21 U.S.C. § 2205 (2024) — Title 21: FOOD AND DRUGS / Chapter 27: FOOD SAFETY MODERNIZATION / Subchapter I: IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS / Section 2205: Food allergy and anaphylaxis management
Food allergy and anaphylaxis management
Status: in_force

(a) Definitions

In this section:

(1) Early childhood education program

The term "early childhood education program" means—

(A) a Head Start program or an Early Head Start program carried out under the Head Start Act (42 U.S.C. 9831 et seq.);

(B) a State licensed or regulated child care program or school; or

(C) a State prekindergarten program that serves children from birth through kindergarten.

(2) ESEA definitions

The terms "local educational agency", "secondary school", "elementary school", and "parent" have the meanings given the terms in section 7801 of title 20.

(3) School

The term "school" includes public—

(A) kindergartens;

(B) elementary schools; and

(C) secondary schools.

(4) Secretary

The term "Secretary" means the Secretary of Health and Human Services.

(b) Establishment of voluntary food allergy and anaphylaxis management guidelines

(1) Establishment

(A) In general

Not later than 1 year after January 4, 2011, the Secretary, in consultation with the Secretary of Education, shall—

(i) develop guidelines to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; and

(ii) make such guidelines available to local educational agencies, schools, early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only.

(B) Applicability of FERPA

Each plan described in subparagraph (A) that is developed for an individual shall be considered an education record for the purpose of section 1232g of title 20 (commonly referred to as the "Family Educational Rights and Privacy Act of 1974").

(2) Contents

The voluntary guidelines developed by the Secretary under paragraph (1) shall address each of the following and may be updated as the Secretary determines necessary:

(A) Parental obligation to provide the school or early childhood education program, prior to the start of every school year, with—

(i) documentation from their child's physician or nurse—

(I) supporting a diagnosis of food allergy, and any risk of anaphylaxis, if applicable;

(II) identifying any food to which the child is allergic;

(III) describing, if appropriate, any prior history of anaphylaxis;

(IV) listing any medication prescribed for the child for the treatment of anaphylaxis;

(V) detailing emergency treatment procedures in the event of a reaction;

(VI) listing the signs and symptoms of a reaction; and

(VII) assessing the child's readiness for self-administration of prescription medication; and

(ii) a list of substitute meals that may be offered to the child by school or early childhood education program food service personnel.

(B) The creation and maintenance of an individual plan for food allergy management, in consultation with the parent, tailored to the needs of each child with a documented risk for anaphylaxis, including any procedures for the self-administration of medication by such children in instances where—

(i) the children are capable of self-administering medication; and

(ii) such administration is not prohibited by State law.

(C) Communication strategies between individual schools or early childhood education programs and providers of emergency medical services, including appropriate instructions for emergency medical response.

(D) Strategies to reduce the risk of exposure to anaphylactic causative agents in classrooms and common school or early childhood education program areas such as cafeterias.

(E) The dissemination of general information on life-threatening food allergies to school or early childhood education program staff, parents, and children.

(F) Food allergy management training of school or early childhood education program personnel who regularly come into contact with children with life-threatening food allergies.

(G) The authorization and training of school or early childhood education program personnel to administer epinephrine when the nurse is not immediately available.

(H) The timely accessibility of epinephrine by school or early childhood education program personnel when the nurse is not immediately available.

(I) The creation of a plan contained in each individual plan for food allergy management that addresses the appropriate response to an incident of anaphylaxis of a child while such child is engaged in extracurricular programs of a school or early childhood education program, such as non-academic outings and field trips, before- and after-school programs or before- and after-early child education program programs,1 and school-sponsored or early childhood education program-sponsored programs held on weekends.

(J) Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents.

(K) Other elements the Secretary determines necessary for the management of food allergies and anaphylaxis in schools and early childhood education programs.

(3) Relation to State law

Nothing in this section or the guidelines developed by the Secretary under paragraph (1) shall be construed to preempt State law, including any State law regarding whether students at risk for anaphylaxis may self-administer medication.

(c) School-based food allergy management grants

(1) In general

The Secretary may award grants to local educational agencies to assist such agencies with implementing voluntary food allergy and anaphylaxis management guidelines described in subsection (b).

(2) Application

(A) In general

To be eligible to receive a grant under this subsection, a local educational agency shall submit an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.

(B) Contents

Each application submitted under subparagraph (A) shall include—

(i) an assurance that the local educational agency has developed plans in accordance with the food allergy and anaphylaxis management guidelines described in subsection (b);

(ii) a description of the activities to be funded by the grant in carrying out the food allergy and anaphylaxis management guidelines, including—

(I) how the guidelines will be carried out at individual schools served by the local educational agency;

(II) how the local educational agency will inform parents and students of the guidelines in place;

(III) how school nurses, teachers, administrators, and other school-based staff will be made aware of, and given training on, when applicable, the guidelines in place; and

(IV) any other activities that the Secretary determines appropriate;

(iii) an itemization of how grant funds received under this subsection will be expended;

(iv) a description of how adoption of the guidelines and implementation of grant activities will be monitored; and

(v) an agreement by the local educational agency to report information required by the Secretary to conduct evaluations under this subsection.

(3) Use of funds

Each local educational agency that receives a grant under this subsection may use the grant funds for the following:

(A) Purchase of materials and supplies, including limited medical supplies such as epinephrine and disposable wet wipes, to support carrying out the food allergy and anaphylaxis management guidelines described in subsection (b).

(B) In partnership with local health departments, school nurse, teacher, and personnel training for food allergy management.

(C) Programs that educate students as to the presence of, and policies and procedures in place related to, food allergies and anaphylactic shock.

(D) Outreach to parents.

(E) Any other activities consistent with the guidelines described in subsection (b).

(4) Duration of awards

The Secretary may award grants under this subsection for a period of not more than 2 years. In the event the Secretary conducts a program evaluation under this subsection, funding in the second year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.

(5) Limitation on grant funding

The Secretary may not provide grant funding to a local educational agency under this subsection after such local educational agency has received 2 years of grant funding under this subsection.

(6) Maximum amount of annual awards

A grant awarded under this subsection may not be made in an amount that is more than $50,000 annually.

(7) Priority

In awarding grants under this subsection, the Secretary shall give priority to local educational agencies with the highest percentages of children who are counted under section 6333(c) of title 20.

(8) Matching funds

(A) In general

The Secretary may not award a grant under this subsection unless the local educational agency agrees that, with respect to the costs to be incurred by such local educational agency in carrying out the grant activities, the local educational agency shall make available (directly or through donations from public or private entities) non-Federal funds toward such costs in an amount equal to not less than 25 percent of the amount of the grant.

(B) Determination of amount of non-Federal contribution

Non-Federal funds required under subparagraph (A) may be cash or in kind, including plant, equipment, or services. Amounts provided by the Federal Government, and any portion of any service subsidized by the Federal Government, may not be included in determining the amount of such non-Federal funds.

(9) Administrative funds

A local educational agency that receives a grant under this subsection may use not more than 2 percent of the grant amount for administrative costs related to carrying out this subsection.

(10) Progress and evaluations

At the completion of the grant period referred to in paragraph (4), a local educational agency shall provide the Secretary with information on how grant funds were spent and the status of implementation of the food allergy and anaphylaxis management guidelines described in subsection (b).

(11) Supplement, not supplant

Grant funds received under this subsection shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this subsection.

(12) Authorization of appropriations

There is authorized to be appropriated to carry out this subsection $30,000,000 for fiscal year 2011 and such sums as may be necessary for each of the 4 succeeding fiscal years.

(d) Voluntary nature of guidelines

(1) In general

The food allergy and anaphylaxis management guidelines developed by the Secretary under subsection (b) are voluntary. Nothing in this section or the guidelines developed by the Secretary under subsection (b) shall be construed to require a local educational agency to implement such guidelines.

(2) Exception

Notwithstanding paragraph (1), the Secretary may enforce an agreement by a local educational agency to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection (c).

(Pub. L. 111–353, title I, §112, Jan. 4, 2011, 124 Stat. 3916; Pub. L. 114–95, title IX, §9215(jj), Dec. 10, 2015, 129 Stat. 2175.)

Editorial Notes

References in Text

The Head Start Act, referred to in subsec. (a)(1)(A), is subchapter B (§635 et seq.) of chapter 8 of subtitle A of title VI of Pub. L. 97–35, Aug. 13, 1981, 95 Stat. 499, which is classified generally to subchapter II (§9831 et seq.) of chapter 105 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 9801 of Title 42 and Tables.

Amendments

2015—Subsec. (a)(2). Pub. L. 114–95 made technical amendment to reference in original act which appears in text as reference to section 7801 of title 20.

Statutory Notes and Related Subsidiaries

Effective Date of 2015 Amendment

Amendment by Pub. L. 114–95 effective Dec. 10, 2015, except with respect to certain noncompetitive programs and competitive programs, see section 5 of Pub. L. 114–95, set out as a note under section 6301 of Title 20, Education.

1 So in original.
21 U.S.C. § 1177 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter IV: OTHER FEDERAL PROGRAMS / Section 1177: Special project grants and contracts
Special project grants and contracts
Status: in_force

(a) Scope of programs; priority

The Secretary 1 acting through the National Institute on Drug Abuse, may make grants to and enter into contracts with individuals and public and private nonprofit entities—

(1) to provide training seminars, educational programs, and technical assistance for the development, demonstration, and evaluation of drug abuse prevention, treatment, and rehabilitation programs; and

(2) to conduct demonstration and evaluation projects, with a high priority on prevention and early intervention projects and on identifying new and more effective drug abuse prevention, treatment, and rehabilitation programs.

In the implementation of his authority under this section, the Secretary shall accord a high priority to applications for grants or contracts for primary prevention programs. For purposes of the preceding sentence, primary prevention programs include programs designed to discourage persons from beginning drug abuse. To the extent that appropriations authorized under this section are used to fund treatment services, the Secretary shall not limit such funding to treatment for opiate abuse, but shall also provide support for treatment for non-opiate drug abuse including polydrug abuse. Furthermore, nothing shall prevent the use of funds provided under this section for programs and projects aimed at the prevention, treatment, and rehabilitation of alcohol abuse and alcoholism as well as drug abuse.

(b) Authorization of appropriations

There are authorized to be appropriated $25,000,000 for the fiscal year ending June 30, 1972; $65,000,000 for the fiscal year ending June 30, 1973; $100,000,000 for the fiscal year ending June 30, 1974; $160,000,000 for each of the fiscal years ending June 30, 1975 and June 30, 1976; $40,000,000 for the period July 1, 1976, through September 30, 1976; and $160,000,000 for each of the fiscal years ending September 30, 1977, and September 30, 1978, to carry out this section. For the fiscal year ending September 30, 1979, there is authorized to be appropriated (1) $153,000,000 for grants and contracts under paragraphs (3) and (6) of subsection (a) for drug abuse treatment programs, and (2) $24,000,000 for grants and contracts under such subsection for other programs and activities. For grants and contracts under paragraphs (3) and (6) of subsection (a) for drug abuse treatment programs there is authorized to be appropriated $149,000,000 for the fiscal year ending September 30, 1980, and $155,000,000 for the fiscal year ending September 30, 1981; and for grants and contracts under such subsection for other programs and activities there is authorized to be appropriated $20,000,000 for the fiscal year ending September 30, 1980, and $30,000,000 for the fiscal year ending September 30, 1981. Of the funds appropriated under the preceding sentence for the fiscal year ending September 30, 1980, at least 7 percent of the funds shall be obligated for grants and contracts for primary prevention and intervention programs designed to discourage individuals, particularly those in high risk populations, from abusing drugs; and of the funds appropriated under the preceding sentence for the next fiscal year, at least 10 percent of the funds shall be obligated for such grants and contracts. For carrying out the purposes of this section, there are authorized to be appropriated $15,000,000 for the fiscal year ending September 30, 1982. Of the funds appropriated under the preceding sentence, at least 25 per centum of the funds shall be obligated for grants and contracts for primary prevention and intervention programs designed to discourage individuals, particularly individuals in high risk populations, from abusing drugs.

(c) Coordination of applications for programs in a State; precedence restriction; project evaluation; application approval; criteria; proposed performance standards or research protocol

(1) In carrying out this section, the Secretary shall require coordination of all applications for programs in a State and shall not give precedence to public agencies over private agencies, institutions, and organizations, or to State agencies over local agencies.

(2) Each applicant within a State, upon filing its application with the Secretary for a grant or contract under this section, shall submit a copy of its application for review by the State agency (if any) responsible for the administration of drug abuse prevention activities. Such State agency shall be given not more than thirty days from the date of receipt of the application to submit to the Secretary, in writing, an evaluation of the project set forth in the application. Such evaluation shall include comments on the relationship of the project to other projects pending and approved and to any State comprehensive plan for treatment and prevention of drug abuse. The State shall furnish the applicant a copy of any such evaluation. A State if it so desires may, in writing, waive its rights under this paragraph.

(3) Approval of any application for a grant or contract under this section by the Secretary, including the earmarking of financial assistance for a program or project, may be granted only if the application substantially meets a set of criteria that—

(A) provide that the activities and services for which assistance under this section is sought will be substantially administered by or under the supervision of the applicant;

(B) provide for such methods of administration as are necessary for the proper and efficient operation of such programs or projects; and

(C) provide for such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement of and accounting for Federal funds paid to the applicant.

(4) Each applicant within a State, upon filing its application with the Secretary for a grant or contract to provide treatment or rehabilitation services shall provide a proposed performance standard or standards, to measure, or research protocol to determine, the effectiveness of such treatment or rehabilitation program or project.

(d) Programs and projects aimed at underserved groups; encouragement and special consideration given to applications

The Secretary shall encourage the submission of and give special consideration to applications under this section to programs and projects aimed at underserved populations such as racial and ethnic minorities, Native Americans (including Native Hawaiians and Native American Pacific Islanders), youth, the elderly, women, handicapped individuals, and families of drug abusers.

(e) Payments; advances; reimbursement; installments

Payment under grants or contracts under this section may be made in advance or by way of reimbursement and in such installments as the Secretary may determine.

(f) Prevention and treatment services

Projects and programs for which grants and contracts are made or entered into under this section shall, in the case of prevention and treatment services, seek to (1) be responsive to special requirements of handicapped individuals in receiving such services; (2) whenever possible, be community based, insure care of good quality in general community care facilities and under health insurance plans, and be integrated with, and provide for the active participation of, a wide range of public and nongovernmental agencies, organizations, institutions, and individuals; (3) where a substantial number of the individuals in the population served by the project or program are of limited English-speaking ability (A) utilize the services of outreach workers fluent in the language spoken by a predominant number of such individuals and develop a plan and make arrangements responsive to the needs of such population for providing services to the extent practicable in the language and cultural context most appropriate to such individuals, and (B) identify an individual who is fluent both in that language and English and whose responsibilities shall include providing guidance to the individuals of limited English-speaking ability and to appropriate staff members with respect to cultural sensitivities and bridging linguistic and cultural differences; and (4) where appropriate, utilize existing community resources (including community mental health centers).

(g) Authorization by chief executive officer of State required; maximum amount and duration of grants

(1) No grant may be made under this section to a State or to any entity within the government of a State unless the grant application has been duly authorized by the chief executive officer of such State.

(2) No grant or contract may be made under this section for a period in excess of five years.

(3)(A) The amount of any grant or contract under this section may not exceed 100 per centum of the cost of carrying out the grant or contract in the first fiscal year for which the grant or contract is made under this section, 80 per centum of such cost in the second fiscal year for which the grant or contract is made under this section, 70 per centum of such cost in the third fiscal year for which the grant or contract is made under this section, and 60 per centum of such cost in each of the fourth and fifth fiscal years for which the grant or contract is made under this section.

(B) For purposes of this paragraph, no grant or contract shall be considered to have been made under this section for a fiscal year ending before September 30, 1981.

(Pub. L. 92–255, title IV, §410, Mar. 21, 1972, 86 Stat. 82; Pub. L. 94–237, §§10, 11, Mar. 19, 1976, 90 Stat. 247; Pub. L. 94–371, §10(c)(1), July 26, 1976, 90 Stat. 1040; Pub. L. 95–461, §§2(b), 6(a), Oct. 14, 1978, 92 Stat. 1268, 1270; Pub. L. 96–181, §7, Jan. 2, 1980, 93 Stat. 1312; Pub. L. 97–35, title IX, §970(b)–(f), Aug. 13, 1981, 95 Stat. 596, 597; Pub. L. 98–24, §5(a)(3), Apr. 26, 1983, 97 Stat. 183.)

Editorial Notes

Amendments

1983—Subsec. (d). Pub. L. 98–24 substituted "Native Americans (including Native Hawaiians and Native American Pacific Islanders)" for "native Americans".

1981—Subsec. (a). Pub. L. 97–35, §970(b), substituted "The Secretary acting through the National Institute on Drug Abuse, may make grants to and enter into contracts with individuals, and public and private nonprofit entities" for "The Secretary shall" in introductory provision preceding par. (1), reduced the enumeration of authorized activities of the Secretary from six paragraphs to two paragraphs thereby eliminating provisions relating to the recruitment, training, and employment of participants in treatment programs, the establishment, conduct, and evaluation of drug abuse prevention, treatment, and rehabilitation programs, the development of methods to deal with drug abuse in particular areas, the improvement of drug maintenance techniques or programs, and the establishment, conduct, and evaluation of drug abuse prevention and treatment programs, and inserted provision that nothing shall prevent the use of funds provided under this section for programs and projects aimed at the prevention, treatment, and rehabilitation of alcohol abuse and alcoholism as well as drug abuse.

Subsec. (b). Pub. L. 97–35, §970(c), inserted provisions relating to fiscal year ending Sept. 30, 1982.

Subsec. (c)(2). Pub. L. 97–35, §970(d)(1), substituted "responsible for the administration of drug abuse prevention activities" for "designated or established under section 1176 of this title" and "any State" for "the State" and struck out reference to drug abuse under section 1176 of this title.

Subsec. (c)(3)(D). Pub. L. 97–35, §970(d)(2), struck out subpar. (D) which had provided that approval of a grant or contract could be granted only if the application provided for reasonable assurances that Federal funds made available under this section would be used to supplement and increase the level of State, local, and other non-Federal funds that would in the absence of such Federal funds be made available for the programs described in this section and would not supplant State or local funds.

Subsec. (d). Pub. L. 97–35, §970(e), inserted applicability to racial and ethnic minorities, handicapped, native Americans, and families of drug abusers.

Subsec. (g). Pub. L. 97–35, §970(f), added subsec. (g).

1980—Subsec. (a)(1). Pub. L. 96–181, §7(a)(1), substituted "development, demonstration and evaluation of drug abuse" for "development of drug abuse".

Subsec. (a)(5). Pub. L. 96–181, §7(a)(2), substituted "drug maintenance and detoxification techniques" for "drug maintenance techniques".

Subsec. (a)(6). Pub. L. 96–181, §7(a)(3), in provisions relating to evaluation of drug abuse prevention and treatment programs, inserted provision that such evaluation be with particular emphasis on replicating effective prevention and treatment programs.

Subsec. (b). Pub. L. 96–181, §7(b), inserted authorization of appropriations for grants and contracts under pars. (3) and (6) of subsec. (a) and for other programs and activities for fiscal years ending Sept. 30, 1980, and Sept. 30, 1981, and required certain percentage of appropriated funds to be obligated for grants and contracts for primary prevention and intervention programs designed to discourage individuals from abusing drugs.

Subsec. (d). Pub. L. 96–181, §7(c), inserted provisions for special consideration to applications for programs and projects for prevention and treatment of drug abuse and drug dependence by elderly.

Subsec. (f). Pub. L. 96–181, §7(d), added subsec. (f).

1978—Subsec. (a). Pub. L. 95–461, §6(a), inserted provision requiring Secretary to act through National Institute on Drug Abuse in making special project grants.

Subsec. (b). Pub. L. 95–461, §2(b), inserted provisions authorizing appropriations for fiscal year ending Sept. 30, 1979.

1976—Subsec. (a). Pub. L. 94–237, §10(a), inserted provisions which authorized Secretary to give a high priority to applications for grants and contracts for primary prevention programs, and set forth programs included within primary prevention programs and scope of Secretary's funding authority.

Subsec. (b). Pub. L. 94–237, §11, substituted "$160,000,000 for each of the fiscal years ending June 30, 1975 and June 30, 1976; $40,000,000 for the period July 1, 1976, through September 30, 1976; and $160,000,000 for each of the fiscal years ending September 30, 1977, and September 30, 1978," for "and $160,000,000 for the fiscal year ending June 30, 1975,".

Subsec. (c)(4). Pub. L. 94–237, §10(b), added par. (4).

Subsecs. (d), (e). Pub. L. 94–371 added subsec. (d) and redesignated former subsec. (d) as (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1976 Amendment

Pub. L. 94–371, §10(c)(2), July 26, 1976, 90 Stat. 1041, provided that: "The amendment made by paragraph (1) [amending this section] shall apply with respect to applications submitted for grants or contracts under section 410 of the Drug Abuse Office and Treatment Act of 1972 [this section] after June 30, 1976."

1 So in original. Probably should be followed by a comma.
21 U.S.C. § 1115 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter II: DRUG ABUSE POLICY COORDINATION / Section 1115: Notice relating to the control of dangerous drugs
Notice relating to the control of dangerous drugs
Status: in_force

Whenever the Attorney General determines that there is evidence that—

(1) a drug or other substance, which is not a controlled substance (as defined in section 802(6) of this title), has a potential for abuse, or

(2) a controlled substance should be transferred or removed from a schedule under section 812 of this title,

he shall, prior to initiating any proceeding under section 811(a) of this title, give the President timely notice of such determination. Information forwarded to the Attorney General pursuant to section 811(f) of this title shall also be forwarded by the Secretary of Health and Human Services to the President.

(Pub. L. 92–255, title II, §201, formerly §205, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1311; amended Pub. L. 97–35, title IX, §973(a), Aug. 13, 1981, 95 Stat. 598; renumbered §201, Pub. L. 100–690, title I, §1007(c)(1), Nov. 18, 1988, 102 Stat. 4187.)

Editorial Notes

Prior Provisions

A prior section 201 of Pub. L. 92–255, title II, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1310; amended Pub. L. 98–473, title II, §1306, Oct. 12, 1984, 98 Stat. 2170, related to concentration of Federal effort in drug abuse prevention, prior to repeal by Pub. L. 100–690, title I, §1007(c)(1), Nov. 18, 1988, 102 Stat. 4187.

A prior section 1115, Pub. L. 92–255, title II, §205, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242, which provided for employment, functions, and travel expenses of employees, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1115, Pub. L. 92–255, title II, §205, Mar. 21, 1972, 86 Stat. 68, provided for the delegation of functions by the Director, prior to repeal by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Provisions similar to this section were contained in section 1118 of this title prior to the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Amendments

1981—Pub. L. 97–35 substituted "Health and Human Services" for "Health, Education, and Welfare".
21 U.S.C. § 1536 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter II: DRUG-FREE COMMUNITIES / Section 1536: Community-based coalition enhancement grants to address local drug crises
Community-based coalition enhancement grants to address local drug crises
Status: in_force

(a) Definitions

In this section:

(1) Administrator

The term "Administrator" means the Administrator of the Substance Abuse and Mental Health Services Administration.

(2) Director

The term "Director" means the Director of the Office of National Drug Control Policy.

(3) Drug-Free Communities Act of 1997

The term "Drug-Free Communities Act of 1997" means chapter 2 of the National Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.).

(4) Eligible entity

The term "eligible entity" means an organization that—

(A) on or before the date of submitting an application for a grant under this section, receives or has received a grant under the Drug-Free Communities Act of 1997; and

(B) has documented, using local data, rates of abuse of opioids or methamphetamines at levels that are—

(i) significantly higher than the national average as determined by the Secretary (including appropriate consideration of the results of the Monitoring the Future Survey published by the National Institute on Drug Abuse and the National Survey on Drug Use and Health published by the Substance Abuse and Mental Health Services Administration); or

(ii) higher than the national average, as determined by the Secretary (including appropriate consideration of the results of the surveys described in clause (i)), over a sustained period of time.

(5) Emerging drug abuse issue

The term "emerging drug abuse issue" means a substance use disorder within an area involving—

(A) a sudden increase in demand for particular drug abuse treatment services relative to previous demand; and

(B) a lack of resources in the area to address the emerging problem.

(6) Local drug crisis

The term "local drug crisis" means, with respect to the area served by an eligible entity—

(A) a sudden increase in the abuse of opioids or methamphetamines, as documented by local data;

(B) the abuse of prescription medications, specifically opioids or methamphetamines, that is significantly higher than the national average, over a sustained period of time, as documented by local data; or

(C) a sudden increase in opioid-related deaths, as documented by local data.

(7) Opioid

The term "opioid" means any drug 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.

(b) Program authorized

The Director, in coordination with the Administrator, may make grants to eligible entities to implement comprehensive community-wide strategies that address local drug crises and emerging drug abuse issues within the area served by the eligible entity.

(c) Application

(1) In general

An eligible entity seeking a grant under this section shall submit an application to the Director at such time, in such manner, and accompanied by such information as the Director may require.

(2) Criteria

As part of an application for a grant under this section, the Director shall require an eligible entity to submit a detailed, comprehensive, multisector plan for addressing the local drug crisis or emerging drug abuse issue within the area served by the eligible entity.

(d) Use of funds

An eligible entity shall use a grant received under this section—

(1) for programs designed to implement comprehensive community-wide prevention strategies to address the local drug crisis in the area served by the eligible entity, in accordance with the plan submitted under subsection (c)(2);

(2) to obtain specialized training and technical assistance from the organization funded under section 4 of Public Law 107–82 (21 U.S.C. 1521 note); and

(3) for programs designed to implement comprehensive community-wide strategies to address emerging drug abuse issues in the community.

(e) Supplement not supplant

An eligible entity shall use Federal funds received under this section only to supplement the funds that would, in the absence of those Federal funds, be made available from other Federal and non-Federal sources for the activities described in this section, and not to supplant those funds.

(f) Evaluation

A grant under this section shall be subject to the same evaluation requirements and procedures as the evaluation requirements and procedures imposed on the recipient of a grant under the Drug-Free Communities Act of 1997, and may also include an evaluation of the effectiveness at reducing abuse of opioids or methamphetamines.

(g) Limitation on administrative expenses

Not more than 8 percent of the amounts made available to carry out this section for a fiscal year may be used to pay for administrative expenses.

(h) Delegation authority

The Director may enter into an interagency agreement with the Administrator to delegate authority for the execution of grants and for such other activities as may be necessary to carry out this section.

(i) Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2017 through 2021.

(Pub. L. 114–198, title I, §103, July 22, 2016, 130 Stat. 699.)

Editorial Notes

References in Text

The Drug-Free Communities Act of 1997, referred to in subsec. (a)(3), is Pub. L. 105–20, June 27, 1997, 111 Stat. 224, section 2(a)(2) of which enacted chapter 2 of the National Narcotics Leadership Act of 1988, which is classified to this subchapter. For complete classification of the Drug-Free Communities Act of 1997 to the Code, see Short Title of 1997 Amendment note set out under section 1501 of this title and Tables.

Codification

Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the National Narcotics Leadership Act of 1988 which comprises this chapter.
21 U.S.C. § 2361 (2024) — Title 21: FOOD AND DRUGS / Chapter 28A: FENTANYL ERADICATION AND NARCOTICS DETERRENCE OFF FENTANYL / Subchapter II: ANTI-MONEY LAUNDERING MATTERS / Section 2361: Treatment of transnational criminal organizations in suspicious transactions reports of the Financial Crimes Enforcement Network
Treatment of transnational criminal organizations in suspicious transactions reports of the Financial Crimes Enforcement Network
Status: in_force

(a) Filing instructions

Not later than 180 days after April 24, 2024, the Director of the Financial Crimes Enforcement Network shall issue guidance or instructions to United States financial institutions for filing reports on suspicious transactions required under section 1010.320 of title 31, Code of Federal Regulations, related to suspected fentanyl trafficking by transnational criminal organizations.

(b) Prioritization of reports relating to fentanyl trafficking or transnational criminal organizations

The Director shall prioritize research into reports described in subsection (a) that indicate a connection to trafficking of fentanyl or related synthetic opioids or financing of suspected transnational criminal organizations.

(Pub. L. 118–50, div. E, title II, §3202, Apr. 24, 2024, 138 Stat. 941.)
21 U.S.C. § 673 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter IV: AUXILIARY PROVISIONS / Section 673: Seizure and condemnation
Seizure and condemnation
Status: in_force

(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 Pub. L. 90–201, §16, Dec. 15, 1967, 81 Stat. 598; amended Pub. L. 101–205, §1, Dec. 7, 1989, 103 Stat. 1829.)

Editorial Notes

Amendments

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).
21 U.S.C. § 151 (2024) — Title 21: FOOD AND DRUGS / Chapter 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS / Section 151: Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments
Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments
Status: in_force

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; Pub. L. 99–198, title XVII, §1768(a), Dec. 23, 1985, 99 Stat. 1654.)

Editorial Notes

Codification

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.

Amendments

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".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Pub. L. 99–198, title XVII, §1768(f), Dec. 23, 1985, 99 Stat. 1655, 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."

Short Title

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".

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.

Appropriations

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 U.S.C. § 865 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 865: Smuggling methamphetamine or methamphetamine precursor chemicals into the United States while using facilitated entry programs
Smuggling methamphetamine or methamphetamine precursor chemicals into the United States while using facilitated entry programs
Status: in_force

(a) Enhanced prison sentence

The sentence of imprisonment imposed on a person convicted of an offense under the Controlled Substances Act (21 U.S.C. 801 et seq.) or the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), involving methamphetamine or any listed chemical that is defined in section 102(33) of the Controlled Substances Act (21 U.S.C. 802(33),1 shall, if the offense is committed under the circumstance described in subsection (b), be increased by a consecutive term of imprisonment of not more than 15 years.

(b) Circumstances

For purposes of subsection (a), the circumstance described in this subsection is that the offense described in subsection (a) was committed by a person who—

(1) was enrolled in, or who was acting on behalf of any person or entity enrolled in, any dedicated commuter lane, alternative or accelerated inspection system, or other facilitated entry program administered or approved by the Federal Government for use in entering the United States; and

(2) committed the offense while entering the United States, using such lane, system, or program.

(c) Permanent ineligibility

Any person whose term of imprisonment is increased under subsection (a) shall be permanently and irrevocably barred from being eligible for or using any lane, system, or program described in subsection (b)(1).

(Pub. L. 109–177, title VII, §731, Mar. 9, 2006, 120 Stat. 270.)

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (a), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to this subchapter. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

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, which is classified principally to subchapter II (§951 et seq.) of this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 951 of this title and Tables.

Codification

Section was enacted as part of the USA PATRIOT Improvement and Reauthorization Act of 2005 and also as part of the Combat Methamphetamine Epidemic Act of 2005, and not as part of the Controlled Substances Act which comprises this subchapter.

1 So in original. A second closing parenthesis probably should precede the comma.
21 U.S.C. § 1710a (2024) — Title 21: FOOD AND DRUGS / Chapter 22: NATIONAL DRUG CONTROL POLICY / Section 1710a: Requirement for disclosure of Federal sponsorship of all Federal advertising or other communication materials
Requirement for disclosure of Federal sponsorship of all Federal advertising or other communication materials
Status: in_force

(a) Requirement

Each advertisement or other communication paid for by the Office, either directly or through a contract awarded by the Office, shall include a prominent notice informing the target audience that the advertisement or other communication is paid for by the Office.

(b) Advertisement or other communication

In this section, the term "advertisement or other communication" includes—

(1) an advertisement disseminated in any form, including print or by any electronic means; and

(2) a communication by an individual in any form, including speech, print, or by any electronic means.

(Pub. L. 105–277, div. C, title VII, §712, as added Pub. L. 109–469, title XI, §1118, Dec. 29, 2006, 120 Stat. 3546; amended Pub. L. 105–277, div. C. title VII, §715, Oct. 21, 1998, 112 Stat. 2681–693; Pub. L. 109–469, title VI, §602, Dec. 29, 2006, 120 Stat. 3533; Pub. L. 115–271, title VIII, §8202(a), (b)(2), Oct. 24, 2018, 132 Stat. 4110.)

Editorial Notes

Codification

Another section 712 of title VII of div. C of Pub. L. 105–277 amended former section 1509 of this title.

Amendments

2018—Pub. L. 115–271, §8202(b)(2), repealed Pub. L. 105–277, §715. See 1998 Amendment note below.

Pub. L. 115–271, §8202(a), revived and restored this section as in effect on Sept. 29, 2003, and as amended by Pub. L. 109–469 and Pub. L. 112–166. See Reauthorization of the Office of National Drug Control Policy note set out under section 1701 of this title.

2006—Pub. L. 109–469, §602, amended Pub. L. 105–277, §715, which provided for the repeal of this section. See 1998 Amendment note below.

1998—Pub. L. 105–277, §715, as amended by Pub. L. 109–469, §602, which provided for the repeal of this section effective Sept. 30, 2010, was repealed by Pub. L. 115–271, §8202(b)(2). See former section 1712 of this title.
21 U.S.C. § 360bbb (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360bbb: Expanded access to unapproved therapies and diagnostics
Expanded access to unapproved therapies and diagnostics
Status: in_force

(a) Emergency situations

The Secretary may, under appropriate conditions determined by the Secretary, authorize the shipment of investigational drugs or investigational devices for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations.

(b) Individual patient access to investigational products intended for serious diseases

Any person, acting through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and any manufacturer or distributor may, after complying with the provisions of this subsection, provide to such physician an investigational drug or investigational device for the diagnosis, monitoring, or treatment of a serious disease or condition if—

(1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition involved, and that the probable risk to the person from the investigational drug or investigational device is not greater than the probable risk from the disease or condition;

(2) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the use of the investigational drug or investigational device in the case described in paragraph (1);

(3) the Secretary determines that provision of the investigational drug or investigational device will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval; and

(4) the sponsor, or clinical investigator, of the investigational drug or investigational device submits to the Secretary a clinical protocol consistent with the provisions of section 355(i) or 360j(g) of this title, including any regulations promulgated under section 355(i) or 360j(g) of this title, describing the use of the investigational drug or investigational device in a single patient or a small group of patients.

(c) Treatment investigational new drug applications and treatment investigational device exemptions

Upon submission by a sponsor or a physician of a protocol intended to provide widespread access to an investigational drug or investigational device for eligible patients (referred to in this subsection as an "expanded access protocol"), the Secretary shall permit such investigational drug or investigational device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if the Secretary determines that—

(1) under the treatment investigational new drug application or treatment investigational device exemption, the investigational drug or investigational device is intended for use in the diagnosis, monitoring, or treatment of a serious or immediately life-threatening disease or condition;

(2) there is no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat that stage of disease or condition in the population of patients to which the investigational drug or investigational device is intended to be administered;

(3)(A) the investigational drug or investigational device is under investigation in a controlled clinical trial for the use described in paragraph (1) under an investigational drug application in effect under section 355(i) of this title or investigational device exemption in effect under section 360j(g) of this title; or

(B) all clinical trials necessary for approval of that use of the investigational drug or investigational device have been completed;

(4) the sponsor of the controlled clinical trials is actively pursuing marketing approval of the investigational drug or investigational device for the use described in paragraph (1) with due diligence;

(5) in the case of an investigational drug or investigational device described in paragraph (3)(A), the provision of the investigational drug or investigational device will not interfere with the enrollment of patients in ongoing clinical investigations under section 355(i) or 360j(g) of this title;

(6) in the case of serious diseases, there is sufficient evidence of safety and effectiveness to support the use described in paragraph (1); and

(7) in the case of immediately life-threatening diseases, the available scientific evidence, taken as a whole, provides a reasonable basis to conclude that the investigational drug or investigational device may be effective for its intended use and would not expose patients to an unreasonable and significant risk of illness or injury.

A protocol submitted under this subsection shall be subject to the provisions of section 355(i) or 360j(g) of this title, including regulations promulgated under section 355(i) or 360j(g) of this title. The Secretary may inform national, State, and local medical associations and societies, voluntary health associations, and other appropriate persons about the availability of an investigational drug or investigational device under expanded access protocols submitted under this subsection. The information provided by the Secretary, in accordance with the preceding sentence, shall be the same type of information that is required by section 282(i)(3) of title 42.

(d) Termination

The Secretary may, at any time, with respect to a sponsor, physician, manufacturer, or distributor described in this section, terminate expanded access provided under this section for an investigational drug or investigational device if the requirements under this section are no longer met.

(e) Definitions

In this section, the terms "investigational drug", "investigational device", "treatment investigational new drug application", and "treatment investigational device exemption" shall have the meanings given the terms in regulations prescribed by the Secretary.

(June 25, 1938, ch. 675, §561, as added Pub. L. 105–115, title IV, §402, Nov. 21, 1997, 111 Stat. 2365; amended Pub. L. 109–482, title I, §102(f)(2), Jan. 15, 2007, 120 Stat. 3685.)

Editorial Notes

Amendments

2007—Subsec. (c). Pub. L. 109–482 substituted "section 282(i)(3)" for "section 282(j)(3)" in concluding provisions.

Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of Title 42, The Public Health and Welfare.

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Investigational Drugs

Pub. L. 115–52, title VI, §610(a), (b), Aug. 18, 2017, 131 Stat. 1051, 1053, provided that:

"(a) Patient Access to Investigational Drugs.—

"(1) Public meeting.—

"(A) In general.—The Secretary of Health and Human Services (referred to in this section as the 'Secretary'), acting through the Commissioner of Food and Drugs, in coordination with the Director of the National Institutes of Health, and in consultation with patients, health care providers, drug sponsors, bioethicists, and other stakeholders, shall, not later than 270 days after the date of enactment of this Act [Aug. 18, 2007], convene a public meeting to discuss clinical trial inclusion and exclusion criteria to inform the guidance under paragraph (3). The Secretary shall inform the Comptroller General of the United States of the date when the public meeting will take place.

"(B) Topics.—The Secretary shall make available on the internet website of the Food and Drug Administration a report on the topics discussed at the meeting described in subparagraph (A) within 90 days of such meeting. Such topics shall include discussion of—

"(i) the rationale for, and potential barriers for patients created by, research clinical trial inclusion and exclusion criteria;

"(ii) how appropriate patient populations can benefit from the results of trials that employ alternative designs;

"(iii) barriers to participation in clinical trials, including—

     "(I) information regarding any potential risks and benefits of participation;

     "(II) regulatory, geographical, and socioeconomic barriers; and

     "(III) the impact of exclusion criteria on the enrollment in clinical trials of particular populations, including infants and children, pregnant and lactating women, seniors, individuals with advanced disease, and individuals with co-morbid conditions;

"(iv) clinical trial designs and methods, including expanded access trials, that increase enrollment of more diverse patient populations, when appropriate, while facilitating the collection of data to establish safe use and support substantial evidence of effectiveness, including data obtained from expanded access trials; and

"(v) how changes to clinical trial inclusion and exclusion criteria may impact the complexity and length of clinical trials, the data necessary to demonstrate safety and effectiveness, and potential approaches to mitigating those impacts.

"(2) Report.—Not later than 1 year after the Secretary issues the report under paragraph (1)(B), the Comptroller General of the United States shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on individual access to investigational drugs through the expanded access program under section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). The report shall include—

"(A) a description of actions taken by manufacturers and distributors under section 561A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–0);

"(B) consideration of whether Form FDA 3926 and the guidance documents titled 'Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers' and 'Individual Patient Expanded Access Applications: Form FDA 3926', issued by the Food and Drug Administration in June 2016, have reduced application burden with respect to individuals and physicians seeking access to investigational new drugs pursuant to section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) and improved clarity for patients, physicians, and drug manufacturers about such process;

"(C) consideration of whether the guidance or regulations issued to implement section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) have improved access for individual patients to investigational drugs who do not qualify for clinical trials of such investigational drugs, and what barriers to such access remain;

"(D) an assessment of methods patients and health care providers use to engage with the Food and Drug Administration or drug sponsors on expanded access; and

"(E) an analysis of the Secretary's report under paragraph (1)(B).

"(3) Guidance.—

"(A) In general.—Not later than 1 year after the publication of the report under paragraph (1)(B), the Secretary, acting through the Commissioner of Food and Drugs, shall issue one or more draft guidances regarding eligibility criteria for clinical trials. Not later than 1 year after the public comment period on each such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.

"(B) Contents.—The guidance documents described in subparagraph (A) shall address methodological approaches that a manufacturer or sponsor of an investigation of a new drug may take to—

"(i) broaden eligibility criteria for clinical trials and expanded access trials, especially with respect to drugs for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical need;

"(ii) develop eligibility criteria for, and increase trial recruitment to, clinical trials so that enrollment in such trials more accurately reflects the patients most likely to receive the drug, as applicable and as appropriate, while establishing safe use and supporting findings of substantial evidence of effectiveness; and

"(iii) use the criteria described in clauses (i) and (ii) in a manner that is appropriate for drugs intended for the treatment of rare diseases or conditions.

"(b) Improving Institutional Review Board Review of Single Patient Expanded Access Protocol.—Not later than 1 year after the date of enactment of this Act [Aug. 18, 2017], the Secretary, acting through the Commissioner of Food and Drugs, shall issue guidance or regulations, or revise existing guidance or regulations, to streamline the institutional review board review of individual patient expanded access protocols submitted under [section] 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). To facilitate the use of expanded access protocols, any guidance or regulations so issued or revised may include a description of the process for any person acting through a physician licensed in accordance with State law to request that an institutional review board chair (or designated member of the institutional review board) review a single patient expanded access protocol submitted under such section 561(b) for a drug. The Secretary shall update any relevant forms associated with individual patient expanded access requests under such section 561(b) as necessary."
21 U.S.C. § 453 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 453: Definitions
Definitions
Status: in_force

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 379e 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 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 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 food, 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; Pub. L. 102–571, title I, §107(13), Oct. 29, 1992, 106 Stat. 4499.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in pars. (x) and (y), is act June 25, 1938, ch. 675, 52 Stat. 1040, 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.

Amendments

1992—Subsec. (g)(2)(D). Pub. L. 102–571 substituted "379e" for "376".

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".

Statutory Notes and Related Subsidiaries

Change of Name

"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.

Effective Date of 1968 Amendment

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 U.S.C. § 2202 (2024) — Title 21: FOOD AND DRUGS / Chapter 27: FOOD SAFETY MODERNIZATION / Subchapter I: IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS / Section 2202: National Agriculture and Food Defense Strategy
National Agriculture and Food Defense Strategy
Status: in_force

(a) Development and submission of strategy

(1) In general

Not later than 1 year after January 4, 2011, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall prepare and transmit to the relevant committees of Congress, and make publicly available on the Internet Web sites of the Department of Health and Human Services and the Department of Agriculture, the National Agriculture and Food Defense Strategy.

(2) Implementation plan

The strategy shall include an implementation plan for use by the Secretaries described under paragraph (1) in carrying out the strategy.

(3) Research

The strategy shall include a coordinated research agenda for use by the Secretaries described under paragraph (1) in conducting research to support the goals and activities described in paragraphs (1) and (2) of subsection (b).

(4) Revisions

Not later than 4 years after the date on which the strategy is submitted to the relevant committees of Congress under paragraph (1), and not less frequently than every 4 years thereafter, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall revise and submit to the relevant committees of Congress the strategy.

(5) Consistency with existing plans

The strategy described in paragraph (1) shall be consistent with—

(A) the National Incident Management System;

(B) the National Response Framework;

(C) the National Infrastructure Protection Plan;

(D) the National Preparedness Goals; and

(E) other relevant national strategies.

(b) Components

(1) In general

The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security—

(A) to achieve each goal described in paragraph (2); and

(B) to evaluate the progress made by Federal, State, local, and tribal governments towards the achievement of each goal described in paragraph (2).

(2) Goals

The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security to achieve the following goals:

(A) Preparedness goal

Enhance the preparedness of the agriculture and food system by—

(i) conducting vulnerability assessments of the agriculture and food system;

(ii) mitigating vulnerabilities of the system;

(iii) improving communication and training relating to the system;

(iv) developing and conducting exercises to test decontamination and disposal plans;

(v) developing modeling tools to improve event consequence assessment and decision support; and

(vi) preparing risk communication tools and enhancing public awareness through outreach.

(B) Detection goal

Improve agriculture and food system detection capabilities by—

(i) identifying contamination in food products at the earliest possible time; and

(ii) conducting surveillance to prevent the spread of diseases.

(C) Emergency response goal

Ensure an efficient response to agriculture and food emergencies by—

(i) immediately investigating animal disease outbreaks and suspected food contamination;

(ii) preventing additional human illnesses;

(iii) organizing, training, and equipping animal, plant, and food emergency response teams of—

(I) the Federal Government; and

(II) State, local, and tribal governments;

(iv) designing, developing, and evaluating training and exercises carried out under agriculture and food defense plans; and

(v) ensuring consistent and organized risk communication to the public by—

(I) the Federal Government;

(II) State, local, and tribal governments; and

(III) the private sector.

(D) Recovery goal

Secure agriculture and food production after an agriculture or food emergency by—

(i) working with the private sector to develop business recovery plans to rapidly resume agriculture, food production, and international trade;

(ii) conducting exercises of the plans described in subparagraph (C) with the goal of long-term recovery results;

(iii) rapidly removing, and effectively disposing of—

(I) contaminated agriculture and food products; and

(II) infected plants and animals; and

(iv) decontaminating and restoring areas affected by an agriculture or food emergency.

(3) Evaluation

The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall—

(A) develop metrics to measure progress for the evaluation process described in paragraph (1)(B); and

(B) report on the progress measured in subparagraph (A) as part of the National Agriculture and Food Defense strategy described in subsection (a)(1).

(c) Limited distribution

In the interest of national security, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, may determine the manner and format in which the National Agriculture and Food Defense strategy established under this section is made publicly available on the Internet Web sites of the Department of Health and Human Services, the Department of Homeland Security, and the Department of Agriculture, as described in subsection (a)(1).

(Pub. L. 111–353, title I, §108, Jan. 4, 2011, 124 Stat. 3910.)

Editorial Notes

References in Text

The Secretary, referred to in subsec. (b)(3), probably means the Secretary of Health and Human Services.
21 U.S.C. § 201 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 201: Doing business without a license unlawful; employment of Chinese subjects
Doing business without a license unlawful; employment of Chinese subjects
Status: in_force

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.)

Editorial Notes

Codification

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 U.S.C. § 23 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter II: MISCELLANEOUS PROVISIONS / Section 23: Penalties
Penalties
Status: in_force

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.)

Editorial Notes

Codification

Section is also set out as section 233 of Title 15, Commerce and Trade.
21 U.S.C. § 379v (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 379v: Safety report disclaimers
Safety report disclaimers
Status: in_force

With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.

(June 25, 1938, ch. 675, §756, as added Pub. L. 105–115, title IV, §420, Nov. 21, 1997, 111 Stat. 2379.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.
21 U.S.C. § 813 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 813: Treatment of controlled substance analogues
Treatment of controlled substance analogues
Status: in_force

(a) In general

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.

(b) Determination

In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors:

(1) The marketing, advertising, and labeling of the substance.

(2) The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose.

(3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold.

(4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance.

(5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means.

(6) Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug laws.

(c) Limitation

For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption.

(Pub. L. 91–513, title II, §203, as added Pub. L. 99–570, title I, §1202, Oct. 27, 1986, 100 Stat. 3207–13; amended Pub. L. 100–690, title VI, §6470(c), Nov. 18, 1988, 102 Stat. 4378; Pub. L. 115–271, title III, §3241, Oct. 24, 2018, 132 Stat. 3950.)

Editorial Notes

References in Text

Schedule I, referred to in subsec. (a), is set out in section 812(c) of this title.

Amendments

2018—Pub. L. 115–271 designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).

1988—Pub. L. 100–690 substituted "any Federal law" for "this subchapter and subchapter II of this chapter".
21 U.S.C. § 209 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 209: Poisons; book entry of sale; labels
Poisons; book entry of sale; labels
Status: in_force

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 U.S.C. § 1053 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1053: Inspection and administration costs
Inspection and administration costs
Status: in_force

(a) Overtime and holiday work costs; availability of funds

The cost of inspection rendered under the requirements of this chapter, and other costs of administration of this chapter, shall be borne by the United States, except that the cost of overtime and holiday work performed in official plants subject to the provisions of this chapter at such rates as the Secretary may determine shall be borne by such official plants. Sums received by the Secretary from official plants under this section shall be available without fiscal year limitation to carry out the purposes of this chapter.

(b) "Holiday" defined

The term "holiday" for the purposes of assessment or reimbursement of the cost of inspection performed under this chapter, the Wholesome Poultry Products Act [21 U.S.C. 467a et seq.] and the Wholesome Meat Act [21 U.S.C. 601 et seq.] shall mean the legal public holidays specified by the Congress in section 6103(a) of title 5.

(Pub. L. 91–597, §24, Dec. 29, 1970, 84 Stat. 1633.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

The Wholesome Poultry Products Act, referred to in subsec. (b), is Pub. L. 90–492, Aug. 18, 1968, 82 Stat. 791, which enacted sections 467a to 467f and 470 of this title, amended sections 451 to 461, 463 to 465, and 467 of this title, and enacted provisions set out as notes under section 451 of this title. For complete classification of this Act to the Code, see Short Title of 1968 Amendment note set out under section 451 of this title and Tables.

The Wholesome Meat Act, referred to in subsec. (b), is Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, 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.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.
21 U.S.C. § 356c (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 356c: Discontinuance or interruption in the production of life-saving drugs
Discontinuance or interruption in the production of life-saving drugs
Status: in_force

(a) In general

A manufacturer of a drug—

(1) that is—

(A) life-supporting;

(B) life-sustaining; or

(C) intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 247d of title 42; and

(2) that is not a radio pharmaceutical drug product or any other product as designated by the Secretary,

shall notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or a permanent discontinuance in the manufacture of an active pharmaceutical ingredient or an interruption in the manufacture of the active pharmaceutical ingredient of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug, and the reasons for such discontinuance or interruption. Notification under this subsection shall include disclosure of reasons for the discontinuation or interruption, and if applicable, an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation or interruption, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known by the manufacturer; whether any associated device used for preparation or administration included in the drug is a reason for, or a risk factor in, such discontinuation or interruption; the expected duration of the interruption; and such other information as the Secretary may require.

(b) Timing

A notice required under subsection (a) shall be submitted to the Secretary—

(1) at least 6 months prior to the date of the discontinuance or interruption; or

(2) if compliance with paragraph (1) is not possible, as soon as practicable.

(c) Distribution

To the maximum extent practicable, the Secretary shall distribute, through such means as the Secretary deems appropriate, information on the discontinuance or interruption of the manufacture of the drugs described in subsection (a) to appropriate organizations, including physician, health provider, and patient organizations, as described in section 356e of this title.

(d) Confidentiality

Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(e) Coordination with Attorney General

Not later than 30 days after the receipt of a notification described in subsection (a), the Secretary shall—

(1) determine whether the notification pertains to a controlled substance subject to a production quota under section 826 of this title; and

(2) if necessary, as determined by the Secretary—

(A) notify the Attorney General that the Secretary has received such a notification;

(B) request that the Attorney General increase the aggregate and individual production quotas under section 826 of this title applicable to such controlled substance and any ingredient therein to a level the Secretary deems necessary to address a shortage of a controlled substance based on the best available market data; and

(C) if the Attorney General determines that the level requested is not necessary to address a shortage of a controlled substance, the Attorney General shall provide to the Secretary a written response detailing the basis for the Attorney General's determination.

The Secretary shall make the written response provided under subparagraph (C) available to the public on the Internet Web site of the Food and Drug Administration.

(f) Failure to meet requirements

If a person fails to submit information required under subsection (a) in accordance with subsection (b)—

(1) the Secretary shall issue a letter to such person informing such person of such failure;

(2) not later than 30 calendar days after the issuance of a letter under paragraph (1), the person who receives such letter shall submit to the Secretary a written response to such letter setting forth the basis for noncompliance and providing information required under subsection (a); and

(3) not later than 45 calendar days after the issuance of a letter under paragraph (1), the Secretary shall make such letter and any response to such letter under paragraph (2) available to the public on the Internet Web site of the Food and Drug Administration, with appropriate redactions made to protect information described in subsection (d), except that, if the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not notifying as required under subsection (a), the requirements of this paragraph shall not apply.

(g) Expedited inspections and reviews

If, based on notifications described in subsection (a) or any other relevant information, the Secretary concludes that there is, or is likely to be, a drug shortage of a drug described in subsection (a), the Secretary shall, as appropriate—

(1) prioritize and expedite the review of a supplement to a new drug application submitted under section 355(b) of this title, an abbreviated new drug application submitted under section 355(j) of this title, or a supplement to such an application submitted under section 355(j) of this title, that could help mitigate or prevent such shortage; or

(2) prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent such drug shortage.

(h) Definitions

For purposes of this section—

(1) the term "drug"—

(A) means a drug (as defined in section 321(g) of this title) that is intended for human use and that is subject to section 353(b)(1) of this title; and

(B) does not include biological products (as defined in section 262 of title 42), unless otherwise provided by the Secretary in the regulations promulgated under subsection (i);

(2) the term "drug shortage" or "shortage", with respect to a drug, means a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug; and

(3) the term "meaningful disruption"—

(A) means a change in production that is reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product; and

(B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.

(i) Regulations

(1) In general

Not later than 18 months after July 9, 2012, the Secretary shall adopt a final regulation implementing this section.

(2) Contents

Such regulation shall define, for purposes of this section, the terms "life-supporting", "life-sustaining", and "intended for use in the prevention or treatment of a debilitating disease or condition".

(3) Inclusion of biological products

(A) In general

The Secretary may by regulation apply this section to biological products (as defined in section 262 of title 42), including plasma products derived from human plasma protein and their recombinant analogs, if the Secretary determines such inclusion would benefit the public health. Such regulation shall take into account any supply reporting programs and shall aim to reduce duplicative notification.

(B) Rule for vaccines

If the Secretary applies this section to vaccines pursuant to subparagraph (A), the Secretary shall—

(i) consider whether the notification requirement under subsection (a) may be satisfied by submitting a notification to the Centers for Disease Control and Prevention under the vaccine shortage notification program of such Centers; and

(ii) explain the determination made by the Secretary under clause (i) in the regulation.

(4) Procedure

In promulgating a regulation implementing this section, the Secretary shall—

(A) issue a notice of proposed rulemaking that includes the proposed regulation;

(B) provide a period of not less than 60 days for comments on the proposed regulation; and

(C) publish the final regulation not less than 30 days before the regulation's effective date.

(5) Restrictions

Notwithstanding any other provision of Federal law, in implementing this section, the Secretary shall only promulgate regulations as described in paragraph (4).

(j) Risk management plans

Each manufacturer of a drug described in subsection (a) or of any active pharmaceutical ingredient or any associated medical device used for preparation or administration included in the drug, shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the drug, as applicable, for each establishment in which such drug or active pharmaceutical ingredient of such drug is manufactured. A risk management plan under this section shall be subject to inspection and copying by the Secretary pursuant to an inspection or a request under section 374(a)(4) of this title.

(June 25, 1938, ch. 675, §506C, as added Pub. L. 105–115, title I, §131(a), Nov. 21, 1997, 111 Stat. 2332; amended Pub. L. 112–144, title X, §1001(a), July 9, 2012, 126 Stat. 1099; Pub. L. 114–255, div. A, title III, §3101(a)(2)(E), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 116–136, div. A, title III, §§3111–3112(b), Mar. 27, 2020, 134 Stat. 361, 362; Pub. L. 117–328, div. FF, title II, §2515(a)(1), (b)(1), Dec. 29, 2022, 136 Stat. 5806.)

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–328, §2515(b)(1), substituted "in the United States," for "in the United States,," in concluding provisions.

Subsec. (g). Pub. L. 117–328, §2515(a)(1), made technical amendment to directory language of Pub. L. 116–136, §3111(1). See 2020 Amendment note below.

2020—Subsec. (a). Pub. L. 116–136, §3112(a)(2), in concluding provisions, inserted ", or a permanent discontinuance in the manufacture of an active pharmaceutical ingredient or an interruption in the manufacture of the active pharmaceutical ingredient of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug," before "and the reasons" and inserted at end "Notification under this subsection shall include disclosure of reasons for the discontinuation or interruption, and if applicable, an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation or interruption, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known by the manufacturer; whether any associated device used for preparation or administration included in the drug is a reason for, or a risk factor in, such discontinuation or interruption; the expected duration of the interruption; and such other information as the Secretary may require."

Subsec. (a)(1)(C). Pub. L. 116–136, §3112(a)(1), inserted "or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 247d of title 42" after "during surgery".

Subsec. (g). Pub. L. 116–136, §3111(1), as amended by Pub. L. 117–328, §2515(a)(1), substituted "the Secretary shall, as appropriate" for "the Secretary may" in introductory provisions.

Subsec. (g)(1). Pub. L. 116–136, §3111(2), inserted "prioritize and" before "expedite the review".

Subsec. (g)(2). Pub. L. 116–136, §3111(3), inserted "prioritize and" before "expedite an inspection".

Subsec. (j). Pub. L. 116–136, §3112(b), added subsec. (j).

2016—Subsec. (c). Pub. L. 114–255, §3101(a)(2)(E)(i), substituted "discontinuance" for "discontinuation".

Subsec. (g)(1). Pub. L. 114–255, §3101(a)(2)(E)(ii), substituted "section 355(j) of this title, that could help" for "section 355(j) of this title that could help".

2012—Pub. L. 112–144 amended section generally. Prior to amendment, section related to discontinuance of life saving products.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title II, §2515(b)(2), Dec. 29, 2022, 136 Stat. 5806, provided that: "The amendment made by paragraph (1) [amending this section] shall take effect as if included in section 3112 of division A of the CARES Act (Public Law 116–136)."

Effective Date of 2020 Amendment

Pub. L. 116–136, div. A, title III, §3112(g), Mar. 27, 2020, 134 Stat. 363, provided that: "The amendments made by this section [amending this section and sections 356e, 360, and 374 of this title] and section 3111 [amending this section] shall take effect on the date that is 180 days after the date of enactment of this Act [Mar. 27, 2020]."

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Construction of 2020 Amendment: Confidentiality

Pub. L. 116–136, div. A, title III, §3112(f), Mar. 27, 2020, 134 Stat. 363, provided that: "Nothing in the amendments made by this section [see Effective Date of 2020 Amendment note set out above] shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code."

Effect of Notification

Pub. L. 112–144, title X, §1001(b), July 9, 2012, 126 Stat. 1101, provided that: "The submission of a notification to the Secretary of Health and Human Services (referred to in this title [see Tables for classification] as the 'Secretary') for purposes of complying with the requirement in section 506C(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356c(a)] (as amended by subsection (a)) shall not be construed—

"(1) as an admission that any product that is the subject of such notification violates any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or

"(2) as evidence of an intention to promote or market the product for an indication or use for which the product has not been approved by the Secretary."

Executive Documents

Ex. Ord. No. 13588. Reducing Prescription Drug Shortages

Ex. Ord. No. 13588, Oct. 31, 2011, 76 F.R. 68295, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Policy. Shortages of pharmaceutical drugs pose a serious and growing threat to public health. While a very small number of drugs in the United States experience a shortage in any given year, the number of prescription drug shortages in the United States nearly tripled between 2005 and 2010, and shortages are becoming more severe as well as more frequent. The affected medicines include cancer treatments, anesthesia drugs, and other drugs that are critical to the treatment and prevention of serious diseases and life-threatening conditions.

For example, over approximately the last 5 years, data indicates that the use of sterile injectable cancer treatments has increased by about 20 percent, without a corresponding increase in production capacity. While manufacturers are currently in the process of expanding capacity, it may be several years before production capacity has been significantly increased. Interruptions in the supplies of these drugs endanger patient safety and burden doctors, hospitals, pharmacists, and patients. They also increase health care costs, particularly because some participants in the market may use shortages as opportunities to hoard scarce drugs or charge exorbitant prices.

The Food and Drug Administration (FDA) in the Department of Health and Human Services has been working diligently to address this problem through its existing regulatory framework. While the root problems and many of their solutions are outside of the FDA's control, the agency has worked cooperatively with manufacturers to prevent or mitigate shortages by expediting review of certain regulatory submissions and adopting a flexible approach to drug manufacturing and importation regulations where appropriate. As a result, the FDA prevented 137 drug shortages in 2010 and 2011. Despite these successes, however, the problem of drug shortages has continued to grow.

Many different factors contribute to drug shortages, and solving this critical public health problem will require a multifaceted approach. An important factor in many of the recent shortages appears to be an increase in demand that exceeds current manufacturing capacity. While manufacturers are in the process of expanding capacity, one important step is ensuring that the FDA and the public receive adequate advance notice of shortages whenever possible. The FDA cannot begin to work with manufacturers or use the other tools at its disposal until it knows there is a potential problem. Similarly, early disclosure of a shortage can help hospitals, doctors, and patients make alternative arrangements before a shortage becomes a crisis. However, drug manufacturers have not consistently provided the FDA with adequate notice of potential shortages.

As part of my Administration's broader effort to work with manufacturers, health care providers, and other stakeholders to prevent drug shortages, this order directs the FDA to take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines.

Sec. 2. Broader Reporting of Manufacturing Discontinuances. To the extent permitted by law, the FDA shall use all appropriate administrative tools, including its authority to interpret and administer the reporting requirements in 21 U.S.C. 356c, to require drug manufacturers to provide adequate advance notice of manufacturing discontinuances that could lead to shortages of drugs that are life-supporting or life-sustaining, or that prevent debilitating disease.

Sec. 3. Expedited Regulatory Review. To the extent practicable, and consistent with its statutory responsibility to ensure the safety and effectiveness of the drug supply, the FDA shall take steps to expand its current efforts to expedite its regulatory reviews, including reviews of new drug suppliers, manufacturing sites, and manufacturing changes, whenever it determines that expedited review would help to avoid or mitigate existing or potential drug shortages. In prioritizing and allocating its limited resources, the FDA should consider both the severity of the shortage and the importance of the affected drug to public health.

Sec. 4. Review of Certain Behaviors by Market Participants. The FDA shall communicate to the Department of Justice (DOJ) any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices. The DOJ shall then determine whether these activities are consistent with applicable law. Based on its determination, DOJ, in coordination with other State and Federal regulatory agencies as appropriate, should undertake whatever enforcement actions, if any, it deems appropriate.

Sec. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) authority granted by law to an agency, or the head thereof; or

(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

Barack Obama.
21 U.S.C. § 951 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 951: Definitions
Definitions
Status: in_force

(a) For purposes of this subchapter—

(1) The term "import" means, with respect to any article, any bringing in or introduction of such article into any area (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States).

(2) The term "customs territory of the United States" has the meaning assigned to such term by general note 2 of the Harmonized Tariff Schedule of the United States.

(b) Each term defined in section 802 of this title shall have the same meaning for purposes of this subchapter as such term has for purposes of subchapter I.

(Pub. L. 91–513, title III, §1001, Oct. 27, 1970, 84 Stat. 1285; Pub. L. 100–418, title I, §1214(m), Aug. 23, 1988, 102 Stat. 1158.)

Editorial Notes

References in Text

The Harmonized Tariff Schedule of the United States, referred to in subsec. (a)(2), is not set out in the Code. See Publication of Harmonized Tariff Schedule note set out under section 1202 of Title 19, Customs Duties.

This subchapter, referred to in subsecs. (a) and (b), was in the original "this title", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises this subchapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

Amendments

1988—Subsec. (a)(2). Pub. L. 100–418 substituted "general note 2 of the Harmonized Tariff Schedule of the United States" for "general headnote 2 to the Tariff Schedules of the United States".

Statutory Notes and Related Subsidiaries

Effective Date of 1988 Amendment

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.

Effective Date

Pub. L. 91–513, title III, §1105(a)–(c), Oct. 27, 1970, 84 Stat. 1295, as amended by Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 2095, 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) Sections 1000, 1001, 1006, 1015, 1016, 1103, 1104 [see Short Title note below and sections 171 note, 951, 956, 957 note, 965, and 966 of this title], and this section shall become effective upon enactment [Oct. 27, 1970].

"(c)(1) If the Attorney General, pursuant to the authority of section 704(c) of title II [set out as a note under section 801 of this title], postpones the effective date of section 306 (relating to manufacturing quotas) [section 826 of this title] for any period beyond the date specified in section 704(a) [set out as a note under section 801 of this title], and such postponement applies to narcotic drugs, the repeal of the Narcotics Manufacturing Act of 1960 [sections 501 to 517 of this title] by paragraph (10) of section 1101(a) of this title is hereby postponed for the same period, except that the postponement made by this paragraph shall not apply to the repeal of sections 4, 5, 13, 15, and 16 of that Act [which were classified to sections 182, 503, 511, and 513 of this title and sections 4702, 4731, and 4731 note of Title 26, Internal Revenue Code].

"(2) Effective for any period of postponement, by paragraph (1) of this subsection, of the repeal of provisions of the Narcotics Manufacturing Act of 1960 [sections 501 to 517 of this title], that Act shall be applied subject to the following modifications:

"(A) The term 'narcotic drug' shall mean a narcotic drug as defined in section 102(16) of title II [section 802(16) of this title], and all references, in the Narcotics Manufacturing Act of 1960 [sections 501 to 517 of this title], to a narcotic drug as defined by section 4731 of the Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4731 of Title 26] are amended to refer to a narcotic drug as defined by such section 102(16) [section 802(16) of this title].

"(B) On and after the date prescribed by the Attorney General pursuant to clause (2) of section 703(c) of title II, [set out as a note under section 822 of this title], the requirements of a manufacturer's license with respect to a basic class of narcotic drug under the Narcotics Manufacturing Act of 1960 [sections 501 to 517 of this title], and of a registration under section 4722 of the Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4722 of Title 26] as a prerequisite to issuance of such a license, shall be superseded by a requirement of actual registration (as distinguished from provisional registration) as a manufacturer of that class of drug under section 303(a) of title II [section 823(a) of this title].

"(C) On and after the effective date of the repeal of such section 4722 [section 4722 of title 26] by section 1101(b)(3) of this title, but prior to the date specified in subparagraph (B) of this paragraph, the requirement of registration under such section 4722 [section 4722 of title 26] as a prerequisite of a manufacturer's license under the Narcotics Manufacturing Act of 1960 [sections 501 to 517 of this title] shall be superseded by a requirement of either (i) actual registration as a manufacturer under section 303 of title II [section 823 of this title] or (ii) provisional registration (by virtue of a preexisting registration under such section 4722) under section 703 of title II [set out as a note under section 822 of this title]."

Short Title

Pub. L. 91–513, title III, §1000, Oct. 27, 1970, 84 Stat. 1285, provided that: "This title [enacting this subchapter, amending sections 162 and 967 of this title, section 4251 of Title 18, Crimes and Criminal Procedure, section 1584 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, sections 529d, 529e, and 529f of former Title 31, Money and Finance, section 304m of former Title 40, Public Buildings, Property, and Works, section 3411 of Title 42, The Public Health and Welfare, section 239a of former Title 46, Shipping, and section 787 of former Title 49, Transportation, repealing sections 171 to 174, 176 to 185, 188 to 188n, 191 to 193, 197, 198, 199, 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, section 1421m of Title 48, Territories and Insular Possessions, and enacting provisions set out as notes under this section and sections 171 and 957 of this title] may be cited as the 'Controlled Substances Import and Export Act'."

Rules and Regulations

Pub. L. 91–513, title III, §1105(d), Oct. 27, 1970, 84 Stat. 1296, provided: "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."
21 U.S.C. § 399i (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 399i: Food and Drug Administration Working Capital Fund
Food and Drug Administration Working Capital Fund
Status: in_force

(a) In general

There is hereby established in the Treasury of the United States a Working Capital Fund (the Fund) to be administered by the Food and Drug Administration (FDA), without fiscal year limitation, for the payment of salaries, travel, and other expenses necessary to the maintenance and operation of (1) a supply service for the purchase, storage, handling, issuance, packing, or shipping of stationery, supplies, materials, equipment, and blank forms, for which stocks may be maintained to meet, in whole or in part, the needs of the FDA and requisitions of other Government Offices, and (2) such other services as the Commissioner of the FDA, subject to review by the Secretary of Health and Human Services, determines may be performed more advantageously as central services. The Fund shall be reimbursed from applicable discretionary resources, notwithstanding any otherwise applicable purpose limitations, available when services are performed or stock furnished, or in advance, on a basis of rates which shall include estimated or actual charges for personal services, materials, equipment, information technology, and other expenses. Charges for equipment and information technology shall include costs associated with maintenance, repair, and depreciation (including improvement and replacement).

(b) Appropriations

Of any discretionary resources appropriated in this Act for fiscal year 2018 for "Department of Health and Human Services, Food and Drug Administration, Salaries and Expenses", not to exceed $5,000,000 of amounts available as of September 30 may be transferred to and merged with the Fund established under subsection (a), notwithstanding any otherwise applicable purpose limitations.

(c) Emergency funds excluded

No amounts may be transferred pursuant to this section that are designated by the Congress as an emergency requirement pursuant to a concurrent resolution on the budget or the Balanced Budget and Emergency Deficit Control Act of 1985.

(Pub. L. 115–141, div. A, title VII, §722, Mar. 23, 2018, 132 Stat. 387.)

Editorial Notes

References in Text

This Act, referred to in subsec. (b), is div. A of Pub. L. 115–141, Mar. 23, 2018, 132 Stat. 351, known as the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018. For complete classification of this Act to the Code, see Tables.

The Balanced Budget and Emergency Deficit Control Act of 1985, referred to in subsec. (c), is title II of Pub. L. 99–177, Dec. 12, 1985, 99 Stat. 1038, which enacted chapter 20 (§900 et seq.) and sections 654 to 656 of Title 2, The Congress, amended sections 602, 622, 631 to 642, and 651 to 653 of Title 2, sections 1104 to 1106, and 1109 of Title 31, Money and Finance, and section 911 of Title 42, The Public Health and Welfare, repealed section 661 of Title 2, enacted provisions set out as notes under section 900 of Title 2 and section 911 of Title 42, and amended provisions set out as a note under section 621 of Title 2. For complete classification of this Act to the Code, see Short Title note set out under section 900 of Title 2 and Tables.

Codification

Section was enacted as part of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018, and also as part of the Consolidated Appropriations Act, 2018, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 399d (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 399d: Employee protections
Employee protections
Status: in_force

(a) In general

No entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may discharge an employee or otherwise discriminate against an employee with respect to compensation, terms, conditions, or privileges of employment because the employee, whether at the employee's initiative or in the ordinary course of the employee's duties (or any person acting pursuant to a request of the employee)—

(1) provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of this chapter or any order, rule, regulation, standard, or ban under this chapter, or any order, rule, regulation, standard, or ban under this chapter; 1

(2) testified or is about to testify in a proceeding concerning such violation;

(3) assisted or participated or is about to assist or participate in such a proceeding; or

(4) objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of this chapter, or any order, rule, regulation, standard, or ban under this chapter.

(b) Process

(1) In general

A person who believes that he or she has been discharged or otherwise discriminated against by any person in violation of subsection (a) may, not later than 180 days after the date on which such violation occurs, file (or have any person file on his or her behalf) a complaint with the Secretary of Labor (referred to in this section as the "Secretary") alleging such discharge or discrimination and identifying the person responsible for such act. Upon receipt of such a complaint, the Secretary shall notify, in writing, the person named in the complaint of the filing of the complaint, of the allegations contained in the complaint, of the substance of evidence supporting the complaint, and of the opportunities that will be afforded to such person under paragraph (2).

(2) Investigation

(A) In general

Not later than 60 days after the date of receipt of a complaint filed under paragraph (1) and after affording the complainant and the person named in the complaint an opportunity to submit to the Secretary a written response to the complaint and an opportunity to meet with a representative of the Secretary to present statements from witnesses, the Secretary shall initiate an investigation and determine whether there is reasonable cause to believe that the complaint has merit and notify, in writing, the complainant and the person alleged to have committed a violation of subsection (a) of the Secretary's findings.

(B) Reasonable cause found; preliminary order

If the Secretary concludes that there is reasonable cause to believe that a violation of subsection (a) has occurred, the Secretary shall accompany the Secretary's findings with a preliminary order providing the relief prescribed by paragraph (3)(B). Not later than 30 days after the date of notification of findings under this paragraph, the person alleged to have committed the violation or the complainant may file objections to the findings or preliminary order, or both, and request a hearing on the record. The filing of such objections shall not operate to stay any reinstatement remedy contained in the preliminary order. Any such hearing shall be conducted expeditiously. If a hearing is not requested in such 30-day period, the preliminary order shall be deemed a final order that is not subject to judicial review.

(C) Dismissal of complaint

(i) Standard for complainant

The Secretary shall dismiss a complaint filed under this subsection and shall not conduct an investigation otherwise required under subparagraph (A) unless the complainant makes a prima facie showing that any behavior described in paragraphs (1) through (4) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint.

(ii) Standard for employer

Notwithstanding a finding by the Secretary that the complainant has made the showing required under clause (i), no investigation otherwise required under subparagraph (A) shall be conducted if the employer demonstrates, by clear and convincing evidence, that the employer would have taken the same unfavorable personnel action in the absence of that behavior.

(iii) Violation standard

The Secretary may determine that a violation of subsection (a) has occurred only if the complainant demonstrates that any behavior described in paragraphs (1) through (4) of subsection (a) was a contributing factor in the unfavorable personnel action alleged in the complaint.

(iv) Relief standard

Relief may not be ordered under subparagraph (A) if the employer demonstrates by clear and convincing evidence that the employer would have taken the same unfavorable personnel action in the absence of that behavior.

(3) Final order

(A) In general

Not later than 120 days after the date of conclusion of any hearing under paragraph (2), the Secretary shall issue a final order providing the relief prescribed by this paragraph or denying the complaint. At any time before issuance of a final order, a proceeding under this subsection may be terminated on the basis of a settlement agreement entered into by the Secretary, the complainant, and the person alleged to have committed the violation.

(B) Content of order

If, in response to a complaint filed under paragraph (1), the Secretary determines that a violation of subsection (a) has occurred, the Secretary shall order the person who committed such violation—

(i) to take affirmative action to abate the violation;

(ii) to reinstate the complainant to his or her former position together with compensation (including back pay) and restore the terms, conditions, and privileges associated with his or her employment; and

(iii) to provide compensatory damages to the complainant.

(C) Penalty

If such an order is issued under this paragraph, the Secretary, at the request of the complainant, shall assess against the person against whom the order is issued a sum equal to the aggregate amount of all costs and expenses (including attorneys' and expert witness fees) reasonably incurred, as determined by the Secretary, by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued.

(D) Bad faith claim

If the Secretary finds that a complaint under paragraph (1) is frivolous or has been brought in bad faith, the Secretary may award to the prevailing employer a reasonable attorneys' fee, not exceeding $1,000, to be paid by the complainant.

(4) Action in court

(A) In general

If the Secretary has not issued a final decision within 210 days after the filing of the complaint, or within 90 days after receiving a written determination, the complainant may bring an action at law or equity for de novo review in the appropriate district court of the United States with jurisdiction, which shall have jurisdiction over such an action without regard to the amount in controversy, and which action shall, at the request of either party to such action, be tried by the court with a jury. The proceedings shall be governed by the same legal burdens of proof specified in paragraph (2)(C).

(B) Relief

The court shall have jurisdiction to grant all relief necessary to make the employee whole, including injunctive relief and compensatory damages, including—

(i) reinstatement with the same seniority status that the employee would have had, but for the discharge or discrimination;

(ii) the amount of back pay, with interest; and

(iii) compensation for any special damages sustained as a result of the discharge or discrimination, including litigation costs, expert witness fees, and reasonable attorney's fees.

(5) Review

(A) In general

Unless the complainant brings an action under paragraph (4), any person adversely affected or aggrieved by a final order issued under paragraph (3) may obtain review of the order in the United States Court of Appeals for the circuit in which the violation, with respect to which the order was issued, allegedly occurred or the circuit in which the complainant resided on the date of such violation. The petition for review must be filed not later than 60 days after the date of the issuance of the final order of the Secretary. Review shall conform to chapter 7 of title 5. The commencement of proceedings under this subparagraph shall not, unless ordered by the court, operate as a stay of the order.

(B) No judicial review

An order of the Secretary with respect to which review could have been obtained under subparagraph (A) shall not be subject to judicial review in any criminal or other civil proceeding.

(6) Failure to comply with order

Whenever any person has failed to comply with an order issued under paragraph (3), the Secretary may file a civil action in the United States district court for the district in which the violation was found to occur, or in the United States district court for the District of Columbia, to enforce such order. In actions brought under this paragraph, the district courts shall have jurisdiction to grant all appropriate relief including, but not limited to, injunctive relief and compensatory damages.

(7) Civil action to require compliance

(A) In general

A person on whose behalf an order was issued under paragraph (3) may commence a civil action against the person to whom such order was issued to require compliance with such order. The appropriate United States district court shall have jurisdiction, without regard to the amount in controversy or the citizenship of the parties, to enforce such order.

(B) Award

The court, in issuing any final order under this paragraph, may award costs of litigation (including reasonable attorneys' and expert witness fees) to any party whenever the court determines such award is appropriate.

(c) Effect of section

(1) Other laws

Nothing in this section preempts or diminishes any other safeguards against discrimination, demotion, discharge, suspension, threats, harassment, reprimand, retaliation, or any other manner of discrimination provided by Federal or State law.

(2) Rights of employees

Nothing in this section shall be construed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement. The rights and remedies in this section may not be waived by any agreement, policy, form, or condition of employment.

(d) Enforcement

Any nondiscretionary duty imposed by this section shall be enforceable in a mandamus proceeding brought under section 1361 of title 28.

(e) Limitation

Subsection (a) shall not apply with respect to an employee of an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food who, acting without direction from such entity (or such entity's agent), deliberately causes a violation of any requirement relating to any violation or alleged violation of any order, rule, regulation, standard, or ban under this chapter.

(June 25, 1938, ch. 675, §1013, formerly §1012, as added Pub. L. 111–353, title IV, §402, Jan. 4, 2011, 124 Stat. 3968; renumbered §1013, Pub. L. 114–255, div. A, title III, §3073(b)(1), Dec. 13, 2016, 130 Stat. 1137.)

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

1 So in original.
21 U.S.C. § 16 (2024) — Title 21: FOOD AND DRUGS / Chapter 1: ADULTERATED OR MISBRANDED FOODS OR DRUGS / Subchapter II: MISCELLANEOUS PROVISIONS / Section 16: Introduction into, or sale in, State or Territory or District of Columbia of dairy or food products falsely labeled or branded
Introduction into, or sale in, State or Territory or District of Columbia of dairy or food products falsely labeled or branded
Status: in_force

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 U.S.C. § 1134 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter II: DRUG ABUSE POLICY COORDINATION / Section 1134: Repealed. Pub. L. 92-255, title I, §104, Mar. 21, 1972, 86 Stat. 67
Repealed. Pub. L. 92-255, title I, §104, Mar. 21, 1972, 86 Stat. 67
Status: repealed

Section 1134, Pub. L. 92–255, title II, §224, Mar. 21, 1972, 86 Stat. 71, provided for establishment of research and development programs by Director.

Section 1135, Pub. L. 92–255, title II, §225, Mar. 21, 1972, 86 Stat. 72, provided for establishment of a single non-Federal share requirement.

Section 1136, Pub. L. 92–255, title II, §226, Mar. 21, 1972, 86 Stat. 72, provided for Director to make drug prevention function recommendations to President and to consult with responsible agencies with respect to drug prevention functions.

Section 1137, Pub. L. 92–255, title II, §227, Mar. 21, 1972, 86 Stat. 72, provided for resolution of agency conflicts with regard to drug prevention functions.

Section 1138, Pub. L. 92–255, title II, §228, Mar. 21, 1972, 86 Stat. 72, provided for communications and liaison with respect to drug prevention functions by one of Assistant Directors.

Section 1139, Pub. L. 92–255, title II, §229, Mar. 21, 1972, 86 Stat. 72, provided, with respect to drug prevention functions, coordination of State and local governments, availability of information and other services and activities.

Section 1140, Pub. L. 92–255, title II, §230, Mar. 21, 1972, 86 Stat. 73, provided for a management oversight review by a Federal officer.

Section 1141, Pub. L. 92–255, title II, §231, Mar. 21, 1972, 86 Stat. 73, provided for convening of a council of officials of Federal agencies responsible for drug prevention functions by Director.

Section 1142, Pub. L. 92–255, title II, §232, Mar. 21, 1972, 86 Stat. 73, provided for designation of the Director to represent Government in international negotiations related to drug prevention functions.

Section 1143, Pub. L. 92–255, title II, §233, Mar. 21, 1972, 86 Stat. 73, provided for an annual written report to the President by the Director.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Section 1104 of this title, prior to repeal by Pub. L. 94–237, §4(c)(1), Mar. 19, 1976, 90 Stat. 244, provided for repeal of sections effective June 30, 1975.
21 U.S.C. § 2206 (2024) — Title 21: FOOD AND DRUGS / Chapter 27: FOOD SAFETY MODERNIZATION / Subchapter I: IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS / Section 2206: Alcohol-related facilities
Alcohol-related facilities
Status: in_force

(a) In general

Except as provided by sections 102, 206, 207, 302, 304, 402, 403, and 404 of this Act, and the amendments made by such sections, nothing in this Act, or the amendments made by this Act, shall be construed to apply to a facility that—

(1) under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.) is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; and

(2) under section 350d of this title is required to register as a facility because such facility is engaged in manufacturing, processing, packing, or holding 1 or more alcoholic beverages, with respect to the activities of such facility that relate to the manufacturing, processing, packing, or holding of alcoholic beverages.

(b) Limited receipt and distribution of non-alcohol food

Subsection (a) shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food, except that such paragraph shall apply to a facility described in such paragraph that receives and distributes non-alcohol food, provided such food is received and distributed—

(1) in a prepackaged form that prevents any direct human contact with such food; and

(2) in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury.

(c) Rule of construction

Except as provided in subsections (a) and (b), this section shall not be construed to exempt any food, other than alcoholic beverages, as defined in section 214 1 of the Federal Alcohol Administration Act (27 U.S.C. 214), from the requirements of this Act (including the amendments made by this Act).

(Pub. L. 111–353, title I, §116, Jan. 4, 2011, 124 Stat. 3922.)

Editorial Notes

References in Text

This Act, referred to in subsecs. (a) and (c), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. Sections 102, 206, 207, 302, 304, 402, 403, and 404 of the Act enacted sections 350l, 350l–1, 384b, 399d, 2251, and 2252 of this title, amended sections 331, 333, 334, 350d, and 381 of this title, and enacted provisions set out as notes under sections 334, 350d, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

The Federal Alcohol Administration Act, referred to in subsecs. (a)(1) and (c), is act Aug. 29, 1935, ch. 814, 49 Stat. 977, which is classified generally to subchapter I (§201 et seq.) of chapter 8 of Title 27, Intoxicating Liquors. Section 214 of the Act probably means section 203 of the Act, which is classified to section 214 of Title 27 and defines "alcoholic beverage". For complete classification of this Act to the Code, see section 201 of Title 27 and Tables.

The Internal Revenue Code of 1986, referred to in subsec. (a)(1), is classified generally to Title 26, Internal Revenue Code.

1 See References in Text note below.
21 U.S.C. § 387s (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387s: User fees
User fees
Status: in_force

(a) Establishment of quarterly fee

Beginning on June 22, 2009, the Secretary shall in accordance with this section assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to this subchapter. The fees shall be assessed and collected with respect to each quarter of each fiscal year, and the total amount assessed and collected for a fiscal year shall be the amount specified in subsection (b)(1) for such year, subject to subsection (c).

(b) Assessment of user fee

(1) Amount of assessment

The total amount of user fees authorized to be assessed and collected under subsection (a) for a fiscal year is the following, as applicable to the fiscal year involved:

(A) For fiscal year 2009, $85,000,000 (subject to subsection (e)).

(B) For fiscal year 2010, $235,000,000.

(C) For fiscal year 2011, $450,000,000.

(D) For fiscal year 2012, $477,000,000.

(E) For fiscal year 2013, $505,000,000.

(F) For fiscal year 2014, $534,000,000.

(G) For fiscal year 2015, $566,000,000.

(H) For fiscal year 2016, $599,000,000.

(I) For fiscal year 2017, $635,000,000.

(J) For fiscal year 2018, $672,000,000.

(K) For fiscal year 2019 and each subsequent fiscal year, $712,000,000.

(2) Allocations of assessment by class of tobacco products

(A) In general

The total user fees assessed and collected under subsection (a) each fiscal year with respect to each class of tobacco products shall be an amount that is equal to the applicable percentage of each class for the fiscal year multiplied by the amount specified in paragraph (1) for the fiscal year.

(B) Applicable percentage

(i) In general

For purposes of subparagraph (A), the applicable percentage for a fiscal year for each of the following classes of tobacco products shall be determined in accordance with clause (ii):

(I) Cigarettes.

(II) Cigars, including small cigars and cigars other than small cigars.

(III) Snuff.

(IV) Chewing tobacco.

(V) Pipe tobacco.

(VI) Roll-your-own tobacco.

(ii) Allocations

The applicable percentage of each class of tobacco product described in clause (i) for a fiscal year shall be the percentage determined under section 518d(c) of title 7 for each such class of product for such fiscal year.

(iii) Requirement of regulations

Notwithstanding clause (ii), no user fees shall be assessed on a class of tobacco products unless such class of tobacco products is listed in section 387a(b) of this title or is deemed by the Secretary in a regulation under section 387a(b) of this title to be subject to this subchapter.

(iv) Reallocations

In the case of a class of tobacco products that is not listed in section 387a(b) of this title or deemed by the Secretary in a regulation under section 387a(b) of this title to be subject to this subchapter, the amount of user fees that would otherwise be assessed to such class of tobacco products shall be reallocated to the classes of tobacco products that are subject to this subchapter in the same manner and based on the same relative percentages otherwise determined under clause (ii).

(3) Determination of user fee by company

(A) In general

The total user fee to be paid by each manufacturer or importer of a particular class of tobacco products shall be determined for each quarter by multiplying—

(i) such manufacturer's or importer's percentage share as determined under paragraph (4); by

(ii) the portion of the user fee amount for the current quarter to be assessed on all manufacturers and importers of such class of tobacco products as determined under paragraph (2).

(B) No fee in excess of percentage share

No manufacturer or importer of tobacco products shall be required to pay a user fee in excess of the percentage share of such manufacturer or importer.

(4) Allocation of assessment within each class of tobacco product

The percentage share of each manufacturer or importer of a particular class of tobacco products of the total user fee to be paid by all manufacturers or importers of that class of tobacco products shall be the percentage determined for purposes of allocations under subsections (e) through (h) of section 518d of title 7.

(5) Allocation for cigars

Notwithstanding paragraph (4), if a user fee assessment is imposed on cigars, the percentage share of each manufacturer or importer of cigars shall be based on the excise taxes paid by such manufacturer or importer during the prior fiscal year.

(6) Timing of assessment

The Secretary shall notify each manufacturer and importer of tobacco products subject to this section of the amount of the quarterly assessment imposed on such manufacturer or importer under this subsection for each quarter of each fiscal year. Such notifications shall occur not later than 30 days prior to the end of the quarter for which such assessment is made, and payments of all assessments shall be made by the last day of the quarter involved.

(7) Memorandum of understanding

(A) In general

The Secretary shall request the appropriate Federal agency to enter into a memorandum of understanding that provides for the regular and timely transfer from the head of such agency to the Secretary of the information described in paragraphs (2)(B)(ii) and (4) and all necessary information regarding all tobacco product manufacturers and importers required to pay user fees. The Secretary shall maintain all disclosure restrictions established by the head of such agency regarding the information provided under the memorandum of understanding.

(B) Assurances

Beginning not later than fiscal year 2015, and for each subsequent fiscal year, the Secretary shall ensure that the Food and Drug Administration is able to determine the applicable percentages described in paragraph (2) and the percentage shares described in paragraph (4). The Secretary may carry out this subparagraph by entering into a contract with the head of the Federal agency referred to in subparagraph (A) to continue to provide the necessary information.

(c) Crediting and availability of fees

(1) In general

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, subject to paragraph (2)(D). Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.

(2) Availability

(A) In general

Fees appropriated under paragraph (3) are available only for the purpose of paying the costs of the activities of the Food and Drug Administration related to the regulation of tobacco products under this subchapter and the Family Smoking Prevention and Tobacco Control Act (referred to in this subsection as "tobacco regulation activities"), except that such fees may be used for the reimbursement specified in subparagraph (C).

(B) Prohibition against use of other funds

(i) In general

Except as provided in clause (ii), fees collected under subsection (a) are the only funds authorized to be made available for tobacco regulation activities.

(ii) Startup costs

Clause (i) does not apply until October 1, 2009. Until such date, any amounts available to the Food and Drug Administration (excluding user fees) shall be available and allocated as needed to pay the costs of tobacco regulation activities.

(C) Reimbursement of start-up amounts

(i) In general

Any amounts allocated for the start-up period pursuant to subparagraph (B)(ii) shall be reimbursed through any appropriated fees collected under subsection (a), in such manner as the Secretary determines appropriate to ensure that such allocation results in no net change in the total amount of funds otherwise available, for the period from October 1, 2008, through September 30, 2010, for Food and Drug Administration programs and activities (other than tobacco regulation activities) for such period.

(ii) Treatment of reimbursed amounts

Amounts reimbursed under clause (i) shall be available for the programs and activities for which funds allocated for the start-up period were available, prior to such allocation, until September 30, 2010, notwithstanding any otherwise applicable limits on amounts for such programs or activities for a fiscal year.

(D) Fee collected during start-up period

Notwithstanding the first sentence of paragraph (1), fees under subsection (a) may be collected through September 30, 2009 under subparagraph (B)(ii) and shall be available for obligation and remain available until expended. Such offsetting collections shall be credited to the salaries and expenses account of the Food and Drug Administration.

(E) Obligation of start-up costs in anticipation of available fee collections

Notwithstanding any other provision of law, following the enactment of an appropriation for fees under this section for fiscal year 2010, or any portion thereof, obligations for costs of tobacco regulation activities during the start-up period may be incurred in anticipation of the receipt of offsetting fee collections through procedures specified in section 1534 of title 31.

(3) Authorization of appropriations

For fiscal year 2009 and each subsequent fiscal year, there is authorized to be appropriated for fees under this section an amount equal to the amount specified in subsection (b)(1) for the fiscal year.

(d) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(e) Applicability to fiscal year 2009

If the date of enactment of the Family Smoking Prevention and Tobacco Control Act occurs during fiscal year 2009, the following applies, subject to subsection (c):

(1) The Secretary shall determine the fees that would apply for a single quarter of such fiscal year according to the application of subsection (b) to the amount specified in paragraph (1)(A) of such subsection (referred to in this subsection as the "quarterly fee amounts").

(2) For the quarter in which such date of enactment occurs, the amount of fees assessed shall be a pro rata amount, determined according to the number of days remaining in the quarter (including such date of enactment) and according to the daily equivalent of the quarterly fee amounts. Fees assessed under the preceding sentence shall not be collected until the next quarter.

(3) For the quarter following the quarter to which paragraph (2) applies, the full quarterly fee amounts shall be assessed and collected, in addition to collection of the pro rata fees assessed under paragraph (2).

(June 25, 1938, ch. 675, §919, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1826.)

Editorial Notes

References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (c)(2)(A), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title.

The date of enactment of the Family Smoking Prevention and Tobacco Control Act and such date of enactment, referred to in subsec. (e), is the date of enactment of Pub. L. 111–31, which was approved June 22, 2009.
21 U.S.C. § 878 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 878: Powers of enforcement personnel
Powers of enforcement personnel
Status: in_force

(a) Any officer or employee of the Drug Enforcement Administration or any State, tribal, or local law enforcement officer designated by the Attorney General may—

(1) carry firearms;

(2) execute and serve search warrants, arrest warrants, administrative inspection warrants, subpenas, and summonses issued under the authority of the United States;

(3) make arrests without warrant (A) for any offense against the United States committed in his presence, or (B) for any felony, cognizable under the laws of the United States, if he has probable cause to believe that the person to be arrested has committed or is committing a felony;

(4) make seizures of property pursuant to the provisions of this subchapter; and

(5) perform such other law enforcement duties as the Attorney General may designate.

(b) State and local law enforcement officers performing functions under this section shall not be deemed Federal employees and shall not be subject to provisions of law relating to Federal employees, except that such officers shall be subject to section 3374(c) of title 5.

(Pub. L. 91–513, title II, §508, Oct. 27, 1970, 84 Stat. 1273; Pub. L. 96–132, §16(b), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 99–570, title I, §1869, Oct. 27, 1986, 100 Stat. 3207–55; Pub. L. 99–646, §86, Nov. 10, 1986, 100 Stat. 3620; Pub. L. 111–211, title II, §232(d), July 29, 2010, 124 Stat. 2278.)

Editorial Notes

Amendments

2010—Subsec. (a). Pub. L. 111–211 inserted ", tribal," after "State" in introductory provisions.

1986—Pub. L. 99–570 and Pub. L. 99–646 amended section substantially identically designating existing provisions as subsec. (a) and adding subsec. (b), with the exception of the amendment of subsec. (a) for which Pub. L. 99–570 directed the insertion of "or (with respect to offenses under this subchapter or subchapter II of this chapter) any State or local law enforcement officer" and Pub. L. 99–646 directed the insertion of "or any State or local law enforcement officer", the latter of which was executed to reflect the probable intent of Congress.

1979—Pub. L. 96–132 substituted "Drug Enforcement Administration" for "Bureau of Narcotics and Dangerous Drugs".
21 U.S.C. § 1104 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter I: GENERAL PROVISIONS / Section 1104: Repealed. Pub. L. 94-237, §4(c)(1), Mar. 19, 1976, 90 Stat. 244
Repealed. Pub. L. 94-237, §4(c)(1), Mar. 19, 1976, 90 Stat. 244
Status: repealed

Section, Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, provided, effective June 30, 1975, that the Special Action Office for Drug Abuse Prevention, each of the positions in the Office of Director, Deputy Director, and Assistant Director, and the National Advisory Council for Drug Abuse Prevention were abolished and former subchapter II of this chapter was repealed.
21 U.S.C. § 962 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 962: Second or subsequent offenses
Second or subsequent offenses
Status: in_force

(a) Term of imprisonment and fine

Any person convicted of any offense under this subchapter is, if the offense is a second or subsequent offense, punishable by a term of imprisonment twice that otherwise authorized, by twice the fine otherwise authorized, or by both. If the conviction is for an offense punishable under section 960(b) of this title, and if it is the offender's second or subsequent offense, the court shall impose, in addition to any term of imprisonment and fine, twice the term of supervised release otherwise authorized.

(b) Determination of status

For purposes of this section, a person shall be considered convicted of a second or subsequent offense if, prior to the commission of such offense, one or more prior convictions of such person for a felony drug offense have become final.

(c) Procedures applicable

Section 851 of this title shall apply with respect to any proceeding to sentence a person under this section.

(Pub. L. 91–513, title III, §1012, Oct. 27, 1970, 84 Stat. 1290; Pub. L. 98–473, title II, §§225(b), 505, Oct. 12, 1984, 98 Stat. 2030, 2070; Pub. L. 99–570, title I, §§1004(a), 1005(c), Oct. 27, 1986, 100 Stat. 3207–6; Pub. L. 103–322, title IX, §90105(b), Sept. 13, 1994, 108 Stat. 1988.)

Editorial Notes

Amendments

1994—Subsec. (b). Pub. L. 103–322 substituted "one or more prior convictions of such person for a felony drug offense have become final" for "one or more prior convictions of him for a felony under any provision of this subchapter or subchapter I 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 drugs, have become final".

1986—Subsec. (a). Pub. L. 99–570, §1005(c), amended Pub. L. 98–473, §225. See 1984 Amendment note below.

Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term".

1984—Subsec. (a). Pub. L. 98–473, §225(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 omitted in the general amendment of section 225 of Pub. L. 98–473 by Pub. L. 99–570, §1005(c).

Subsec. (b). Pub. L. 98–473, §505, inserted references to laws of a State or of a foreign country.

Statutory Notes and Related Subsidiaries

Effective Date of 1986 Amendment

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.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.
21 U.S.C. § 811 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 811: Authority and criteria for classification of substances
Authority and criteria for classification of substances
Status: in_force

(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), 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) 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) 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).

(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 drug which contains a controlled substance from the application of this subchapter and subchapter II of this chapter if such drug 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.

(C) Upon the recommendation of the Secretary of Health and Human Services, a compound, mixture, or preparation which contains any anabolic steroid, which is intended for administration to a human being or an animal, and which, because of its concentration, preparation, formulation or delivery system, 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) 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 2 years 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) with respect to the substance, extend the temporary scheduling for up to 1 year.

(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), 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) with respect to such substance.

(6) An order issued under paragraph (1) is not subject to judicial review.

(i) Temporary and permanent scheduling of recently emerged anabolic steroids

(1) The Attorney General may issue a temporary order adding a drug or other substance to the definition of anabolic steroids if the Attorney General finds that—

(A) the drug or other substance satisfies the criteria for being considered an anabolic steroid under section 802(41) of this title but is not listed in that section or by regulation of the Attorney General as being an anabolic steroid; and

(B) adding such drug or other substance to the definition of anabolic steroids will assist in preventing abuse or misuse of the drug or other substance.

(2) An order issued under paragraph (1) shall not take effect until 30 days after 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. The order shall expire not later than 24 months after the date it becomes effective, except that the Attorney General may, during the pendency of proceedings under paragraph (6), extend the temporary scheduling order for up to 6 months.

(3) 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.

(4) A temporary scheduling order issued under paragraph (1) shall be vacated upon the issuance of a permanent scheduling order under paragraph (6).

(5) An order issued under paragraph (1) is not subject to judicial review.

(6) The Attorney General may, by rule, issue a permanent order adding a drug or other substance to the definition of anabolic steroids if such drug or other substance satisfies the criteria for being considered an anabolic steroid under section 802(41) of this title. Such rulemaking may be commenced simultaneously with the issuance of the temporary order issued under paragraph (1).

(j) Interim final rule; date of issuance; procedure for final rule

(1) With respect to a drug referred to in subsection (f), if the Secretary of Health and Human Services recommends that the Attorney General control the drug in schedule II, III, IV, or V pursuant to subsections (a) and (b), the Attorney General shall, not later than 90 days after the date described in paragraph (2), issue an interim final rule controlling the drug in accordance with such subsections and section 812(b) of this title using the procedures described in paragraph (3).

(2) The date described in this paragraph shall be the later of—

(A) the date on which the Attorney General receives the scientific and medical evaluation and the scheduling recommendation from the Secretary of Health and Human Services in accordance with subsection (b); or

(B) the date on which the Attorney General receives notification from the Secretary of Health and Human Services that the Secretary has approved an application under section 505(c), 512, or 571 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c), 360b, 360ccc] or section 262(a) of title 42, or indexed a drug under section 572 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ccc–1], with respect to the drug described in paragraph (1).

(3) A rule issued by the Attorney General under paragraph (1) shall become immediately effective as an interim final rule without requiring the Attorney General to demonstrate good cause therefor. The interim final rule shall give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, the Attorney General shall issue a final rule in accordance with the scheduling criteria of subsections (b), (c), and (d) of this section and section 812(b) of this title.

(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; Pub. L. 108–358, §2(b), Oct. 22, 2004, 118 Stat. 1663; Pub. L. 112–144, title XI, §1153, July 9, 2012, 126 Stat. 1132; Pub. L. 113–260, §2(b), Dec. 18, 2014, 128 Stat. 2930; Pub. L. 114–89, §2(b), Nov. 25, 2015, 129 Stat. 700.)

Editorial Notes

References in Text

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, 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, 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, II, III, IV, and V, referred to in subsecs. (d)(4)(A), (B), (h)(1), and (j)(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.

This subchapter and subchapter II of this chapter, referred to in subsec. (g)(1), was in the original "titles II and III of the Comprehensive Drug Abuse Prevention and Control Act", which was translated as meaning titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, 1285, to reflect the probable intent of Congress. Title II is classified principally to this subchapter and part A of title III comprises subchapter II of this chapter. For complete classification of this Act to the Code, see Short Title notes set out under section 801 of this title and Tables.

Amendments

2015—Subsec. (j). Pub. L. 114–89 added subsec. (j).

2014—Subsec. (i). Pub. L. 113–260 added subsec. (i).

2012—Subsec. (h)(2). Pub. L. 112–144 substituted "2 years" for "one year" and "1 year" for "six months".

2004—Subsec. (g)(1). Pub. L. 108–358, §2(b)(1), substituted "drug which contains a controlled substance from the application of this subchapter and subchapter II of this chapter if such drug" for "substance from a schedule if such substance".

Subsec. (g)(3)(C). Pub. L. 108–358, §2(b)(2), added subpar. (C).

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).

Statutory Notes and Related Subsidiaries

Change of Name

"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.

Effective Date of 2004 Amendment

Amendment by Pub. L. 108–358 effective 90 days after Oct. 22, 2004, see section 2(d) of Pub. L. 108–358, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

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".