; Pub.
L. 98-473, title II, 510, Oct. 12, 1984, 98 Stat. 2072.)
This subchapter, referred to in subsecs. (b) and (c), was in the
original ''this title'', meaning title II of Pub. L. 91-513, Oct. 27,
1970, 84 Stat. 1242, as amended, and is popularly known as the
''Controlled Substances Act''. For complete classification of title II
to the Code, see second paragraph of Short Title note set out under
section 801 of this title and Tables.
Section 802(25) of this title, referred to in subsec. (c)(3), was
redesignated section 802(26) of this title by Pub. L. 98-473, title II,
507(a), Oct. 12, 1984, 98 Stat. 2071, and was further redesignated
section 802(27) of this title by Pub. L. 99-570, title I, 1003(b)(2),
Oct. 27, 1986, 100 Stat. 3207-6.
1984 -- Subsec. (a). Pub. L. 98-473 designated existing provisions
as par. (1), struck out provisions relating to dispensing controlled
substances, and added par. (2).
Section 703 of Pub. L. 91-513, as amended by Pub. L. 99-514, 2,
Oct. 22, 1986, 100 Stat. 2095, provided that:
''(a)(1) Any person who --
''(A) is engaged in manufacturing, distributing, or dispensing any
controlled substance on the day before the effective date of section 302
(this section), and
''(B) is registered on such day under section 510 of the Federal
Food, Drug, and Cosmetic Act (section 360 of this title) or under
section 4722 of the Internal Revenue Code of 1986 (formerly I.R.C.
1954, section 4722 of Title 26),
shall, with respect to each establishment for which such registration
is in effect under any such section, be deemed to have a provisional
registration under section 303 (section 823 of this title) for the
manufacture, distribution, or dispensing (as the case may be) of
controlled substances.
''(2) During the period his provisional registration is in effect
under this section, the registration number assigned such person under
such section 510 (section 360 of this title) or under such section 4722
(section 4722 of Title 26) (as the case may be) shall be his
registration number for purposes of section 303 of this title (section
823 of this title).
''(b) The provisions of section 304 (section 824 of this title),
relating to suspension and revocation of registration, shall apply to a
provisional registration under this section.
''(c) Unless sooner suspended or revoked under subsection (b), a
provisional registration of a person under subsection (a)(1) of this
section shall be in effect until --
''(1) the date on which such person has registered with the Attorney
General under section 303 (section 823 of this title) or has had his
registration denied under such section, or
''(2) such date as may be prescribed by the Attorney General for
registration of manufacturers, distributors, or dispensers, as the case
may be,
whichever occurs first.''
/1/ See References in Text note below.
21 USC 823. Registration requirements
TITLE 21 -- FOOD AND DRUGS
(a) Manufacturers of controlled substances in schedule I or II
The Attorney General shall register an applicant to manufacture
controlled substances in schedule I or II if he determines that such
registration is consistent with the public interest and with United
States obligations under international treaties, conventions, or
protocols in effect on May 1, 1971. In determining the public interest,
the following factors shall be considered:
(1) maintenance of effective controls against diversion of particular
controlled substances and any controlled substance in schedule I or II
compounded therefrom into other than legitimate medical, scientific,
research, or industrial channels, by limiting the importation and bulk
manufacture of such controlled substances to a number of establishments
which can produce an adequate and uninterrupted supply of these
substances under adequately competitive conditions for legitimate
medical, scientific, research, and industrial purposes;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of manufacturing these
substances and the development of new substances;
(4) prior conviction record of applicant under Federal and State laws
relating to the manufacture, distribution, or dispensing of such
substances;
(5) past experience in the manufacture of controlled substances, and
the existence in the establishment of effective control against
diversion; and
(6) such other factors as may be relevant to and consistent with the
public health and safety.
(b) Distributors of controlled substances in schedule I or II
The Attorney General shall register an applicant to distribute a
controlled substance in schedule I or II unless he determines that the
issuance of such registration is inconsistent with the public interest.
In determining the public interest, the following factors shall be
considered:
(1) maintenance of effective control against diversion of particular
controlled substances into other than legitimate medical, scientific,
and industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under Federal or State laws
relating to the manufacture, distribution, or dispensing of such
substances;
(4) past experience in the distribution of controlled substances;
and
(5) such other factors as may be relevant to and consistent with the
public health and safety.
(c) Limits of authorized activities
Registration granted under subsections (a) and (b) of this section
shall not entitle a registrant to (1) manufacture or distribute
controlled substances in schedule I or II other than those specified in
the registration, or (2) manufacture any quantity of those controlled
substances in excess of the quota assigned pursuant to section 826 of
this title.
(d) Manufacturers of controlled substances in schedule III, IV, or V
The Attorney General shall register an applicant to manufacture
controlled substances in schedule III, IV, or V, unless he determines
that the issuance of such registration is inconsistent with the public
interest. In determining the public interest, the following factors
shall be considered:
(1) maintenance of effective controls against diversion of particular
controlled substances and any controlled substance in schedule III, IV,
or V compounded therefrom into other than legitimate medical,
scientific, or industrial channels;
(2) compliance with applicable State and local law;
(3) promotion of technical advances in the art of manufacturing these
substances and the development of new substances;
(4) prior conviction record of applicant under Federal or State laws
relating to the manufacture, distribution, or dispensing of such
substances;
(5) past experience in the manufacture, distribution, and dispensing
of controlled substances, and the existence in the establishment of
effective controls against diversion; and
(6) such other factors as may be relevant to and consistent with the
public health and safety.
(e) Distributors of controlled substances in schedule III, IV, or V
The Attorney General shall register an applicant to distribute
controlled substances in schedule III, IV, or V, unless he determines
that the issuance of such registration is inconsistent with the public
interest. In determining the public interest, the following factors
shall be considered:
(1) maintenance of effective controls against diversion of particular
controlled substances into other than legitimate medical, scientific,
and industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under Federal or State laws
relating to the manufacture, distribution, or dispensing of such
substances;
(4) past experience in the distribution of controlled substances;
and
(5) such other factors as may be relevant to and consistent with the
public health and safety.
(f) Research by practitioners; pharmacies; research applications;
construction of Article 7 of the Convention on Psychotropic Substances
The Attorney General shall register practitioners (including
pharmacies, as distinguished from pharmacists) to dispense, or conduct
research with, controlled substances in schedule II, III, IV, or V, if
the applicant is authorized to dispense, or conduct research with
respect to, controlled substances under the laws of the State in which
he practices. The Attorney General may deny an application for such
registration if he determines that the issuance of such registration
would be inconsistent with the public interest. In determining the
public interest, the following factors shall be considered:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research
with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws relating
to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Separate registration under this part for practitioners engaging in
research with controlled substances in schedule II, III, IV, or V, who
are already registered under this part in another capacity, shall not be
required. Registration applications by practitioners wishing to conduct
research with controlled substances in schedule I shall be referred to
the Secretary, who shall determine the qualifications and competency of
each practitioner requesting registration, as well as the merits of the
research protocol. The Secretary, in determining the merits of each
research protocol, shall consult with the Attorney General as to
effective procedures to adequately safeguard against diversion of such
controlled substances from legitimate medical or scientific use.
Registration for the purpose of bona fide research with controlled
substances in schedule I by a practitioner deemed qualified by the
Secretary may be denied by the Attorney General only on a ground
specified in section 824(a) of this title. Article 7 of the Convention
on Psychotropic Substances shall not be construed to prohibit, or impose
additional restrictions upon, research involving drugs or other
substances scheduled under the convention which is conducted in
conformity with this subsection and other applicable provisions of this
subchapter.
(g) Practitioners dispensing narcotic drugs for narcotic treatment;
annual registration; separate registration; qualifications
Practitioners who dispense narcotic drugs to individuals for
maintenance treatment or detoxification treatment shall obtain annually
a separate registration for that purpose. The Attorney General shall
register an applicant to dispense narcotic drugs to individuals for
maintenance treatment or detoxification treatment (or both)
(1) if the applicant is a practitioner who is determined by the
Secretary to be qualified (under standards established by the Secretary)
to engage in the treatment with respect to which registration is sought;
(2) if the Attorney General determines that the applicant will comply
with standards established by the Attorney General respecting (A)
security of stocks of narcotic drugs for such treatment, and (B) the
maintenance of records (in accordance with section 827 of this title) on
such drugs; and
(3) if the Secretary determines that the applicant will comply with
standards established by the Secretary (after consultation with the
Attorney General) respecting the quantities of narcotic drugs which may
be provided for unsupervised use by individuals in such treatment.
(Pub. L. 91-513, title II, 303, Oct. 27, 1970, 84 Stat. 1253; Pub.
L. 93-281, 3, May 14, 1974, 88 Stat. 124; Pub. L. 95-633, title I, 109,
Nov. 10, 1978, 92 Stat. 3773; Pub. L. 98-473, title II, 511, Oct. 12,
1984, 98 Stat. 2073.)
Schedules I, II, III, IV, and V, referred to in subsecs. (a) to (f),
are set out in section 812(c) of this title.
1984 -- Subsec. (f). Pub. L. 98-473 amended subsec. (f) generally,
substituting provisions relating to registration authority of Attorney
General respecting dispensation or conduct of research with controlled
research, and separate authority of Secretary respecting registration,
for provisions relating to general registration requirements respecting
dispensation or conduct of research with controlled or nonnarcotic
controlled substances.
1978 -- Subsec. (f). Pub. L. 95-633 inserted provision relating to
the construction of the Convention on Psychotropic Substances.
1974 -- Subsec. (g). Pub. L. 93-281 added subsec. (g).
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States (July 15,
1980), see section 112 of Pub. L. 95-633, set out as an Effective Date
note under section 801a of this title.
For provisional registration of persons engaged in manufacturing,
distributing, or dispensing of controlled substances on the day before
the effective date of section 822 of this title who are registered on
such date under section 360 of this title or section 4722 of Title 26,
Internal Revenue Code, see section 703 of Pub. L. 91-513, set out as a
note under section 822 of this title.
21 USC 824. Denial, revocation, or suspension of registration
TITLE 21 -- FOOD AND DRUGS
(a) Grounds
A registration pursuant to section 823 of this title to manufacture,
distribute, or dispense a controlled substance may be suspended or
revoked by the Attorney General upon a finding that the registrant --
(1) has materially falsified any application filed pursuant to or
required by this subchapter or subchapter II of this chapter;
(2) has been convicted of a felony under this subchapter or
subchapter II of this chapter or any other law of the United States, or
of any State, relating to any substance defined in this subchapter as a
controlled substance;
(3) has had his State license or registration suspended, revoked, or
denied by competent State authority and is no longer authorized by State
law to engage in the manufacturing, distribution, or dispensing of
controlled substances or has had the suspension, revocation, or denial
of his registration recommended by competent State authority;
(4) has committed such acts as would render his registration under
section 823 of this title inconsistent with the public interest as
determined under such section; or
(5) has been excluded (or directed to be excluded) from participation
in a program pursuant to section 1320a-7(a) of title 42.
A registration pursuant to section 823(g) of this title to dispense a
narcotic drug for maintenance treatment or detoxification treatment may
be suspended or revoked by the Attorney General upon a finding that the
registrant has failed to comply with any standard referred to in section
823(g) of this title.
(b) Limits of revocation or suspension
The Attorney General may limit revocation or suspension of a
registration to the particular controlled substance with respect to
which grounds for revocation or suspension exist.
(c) Service of show cause order; proceedings
Before taking action pursuant to this section, or pursuant to a
denial of registration under section 823 of this title, the Attorney
General shall serve upon the applicant or registrant an order to show
cause why registration should not be denied, revoked, or suspended. The
order to show cause shall contain a statement of the basis thereof and
shall call upon the applicant or registrant to appear before the
Attorney General at a time and place stated in the order, but in no
event less than thirty days after the date of receipt of the order.
Proceedings to deny, revoke, or suspend shall be conducted pursuant to
this section in accordance with subchapter II of chapter 5 of title 5.
Such proceedings shall be independent of, and not in lieu of, criminal
prosecutions or other proceedings under this subchapter or any other law
of the United States.
(d) Suspension of registration in cases of imminent danger
The Attorney General may, in his discretion, suspend any registration
simultaneously with the institution of proceedings under this section,
in cases where he finds that there is an imminent danger to the public
health or safety. A failure to comply with a standard referred to in
section 823(g) of this title may be treated under this subsection as
grounds for immediate suspension of a registration granted under such
section. A suspension under this subsection shall continue in effect
until the conclusion of such proceedings, including judicial review
thereof, unless sooner withdrawn by the Attorney General or dissolved by
a court of competent jurisdiction.
(e) Suspension and revocation of quotas
The suspension or revocation of a registration under this section
shall operate to suspend or revoke any quota applicable under section
826 of this title.
(f) Disposition of controlled substances
In the event the Attorney General suspends or revokes a registration
granted under section 823 of this title, all controlled substances owned
or possessed by the registrant pursuant to such registration at the time
of suspension or the effective date of the revocation order, as the case
may be, may, in the discretion of the Attorney General, be placed under
seal. No disposition may be made of any controlled substances under
seal until the time for taking an appeal has elapsed or until all
appeals have been concluded except that a court, upon application
therefor, may at any time order the sale of perishable controlled
substances. Any such order shall require the deposit of the proceeds of
the sale with the court. Upon a revocation order becoming final, all
such controlled substances (or proceeds of sale deposited in court)
shall be forfeited to the United States; and the Attorney General shall
dispose of such controlled substances in accordance with section 881(e)
of this title. All right, title, and interest in such controlled
substances shall vest in the United States upon a revocation order
becoming final.
(g) Seizure or placement under seal of controlled substances
The Attorney General may, in his discretion, seize or place under
seal any controlled substances owned or possessed by a registrant whose
registration has expired or who has ceased to practice or do business in
the manner contemplated by his registration. Such controlled substances
shall be held for the benefit of the registrant, or his successor in
interest. The Attorney General shall notify a registrant, or his
successor in interest, who has any controlled substance seized or placed
under seal of the procedures to be followed to secure the return of the
controlled substance and the conditions under which it will be returned.
The Attorney General may not dispose of any controlled substance seized
or placed under seal under this subsection until the expiration of one
hundred and eighty days from the date such substance was seized or
placed under seal.
(Pub. L. 91-513, title II, 304, Oct. 27, 1970, 84 Stat. 1255; Pub.
L. 93-281, 4, May 14, 1974, 88 Stat. 125; Pub. L. 98-473, title II,
304, 512, 513, Oct. 12, 1984, 98 Stat. 2050, 2073; Pub. L. 100-93,
8(j), Aug. 18, 1987, 101 Stat. 695.)
This subchapter, referred to in subsec. (a)(1), (2), was in the
original ''this title'', meaning title II of Pub. L. 91-513, Oct. 27,
1970, 84 Stat. 1242, as amended, and is popularly known as the
''Controlled Substances Act''. For complete classification of title II
to the Code, see second paragraph of Short Title note set out under
section 801 of this title and Tables.
Subchapter II of this chapter, referred to in subsec. (a)(1), (2),
was in the original ''title III'', meaning title III of Pub. L.
91-513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises
subchapter II of this chapter. For classification of Part B, consisting
of sections 1101 to 1105 of title III, see Tables.
1987 -- Subsec. (a)(5). Pub. L. 100-93 added par. (5).
1984 -- Subsec. (a)(3). Pub. L. 98-473, 512(1), inserted provisions
relating to suspension, etc., recommended by competent State authority.
Subsec. (a)(4). Pub. L. 98-473, 512(2), added par. (4).
Subsec. (f). Pub. L. 98-473, 304, inserted provisions relating to
vesting of right, title, and interest in the United States.
Subsec. (g). Pub. L. 98-473, 513, added subsec. (g).
1974 -- Subsec. (a). Pub. L. 93-281, 4(a), provided for revocation
or suspension of a registration pursuant to section 823(g) of this title
for failure of a registrant to comply with standards referred to in such
section 823(g).
Subsec. (d). Pub. L. 93-281, 4(b), substituted ''A suspension under
this subsection'' for ''Such suspension'' in third sentence.
Amendment by Pub. L. 100-93 effective at end of fourteen-day period
beginning Aug. 18, 1987, and inapplicable to administrative proceedings
commenced before end of such period, see section 15(a) of Pub. L.
100-93, set out as a note under section 1320a-7 of Title 42, The Public
Health and Welfare.
Applicability of this section to provisional registrations, see
section 703 of Pub. L. 91-513, set out as a note under section 822 of
this title.
21 USC 825. Labeling and packaging
TITLE 21 -- FOOD AND DRUGS
(a) Symbol
It shall be unlawful to distribute a controlled substance in a
commercial container unless such container, when and as required by
regulations of the Attorney General, bears a label (as defined in
section 321(k) of this title) containing an identifying symbol for such
substance in accordance with such regulations. A different symbol shall
be required for each schedule of controlled substances.
(b) Unlawful distribution without identifying symbol
It shall be unlawful for the manufacturer of any controlled substance
to distribute such substance unless the labeling (as defined in section
321(m) of this title) of such substance contains, when and as required
by regulations of the Attorney General, the identifying symbol required
under subsection (a) of this section.
(c) Warning on label
The Secretary shall prescribe regulations under section 353(b) of
this title which shall provide that the label of a drug listed in
schedule II, III, or IV shall, when dispensed to or for a patient,
contain a clear, concise warning that it is a crime to transfer the drug
to any person other than the patient.
(d) Containers to be securely sealed
It shall be unlawful to distribute controlled substances in schedule
I or II, and narcotic drugs in schedule III or IV, unless the bottle or
other container, stopper, covering, or wrapper thereof is securely
sealed as required by regulations of the Attorney General.
(Pub. L. 91-513, title II, 305, Oct. 27, 1970, 84 Stat. 1256.)
Schedules I, II, III, and IV, referred to in subsecs. (c) and (d),
are set out in section 812(c) of this title.
Section effective on first day of seventh calendar month that begins
after Oct. 26, 1970, but with Attorney General authorized to postpone
such effective date for such period as he might determine to be
necessary for the efficient administration of this subchapter, see
section 704(c) of Pub. L. 91-513, set out as a note under section 801
of this title.
21 USC 826. Production quotas for controlled substances
TITLE 21 -- FOOD AND DRUGS
(a) Establishment of total annual needs
The Attorney General shall determine the total quantity and establish
production quotas for each basic class of controlled substance in
schedules I and II to be manufactured each calendar year to provide for
the estimated medical, scientific, research, and industrial needs of the
United States, for lawful export requirements, and for the establishment
and maintenance of reserve stocks. Production quotas shall be
established in terms of quantities of each basic class of controlled
substance and not in terms of individual pharmaceutical dosage forms
prepared from or containing such a controlled substance.
(b) Individual production quotas; revised quotas
The Attorney General shall limit or reduce individual production
quotas to the extent necessary to prevent the aggregate of individual
quotas from exceeding the amount determined necessary each year by the
Attorney General under subsection (a) of this section. The quota of
each registered manufacturer for each basic class of controlled
substance in schedule I or II shall be revised in the same proportion as
the limitation or reduction of the aggregate of the quotas. However, if
any registrant, before the issuance of a limitation or reduction in
quota, has manufactured in excess of his revised quota, the amount of
the excess shall be subtracted from his quota for the following year.
(c) Manufacturing quotas for registered manufacturers
On or before October 1 of each year, upon application therefor by a
registered manufacturer, the Attorney General shall fix a manufacturing
quota for the basic classes of controlled substances in schedules I and
II that the manufacturer seeks to produce. The quota shall be subject
to the provisions of subsections (a) and (b) of this section. In fixing
such quotas, the Attorney General shall determine the manufacturer's
estimated disposal, inventory, and other requirements for the calendar
year; and, in making his determination, the Attorney General shall
consider the manufacturer's current rate of disposal, the trend of the
national disposal rate during the preceding calendar year, the
manufacturer's production cycle and inventory position, the economic
availability of raw materials, yield and stability problems, emergencies
such as strikes and fires, and other factors.
(d) Quotas for registrants who have not manufactured controlled
substance during one or more preceding years
The Attorney General shall, upon application and subject to the
provisions of subsections (a) and (b) of this section, fix a quota for a
basic class of controlled substance in schedule I or II for any
registrant who has not manufactured that basic class of controlled
substance during one or more preceding calendar years. In fixing such
quota, the Attorney General shall take into account the registrant's
reasonably anticipated requirements for the current year; and, in
making his determination of such requirements, he shall consider such
factors specified in subsection (c) of this section as may be relevant.
(e) Quota increases
At any time during the year any registrant who has applied for or
received a manufacturing quota for a basic class of controlled substance
in schedule I or II may apply for an increase in that quota to meet his
estimated disposal, inventory, and other requirements during the
remainder of that year. In passing upon the application the Attorney
General shall take into consideration any occurrences since the filing
of the registrant's initial quota application that may require an
increased manufacturing rate by the registrant during the balance of the
year. In passing upon the application the Attorney General may also
take into account the amount, if any, by which the determination of the
Attorney General under subsection (a) of this section exceeds the
aggregate of the quotas of all registrants under this section.
(f) Incidental production exception
Notwithstanding any other provisions of this subchapter, no
registration or quota may be required for the manufacture of such
quantities of controlled substances in schedules I and II as
incidentally and necessarily result from the manufacturing process used
for the manufacture of a controlled substance with respect to which its
manufacturer is duly registered under this subchapter. The Attorney
General may, by regulation, prescribe restrictions on the retention and
disposal of such incidentally produced substances.
(Pub. L. 91-513, title II, 306, Oct. 27, 1970, 84 Stat. 1257; Pub.
L. 94-273, 3(16), Apr. 21, 1976, 90 Stat. 377.)
Schedules I and II, referred to in text, are set out in section 812(
c) of this title.
1976 -- Subsec. (c). Pub. L. 94-273 substituted ''October'' for
''July''.
Section effective on first day of seventh calendar month that begins
after Oct. 26, 1970, but with Attorney General authorized to postpone
such effective date for such period as he might determine to be
necessary for the efficient administration of this subchapter, see
section 704(c) of Pub. L. 91-513, set out as a note under section 801
of this title.
21 USC 827. Records and reports of registrants
TITLE 21 -- FOOD AND DRUGS
(a) Inventory
Except as provided in subsection (c) of this section --
(1) every registrant under this subchapter shall, on May 1, 1971, or
as soon thereafter as such registrant first engages in the manufacture,
distribution, or dispensing of controlled substances, and every second
year thereafter, make a complete and accurate record of all stocks
thereof on hand, except that the regulations prescribed under this
section shall permit each such biennial inventory (following the initial
inventory required by this paragraph) to be prepared on such
registrant's regular general physical inventory date (if any) which is
nearest to and does not vary by more than six months from the biennial
date that would otherwise apply;
(2) on the effective date of each regulation of the Attorney General
controlling a substance that immediately prior to such date was not a
controlled substance, each registrant under this subchapter
manufacturing, distributing, or dispensing such substance shall make a
complete and accurate record of all stocks thereof on hand; and
(3) on and after May 1, 1971, every registrant under this subchapter
manufacturing, distributing, or dispensing a controlled substance or
substances shall maintain, on a current basis, a complete and accurate
record of each such substance manufactured, received, sold, delivered,
or otherwise disposed of by him, except that this paragraph shall not
require the maintenance of a perpetual inventory.
(b) Availability of records
Every inventory or other record required under this section (1) shall
be in accordance with, and contain such relevant information as may be
required by, regulations of the Attorney General, (2) shall (A) be
maintained separately from all other records of the registrant, or (B)
alternatively, in the case of nonnarcotic controlled substances, be in
such form that information required by the Attorney General is readily
retrievable from the ordinary business records of the registrant, and
(3) shall be kept and be available, for at least two years, for
inspection and copying by officers or employees of the United States
authorized by the Attorney General.
(c) Nonapplicability
The foregoing provisions of this section shall not apply --
(1)(A) to the prescribing of controlled substances in schedule II,
III, IV, or V by practitioners acting in the lawful course of their
professional practice unless such substance is prescribed in the course
of maintenance or detoxification treatment of an individual; or
(B) to the administering of a controlled substance in schedule II,
III, IV, or V unless the practitioner regularly engages in the
dispensing or administering of controlled substances and charges his
patients, either separately or together with charges for other
professional services, for substances so dispensed or administered or
unless such substance is administered in the course of maintenance
treatment or detoxification treatment of an individual;
(2)(A) to the use of controlled substances, at establishments
registered under this subchapter which keep records with respect to such
substances, in research conducted in conformity with an exemption
granted under section 355(i) or 360b(j) of this title;
(B) to the use of controlled substances, at establishments registered
under this subchapter which keep records with respect to such
substances, in preclinical research or in teaching; or
(3) to the extent of any exemption granted to any person, with
respect to all or part of such provisions, by the Attorney General by or
pursuant to regulation on the basis of a finding that the application of
such provisions (or part thereof) to such person is not necessary for
carrying out the purposes of this subchapter.
Nothing in the Convention on Psychotropic Substances shall be
construed as superseding or otherwise affecting the provisions of
paragraph (1)(B), (2), or (3) of this subsection.
(d) Periodic reports to Attorney General
Every manufacturer registered under section 823 of this title shall,
at such time or times and in such form as the Attorney General may
require, make periodic reports to the Attorney General of every sale,
delivery or other disposal by him of any controlled substance, and each
distributor shall make such reports with respect to narcotic controlled
substances, identifying by the registration number assigned under this
subchapter the person or establishment (unless exempt from registration
under section 822(d) of this title) to whom such sale, delivery, or
other disposal was made.
(e) Reporting and recordkeeping requirements of drug conventions
In addition to the reporting and recordkeeping requirements under any
other provision of this subchapter, each manufacturer registered under
section 823 of this title shall, with respect to narcotic and
nonnarcotic controlled substances manufactured by it, make such reports
to the Attorney General, and maintain such records, as the Attorney
General may require to enable the United States to meet its obligations
under articles 19 and 20 of the Single Convention on Narcotic Drugs and
article 16 of the Convention on Psychotropic Substances. The Attorney
General shall administer the requirements of this subsection in such a
manner as to avoid the unnecessary imposition of duplicative
requirements under this subchapter on manufacturers subject to the
requirements of this subsection.
(f) Investigational uses of drugs; procedures
Regulations under sections 355(i) and 360(j) of this title, relating
to investigational use of drugs, shall include such procedures as the
Secretary, after consultation with the Attorney General, determines are
necessary to insure the security and accountability of controlled
substances used in research to which such regulations apply.
(g) Change of address
Every registrant under this subchapter shall be required to report
any change of professional or business address in such manner as the
Attorney General shall by regulation require.
(Pub. L. 91-513, title II, 307, Oct. 27, 1970, 84 Stat. 1258; Pub.
L. 93-281, 5, May 14, 1974, 88 Stat. 125; Pub. L. 95-633, title I,
104, 110, Nov. 10, 1978, 92 Stat. 3772, 3773; Pub. L. 98-473, title
II, 514, 515, Oct. 12, 1984, 98 Stat. 2074.)
Schedules II, III, IV, and V, referred to in subsec. (c), are set
out in section 812(c) of this title.
1984 -- Subsec. (c)(1)(A). Pub. L. 98-473, 514(a), substituted ''to
the prescribing of controlled substances in schedule II, III, IV, or V
by practitioners acting in the lawful course of their professional
practice unless such substance is prescribed in the course of
maintenance or detoxification treatment of an individual'' for ''with
respect to any narcotic controlled substance in schedule II, III, IV, or
V, to the prescribing or administering of such substance by a
practitioner in the lawful course of his professional practice unless
such substance was prescribed or administered in the course of
maintenance treatment or detoxification treatment of an individual''.
Subsec. (c)(1)(B). Pub. L. 98-473, 514(b), substituted ''to the
administering of a controlled substance in schedule II, III, IV, or V
unless the practitioner regularly engages in the dispensing or
administering of controlled substances and charges his patients, either
separately or together with charges for other professional services, for
substances so dispensed or administered or unless such substance is
administered in the course of maintenance treatment or detoxification
treatment of an individual'' for ''with respect to nonnarcotic
controlled substances in schedule II, III, IV, or V, to any practitioner
who dispenses such substances to his patients, unless the practitioner
is regularly engaged in charging his patients, either separately or
together with charges for other professional services, for substances so
dispensed''.
Subsec. (g). Pub. L. 98-473, 515, added subsec. (g).
1978 -- Subsec. (c). Pub. L. 95-633, 110, inserted provision
following par. (3) relating to the construction of the Convention on
Psychotropic Substances.
Subsecs. (e), (f). Pub. L. 95-633 added subsec. (e) and
redesignated former subsec. (e) as (f).
1974 -- Subsec. (c)(1)(A). Pub. L. 93-281 substituted ''any narcotic
controlled substance'' for ''narcotic controlled substances'' and made
section applicable to any narcotic controlled substance prescribed or
administered in the course of maintenance treatment or detoxification
treatment of an individual.
Amendment by Pub. L. 95-633 effective on date the Convention on
Psychotropic Substances enters into force in the United States (July 15,
1980), see section 112 of Pub. L. 95-633, set out as an Effective Date
note under section 801a of this title.
21 USC 828. Order forms
TITLE 21 -- FOOD AND DRUGS
(a) Unlawful distribution of controlled substances
It shall be unlawful for any person to distribute a controlled
substance in schedule I or II to another except in pursuance of a
written order of the person to whom such substance is distributed, made
on a form to be issued by the Attorney General in blank in accordance
with subsection (d) of this section and regulations prescribed by him
pursuant to this section.
(b) Nonapplicability of provisions
Nothing in subsection (a) of this section shall apply to --
(1) the exportation of such substances from the United States in
conformity with subchapter II of this chapter;
(2) the delivery of such a substance to or by a common or contract
carrier for carriage in the lawful and usual course of its business, or
to or by a warehouseman for storage in the lawful and usual course of
its business; but where such carriage or storage is in connection with
the distribution by the owner of the substance to a third person, this
paragraph shall not relieve the distributor from compliance with
subsection (a) of this section.
(c) Preservation and availability
(1) Every person who in pursuance of an order required under
subsection (a) of this section distributes a controlled substance shall
preserve such order for a period of two years, and shall make such order
available for inspection and copying by officers and employees of the
United States duly authorized for that purpose by the Attorney General,
and by officers or employees of States or their political subdivisions
who are charged with the enforcement of State or local laws regulating
the production, or regulating the distribution or dispensing, of
controlled substances and who are authorized under such laws to inspect
such orders.
(2) Every person who gives an order required under subsection (a) of
this section shall, at or before the time of giving such order, make or
cause to be made a duplicate thereof on a form to be issued by the
Attorney General in blank in accordance with subsection (d) of this
section and regulations prescribed by him pursuant to this section, and
shall, if such order is accepted, preserve such duplicate for a period
of two years and make it available for inspection and copying by the
officers and employees mentioned in paragraph (1) of this subsection.
(d) Issuance
(1) The Attorney General shall issue forms pursuant to subsections
(a) and (c)(2) of this section only to persons validly registered under
section 823 of this title (or exempted from registration under section
822(d) of this title). Whenever any such form is issued to a person,
the Attorney General shall, before delivery thereof, insert therein the
name of such person, and it shall be unlawful for any other person (A)
to use such form for the purpose of obtaining controlled substances or
(B) to furnish such form to any person with intent thereby to procure
the distribution of such substances.
(2) The Attorney General may charge reasonable fees for the issuance
of such forms in such amounts as he may prescribe for the purpose of
covering the cost to the United States of issuing such forms, and other
necessary activities in connection therewith.
(e) Unlawful acts
It shall be unlawful for any person to obtain by means of order forms
issued under this section controlled substances for any purpose other
than their use, distribution, dispensing, or administration in the
conduct of a lawful business in such substances or in the course of his
professional practice or research.
(Pub. L. 91-513, title II, 308, Oct. 27, 1970, 84 Stat. 1259.)
Schedules I and II, referred to in subsec. (a), are set out in
section 812(c) of this title.
21 USC 829. Prescriptions
TITLE 21 -- FOOD AND DRUGS
(a) Schedule II substances
Except when dispensed directly by a practitioner, other than a
pharmacist, to an ultimate user, no controlled substance in schedule II,
which is a prescription drug as determined under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.), may be dispensed without the
written prescription of a practitioner, except that in emergency
situations, as prescribed by the Secretary by regulation after
consultation with the Attorney General, such drug may be dispensed upon
oral prescription in accordance with section 503(b) of that Act (21
U.S.C. 353(b)). Prescriptions shall be retained in conformity with the
requirements of section 827 of this title. No prescription for a
controlled substance in schedule II may be refilled.
(b) Schedule III and IV substances
Except when dispensed directly by a practitioner, other than a
pharmacist, to an ultimate user, no controlled substance in schedule III
or IV, which is a prescription drug as determined under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), may be dispensed
without a written or oral prescription in conformity with section 503(
b) of that Act (21 U.S.C. 353(b)). Such prescriptions may not be filled
or refilled more than six months after the date thereof or be refilled
more than five times after the date of the prescription unless renewed
by the practitioner.
(c) Schedule V substances
No controlled substance in schedule V which is a drug may be
distributed or dispensed other than for a medical purpose.
(d) Non-prescription drugs with abuse potential
Whenever it appears to the Attorney General that a drug not
considered to be a prescription drug under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) should be so considered because of
its abuse potential, he shall so advise the Secretary and furnish to him
all available data relevant thereto.
(Pub. L. 91-513, title II, 309, Oct. 27, 1970, 84 Stat. 1260.)
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
(a), (b), and (d), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to chapter 9 ( 301 et seq.) of
this title. For complete classification of this Act to the Code, see
section 301 of this title and Tables.
Schedules II, III, IV, and V, referred to in subsecs. (a) to (c),
are set out in section 812(c) of this title.
Pub. L. 101-647, title XIX, 1902(c), Nov. 29, 1990, 104 Stat. 4852,
provided that: ''Any prescription for anabolic steroids subject to
refill on or after the date of enactment of the amendments made by this
section (Nov. 29, 1990) may be refilled without restriction under
section 309(a) of the Controlled Substances Act (21 U.S.C. 829(a)).''
21 USC 830. Regulation of listed chemicals and certain machines
TITLE 21 -- FOOD AND DRUGS
(a) Record of regulated transactions
(1) Each regulated person who engages in a regulated transaction
involving a listed chemical, a tableting machine, or an encapsulating
machine shall keep a record of the transaction --
(A) for 4 years after the date of the transaction, if the listed
chemical is a precursor chemical or if the transaction involves a
tableting machine or an encapsulating machine; and
(B) for 2 years after the date of the transaction, if the listed
chemical is an essential chemical.
(2) A record under this subsection shall be retrievable and shall
include the date of the regulated transaction, the identity of each
party to the regulated transaction, a statement of the quantity and form
of the listed chemical, a description of the tableting machine or
encapsulating machine, and a description of the method of transfer.
Such record shall be available for inspection and copying by the
Attorney General.
(3) It is the duty of each regulated person who engages in a
regulated transaction to identify each other party to the transaction.
It is the duty of such other party to present proof of identity to the
regulated person. The Attorney General shall specify by regulation the
types of documents and other evidence that constitute proof of identity
for purposes of this paragraph.
(b) Reports to Attorney General
Each regulated person shall report to the Attorney General, in such
form and manner as the Attorney General shall prescribe by regulation --
(1) any regulated transaction involving an extraordinary quantity of
a listed chemical, an uncommon method of payment or delivery, or any
other circumstance that the regulated person believes may indicate that
the listed chemical will be used in violation of this subchapter;
(2) any proposed regulated transaction with a person whose
description or other identifying characteristic the Attorney General
furnishes in advance to the regulated person;
(3) any unusual or excessive loss or disappearance of a listed
chemical under the control of the regulated person; and
(4) any regulated transaction in a tableting machine or an
encapsulating machine.
Each report under paragraph (1) shall be made at the earliest
practicable opportunity after the regulated person becomes aware of the
circumstance involved. A regulated person may not complete a
transaction with a person whose description or identifying
characteristic is furnished to the regulated person under paragraph (2)
unless the transaction is approved by the Attorney General. The
Attorney General shall make available to regulated persons guidance
documents describing transactions and circumstances for which reports
are required under paragraph (1) and paragraph (3).
(c) Confidentiality of information obtained by Attorney General;
non-disclosure; exceptions
(1) Except as provided in paragraph (2), any information obtained by
the Attorney General under this section which is exempt from disclosure
under section 552(a) of title 5, by reason of section 552(b)(4) of such
title, is confidential and may not be disclosed to any person.
(2) Information referred to in paragraph (1) may be disclosed only --
(A) to an officer or employee of the United States engaged in
carrying out this subchapter, subchapter II of this chapter, or the
customs laws;
(B) when relevant in any investigation or proceeding for the
enforcement of this subchapter, subchapter II of this chapter, or the
customs laws;
(C) when necessary to comply with an obligation of the United States
under a treaty or other international agreement; or
(D) to a State or local official or employee in conjunction with the
enforcement of controlled substances laws or precursor chemical laws.
(3) The Attorney General shall --
(A) take such action as may be necessary to prevent unauthorized
disclosure of information by any person to whom such information is
disclosed under paragraph (2); and
(B) issue guidelines that limit, to the maximum extent feasible, the
disclosure of proprietary business information, including the names or
identities of United States exporters of listed chemicals, to any person
to whom such information is disclosed under paragraph (2).
(4) Any person who is aggrieved by a disclosure of information in
violation of this section may bring a civil action against the violator
for appropriate relief.
(5) Notwithstanding paragraph (4), a civil action may not be brought
under such paragraph against investigative or law enforcement personnel
of the Drug Enforcement Administration.
(Pub. L. 91-513, title II, 310, as added Pub. L. 95-633, title II,
202(a), Nov. 10, 1978, 92 Stat. 3774, and amended Pub. L. 100-690, title
VI, 6052(a), Nov. 18, 1988, 102 Stat. 4312.)
Subchapter II of this chapter, referred to in subsec. (c)(2)(A),
(B), was in the original ''title III'', meaning title III of Pub. L.
91-513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises
subchapter II of this chapter. For classification of Part B, consisting
of sections 1101 to 1105 of title III, see Tables.
The customs laws, referred to in subsec. (c)(2)(A), (B), are
classified generally to Title 19, Customs Duties.
1988 -- Pub. L. 100-690 amended section generally, substituting
provisions relating to regulation of listed chemicals and certain
machines for provisions relating to reporting by any person who
distributes, sells, or imports any piperidine.
Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
1988, see section 6061 of Pub. L. 100-690, set out as a note under
section 802 of this title.
ed Information
Section 203(a) of title II of Pub. L. 95-633 provided that:
''(1) Except as provided under paragraph (2), the amendments made by
this title (enacting this section and amending sections 841 to 843 of
this title) shall take effect on the date of the enactment of this Act
(Nov. 10, 1978).
''(2) Any person required to submit a report under section 310(a)(1)
of the Controlled Substances Act (subsec. (a)(1) of this section)
respecting a distribution, sale, or importation of piperidine during the
90 days after the date of the enactment of this Act (Nov. 10, 1978) may
submit such report any time up to 97 days after such date of enactment.
''(3) Until otherwise provided by the Attorney General by regulation,
the information required to be reported by a person under section
310(a)(1) of the Controlled Substances Act (as added by section
202(a)(2) of this title) (subsec. (a)(1) of this section) with respect
to the person's distribution, sale, or importation of piperidine shall
--
''(A) be the information described in subparagraphs (A) and (B) of
such section, and
''(B) except as provided in paragraph (2) of this subsection, be
reported not later than seven days after the date of such distribution,
sale, or importation.''
Pub. L. 96-359, 8(b), Sept. 26, 1980, 94 Stat. 1194, repealed
section 203(d) of Pub. L. 95-633, which had provided for the repeal of
this section effective Jan. 1, 1981.
Section 203(b) of Pub. L. 95-633 required the Attorney General to
publish proposed interim regulations for piperidine reporting under
section 830(a) of this title not later than 30 days after enactment, and
final interim regulations not later than 75 days after enactment, such
final interim regulations to be effective on and after the ninety-first
day after enactment.
Section 203(c) of Pub. L. 95-633 required the Attorney General to
analyze and evaluate the impact and effectiveness of the amendments made
by title II of Pub. L. 95-633, and report to the President and Congress
not later than Mar. 1, 1980.
21 USC Part D -- Offenses and Penalties
TITLE 21 -- FOOD AND DRUGS
21 USC 841. Prohibited acts A
TITLE 21 -- FOOD AND DRUGS
(a) Unlawful acts
Except as authorized by this subchapter, it shall be unlawful for any
person knowingly or intentionally --
(1) to manufacture, distribute, or dispense, or possess with intent
to manufacture, distribute, or dispense, a controlled substance; or
(2) to create, distribute, or dispense, or possess with intent to
distribute or dispense, a counterfeit substance.
(b) Penalties
Except as otherwise provided in section 859, 860, or 861 of this
title, any person who violates subsection (a) of this section shall be
sentenced as follows:
(1)(A) In the case of a violation of subsection (a) of this section
involving --
(i) 1 kilogram or more of a mixture or substance containing a
detectable amount of heroin;
(ii) 5 kilograms or more of a mixture or substance containing a
detectable amount of --
(I) coca leaves, except coca leaves and extracts of coca leaves from
which cocaine, ecgonine, and derivatives of ecgonine or their salts have
been removed;
(II) cocaine, its salts, optical and geometric isomers, and salts of
isomers;
(III) ecgonine, its derivatives, their salts, isomers, and salts of
isomers; or
(IV) any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in subclauses (I) through
(III);
(iii) 50 grams or more of a mixture or substance described in clause
(ii) which contains cocaine base;
(iv) 100 grams or more of phencyclidine (PCP) or 1 kilogram or more
of a mixture or substance containing a detectable amount of
phencyclidine (PCP);
(v) 10 grams or more of a mixture or substance containing a
detectable amount of lysergic acid diethylamide (LSD);
(vi) 400 grams or more of a mixture or substance containing a
detectable amount of N-phenyl-N-( 1-(2-phenylethyl)-4-piperidinyl )
propanamide or 100 grams or more of a mixture or substance containing a
detectable amount of any analogue of N-phenyl-N-(1-(2-phenylethyl)-
4-piperidinyl) propanamide;
(vii) 1000 kilograms or more of a mixture or substance containing a
detectable amount of marihuana, or 1,000 or more marihuana plants
regardless of weight; or
(viii) 100 grams or more of methamphetamine, its salts, isomers, and
salts of its isomers or 1 kilogram or more of a mixture or substance
containing a detectable amount of methamphetamine, its salts, isomers,
or salts of its isomers;
such person shall be sentenced to a term of imprisonment which may
not be less than 10 years or more than life and if death or serious
bodily injury results from the use of such substance shall be not less
than 20 years or more than life, a fine not to exceed the greater of
that authorized in accordance with the provisions of title 18 or
$4,000,000 if the defendant is an individual or $10,000,000 if the
defendant is other than an individual, or both. If any person commits
such a violation after a prior conviction for a felony drug offense has
become final, such person shall be sentenced to a term of imprisonment
which may not be less than 20 years and not more than life imprisonment
and if death or serious bodily injury results from the use of such
substance shall be sentenced to life imprisonment, a fine not to exceed
the greater of twice that authorized in accordance with the provisions
of title 18 or $8,000,000 if the defendant is an individual or
$20,000,000 if the defendant is other than an individual, or both. If
any person commits a violation of this subparagraph or of section 859,
860, or 861 of this title after two or more prior convictions for a
felony drug offense have become final, such person shall be sentenced to
a mandatory term of life imprisonment without release and fined in
accordance with the preceding sentence. For purposes of this
subparagraph, the term ''felony drug offense'' means an offense that is
a felony under any provision of this subchapter or any other Federal law
that prohibits or restricts conduct relating to narcotic drugs,
marihuana, or depressant or stimulant substances or a felony under any
law of a State or a foreign country that prohibits or restricts conduct
relating to narcotic drugs, marihuana, or depressant or stimulant
substances. Any sentence under this subparagraph shall, in the absence
of such a prior conviction, impose a term of supervised release of at
least 5 years in addition to such term of imprisonment and shall, if
there was such a prior conviction, impose a term of supervised release
of at least 10 years in addition to such term of imprisonment.
Notwithstanding any other provision of law, the court shall not place on
probation or suspend the sentence of any person sentenced under this
subparagraph. No person sentenced under this subparagraph shall be
eligible for parole during the term of imprisonment imposed therein.
(B) In the case of a violation of subsection (a) of this section
involving --
(i) 100 grams or more of a mixture or substance containing a
detectable amount of heroin;
(ii) 500 grams or more of a mixture or substance containing a
detectable amount of --
(I) coca leaves, except coca leaves and extracts of coca leaves from
which cocaine, ecgonine, and derivatives of ecgonine or their salts have
been removed;
(II) cocaine, its salts, optical and geometric isomers, and salts of
isomers;
(III) ecgonine, its derivatives, their salts, isomers, and salts of
isomers; or
(IV) any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in subclauses (I) through
(III);
(iii) 5 grams or more of a mixture or substance described in clause
(ii) which contains cocaine base;
(iv) 10 grams or more of phencyclidine (PCP) or 100 grams or more of
a mixture or substance containing a detectable amount of phencyclidine
(PCP);
(v) 1 gram or more of a mixture or substance containing a detectable
amount of lysergic acid diethylamide (LSD);
(vi) 40 grams or more of a mixture or substance containing a
detectable amount of N-phenyl-N-( 1-(2-phenylethyl)-4-piperidinyl )
propanamide or 10 grams or more of a mixture or substance containing a
detectable amount of any analogue of N-phenyl-N-(1-(2-phenylethyl)-
4-piperidinyl) propanamide;
(vii) 100 kilograms or more of a mixture or substance containing a
detectable amount of marihuana, or 100 or more marihuana plants
regardless of weight; or
(viii) 10 grams or more of methamphetamine, its salts, isomers, and
salts of its isomers or 100 grams or more of a mixture or substance
containing a detectable amount of methamphetamine, its salts, isomers,
or salts of its isomers;
such person shall be sentenced to a term of imprisonment which may
not be less than 5 years and not more than 40 years and if death or
serious bodily injury results from the use of such substance shall be
not less than 20 years or more than life, a fine not to exceed the
greater of that authorized in accordance with the provisions of title 18
or $2,000,000 if the defendant is an individual or $5,000,000 if the
defendant is other than an individual, or both. If any person commits
such a violation after one or more prior convictions for an offense
punishable under this paragraph, or for a felony under any other
provision of this subchapter or subchapter II of this chapter or other
law of a State, the United States, or a foreign country relating to
narcotic drugs, marihuana, or depressant or stimulant substances, have
become final, such person shall be sentenced to a term of imprisonment
which may not be less than 10 years and not more than life imprisonment
and if death or serious bodily injury results from the use of such
substance shall be sentenced to life imprisonment, a fine not to exceed
the greater of twice that authorized in accordance with the provisions
of title 18 or $4,000,000 if the defendant is an individual or
$10,000,000 if the defendant is other than an individual, or both. Any
sentence imposed under this subparagraph shall, in the absence of such a
prior conviction, include a term of supervised release of at least 4
years in addition to such term of imprisonment and shall, if there was
such a prior conviction, include a term of supervised release of at
least 8 years in addition to such term of imprisonment. Notwithstanding
any other provision of law, the court shall not place on probation or
suspend the sentence of any person sentenced under this subparagraph.
No person sentenced under this subparagraph shall be eligible for parole
during the term of imprisonment imposed therein.
(C) In the case of a controlled substance in schedule I or II except
as provided in subparagraphs (A), (B), and (D), such person shall be
sentenced to a term of imprisonment of not more than 20 years and if
death or serious bodily injury results from the use of such substance
shall be sentenced to a term of imprisonment of not less than twenty
years or more than life, a fine not to exceed the greater of that
authorized in accordance with the provisions of title 18 or $1,000,000
if the defendant is an individual or $5,000,000 if the defendant is
other than an individual, or both. If any person commits such a
violation after one or more prior convictions for an offense punishable
under this paragraph, or for a felony under any other provision of this
subchapter or subchapter II of this chapter or other law of a State, the
United States or a foreign country relating to narcotic drugs,
marihuana, or depressant or stimulant substances, have become final,
such person shall be sentenced to a term of imprisonment of not more
than 30 years and if death or serious bodily injury results from the use
of such substance shall be sentenced to life imprisonment, a fine not to
exceed the greater of twice that authorized in accordance with the
provisions of title 18 or $2,000,000 if the defendant is an individual
or $10,000,000 if the defendant is other than an individual, or both.
Any sentence imposing a term of imprisonment under this paragraph shall,
in the absence of such a prior conviction, impose a term of supervised
release of at least 3 years in addition to such term of imprisonment and
shall, if there was such a prior conviction, impose a term of supervised
release of at least 6 years in addition to such term of imprisonment.
Notwithstanding any other provision of law, the court shall not place on
probation or suspend the sentence of any person sentenced under the
provisions of this subparagraph which provide for a mandatory term of
imprisonment if death or serious bodily injury results, nor shall a
person so sentenced be eligible for parole during the term of such a
sentence.
(D) In the case of less than 50 kilograms of marihuana, except in the
case of 50 or more marihuana plants regardless of weight, 10 kilograms
of hashish, or one kilogram of hashish oil or in the case of any
controlled substance in schedule III, such person shall, except as
provided in paragraphs (4) and (5) of this subsection, be sentenced to a
term of imprisonment of not more than 5 years, a fine not to exceed the
greater of that authorized in accordance with the provisions of title 18
or $250,000 if the defendant is an individual or $1,000,000 if the
defendant is other than an individual, or both. If any person commits
such a violation after one or more prior convictions of him for an
offense punishable under this paragraph, or for a felony under any other
provision of this subchapter or subchapter II of this chapter or other
law of a State, the United States, or a foreign country relating to
narcotic drugs, marihuana, or depressant or stimulant substances, have
become final, such person shall be sentenced to a term of imprisonment
of not more than 10 years, a fine not to exceed the greater of twice
that authorized in accordance with the provisions of title 18 or
$500,000 if the defendant is an individual or $2,000,000 if the
defendant is other than an individual, or both. Any sentence imposing a
term of imprisonment under this paragraph shall, in the absence of such
a prior conviction, impose a term of supervised release of at least 2
years in addition to such term of imprisonment and shall, if there was
such a prior conviction, impose a term of supervised release of at least
4 years in addition to such term of imprisonment.
(2) In the case of a controlled substance in schedule IV, such person
shall be sentenced to a term of imprisonment of not more than 3 years, a
fine not to exceed the greater of that authorized in accordance with the
provisions of title 18 or $250,000 if the defendant is an individual or
$1,000,000 if the defendant is other than an individual, or both. If
any person commits such a violation after one or more prior convictions
of him for an offense punishable under this paragraph, or for a felony
under any other provision of this subchapter or subchapter II of this
chapter or other law of a State, the United States, or a foreign country
relating to narcotic drugs, marihuana, or depressant or stimulant
substances, have become final, such person shall be sentenced to a term
of imprisonment of not more than 6 years, a fine not to exceed the
greater of twice that authorized in accordance with the provisions of
title 18 or $500,000 if the defendant is an individual or $2,000,000 if
the defendant is other than an individual, or both. Any sentence
imposing a term of imprisonment under this paragraph shall, in the
absence of such a prior conviction, impose a term of supervised release
of at least one year in addition to such term of imprisonment and shall,
if there was such a prior conviction, impose a term of supervised
release of at least 2 years in addition to such term of imprisonment.
(3) In the case of a controlled substance in schedule V, such person
shall be sentenced to a term of imprisonment of not more than one year,
a fine not to exceed the greater of that authorized in accordance with
the provisions of title 18 or $100,000 if the defendant is an individual
or $250,000 if the defendant is other than an individual, or both. If
any person commits such a violation after one or more convictions of him
for an offense punishable under this paragraph, or for a crime under any
other provision of this subchapter or subchapter II of this chapter or
other law of a State, the United States, or a foreign country relating
to narcotic drugs, marihuana, or depressant or stimulant substances,
have become final, such person shall be sentenced to a term of
imprisonment of not more than 2 years, a fine not to exceed the greater
of twice that authorized in accordance with the provisions of title 18
or $200,000 if the defendant is an individual or $500,000 if the
defendant is other than an individual, or both.
(4) Notwithstanding paragraph (1)(D) of this subsection, any person
who violates subsection (a) of this section by distributing a small
amount of marihuana for no remuneration shall be treated as provided in
section 844 of this title and section 3607 of title 18.
(5) Any person who violates subsection (a) of this section by
cultivating a controlled substance on Federal property shall be
imprisoned as provided in this subsection and shall be fined any amount
not to exceed --
(A) the amount authorized in accordance with this section;
(B) the amount authorized in accordance with the provisions of title
18;
(C) $500,000 if the defendant is an individual; or
(D) $1,000,000 if the defendant is other than an individual;
or both.
(6) Any person who violates subsection (a) of this section, or
attempts to do so, and knowingly or intentionally uses a poison,
chemical, or other hazardous substance on Federal land, and, by such use
--
(A) creates a serious hazard to humans, wildlife, or domestic
animals,
(B) degrades or harms the environment or natural resources, or
(C) pollutes an aquifer, spring, stream, river, or body of water,
shall be fined in accordance with title 18 or imprisoned not more
than five years, or both.
(c) Repealed. Pub. L. 98-473, title II, 224(a)(2), formerly 224(
a)(6), Oct. 12, 1984, 98 Stat. 2030, as renumbered by Pub. L.
99-570, title I, 1005(a)(2), Oct. 27, 1986, 100 Stat. 3207-6
(d) Offenses involving listed chemicals
Any person who knowingly or intentionally --
(1) possesses a listed chemical with intent to manufacture a
controlled substance except as authorized by this subchapter;
(2) possesses or distributes a listed chemical knowing, or having
reasonable cause to believe, that the listed chemical will be used to
manufacture a controlled substance except as authorized by this
subchapter; or
(3) with the intent of causing the evasion of the recordkeeping or
reporting requirements of section 830 of this title, or the regulations
issued under that section, receives or distributes a reportable amount
of any listed chemical in units small enough so that the making of
records or filing of reports under that section is not required;
shall be fined in accordance with title 18 or imprisoned not more
than 10 years, or both.
(e) Boobytraps on Federal property; penalties; ''boobytrap''
defined
(1) Any person who assembles, maintains, places, or causes to be
placed a boobytrap on Federal property where a controlled substance is
being manufactured, distributed, or dispensed shall be sentenced to a
term of imprisonment for not more than 10 years and shall be fined not
more than $10,000.
(2) If any person commits such a violation after 1 or more prior
convictions for an offense punishable under this subsection, such person
shall be sentenced to a term of imprisonment of not more than 20 years
and shall be fined not more than $20,000.
(3) For the purposes of this subsection, the term ''boobytrap'' means
any concealed or camouflaged device designed to cause bodily injury when
triggered by any action of any unsuspecting person making contact with
the device. Such term includes guns, ammunition, or explosive devices
attached to trip wires or other triggering mechanisms, sharpened stakes,
and lines or wires with hooks attached.
(f) Ten-year injunction as additional penalty
In addition to any other applicable penalty, any person convicted of
a felony violation of this section relating to the receipt,
distribution, or importation of a listed chemical may be enjoined from
engaging in any regulated transaction involving a listed chemical for
not more than ten years.
(g) Wrongful distribution or possession of listed chemicals
(1) Whoever knowingly distributes a listed chemical in violation of
this subchapter (other than in violation of a recordkeeping or reporting
requirement of section 830 of this title) shall be fined under title 18
or imprisoned not more than 5 years, or both.
(2) Whoever possesses any listed chemical, with knowledge that the
recordkeeping or reporting requirements of section 830 of this title
have not been adhered to, if, after such knowledge is acquired, such
person does not take immediate steps to remedy the violation shall be
fined under title 18 or imprisoned not more than one year, or both.
(Pub. L. 91-513, title II, 401, Oct. 27, 1970, 84 Stat. 1260; Pub.
L. 95-633, title II, 201, Nov. 10, 1978, 92 Stat. 3774; Pub. L.
96-359, 8(c), Sept. 26, 1980, 94 Stat. 1194; Pub. L. 98-473, title II,
224(a), 502, 503(b)(1), (2), Oct. 12, 1984, 98 Stat. 2030, 2068, 2070;
Pub. L. 99-570, title I, 1002, 1003(a), 1004(a), 1005(a), 1103, title
XV, 15005, Oct. 27, 1986, 100 Stat. 3207-2, 3207-5, 3207-6, 3207-11,
3702-192; Pub. L. 100-690, title VI, 6055, 6254(h), 6452(a), 6470(g),
(h), 6479, Nov. 18, 1988, 102 Stat. 4318, 4367, 4371, 4378, 4381; Pub.
L. 101-647, title X, 1002(e), title XII, 1202, title XXXV, 3599K, Nov.
29, 1990, 104 Stat. 4828, 4830, 4932.)
This subchapter, referred to in subsecs. (a), (b)(1) to (3), (d)(
1), (2), and (g)(1), was in the original ''this title'', meaning title
II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as amended, and
is popularly known as the ''Controlled Substances Act''. For complete
classification of title II to the Code, see second paragraph of Short
Title note set out under section 801 of this title and Tables.
Schedules I, II, III, IV, and V, referred to in subsec. (b), are set
out in section 812(c) of this title.
Subchapter II of this chapter, referred to in subsec. (b)(1) to (3),
was in the original ''title III'', meaning title III of Pub. L.
91-513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises
subchapter II of this chapter. For classification of Part B, consisting
of sections 1101 to 1105 of title III, see Tables.
1990 -- Subsec. (b). Pub. L. 101-647, 1002(e)(1), substituted
''section 859, 860, or 861'' for ''section 845, 845a, or 845b'' in
introductory provisions.
Subsec. (b)(1)(A). Pub. L. 101-647, 1002(e)(1), substituted ''section
859, 860, or 861'' for ''section 845, 845a, or 845b'' in concluding
provisions.
Subsec. (b)(1)(A)(ii)(IV). Pub. L. 101-647, 3599K, substituted ''any
of the substances'' for ''any of the substance''.
Subsec. (b)(1)(A)(viii). Pub. L. 101-647, 1202, substituted ''or 1
kilogram or more of a mixture or substance containing a detectable
amount of methamphetamine'' for ''or 100 grams or more of a mixture or
substance containing a detectable amount of methamphetamine''.
Subsec. (b)(1)(B)(ii)(IV). Pub. L. 101-647, 3599K, substituted ''any
of the substances'' for ''any of the substance''.
Subsec. (c). Pub. L. 101-647, 1002(e)(2), directed amendment of
subsec. (c) by substituting ''section 859, 860, or 861 of this title''
for ''section 845, 845a, or 845b of this title''. Subsec. (c) was
previously repealed by Pub. L. 98-473, 224(a)(2), as renumbered by Pub.
L. 99-570, 1005(a), effective Nov. 1, 1987, and applicable only to
offenses committed after the taking effect of such amendment. See 1984
Amendment note and Effective Date of 1984 Amendment note below.
1988 -- Subsec. (b)(1)(A). Pub. L. 100-690, 6452(a), 6470(g), 6479(
1), inserted '', or 1,000 or more marihuana plants regardless of
weight'' in cl. (vii), added cl. (viii), substituted ''a prior
conviction for a felony drug offense has become final'' for ''one or
more prior convictions for an offense punishable under this paragraph,
or for a felony under any other provision of this subchapter or
subchapter II of this chapter or other law of a State, the United
States, or a foreign country relating to narcotic drugs, marihuana, or
depressant or stimulant substances, have become final'' in second
sentence, and added provisions relating to sentencing for a person who
violates this subpar. or section 485, 485a, or 485b of this title after
two or more prior convictions for a felony drug offense have become
final and defining ''felony drug offense''.
Subsec. (b)(1)(B). Pub. L. 100-690, 6470(h), 6479(2), inserted '', or
100 or more marihuana plants regardless of weight'' in cl. (vii) and
added cl. (viii).
Subsec. (b)(1)(D). Pub. L. 100-690, 6479(3), substituted ''50 or more
marihuana plants'' for ''100 or more marihuana plants''.
Subsec. (b)(6). Pub. L. 100-690, 6254(h), added par. (6).
Subsec. (d). Pub. L. 100-690, 6055(a), amended subsec. (d)
generally. Prior to amendment, subsec. (d) read as follows: ''Any
person who knowingly or intentionally --
''(1) possesses any piperidine with intent to manufacture
phencyclidine except as authorized by this subchapter, or
''(2) possesses any piperidine knowing, or having reasonable cause to
believe, that the piperidine will be used to manufacture phencyclidine
except as authorized by this subchapter,
shall be sentenced to a term of imprisonment of not more than 5
years, a fine not to exceed the greater of that authorized in accordance
with the provisions of title 18 or $250,000 if the defendant is an
individual or $1,000,000 if the defendant is other than an individual,
or both.''
Subsecs. (f), (g). Pub. L. 100-690, 6055(b), added subsecs. (f) and
(g).
1986 -- Pub. L. 99-570, 1005(a), amended Pub. L. 98-473, 224(a).
See 1984 Amendment note below.
Subsec. (b). Pub. L. 99-570, 1103(a), substituted '', 845a, or 845b''
for ''or 845a'' in introductory provisions.
Subsec. (b)(1)(A). Pub. L. 99-570, 1002(2), amended subpar. (A)
generally. Prior to amendment, subpar. (A) read as follows: ''In the
case of a violation of subsection (a) of this section involving --
''(i) 100 grams or more of a controlled substance in schedule I or II
which is a mixture or substance containing a detectable amount of a
narcotic drug other than a narcotic drug consisting of --
''(I) coca leaves;
''(II) a compound, manufacture, salt, derivative, or preparation of
coca leaves; or
''(III) a substance chemically identical thereto;
''(ii) a kilogram or more of any other controlled substance in
schedule I or II which is a narcotic drug;
''(iii) 500 grams or more of phencyclidine (PCP); or
''(iv) 5 grams or more of lysergic acid diethylamide (LSD);
such person shall be sentenced to a term of imprisonment of not more
than 20 years, a fine of not more than $250,000, or both. If any person
commits such a violation after one or more prior convictions of him for
an offense punishable under this paragraph, or for a felony under any
other provision of this subchapter or subchapter II of this chapter or
other law of a State, the United States, or a foreign country relating
to narcotic drugs, marihuana, or depressant or stimulant substances,
have become final, such person shall be sentenced to a term of
imprisonment of not more than 40 years, a fine of not more than
$500,000, or both''.
Subsec. (b)(1)(B). Pub. L. 99-570, 1002(2), amended subpar. (B)
generally. Prior to amendment, subpar. (B) read as follows: ''In the
case of a controlled substance in schedule I or II except as provided in
subparagraphs (A) and (C),, such person shall be sentenced to a term of
imprisonment of not more than 15 years, a fine of not more than
$125,000, or both. If any person commits such a violation after one or
more prior convictions of him for an offense punishable under this
paragraph, or for a felony under any other provision of this subchapter
or subchapter II of this chapter or other law of a State, the United
States, or a foreign country relating to narcotic drugs, marihuana, or
depressant or stimulant substances, have become final, such person shall
be sentenced to a term of imprisonment of not more than 30 years, a fine
of not more than $250,000, or both. Any sentence imposing a term of
imprisonment under this paragraph shall, in the absence of such a prior
conviction, impose a special parole term of at least 3 years in addition
to such term of imprisonment and shall, if there was such a prior
conviction, impose a special parole term of at least 6 years in addition
to such term of imprisonment.''
Subsec. (b)(1)(C). Pub. L. 99-570, 1002(2), added subpar. (C).
Former subpar. (C) redesignated (D).
Subsec. (b)(1)(D). Pub. L. 99-570, 1004(a), substituted ''term of
supervised release'' for ''special parole term'' in two places.
Pub. L. 99-570, 1002(1), 1003(a)(1), redesignated former subpar. (C)
as (D), substituted ''a fine not to exceed the greater of that
authorized in accordance with the provisions of title 18 or $250,000 if
the defendant is an individual or $1,000,000 if the defendant is other
than an individual'' for ''a fine of not more than $50,000'' and ''a
fine not to exceed the greater of twice that authorized in accordance
with the provisions of title 18 or $500,000 if the defendant is an
individual or $2,000,000 if the defendant is other than an individual''
for ''a fine of not more than $100,000'', and inserted ''except in the
case of 100 or more marihuana plants regardless of weight,''.
Subsec. (b)(2). Pub. L. 99-570, 1004(a), substituted ''term of
supervised release'' for ''special parole term'' in two places.
Pub. L. 99-570, 1003(a)(2), substituted ''a fine not to exceed the
greater of that authorized in accordance with the provisions of title 18
or $250,000 if the defendant is an individual or $1,000,000 if the
defendant is other than an individual'' for ''a fine of not more than
$25,000'' and ''a fine not to exceed the greater of twice that
authorized in accordance with the provisions of title 18 or $500,000 if
the defendant is an individual or $2,000,000 if the defendant is other
than an individual'' for ''a fine of not more than $50,000''.
Subsec. (b)(3). Pub. L. 99-570, 1003(a)(3), substituted ''a fine not
to exceed the greater of that authorized in accordance with the
provisions of title 18 or $100,000 if the defendant is an individual or
$250,000 if the defendant is other than an individual'' for ''a fine of
not more than $10,000'' and ''a fine not to exceed the greater of twice
that authorized in accordance with the provisions of title 18 or
$200,000 if the defendant is an individual or $500,000 if the defendant
is other than an individual'' for ''a fine of not more than $20,000''.
Subsec. (b)(4). Pub. L. 99-570, 1003(a)(4), which directed the
substitution of ''1(D)'' for ''1(C)'' was executed by substituting
''(1)(D)'' for ''(1)(C)'' as the probable intent of Congress.
Subsec. (b)(5). Pub. L. 99-570, 1003(a)(5), amended par. (5)
generally. Prior to amendment, par. (5) read as follows:
''Notwithstanding paragraph (1), any person who violates subsection (a)
of this section by cultivating a controlled substance on Federal
property shall be fined not more than --
''(A) $500,000 if such person is an individual; and
''(B) $1,000,000 if such person is not an individual.''
Subsec. (c). Pub. L. 99-570, 1004(a), substituted ''term of
supervised release'' for ''special parole term'' wherever appearing,
effective Nov. 1, 1987, the effective date of the repeal of subsec.
(c) by Pub. L. 98-473, 224(a)(2). See 1984 Amendment note below.
Pub. L. 99-570, 1103(b), substituted '', 845a, or 845b'' for ''845a''
in two places.
Subsec. (d). Pub. L. 99-570, 1003(a)(6), substituted ''a fine not to
exceed the greater of that authorized in accordance with the provisions
of title 18 or $250,000 if the defendant is an individual or $1,000,000
if the defendant is other than an individual'' for ''a fine of not more
than $15,000''.
Subsec. (e). Pub. L. 99-570, 15005, added subsec. (e).
1984 -- Subsec. (b). Pub. L. 98-473, 503(b)(1), inserted reference
to section 845a of this title in provisions preceding par. (1)(A).
Pub. L. 98-473, 224(a)(1)-(3), (5), which directed amendment of this
subsection effective Nov. 1, 1987 (see section 235(a)(1) of Pub. L.
98-473 set out as an Effective Date note under section 3551 of Title 18,
Crimes and Criminal Procedure) was repealed by Pub. L. 99-570, 1005(a),
and the remaining pars. (4) and (6) of Pub. L. 98-473, 224( a), were
redesignated as pars. (1) and (2), respectively.
Subsec. (b)(1)(A). Pub. L. 98-473, 502(1)(A), added subpar. (A).
Former subpar. (A) redesignated (B).
Subsec. (b)(1)(B). Pub. L. 98-473, 502(1)(A), (B), redesignated
former subpar. (A) as (B), substituted ''except as provided in
subparagraphs (A) and (C),'' for ''which is a narcotic drug'',
''$125,000'' for ''$25,000'', and ''$250,000'' for ''$50,000'', and
inserted references to laws of a State and a foreign country. Former
subpar. (B) redesignated (C).
Subsec. (b)(1)(C). Pub. L. 98-473, 502(1)(A), (C), redesignated
former subpar. (B) as (C), substituted ''less than 50 kilograms of
marihuana, 10 kilograms of hashish, or one kilogram of hashish oil'' for
''a controlled substance in schedule I or II which is not a narcotic
drug'', ''and (5)'' for '', (5), and (6)'', ''$50,000'' for ''$15,000'',
and ''$100,000'' for ''$30,000'', and inserted references to laws of a
State and a foreign country.
Subsec. (b)(2). Pub. L. 98-473, 502(2), substituted ''$25,000'' for
''$10,000'' and ''$50,000'' for ''$20,000'', and inserted references to
laws of a State or of a foreign country.
Subsec. (b)(3). Pub. L. 98-473, 502(3), substituted ''$10,000'' for
''$5,000'' and ''$20,000'' for ''$10,000'', and inserted references to
laws of a State or of a foreign country.
Subsec. (b)(4). Pub. L. 98-473, 502(4), substituted ''(1)(C)'' for
''(1)(B)''.
Pub. L. 98-473, 224(a)(1), as renumbered by Pub. L. 99-570, 1005(
a), substituted ''in section 844 of this title and section 3607 of title
18'' for ''in subsections (a) and (b) of section 844 of this title''.
Subsec. (b)(5). Pub. L. 98-473, 502(5), (6), added par. (5) and
struck out former par. (5) which related to penalties for
manufacturing, etc., phencyclidine.
Subsec. (b)(6). Pub. L. 98-473, 502(5), struck out par. (6) which
related to penalties for violations involving a quantity of marihuana
exceeding 1,000 pounds.
Subsec. (c). Pub. L. 98-473, 224(a)(2), as renumbered by Pub. L.
99-570, 1005(a), struck out subsec. (c) which read as follows: ''A
special parole term imposed under this section or section 845, 845a, or
845b of this title may be revoked if its terms and conditions are
violated. In such circumstances the original term of imprisonment shall
be increased by the period of the special parole term and the resulting
new term of imprisonment shall not be diminished by the time which was
spent on special parole. A person whose special parole term has been
revoked may be required to serve all or part of the remainder of the new
term of imprisonment. A special parole term provided for in this
section or section 845, 845a, or 845b of this title shall be in addition
to, and not in lieu of, any other parole provided for by law.''
Pub. L. 98-473, 503(b)(2), inserted reference to section 845a of this
title in two places.
1980 -- Subsec. (b)(1)(B). Pub. L. 96-359, 8(c)(1), inserted
reference to par. (6) of this subsection.
Subsec. (b)(6). Pub. L. 96-359, 8(c)(2), added par. (6).
1978 -- Subsec. (b)(1)(B). Pub. L. 95-633, 201(1), inserted '',
except as provided in paragraphs (4) and (5) of this subsection,'' after
''such person shall''.
Subsec. (b)(5). Pub. L. 95-633, 201(2), added par. (5).
Subsec. (d). Pub. L. 95-633, 201(3), added subsec. (d).
Amendment by section 6055 of Pub. L. 100-690 effective 120 days
after Nov. 18, 1988, see section 6061 of Pub. L. 100-690, set out as a
note under section 802 of this title.
Section 1004(b) of Pub. L. 99-570 provided that: ''The amendments
made by this section (amending this section and sections 845, 845a, 960,
and 962 of this title) shall take effect on the date of the taking
effect of section 3583 of title 18, United States Code (Nov. 1, 1987).''
Amendment by section 224(a) of Pub. L. 98-473 effective Nov. 1,
1987, and applicable only to offenses committed after the taking effect
of such amendment, see section 235(a)(1) of Pub. L. 98-473, set out as
an Effective Date note under section 3551 of Title 18, Crimes and
Criminal Procedure.
Amendment by Pub. L. 95-633 effective Nov. 10, 1978, see section
203(a) of Pub. L. 95-633 set out as an Effective Date note under
section 830 of this title.
Pub. L. 96-359, 8(b), Sept. 26, 1980, 94 Stat. 1194, repealed
section 203(d) of Pub. L. 95-633, which had provided for the repeal of
subsec. (d) of this section effective Jan. 1, 1981.
559d; title 18 sections 5032, 5038; title 28 section
994.
21 USC 842. Prohibited acts B
TITLE 21 -- FOOD AND DRUGS
(a) Unlawful acts
It shall be unlawful for any person --
(1) who is subject to the requirements of part C to distribute or
dispense a controlled substance in violation of section 829 of this
title;
(2) who is a registrant to distribute or dispense a controlled
substance not authorized by his registration to another registrant or
other authorized person or to manufacture a controlled substance not
authorized by his registration;
(3) who is a registrant to distribute a controlled substance in
violation of section 825 of this title;
(4) to remove, alter, or obliterate a symbol or label required by
section 825 of this title;
(5) to refuse or fail to make, keep, or furnish any record, report,
notification, declaration, order or order form, statement, invoice, or
information required under this subchapter or subchapter II of this
chapter;
(6) to refuse any entry into any premises or inspection authorized by
this subchapter or subchapter II of this chapter;
(7) to remove, break, injure, or deface a seal placed upon controlled
substances pursuant to section 824(f) or 881 of this title or to remove
or dispose of substances so placed under seal;
(8) to use, to his own advantage, or to reveal, other than to duly
authorized officers or employees of the United States, or to the courts
when relevant in any judicial proceeding under this subchapter or
subchapter II of this chapter, any information acquired in the course of
an inspection authorized by this subchapter concerning any method or
process which as a trade secret is entitled to protection, or to use to
his own advantage or reveal (other than as authorized by section 830 of
this title) any information that is confidential under such section;
(9) who is a regulated person to engage in a regulated transaction
without obtaining the identification required by 830(a)(3) of this
title; or
(10) to fail to keep a record or make a report under section 830 of
this title.
(b) Manufacture
It shall be unlawful for any person who is a registrant to
manufacture a controlled substance in schedule I or II which is --
(1) not expressly authorized by his registration and by a quota
assigned to him pursuant to section 826 of this title; or
(2) in excess of a quota assigned to him pursuant to section 826 of
this title.
(c) Penalties
(1) Except as provided in paragraph (2), any person who violates this
section shall, with respect to any such violation, be subject to a civil
penalty of not more than $25,000. The district courts of the United
States (or, where there is no such court in the case of any territory or
possession of the United States, then the court in such territory or
possession having the jurisdiction of a district court of the United
States in cases arising under the Constitution and laws of the United
States) shall have jurisdiction in accordance with section 1355 of title
28 to enforce this paragraph.
(2)(A) If a violation of this section is prosecuted by an information
or indictment which alleges that the violation was committed knowingly
and the trier of fact specifically finds that the violation was so
committed, such person shall, except as otherwise provided in
subparagraph (B) of this paragraph, be sentenced to imprisonment of not
more than one year or a fine of not more than $25,000, or both.
(B) If a violation referred to in subparagraph (A) was committed
after one or more prior convictions of the offender for an offense
punishable under this paragraph (2), or for a crime under any other
provision of this subchapter or subchapter II of this chapter or other
law of the United States relating to narcotic drugs, marihuana, or
depressant or stimulant substances, have become final, such person shall
be sentenced to a term of imprisonment of not more than 2 years, a fine
of $50,000, or both.
(3) Except under the conditions specified in paragraph (2) of this
subsection, a violation of this section does not constitute a crime, and
a judgment for the United States and imposition of a civil penalty
pursuant to paragraph (1) shall not give rise to any disability or legal
disadvantage based on conviction for a criminal offense.
(Pub. L. 91-513, title II, 402, Oct. 27, 1970, 84 Stat. 1262; Pub.
L. 95-633, title II, 202(b)(1), (2), Nov. 10, 1978, 92 Stat. 3776; Pub.
L. 100-690, title VI, 6056, Nov. 18, 1988, 102 Stat. 4318.)
Schedules I and II, referred to in subsec. (b), are set out in
section 812(c) of this title.
1988 -- Subsec. (a)(8). Pub. L. 100-690, 6056(a), inserted '', or to
use to his own advantage or reveal (other than as authorized by section
830 of this title) any information that is confidential under such
section'' after ''protection''.
Subsec. (a)(9). Pub. L. 100-690, 6056(b), amended par. (9)
generally. Prior to amendment, par. (9) read as follows: ''to
distribute or sell piperidine in violation of regulations established
under section 830(a)(2) of this title, respecting presentation of
identification.''
Subsec. (a)(10). Pub. L. 100-690, 6056(d), added par. (10).
Subsec. (c)(2)(C). Pub. L. 100-690, 6056(c), struck out subpar. (C)
which read as follows: ''Subparagraphs (A) and (B) shall not apply to a
violation of subsection (a)(5) of this section with respect to a refusal
or failure to make a report required under section 830(a) of this title
(relating to piperidine reporting).''
1978 -- Subsec. (a)(9). Pub. L. 95-633, 202(b)(1), added par. (9).
Subsec. (c)(2)(C). Pub. L. 95-633, 202(b)(2), added subpar. (C).
Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
1988, see section 6061 of Pub. L. 100-690, set out as a note under
section 802 of this title.
Amendment by Pub. L. 95-633 effective Nov. 10, 1978, see section
203(a) of Pub. L. 95-633 set out as an Effective Date note under
section 830 of this title.
Pub. L. 96-359, 8(b), Sept. 26, 1980, 94 Stat. 1194, repealed
section 203(d) of Pub. L. 95-633, which had provided for the repeal of
subsecs. (a)(9) and (c)(2)(C) of this section effective Jan. 1, 1981.
21 USC 843. Prohibited acts C
TITLE 21 -- FOOD AND DRUGS
(a) Unlawful acts
It shall be unlawful for any person knowingly or intentionally --
(1) who is a registrant to distribute a controlled substance
classified in schedule I or II, in the course of his legitimate
business, except pursuant to an order or an order form as required by
section 828 of this title;
(2) to use in the course of the manufacture, distribution, or
dispensing of a controlled substance, or to use for the purpose of
acquiring or obtaining a controlled substance, a registration number
which is fictitious, revoked, suspended, expired, or issued to another
person;
(3) to acquire or obtain possession of a controlled substance by
misrepresentation, fraud, forgery, deception, or subterfuge;
(4)(A) to furnish false or fraudulent material information in, or
omit any material information from, any application, report, record, or
other document required to be made, kept, or filed under this subchapter
or subchapter II of this chapter, or (B) to present false or fraudulent
identification where the person is receiving or purchasing a listed
chemical and the person is required to present identification under
section 830(a) of this title;
(5) to make, distribute, or possess any punch, die, plate, stone, or
other thing designed to print, imprint, or reproduce the trademark,
trade name, or other identifying mark, imprint, or device of another or
any likeness of any of the foregoing upon any drug or container or
labeling thereof so as to render such drug a counterfeit substance;
(6) to possess any three-neck round-bottom flask, tableting machine,
encapsulating machine, gelatin capsule, or equipment specially designed
or modified to manufacture a controlled substance, with intent to
manufacture a controlled substance except as authorized by this
subchapter;
(7) to manufacture, distribute, or import any three-neck round-bottom
flask, tableting machine, encapsulating machine, gelatin capsule, or
equipment specially designed or modified to manufacture a controlled
substance, knowing that it will be used to manufacture a controlled
substance except as authorized by this subchapter; or
(8) to create a chemical mixture for the purpose of evading a
requirement of section 830 of this title or to receive a chemical
mixture created for that purpose.
(b) Communication facility
It shall be unlawful for any person knowingly or intentionally to use
any communication facility in committing or in causing or facilitating
the commission of any act or acts constituting a felony under any
provision of this subchapter or subchapter II of this chapter. Each
separate use of a communication facility shall be a separate offense
under this subsection. For purposes of this subsection, the term
''communication facility'' means any and all public and private
instrumentalities used or useful in the transmission of writing, signs,
signals, pictures, or sounds of all kinds and includes mail, telephone,
wire, radio, and all other means of communication.
(c) Penalties
Any person who violates this section shall be sentenced to a term of
imprisonment of not more than 4 years, a fine of not more than $30,000,
or both; except that if any person commits such a violation after one
or more prior convictions of him for violation of this section, or for a
felony under any other provision of this subchapter or subchapter II of
this chapter or other law of the United States relating to narcotic
drugs, marihuana, or depressant or stimulant substances, have become
final, such person shall be sentenced to a term of imprisonment of not
more than 8 years, a fine of not more than $60,000, or both.
(d) Additional penalties
In addition to any other applicable penalty, any person convicted of
a felony violation of this section relating to the receipt,
distribution, or importation of a listed chemical may be enjoined from
engaging in any regulated transaction involving a listed chemical for
not more than ten years.
(Pub. L. 91-513, title II, 403, Oct. 27, 1970, 84 Stat. 1263; Pub.
L. 95-633, title II, 202(b)(3), Nov. 10, 1978, 92 Stat. 3776; Pub. L.
98-473, title II, 516, Oct. 12, 1984, 98 Stat. 2074; Pub. L. 99-570,
title I, 1866(a), Oct. 27, 1986, 100 Stat. 3207-54; Pub. L. 100-690,
title VI, 6057, Nov. 18, 1988, 102 Stat. 4319.)
Schedules I and II, referred to in subsec. (a)(1), are set out in
section 812(c) of this title.
1988 -- Subsec. (a)(4)(B). Pub. L. 100-690, 6057(a)(1), substituted
''a listed chemical'' for ''piperidine''.
Subsec. (a)(6) to (8). Pub. L. 100-690, 6057(a)(2)-(4), added pars.
(6) to (8).
Subsec. (d). Pub. L. 100-690, 6057(b), added subsec. (d).
1986 -- Subsec. (a)(2). Pub. L. 99-570 substituted a semicolon for
the period at end.
1984 -- Subsec. (a)(2). Pub. L. 98-473 added applicability to
dispensing, acquiring, or obtaining a controlled substance, and
applicability to an expired number.
1978 -- Subsec. (a)(4). Pub. L. 95-633, 202(b)(3), designated
existing provisions as subpar. (A) and added subpar. (B).
Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
1988, see section 6061 of Pub. L. 100-690, set out as a note under
section 802 of this title.
Amendment by Pub. L. 95-633 effective Nov. 10, 1978, except as
otherwise provided, see section 203(a) of Pub. L. 95-633, set out as an
Effective Date note under section 830 of this title.
Pub. L. 96-359, 8(b), Sept. 26, 1980, 94 Stat. 1194, repealed
section 203(d) of Pub. L. 95-633, which had provided for the repeal of
subsec. (a)(4)(B) of this section effective Jan. 1, 1981.
21 USC 844. Penalties for simple possession
TITLE 21 -- FOOD AND DRUGS
(a) Unlawful acts; penalties
It shall be unlawful for any person knowingly or intentionally to
possess a controlled substance unless such substance was obtained
directly, or pursuant to a valid prescription or order, from a
practitioner, while acting in the course of his professional practice,
or except as otherwise authorized by this subchapter or subchapter II of
this chapter. Any person who violates this subsection may be sentenced
to a term of imprisonment of not more than 1 year, and shall be fined a
minimum of $1,000, or both, except that if he commits such offense after
a prior conviction under this subchapter or subchapter II of this
chapter, or a prior conviction for any drug or narcotic offense
chargeable under the law of any State, has become final, he shall be
sentenced to a term of imprisonment for not less than 15 days but not
more than 2 years, and shall be fined a minimum of $2,500, except,
further, that if he commits such offense after two or more prior
convictions under this subchapter or subchapter II of this chapter, or
two or more prior convictions for any drug or narcotic offense
chargeable under the law of any State, or a combination of two or more
such offenses have become final, he shall be sentenced to a term of
imprisonment for not less than 90 days but not more than 3 years, and
shall be fined a minimum of $5,000. Notwithstanding the preceding
sentence, a person convicted under this subsection for the possession of
a mixture or substance which contains cocaine base shall be imprisoned
not less than 5 years and not more than 20 years, and fined a minimum of
$1,000, if the conviction is a first conviction under this subsection
and the amount of the mixture or substance exceeds 5 grams, if the
conviction is after a prior conviction for the possession of such a
mixture or substance under this subsection becomes final and the amount
of the mixture or substance exceeds 3 grams, or if the conviction is
after 2 or more prior convictions for the possession of such a mixture
or substance under this subsection become final and the amount of the
mixture or substance exceeds 1 gram. The imposition or execution of a
minimum sentence required to be imposed under this subsection shall not
be suspended or deferred. Further, upon conviction, a person who
violates this subsection shall be fined the reasonable costs of the
investigation and prosecution of the offense, including the costs of
prosecution of an offense as defined in sections 1918 and 1920 of title
28, except that this sentence shall not apply and a fine under this
section need not be imposed if the court determines under the provision
of title 18 that the defendant lacks the ability to pay.
(b) Repealed. Pub. L. 98-473, title II, 219(a), Oct. 12, 1984, 98
Stat. 2027
(c) ''Drug or narcotic offense'' defined
As used in this section, the term ''drug or narcotic offense'' means
any offense which proscribes the possession, distribution, manufacture,
cultivation, sale, transfer, or the attempt or conspiracy to possess,
distribute, manufacture, cultivate, sell or transfer any substance the
possession of which is prohibited under this subchapter.
(Pub. L. 91-513, title II, 404, Oct. 27, 1970, 84 Stat. 1264; Pub.
L. 98-473, title II, 219, Oct. 12, 1984, 98 Stat. 2027; Pub. L.
99-570, title I, 1052, Oct. 27, 1986, 100 Stat. 3207-8; Pub. L.
100-690, title VI, 6371, 6480, Nov. 18, 1988, 102 Stat. 4370, 4382;
Pub. L. 101-647, title XII, 1201, title XIX, 1907, Nov. 29, 1990, 104
Stat. 4829, 4854.)
1990 -- Subsec. (a). Pub. L. 101-647, 1907, inserted subsec. (a)
designation.
Pub. L. 101-647, 1201, substituted ''shall be imprisoned not less
than 5 years and not more than 20 years, and fined a minimum of $1,000''
for ''shall be fined under title 18 or imprisoned not less than 5 years
and not more than 20 years, or both''.
1988 -- Subsec. (a). Pub. L. 100-690, 6480(1)(A)-(C), struck out
''but not more than $5,000'' after ''$1,000'', ''but not more than
$10,000'' after ''$2,500'', and ''but not more than $25,000'' after
''$5,000'' in second sentence.
Pub. L. 100-690, 6371, inserted provisions relating to increased
penalties in cases of certain serious crack possession offenses, making
offenders subject to fines under title 18 or imprisonment to terms not
less than 5 years nor more than 20 years, or both.
1986 -- Subsec. (a). Pub. L. 99-570 amended subsec. (a) generally.
Prior to amendment, subsec. (a) read as follows: ''It shall be
unlawful for any person knowingly or intentionally to possess a
controlled substance unless such substance was obtained directly, or
pursuant to a valid prescription or order, from a practitioner, while
acting in the course of his professional practice, or except as
otherwise authorized by this subchapter or subchapter II of this
chapter. Any person who violates this subsection shall be sentenced to
a term of imprisonment of not more than one year, a fine of not more
than $5,000, or both, except that if he commits such offense after a
prior conviction or convictions under this subsection have become final,
he shall be sentenced to a term of imprisonment of not more than 2
years, a fine of not more than $10,000 or both.''
Subsec. (b). Pub. L. 99-570, in amending subsec. (b) generally,
substituted ''Upon the discharge of such person and dismissal of the
proceedings'' for ''Upon the dismissal of such person and discharge of
the proceedings'' in par. (2).
Subsec. (c). Pub. L. 99-570, in amending section generally, added
subsec. (c).
1984 -- Pub. L. 98-473 struck out subsec. (a) designation and
struck out subsec. (b) which related to probation before judgment and
expunging of records for first offense.
Amendment by Pub. L. 98-473 effective Nov. 1, 1987, and applicable
only to offenses committed after the taking effect of such amendment,
see section 235(a)(1) of Pub. L. 98-473, set out as an Effective Date
note under section 3551 of Title 18, Crimes and Criminal Procedure.
21 USC 844a. Civil penalty for possession of small amounts of certain
controlled substances
TITLE 21 -- FOOD AND DRUGS
(a) In general
Any individual who knowingly possesses a controlled substance that is
listed in section 841(b)(1)(A) of this title in violation of section 844
of this title in an amount that, as specified by regulation of the
Attorney General, is a personal use amount shall be liable to the United
States for a civil penalty in an amount not to exceed $10,000 for each
such violation.
(b) Income and net assets
The income and net assets of an individual shall not be relevant to
the determination whether to assess a civil penalty under this section
or to prosecute the individual criminally. However, in determining the
amount of a penalty under this section, the income and net assets of an
individual shall be considered.
(c) Prior conviction
A civil penalty may not be assessed under this section if the
individual previously was convicted of a Federal or State offense
relating to a controlled substance.
(d) Limitation on number of assessments
A civil penalty may not be assessed on an individual under this
section on more than two separate occasions.
(e) Assessment
A civil penalty under this section may be assessed by the Attorney
General only by an order made on the record after opportunity for a
hearing in accordance with section 554 of title 5. The Attorney General
shall provide written notice to the individual who is the subject of the
proposed order informing the individual of the opportunity to receive
such a hearing with respect to the proposed order. The hearing may be
held only if the individual makes a request for the hearing before the
expiration of the 30-day period beginning on the date such notice is
issued.
(f) Compromise
The Attorney General may compromise, modify, or remit, with or
without conditions, any civil penalty imposed under this section.
(g) Judicial review
If the Attorney General issues an order pursuant to subsection (e) of
this section after a hearing described in such subsection, the
individual who is the subject of the order may, before the expiration of
the 30-day period beginning on the date the order is issued, bring a
civil action in the appropriate district court of the United States. In
such action, the law and the facts of the violation and the assessment
of the civil penalty shall be determined de novo, and shall include the
right of a trial by jury, the right to counsel, and the right to
confront witnesses. The facts of the violation shall be proved beyond a
reasonable doubt.
(h) Civil action
If an individual does not request a hearing pursuant to subsection
(e) of this section and the Attorney General issues an order pursuant to
such subsection, or if an individual does not under subsection (g) of
this section seek judicial review of such an order, the Attorney General
may commence a civil action in any appropriate district court of the
United States for the purpose of recovering the amount assessed and an
amount representing interest at a rate computed in accordance with
section 1961 of title 28. Such interest shall accrue from the
expiration of the 30-day period described in subsection (g) of this
section. In such an action, the decision of the Attorney General to
issue the order, and the amount of the penalty assessed by the Attorney
General, shall not be subject to review.
(i) Limitation
The Attorney General may not under this subsection /1/ commence
proceeding against an individual after the expiration of the 5-year
period beginning on the date on which the individual allegedly violated
subsection (a) of this section.
(j) Expungement procedures
The Attorney General shall dismiss the proceedings under this section
against an individual upon application of such individual at any time
after the expiration of 3 years if --
(1) the individual has not previously been assessed a civil penalty
under this section;
(2) the individual has paid the assessment;
(3) the individual has complied with any conditions imposed by the
Attorney General;
(4) the individual has not been convicted of a Federal or State
offense relating to a controlled substance; and
(5) the individual agrees to submit to a drug test, and such test
shows the individual to be drug free.
A nonpublic record of a disposition under this subsection shall be
retained by the Department of Justice solely for the purpose of
determining in any subsequent proceeding whether the person qualified
for a civil penalty or expungement under this section. If a record is
expunged under this subsection, an individual concerning whom such an
expungement has been made shall not be held thereafter under any
provision of law to be guilty of perjury, false swearing, or making a
false statement by reason of his failure to recite or acknowledge a
proceeding under this section or the results thereof in response to an
inquiry made of him for any purpose.
(Pub. L. 91-513, title II, 405, formerly Pub. L. 100-690, title VI,
6486, Nov. 18, 1988, 102 Stat. 4384, redesignated 405 of Pub. L.
91-513, and amended Pub. L. 101-647, title X, 1002(g)(1), (2), Nov. 29,
1990, 104 Stat. 4828.)
A prior section 405 of Pub. L. 91-513 was renumbered section 418 and
is classified to section 859 of this title.
1990 -- Subsec. (a). Pub. L. 101-647, 1002(g)(2)(A), made technical
amendments to references to sections 841(b)(1)(A) and 844 of this title
to correct references to corresponding provisions of original act.
Subsecs. (c), (j)(4). Pub. L. 101-647, 1002(g)(2)(B), (C), struck
out ''as defined in section 802 of this title'' after ''controlled
substance''.
/1/ So in original. Probably should be ''section''.
21 USC 845 to 845b. Transferred
TITLE 21 -- FOOD AND DRUGS
Section 845, Pub. L. 91-513, title II, 405, Oct. 27, 1970, 84 Stat.
1265, as amended, which related to distribution of controlled
substances to persons under age twenty-one, was renumbered 418 of Pub.
L. 91-513 by Pub. L. 101-647, title X, 1002(a)(1), Nov. 29, 1990, 104
Stat. 4827, and was transferred to section 859 of this title.
Section 845a, Pub. L. 91-513, title II, 405A, as added Pub. L.
98-473, title II, 503(a), Oct. 12, 1984, 98 Stat. 2069, and as
amended, which related to distribution or manufacturing of controlled
substances in or near schools and colleges, was renumbered 419 of Pub.
L. 91-513 by Pub. L. 101-647, title X, 1002(b), Nov. 29, 1990, 104
Stat. 4827, and was transferred to section 860 of this title.
Section 845b, Pub. L. 91-513, title II, 405B, as added Pub. L.
99-570, title I, 1102, Oct. 27, 1986, 100 Stat. 3207-10, and as
amended, which related to employment or use of persons under 18 years of
age in drug operations, was renumbered 420 of Pub. L. 91-513 by Pub.
L. 101-647, title X, 1002(c), Nov. 29, 1990, 104 Stat. 4827, and was
transferred to section 861 of this title.
21 USC 846. Attempt and conspiracy
TITLE 21 -- FOOD AND DRUGS
Any person who attempts or conspires to commit any offense defined in
this subchapter shall be subject to the same penalties as those
prescribed for the offense, the commission of which was the object of
the attempt or conspiracy.
(Pub. L. 91-513, title II, 406, Oct. 27, 1970, 84 Stat. 1265; Pub.
L. 100-690, title VI, 6470(a), Nov. 18, 1988, 102 Stat. 4377.)
1988 -- Pub. L. 100-690 substituted ''shall be subject to the same
penalties as those prescribed for the offense'' for ''is punishable by
imprisonment or fine or both which may not exceed the maximum punishment
prescribed for the offense''.
21 USC 847. Additional penalties
TITLE 21 -- FOOD AND DRUGS
Any penalty imposed for violation of this subchapter shall be in
addition to, and not in lieu of, any civil or administrative penalty or
sanction authorized by law.
(Pub. L. 91-513, title II, 407, Oct. 27, 1970, 84 Stat. 1265.)
21 USC 848. Continuing criminal enterprise
TITLE 21 -- FOOD AND DRUGS
(a) Penalties; forfeitures
Any person who engages in a continuing criminal enterprise shall be
sentenced to a term of imprisonment which may not be less than 20 years
and which may be up to life imprisonment, to a fine not to exceed the
greater of that authorized in accordance with the provisions of title 18
or $2,000,000 if the defendant is an individual or $5,000,000 if the
defendant is other than an individual, and to the forfeiture prescribed
in section 853 of this title; except that if any person engages in such
activity after one or more prior convictions of him under this section
have become final, he shall be sentenced to a term of imprisonment which
may not be less than 30 years and which may be up to life imprisonment,
to a fine not to exceed the greater of twice the amount authorized in
accordance with the provisions of title 18 or $4,000,000 if the
defendant is an individual or $10,000,000 if the defendant is other than
an individual, and to the forfeiture prescribed in section 853 of this
title.
(b) Life imprisonment for engaging in continuing criminal enterprise
Any person who engages in a continuing criminal enterprise shall be
imprisoned for life and fined in accordance with subsection (a) of this
section, if --
(1) such person is the principal administrator, organizer, or leader
of the enterprise or is one of several such principal administrators,
organizers, or leaders; and
(2)(A) the violation referred to in subsection (d)(1) of this section
involved at least 300 times the quantity of a substance described in
subsection 841(b)(1)(B) of this title, or
(B) the enterprise, or any other enterprise in which the defendant
was the principal or one of several principal administrators,
organizers, or leaders, received $10 million dollars in gross receipts
during any twelve-month period of its existence for the manufacture,
importation, or distribution of a substance described in section 841(
b)(1)(B) of this title.
(c) ''Continuing criminal enterprise'' defined
For purposes of subsection (a) of this section, a person is engaged
in a continuing criminal enterprise if --
(1) he violates any provision of this subchapter or subchapter II of
this chapter the punishment for which is a felony, and
(2) such violation is a part of a continuing series of violations of
this subchapter or subchapter II of this chapter --
(A) which are undertaken by such person in concert with five or more
other persons with respect to whom such person occupies a position of
organizer, a supervisory position, or any other position of management,
and
(B) from which such person obtains substantial income or resources.
(d) Suspension of sentence and probation prohibited
In the case of any sentence imposed under this section, imposition or
execution of such sentence shall not be suspended, probation shall not
be granted, and the Act of July 15, 1932 (D.C. Code, secs. 24-203 --
24-207), shall not apply.
(e) Death penalty
(1) In addition to the other penalties set forth in this section --
(A) any person engaging in or working in furtherance of a continuing
criminal enterprise, or any person engaging in an offense punishable
under section 841(b)(1)(A) of this title or section 960(b)(1) of this
title who intentionally kills or counsels, commands, induces, procures,
or causes the intentional killing of an individual and such killing
results, shall be sentenced to any term of imprisonment, which shall not
be less than 20 years, and which may be up to life imprisonment, or may
be sentenced to death; and
(B) any person, during the commission of, in furtherance of, or while
attempting to avoid apprehension, prosecution or service of a prison
sentence for, a felony violation of this subchapter or subchapter II of
this chapter who intentionally kills or counsels, commands, induces,
procures, or causes the intentional killing of any Federal, State, or
local law enforcement officer engaged in, or on account of, the
performance of such officer's official duties and such killing results,
shall be sentenced to any term of imprisonment, which shall not be less
than 20 years, and which may be up to life imprisonment, or may be
sentenced to death.
(2) As used in paragraph (1)(b), /1/ the term ''law enforcement
officer'' means a public servant authorized by law or by a Government
agency or Congress to conduct or engage in the prevention,
investigation, prosecution or adjudication of an offense, and includes
those engaged in corrections, probation, or parole functions.
(g) /2/ Hearing required with respect to death penalty
A person shall be subjected to the penalty of death for any offense
under this section only if a hearing is held in accordance with this
section.
(h) Notice by Government in death penalty cases
(1) Whenever the Government intends to seek the death penalty for an
offense under this section for which one of the sentences provided is
death, the attorney for the Government, a reasonable time before trial
or acceptance by the court of a plea of guilty, shall sign and file with
the court, and serve upon the defendant, a notice --
(A) that the Government in the event of conviction will seek the
sentence of death; and
(B) setting forth the aggravating factors enumerated in subsection
(n) of this section and any other aggravating factors which the
Government will seek to prove as the basis for the death penalty.
(2) The court may permit the attorney for the Government to amend
this notice for good cause shown.
(i) Hearing before court or jury
(1) When the attorney for the Government has filed a notice as
required under subsection (h) of this section and the defendant is found
guilty of or pleads guilty to an offense under subsection (e) of this
section, the judge who presided at the trial or before whom the guilty
plea was entered, or any other judge if the judge who presided at the
trial or before whom the guilty plea was entered is unavailable, shall
conduct a separate sentencing hearing to determine the punishment to be
imposed. The hearing shall be conducted --
(A) before the jury which determined the defendant's guilt;
(B) before a jury impaneled for the purpose of the hearing if --
(i) the defendant was convicted upon a plea of guilty;
(ii) the defendant was convicted after a trial before the court
sitting without a jury;
(iii) the jury which determined the defendant's guilt has been
discharged for good cause; or
(iv) after initial imposition of a sentence under this section,
redetermination of the sentence under this section is necessary; or
(C) before the court alone, upon the motion of the defendant and with
the approval of the Government.
(2) A jury impaneled under paragraph (1)(B) shall consist of 12
members, unless, at any time before the conclusion of the hearing, the
parties stipulate with the approval of the court that it shall consist
of any number less than 12.
(j) Proof of aggravating and mitigating factors
Notwithstanding rule 32(c) of the Federal Rules of Criminal
Procedure, when a defendant is found guilty of or pleads guilty to an
offense under subsection (e) of this section, no presentence report
shall be prepared. In the sentencing hearing, information may be
presented as to matters relating to any of the aggravating or mitigating
factors set forth in subsections (m) and (n) of this section, or any
other mitigating factor or any other aggravating factor for which notice
has been provided under subsection (h)(1)(B) of this section. Where
information is presented relating to any of the aggravating factors set
forth in subsection (n) of this section, information may be presented
relating to any other aggravating factor for which notice has been
provided under subsection (h)(1)(B) of this section. Information
presented may include the trial transcript and exhibits if the hearing
is held before a jury or judge not present during the trial, or at the
trial judge's discretion. Any other information relevant to such
mitigating or aggravating factors may be presented by either the
Government or the defendant, regardless of its admissibility under the
rules governing admission of evidence at criminal trials, except that
information may be excluded if its probative value is substantially
outweighed by the danger of unfair prejudice, confusion of the issues,
or misleading the jury. The Government and the defendant shall be
permitted to rebut any information received at the hearing and shall be
given fair opportunity to present argument as to the adequacy of the
information to establish the existence of any of the aggravating or
mitigating factors and as to appropriateness in that case of imposing a
sentence of death. The Government shall open the argument. The
defendant shall be permitted to reply. The Government shall then be
permitted to reply in rebuttal. The burden of establishing the
existence of any aggravating factor is on the Government, and is not
satisfied unless established beyond a reasonable doubt. The burden of
establishing the existence of any mitigating factor is on the defendant,
and is not satisfied unless established by a preponderance of the
evidence.
(k) Return of findings
The jury, or if there is no jury, the court, shall consider all the
information received during the hearing. It shall return special
findings identifying any aggravating factors set forth in subsection (n)
of this section, found to exist. If one of the aggravating factors set
forth in subsection (n)(1) of this section and another of the
aggravating factors set forth in paragraphs (2) through (12) of
subsection (n) of this section is found to exist, a special finding
identifying any other aggravating factor for which notice has been
provided under subsection (h)(1)(B) of this section, may be returned. A
finding with respect to a mitigating factor may be made by one or more
of the members of the jury, and any member of the jury who finds the
existence of a mitigating factor may consider such a factor established
for purposes of this subsection, regardless of the number of jurors who
concur that the factor has been established. A finding with respect to
any aggravating factor must be unanimous. If an aggravating factor set
forth in subsection (n)(1) of this section is not found to exist or an
aggravating factor set forth in subsection (n)(1) of this section is
found to exist but no other aggravating factor set forth in subsection
(n) of this section is found to exist, the court shall impose a
sentence, other than death, authorized by law. If an aggravating factor
set forth in subsection (n)(1) of this section and one or more of the
other aggravating factors set forth in subsection (n) of this section
are found to exist, the jury, or if there is no jury, the court, shall
then consider whether the aggravating factors found to exist
sufficiently outweigh any mitigating factor or factors found to exist,
or in the absence of mitigating factors, whether the aggravating factors
are themselves sufficient to justify a sentence of death. Based upon
this consideration, the jury by unanimous vote, or if there is no jury,
the court, shall recommend that a sentence of death shall be imposed
rather than a sentence of life imprisonment without possibility of
release or some other lesser sentence. The jury or the court,
regardless of its findings with respect to aggravating and mitigating
factors, is never required to impose a death sentence and the jury shall
be so instructed.
(l) Imposition of sentence
Upon the recommendation that the sentence of death be imposed, the
court shall sentence the defendant to death. Otherwise the court shall
impose a sentence, other than death, authorized by law. A sentence of
death shall not be carried out upon a person who is under 18 years of
age at the time the crime was committed. A sentence of death shall not
be carried out upon a person who is mentally retarded. A sentence of
death shall not be carried out upon a person who, as a result of mental
disability --
(1) cannot understand the nature of the pending proceedings, what
such person was tried for, the reason for the punishment, or the nature
of the punishment; or
(2) lacks the capacity to recognize or understand facts which would
make the punishment unjust or unlawful, or lacks the ability to convey
such information to counsel or to the court.
(m) Mitigating factors
In determining whether a sentence of death is to be imposed on a
defendant, the finder of fact shall consider mitigating factors,
including the following:
(1) The defendant's capacity to appreciate the wrongfulness of the
defendant's conduct or to conform conduct to the requirements of law was
significantly impaired, regardless of whether the capacity was so
impaired as to constitute a defense to the charge.
(2) The defendant was under unusual and substantial duress,
regardless of whether the duress was of such a degree as to constitute a
defense to the charge.
(3) The defendant is punishable as a principal (as defined in section
2 of title 18) in the offense, which was committed by another, but the
defendant's participation was relatively minor, regardless of whether
the participation was so minor as to constitute a defense to the charge.
(4) The defendant could not reasonably have foreseen that the
defendant's conduct in the course of the commission of murder, or other
offense resulting in death for which the defendant was convicted, would
cause, or would create a grave risk of causing, death to any person.
(5) The defendant was youthful, although not under the age of 18.
(6) The defendant did not have a significant prior criminal record.
(7) The defendant committed the offense under severe mental or
emotional disturbance.
(8) Another defendant or defendants, equally culpable in the crime,
will not be punished by death.
(9) The victim consented to the criminal conduct that resulted in the
victim's death.
(10) That other factors in the defendant's background or character
mitigate against imposition of the death sentence.
(n) Aggravating factors for homicide
If the defendant is found guilty of or pleads guilty to an offense
under subsection (e) of this section, the following aggravating factors
are the only aggravating factors that shall be considered, unless notice
of additional aggravating factors is provided under subsection (h)(1)(B)
of this section:
(1) The defendant --
(A) intentionally killed the victim;
(B) intentionally inflicted serious bodily injury which resulted in
the death of the victim;
(C) intentionally engaged in conduct intending that the victim be
killed or that lethal force be employed against the victim, which
resulted in the death of the victim;
(D) intentionally engaged in conduct which --
(i) the defendant knew would create a grave risk of death to a
person, other than one of the participants in the offense; and
(ii) resulted in the death of the victim.
(2) The defendant has been convicted of another Federal offense, or a
State offense resulting in the death of a person, for which a sentence
of life imprisonment or a sentence of death was authorized by statute.
(3) The defendant has previously been convicted of two or more State
or Federal offenses punishable by a term of imprisonment of more than
one year, committed on different occasions, involving the infliction of,
or attempted infliction of, serious bodily injury upon another person.
(4) The defendant has previously been convicted of two or more State
or Federal offenses punishable by a term of imprisonment of more than
one year, committed on different occasions, involving the distribution
of a controlled substance.
(5) In the commission of the offense or in escaping apprehension for
a violation of subsection (e) of this section, the defendant knowingly
created a grave risk of death to one or more persons in addition to the
victims of the offense.
(6) The defendant procured the commission of the offense by payment,
or promise of payment, of anything of pecuniary value.
(7) The defendant committed the offense as consideration for the
receipt, or in the expectation of the receipt, of anything of pecuniary
value.
(8) The defendant committed the offense after substantial planning
and premeditation.
(9) The victim was particularly vulnerable due to old age, youth, or
infirmity.
(10) The defendant had previously been convicted of violating this
subchapter or subchapter II of this chapter for which a sentence of five
or more years may be imposed or had previously been convicted of
engaging in a continuing criminal enterprise.
(11) The violation of this subchapter in relation to which the
conduct described in subsection (e) of this section occurred was a
violation of section 859 /3/ of this title.
(12) The defendant committed the offense in an especially heinous,
cruel, or depraved manner in that it involved torture or serious
physical abuse to the victim.
(o) Right of defendant to justice without discrimination
(1) In any hearing held before a jury under this section, the court
shall instruct the jury that in its consideration of whether the
sentence of death is justified it shall not consider the race, color,
religious beliefs, national origin, or sex of the defendant or the
victim, and that the jury is not to recommend a sentence of death unless
it has concluded that it would recommend a sentence of death for the
crime in question no matter what the race, color, religious beliefs,
national origin, or sex of the defendant, or the victim, may be. The
jury shall return to the court a certificate signed by each juror that
consideration of the race, color, religious beliefs, national origin, or
sex of the defendant or the victim was not involved in reaching his or
her individual decision, and that the individual juror would have made
the same recommendation regarding a sentence for the crime in question
no matter what the race, color, religious beliefs, national origin, or
sex of the defendant, or the victim, may be.
(2) Not later than one year from November 18, 1988, the Comptroller
General shall conduct a study of the various procedures used by the
several States for determining whether or not to impose the death
penalty in particular cases, and shall report to the Congress on whether
or not any or all of the various procedures create a significant risk
that the race of a defendant, or the race of a victim against whom a
crime was committed, influence the likelihood that defendants in those
States will be sentenced to death. In conducting the study required by
this paragraph, the General Accounting Office shall --
(A) use ordinary methods of statistical analysis, including methods
comparable to those ruled admissible by the courts in race
discrimination cases under title VII of the Civil Rights Act of 1964 (42
U.S.C. 2000e et seq.);
(B) study only crimes occurring after January 1, 1976; and
(C) determine what, if any, other factors, including any relation
between any aggravating or mitigating factors and the race of the victim
or the defendant, may account for any evidence that the race of the
defendant, or the race of the victim, influences the likelihood that
defendants will be sentenced to death. In addition, the General
Accounting Office shall examine separately and include in the report,
death penalty cases involving crimes similar to those covered under this
section.
(p) Sentencing in capital cases in which death penalty is not sought
or imposed
If a person is convicted for an offense under subsection (e) of this
section and the court does not impose the penalty of death, the court
may impose a sentence of life imprisonment without the possibility of
parole.
(q) Appeal in capital cases; counsel for financially unable
defendants
(1) In any case in which the sentence of death is imposed under this
section, the sentence of death shall be subject to review by the court
of appeals upon appeal by the defendant. Notice of appeal must be filed
within the time prescribed for appeal of judgment in section 2107 of
title 28. An appeal under this section may be consolidated with an
appeal of the judgment of conviction. Such review shall have priority
over all other cases.
(2) On review of the sentence, the court of appeals shall consider
the record, the evidence submitted during the trial, the information
submitted during the sentencing hearing, the procedures employed in the
sentencing hearing, and the special findings returned under this
section.
(3) The court shall affirm the sentence if it determines that --
(A) the sentence of death was not imposed under the influence of
passion, prejudice, or any other arbitrary factor; and
(B) the information supports the special finding of the existence of
every aggravating factor upon which the sentence was based, together
with, or the failure to find, any mitigating factors as set forth or
allowed in this section.
In all other cases the court shall remand the case for
reconsideration under this section. The court of appeals shall state in
writing the reasons for its disposition of the review of the sentence.
(4)(A) Notwithstanding any other provision of law to the contrary, in
every criminal action in which a defendant is charged with a crime which
may be punishable by death, a defendant who is or becomes financially
unable to obtain adequate representation or investigative, expert, or
other reasonably necessary services at any time either --
(i) before judgment; or
(ii) after the entry of a judgment imposing a sentence of death but
before the execution of that judgment;
shall be entitled to the appointment of one or more attorneys and the
furnishing of such other services in accordance with paragraphs (5),
(6), (7), (8), and (9).
(B) In any post conviction proceeding under section 2254 or 2255 of
title 28 seeking to vacate or set aside a death sentence, any defendant
who is or becomes financially unable to obtain adequate representation
or investigative, expert, or other reasonably necessary services shall
be entitled to the appointment of one or more attorneys and the
furnishing of such other services in accordance with paragraphs (5),
(6), (7), (8), and (9).
(5) If the appointment is made before judgment, at least one attorney
so appointed must have been admitted to practice in the court in which
the prosecution is to be tried for not less than five years, and must
have had not less than three years experience in the actual trial of
felony prosecutions in that court.
(6) If the appointment is made after judgment, at least one attorney
so appointed must have been admitted to practice in the court of appeals
for not less than five years, and must have had not less than three
years experience in the handling of appeals in that court in felony
cases.
(7) With respect to paragraphs (5) and (6), the court, for good
cause, may appoint another attorney whose background, knowledge, or
experience would otherwise enable him or her to properly represent the
defendant, with due consideration to the seriousness of the possible
penalty and to the unique and complex nature of the litigation.
(8) Unless replaced by similarly qualified counsel upon the
attorney's own motion or upon motion of the defendant, each attorney so
appointed shall represent the defendant throughout every subsequent
stage of available judicial proceedings, including pretrial proceedings,
trial, sentencing, motions for new trial, appeals, applications, /4/ for
writ of certiorari to the Supreme Court of the United States, and all
available post-conviction process, together with applications for stays
of execution and other appropriate motions and procedures, and shall
also represent the defendant in such competency proceedings and
proceedings for executive or other clemency as may be available to the
defendant.
(9) Upon a finding in ex parte proceedings that investigative, expert
or other services are reasonably necessary for the representation of the
defendant, whether in connection with issues relating to guilt or
sentence, the court shall authorize the defendant's attorneys to obtain
such services on behalf of the defendant and shall order the payment of
fees and expenses therefore, under paragraph (10). Upon a finding that
timely procurement of such services could not practicably await prior
authorization, the court may authorize the provision of and payment for
such services nunc pro tunc.
(10) Notwithstanding the rates and maximum limits generally
applicable to criminal cases and any other provision of law to the
contrary, the court shall fix the compensation to be paid to attorneys
appointed under this subsection and the fees and expenses to be paid for
investigative, expert, and other reasonably necessary services
authorized under paragraph (9), at such rates or amounts as the court
determines to be reasonably necessary to carry out the requirements of
paragraphs (4) through (9).
(r) Refusal to participate by State and Federal correctional
employees
No employee of any State department of corrections or the Federal
Bureau of Prisons and no employee providing services to that department
or bureau under contract shall be required, as a condition of that
employment, or contractual obligation to be in attendance at or to
participate in any execution carried out under this section if such
participation is contrary to the moral or religious convictions of the
employee. For purposes of this subsection, the term ''participation in
executions'' includes personal preparation of the condemned individual
and the apparatus used for execution and supervision of the activities
of other personnel in carrying out such activities.
(Pub. L. 91-513, title II, 408, Oct. 27, 1970, 84 Stat. 1265; Pub.
L. 98-473, title II, 224(b), formerly 224(c), 305, Oct. 12, 1984, 98
Stat. 2030, 2050; Pub. L. 99-570, title I, 1005(b)(2), 1252, 1253, Oct.
27, 1986, 100 Stat. 3207-6, 3207-14; Pub. L. 100-690, title VI, 6481,
title VII, 7001, Nov. 18, 1988, 102 Stat. 4382, 4387.)
Act of July 15, 1932 (D.C. Code, secs. 24-203 -- 24-207), referred to
in subsec. (d), is act July 15, 1932, ch. 492, 47 Stat. 696, as
amended, which appears in sections 24-203 to 24-209 of Title 24,
Prisoners and Their Treatment, and section 22-2601 of Title 22, Criminal
Offenses, of the District of Columbia Code.
The Federal Rules of Criminal Procedure, referred to in subsec. (j),
are set out in the Appendix to Title 18, Crimes and Criminal Procedure.
Section 859 of this title, referred to in subsec. (n)(11), was in
the original a reference to section 405, meaning section 405 of the
Controlled Substances Act. Section 405 of the Act was renumbered
section 418 by Pub. L. 101-647, title X, 1002(a)(1), Nov. 29, 1990,
104 Stat. 4827, and was transferred to section 859 of this title. A
new section 405 of the Controlled Substances Act is classified to
section 844a of this title.
The Civil Rights Act of 1964, referred to in subsec. (o)(2)(A), is
Pub. L. 88-352, July 2, 1964, 78 Stat. 252, as amended. Title VII of
the Civil Rights Act of 1964 is classified generally to subchapter VI (
2000e et seq.) of chapter 21 of Title 42, The Public Health and Welfare.
For complete classification of this Act to the Code, see Short Title
note set out under section 2000a of Title 42 and Tables.
1988 -- Subsec. (a). Pub. L. 100-690, 6481(a), increased minimum
term of imprisonment for first violations to 20 from 10 years and for
subsequent violations to 30 from 20 years.
Subsecs. (c), (d). Pub. L. 100-690, 6481(b), redesignated subsecs.
(d) and (e) as (c) and (d), respectively.
Subsec. (e). Pub. L. 100-690, 7001(a)(2), added subsec. (e). Former
subsec. (e) redesignated (d).
Pub. L. 100-690, 7001(a)(1), which directed redesignation of former
subsec. (e) as (f), could not be executed because of prior
redesignation of former subsec. (e) as (d) by Pub. L. 100-690, 6481(
b), which resulted in there not being a subsec. (f).
Subsecs. (g) to (r). Pub. L. 100-690, 7001(b), added subsecs. (g) to
(r).
1986 -- Subsec. (a). Pub. L. 99-570, 1252, substituted ''to a fine
not to exceed the greater of that authorized in accordance with the
provisions of title 18 or $2,000,000 if the defendant is an individual
or $5,000,000 if the defendant is other than an individual,'' for ''to a
fine of not more than $100,000,'' and ''to a fine not to exceed the
greater of twice the amount authorized in accordance with the provisions
of title 18 or $4,000,000 if the defendant is an individual or
$10,000,000 if the defendant is other than an individual,'' for ''to a
fine of not more than $200,000,''.
Subsecs. (b) to (e). Pub. L. 99-570, 1253, added subsec. (b) and
redesignated former subsecs. (b) and (c) as (d) and (e), respectively,
which resulted in there not being a subsec. (c).
1984 -- Subsec. (a). Pub. L. 98-473, 305, struck out par. (1)
designation, substituted references to section 853 of this title for
references to paragraph (2) in two places, and struck out par. (2)
which related to forfeitures to the United States by any person
convicted under par. (1).
Subsec. (d). Pub. L. 98-473, 305(b), struck out subsec. (d) relating
to jurisdiction of courts of the United States.
Subsec. (e). Pub. L. 98-473, 224(b), as renumbered by Pub. L.
99-570, 1005(b)(2), which directed the amendment of subsec. (c) of this
section by striking out ''and section 4202 of title 18 of the United
States Code'', was executed by striking out that language in subsec.
(e) to reflect the probable intent of Congress and the intervening
amendment by Pub. L. 99-570, 1253, which redesignated subsec. (c) as
(e). See 1986 Amendment note above.
Amendment by section 224(b) of Pub. L. 98-473 effective Nov. 1,
1987, and applicable only to offenses committed after the taking effect
of such amendment, see section 235(a)(1) of Pub. L. 98-473, set out as
an Effective Date note under section 3551 of Title 18, Crimes and
Criminal Procedure.
Section 7002 of title VII of Pub. L. 100-690 provided that:
''(a) Study. -- No later than three years after the date of the
enactment of this Act (Nov. 18, 1988), the Comptroller General shall
carry out a study to review the cost of implementing the procedures for
imposing and carrying out a death sentence prescribed by this title (see
Tables for classification).
''(b) Specific Requirement. -- Such study shall consider, but not be
limited to, information concerning impact on workload of the Federal
prosecutors and judiciary and law enforcement necessary to obtain
capital sentences and executions under this Act (see Short Title note
set out under section 1501 of this title).
''(c) Submission of Report. -- Not later than four years after date
of the enactment of this Act (Nov. 18, 1988), the Comptroller General
shall submit to Congress a report describing the results of the study.''
title 18 section 1956.
/1/ So in original. Probably should be paragraph ''(1)(B),''.
/2/ So in original. Section does not contain a subsec. (f), see
1988 Amendment note below.
/3/ See References in Text note below.
/4/ So in original. The comma probably should not appear.
21 USC 849. Repealed. Pub. L. 98-473, title II, 219(a), Oct. 12, 1984,
98 Stat. 2027
TITLE 21 -- FOOD AND DRUGS
Nov. 1, 1987
Section 235(a)(1) of Pub. L. 98-473, set out as an Effective Date
note under section 3551 of Title 18, Crimes and Criminal Procedure,
provided that the repeal of this section is effective Nov. 1, 1987, and
applicable only to offenses committed after the taking effect of such
repeal. Prior to repeal, this section read as follows:
849. Dangerous special drug offender sentencing
(a) Notice to court by United States Attorney
Whenever a United States attorney charged with the prosecution of a
defendant in a court of the United States for an alleged felonious
violation of any provision of this subchapter or subchapter II of this
chapter committed when the defendant was over the age of twenty-one
years has reasons to believe that the defendant is a dangerous special
drug offender such United States attorney, a reasonable time before
trial or acceptance by the court of a plea of guilty or nolo contendere,
may sign and file with the court, and may amend, a notice (1) specifying
that the defendant is a dangerous special drug offender who upon
conviction of such felonious violation is subject to the imposition of a
sentence under subsection (b) of this section, and (2) setting out with
particularity the reasons why such attorney believes the defendant to be
a dangerous special drug offender. In no case shall the fact that the
defendant is alleged to be a dangerous special drug offender be an issue
upon the trial of such felonious violation, be disclosed to the jury, or
be disclosed before any plea of guilty or nolo contendere or verdict or
finding of guilty to the presiding judge without the consent of the
parties. If the court finds that the filing of the notice as a public
record may prejudice fair consideration of a pending criminal matter, it
may order the notice sealed and the notice shall not be subject to
subpena or public inspection during the pendency of such criminal
matter, except on order of the court, but shall be subject to inspection
by the defendant alleged to be a dangerous special drug offender and his
counsel.
(b) Hearing; inspection of presentence report; counsel; process;
examination of witnesses; penalty; sentence
Upon any plea of guilty or nolo contendere or verdict or finding of
guilty of the defendant of such felonious violation, a hearing shall be
held, before sentence is imposed, by the court sitting without a jury.
The court shall fix a time for the hearing, and notice thereof shall be
given to the defendant and the United States at least ten days prior
thereto. The court shall permit the United States and counsel for the
defendant, or the defendant if he is not represented by counsel, to
inspect the presentence report sufficiently prior to the hearing as to
afford a reasonable opportunity for verification. In extraordinary
cases, the court may withhold material not relevant to a proper
sentence, diagnostic opinion which might seriously disrupt a program of
rehabilitation, any source of information obtained on a promise of
confidentiality, and material previously disclosed in open court. A
court withholding all or part of a presentence report shall inform the
parties of its action and place in the record the reasons therefor. The
court may require parties inspecting all or part of a presentence report
to give notice of any part thereof intended to be controverted. In
connection with the hearing, the defendant and the United States shall
be entitled to assistance of counsel, compulsory process, and
cross-examination of such witnesses as appear at the hearing. A duly
authenticated copy of a former judgment or commitment shall be prima
facie evidence of such former judgment or commitment. If it appears by
a preponderance of the information, including information submitted
during the trial of such felonious violation and the sentencing hearing
and so much of the presentence report as the court relies upon, that the
defendant is a dangerous special drug offender, the court shall sentence
the defendant to imprisonment for an appropriate term not to exceed
twenty-five years and not disproportionate in severity to the maximum
term otherwise authorized by law for such felonious violation.
Otherwise it shall sentence the defendant in accordance with the law
prescribing penalties for such felonious violation. The court shall
place in the record its findings, including an identification of the
information relied upon in making such findings, and its reasons for the
sentence imposed.
(c) Sentences for life or for a term exceeding twenty-five years
This section shall not prevent the imposition and execution of a
sentence of imprisonment for life or for a term exceeding twenty-five
years upon any person convicted of an offense so punishable.
(d) Mandatory minimum penalties
Notwithstanding any other provision of this section, the court shall
not sentence a dangerous special drug offender to less than any
mandatory minimum penalty prescribed by law for such felonious
violation. This section shall not be construed as creating any
mandatory minimum penalty.
(e) ''Special drug offender'' defined
A defendant is a special drug offender for purposes of this section
if --
(1) the defendant has previously been convicted in courts of the
United States or a State or any political subdivision thereof for two or
more offenses involving dealing in controlled substances, committed on
occasions different from one another and different from such felonious
violation, and punishable in such courts by death or imprisonment in
excess of one year, for one or more of such convictions the defendant
has been imprisoned prior to the commission of such felonious violation,
and less than five years have elapsed between the commission of such
felonious violation and either the defendant's release, or parole or
otherwise, from imprisonment for one such conviction or his commission
of the last such previous offense or another offense involving dealing
in controlled substances and punishable by death or imprisonment in
excess of one year under applicable laws of the United States or a State
or any political subdivision thereof; or
(2) the defendant committed such felonious violation as part of a
pattern of dealing in controlled substances which was criminal under
applicable laws of any jurisdiction, which constituted a substantial
source of his income, and in which he manifested special skill or
expertise; or
(3) such felonious violation was, or the defendant committed such
felonious violation in furtherance of, a conspiracy with three or more
other persons to engage in a pattern of dealing in controlled substances
which was criminal under applicable laws of any jurisdiction, and the
defendant did, or agreed that he would, initiate, organize, plan,
finance, direct, manage, or supervise all or part of such conspiracy or
dealing, or give or receive a bribe or use force in connection with such
dealing.
A conviction shown on direct or collateral review or at the hearing
to be invalid or for which the defendant has been pardoned on the ground
of innocence shall be disregarded for purposes of paragraph (1) of this
subsection. In support of findings under paragraph (2) of this
subsection, it may be shown that the defendant has had in his own name
or under his control income or property not explained as derived from a
source other than such dealing. For purposes of paragraph (2) of this
subsection, a substantial source of income means a source of income
which for any period of one year or more exceeds the minimum wage,
determined on the basis of a forty-hour week and fifty-week year,
without reference to exceptions, under section 206(a)(1) of title 29 for
an employee engaged in commerce or in the production of goods for
commerce, and which for the same period exceeds fifty percent of the
defendant's declared adjusted gross income under section 62 of title 26.
For purposes of paragraph (2) of this subsection, special skill or
expertise in such dealing includes unusual knowledge, judgment or
ability, including manual dexterity, facilitating the initiation,
organizing, planning, financing, direction, management, supervision,
execution or concealment of such dealing, the enlistment of accomplices
in such dealing, the escape from detection or apprehension for such
dealing, or the disposition of the fruits or proceeds of such dealing.
For purposes of paragraphs (2) and (3) of this subsection, such dealing
forms a pattern if it embraces criminal acts that have the same or
similar purposes, results, participants, victims, or methods of
commission, or otherwise are interrelated by distinguishing
characteristics and are not isolated events.
(f) Dangerous defendants
A defendant is dangerous for purposes of this section if a period of
confinement longer than that provided for such felonious violation is
required for the protection of the public from further criminal conduct
by the defendant.
(g) Appeal
The time for taking an appeal from a conviction for which sentence is
imposed after proceedings under this section shall be measured from
imposition of the original sentence.
(h) Review of sentence
With respect to the imposition, correction, or reduction of a
sentence after proceedings under this section, a review of the sentence
on the record of the sentencing court may be taken by the defendant or
the United States to a court of appeals. Any review of the sentence
taken by the United States shall be taken at least five days before
expiration of the time for taking a review of the sentence or appeal of
the conviction by the defendant and shall be diligently prosecuted. The
sentencing court may, with or without motion and notice, extend the time
for taking a review of the sentence for a period not to exceed thirty
days from the expiration of the time otherwise prescribed by law. The
court shall not extend the time for taking a review of the sentence by
the United States after the time has expired. A court extending the
time for taking a review of the sentence by the United States shall
extend the time for taking a review of the sentence or appeal of the
conviction by the defendant for the same period. The taking of a review
of the sentence by the United States shall be deemed the taking of a
review of the sentence and an appeal of the conviction by the defendant.
Review of the sentence shall include review of whether the procedure
employed was lawful, the findings made were clearly erroneous, or the
sentencing court's discretion was abused. The court of appeals on review
of the sentence may, after considering the record, including the entire
presentence report, information submitted during the trial of such
felonious violation and the sentencing hearing, and the findings and
reasons of the sentencing court, affirm the sentence, impose or direct
the imposition of any sentence which the sentencing court could
originally have imposed, or remand for further sentencing proceedings
and imposition of sentence, except that a sentence may be made more
severe only on review of the sentence taken by the United States and
after hearing. Failure of the United States to take a review of the
imposition of the sentence shall, upon review taken by the United States
of the correction or reduction of the sentence, foreclose imposition of
a sentence more severe than that previously imposed. Any withdrawal or
dismissal of review of the sentence taken by the United States shall
foreclose imposition of a sentence more severe than that reviewed but
shall not otherwise foreclose the review of the sentence or the appeal
of the conviction. The court of appeals shall state in writing the
reasons for its disposition of the review of the sentence. Any review
of the sentence taken by the United States may be dismissed on a showing
of the abuse of the right of the United States to take such review.
(Pub. L. 91-513, title II, 409, Oct. 27, 1970, 84 Stat. 1266; Pub.
L. 99-514, 2, Oct. 22, 1986, 100 Stat. 2095.)
21 USC 850. Information for sentencing
TITLE 21 -- FOOD AND DRUGS
Except as otherwise provided in this subchapter or section 242a(a) of
title 42, no limitation shall be placed on the information concerning
the background, character, and conduct of a person convicted of an
offense which a court of the United States may receive and consider for
the purpose of imposing an appropriate sentence under this subchapter or
subchapter II of this chapter.
(Pub. L. 91-513, title II, 410, Oct. 27, 1970, 84 Stat. 1269.)
21 USC 851. Proceedings to establish prior convictions
TITLE 21 -- FOOD AND DRUGS
(a) Information filed by United States Attorney
(1) No person who stands convicted of an offense under this part
shall be sentenced to increased punishment by reason of one or more
prior convictions, unless before trial, or before entry of a plea of
guilty, the United States attorney files an information with the court
(and serves a copy of such information on the person or counsel for the
person) stating in writing the previous convictons to be relied upon.
Upon a showing by the United States attorney that facts regarding prior
convictions could not with due diligence be obtained prior to trial or
before entry of a plea of guilty, the court may postpone the trial or
the taking of the plea of guilty for a reasonable period for the purpose
of obtaining such facts. Clerical mistakes in the information may be
amended at any time prior to the pronouncement of sentence.
(2) An information may not be filed under this section if the
increased punishment which may be imposed is imprisonment for a term in
excess of three years unless the person either waived or was afforded
prosecution by indictment for the offense for which such increased
punishment may be imposed.
(b) Affirmation or denial of previous conviction
If the United States attorney files an information under this
section, the court shall after conviction but before pronouncement of
sentence inquire of the person with respect to whom the information was
filed whether he affirms or denies that he has been previously convicted
as alleged in the information, and shall inform him that any challenge
to a prior conviction which is not made before sentence is imposed may
not thereafter be raised to attack the sentence.
(c) Denial; written response; hearing
(1) If the person denies any allegation of the information of prior
conviction, or claims that any conviction alleged is invalid, he shall
file a written response to the information. A copy of the response
shall be served upon the United States attorney. The court shall hold a
hearing to determine any issues raised by the response which would
except the person from increased punishment. The failure of the United
States attorney to include in the information the complete criminal
record of the person or any facts in addition to the convictions to be
relied upon shall not constitute grounds for invalidating the notice
given in the information required by subsection (a)(1) of this section.
The hearing shall be before the court without a jury and either party
may introduce evidence. Except as otherwise provided in paragraph (2)
of this subsection, the United States attorney shall have the burden of
proof beyond a reasonable doubt on any issue of fact. At the request of
either party, the court shall enter findings of fact and conclusions of
law.
(2) A person claiming that a conviction alleged in the information
was obtained in violation of the Constitution of the United States shall
set forth his claim, and the factual basis therefor, with particularity
in his response to the information. The person shall have the burden of
proof by a preponderance of the evidence on any issue of fact raised by
the response. Any challenge to a prior conviction, not raised by
response to the information before an increased sentence is imposed in
reliance thereon, shall be waived unless good cause be shown for failure
to make a timely challenge.
(d) Imposition of sentence
(1) If the person files no response to the information, or if the
court determines, after hearing, that the person is subject to increased
punishment by reason of prior convictions, the court shall proceed to
impose sentence upon him as provided by this part.
(2) If the court determines that the person has not been convicted as
alleged in the information, that a conviction alleged in the information
is invalid, or that the person is otherwise not subject to an increased
sentence as a matter of law, the court shall, at the request of the
United States attorney, postpone sentence to allow an appeal from that
determination. If no such request is made, the court shall impose
sentence as provided by this part. The person may appeal from an order
postponing sentence as if sentence had been pronounced and a final
judgment of conviction entered.
(e) Statute of limitations
No person who stands convicted of an offense under this part may
challenge the validity of any prior conviction alleged under this
section which occurred more than five years before the date of the
information alleging such prior conviction.
(Pub. L. 91-513, title II, 411, Oct. 27, 1970, 84 Stat. 1269.)
21 USC 852. Application of treaties and other international agreements
TITLE 21 -- FOOD AND DRUGS
Nothing in the Single Convention on Narcotic Drugs, the Convention on
Psychotropic Substances, or other treaties or international agreements
shall be construed to limit the provision of treatment, education, or
rehabilitation as alternatives to conviction or criminal penalty for
offenses involving any drug or other substance subject to control under
any such treaty or agreement.
(Pub. L. 91-513, title II, 412, as added Pub. L. 95-633, title I,
107(a), Nov. 10, 1978, 92 Stat. 3773.)
Section effective on date the Convention on Psychotropic Substances
enters into force in the United States (July 15, 1980), see section 112
of Pub. L. 95-633, set out as a note under section 801a of this title.
21 USC 853. Criminal forfeitures
TITLE 21 -- FOOD AND DRUGS
(a) Property subject to criminal forfeiture
Any person convicted of a violation of this subchapter or subchapter
II of this chapter punishable by imprisonment for more than one year
shall forfeit to the United States, irrespective of any provision of
State law --
(1) any property constituting, or derived from, any proceeds the
person obtained, directly or indirectly, as the result of such
violation;
(2) any of the person's property used, or intended to be used, in any
manner or part, to commit, or to facilitate the commission of, such
violation; and
(3) in the case of a person convicted of engaging in a continuing
criminal enterprise in violation of section 848 of this title, the
person shall forfeit, in addition to any property described in paragraph
(1) or (2), any of his interest in, claims against, and property or
contractual rights affording a source of control over, the continuing
criminal enterprise.
The court, in imposing sentence on such person, shall order, in
addition to any other sentence imposed pursuant to this subchapter or
subchapter II of this chapter, that the person forfeit to the United
States all property described in this subsection. In lieu of a fine
otherwise authorized by this part, a defendant who derives profits or
other proceeds from an offense may be fined not more than twice the
gross profits or other proceeds.
(b) Meaning of term ''property''
Property subject to criminal forfeiture under this section includes
--
(1) real property, including things growing on, affixed to, and found
in land; and
(2) tangible and intangible personal property, including rights,
privileges, interests, claims, and securities.
(c) Third party transfers
All right, title, and interest in property described in subsection
(a) of this section vests in the United States upon the commission of
the act giving rise to forfeiture under this section. Any such property
that is subsequently transferred to a person other than the defendant
may be the subject of a special verdict of forfeiture and thereafter
shall be ordered forfeited to the United States, unless the transferee
establishes in a hearing pursuant to subsection (n) of this section that
he is a bona fide purchaser for value of such property who at the time
of purchase was reasonably without cause to believe that the property
was subject to forfeiture under this section.
(d) Rebuttable presumption
There is a rebuttable presumption at trial that any property of a
person convicted of a felony under this subchapter or subchapter II of
this chapter is subject to forfeiture under this section if the United
States establishes by a preponderance of the evidence that --
(1) such property was acquired by such person during the period of
the violation of this subchapter or subchapter II of this chapter or
within a reasonable time after such period; and
(2) there was no likely source for such property other than the
violation of this subchapter or subchapter II of this chapter.
(e) Protective orders
(1) Upon application of the United States, the court may enter a
restraining order or injunction, require the execution of a satisfactory
performance bond, or take any other action to preserve the availability
of property described in subsection (a) of this section for forfeiture
under this section --
(A) upon the filing of an indictment or information charging a
violation of this subchapter or subchapter II of this chapter for which
criminal forfeiture may be ordered under this section and alleging that
the property with respect to which the order is sought would, in the
event of conviction, be subject to forfeiture under this section; or
(B) prior to the filing of such an indictment or information, if,
after notice to persons appearing to have an interest in the property
and opportunity for a hearing, the court determines that --
(i) there is a substantial probability that the United States will
prevail on the issue of forfeiture and that failure to enter the order
will result in the property being destroyed, removed from the
jurisdiction of the court, or otherwise made unavailable for forfeiture;
and
(ii) the need to preserve the availability of the property through
the entry of the requested order outweighs the hardship on any party
against whom the order is to be entered:
Provided, however, That an order entered pursuant to subparagraph (B)
shall be effective for not more than ninety days, unless extended by the
court for good cause shown or unless an indictment or information
described in subparagraph (A) has been filed.
(2) A temporary restraining order under this subsection may be
entered upon application of the United States without notice or
opportunity for a hearing when an information or indictment has not yet
been filed with respect to the property, if the United States
demonstrates that there is probable cause to believe that the property
with respect to which the order is sought would, in the event of
conviction, be subject to forfeiture under this section and that
provision of notice will jeopardize the availability of the property for
forfeiture. Such a temporary order shall expire not more than ten days
after the date on which it is entered, unless extended for good cause
shown or unless the party against whom it is entered consents to an
extension for a longer period. A hearing requested concerning an order
entered under this paragraph shall be held at the earliest possible time
and prior to the expiration of the temporary order.
(3) The court may receive and consider, at a hearing held pursuant to
this subsection, evidence and information that would be inadmissible
under the Federal Rules of Evidence.
(f) Warrant of seizure
The Government may request the issuance of a warrant authorizing the
seizure of property subject to forfeiture under this section in the same
manner as provided for a search warrant. If the court determines that
there is probable cause to believe that the property to be seized would,
in the event of conviction, be subject to forfeiture and that an order
under subsection (e) of this section may not be sufficient to assure the
availability of the property for forfeiture, the court shall issue a
warrant authorizing the seizure of such property.
(g) Execution
Upon entry of an order of forfeiture under this section, the court
shall authorize the Attorney General to seize all property ordered
forfeited upon such terms and conditions as the court shall deem proper.
Following entry of an order declaring the property forfeited, the court
may, upon application of the United States, enter such appropriate
restraining orders or injunctions, require the execution of satisfactory
performance bonds, appoint receivers, conservators, appraisers,
accountants, or trustees, or take any other action to protect the
interest of the United States in the property ordered forfeited. Any
income accruing to or derived from property ordered forfeited under this
section may be used to offset ordinary and necessary expenses to the
property which are required by law, or which are necessary to protect
the interests of the United States or third parties.
(h) Disposition of property
Following the seizure of property ordered forfeited under this
section, the Attorney General shall direct the disposition of the
property by sale or any other commercially feasible means, making due
provision for the rights of any innocent persons. Any property right or
interest not exercisable by, or transferable for value to, the United
States shall expire and shall not revert to the defendant, nor shall the
defendant or any person acting in concert with him or on his behalf be
eligible to purchase forfeited property at any sale held by the United
States. Upon application of a person, other than the defendant or a
person acting in concert with him or on his behalf, the court may
restrain or stay the sale or disposition of the property pending the
conclusion of any appeal of the criminal case giving rise to the
forfeiture, if the applicant demonstrates that proceeding with the sale
or disposition of the property will result in irreparable injury, harm,
or loss to him.
(i) Authority of the Attorney General
With respect to property ordered forfeited under this section, the
Attorney General is authorized to --
(1) grant petitions for mitigation or remission of forfeiture,
restore forfeited property to victims of a violation of this subchapter,
or take any other action to protect the rights of innocent persons which
is in the interest of justice and which is not inconsistent with the
provisions of this section;
(2) compromise claims arising under this section;
(3) award compensation to persons providing information resulting in
a forfeiture under this section;
(4) direct the disposition by the United States, in accordance with
the provisions of section 881(e) of this title, of all property ordered
forfeited under this section by public sale or any other commercially
feasible means, making due provision for the rights of innocent persons;
and
(5) take appropriate measures necessary to safeguard and maintain
property ordered forfeited under this section pending its disposition.
(j) Applicability of civil forfeiture provisions
Except to the extent that they are inconsistent with the provisions
of this section, the provisions of section 881(d) of this title shall
apply to a criminal forfeiture under this section.
(k) Bar on intervention
Except as provided in subsection (n) of this section, no party
claiming an interest in property subject to forfeiture under this
section may --
(1) intervene in a trial or appeal of a criminal case involving the
forfeiture of such property under this section; or
(2) commence an action at law or equity against the United States
concerning the validity of his alleged interest in the property
subsequent to the filing of an indictment or information alleging that
the property is subject to forfeiture under this section.
(l) Jurisdiction to enter orders
The district courts of the United States shall have jurisdiction to
enter orders as provided in this section without regard to the location
of any property which may be subject to forfeiture under this section or
which has been ordered forfeited under this section.
(m) Depositions
In order to facilitate the identification and location of property
declared forfeited and to facilitate the disposition of petitions for
remission or mitigation of forfeiture, after the entry of an order
declaring property forfeited to the United States, the court may, upon
application of the United States, order that the testimony of any
witness relating to the property forfeited be taken by deposition and
that any designated book, paper, document, record, recording, or other
material not privileged be produced at the same time and place, in the
same manner as provided for the taking of depositions under Rule 15 of
the Federal Rules of Criminal Procedure.
(n) Third party interests
(1) Following the entry of an order of forfeiture under this section,
the United States shall publish notice of the order and of its intent to
dispose of the property in such manner as the Attorney General may
direct. The Government may also, to the extent practicable, provide
direct written notice to any person known to have alleged an interest in
the property that is the subject of the order of forfeiture as a
substitute for published notice as to those persons so notified.
(2) Any person, other than the defendant, asserting a legal interest
in property which has been ordered forfeited to the United States
pursuant to this section may, within thirty days of the final
publication of notice or his receipt of notice under paragraph (1),
whichever is earlier, petition the court for a hearing to adjudicate the
validity of his alleged interest in the property. The hearing shall be
held before the court alone, without a jury.
(3) The petition shall be signed by the petitioner under penalty of
perjury and shall set forth the nature and extent of the petitioner's
right, title, or interest in the property, the time and circumstances of
the petitioner's acquisition of the right, title, or interest in the
property, any additional facts supporting the petitioner's claim, and
the relief sought.
(4) The hearing on the petition shall, to the extent practicable and
consistent with the interests of justice, be held within thirty days of
the filing of the petition. The court may consolidate the hearing on
the petition with a hearing on any other petition filed by a person
other than the defendant under this subsection.
(5) At the hearing, the petitioner may testify and present evidence
and witnesses on his own behalf, and cross-examine witnesses who appear
at the hearing. The United States may present evidence and witnesses in
rebuttal and in defense of its claim to the property and cross-examine
witnesses who appear at the hearing. In addition to testimony and
evidence presented at the hearing, the court shall consider the relevant
portions of the record of the criminal case which resulted in the order
of forfeiture.
(6) If, after the hearing, the court determines that the petitioner
has established by a preponderance of the evidence that --
(A) the petitioner has a legal right, title, or interest in the
property, and such right, title, or interest renders the order of
forfeiture invalid in whole or in part because the right, title, or
interest was vested in the petitioner rather than the defendant or was
superior to any right, title, or interest of the defendant at the time
of the commission of the acts which gave rise to the forfeiture of the
property under this section; or
(B) the petitioner is a bona fide purchaser for value of the right,
title, or interest in the property and was at the time of purchase
reasonably without cause to believe that the property was subject to
forfeiture under this section;
the court shall amend the order of forfeiture in accordance with its
determination.
(7) Following the court's disposition of all petitions filed under
this subsection, or if no such petitions are filed following the
expiration of the period provided in paragraph (2) for the filing of
such petitions, the United States shall have clear title to property
that is the subject of the order of forfeiture and may warrant good
title to any subsequent purchaser or transferee.
(o) Construction
The provisions of this section shall be liberally construed to
effectuate its remedial purposes.
(p) Forfeiture of substitute property
If any of the property described in subsection (a) of this section,
as a result of any act or omission of the defendant --
(1) cannot be located upon the exercise of due diligence;
(2) has been transferred or sold to, or deposited with, a third
party;
(3) has been placed beyond the jurisdiction of the court;
(4) has been substantially diminished in value; or
(5) has been commingled with other property which cannot be divided
without difficulty;
the court shall order the forfeiture of any other property of the
defendant up to the value of any property described in paragraphs (1)
through (5).
(Pub. L. 91-513, title II, 413, as added and amended Pub. L. 98-473,
title II, 303, 2301(d)-(f), Oct. 12, 1984, 98 Stat. 2044, 2192, 2193;
Pub. L. 99-570, title I, 1153(b), 1864, Oct. 27, 1986, 100 Stat.
3207-13, 3207-54.)
The Federal Rules of Evidence, referred to in subsec. (e)(3), are
set out in the Appendix to Title 28, Judiciary and Judicial Procedure.
The Federal Rules of Criminal Procedure, referred to in subsec. (m),
are set out in the Appendix to Title 18, Crimes and Criminal Procedure.
1986 -- Subsec. (c). Pub. L. 99-570, 1864(1), substituted
''subsection (n)'' for ''subsection (o)''.
Subsec. (f). Pub. L. 99-570, 1864(2), substituted ''subsection (e)''
for ''subsection (f)''.
Subsec. (i)(1). Pub. L. 99-570, 1864(3), substituted ''this
subchapter'' for ''this chapter''.
Subsec. (k). Pub. L. 99-570, 1864(1), (4), which directed the
substitution of ''subsection (n)'' for ''subsection (o)'' in ''the
second subsection (h)'', and directed the redesignation of ''the second
subsection (h)'' as subsection (k), were executed to this subsection
because the ''second subsection (h)'' had been editorially redesignated
subsec. (k) to reflect the probable intent of Congress. See 1984
Amendment note below.
Subsec. (p). Pub. L. 99-570, 1153(b), which directed that ''section
413 of title II of the Comprehensive Drug Abuse Prevention and Control
Act of 1975'' be amended ''by redesignating subsection '(p)' as
subsection '(q)''' and adding subsec. (p) was executed to this section,
which is section 413 of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as the probable intent of Congress, by adding a
subsec. (p) in view of the prior redesignation of subsec. (p) as (o)
by Pub. L. 98-473, 2301(e)(2). See 1984 Amendment note below.
1984 -- Subsec. (a). Pub. L. 98-473, 2301(d), inserted ''In lieu of
a fine otherwise authorized by this part, a defendant who derives
profits or other proceeds from an offense may be fined not more than
twice the gross profits or other proceeds.''
Subsec. (d). Pub. L. 98-473, 2301(e), struck out subsec. (d) which
related to forfeiture of property other than that described in subsec.
(a) and the conditions therefor, and redesignated former subsec. (e) as
(d).
Subsecs. (e) to (p). Pub. L. 98-473, 2301(e)(2), which directed that
this section be amended by redesignating subsecs. (e), (f), (g), (h),
(i), (l), (m), (n), (o), and (p) as subsecs. (d), (e), (f), (g), (h),
(i), (j), (h), (l), (m), (n), and (o), respectively, was executed by
redesignating subsecs. (e) to (p) as (d) to (o), respectively, to give
effect to the probable intent of Congress.
Subsec. (n)(1). Pub. L. 98-473, 2301(f), struck out ''for at least
seven successive court days'' after ''to dispose of the property''.
21 USC 853a. Transferred
TITLE 21 -- FOOD AND DRUGS
Section, Pub. L. 100-690, title V, 5301, Nov. 18, 1988, 102 Stat.
4310, which related to denial of Federal benefits to drug traffickers
and possessors, was redesignated section 421 of the Controlled
Substances Act by Pub. L. 101-647, title X, 1002(d)(1), Nov. 29, 1990,
104 Stat. 4827, and was transferred to section 862 of this title.
21 USC 854. Investment of illicit drug profits
TITLE 21 -- FOOD AND DRUGS
(a) Prohibition
It shall be unlawful for any person who has received any income
derived, directly or indirectly, from a violation of this subchapter or
subchapter II of this chapter punishable by imprisonment for more than
one year in which such person has participated as a principal within the
meaning of section 2 of title 18, to use or invest, directly or
indirectly, any part of such income, or the proceeds of such income, in
acquisition of any interest in, or the establishment or operation of,
any enterprise which is engaged in, or the activities of which affect
interstate or foreign commerce. A purchase of securities on the open
market for purposes of investment, and without the intention of
controlling or participating in the control of the issuer, or of
assisting another to do so, shall not be unlawful under this section if
the securities of the issuer held by the purchaser, the members of his
immediate family, and his or their accomplices in any violation of this
subchapter or subchapter II of this chapter after such purchase do not
amount in the aggregate to 1 per centum of the outstanding securities of
any one class, and do not confer, either in law or in fact, the power to
elect one or more directors of the issuer.
(b) Penalty
Whoever violates this section shall be fined not more than $50,000 or
imprisoned not more than ten years, or both.
(c) ''Enterprise'' defined
As used in this section, the term ''enterprise'' includes any
individual, partnership, corporation, association, or other legal
entity, and any union or group of individuals associated in fact
although not a legal entity.
(d) Construction
The provisions of this section shall be liberally construed to
effectuate its remedial purposes.
(Pub. L. 91-513, title II, 414, as added Pub. L. 98-473, title II,
303, Oct. 12, 1984, 98 Stat. 2049.)
21 USC 855. Alternative fine
TITLE 21 -- FOOD AND DRUGS
In lieu of a fine otherwise authorized by this part, a defendant who
derives profits or other proceeds from an offense may be fined not more
than twice the gross profits or other proceeds.
(Pub. L. 91-513, title II, 415, as added Pub. L. 98-473, title II,
2302, Oct. 12, 1984, 98 Stat. 2193.)
21 USC 856. Establishment of manufacturing operations
TITLE 21 -- FOOD AND DRUGS
(a) Except as authorized by this subchapter, it shall be unlawful to
--
(1) knowingly open or maintain any place for the purpose of
manufacturing, distributing, or using any controlled substance;
(2) manage or control any building, room, or enclosure, either as an
owner, lessee, agent, employee, or mortgagee, and knowingly and
intentionally rent, lease, or make available for use, with or without
compensation, the building, room, or enclosure for the purpose of
unlawfully manufacturing, storing, distributing, or using a controlled
substance.
(b) Any person who violates subsection (a) of this section shall be
sentenced to a term of imprisonment of not more than 20 years or a fine
of not more than $500,000, or both, or a fine of $2,000,000 for a person
other than an individual.
(Pub. L. 91-513, title II, 416, as added Pub. L. 99-570, title I,
1841(a), Oct. 27, 1986, 100 Stat. 3207-52.)
21 USC 857. Repealed. Pub. L. 101-647, title XXIV, 2401(d), Nov. 29,
1990, 104 Stat. 4859
TITLE 21 -- FOOD AND DRUGS
Section, Pub. L. 99-570, title I, 1822, Oct. 27, 1986, 100 Stat.
3207-51; Pub. L. 100-690, title VI, 6485, Nov. 18, 1988, 102 Stat.
4384; Pub. L. 101-647, title XXIV, 2401(b), Nov. 29, 1990, 104 Stat.
4859, related to interstate and foreign sale and transportation of drug
paraphernalia.
Subsec. (a), which related to unlawful acts, was repealed.
Subsecs. (b) to (f) were redesignated as subsecs. (b) to (f) of
section 422 of the Controlled Substances Act by section 2401(b) of Pub.
L. 101-647 and transferred to section 863(b) to (f) of this title.
Section 1823 of Pub. L. 99-570 which provided that subtitle O (
1821-1823) of title I of Pub. L. 99-570, enacting this section and
provisions set out as a note under section 801 of this title, was to
become effective 90 days after Oct. 27, 1986, was repealed by Pub. L.
101-647, title XXIV, 2401(d), Nov. 29, 1990, 104 Stat. 4859.
21 USC 858. Endangering human life while illegally manufacturing
controlled substance
TITLE 21 -- FOOD AND DRUGS
Whoever, while manufacturing a controlled substance in violation of
this subchapter, or attempting to do so, or transporting or causing to
be transported materials, including chemicals, to do so, creates a
substantial risk of harm to human life shall be fined in accordance with
title 18 or imprisoned not more than 10 years, or both.
(Pub. L. 91-513, title II, 417, as added Pub. L. 100-690, title VI,
6301(a), Nov. 18, 1988, 102 Stat. 4370.)
21 USC 859. Distribution to persons under age twenty-one
TITLE 21 -- FOOD AND DRUGS
(a) First offense
Except as provided in section 860 of this title, any person at least
eighteen years of age who violates section 841(a)(1) of this title by
distributing a controlled substance to a person under twenty-one years
of age is (except as provided in subsection (b) of this section) subject
to (1) twice the maximum punishment authorized by section 841( b) of
this title, and (2) at least twice any term of supervised release
authorized by section 841(b) of this title, for a first offense
involving the same controlled substance and schedule. Except to the
extent a greater minimum sentence is otherwise provided by section 841(
b) of this title, a term of imprisonment under this subsection shall be
not less than one year. The mandatory minimum sentencing provisions of
this subsection shall not apply to offenses involving 5 grams or less of
marihuana.
(b) Second offense
Except as provided in section 860 of this title, any person at least
eighteen years of age who violates section 841(a)(1) of this title by
distributing a controlled substance to a person under twenty-one years
of age after a prior conviction under subsection (a) of this section (or
under section 333(b) of this title as in effect prior to May 1, 1971)
has become final, is subject to (1) three times the maximum punishment
authorized by section 841(b) of this title, and (2) at least three times
any term of supervised release authorized by section 841(b) of this
title, for a second or subsequent offense involving the same controlled
substance and schedule. Except to the extent a greater minimum sentence
is otherwise provided by section 841(b) of this title, a term of
imprisonment under this subsection shall be not less than one year.
Penalties for third and subsequent convictions shall be governed by
section 841(b)(1)(A) of this title.
(Pub. L. 91-513, title II, 418, formerly 405, Oct. 27, 1970, 84 Stat.
1265; Pub. L. 98-473, title II, 224(b), 503(b)(3), Oct. 12, 1984, 98
Stat. 2030, 2070; Pub. L. 99-570, title I, 1004(a), 1005( b)( 1),
1105(a), (b), Oct. 27, 1986, 100 Stat. 3207-6, 3207-11; Pub. L.
100-690, title VI, 6452(b), 6455, 6456, Nov. 18, 1988, 102 Stat. 4371,
4372; renumbered 418 and amended Pub. L. 101-647, title X,
1002(a), 1003(a), title XXXV, 3599L, Nov. 29, 1990, 104 Stat. 4827,
4828, 4932.)
Section was classified to section 845 of this title prior to
renumbering by Pub. L. 101-647.
1990 -- Subsec. (a). Pub. L. 101-647, 1003(a)(1), substituted
''subject to (1) twice the maximum punishment authorized by section
841(b) of this title'' for ''punishable by (1) a term of imprisonment,
or a fine, or both, up to twice that authorized by section 841(b) of
this title''.
Pub. L. 101-647, 1002(a)(2)(A), substituted ''section 860'' for
''section 845a''.
Subsec. (b). Pub. L. 101-647, 3599L, substituted ''has become final''
for ''have become final''.
Pub. L. 101-647, 1003(a)(2), substituted ''subject to (1) three times
the maximum punishment authorized by section 841(b) of this title'' for
''punishable by (1) a term of imprisonment, or a fine, or both, up to
three times that authorized by section 841(b) of this title''.
Pub. L. 101-647, 1002(a)(2)(B), substituted ''section 860'' for
''section 845a''.
1988 -- Subsec. (a). Pub. L. 100-690, 6455, inserted at end ''The
mandatory minimum sentencing provisions of this subsection shall not
apply to offenses involving 5 grams or less of marihuana.''
Subsec. (b). Pub. L. 100-690, 6452(b), struck out ''or subsequent''
after ''Second'' in heading, and in text struck out ''or convictions''
after ''a prior conviction'', and inserted at end ''Penalties for third
and subsequent convictions shall be governed by section 841(b)(1)(A) of
this title.''
Pub. L. 100-690, 6456, struck out ''The mandatory minimum sentencing
provisions of this paragraph shall not apply to offenses involving 5
grams or less of marihuana.''
1986 -- Subsec. (a). Pub. L. 99-570, 1105(a), inserted ''Except to
the extent a greater minimum sentence is otherwise provided by section
841(b) of this title, a term of imprisonment under this subsection shall
be not less than one year.''
Pub. L. 99-570, 1004(a), substituted ''term of supervised release''
for ''special parole term''.
Subsec. (b). Pub. L. 99-570, 1105(b), inserted ''Except to the extent
a greater minimum sentence is otherwise provided by section 841( b) of
this title, a term of imprisonment under this subsection shall be not
less than one year. The mandatory minimum sentencing provisions of this
paragraph shall not apply to offenses involving 5 grams or less of
marihuana.''
Pub. L. 99-570, 1004(a), substituted ''term of supervised release''
for ''special parole term''.
1984 -- Subsecs. (a), (b). Pub. L. 98-473, 503(b)(3), substituted
''Except as provided in section 845a of this title, any'' for ''Any''.
Pub. L. 98-473, 224(b), which directed amendment of this section
effective Nov. 1, 1987 (see section 235(a)(1) of Pub. L. 98-473 set out
as an Effective Date note under section 3551 of Title 18, Crimes and
Criminal Procedure) was repealed by Pub. L. 99-570, 1005(b)(1).
Amendment by section 1004(a) of Pub. L. 99-570 effective on date of
taking effect of section 3583 of Title 18, Crimes and Criminal Procedure
(Nov. 1, 1987), see section 1004(b) of Pub. L. 99-570 set out as a note
under section 841 of this title.
21 USC 860. Distribution or manufacturing in or near schools and
colleges
TITLE 21 -- FOOD AND DRUGS
(a) Penalty
Any person who violates section 841(a)(1) of this title or section
856 of this title by distributing, possessing with intent to distribute,
or manufacturing a controlled substance in or on, or within one thousand
feet of, the real property comprising a public or private elementary,
vocational, or secondary school or a public or private college, junior
college, or university, or a playground, or within 100 feet of a public
or private youth center, public swimming pool, or video arcade facility,
is (except as provided in subsection (b) of this section) subject to (1)
twice the maximum punishment authorized by section 841(b) of this title;
and (2) at least twice any term of supervised release authorized by
section 841(b) of this title for a first offense. A fine up to twice
that authorized by section 841(b) of this title may be imposed in
addition to any term of imprisonment authorized by this subsection.
Except to the extent a greater minimum sentence is otherwise provided by
section 841(b) of this title, a person shall be sentenced under this
subsection to a term of imprisonment of not less than one year. The
mandatory minimum sentencing provisions of this paragraph shall not
apply to offenses involving 5 grams or less of marihuana.
(b) Second offenders
Any person who violates section 841(a)(1) of this title or section
856 of this title by distributing, possessing with intent to distribute,
or manufacturing a controlled substance in or on, or within one thousand
feet of, the real property comprising a public or private elementary,
vocational, or secondary school or a public or private college, junior
college, or university, or a playground, or within 100 feet of a public
or private youth center, public swimming pool, or video arcade facility,
after a prior conviction under subsection (a) of this section has become
final is punishable (1) by the greater of (A) a term of imprisonment of
not less than three years and not more than life imprisonment or (B)
three times the maximum punishment authorized by section 841(b) of this
title for a first offense, and (2) at least three times any term of
supervised release authorized by section 841(b) of this title for a
first offense. A fine up to three times that authorized by section
841(b) of this title may be imposed in addition to any term of
imprisonment authorized by this subsection. Except to the extent a
greater minimum sentence is otherwise provided by section 841(b) of this
title, a person shall be sentenced under this subsection to a term of
imprisonment of not less than three years /1/ Penalties for third and
subsequent convictions shall be governed by section 841( b)(1)(A) of
this title.
(c) Suspension of sentence; probation; parole
In the case of any mandatory minimum sentence imposed under this
section, imposition or execution of such sentence shall not be suspended
and probation shall not be granted. An individual convicted under this
section shall not be eligible for parole until the individual has served
the mandatory minimum term of imprisonment as provided by this section.
(d) Definitions
For the purposes of this section --
(1) The term ''playground'' means any outdoor facility (including any
parking lot appurtenant thereto) intended for recreation, open to the
public, and with any portion thereof containing three or more separate
apparatus intended for the recreation of children including, but not
limited to, sliding boards, swingsets, and teeterboards.
(2) The term ''youth center'' means any recreational facility and/or
gymnasium (including any parking lot appurtenant thereto), intended
primarily for use by persons under 18 years of age, which regularly
provides athletic, civic, or cultural activities.
(3) The term ''video arcade facility'' means any facility, legally
accessible to persons under 18 years of age, intended primarily for the
use of pinball and video machines for amusement containing a minimum of
ten pinball and/or video machines.
(4) The term ''swimming pool'' includes any parking lot appurtenant
thereto.
(Pub. L. 91-513, title II, 419, formerly 405A, as added Pub. L.
98-473, title II, 503(a), Oct. 12, 1984, 98 Stat. 2069, and amended Pub.
L. 99-570, title I, 1004(a), 1104, 1105(c), 1841(b), 1866(b), (c), Oct.
27, 1986, 100 Stat. 3207-6, 3207-11, 3207-52, 3207-55; Pub. L. 99-646,
28, Nov. 10, 1986, 100 Stat. 3598; Pub. L. 100-690, title VI,
6452(b)(1), 6457, 6458, Nov. 18, 1988, 102 Stat. 4371, 4373; renumbered
419 and amended Pub. L. 101-647, title X, 1002(b), 1003( b), title XII,
1214, title XV, 1502, title XXXV, 3599L, Nov. 29, 1990, 104 Stat. 4827,
4829, 4833, 4836, 4932.)
Section was classified to section 845a of this title prior to
renumbering by Pub. L. 101-647.
1990 -- Subsec. (a). Pub. L. 101-647, 1502(1), inserted ''or a
playground,'' after ''university,'' and struck out ''playground,'' after
''within 100 feet of a''.
Pub. L. 101-647, 1214(1)(C), substituted ''a person shall be
sentenced under this subsection to a term of imprisonment of not less
than one year'' for ''a term of imprisonment under this subsection shall
be not less than one year''.
Pub. L. 101-647, 1214(1)(B), inserted ''A fine up to twice that
authorized by section 841(b) of this title may be imposed in addition to
any term of imprisonment authorized by this subsection.''
Pub. L. 101-647, 1214(1)(A), which directed the amendment of par.
(1) by striking out '', or a fine, or both,'' could not be executed
because those words did not appear. See note below.
Pub. L. 101-647, 1003(b)(1), which directed the substitution of
''subject to (1) twice the maximum punishment authorized by section
841(b) of this title'' for ''punishable (1) by a term of imprisonment,
or a fine, or both, up to twice that authorized by section 841(b) of
this title'', was executed by making the substitution for ''punishable
(1) by a term of imprisonment, or fine, or both, up to twice that
authorized by section 841(b) of this title'' to reflect the probable
intent of Congress.
Subsec. (b). Pub. L. 101-647, 3599L, substituted ''has become final''
for ''have become final''.
Pub. L. 101-647, 1502(2), inserted ''or a playground,'' after
''university,'' and struck out ''playground,'' after ''within 100 feet
of a''.
Pub. L. 101-647, 1214(2)(B), inserted after first sentence ''A fine
up to three times that authorized by section 841(b) of this title may be
imposed in addition to any term of imprisonment authorized by this
subsection. Except to the extent a greater minimum sentence is
otherwise provided by section 841(b) of this title, a person shall be
sentenced under this subsection to a term of imprisonment of not less
than three years''.
Subsec. (b)(1)(B). Pub. L. 101-647, 1214(2)(A), which directed the
amendment of subpar. (B) by striking '', or a fine up to three times
that'' through ''or both'', could not be exected because the language
did not appear after execution of the intervening amendment by Pub. L.
101-647, 1003(b)(2). See below.
Pub. L. 101-647, 1003(b)(2), substituted ''three times the maximum
punishment authorized by section 841(b) of this title for a first
offense'' for ''a term of imprisonment of up to three times that
authorized by section 841(b) of this title for a first offense, or a
fine up to three times that authorized by section 841(b) of this title
for a first offense, or both''.
Subsec. (c). Pub. L. 101-647, 1214(3), inserted ''mandatory minimum''
after ''In the case of any'', struck out ''subsection (b) of'' after
''imposed under'', and substituted ''An individual convicted under this
section shall not be eligible for parole until the individual has served
the mandatory minimum term of imprisonment as provided by this section''
for ''An individual convicted under subsection (b) of this section shall
not be eligible for parole under chapter 311 of title 18 until the
individual has served the minimum sentence required by such
subsection''.
1988 -- Subsec. (a). Pub. L. 100-690, 6457, 6458(a), inserted '',
possessing with intent to distribute,'' after ''distributing'' and '',
or within 100 feet of a playground, public or private youth center,
public swimming pool, or video arcade facility,'' after ''university''.
Subsec. (b). Pub. L. 100-690, 6452(b)(1), 6457, 6458(a), inserted '',
possessing with intent to distribute,'' after ''distributing'', and '',
or within 100 feet of a playground, public or private youth center,
public swimming pool, or video arcade facility,'' after ''university'',
substituted ''a prior conviction'' for ''a prior conviction or
convictions'', and inserted at end ''Penalties for third and subsequent
convictions shall be governed by section 841(b)(1)(A) of this title.''
Subsec. (d). Pub. L. 100-690, 6458(b), added subsec. (d).
1986 -- Subsec. (a). Pub. L. 99-570, 1104(a), (b), 1105(c), 1841(
b)(1), inserted ''or section 856 of this title'' and ''or
manufacturing'', substituted ''a public or private elementary,
vocational, or secondary school or a public or private college, junior
college, or university'' for ''a public or private elementary or
secondary school'', struck out ''involving the same controlled substance
and schedule'' after ''for a first offense'', and inserted ''Except to
the extent a greater minimum sentence is otherwise provided by section
841(b) of this title, a term of imprisonment under this subsection shall
be not less than one year. The mandatory minimum sentencing provisions
of this paragraph shall not apply to offenses involving 5 grams or less
of marihuana.''
Pub. L. 99-570, 1004(a), substituted ''term of supervised release''
for ''special parole term''.
Subsec. (b). Pub. L. 99-646 which directed that ''parole'' be
inserted after ''(2) at least three times any special'' could not be
executed in view of prior amendment by Pub. L. 99-570, 1104(c) below.
Pub. L. 99-570, 1166(b), which directed that ''term of supervised
release'' be substituted for ''special term'' could not be executed in
view of prior amendment by Pub. L. 99-570, 1104(c) below.
Pub. L. 99-570, 1104(a), 1841(b)(2), inserted reference to section
856 of this title, inserted ''or manufacturing'' after ''distributing''
and substituted ''a public or private elementary, vocational, or
secondary school or a public or private college, junior college, or
university'' for ''a public or private elementary or secondary school''.
Pub. L. 99-570, 1104(c), amended cls. (1) and (2) generally. Prior
to amendment, cls. (1) and (2) read as follows: ''(1) by a term of
imprisonment of not less than three years and not more than life
imprisonment and (2) at least three times any special term authorized by
section 841(b) of this title for a second or subsequent offense
involving the same controlled substance and schedule.''
Subsec. (c). Pub. L. 99-570, 1866(c), substituted reference to
chapter 311 of title 18 for reference to section 4202 of that title.
Amendment by section 1004(a) of Pub. L. 99-570 effective on date of
taking effect of section 3583 of Title 18, Crimes and Criminal Procedure
(Nov. 1, 1987), see section 1004(b) of Pub. L. 99-570 set out as a note
under section 841 of this title.
/1/ So in original. Probably should be followed by a period.
21 USC 861. Employment or use of persons under 18 years of age in drug
operations
TITLE 21 -- FOOD AND DRUGS
(a) Unlawful acts
It shall be unlawful for any person at least eighteen years of age to
knowingly and intentionally --
(1) employ, hire, use, persuade, induce, entice, or coerce, a person
under eighteen years of age to violate any provision of this subchapter
or subchapter II of this chapter;
(2) employ, hire, use, persuade, induce, entice, or coerce, a person
under eighteen years of age to assist in avoiding detection or
apprehension for any offense of this subchapter or subchapter II of this
chapter by any Federal, State, or local law enforcement official; or
(3) receive a controlled substance from a person under 18 years of
age, other than an immediate family member, in violation of this
subchapter or subchapter II of this chapter.
(b) Penalty for first offense
Any person who violates subsection (a) of this section is subject to
twice the maximum punishment otherwise authorized and at least twice any
term of supervised release otherwise authorized for a first offense.
Except to the extent a greater minimum sentence is otherwise provided, a
term of imprisonment under this subsection shall not be less than one
year.
(c) Penalty for subsequent offenses
Any person who violates subsection (a) of this section after a prior
conviction under subsection (a) of this section has become final, is
subject to three times the maximum punishment otherwise authorized and
at least three times any term of supervised release otherwise authorized
for a first offense. Except to the extent a greater minimum sentence is
otherwise provided, a term of imprisonment under this subsection shall
not be less than one year. Penalties for third and subsequent
convictions shall be governed by section 841(b)(1)(A) of this title.
(d) Penalty for providing or distributing controlled substance to
underage person
Any person who violates subsection (a)(1) or (2) of this section /1/
(1) by knowingly providing or distributing a controlled substance or
a controlled substance analogue to any person under eighteen years of
age; or
(2) if the person employed, hired, or used is fourteen years of age
or younger,
shall be subject to a term of imprisonment for not more than five
years or a fine of not more than $50,000, or both, in addition to any
other punishment authorized by this section.
(e) Suspension of sentence; probation; parole
In any case of any sentence imposed under this section, imposition or
execution of such sentence shall not be suspended and probation shall
not be granted. An individual convicted under this section of an
offense for which a mandatory minimum term of imprisonment is applicable
shall not be eligible for parole under section 4202 of title 18 /2/
until the individual has served the mandatory term of imprisonment as
enhanced by this section.
(f) Distribution of controlled substance to pregnant individual
Except as authorized by this subchapter, it shall be unlawful for any
person to knowingly or intentionally provide or distribute any
controlled substance to a pregnant individual in violation of any
provision of this subchapter. Any person who violates this subsection
shall be subject to the provisions of subsections (b), (c), and (e) of
this section.
(Pub. L. 91-513, title II, 420, formerly 405B, as added Pub. L.
99-570, title I, 1102, Oct. 27, 1986, 100 Stat. 3207-10, and amended
Pub. L. 100-690, title VI, 6452(b)(1), 6459, 6470(d), Nov. 18, 1988, 102
Stat. 4371, 4373, 4378; renumbered 420 and amended Pub. L. 101-647,
title X, 1002(c), 1003(c), title XXXV, 3599L, Nov. 29, 1990, 104 Stat.
4827, 4829, 4932.)
Section 4202 of title 18, referred to in subsec. (e), which, as
originally enacted in Title 18, Crimes and Criminal Procedure, related
to eligibility of prisoners for parole, was repealed and a new section
4202 enacted as part of the repeal and enactment of a new chapter 311 (
4201 et seq.) of Title 18, by Pub. L. 94-233, 2, Mar. 15, 1976, 90
Stat. 219. For provisions relating to the eligibility of prisoners for
parole, see section 4205 of Title 18. Pub. L. 98-473, title II, 218(
a)(5), 235(a)(1), (b)(1), Oct. 12, 1984, 98 Stat. 2027, 2031, 2032, as
amended, provided that, effective on the first day of the first calendar
month beginning 36 months after Oct. 12, 1984 (Nov. 1, 1987), chapter
311 of Title 18 is repealed, subject to remaining effective for five
years after Nov. 1, 1987, in certain circumstances. See Effective Date
note set out under section 3551 of Title 18.
Section was classified to section 845b of this title prior to
renumbering by Pub. L. 101-647.
1990 -- Subsec. (b). Pub. L. 101-647, 1003(c)(1), which directed the
substitution of ''is subject to twice the maximum punishment otherwise
authorized'' for ''is punishable by a term of imprisonment up to twice
that authorized, or up to twice the fine authorized, or both,'' was
executed by making the substitution for ''is punishable by a term of
imprisonment up to twice that otherwise authorized, or up to twice the
fine otherwise authorized, or both,'' to reflect the probable intent of
Congress.
Subsec. (c). Pub. L. 101-647, 3599L, substituted ''has become final''
for ''have become final''.
Pub. L. 101-647, 1003(c)(2), which directed the substitution of ''is
subject to three times the maximum punishment otherwise authorized'' for
''is punishable by a term of imprisonment up to three times that
authorized, or up to three times the fine authorized, or both,'' was
executed by making the substitution for ''is punishable by a term of
imprisonment up to three times that otherwise authorized, or up to three
times the fine otherwise authorized, or both,'' to reflect the probable
intent of Congress.
1988 -- Subsec. (a)(3). Pub. L. 100-690, 6459, added par. (3).
Subsec. (c). Pub. L. 100-690, 6452(b)(1), struck out ''or
convictions'' after ''a prior conviction'' and inserted at end
''Penalties for third and subsequent convictions shall be governed by
section 841(b)(1)(A) of this title.''
Subsec. (e). Pub. L. 100-690, 6470(d), struck out ''required by
section 841(b) of this title'' after ''mandatory term of imprisonment''.
/1/ So in original. Probably should be followed by a dash.
/2/ See References in Text note below.
21 USC 862. Denial of Federal benefits to drug traffickers and
possessors
TITLE 21 -- FOOD AND DRUGS
(a) Drug traffickers
(1) Any individual who is convicted of any Federal or State offense
consisting of the distribution of controlled substances shall --
(A) at the discretion of the court, upon the first conviction for
such an offense be ineligible for any or all Federal benefits for up to
5 years after such conviction;
(B) at the discretion of the court, upon a second conviction for such
an offense be ineligible for any or all Federal benefits for up to 10
years after such conviction; and
(C) upon a third or subsequent conviction for such an offense be
permanently ineligible for all Federal benefits.
(2) The benefits which are denied under this subsection shall not
include benefits relating to long-term drug treatment programs for
addiction for any person who, if there is a reasonable body of evidence
to substantiate such declaration, declares himself to be an addict and
submits himself to a long-term treatment program for addiction, or is
deemed to be rehabilitated pursuant to rules established by the
Secretary of Health and Human Services.
(b) Drug possessors
(1) Any individual who is convicted of any Federal or State offense
involving the possession of a controlled substance (as such term is
defined for purposes of this subchapter) shall --
(A) upon the first conviction for such an offense and at the
discretion of the court --
(i) be ineligible for any or all Federal benefits for up to one year;
(ii) be required to successfully complete an approved drug treatment
program which includes periodic testing to insure that the individual
remains drug free;
(iii) be required to perform appropriate community service; or
(iv) any combination of clause (i), (ii), or (iii); and
(B) upon a second or subsequent conviction for such an offense be
ineligible for all Federal benefits for up to 5 years after such
conviction as determined by the court. The court shall continue to have
the discretion in subparagraph (A) above. In imposing penalties and
conditions under subparagraph (A), the court may require that the
completion of the conditions imposed by clause (ii) or (iii) be a
requirement for the reinstatement of benefits under clause (i).
(2) The penalties and conditions which may be imposed under this
subsection shall be waived in the case of a person who, if there is a
reasonable body of evidence to substantiate such declaration, declares
himself to be an addict and submits himself to a long-term treatment
program for addiction, or is deemed to be rehabilitated pursuant to
rules established by the Secretary of Health and Human Services.
(c) Suspension of period of ineligibility
The period of ineligibility referred to in subsections (a) and (b) of
this section shall be suspended if the individual --
(A) completes a supervised drug rehabilitation program after becoming
ineligible under this section;
(B) has otherwise been rehabilitated; or
(C) has made a good faith effort to gain admission to a supervised
drug rehabilitation program, but is unable to do so because of
inaccessibility or unavailability of such a program, or the inability of
the individual to pay for such a program.
(d) Definitions
As used in this section --
(1) the term ''Federal benefit'' --
(A) means the issuance of any grant, contract, loan, professional
license, or commercial license provided by an agency of the United
States or by appropriated funds of the United States; and
(B) does not include any retirement, welfare, Social Security,
health, disability, veterans benefit, public housing, or other similar
benefit, or any other benefit for which payments or services are
required for eligibility; and
(2) the term ''veterans benefit'' means all benefits provided to
veterans, their families, or survivors by virtue of the service of a
veteran in the Armed Forces of the United States.
(e) Inapplicability of this section to Government witnesses
The penalties provided by this section shall not apply to any
individual who cooperates or testifies with the Government in the
prosecution of a Federal or State offense or who is in a Government
witness protection program.
(f) Indian provision
Nothing in this section shall be construed to affect the obligation
of the United States to any Indian or Indian tribe arising out of any
treaty, statute, Executive order, or the trust responsibility of the
United States owing to such Indian or Indian tribe. Nothing in this
subsection shall exempt any individual Indian from the sanctions
provided for in this section, provided that no individual Indian shall
be denied any benefit under Federal Indian programs comparable to those
described in subsection (d)(1)(B) or (d)(2) of this section.
(g) Presidential report
(1) On or before May 1, 1989, the President shall transmit to the
Congress a report --
(A) delineating the role of State courts in implementing this
section;
(B) describing the manner in which Federal agencies will implement
and enforce the requirements of this section;
(C) detailing the means by which Federal and State agencies, courts,
and law enforcement agencies will exchange and share the data and
information necessary to implement and enforce the withholding of
Federal benefits; and
(D) recommending any modifications to improve the administration of
this section or otherwise achieve the goal of discouraging the
trafficking and possession of controlled substances.
(2) No later than September 1, 1989, the Congress shall consider the
report of the President and enact such changes as it deems appropriate
to further the goals of this section.
(h) Effective date
The denial of Federal benefits set forth in this section shall take
effect for convictions occurring after September 1, 1989.
(Pub. L. 91-513, title II, 421, formerly Pub. L. 100-690, title V,
5301, Nov. 18, 1988, 102 Stat. 4310, redesignated 421 of Pub. L. 91-513
and amended Pub. L. 101-647, title X, 1002(d), Nov. 29, 1990, 104 Stat.
4827.)
Section was classified to section 853a of this title prior to
redesignation by Pub. L. 101-647.
1990 -- Pub. L. 101-647, 1002(d)(1), redesignated section 853a of
this title as this section.
Subsec. (a)(1). Pub. L. 101-647, 1002(d)(2), struck out ''(as such
terms are defined for purposes of the Controlled Substances Act)'' after
''controlled substances'' in introductory provisions.
21 USC 863. Drug paraphernalia
TITLE 21 -- FOOD AND DRUGS
(a) In general
It is unlawful for any person --
(1) to sell or offer for sale drug paraphernalia;
(2) to use the mails or any other facility of interstate commerce to
transport drug paraphernalia; or
(3) to import or export drug paraphernalia.
(b) Penalties
Anyone convicted of an offense under subsection (a) of this section
shall be imprisoned for not more than three years and fined under title
18.
(c) Seizure and forfeiture
Any drug paraphernalia involved in any violation of subsection (a) of
this section shall be subject to seizure and forfeiture upon the
conviction of a person for such violation. Any such paraphernalia shall
be delivered to the Administrator of General Services, General Services
Administration, who may order such paraphernalia destroyed or may
authorize its use for law enforcement or educational purposes by
Federal, State, or local authorities.
(d) ''Drug paraphernalia'' defined
The term ''drug paraphernalia'' means any equipment, product, or
material of any kind which is primarily intended or designed for use in
manufacturing, compounding, converting, concealing, producing,
processing, preparing, injecting, ingesting, inhaling, or otherwise
introducing into the human body a controlled substance, possession of
which is unlawful under this subchapter. It includes items primarily
intended or designed for use in ingesting, inhaling, or otherwise
introducing marijuana, /1/ cocaine, hashish, hashish oil, PCP, or
amphetamines into the human body, such as --
(1) metal, wooden, acrylic, glass, stone, plastic, or ceramic pipes
with or without screens, permanent screens, hashish heads, or punctured
metal bowls;
(2) water pipes;
(3) carburetion tubes and devices;
(4) smoking and carburetion masks;
(5) roach clips: meaning objects used to hold burning material, such
as a marihuana cigarette, that has become too small or too short to be
held in the hand;
(6) miniature spoons with level capacities of one-tenth cubic
centimeter or less;
(7) chamber pipes;
(8) carburetor pipes;
(9) electric pipes;
(10) air-driven pipes;
(11) chillums;
(12) bongs;
(13) ice pipes or chillers;
(14) wired cigarette papers; or
(15) cocaine freebase kits.
(e) Matters considered in determination of what constitutes drug
paraphernalia
In determining whether an item constitutes drug paraphernalia, in
addition to all other logically relevant factors, the following may be
considered:
(1) instructions, oral or written, provided with the item concerning
its use;
(2) descriptive materials accompanying the item which explain or
depict its use;
(3) national and local advertising concerning its use;
(4) the manner in which the item is displayed for sale;
(5) whether the owner, or anyone in control of the item, is a
legitimate supplier of like or related items to the community, such as a
licensed distributor or dealer of tobacco products;
(6) direct or circumstantial evidence of the ratio of sales of the
item(s) to the total sales of the business enterprise;
(7) the existence and scope of legitimate uses of the item in the
community; and
(8) expert testimony concerning its use.
(f) Exemptions
This section shall not apply to --
(1) any person authorized by local, State, or Federal law to
manufacture, possess, or distribute such items; or
(2) any item that, in the normal lawful course of business, is
imported, exported, transported, or sold through the mail or by any
other means, and traditionally intended for use with tobacco products,
including any pipe, paper, or accessory.
(Pub. L. 91-513, title II, 422(a), as added Pub. L. 101-647, title
XXIV, 2401(a), Nov. 29, 1990, 104 Stat. 4858; Pub. L. 91-513, title II,
422(b)-(f), formerly Pub. L. 99-570, title I, 1822(b)-(f), Oct. 27,
1986, 100 Stat. 3207-51, amended Pub. L. 100-690, title VI, 6485, Nov.
18, 1988, 102 Stat. 4384; redesignated 422(b)-(f) of Pub. L. 91-513,
and amended Pub. L. 101-647, title XXIV, 2401(b), (c), Nov. 29, 1990,
104 Stat. 4859.)
Pub. L. 101-647, 2401(b), transferred section 1822(b) to (f) of Pub.
L. 99-570, which was classified to section 857 of this title, to
subsecs. (b) to (f) of this section.
1990 -- Subsec. (b). Pub. L. 101-647, 2401(c)(1), substituted
''fined under title 18'' for ''fined not more than $100,000''.
Pub. L. 101-647, 2401(b), redesignated subsec. (b) of section 857 of
this title as subsec. (b) of this section.
Subsecs. (c) to (e). Pub. L. 101-647, 2401(b), redesignated subsecs.
(c) to (e) of section 857 of this title as subsecs. (c) to (e) of this
section.
Subsec. (f). Pub. L. 101-647, 2401(c)(2), made technical amendment to
reference to ''This section'' to correct reference to corresponding
provision of original act.
Pub. L. 101-647, 2401(b), redesignated subsec. (f) of section 857 of
this title as subsec. (f) of this section.
1988 -- Subsec. (d) (formerly 857(d)). Pub. L. 100-690, 6485(1),
substituted '', possession of which is unlawful under the Controlled
Substances Act'' for ''in violation of the Controlled Substances Act''.
See 1990 Amendment note above.
Subsec. (f)(2) (formerly 857(f)(2)). Pub. L. 100-690, 6485(2),
substituted ''traditionally'' for ''primarily'' before ''intended for
use with''. See 1990 Amendment note above.
/1/ So in original. Probably should be ''marihuana,''.