21 U.S.C. § 842 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 842: Prohibited acts B
Prohibited acts B
Status: in_force

(a) Unlawful acts

It shall be unlawful for any person—

(1) who is subject to the requirements of part C to distribute or dispense a controlled substance in violation of section 829 of this title;

(2) who is a registrant to distribute or dispense a controlled substance not authorized by his registration to another registrant or other authorized person or to manufacture a controlled substance not authorized by his registration;

(3) who is a registrant to distribute a controlled substance in violation of section 825 of this title;

(4) to remove, alter, or obliterate a symbol or label required by section 825 of this title;

(5) to refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II;

(6) to refuse any entry into any premises or inspection authorized by this subchapter or subchapter II;

(7) to remove, break, injure, or deface a seal placed upon controlled substances pursuant to section 824(f) or 881 of this title or to remove or dispose of substances so placed under seal;

(8) to use, to his own advantage, or to reveal, other than to duly authorized officers or employees of the United States, or to the courts when relevant in any judicial proceeding under this subchapter or subchapter II, any information acquired in the course of an inspection authorized by this subchapter concerning any method or process which as a trade secret is entitled to protection, or to use to his own advantage or reveal (other than as authorized by section 830 of this title) any information that is confidential under such section;

(9) who is a regulated person to engage in a regulated transaction without obtaining the identification required by 830(a)(3) of this title.1

(10) negligently to fail to keep a record or make a report under section 830 of this title or negligently to fail to self-certify as required under section 830 of this title;

(11) to distribute a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, in violation of this subchapter or subchapter II, with reckless disregard for the illegal uses to which such a laboratory supply will be put;

(12) who is a regulated seller, or a distributor required to submit reports under subsection (b)(3) of section 830 of this title—

(A) to sell at retail a scheduled listed chemical product in violation of paragraph (1) of subsection (d) of such section, knowing at the time of the transaction involved (independent of consulting the logbook under subsection (e)(1)(A)(iii) of such section) that the transaction is a violation; or

(B) to knowingly or recklessly sell at retail such a product in violation of paragraph (2) of such subsection (d);

(13) who is a regulated seller to knowingly or recklessly sell at retail a scheduled listed chemical product in violation of subsection (e) of such section;

(14) who is a regulated seller or an employee or agent of such seller to disclose, in violation of regulations under subparagraph (C) of section 830(e)(1) of this title, information in logbooks under subparagraph (A)(iii) of such section, or to refuse to provide such a logbook to Federal, State, or local law enforcement authorities;

(15) to distribute a scheduled listed chemical product to a regulated seller, or to a regulated person referred to in section 830(b)(3)(B) of this title, unless such regulated seller or regulated person is, at the time of such distribution, currently registered with the Drug Enforcement Administration, or on the list of persons referred to under section 830(e)(1)(B)(v) of this title;

(16) to violate subsection (e) of section 825 of this title; 2 or

(17) in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with section 827(f) of this title.

As used in paragraph (11), the term "laboratory supply" means a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General, which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. For purposes of paragraph (11), there is a rebuttable presumption of reckless disregard at trial if the Attorney General notifies a firm in writing that a laboratory supply sold by the firm, or any other person or firm, has been used by a customer of the notified firm, or distributed further by that customer, for the unlawful production of controlled substances or listed chemicals a firm distributes and 2 weeks or more after the notification the notified firm distributes a laboratory supply to the customer. For purposes of paragraph (15), if the distributor is temporarily unable to access the list of persons referred to under section 830(e)(1)(B)(v) of this title, the distributor may rely on a written, faxed, or electronic copy of a certificate of self-certification submitted by the regulated seller or regulated person, provided the distributor confirms within 7 business days of the distribution that such regulated seller or regulated person is on the list referred to under section 830(e)(1)(B)(v) of this title.

(b) Manufacture

It shall be unlawful for any person who is a registrant to manufacture a controlled substance in schedule I or II, or ephedrine, pseudoephedrine, or phenylpropanolamine or any of the salts, optical isomers, or salts of optical isomers of such chemical, which is—

(1) not expressly authorized by his registration and by a quota assigned to him pursuant to section 826 of this title; or

(2) in excess of a quota assigned to him pursuant to section 826 of this title.

(c) Penalties

(1)(A) Except as provided in subparagraph (B), (C), or (D) of this paragraph and paragraph (2), any person who violates this section shall, with respect to any such violation, be subject to a civil penalty of not more than $25,000. The district courts of the United States (or, where there is no such court in the case of any territory or possession of the United States, then the court in such territory or possession having the jurisdiction of a district court of the United States in cases arising under the Constitution and laws of the United States) shall have jurisdiction in accordance with section 1355 of title 28 to enforce this paragraph.

(B)(i) Except as provided in clause (ii), in the case of a violation of paragraph (5), (10), or (17) of subsection (a), the civil penalty shall not exceed $10,000.

(ii) In the case of a violation described in clause (i) committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 827(f) of this title, the penalty shall not exceed $100,000.

(C) In the case of a violation of paragraph (16) of subsection (a) of this section by an importer, exporter, manufacturer, or distributor (other than as provided in subparagraph (D)), up to $500,000 per violation. For purposes of this subparagraph, a violation is defined as each instance of importation, exportation, manufacturing, distribution, or possession with intent to manufacture or distribute, in violation of paragraph (16) of subsection (a).

(D) In the case of a distribution, dispensing, or possession with intent to distribute or dispense in violation of paragraph (16) of subsection (a) of this section at the retail level, up to $1000 per violation. For purposes of this paragraph, the term "at the retail level" refers to products sold, or held for sale, directly to the consumer for personal use. Each package, container or other separate unit containing an anabolic steroid that is distributed, dispensed, or possessed with intent to distribute or dispense at the retail level in violation of such paragraph (16) of subsection (a) shall be considered a separate violation.

(2)(A) If a violation of this section is prosecuted by an information or indictment which alleges that the violation was committed knowingly and the trier of fact specifically finds that the violation was so committed, such person shall, except as otherwise provided in subparagraph (B) or (D) of this paragraph, be sentenced to imprisonment of not more than one year or a fine under title 18, or both.

(B) If a violation referred to in subparagraph (A) was committed after one or more prior convictions of the offender for an offense punishable under this paragraph (2), or for a crime under any other provision of this subchapter or subchapter II or other law of the United States relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final, such person shall be sentenced to a term of imprisonment of not more than 2 years, a fine under title 18, or both.

(C) In addition to the penalties set forth elsewhere in this subchapter or subchapter II, any business that violates paragraph (11) of subsection (a) shall, with respect to the first such violation, be subject to a civil penalty of not more than $250,000, but shall not be subject to criminal penalties under this section, and shall, for any succeeding violation, be subject to a civil fine of not more than $250,000 or double the last previously imposed penalty, whichever is greater.

(D) In the case of a violation described in subparagraph (A) that was a violation of paragraph (5), (10), or (17) of subsection (a) committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 827(f) of this title, the criminal fine under title 18 shall not exceed $500,000.

(3) Except under the conditions specified in paragraph (2) of this subsection, a violation of this section does not constitute a crime, and a judgment for the United States and imposition of a civil penalty pursuant to paragraph (1) shall not give rise to any disability or legal disadvantage based on conviction for a criminal offense.

(4)(A) If a regulated seller, or a distributor required to submit reports under section 830(b)(3) of this title, violates paragraph (12) of subsection (a) of this section, or if a regulated seller violates paragraph (13) of such subsection, the Attorney General may by order prohibit such seller or distributor (as the case may be) from selling any scheduled listed chemical product. Any sale of such a product in violation of such an order is subject to the same penalties as apply under paragraph (2).

(B) An order under subparagraph (A) may be imposed only through the same procedures as apply under section 824(c) of this title for an order to show cause.

(Pub. L. 91–513, title II, §402, Oct. 27, 1970, 84 Stat. 1262; Pub. L. 95–633, title II, §202(b)(1), (2), Nov. 10, 1978, 92 Stat. 3776; Pub. L. 100–690, title VI, §6056, Nov. 18, 1988, 102 Stat. 4318; Pub. L. 104–237, title II, §205, Oct. 3, 1996, 110 Stat. 3103; Pub. L. 105–277, div. A, §101(b) [title I, §117], Oct. 21, 1998, 112 Stat. 2681–50, 2681–68; Pub. L. 107–273, div. B, title IV, §4002(b)(16), (d)(2)(B), Nov. 2, 2002, 116 Stat. 1808, 1809; Pub. L. 109–177, title VII, §§711(f)(1)(A), (2), 714, Mar. 9, 2006, 120 Stat. 262–264; Pub. L. 111–268, §§4, 5, Oct. 12, 2010, 124 Stat. 2847, 2848; Pub. L. 113–260, §3(c), Dec. 18, 2014, 128 Stat. 2931; Pub. L. 115–271, title III, §3273(c), Oct. 24, 2018, 132 Stat. 3953.)

Editorial Notes

References in Text

Section 825 of this title, referred to in subsec. (a)(16), was so in the original, but probably should have been a reference to section 305 of Pub. L. 91–513, which is classified to section 825 of this title.

Schedules I and II, referred to in subsec. (b), are set out in section 812(c) of this title.

Amendments

2018—Subsec. (a)(17). Pub. L. 115–271, §3273(c)(1), added par. (17).

Subsec. (c)(1)(B). Pub. L. 115–271, §3273(c)(2)(A), added subpar. (B) and struck out former subpar. (B) which read as follows: "In the case of a violation of paragraph (5) or (10) of subsection (a), the civil penalty shall not exceed $10,000."

Subsec. (c)(2)(A). Pub. L. 115–271, §3273(c)(2)(B)(i), inserted "or (D)" after "subparagraph (B)".

Subsec. (c)(2)(D). Pub. L. 115–271, §3273(c)(2)(B)(ii), added subpar. (D).

2014—Subsec. (a)(16). Pub. L. 113–260, §3(c)(1), added par. (16).

Subsec. (c)(1)(A). Pub. L. 113–260, §3(c)(2)(A), inserted ", (C), or (D)" after "subparagraph (B)".

Subsec. (c)(1)(C), (D). Pub. L. 113–260, §3(c)(2)(B), added subpars. (C) and (D).

2010—Subsec. (a). Pub. L. 111–268, §4(4), inserted "For purposes of paragraph (15), if the distributor is temporarily unable to access the list of persons referred to under section 830(e)(1)(B)(v) of this title, the distributor may rely on a written, faxed, or electronic copy of a certificate of self-certification submitted by the regulated seller or regulated person, provided the distributor confirms within 7 business days of the distribution that such regulated seller or regulated person is on the list referred to under section 830(e)(1)(B)(v) of this title." at end of concluding provisions.

Subsec. (a)(10). Pub. L. 111–268, §5, inserted "or negligently to fail to self-certify as required under section 830 of this title" before semicolon.

Subsec. (a)(15). Pub. L. 111–268, §4(1)–(3), added par. (15).

2006—Subsec. (a)(12) to (14). Pub. L. 109–177, §711(f)(1)(A), added pars. (12) to (14).

Subsec. (b). Pub. L. 109–177, §714, inserted ", or ephedrine, pseudoephedrine, or phenylpropanolamine or any of the salts, optical isomers, or salts of optical isomers of such chemical," after "manufacture a controlled substance in schedule I or II" in introductory provisions.

Subsec. (c)(4). Pub. L. 109–177, §711(f)(2), added par. (4).

2002—Subsec. (c)(2)(A). Pub. L. 107–273, §4002(d)(2)(B)(i), substituted "under title 18" for "of not more than $25,000".

Subsec. (c)(2)(B). Pub. L. 107–273, §4002(d)(2)(B)(ii), substituted "under title 18" for "of $50,000".

Subsec. (c)(2)(C). Pub. L. 107–273, §4002(b)(16), realigned margins.

1998—Subsec. (a)(5). Pub. L. 105–277, §101(b) [title I, §117(1)], inserted "negligently" before "fail".

Subsec. (a)(10). Pub. L. 105–277, §101(b) [title I, §117(2)], inserted "negligently" before "to fail".

Subsec. (c)(1). Pub. L. 105–277, §101(b) [title I, §117(3)], designated existing provisions as subpar. (A), inserted "subparagraph (B) of this paragraph and" before "paragraph (2)", and added subpar. (B).

1996—Subsec. (a). Pub. L. 104–237, §205(a), added par. (11) and closing provisions.

Subsec. (c)(2)(C). Pub. L. 104–237, §205(b), added subpar. (C).

1988—Subsec. (a)(8). Pub. L. 100–690, §6056(a), inserted ", or to use to his own advantage or reveal (other than as authorized by section 830 of this title) any information that is confidential under such section" after "protection".

Subsec. (a)(9). Pub. L. 100–690, §6056(b), amended par. (9) generally. Prior to amendment, par. (9) read as follows: "to distribute or sell piperidine in violation of regulations established under section 830(a)(2) of this title, respecting presentation of identification."

Subsec. (a)(10). Pub. L. 100–690, §6056(d), added par. (10).

Subsec. (c)(2)(C). Pub. L. 100–690, §6056(c), struck out subpar. (C) which read as follows: "Subparagraphs (A) and (B) shall not apply to a violation of subsection (a)(5) of this section with respect to a refusal or failure to make a report required under section 830(a) of this title (relating to piperidine reporting)."

1978—Subsec. (a)(9). Pub. L. 95–633, §202(b)(1), added par. (9).

Subsec. (c)(2)(C). Pub. L. 95–633, §202(b)(2), added subpar. (C).

Statutory Notes and Related Subsidiaries

Effective Date of 2010 Amendment

Amendment by Pub. L. 111–268 effective 180 days after Oct. 12, 2010, see section 6(a) of Pub. L. 111–268, set out as a note under section 830 of this title.

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective Nov. 10, 1978, see section 203(a) of Pub. L. 95–633 set out as an Effective Date note under section 830 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Repeals

Pub. L. 96–359, §8(b), Sept. 26, 1980, 94 Stat. 1194, repealed section 203(d) of Pub. L. 95–633, which had provided for the repeal of subsecs. (a)(9) and (c)(2)(C) of this section effective Jan. 1, 1981.

1 So in original. Probably should be "section 830(a)(3) of this title;".

2 See References in Text note below.
21 U.S.C. § 1117 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter II: DRUG ABUSE POLICY COORDINATION / Section 1117: Repealed. Pub. L. 98-24, §4(b), Apr. 26, 1983, 97 Stat. 183
Repealed. Pub. L. 98-24, §4(b), Apr. 26, 1983, 97 Stat. 183
Status: repealed

Section, Pub. L. 92–255, title II, §207, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1311, required the President to make annual reports to the Congress on the drug abuse prevention activities under this subchapter. See section 290aa–4 of Title 42, The Public Health and Welfare.

A prior section 1117, Pub. L. 92–255, title II, §207, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 243, which provided for acceptance of uncompensated services, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1117, Pub. L. 92–255, title II, §207, Mar. 21, 1972, 86 Stat. 68, which provided for the procurement of experts and consultants by the Director, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.
21 U.S.C. § 1908 (2024) — Title 21: FOOD AND DRUGS / Chapter 24: INTERNATIONAL NARCOTICS TRAFFICKING / Section 1908: Judicial Review Commission on Foreign Asset Control
Judicial Review Commission on Foreign Asset Control
Status: in_force

(a) Establishment

There is established a commission to be known as the "Judicial Review Commission on Foreign Asset Control" (in this section referred to as the "Commission").

(b) Membership and procedural matters

(1) The Commission shall be composed of five members, as follows:

(A) One member shall be appointed by the Chairman of the Select Committee on Intelligence of the Senate.

(B) One member shall be appointed by the Vice Chairman of the Select Committee on Intelligence of the Senate.

(C) One member shall be appointed by the Chairman of the Permanent Select Committee on Intelligence of the House of Representatives.

(D) One member shall be appointed by the Ranking Minority Member of the Permanent Select Committee on Intelligence of the House of Representatives.

(E) One member shall be appointed jointly by the members appointed under subparagraphs (A) through (D).

(2) Each member of the Commission shall, for purposes of the activities of the Commission under this section, possess or obtain an appropriate security clearance in accordance with applicable laws and regulations regarding the handling of classified information.

(3) The members of the Commission shall choose the chairman of the Commission from among the members of the Commission.

(4) The members of the Commission shall establish rules governing the procedures and proceedings of the Commission.

(c) Duties

The Commission shall have as its duties the following:

(1) To conduct a review of the current judicial, regulatory, and administrative authorities relating to the blocking of assets of foreign persons by the United States Government.

(2) To conduct a detailed examination and evaluation of the remedies available to United States persons affected by the blocking of assets of foreign persons by the United States Government.

(d) Powers

(1) The Commission may hold such hearings, sit and act at such times and places, take such testimony, and receive such evidence as the Commission considers advisable to carry out the purposes of this section.

(2) The Commission may secure directly from any executive department, agency, bureau, board, commission, office, independent establishment, or instrumentality of the Government information, suggestions, estimates, and statistics for the purposes of this section. Each such department, agency, bureau, board, commission, office, establishment, or instrumentality shall, to the extent authorized by law, furnish such information, suggestions, estimates, and statistics directly to the Commission, upon request of the chairman of the Commission. The Commission shall handle and protect all classified information provided to it under this section in accordance with applicable statutes and regulations.

(3) The Attorney General and the Secretary of the Treasury shall provide to the Commission, on a nonreimbursable basis, such administrative services, funds, facilities, and other support services as are necessary for the performance of the Commission's duties under this section.

(4) The Commission shall receive the full and timely cooperation of any official, department, or agency of the United States Government whose assistance is necessary for the fulfillment of the duties of the Commission under this section, including the provision of full and current briefings and analyses.

(5) No department or agency of the Government may withhold information from the Commission on the grounds that providing the information to the Commission would constitute the unauthorized disclosure of classified information or information relating to intelligence sources or methods.

(6) The Commission may use the United States mails in the same manner and under the same conditions as the departments and agencies of the United States.

(e) Staff

(1) Subject to paragraph (2), the chairman of the Commission, in accordance with rules agreed upon by the Commission, shall appoint and fix the compensation of a staff director and such other personnel as may be necessary to enable the Commission to carry out its duties, without regard to the provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III or 1 chapter 53 of such title relating to classification and General Schedule pay rates, except that no rate of pay fixed under this subsection may exceed the equivalent of that payable to a person occupying a position at level V of the Executive Schedule under section 5316 of such title.

(2)(A) Any employee of a department or agency referred to in subparagraph (B) may be detailed to the Commission without reimbursement from the Commission, and such detailee shall retain the rights, status, and privileges of his or her regular employment without interruption.

(B) The departments and agencies referred to in this subparagraph are as follows:

(i) The Department of Justice.

(ii) The Department of the Treasury.

(iii) The Central Intelligence Agency.

(3) All staff of the Commission shall possess a security clearance in accordance with applicable laws and regulations concerning the handling of classified information.

(f) Compensation and travel expenses

(1)(A) Except as provided in subparagraph (B), each member of the Commission may be compensated at not to exceed the daily equivalent of the annual rate of basic pay in effect for a position at level IV of the Executive Schedule under section 5315 of title 5 for each day during which that member is engaged in the actual performance of the duties of the Commission under this section.

(B) Members of the Commission who are officers or employees of the United States shall receive no additional pay by reason of their service on the Commission.

(2) While away from their homes or regular places of business in the performance of services for the Commission, members of the Commission may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in the Government service are allowed expenses under section 5703(b) 2 of title 5.

(g) Report

(1) Not later than 1 year after December 3, 1999, the Commissions 3 shall submit to the committees of Congress referred to in paragraph (4) a report on the activities of the Commission under this section, including the findings, conclusions, and recommendations, if any, of the Commission as a result of the review under subsection (c)(1) and the examination and evaluation under subsection (c)(2).

(2) The report under paragraph (1) shall include any additional or dissenting views of a member of the Commission upon the request of the member.

(3) The report under paragraph (1) shall be submitted in unclassified form, but may include a classified annex.

(4) The committees of Congress referred to in this paragraph are the following:

(A) The Select Committee on Intelligence and the Committees on Foreign Relations and the Judiciary of the Senate.

(B) The Permanent Select Committee on Intelligence and the Committees on International Relations and the Judiciary of the House of Representatives.

(h) Termination

The Commission shall terminate at the end of the 60-day period beginning on the date on which the report required by subsection (g) is submitted to the committees of Congress referred to in that subsection.

(i) Inapplicability of certain administrative provisions

(1) The provisions of chapter 10 of title 5 shall not apply to the activities of the Commission under this section.

(2) The provisions of section 552 of title 5 (commonly referred to as the Freedom of Information Act) shall not apply to the activities, records, and proceedings of the Commission under this chapter.

(j) Funding

The Attorney General shall, from amounts authorized to be appropriated to the Attorney General by this Act, make available to the Commission $1,000,000 for purposes of the activities of the Commission under this section. Amounts made available to the Commission under the preceding sentence shall remain available until expended.

(Pub. L. 106–120, title VIII, §810, Dec. 3, 1999, 113 Stat. 1633; Pub. L. 117–286, §4(a)(162), Dec. 27, 2022, 136 Stat. 4323.)

Editorial Notes

References in Text

This Act, referred to in subsec. (j), is Pub. L. 106–120, Dec. 3, 1999, 113 Stat. 1606, known as the Intelligence Authorization Act for Fiscal Year 2000. For complete classification of this Act to the Code, see Tables.

Amendments

2022—Subsec. (i)(1). Pub. L. 117–286 substituted "chapter 10 of title 5" for "the Federal Advisory Committee Act (5 U.S.C. App.)".

Statutory Notes and Related Subsidiaries

Change of Name

Committee on International Relations of House of Representatives changed to Committee on Foreign Affairs of House of Representatives by House Resolution No. 6, One Hundred Tenth Congress, Jan. 5, 2007.

1 So in original. Probably should be "of".

2 So in original. Section 5703 of title 5 does not contain a subsec. (b).

3 So in original. Probably should be "Commission".
21 U.S.C. § 387g (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387g: Tobacco product standards
Tobacco product standards
Status: in_force

(a) In general

(1) Special rules

(A) Special rule for cigarettes

Beginning 3 months after June 22, 2009, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. Nothing in this subparagraph shall be construed to limit the Secretary's authority to take action under this section or other sections of this chapter applicable to menthol or any artificial or natural flavor, herb, or spice not specified in this subparagraph.

(B) Additional special rule

Beginning 2 years after June 22, 2009, a tobacco product manufacturer shall not use tobacco, including foreign grown tobacco, that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.

(2) Revision of tobacco product standards

The Secretary may revise the tobacco product standards in paragraph (1) in accordance with subsection (c).

(3) Tobacco product standards

(A) In general

The Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health.

(B) Determinations

(i) Considerations

In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning—

(I) the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard;

(II) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

(III) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

(ii) Additional considerations

In the event that the Secretary makes a determination, set forth in a proposed tobacco product standard in a proposed rule, that it is appropriate for the protection of public health to require the reduction or elimination of an additive, constituent (including a smoke constituent), or other component of a tobacco product because the Secretary has found that the additive, constituent, or other component is or may be harmful, any party objecting to the proposed standard on the ground that the proposed standard will not reduce or eliminate the risk of illness or injury may provide for the Secretary's consideration scientific evidence that demonstrates that the proposed standard will not reduce or eliminate the risk of illness or injury.

(4) Content of tobacco product standards

A tobacco product standard established under this section for a tobacco product—

(A) shall include provisions that are appropriate for the protection of the public health, including provisions, where appropriate—

(i) for nicotine yields of the product;

(ii) for the reduction or elimination of other constituents, including smoke constituents, or harmful components of the product; or

(iii) relating to any other requirement under subparagraph (B);

(B) shall, where appropriate for the protection of the public health, include—

(i) provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the tobacco product;

(ii) provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the tobacco product;

(iii) provisions for the measurement of the tobacco product characteristics of the tobacco product;

(iv) provisions requiring that the results of each or of certain of the tests of the tobacco product required to be made under clause (ii) show that the tobacco product is in conformity with the portions of the standard for which the test or tests were required; and

(v) a provision requiring that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 387f(d) of this title;

(C) shall, where appropriate, require the use and prescribe the form and content of labeling for the proper use of the tobacco product; and

(D) shall require tobacco products containing foreign-grown tobacco to meet the same standards applicable to tobacco products containing domestically grown tobacco.

(5) Periodic reevaluation of tobacco product standards

The Secretary shall provide for periodic evaluation of tobacco product standards established under this section to determine whether such standards should be changed to reflect new medical, scientific, or other technological data. The Secretary may provide for testing under paragraph (4)(B) by any person.

(6) Involvement of other agencies; informed persons

In carrying out duties under this section, the Secretary shall endeavor to—

(A) use personnel, facilities, and other technical support available in other Federal agencies;

(B) consult with other Federal agencies concerned with standard setting and other nationally or internationally recognized standard-setting entities; and

(C) invite appropriate participation, through joint or other conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, agricultural, or consumer organizations who in the Secretary's judgment can make a significant contribution.

(b) Considerations by Secretary

(1) Technical achievability

The Secretary shall consider information submitted in connection with a proposed standard regarding the technical achievability of compliance with such standard, including with regard to any differences related to the technical achievability of compliance with such standard for products in the same class containing nicotine not made or derived from tobacco and products containing nicotine made or derived from tobacco.

(2) Other considerations

The Secretary shall consider all other information submitted in connection with a proposed standard, including information concerning the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or nontobacco users, such as the creation of a significant demand for contraband or other tobacco products that do not meet the requirements of this subchapter and the significance of such demand.

(c) Proposed standards

(1) In general

The Secretary shall publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any tobacco product standard.

(2) Requirements of notice

A notice of proposed rulemaking for the establishment or amendment of a tobacco product standard for a tobacco product shall—

(A) set forth a finding with supporting justification that the tobacco product standard is appropriate for the protection of the public health;

(B) invite interested persons to submit a draft or proposed tobacco product standard for consideration by the Secretary;

(C) invite interested persons to submit comments on structuring the standard so that it does not advantage foreign-grown tobacco over domestically grown tobacco; and

(D) invite the Secretary of Agriculture to provide any information or analysis which the Secretary of Agriculture believes is relevant to the proposed tobacco product standard.

(3) Finding

A notice of proposed rulemaking for the revocation of a tobacco product standard shall set forth a finding with supporting justification that the tobacco product standard is no longer appropriate for the protection of the public health.

(4) Comment

The Secretary shall provide for a comment period of not less than 60 days.

(d) Promulgation

(1) In general

After the expiration of the period for comment on a notice of proposed rulemaking published under subsection (c) respecting a tobacco product standard and after consideration of comments submitted under subsections (b) and (c) and any report from the Tobacco Products Scientific Advisory Committee, the Secretary shall—

(A) if the Secretary determines that the standard would be appropriate for the protection of the public health, promulgate a regulation establishing a tobacco product standard and publish in the Federal Register findings on the matters referred to in subsection (c); or

(B) publish a notice terminating the proceeding for the development of the standard together with the reasons for such termination.

(2) Effective date

A regulation establishing a tobacco product standard shall set forth the date or dates upon which the standard shall take effect, but no such regulation may take effect before 1 year after the date of its publication unless the Secretary determines that an earlier effective date is necessary for the protection of the public health. Such date or dates shall be established so as to minimize, consistent with the public health, economic loss to, and disruption or dislocation of, domestic and international trade. In establishing such effective date or dates, the Secretary shall consider information submitted in connection with a proposed product standard by interested parties, including manufacturers and tobacco growers, regarding the technical achievability of compliance with the standard, and including information concerning the existence of patents that make it impossible to comply in the timeframe envisioned in the proposed standard. If the Secretary determines, based on the Secretary's evaluation of submitted comments, that a product standard can be met only by manufacturers requiring substantial changes to the methods of farming the domestically grown tobacco used by the manufacturer, the effective date of that product standard shall be not less than 2 years after the date of publication of the final regulation establishing the standard.

(3) Limitation on power granted to the Food and Drug Administration

Because of the importance of a decision of the Secretary to issue a regulation—

(A) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or

(B) requiring the reduction of nicotine yields of a tobacco product to zero,

the Secretary is prohibited from taking such actions under this chapter.

(4) Amendment; revocation

(A) Authority

The Secretary, upon the Secretary's own initiative or upon petition of an interested person, may by a regulation, promulgated in accordance with the requirements of subsection (c) and paragraph (2), amend or revoke a tobacco product standard.

(B) Effective date

The Secretary may declare a proposed amendment of a tobacco product standard to be effective on and after its publication in the Federal Register and until the effective date of any final action taken on such amendment if the Secretary determines that making it so effective is in the public interest.

(5) Referral to Advisory Committee

(A) In general

The Secretary may refer a proposed regulation for the establishment, amendment, or revocation of a tobacco product standard to the Tobacco Products Scientific Advisory Committee for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment.

(B) Initiation of referral

The Secretary may make a referral under this paragraph—

(i) on the Secretary's own initiative; or

(ii) upon the request of an interested person that—

(I) demonstrates good cause for the referral; and

(II) is made before the expiration of the period for submission of comments on the proposed regulation.

(C) Provision of data

If a proposed regulation is referred under this paragraph to the Tobacco Products Scientific Advisory Committee, the Secretary shall provide the Advisory Committee with the data and information on which such proposed regulation is based.

(D) Report and recommendation

The Tobacco Products Scientific Advisory Committee shall, within 60 days after the referral of a proposed regulation under this paragraph and after independent study of the data and information furnished to it by the Secretary and other data and information before it, submit to the Secretary a report and recommendation respecting such regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation.

(E) Public availability

The Secretary shall make a copy of each report and recommendation under subparagraph (D) publicly available.

(e) Menthol cigarettes

(1) Referral; considerations

Immediately upon the establishment of the Tobacco Products Scientific Advisory Committee under section 387q(a) of this title, the Secretary shall refer to the Committee for report and recommendation, under section 387q(c)(4) of this title, the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsections (a)(3)(B)(i) and (b).

(2) Report and recommendation

Not later than 1 year after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and recommendations required pursuant to paragraph (1).

(3) Rule of construction

Nothing in this subsection shall be construed to limit the Secretary's authority to take action under this section or other sections of this chapter applicable to menthol.

(f) Dissolvable tobacco products

(1) Referral; considerations

The Secretary shall refer to the Tobacco Products Scientific Advisory Committee for report and recommendation, under section 387q(c)(4) of this title, the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsection (a)(3)(B)(i).

(2) Report and recommendation

Not later than 2 years after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and recommendations required pursuant to paragraph (1).

(3) Rule of construction

Nothing in this subsection shall be construed to limit the Secretary's authority to take action under this section or other sections of this chapter at any time applicable to any dissolvable tobacco product.

(June 25, 1938, ch. 675, §907, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1799; amended Pub. L. 117–103, div. P, title I, §111(f), Mar. 15, 2022, 136 Stat. 790.)

Editorial Notes

Prior Provisions

A prior section 907 of act June 25, 1938, was renumbered section 1007 and is classified to section 397 of this title.

Amendments

2022—Subsec. (b)(1). Pub. L. 117–103 inserted before period at end ", including with regard to any differences related to the technical achievability of compliance with such standard for products in the same class containing nicotine not made or derived from tobacco and products containing nicotine made or derived from tobacco".
21 U.S.C. § 1605 (2024) — Title 21: FOOD AND DRUGS / Chapter 21: BIOMATERIALS ACCESS ASSURANCE / Section 1605: Procedures for dismissal of civil actions against biomaterials suppliers
Procedures for dismissal of civil actions against biomaterials suppliers
Status: in_force

(a) Motion to dismiss

A defendant may, at any time during which a motion to dismiss may be filed under applicable law, move to dismiss an action against it on the grounds that the defendant is a biomaterials supplier and one or more of the following:

(1) The defendant is not liable as a manufacturer, as provided in section 1604(b) of this title.

(2) The defendant is not liable as a seller, as provided in section 1604(c) of this title.

(3) The defendant is not liable for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in section 1604(d) of this title.

(4) The claimant did not name the manufacturer as a party to the action, as provided in subsection (b).

(b) Manufacturer of implant shall be named a party

In any civil action covered by this chapter, the claimant shall be required to name the manufacturer of the implant as a party to the action, unless—

(1) the manufacturer is subject to service of process solely in a jurisdiction in which the biomaterials supplier is not domiciled or subject to a service of process; or

(2) a claim against the manufacturer is barred by applicable law or rule of practice.

(c) Proceeding on motion to dismiss

The following rules shall apply to any proceeding on a motion to dismiss filed by a defendant under this section:

(1) Effect of motion to dismiss on discovery

(A) In general

Except as provided in subparagraph (B), if a defendant files a motion to dismiss under subsection (a), no discovery shall be permitted in connection with the action that is the subject of the motion, other than discovery necessary to determine a motion to dismiss for lack of jurisdiction, until such time as the court rules on the motion to dismiss.

(B) Discovery

If a defendant files a motion to dismiss under subsection (a)(3) on the grounds that it did not furnish raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, the court may permit discovery limited to issues that are directly relevant to—

(i) the pending motion to dismiss; or

(ii) the jurisdiction of the court.

(2) Affidavits

(A) Defendant

A defendant may submit affidavits supporting the grounds for dismissal contained in its motion to dismiss under subsection (a). If the motion is made under subsection (a)(1), the defendant may submit an affidavit demonstrating that the defendant has not included the implant on a list, if any, filed with the Secretary pursuant to section 360(j) of this title.

(B) Claimant

In response to a motion to dismiss, the claimant may submit affidavits demonstrating that—

(i) the Secretary has, with respect to the defendant and the implant that allegedly caused harm to the claimant, issued a declaration pursuant to section 1604(b)(2)(B) of this title; or

(ii) the defendant is a seller of the implant who is liable under section 1604(c) of this title.

(3) Basis of ruling on motion to dismiss

The court shall rule on a motion to dismiss filed under subsection (a) solely on the basis of the pleadings and affidavits of the parties made pursuant to this subsection. The court shall grant a motion to dismiss filed under subsection (a)—

(A) unless the claimant submits a valid affidavit that demonstrates that the defendant is not a biomaterials supplier;

(B) unless the court determines, to the extent raised in the pleadings and affidavits, that one or more of the following apply:

(i) the defendant may be liable as a manufacturer, as provided in section 1604(b) of this title;

(ii) the defendant may be liable as a seller, as provided in section 1604(c) of this title; or

(iii) the defendant may be liable for furnishing raw materials or component parts for the implant that failed to meet applicable contractual requirements or specifications, as provided in section 1604(d) of this title; or

(C) if the claimant did not name the manufacturer as a party to the action, as provided in subsection (b).

(4) Treatment of motion as motion for summary judgment

The court may treat a motion to dismiss as a motion for summary judgment subject to subsection (d) in order to determine whether the pleadings and affidavits, in connection with such action, raise genuine issues of material fact concerning whether the defendant furnished raw materials or component parts of the implant that failed to meet applicable contractual requirements or specifications as provided in section 1604(d) of this title.

(d) Summary judgment

(1) In general

(A) Basis for entry of judgment

If a motion to dismiss of a biomaterials supplier is to be treated as a motion for summary judgment under subsection (c)(4) or if a biomaterials supplier moves for summary judgment, the biomaterials supplier shall be entitled to entry of judgment without trial if the court finds there is no genuine issue of material fact for each applicable element set forth in paragraphs (1) and (2) of section 1604(d) of this title.

(B) Issues of material fact

With respect to a finding made under subparagraph (A), the court shall consider a genuine issue of material fact to exist only if the evidence submitted by the claimant would be sufficient to allow a reasonable jury to reach a verdict for the claimant if the jury found the evidence to be credible.

(2) Discovery made prior to a ruling on a motion for summary judgment

If, under applicable rules, the court permits discovery prior to a ruling on a motion for summary judgment governed by section 1604(d) of this title, such discovery shall be limited solely to establishing whether a genuine issue of material fact exists as to the applicable elements set forth in paragraphs (1) and (2) of section 1604(d) of this title.

(3) Discovery with respect to a biomaterials supplier

A biomaterials supplier shall be subject to discovery in connection with a motion seeking dismissal or summary judgment on the basis of the inapplicability of section 1604(d) of this title or the failure to establish the applicable elements of section 1604(d) of this title solely to the extent permitted by the applicable Federal or State rules for discovery against nonparties.

(e) Dismissal with prejudice

An order granting a motion to dismiss or for summary judgment pursuant to this section shall be entered with prejudice, except insofar as the moving defendant may be rejoined to the action as provided in section 1606 of this title.

(f) Manufacturer conduct of litigation

The manufacturer of an implant that is the subject of an action covered under this chapter shall be permitted to conduct litigation on any motion for summary judgment or dismissal filed by a biomaterials supplier who is a defendant under this section on behalf of such supplier if the manufacturer and any other defendant in such action enter into a valid and applicable contractual agreement under which the manufacturer agrees to bear the cost of such litigation or to conduct such litigation.

(Pub. L. 105–230, §6, Aug. 13, 1998, 112 Stat. 1526.)

Statutory Notes and Related Subsidiaries

Effective Date

Section applicable to all civil actions covered under this chapter commenced on or after Aug. 13, 1998, including any in which the harm or harmful conduct occurred before such date, see section 8 of Pub. L. 105–230, set out as a note under section 1601 of this title.
21 U.S.C. § 350i (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 350i: Protection against intentional adulteration
Protection against intentional adulteration
Status: in_force

(a) Determinations

(1) In general

The Secretary shall—

(A) conduct a vulnerability assessment of the food system, including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments;

(B) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; and

(C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.

(2) Limited distribution

In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which determinations made under paragraph (1) are made publicly available.

(b) Regulations

Not later than 18 months after January 4, 2011, the Secretary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this chapter. Such regulations shall—

(1) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and

(2) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate.

(c) Applicability

Regulations promulgated under subsection (b) shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under subsection (a), that could cause serious adverse health consequences or death to humans or animals and shall include those foods—

(1) for which the Secretary has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points); and

(2) in bulk or batch form, prior to being packaged for the final consumer.

(d) Exception

This section shall not apply to farms, except for those that produce milk.

(e) Definition

For purposes of this section, the term "farm" has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).

(June 25, 1938, ch. 675, §420, as added Pub. L. 111–353, title I, §106(a), Jan. 4, 2011, 124 Stat. 3905.)

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, 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 2206, 2251, and 2252 of this title.

Guidance Documents

Pub. L. 111–353, title I, §106(b), Jan. 4, 2011, 124 Stat. 3906, provided that:

"(1) In general.—Not later than 1 year after the date of enactment of this Act [Jan. 4, 2011], the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i], as added by subsection (a).

"(2) Content.—The guidance documents issued under paragraph (1) shall—

"(A) include a model assessment for a person to use under subsection (b)(1) of section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);

"(B) include examples of mitigation strategies or measures described in subsection (b)(2) of such section; and

"(C) specify situations in which the examples of mitigation strategies or measures described in subsection (b)(2) of such section are appropriate.

"(3) Limited distribution.—In the interest of national security, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which the guidance documents issued under paragraph (1) are made public, including by releasing such documents to targeted audiences."

Periodic Review

Pub. L. 111–353, title I, §106(c), Jan. 4, 2011, 124 Stat. 3906, provided that: "The Secretary of Health and Human Services shall periodically review and, as appropriate, update the regulations under section 420(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i(b)], as added by subsection (a), and the guidance documents under subsection (b) [section 106(b) of Pub. L. 111–353, set out above]."
21 U.S.C. § 1111 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter II: DRUG ABUSE POLICY COORDINATION / Section 1111: Repealed. Pub. L. 100-690, title I, §1007(c)(1), Nov. 18, 1988, 102 Stat. 4187
Repealed. Pub. L. 100-690, title I, §1007(c)(1), Nov. 18, 1988, 102 Stat. 4187
Status: repealed

Section 1111, Pub. L. 92–255, title II, §201, 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.

A prior section 1111, Pub. L. 92–255, title II, §201, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242, which provided for the establishment of the Office of Drug Abuse Policy, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309. Previously, the Office of Drug Abuse Policy was abolished and the functions of the Office and its Director were transferred to the President by sections 3 and 5 of Reorg. Plan No. 1 of 1977, effective Mar. 27, 1978, as provided by Ex. Ord. No. 12045, Mar. 27, 1978, 43 F.R. 13347, set out as notes preceding section 101 of Title 3, The President.

Another prior section 1111, Pub. L. 92–255, title II, §201, Mar. 21, 1972, 86 Stat. 67, which provided for the establishment of the Special Action Office for Drug Abuse Prevention, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Section 1112, Pub. L. 92–255, title II, §202, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1310, related to designation of a representative to direct activities required by this subchapter.

A prior section 1112, Pub. L. 92–255, title II, §202, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242; amended Pub. L. 95–83, title III, §311(d), Aug. 1, 1977, 91 Stat. 398, which provided for the appointment of the Director of the Office of Drug Abuse Policy, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1112, Pub. L. 92–255, title II, §202, Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of a Director of the Special Action Office for Drug Abuse Prevention, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Section 1113, Pub. L. 92–255, title II, §203, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1310, related to employment of officers and employees.

A prior section 1113, Pub. L. 92–255, title II, §203, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242, which provided for the appointment and functions of Deputy Director of the Office of Drug Abuse Policy, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1113, Pub. L. 92–255, title II, §203, Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of a Deputy Director of the Special Office for Drug Abuse Prevention, was repealed by Pub. L. 92–255, title I, §104, Mar. 21, 1972, 86 Stat. 67, eff. June 30, 1975.

Section 1114, Pub. L. 92–255, title II, §204, as added Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1310, related to acceptance of uncompensated services.

A prior section 1114, Pub. L. 92–255, title II, §204, as added Pub. L. 94–237, §4(b), Mar. 19, 1976, 90 Stat. 242, which provided for the delegation of functions by the Director of the Office of Drug Abuse Policy, was omitted in the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Another prior section 1114, Pub. L. 92–255, title II, §204, Mar. 21, 1972, 86 Stat. 68, which provided for the appointment of six Assistant Directors, was repealed 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 1117 of this title prior to the general revision of this subchapter by Pub. L. 96–181, §4, Jan. 2, 1980, 93 Stat. 1309.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Jan. 21, 1989, see section 1012 of Pub. L. 100–690.

Executive Documents

Executive Order No. 12368

Ex. Ord. No. 12368, June 24, 1982, 47 F.R. 27843, as amended by Ex. Ord. No. 12590, Mar. 26, 1987, 52 F.R. 10021, related to assignment of drug abuse policy functions.
21 U.S.C. § 378 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 378: Advertising of foods
Advertising of foods
Status: in_force

(a) Determination of misbranding; notification of Federal Trade Commission by Secretary; contents

(1) Except as provided in subsection (c), before the Secretary may initiate any action under subchapter III—

(A) with respect to any food which the Secretary determines is misbranded under section 343(a)(2) of this title because of its advertising, or

(B) with respect to a food's advertising which the Secretary determines causes the food to be so misbranded,

the Secretary shall, in accordance with paragraph (2), notify in writing the Federal Trade Commission of the action the Secretary proposes to take respecting such food or advertising.

(2) The notice required by paragraph (1) shall—

(A) contain (i) a description of the action the Secretary proposes to take and of the advertising which the Secretary has determined causes a food to be misbranded, (ii) a statement of the reasons for the Secretary's determination that such advertising has caused such food to be misbranded, and

(B) be accompanied by the records, documents, and other written materials which the Secretary determines supports his determination that such food is misbranded because of such advertising.

(b) Action by Federal Trade Commission precluding action by Secretary; exception

(1) If the Secretary notifies the Federal Trade Commission under subsection (a) of action proposed to be taken under subchapter III with respect to a food or food advertising and the Commission notifies the Secretary in writing, within the 30-day period beginning on the date of the receipt of such notice, that—

(A) it has initiated under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] an investigation of such advertising to determine if it is prohibited by such Act or any order or rule under such Act,

(B) it has commenced (or intends to commence) a civil action under section 5, 13, or 19 [15 U.S.C. 45, 53, or 57b] with respect to such advertising or the Attorney General has commenced (or intends to commence) a civil action under section 5 [15 U.S.C. 45] with respect to such advertising,

(C) it has issued and served (or intends to issue and serve) a complaint under section 5(b) of such Act [15 U.S.C. 45(b)] respecting such advertising, or

(D) pursuant to section 16(b) of such Act [15 U.S.C. 56(b)] it has made a certification to the Attorney General respecting such advertising,

the Secretary may not, except as provided by paragraph (2), initiate the action described in the Secretary's notice to the Federal Trade Commission.

(2) If, before the expiration of the 60-day period beginning on the date the Secretary receives a notice described in paragraph (1) from the Federal Trade Commission in response to a notice of the Secretary under subsection (a)—

(A) the Commission or the Attorney General does not commence a civil action described in subparagraph (B) of paragraph (1) of this subsection respecting the advertising described in the Secretary's notice,

(B) the Commission does not issue and serve a complaint described in subparagraph (C) of such paragraph respecting such advertising, or

(C) the Commission does not (as described in subparagraph (D) of such paragraph) make a certification to the Attorney General respecting such advertising, or, if the Commission does make such a certification to the Attorney General respecting such advertising, the Attorney General, before the expiration of such period, does not cause appropriate criminal proceedings to be brought against such advertising,

the Secretary may, after the expiration of such period, initiate the action described in the notice to the Commission pursuant to subsection (a). The Commission shall promptly notify the Secretary of the commencement by the Commission of such a civil action, the issuance and service by it of such a complaint, or the causing by the Attorney General of criminal proceedings to be brought against such advertising.

(c) Secretary's determination of imminent hazard to health as suspending applicability of provisions

The requirements of subsections (a) and (b) do not apply with respect to action under subchapter III with respect to any food or food advertising if the Secretary determines that such action is required to eliminate an imminent hazard to health.

(d) Coordination of action by Secretary with Federal Trade Commission

For the purpose of avoiding unnecessary duplication, the Secretary shall coordinate any action taken under subchapter III because of advertising which the Secretary determines causes a food to be misbranded with any action of the Federal Trade Commission under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] with respect to such advertising.

(June 25, 1938, ch. 675, §707, as added Pub. L. 94–278, title V, §502(b), Apr. 22, 1976, 90 Stat. 412.)

Editorial Notes

References in Text

The Federal Trade Commission Act, referred to in subsecs. (b) and (d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, which is classified generally to subchapter I (§41 et seq.) of chapter 2 of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see section 58 of Title 15 and Tables.
21 U.S.C. § 387f (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387f: General provisions respecting control of tobacco products
General provisions respecting control of tobacco products
Status: in_force

(a) In general

Any requirement established by or under section 387b, 387c, 387e, or 387i of this title applicable to a tobacco product shall apply to such tobacco product until the applicability of the requirement to the tobacco product has been changed by action taken under section 387g of this title, section 387j of this title, section 387k of this title, or subsection (d) of this section, and any requirement established by or under section 387b, 387c, 387e, or 387i of this title which is inconsistent with a requirement imposed on such tobacco product under section 387g of this title, section 387j of this title, section 387k of this title, or subsection (d) of this section shall not apply to such tobacco product.

(b) Information on public access and comment

Each notice of proposed rulemaking or other notification under section 387g, 387h, 387i, 387j, or 387k of this title or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth—

(1) the manner in which interested persons may examine data and other information on which the notice or findings is 1 based; and

(2) the period within which interested persons may present their comments on the notice or findings (including the need therefore) orally or in writing, which period shall be at least 60 days but may not exceed 90 days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefore.

(c) Limited confidentiality of information

Any information reported to or otherwise obtained by the Secretary or the Secretary's representative under section 387c, 387d, 387g, 387h, 387i, 387j, 387k, or 374 of this title, or under subsection (e) or (f) of this section, which is exempt from disclosure under subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of that section shall be considered confidential and shall not be disclosed, except that the information may be disclosed to other officers or employees concerned with carrying out this subchapter, or when relevant in any proceeding under this subchapter.

(d) Restrictions

(1) In general

The Secretary may by regulation require restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, if the Secretary determines that such regulation would be appropriate for the protection of the public health. The Secretary may by regulation impose restrictions on the advertising and promotion of a tobacco product consistent with and to full extent permitted by the first amendment to the Constitution. The finding as to whether such regulation would be appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—

(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

No such regulation may require that the sale or distribution of a tobacco product be limited to the written or oral authorization of a practitioner licensed by law to prescribe medical products.

(2) Label statements

The label of a tobacco product shall bear such appropriate statements of the restrictions required by a regulation under subsection (a) as the Secretary may in such regulation prescribe.

(3) Limitations

(A) In general

No restrictions under paragraph (1) may—

(i) prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets; or

(ii) establish a minimum age of sale of tobacco products to any person older than 21 years of age.

(B) Matchbooks

For purposes of any regulations issued by the Secretary, matchbooks of conventional size containing not more than 20 paper matches, and which are customarily given away for free with the purchase of tobacco products, shall be considered as adult-written publications which shall be permitted to contain advertising. Notwithstanding the preceding sentence, if the Secretary finds that such treatment of matchbooks is not appropriate for the protection of the public health, the Secretary may determine by regulation that matchbooks shall not be considered adult-written publications.

(4) Remote sales

(A) In general

The Secretary shall—

(i) within 18 months after June 22, 2009, promulgate regulations regarding the sale and distribution of tobacco products that occur through means other than a direct, face-to-face exchange between a retailer and a consumer in order to prevent the sale and distribution of tobacco products to individuals who have not attained the minimum age established by applicable law for the purchase of such products, including requirements for age verification; and

(ii) within 2 years after June 22, 2009, issue regulations to address the promotion and marketing of tobacco products that are sold or distributed through means other than a direct, face-to-face exchange between a retailer and a consumer in order to protect individuals who have not attained the minimum age established by applicable law for the purchase of such products.

(B) Relation to other authority

Nothing in this paragraph limits the authority of the Secretary to take additional actions under the other paragraphs of this subsection.

(5) Minimum age of sale

It shall be unlawful for any retailer to sell a tobacco product to any person younger than 21 years of age.

(e) Good manufacturing practice requirements

(1) Methods, facilities, and controls to conform

(A) In general

In applying manufacturing restrictions to tobacco, the Secretary shall, in accordance with subparagraph (B), prescribe regulations (which may differ based on the type of tobacco product involved) requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to current good manufacturing practice, or hazard analysis and critical control point methodology, as prescribed in such regulations to assure that the public health is protected and that the tobacco product is in compliance with this subchapter. Such regulations may provide for the testing of raw tobacco for pesticide chemical residues regardless of whether a tolerance for such chemical residues has been established.

(B) Requirements

The Secretary shall—

(i) before promulgating any regulation under subparagraph (A), afford the Tobacco Products Scientific Advisory Committee an opportunity to submit recommendations with respect to the regulation proposed to be promulgated;

(ii) before promulgating any regulation under subparagraph (A), afford opportunity for an oral hearing;

(iii) provide the Tobacco Products Scientific Advisory Committee a reasonable time to make its recommendation with respect to proposed regulations under subparagraph (A);

(iv) in establishing the effective date of a regulation promulgated under this subsection, take into account the differences in the manner in which the different types of tobacco products have historically been produced, the financial resources of the different tobacco product manufacturers, and the state of their existing manufacturing facilities, and shall provide for a reasonable period of time for such manufacturers to conform to good manufacturing practices; and

(v) not require any small tobacco product manufacturer to comply with a regulation under subparagraph (A) for at least 4 years following the effective date established by the Secretary for such regulation.

(2) Exemptions; variances

(A) Petition

Any person subject to any requirement prescribed under paragraph (1) may petition the Secretary for a permanent or temporary exemption or variance from such requirement. Such a petition shall be submitted to the Secretary in such form and manner as the Secretary shall prescribe and shall—

(i) in the case of a petition for an exemption from a requirement, set forth the basis for the petitioner's determination that compliance with the requirement is not required to assure that the tobacco product will be in compliance with this subchapter;

(ii) in the case of a petition for a variance from a requirement, set forth the methods proposed to be used in, and the facilities and controls proposed to be used for, the manufacture, packing, and storage of the tobacco product in lieu of the methods, facilities, and controls prescribed by the requirement; and

(iii) contain such other information as the Secretary shall prescribe.

(B) Referral to the Tobacco Products Scientific Advisory Committee

The Secretary may refer to the Tobacco Products Scientific Advisory Committee any petition submitted under subparagraph (A). The Tobacco Products Scientific Advisory Committee shall report its recommendations to the Secretary with respect to a petition referred to it within 60 days after the date of the petition's referral. Within 60 days after—

(i) the date the petition was submitted to the Secretary under subparagraph (A); or

(ii) the day after the petition was referred to the Tobacco Products Scientific Advisory Committee,

whichever occurs later, the Secretary shall by order either deny the petition or approve it.

(C) Approval

The Secretary may approve—

(i) a petition for an exemption for a tobacco product from a requirement if the Secretary determines that compliance with such requirement is not required to assure that the tobacco product will be in compliance with this subchapter; and

(ii) a petition for a variance for a tobacco product from a requirement if the Secretary determines that the methods to be used in, and the facilities and controls to be used for, the manufacture, packing, and storage of the tobacco product in lieu of the methods, facilities, and controls prescribed by the requirement are sufficient to assure that the tobacco product will be in compliance with this subchapter.

(D) Conditions

An order of the Secretary approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, and storage of the tobacco product to be granted the variance under the petition as may be necessary to assure that the tobacco product will be in compliance with this subchapter.

(E) Hearing

After the issuance of an order under subparagraph (B) respecting a petition, the petitioner shall have an opportunity for an informal hearing on such order.

(3) Compliance

Compliance with requirements under this subsection shall not be required before the end of the 3-year period following June 22, 2009.

(f) Research and development

The Secretary may enter into contracts for research, testing, and demonstrations respecting tobacco products and may obtain tobacco products for research, testing, and demonstration purposes.

(June 25, 1938, ch. 675, §906, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1795; amended Pub. L. 116–94, div. N, title I, §603(a), Dec. 20, 2019, 133 Stat. 3123.)

Editorial Notes

Prior Provisions

A prior section 906 of act June 25, 1938, was renumbered section 1006 and is classified to section 396 of this title.

Amendments

2019—Subsec. (d)(3)(A)(ii). Pub. L. 116–94, §603(a)(1), substituted "21 years" for "18 years".

Subsec. (d)(5). Pub. L. 116–94, §603(a)(2), added par. (5).

Statutory Notes and Related Subsidiaries

Regulations

Pub. L. 116–94, div. N, title I, §603(b), Dec. 20, 2019, 133 Stat. 3123, provided that:

"(1) In general.—Not later than 180 days after the date of enactment of this Act [Dec. 20, 2019], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall publish in the Federal Register a final rule to update the regulations issued under chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 et seq.) as appropriate, only to carry out the amendments made by subsection (a) [amending this section], including to update all references to persons younger than 18 years of age in subpart B of part 1140 of title 21, Code of Federal Regulations, and to update the relevant age verification requirements under such part 1140 to require age verification for individuals under the age of 30. Such final rule shall—

"(A) take full effect not later than 90 days after the date on which such final rule is published; and

"(B) be deemed to be in compliance with all applicable provisions of chapter 5 of title 5, United States Code[,] and all other provisions of law relating to rulemaking procedures.

"(2) Other regulations.—Prior to making amendments to part 1140 of title 21, Code of Federal Regulations[,] other than the amendments described in paragraph (1), the Secretary shall promulgate a proposed rule in accordance with chapter 5 of title 5, United States Code."

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

1 So in original. Probably should be "are".
21 U.S.C. § 93 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter I: EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Section 93: Repealed. May 29, 1928, ch. 901, §1(92), 45 Stat. 993
Repealed. May 29, 1928, ch. 901, §1(92), 45 Stat. 993
Status: repealed

Section, act Mar. 4, 1907, ch. 2907, 34 Stat. 1265, related to statement in annual estimates as to persons employed, their compensation and expenses.
21 U.S.C. § 862 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 862: Denial of Federal benefits to drug traffickers and possessors
Denial of Federal benefits to drug traffickers and possessors
Status: in_force

(a) Drug traffickers

(1) Any individual who is convicted of any Federal or State offense consisting of the distribution of controlled substances shall—

(A) at the discretion of the court, upon the first conviction for such an offense be ineligible for any or all Federal benefits for up to 5 years after such conviction;

(B) at the discretion of the court, upon a second conviction for such an offense be ineligible for any or all Federal benefits for up to 10 years after such conviction; and

(C) upon a third or subsequent conviction for such an offense be permanently ineligible for all Federal benefits.

(2) The benefits which are denied under this subsection shall not include benefits relating to long-term drug treatment programs for addiction for any person who, if there is a reasonable body of evidence to substantiate such declaration, declares himself to be an addict and submits himself to a long-term treatment program for addiction, or is deemed to be rehabilitated pursuant to rules established by the Secretary of Health and Human Services.

(b) Drug possessors

(1) Any individual who is convicted of any Federal or State offense involving the possession of a controlled substance (as such term is defined for purposes of this subchapter) shall—

(A) upon the first conviction for such an offense and at the discretion of the court—

(i) be ineligible for any or all Federal benefits for up to one year;

(ii) be required to successfully complete an approved drug treatment program which includes periodic testing to insure that the individual remains drug free;

(iii) be required to perform appropriate community service; or

(iv) any combination of clause (i), (ii), or (iii); and

(B) upon a second or subsequent conviction for such an offense be ineligible for all Federal benefits for up to 5 years after such conviction as determined by the court. The court shall continue to have the discretion in subparagraph (A) above. In imposing penalties and conditions under subparagraph (A), the court may require that the completion of the conditions imposed by clause (ii) or (iii) be a requirement for the reinstatement of benefits under clause (i).

(2) The penalties and conditions which may be imposed under this subsection shall be waived in the case of a person who, if there is a reasonable body of evidence to substantiate such declaration, declares himself to be an addict and submits himself to a long-term treatment program for addiction, or is deemed to be rehabilitated pursuant to rules established by the Secretary of Health and Human Services.

(c) Suspension of period of ineligibility

The period of ineligibility referred to in subsections (a) and (b) shall be suspended if the individual—

(A) completes a supervised drug rehabilitation program after becoming ineligible under this section;

(B) has otherwise been rehabilitated; or

(C) has made a good faith effort to gain admission to a supervised drug rehabilitation program, but is unable to do so because of inaccessibility or unavailability of such a program, or the inability of the individual to pay for such a program.

(d) Definitions

As used in this section—

(1) the term "Federal benefit"—

(A) means the issuance of any grant, contract, loan, professional license, or commercial license provided by an agency of the United States or by appropriated funds of the United States; and

(B) does not include any retirement, welfare, Social Security, health, disability, veterans benefit, public housing, or other similar benefit, or any other benefit for which payments or services are required for eligibility; and

(2) the term "veterans benefit" means all benefits provided to veterans, their families, or survivors by virtue of the service of a veteran in the Armed Forces of the United States.

(e) Inapplicability of this section to Government witnesses

The penalties provided by this section shall not apply to any individual who cooperates or testifies with the Government in the prosecution of a Federal or State offense or who is in a Government witness protection program.

(f) Indian provision

Nothing in this section shall be construed to affect the obligation of the United States to any Indian or Indian tribe arising out of any treaty, statute, Executive order, or the trust responsibility of the United States owing to such Indian or Indian tribe. Nothing in this subsection shall exempt any individual Indian from the sanctions provided for in this section, provided that no individual Indian shall be denied any benefit under Federal Indian programs comparable to those described in subsection (d)(1)(B) or (d)(2).

(g) Presidential report

(1) On or before May 1, 1989, the President shall transmit to the Congress a report—

(A) delineating the role of State courts in implementing this section;

(B) describing the manner in which Federal agencies will implement and enforce the requirements of this section;

(C) detailing the means by which Federal and State agencies, courts, and law enforcement agencies will exchange and share the data and information necessary to implement and enforce the withholding of Federal benefits; and

(D) recommending any modifications to improve the administration of this section or otherwise achieve the goal of discouraging the trafficking and possession of controlled substances.

(2) No later than September 1, 1989, the Congress shall consider the report of the President and enact such changes as it deems appropriate to further the goals of this section.

(h) Effective date

The denial of Federal benefits set forth in this section shall take effect for convictions occurring after September 1, 1989.

(Pub. L. 91–513, title II, §421, formerly Pub. L. 100–690, title V, §5301, Nov. 18, 1988, 102 Stat. 4310; renumbered §421 of Pub. L. 91–513 and amended Pub. L. 101–647, title X, §1002(d), Nov. 29, 1990, 104 Stat. 4827.)

Editorial Notes

Codification

Section was classified to section 853a of this title prior to renumbering by Pub. L. 101–647.

Amendments

1990—Pub. L. 101–647, §1002(d)(1), renumbered section 853a of this title as this section.

Subsec. (a)(1). Pub. L. 101–647, §1002(d)(2), struck out "(as such terms are defined for purposes of the Controlled Substances Act)" after "controlled substances" in introductory provisions.
21 U.S.C. § 848 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 848: Continuing criminal enterprise
Continuing criminal enterprise
Status: in_force

(a) Penalties; forfeitures

Any person who engages in a continuing criminal enterprise shall be sentenced to a term of imprisonment which may not be less than 20 years and which may be up to life imprisonment, to a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $2,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, and to the forfeiture prescribed in section 853 of this title; except that if any person engages in such activity after one or more prior convictions of him under this section have become final, he shall be sentenced to a term of imprisonment which may not be less than 30 years and which may be up to life imprisonment, to a fine not to exceed the greater of twice the amount authorized in accordance with the provisions of title 18 or $4,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, and to the forfeiture prescribed in section 853 of this title.

(b) Life imprisonment for engaging in continuing criminal enterprise

Any person who engages in a continuing criminal enterprise shall be imprisoned for life and fined in accordance with subsection (a), if—

(1) such person is the principal administrator, organizer, or leader of the enterprise or is one of several such principal administrators, organizers, or leaders; and

(2)(A) the violation referred to in subsection (c)(1) involved at least 300 times the quantity of a substance described in subsection 841(b)(1)(B) of this title, or

(B) the enterprise, or any other enterprise in which the defendant was the principal or one of several principal administrators, organizers, or leaders, received $10 million dollars in gross receipts during any twelve-month period of its existence for the manufacture, importation, or distribution of a substance described in section 841(b)(1)(B) of this title.

(c) "Continuing criminal enterprise" defined

For purposes of subsection (a), a person is engaged in a continuing criminal enterprise if—

(1) he violates any provision of this subchapter or subchapter II the punishment for which is a felony, and

(2) such violation is a part of a continuing series of violations of this subchapter or subchapter II—

(A) which are undertaken by such person in concert with five or more other persons with respect to whom such person occupies a position of organizer, a supervisory position, or any other position of management, and

(B) from which such person obtains substantial income or resources.

(d) Suspension of sentence and probation prohibited

In the case of any sentence imposed under this section, imposition or execution of such sentence shall not be suspended, probation shall not be granted, and the Act of July 15, 1932 (D.C. Code, secs. 24–203—24–207), shall not apply.

(e) Death penalty

(1) In addition to the other penalties set forth in this section—

(A) any person engaging in or working in furtherance of a continuing criminal enterprise, or any person engaging in an offense punishable under section 841(b)(1)(A) 1 of this title or section 960(b)(1) 1 of this title who intentionally kills or counsels, commands, induces, procures, or causes the intentional killing of an individual and such killing results, shall be sentenced to any term of imprisonment, which shall not be less than 20 years, and which may be up to life imprisonment, or may be sentenced to death; and

(B) any person, during the commission of, in furtherance of, or while attempting to avoid apprehension, prosecution or service of a prison sentence for, a felony violation of this subchapter or subchapter II who intentionally kills or counsels, commands, induces, procures, or causes the intentional killing of any Federal, State, or local law enforcement officer engaged in, or on account of, the performance of such officer's official duties and such killing results, shall be sentenced to any term of imprisonment, which shall not be less than 20 years, and which may be up to life imprisonment, or may be sentenced to death.

(2) As used in paragraph (1)(B), the term "law enforcement officer" means a public servant authorized by law or by a Government agency or Congress to conduct or engage in the prevention, investigation, prosecution or adjudication of an offense, and includes those engaged in corrections, probation, or parole functions.

(g) 2 to (p) Repealed. Pub. L. 109–177, title II, §221(2), Mar. 9, 2006, 120 Stat. 231

(q) Repealed. Pub. L. 109–177, title II, §§221(4), 222(c), Mar. 9, 2006, 120 Stat. 231, 232

(r) Repealed. Pub. L. 109–177, title II, §221(3), Mar. 9, 2006, 120 Stat. 231

(s) Special provision for methamphetamine

For the purposes of subsection (b), in the case of continuing criminal enterprise involving methamphetamine or its salts, isomers, or salts of isomers, paragraph (2)(A) shall be applied by substituting "200" for "300", and paragraph (2)(B) shall be applied by substituting "$5,000,000" for "$10 million dollars".

(Pub. L. 91–513, title II, §408, Oct. 27, 1970, 84 Stat. 1265; Pub. L. 98–473, title II, §§224(b), formerly §224(c), 305, Oct. 12, 1984, 98 Stat. 2030, 2050; Pub. L. 99–570, title I, §§1005(b)(2), 1252, 1253, Oct. 27, 1986, 100 Stat. 3207–6, 3207–14; Pub. L. 100–690, title VI, §6481, title VII, §7001, Nov. 18, 1988, 102 Stat. 4382, 4387; Pub. L. 103–322, title XXXIII, §§330003(e), 330009(d), 330014, Sept. 13, 1994, 108 Stat. 2141, 2143, 2146; Pub. L. 104–132, title I, §108, title IX, §903(b), Apr. 24, 1996, 110 Stat. 1226, 1318; Pub. L. 109–177, title II, §§221, 222(c), title VII, §733, Mar. 9, 2006, 120 Stat. 231, 232, 270.)

Editorial Notes

References in Text

Section 841(b)(1)(A), referred to in subsec. (e)(1)(A), was in the original a reference to "section 841(b)(1)(A)" but probably should be a reference to "section 401(b)(1)(A)", meaning section 401(b)(1)(A) of Pub. L. 91–513, title II, Oct. 27, 1970, 84 Stat. 1260.

Section 960(b)(1), referred to in subsec. (e)(1)(A), was in the original a reference to "section 960(b)(1)" but probably should be a reference to "section 1010(b)(1)", meaning section 1010(b)(1) of Pub. L. 91–513, title III, Oct. 27, 1970, 84 Stat. 1290.

Act of July 15, 1932 (D.C. Code, secs. 24–203—24–207), referred to in subsec. (d), is act July 15, 1932, ch. 492, 47 Stat. 696, which is not classified to the Code.

Amendments

2006—Subsec. (e)(2). Pub. L. 109–177, §221(1), substituted "(1)(B)" for "(1)(b)".

Subsecs. (g) to (p). Pub. L. 109–177, §221(2), struck out subsecs. (g) to (p) which related to hearing and sentencing procedures in death penalty cases and sentencing in capital cases in which the death penalty is not sought or imposed.

Subsec. (q). Pub. L. 109–177, §§221(4), 222(c), struck out subsec. (q) which related to appeal in capital cases and counsel for financially unable defendants.

Subsec. (r). Pub. L. 109–177, §221(3), struck out subsec. (r) which provided for refusal by State and Federal correctional employees to participate in executions.

Subsec. (s). Pub. L. 109–177, §733, added subsec. (s).

1996—Subsec. (q)(9). Pub. L. 104–132, §108, amended par. (9) generally. Prior to amendment, par. (9) read as follows: "Upon a finding in ex parte proceedings that investigative, expert or other services are reasonably necessary for the representation of the defendant, whether in connection with issues relating to guilt or sentence, the court shall authorize the defendant's attorneys to obtain such services on behalf of the defendant and shall order the payment of fees and expenses therefore, under paragraph (10). Upon a finding that timely procurement of such services could not practicably await prior authorization, the court may authorize the provision of and payment for such services nunc pro tunc."

Subsec. (q)(10). Pub. L. 104–132, §903(b), amended par. (10) generally. Prior to amendment, par. (10) read as follows: "Notwithstanding the rates and maximum limits generally applicable to criminal cases and any other provision of law to the contrary, the court shall fix the compensation to be paid to attorneys appointed under this subsection and the fees and expenses to be paid for investigative, expert, and other reasonably necessary services authorized under paragraph (9), at such rates or amounts as the court determines to be reasonably necessary to carry out the requirements of paragraphs (4) through (9)."

1994—Subsec. (b)(2)(A). Pub. L. 103–322, §330003(e), substituted "subsection (c)(1)" for "subsection (d)(1)".

Subsec. (n)(11). Pub. L. 103–322, §330014, made technical amendment to reference to section 859 of this title to correct reference to corresponding section of original act.

Subsec. (q)(8). Pub. L. 103–322, §330009(d), substituted "applications for writ" for "applications, for writ".

1988—Subsec. (a). Pub. L. 100–690, §6481(a), increased minimum term of imprisonment for first violations to 20 from 10 years and for subsequent violations to 30 from 20 years.

Subsecs. (c), (d). Pub. L. 100–690, §6481(b), redesignated subsecs. (d) and (e) as (c) and (d), respectively.

Subsec. (e). Pub. L. 100–690, §7001(a)(2), added subsec. (e). Former subsec. (e) redesignated (d).

Pub. L. 100–690, §7001(a)(1), which directed redesignation of former subsec. (e) as (f), could not be executed because of prior redesignation of former subsec. (e) as (d) by Pub. L. 100–690, §6481(b), which resulted in there not being a subsec. (f).

Subsecs. (g) to (r). Pub. L. 100–690, §7001(b), added subsecs. (g) to (r).

1986—Subsec. (a). Pub. L. 99–570, §1252, substituted "to a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $2,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual," for "to a fine of not more than $100,000," and "to a fine not to exceed the greater of twice the amount authorized in accordance with the provisions of title 18 or $4,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual," for "to a fine of not more than $200,000,".

Subsecs. (b) to (e). Pub. L. 99–570, §1253, added subsec. (b) and redesignated former subsecs. (b) and (c) as (d) and (e), respectively, which resulted in there not being a subsec. (c).

1984—Subsec. (a). Pub. L. 98–473, §305, struck out par. (1) designation, substituted references to section 853 of this title for references to paragraph (2) in two places, and struck out par. (2) which related to forfeitures to the United States by any person convicted under par. (1).

Subsec. (d). Pub. L. 98–473, §305(b), struck out subsec. (d) relating to jurisdiction of courts of the United States.

Subsec. (e). Pub. L. 98–473, §224(b), as renumbered by Pub. L. 99–570, §1005(b)(2), which directed the amendment of subsec. (c) of this section by striking out "and section 4202 of title 18 of the United States Code", was executed by striking out that language in subsec. (e) to reflect the probable intent of Congress and the intervening amendment by Pub. L. 99–570, §1253, which redesignated subsec. (c) as (e). See 1986 Amendment note above.

Statutory Notes and Related Subsidiaries

Effective Date of 1996 Amendment

Amendment by section 903(b) of Pub. L. 104–132 effective as to cases commenced or appeals perfected on or after Apr. 24, 1996, see section 903(c) of Pub. L. 104–132, set out as a note under section 3006A of Title 18, Crimes and Criminal Procedure.

Effective Date of 1984 Amendment

Amendment by section 224(b) of Pub. L. 98–473 effective Nov. 1, 1987, and applicable only to offenses committed after the taking effect of such amendment, see section 235(a)(1) of Pub. L. 98–473, set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

GAO Study of Cost of Executions

Pub. L. 100–690, title VII, §7002, Nov. 18, 1988, 102 Stat. 4395, directed Comptroller General to conduct a study of cost of executions and report to Congress, prior to repeal by Pub. L. 104–66, title I, §1091(d), Dec. 21, 1995, 109 Stat. 722.

1 See References in Text note below.

2 So in original. Section does not contain a subsec. (f), see 1988 Amendment note below.
21 U.S.C. § 341 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 341: Definitions and standards for food
Definitions and standards for food
Status: in_force

Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container. No definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegetables, or butter, except that definitions and standards of identity may be established for avocadoes, cantaloupes, citrus fruits, and melons. In prescribing any standard of fill of container, the Secretary shall give due consideration to the natural shrinkage in storage and in transit of fresh natural food and to need for the necessary packing and protective material. In the prescribing of any standard of quality for any canned fruit or canned vegetable, consideration shall be given and due allowance made for the differing characteristics of the several varieties of such fruit or vegetable. In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the Secretary shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label. Any definition and standard of identity prescribed by the Secretary for avocadoes, cantaloupes, citrus fruits, or melons shall relate only to maturity and to the effects of freezing.

(June 25, 1938, ch. 675, §401, 52 Stat. 1046; Apr. 15, 1954, ch. 143, §1, 68 Stat. 54; Aug. 1, 1956, ch. 861, §1, 70 Stat. 919; Pub. L. 103–80, §3(h), Aug. 13, 1993, 107 Stat. 776.)

Editorial Notes

Amendments

1993—Pub. L. 103–80 substituted "or reasonable standards of fill of container. No definition" for "and/or reasonable standards of fill of container: Provided, That no definition".

1956—Act Aug. 1, 1956, designated provisions constituting subsec. (a) as entire section and repealed subsec. (b) which provided the procedure for establishment of regulations and is covered by section 371(e) of this title.

1954—Act Apr. 15, 1954, designated existing provisions as subsec. (a) and added subsec. (b).

Statutory Notes and Related Subsidiaries

Savings Provision

Act Aug. 1, 1956, ch. 861, §3, 70 Stat. 919, provided that: "In any case in which, prior to the enactment of this Act [Aug. 1, 1956], a public hearing has been begun in accordance with section 401 of the Federal Food, Drug, and Cosmetic Act [341 of this title] upon a proposal to issue, amend, or repeal any regulation contemplated by such section, or has been begun in accordance with section 701(e) of such Act [section 371(e) of this title] upon a proposal to issue, amend, or repeal any regulation contemplated by section 403(j), 404(a), 406(a) or (b), 501(b), 502(d), 502(h), 504 or 604 of such Act [section 343(j), 344(a), 346(a) or (b), 351(b), 352(d), 352(h), 354, or 364 of this title], the provisions of such section 401 or 701(e), as the case may be, as in force immediately prior to the date of the enactment of this Act [Aug. 1, 1956], shall be applicable as though this Act [amending this section and section 371(e) of this title] had not been enacted."

Food Safety and Security Strategy

Pub. L. 107–188, title III, §301, June 12, 2002, 116 Stat. 662, provided that:

"(a) In General.—The President's Council on Food Safety (as established by Executive Order No. 13100 [set out below]) shall, in consultation with the Secretary of Transportation, the Secretary of the Treasury, other relevant Federal agencies, the food industry, consumer and producer groups, scientific organizations, and the States, develop a crisis communications and education strategy with respect to bioterrorist threats to the food supply. Such strategy shall address threat assessments; technologies and procedures for securing food processing and manufacturing facilities and modes of transportation; response and notification procedures; and risk communications to the public.

"(b) Authorization of Appropriations.—For the purpose of implementing the strategy developed under subsection (a), there are authorized to be appropriated $750,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year."

Food Safety Commission

Pub. L. 107–171, title X, §10807, May 13, 2002, 116 Stat. 527, provided that:

"(a) Establishment.—

"(1) In general.—There is established a commission to be known as the 'Food Safety Commission' (referred to in this section as the 'Commission').

"(2) Membership.—

"(A) Composition.—The Commission shall be composed of 15 members (including a Chairperson, appointed by the President[)].

"(B) Eligibility.—

"(i) In general.—Members of the Commission—

     "(I) shall have specialized training or significant experience in matters under the jurisdiction of the Commission; and

     "(II) shall represent, at a minimum—

"(aa) consumers;

"(bb) food scientists;

"(cc) the food industry; and

"(dd) health professionals.

"(ii) Federal employees.—Not more than 3 members of the Commission may be Federal employees.

"(C) Date of appointments.—The appointment of the members of the Commission shall be made as soon as practicable after the date on which funds authorized to be appropriated under subsection (e)(1) are made available.

"(D) Vacancies.—A vacancy on the Commission—

"(i) shall not affect the powers of the Commission; and

"(ii) shall be filled—

     "(I) not later than 60 days after the date on which the vacancy occurs; and

     "(II) in the same manner as the original appointment was made.

"(3) Meetings.—

"(A) Initial meeting.—The initial meeting of the Commission shall be conducted not later than 30 days after the date of appointment of the final member of the Commission.

"(B) Other meetings.—The Commission shall meet at the call of the Chairperson.

"(4) Quorum; standing rules.—

"(A) Quorum.—A majority of the members of the Commission shall constitute a quorum to conduct business.

"(B) Standing rules.—At the first meeting of the Commission, the Commission shall adopt standing rules of the Commission to guide the conduct of business and decisionmaking of the Commission.

"(b) Duties.—

"(1) Recommendations.—The Commission shall make specific recommendations to enhance the food safety system of the United States, including a description of how each recommendation would improve food safety.

"(2) Components.—Recommendations made by the Commission under paragraph (1) shall address all food available commercially in the United States.

"(3) Report.—Not later than 1 year after the date on which the Commission first meets, the Commission shall submit to the President and Congress—

"(A) the findings, conclusions, and recommendations of the Commission, including a description of how each recommendation would improve food safety;

"(B) a summary of any other material used by the Commission in the preparation of the report under this paragraph; and

"(C) if requested by 1 or more members of the Commission, a statement of the minority views of the Commission.

"(c) Powers of the Commission.—

"(1) Hearings.—The Commission may, for the purpose of carrying out this section, hold such hearings, meet and act at such times and places, take such testimony, and receive such evidence as the Commission considers advisable.

"(2) Information from federal agencies.—

"(A) In general.—The Commission may secure directly, from any Federal agency, such information as the Commission considers necessary to carry out this section.

"(B) Provision of information.—

"(i) In general.—Subject to subparagraph (C), on the request of the Commission, the head of a Federal agency described in subparagraph (A) may furnish information requested by the Commission to the Commission.

"(ii) Administration.—The furnishing of information by a Federal agency to the Commission shall not be considered a waiver of any exemption available to the agency under section 552 of title 5, United States Code.

"(C) Information to be kept confidential.—

"(i) In general.—For purposes of section 1905 of title 18, United States Code—

     "(I) the Commission shall be considered an agency of the Federal Government; and

     "(II) any individual employed by an individual, entity, or organization that is a party to a contract with the Commission under this section shall be considered an employee of the Commission.

"(ii) Prohibition on disclosure.—Information obtained by the Commission, other than information that is available to the public, shall not be disclosed to any person in any manner except to an employee of the Commission as described in clause (i), for the purpose of receiving, reviewing, or processing the information.

"(d) Commission Personnel Matters.—

"(1) Members.—

"(A) Compensation.—A member of the Commission shall serve without compensation for the services of the member on the Commission.

"(B) Travel expenses.—A member of the Commission shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for an employee of an agency under subchapter I of chapter 57 of title 5, United States Code, while away from the home or regular place of business of the member in the performance of the duties of the Commission.

"(2) Staff.—

"(A) In general.—The Chairperson of the Commission may, without regard to the civil service laws (including regulations), appoint and terminate the appointment of an executive director and such other additional personnel as are necessary to enable the Commission to perform the duties of the Commission.

"(B) Confirmation of executive director.—The employment of an executive director shall be subject to confirmation by the Commission.

"(C) Compensation.—

"(i) In general.—Except as provided in clause (ii), the Chairperson of the Commission may fix the compensation of the executive director and other personnel without regard to the provisions of chapter 51 and subchapter III of chapter 53 of title 5, United States Code, relating to classification of positions and General Schedule pay rates.

"(ii) Maximum rate of pay.—The rate of pay for the executive director and other personnel shall not exceed the rate payable for level II of the Executive Schedule under section 5316 of title 5, United States Code.

"(3) Detail of federal government employees.—

"(A) In general.—An employee of the Federal Government may be detailed to the Commission, without reimbursement, for such period of time as is permitted by law.

"(B) Civil service status.—The detail of the employee shall be without interruption or loss of civil service status or privilege.

"(4) Procurement of temporary and intermittent services.—The Chairperson of the Commission may procure temporary and intermittent services in accordance with section 3109(b) of title 5, United States Code, at rates for individuals that do not exceed the daily equivalent of the annual rate of basic pay prescribed for level II of the Executive Schedule under section 5316 of that title.

"(e) Authorization of Appropriations.—

"(1) In general.—There is authorized to be appropriated such sums as are necessary to carry out this section.

"(2) Limitation.—No payment may be made under subsection (d) except to the extent provided for in advance in an appropriations Act.

"(f) Termination.—The Commission shall terminate on the date that is 60 days after the date on which the Commission submits the recommendations and report under subsection (b)(3)."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

Ex. Ord. No. 13100. President's Council on Food Safety

Ex. Ord. No. 13100, Aug. 25, 1998, 63 F.R. 45661, as amended by Ex. Ord. No. 13286, §16, Feb. 28, 2003, 68 F.R. 10623, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, and in order to improve the safety of the food supply through science-based regulation and well-coordinated inspection, enforcement, research, and education programs, it is hereby ordered as follows:

Section 1. Establishment of President's Council on Food Safety. (a) There is established the President's Council on Food Safety ("Council"). The Council shall comprise the Secretaries of Agriculture, Commerce, Health and Human Services, and Homeland Security, the Director of the Office of Management and Budget (OMB), the Administrator of the Environmental Protection Agency, the Assistant to the President for Science and Technology/Director of the Office of Science and Technology Policy, the Assistant to the President for Domestic Policy, and the Director of the National Partnership for Reinventing Government. The Council shall consult with other Federal agencies and State, local, and tribal government agencies, and consumer, producer, scientific, and industry groups, as appropriate.

(b) The Secretaries of Agriculture and of Health and Human Services and the Assistant to the President for Science and Technology/Director of the Office of Science and Technology Policy shall serve as Joint Chairs of the Council.

Sec. 2. Purpose. The purpose of the Council shall be to develop a comprehensive strategic plan for Federal food safety activities, taking into consideration the findings and recommendations of the National Academy of Sciences report "Ensuring Safe Food from Production to Consumption" and other input from the public on how to improve the effectiveness of the current food safety system. The Council shall make recommendations to the President on how to advance Federal efforts to implement a comprehensive science-based strategy to improve the safety of the food supply and to enhance coordination among Federal agencies, State, local, and tribal governments, and the private sector. The Council shall advise Federal agencies in setting priority areas for investment in food safety.

Sec. 3. Specific Activities and Functions. (a) The Council shall develop a comprehensive strategic Federal food safety plan that contains specific recommendations on needed changes, including measurable outcome goals. The principal goal of the plan should be the establishment of a seamless, science-based food safety system. The plan should address the steps necessary to achieve this goal, including the key public health, resource, and management issues regarding food safety. The planning process should consider both short-term and long-term issues including new and emerging threats and the special needs of vulnerable populations such as children and the elderly. In developing this plan, the Council shall consult with all interested parties, including State and local agencies, tribes, consumers, producers, industry, and academia.

(b) Consistent with the comprehensive strategic Federal food safety plan described in section 3(a) of this order, the Council shall advise agencies of priority areas for investment in food safety and ensure that Federal agencies annually develop coordinated food safety budgets for submission to the OMB that sustain and strengthen existing capacities, eliminate duplication, and ensure the most effective use of resources for improving food safety. The Council shall also ensure that Federal agencies annually develop a unified budget for submission to the OMB for the President's Food Safety Initiative and such other food safety issues as the Council determines appropriate.

(c) The Council shall ensure that the Joint Institute for Food Safety Research (JIFSR), in consultation with the National Science and Technology Council, establishes mechanisms to guide Federal research efforts toward the highest priority food safety needs. The JIFSR shall report to the Council on a regular basis on its efforts: (i) to develop a strategic plan for conducting food safety research activities consistent with the President's Food Safety Initiative and such other food safety activities as the JIFSR determines appropriate; and (ii) to coordinate efficiently, within the executive branch and with the private sector and academia, all Federal food safety research.

Sec. 4. Cooperation. All actions taken by the Council shall, as appropriate, promote partnerships and cooperation with States, tribes, and other public and private sector efforts wherever possible to improve the safety of the food supply.

Sec. 5. General Provisions. This order is intended only to improve the internal management of the executive branch and is not intended to, nor does it, create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, its agencies, its officers or any person. Nothing in this order shall affect or alter the statutory responsibilities of any Federal agency charged with food safety responsibilities.
21 U.S.C. § 2204 (2024) — Title 21: FOOD AND DRUGS / Chapter 27: FOOD SAFETY MODERNIZATION / Subchapter I: IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS / Section 2204: Building domestic capacity
Building domestic capacity
Status: in_force

(a) In general

(1) Initial report

The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall, not later than 2 years after January 4, 2011, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities. Such report shall include a description of the following:

(A) Analysis of the need for further regulations or guidance to industry.

(B) Outreach to food industry sectors, including through the Food and Agriculture Coordinating Councils referred to in section 2203 of this title, to identify potential sources of emerging threats to the safety and security of the food supply and preventive strategies to address those threats.

(C) Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies.

(D) Communication systems to ensure that information about specific threats to the safety and security of the food supply are rapidly and effectively disseminated.

(E) Surveillance systems and laboratory networks to rapidly detect and respond to foodborne illness outbreaks and other food-related hazards, including how such systems and networks are integrated.

(F) Outreach, education, and training provided to States and local governments to build State and local food safety and food defense capabilities, including progress implementing strategies developed under sections 2202 and 2224 of this title.

(G) The estimated resources needed to effectively implement the programs and practices identified in the report developed in this section over a 5-year period.

(H) The impact of requirements under this Act (including amendments made by this Act) on certified organic farms and facilities (as defined in section 350d of this title.1

(I) Specific efforts taken pursuant to the agreements authorized under section 350j(c) of this title (as added by section 201),2 together with, as necessary, a description of any additional authorities necessary to improve seafood safety.

(2) Biennial reports

On a biennial basis following the submission of the report under paragraph (1), the Secretary shall submit to Congress a report that—

(A) reviews previous food safety programs and practices;

(B) outlines the success of those programs and practices;

(C) identifies future programs and practices; and

(D) includes information related to any matter described in subparagraphs (A) through (H) of paragraph (1), as necessary.

(b) Risk-based activities

The report developed under subsection (a)(1) shall describe methods that seek to ensure that resources available to the Secretary for food safety-related activities are directed at those actions most likely to reduce risks from food, including the use of preventive strategies and allocation of inspection resources. The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the food supply.

(c) Capability for laboratory analyses; research

The report developed under subsection (a)(1) shall provide a description of methods to increase capacity to undertake analyses of food samples promptly after collection, to identify new and rapid analytical techniques, including commercially-available techniques that can be employed at ports of entry and by Food Emergency Response Network laboratories, and to provide for well-equipped and staffed laboratory facilities and progress toward laboratory accreditation under section 350k of this title (as added by section 202).2

(d) Information technology

The report developed under subsection (a)(1) shall include a description of such information technology systems as may be needed to identify risks and receive data from multiple sources, including foreign governments, State, local, and tribal governments, other Federal agencies, the food industry, laboratories, laboratory networks, and consumers. The information technology systems that the Secretary describes shall also provide for the integration of the facility registration system under section 350d of this title, and the prior notice system under section 381(m) of this title with other information technology systems that are used by the Federal Government for the processing of food offered for import into the United States.

(e) Automated risk assessment

The report developed under subsection (a)(1) shall include a description of progress toward developing and improving an automated risk assessment system for food safety surveillance and allocation of resources.

(f) Traceback and surveillance report

The Secretary shall include in the report developed under subsection (a)(1) an analysis of the Food and Drug Administration's performance in foodborne illness outbreaks during the 5-year period preceding January 4, 2011, involving fruits and vegetables that are raw agricultural commodities (as defined in section 321(r) of this title) and recommendations for enhanced surveillance, outbreak response, and traceability. Such findings and recommendations shall address communication and coordination with the public, industry, and State and local governments, as such communication and coordination relates to outbreak identification and traceback.

(g) Biennial food safety and food defense research plan

The Secretary, the Secretary of Agriculture, and the Secretary of Homeland Security shall, on a biennial basis, submit to Congress a joint food safety and food defense research plan which may include studying the long-term health effects of foodborne illness. Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the subsequent 2-year period.

(h) Effectiveness of programs administered by the Department of Health and Human Services

(1) In general

To determine whether existing Federal programs administered by the Department of Health and Human Services are effective in achieving the stated goals of such programs, the Secretary shall, beginning not later than 1 year after January 4, 2011—

(A) conduct an annual evaluation of each program of such Department to determine the effectiveness of each such program in achieving legislated intent, purposes, and objectives; and

(B) submit to Congress a report concerning such evaluation.

(2) Content

The report described under paragraph (1)(B) shall—

(A) include conclusions concerning the reasons that such existing programs have proven successful or not successful and what factors contributed to such conclusions;

(B) include recommendations for consolidation and elimination to reduce duplication and inefficiencies in such programs at such Department as identified during the evaluation conduct 3 under this subsection; and

(C) be made publicly available in a publication entitled "Guide to the U.S. Department of Health and Human Services Programs".

(i) Unique identification numbers

(1) In general

Not later than 1 year after January 4, 2011, the Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study regarding the need for, and challenges associated with, development and implementation of a program that requires a unique identification number for each food facility registered with the Secretary and, as appropriate, each broker that imports food into the United States. Such study shall include an evaluation of the costs associated with development and implementation of such a system, and make recommendations about what new authorities, if any, would be necessary to develop and implement such a system.

(2) Report

Not later than 15 months after January 4, 2011, the Secretary shall submit to Congress a report that describes the findings of the study conducted under paragraph (1) and that includes any recommendations determined appropriate by the Secretary.

(Pub. L. 111–353, title I, §110, Jan. 4, 2011, 124 Stat. 3913.)

Editorial Notes

References in Text

The Secretary, referred to in subsecs. (a), (b), (d), (f), (g), (h)(1), and (i), probably means the Secretary of Health and Human Services.

This Act, referred to in subsec. (a)(1)(H), 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. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Section 350d of this title, referred to in subsec. (a)(1)(H), and section 321(r) of this title, referred to in subsec. (f), were in the original "section 415 (21 U.S.C. 350d)" and "section 201(r) (21 U.S.C. 321(r))", respectively, and were translated as meaning sections 415 and 201(r) of the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, to reflect the probable intent of Congress.

Section 201, referred to in subsec. (a)(1)(I), and section 202, referred to in subsec. (c), mean sections 201 and 202, respectively, of Pub. L. 111–353.

1 So in original. Probably should be "title)."

2 See References in Text note below.

3 So in original. Probably should be "conducted".
21 U.S.C. § 604 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 604: Post mortem examination of carcasses and marking or labeling; destruction of carcasses condemned; reinspection
Post mortem examination of carcasses and marking or labeling; destruction of carcasses condemned; reinspection
Status: in_force

For the purposes hereinbefore set forth the Secretary shall cause to be made by inspectors appointed for that purpose a post mortem examination and inspection of the carcasses and parts thereof of all amenable species to be prepared at any slaughtering, meat-canning, salting, packing, rendering, or similar establishment in any State, Territory, or the District of Columbia as articles of commerce which are capable of use as human food; and the carcasses and parts thereof of all such animals found to be not adulterated shall be marked, stamped, tagged, or labeled as "Inspected and passed"; and said inspectors shall label, mark, stamp, or tag as "Inspected and condemned" all carcasses and parts thereof of animals found to be adulterated; and all carcasses and parts thereof thus inspected and condemned shall be destroyed for food purposes by the said establishment in the presence of an inspector, and the Secretary may remove inspectors from any such establishment which fails to so destroy any such condemned carcass or part thereof, and said inspectors, after said first inspection, shall, when they deem it necessary, reinspect said carcasses or parts thereof to determine whether since the first inspection the same have become adulterated, and if any carcass or any part thereof shall, upon examination and inspection subsequent to the first examination and inspection, be found to be adulterated, it shall be destroyed for food purposes by the said establishment in the presence of an inspector, and the Secretary may remove inspectors from any establishment which fails to so destroy any such condemned carcass or part thereof.

(Mar. 4, 1907, ch. 2907, title I, §4, formerly 2nd par., 34 Stat. 1260; renumbered §4 and amended Pub. L. 90–201, §§1, 3, 4, 12(a)–(d), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, §798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)

Editorial Notes

Codification

Section was formerly classified to section 72 of this title.

Amendments

2005—Pub. L. 109–97 substituted "amenable species" for "cattle, sheep, swine, goats, horses, mules, and other equines".

1967—Pub. L. 90–201, §§3, 4, 12(a)–(d), struck out "interstate or foreign" before "commerce" and "of Agriculture" after "Secretary" in three places; struck out "for human consumption" before "at any slaughtering" and "for transportation or sale" after "District of Columbia" and inserted "which are capable of use as human food" after "commerce"; included horses, mules, and other equines in the list of animals; substituted "adulterated" for "unsound, unhealthful, unwholesome, or otherwise unfit for human food" after " 'Inspected and condemned,' all carcasses and parts thereof of animals found to be" and before ", it shall be destroyed"; substituted "not adulterated" for "sound, healthful, wholesome, and fit for human food"; and substituted "adulterated" for "unsound, unhealthful, unwholesome, or in any way unfit for human food" before "and if any carcass", respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 882 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 882: Injunctions
Injunctions
Status: in_force

(a) Jurisdiction

The district courts of the United States and all courts exercising general jurisdiction in the territories and possessions of the United States shall have jurisdiction in proceedings in accordance with the Federal Rules of Civil Procedure to enjoin violations of this subchapter.

(b) Jury trial

In case of an alleged violation of an injunction or restraining order issued under this section, trial shall, upon demand of the accused, be by a jury in accordance with the Federal Rules of Civil Procedure.

(c) State cause of action pertaining to online pharmacies

(1) In general

In any case in which the State has reason to believe that an interest of the residents of that State has been or is being threatened or adversely affected by the action of a person, entity, or Internet site that violates the provisions of section 823(g), 829(e), or 831 of this title, the State may bring a civil action on behalf of such residents in a district court of the United States with appropriate jurisdiction—

(A) to enjoin the conduct which violates this section;

(B) to enforce compliance with this section;

(C) to obtain damages, restitution, or other compensation, including civil penalties under section 842(b) of this title; and

(D) to obtain such other legal or equitable relief as the court may find appropriate.

(2) Service; intervention

(A) Prior to filing a complaint under paragraph (1), the State shall serve a copy of the complaint upon the Attorney General and upon the United States Attorney for the judicial district in which the complaint is to be filed. In any case where such prior service is not feasible, the State shall serve the complaint on the Attorney General and the appropriate United States Attorney on the same day that the State's complaint is filed in Federal district court of the United States. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or any other proceedings under this subchapter or any other laws of the United States.

(B) Upon receiving notice respecting a civil action pursuant to this section, the United States shall have the right to intervene in such action and, upon so intervening, to be heard on all matters arising therein, and to file petitions for appeal.

(C) Service of a State's complaint on the United States as required in this paragraph shall be made in accord with the requirements of rule 4(i)(1) of the Federal Rule 1 of Civil Procedure.

(3) Powers conferred by State law

For purposes of bringing any civil action under paragraph (1), nothing in this chapter shall prevent an attorney general of a State from exercising the powers conferred on the attorney general of a State by the laws of such State to conduct investigations or to administer oaths or affirmations or to compel the attendance of witnesses of or the production of documentary or other evidence.

(4) Venue

Any civil action brought under paragraph (1) in a district court of the United States may be brought in the district in which the defendant is found, is an inhabitant, or transacts business or wherever venue is proper under section 1391 of title 28. Process in such action may be served in any district in which the defendant is an inhabitant or in which the defendant may be found.

(5) No private right of action

No private right of action is created under this subsection.

(6) Limitation

No civil action may be brought under paragraph (1) against—

(A) the United States;

(B) an Indian Tribe or tribal organization, to the extent such tribe or tribal organization is lawfully carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.]; or

(C) any employee of the United States or such Indian tribe or tribal organization, provided such agent or employee is acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee therewith.

(Pub. L. 91–513, title II, §512, Oct. 27, 1970, 84 Stat. 1278; Pub. L. 110–425, §3(h), Oct. 15, 2008, 122 Stat. 4830; Pub. L. 117–215, title I, §103(b)(1)(I), Dec. 2, 2022, 136 Stat. 2263.)

Editorial Notes

References in Text

The Federal Rules of Civil Procedure, referred to in subsecs. (a), (b), and (c)(2)(C), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.

This subchapter, referred to in subsecs. (a) and (c)(2)(A), 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.

This chapter, referred to in subsec. (c)(3), was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Indian Self-Determination and Education Assistance Act, referred to in subsec. (c)(6)(B), is Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to chapter 46 (§5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

Amendments

2022—Subsec. (c)(1). Pub. L. 117–215 substituted "823(g)" for "823(f)" in introductory provisions.

2008—Subsec. (c). Pub. L. 110–425 added subsec. (c).

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title.

1 So in original. Probably should be "Rules".
21 U.S.C. § 399h (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter X: MISCELLANEOUS / Section 399h: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
Status: in_force

(a) In general

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs—

(1) may, to support the advancement, development, and implementation of advanced and continuous pharmaceutical manufacturing—

(A) solicit requests for designation as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing (in this section referred to as a "National Center of Excellence");

(B) beginning not later than one year after December 29, 2022, designate as National Centers of Excellence institutions of higher education or consortia of institutions of higher education that—

(i) request such designation; and

(ii) meet the eligibility criteria specified in subsection (c); and

(C) award grants to such institutions or consortia of institutions; and

(2) shall so designate not more than 5 institutions of higher education or consortia of such institutions.

(b) Request for designation

A request for designation under subsection (a) shall be made to the Secretary at such time, in such manner, and containing such information as the Secretary may require.

(c) Eligibility criteria for designation

To be eligible to receive a designation under this section, an institution of higher education or consortium of institutions of higher education shall include in its request for designation a description of the institution's or consortium's—

(1) physical capacity and technical capabilities to conduct advanced research on, and to develop and implement, advanced and continuous pharmaceutical manufacturing;

(2) collaboration or partnerships with other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, contract manufacturers, and other relevant entities;

(3) proven capacity to design, develop, implement, and demonstrate new, highly effective technologies for use in advanced and continuous pharmaceutical manufacturing;

(4) proven ability to facilitate training of a qualified workforce for advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing; and

(5)(A) experience in participating in and leading advanced and continuous pharmaceutical manufacturing technology partnerships with other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, contract manufacturers, and other relevant entities to—

(i) support the implementation of advanced or continuous pharmaceutical manufacturing for companies manufacturing or seeking to manufacture in the United States;

(ii) support Federal agencies with technical assistance and workforce training, which may include regulatory and quality metric guidance as applicable, and hands-on training, for advanced and continuous pharmaceutical manufacturing;

(iii) organize and conduct advanced research and development activities, with respect to advanced or continuous pharmaceutical manufacturing, needed to develop new and more effective technology, and to develop and support technological leadership;

(iv) develop best practices for designing, developing, and implementing advanced and continuous pharmaceutical manufacturing processes; and

(v) identify and assess workforce needs for advanced and continuous pharmaceutical manufacturing, and address such workforce needs, which may include the development and implementing of training programs; or

(B) a plan, to be implemented within 2 years, to establish partnerships described in subparagraph (A).

(d) Termination of designation

The Secretary may terminate the designation of any National Center of Excellence designated under this section if the Secretary determines such National Center of Excellence no longer meets the criteria specified in subsection (c). Not later than 90 days before the effective date of such a termination, the Secretary shall provide written notice to the National Center of Excellence, including the rationale for such termination.

(e) Conditions for designation

As a condition of designation as a National Center of Excellence under this section, the Secretary shall require that an institution of higher education or consortium of institutions of higher education enter into an agreement with the Secretary under which the institution or consortium agrees—

(1) to collaborate directly with the Food and Drug Administration to publish the reports required by subsection (g);

(2) to share data with the Food and Drug Administration regarding best practices and research generated through the funding under subsection (f);

(3) to develop, along with industry partners (which may include large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, and contract research organizations or contract manufacturers that carry out drug development and manufacturing activities) and another institution or consortium designated under this section, if any, a strategic plan for developing an advanced and continuous pharmaceutical manufacturing workforce;

(4) to develop, along with industry partners and other institutions or consortia of such institutions designated under this section, a strategic plan for strengthening existing, and developing new, partnerships with other institutions of higher education or consortia thereof, or nonprofit organizations; and

(5) to provide an annual report to the Food and Drug Administration regarding the designee's activities under this section, including a description of how the designee continues to meet and make progress on the criteria specified in subsection (c).

(f) Funding

(1) In general

The Secretary shall award funding, through grants, contracts, or cooperative agreements, to the entities designated as National Centers of Excellence under this section for the purposes of supporting the advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing, and recommending improvements to advanced and continuous pharmaceutical manufacturing, including—

(A) expanding capacity for advanced research on, and development of, advanced and continuous pharmaceutical manufacturing; and

(B) implementing advanced research capacity and capabilities in advanced and continuous pharmaceutical manufacturing suitable for accelerating the development of drug products needed to respond to public health threats, mitigate or prevent drug shortages, address drug quality issues and supply chain disruptions, and other circumstances with respect to which the Secretary may determine the rapid development of new products or new manufacturing processes may be appropriate.

(2) Consistency with FDA mission

As a condition on receipt of funding under this subsection, a National Center of Excellence shall consider any input from the Secretary regarding the use of funding related to—

(A) best practices to increase, and provide for the advancement of, advanced and continuous pharmaceutical manufacturing through the National Center of Excellence; and

(B) the extent to which activities conducted by the National Center of Excellence are consistent with the mission of the Food and Drug Administration.

(3) Rule of construction

Nothing in this section shall be construed as precluding a National Center for Excellence designated under this section from receiving funds under any other provision of this Act or any other Federal law.

(g) Annual review and reports

(1) Annual report to Congress

Beginning not later than one year after the date on which the first designation is made under subsection (a), and annually thereafter, the Secretary shall—

(A) submit to Congress a report describing the activities, partnerships and collaborations, Federal policy recommendations, previous and continuing funding, and findings of, and any other applicable information from, the National Centers of Excellence designated under this section;

(B) include in such report an accounting of the Federal administrative expenses described in subsection (i)(2) over the reporting period; and

(C) make such report available to the public in an easily accessible electronic format on the website of the Food and Drug Administration.

(2) Center of Excellence report

An entity receiving a grant under this section shall, not later than 1 year after receiving such grant, and annually thereafter for the duration of the grant period, submit to the Secretary a summary of programs and activities funded under the grant.

(3) Periodic review

The Secretary shall periodically review the National Centers of Excellence designated under this section to ensure that such National Centers of Excellence continue to meet the criteria for designation under this section.

(4) Additional report to Congress

Not later than 1 year after the date on which the first designation is made under subsection (a), the Secretary, in consultation with the National Centers of Excellence designated under this section, shall submit a report to the Congress on the role of the Food and Drug Administration in supporting advanced and continuous pharmaceutical manufacturing, including—

(A) a national framework of principles related to the implementation of advanced and continuous pharmaceutical manufacturing;

(B) a plan for the development of Federal regulations and guidance to support and facilitate the incorporation of advanced or continuous manufacturing into the development of pharmaceuticals;

(C) a plan for development of Federal regulations or guidance related to the review of advanced and continuous pharmaceutical manufacturing, including how such manufacturing practices may be incorporated into the review of medical product applications; and

(D) a summary of relevant feedback related to improving advanced and continuous pharmaceutical manufacturing solicited from the public, which may include other institutions of higher education, nonprofit organizations, and large and small pharmaceutical manufacturers, including generic and nonprescription manufacturers, and contract manufacturers, and other relevant entities.

(h) Definitions

In this section:

(1) Advanced and continuous pharmaceutical manufacturing

The term "advanced and continuous pharmaceutical manufacturing" refers to a method of pharmaceutical manufacturing, or a combination of pharmaceutical manufacturing methods—

(A) that incorporates a novel technology, or uses an established technique or technology in a new or innovative way, that enhances drug quality or improves the manufacturing process for a drug, including processes that may apply to advanced therapies and the production of biological products, such as cell and gene therapies; or

(B) for which the input materials are continuously fed into and transformed within the process, and the output materials are continuously removed from the system, utilizing an integrated manufacturing process that consists of a series of 2 or more simultaneous unit operations.

(2) Biological product

The term "biological product" has the meaning given such term in section 262(i) of title 42.

(3) Drug

The term "drug" has the meaning given such term in section 321(g) of this title.

(4) Institution of higher education

The term "institution of higher education" has the meaning given such term in section 1001(a) of title 20.

(5) Secretary

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

(i) Authorization of appropriations

(1) In general

There is authorized to be appropriated to carry out this section $100,000,000 for the period of fiscal years 2023 through 2027.

(2) Federal administrative expenses

Of the amounts made available to carry out this section for a fiscal year, the Secretary shall not use more than 8 percent for Federal administrative expenses, including training, technical assistance, reporting, and evaluation.

(Pub. L. 114–255, div. A, title III, §3016, Dec. 13, 2016, 130 Stat. 1095; Pub. L. 117–328, div. FF, title III, §3204(a), Dec. 29, 2022, 136 Stat. 5815.)

Editorial Notes

References in Text

This Act, referred to in subsec. (f)(3), is Pub. L. 114–255, Dec. 13, 2016, 130 Stat. 1033, known as the 21st Century Cures Act. For complete classification of this Act to the Code, see Short Title of 2016 Amendment note set out under section 201 of Title 42, The Public Health and Welfare, and Tables.

Codification

Section was enacted as part of the 21st Century Cures Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Amendments

2022—Pub. L. 117–328 amended section generally. Prior to amendment, section related to grants for studying continuous drug manufacturing.

Statutory Notes and Related Subsidiaries

Transition Rule

Pub. L. 117–328, div. FF, title III, §3204(b), Dec. 29, 2022, 136 Stat. 5819, provided that: "Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h), as in effect on the day before the date of the enactment of this section [Dec. 29, 2022], shall apply with respect to grants awarded under such section before such date of enactment."
21 U.S.C. § 356a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 356a: Manufacturing changes
Manufacturing changes
Status: in_force

(a) In general

With respect to a drug for which there is in effect an approved application under section 355 or 360b of this title or a license under section 262 of title 42, a change from the manufacturing process approved pursuant to such application or license may be made, and the drug as made with the change may be distributed, if—

(1) the holder of the approved application or license (referred to in this section as a "holder") has validated the effects of the change in accordance with subsection (b); and

(2)(A) in the case of a major manufacturing change, the holder has complied with the requirements of subsection (c); or

(B) in the case of a change that is not a major manufacturing change, the holder complies with the applicable requirements of subsection (d).

(b) Validation of effects of changes

For purposes of subsection (a)(1), a drug made with a manufacturing change (whether a major manufacturing change or otherwise) may be distributed only if, before distribution of the drug as so made, the holder involved validates the effects of the change on the identity, strength, quality, purity, and potency of the drug as the identity, strength, quality, purity, and potency may relate to the safety or effectiveness of the drug.

(c) Major manufacturing changes

(1) Requirement of supplemental application

For purposes of subsection (a)(2)(A), a drug made with a major manufacturing change may be distributed only if, before the distribution of the drug as so made, the holder involved submits to the Secretary a supplemental application for such change and the Secretary approves the application. The application shall contain such information as the Secretary determines to be appropriate, and shall include the information developed under subsection (b) by the holder in validating the effects of the change.

(2) Changes qualifying as major changes

For purposes of subsection (a)(2)(A), a major manufacturing change is a manufacturing change that is determined by the Secretary to have substantial potential to adversely affect the identity, strength, quality, purity, or potency of the drug as they may relate to the safety or effectiveness of a drug. Such a change includes a change that—

(A) is made in the qualitative or quantitative formulation of the drug involved or in the specifications in the approved application or license referred to in subsection (a) for the drug (unless exempted by the Secretary by regulation or guidance from the requirements of this subsection);

(B) is determined by the Secretary by regulation or guidance to require completion of an appropriate clinical study demonstrating equivalence of the drug to the drug as manufactured without the change; or

(C) is another type of change determined by the Secretary by regulation or guidance to have a substantial potential to adversely affect the safety or effectiveness of the drug.

(d) Other manufacturing changes

(1) In general

For purposes of subsection (a)(2)(B), the Secretary may regulate drugs made with manufacturing changes that are not major manufacturing changes as follows:

(A) The Secretary may in accordance with paragraph (2) authorize holders to distribute such drugs without submitting a supplemental application for such changes.

(B) The Secretary may in accordance with paragraph (3) require that, prior to the distribution of such drugs, holders submit to the Secretary supplemental applications for such changes.

(C) The Secretary may establish categories of such changes and designate categories to which subparagraph (A) applies and categories to which subparagraph (B) applies.

(2) Changes not requiring supplemental application

(A) Submission of report

A holder making a manufacturing change to which paragraph (1)(A) applies shall submit to the Secretary a report on the change, which shall contain such information as the Secretary determines to be appropriate, and which shall include the information developed under subsection (b) by the holder in validating the effects of the change. The report shall be submitted by such date as the Secretary may specify.

(B) Authority regarding annual reports

In the case of a holder that during a single year makes more than one manufacturing change to which paragraph (1)(A) applies, the Secretary may in carrying out subparagraph (A) authorize the holder to comply with such subparagraph by submitting a single report for the year that provides the information required in such subparagraph for all the changes made by the holder during the year.

(3) Changes requiring supplemental application

(A) Submission of supplemental application

The supplemental application required under paragraph (1)(B) for a manufacturing change shall contain such information as the Secretary determines to be appropriate, which shall include the information developed under subsection (b) by the holder in validating the effects of the change.

(B) Authority for distribution

In the case of a manufacturing change to which paragraph (1)(B) applies:

(i) The holder involved may commence distribution of the drug involved 30 days after the Secretary receives the supplemental application under such paragraph, unless the Secretary notifies the holder within such 30-day period that prior approval of the application is required before distribution may be commenced.

(ii) The Secretary may designate a category of such changes for the purpose of providing that, in the case of a change that is in such category, the holder involved may commence distribution of the drug involved upon the receipt by the Secretary of a supplemental application for the change.

(iii) If the Secretary disapproves the supplemental application, the Secretary may order the manufacturer to cease the distribution of the drugs that have been made with the manufacturing change.

(June 25, 1938, ch. 675, §506A, as added Pub. L. 105–115, title I, §116(a), Nov. 21, 1997, 111 Stat. 2313.)

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 105–115, title I, §116(b), Nov. 21, 1997, 111 Stat. 2315, provided that: "The amendment made by subsection (a) [enacting this section] takes effect upon the effective date of regulations promulgated by the Secretary of Health and Human Services to implement such amendment, or upon the expiration of the 24-month period beginning on the date of the enactment of this Act [Nov. 21, 1997], whichever occurs first."
21 U.S.C. § 872 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 872: Education and research programs of Attorney General
Education and research programs of Attorney General
Status: in_force

(a) Authorization

The Attorney General is authorized to carry out educational and research programs directly related to enforcement of the laws under his jurisdiction concerning drugs or other substances which are or may be subject to control under this subchapter. Such programs may include—

(1) educational and training programs on drug abuse and controlled substances law enforcement for local, State, tribal, and Federal personnel;

(2) studies or special projects designed to compare the deterrent effects of various enforcement strategies on drug use and abuse;

(3) studies or special projects designed to assess and detect accurately the presence in the human body of drugs or other substances which are or may be subject to control under this subchapter, including the development of rapid field identification methods which would enable agents to detect microquantities of such drugs or other substances;

(4) studies or special projects designed to evaluate the nature and sources of the supply of illegal drugs throughout the country;

(5) studies or special projects to develop more effective methods to prevent diversion of controlled substances into illegal channels; and

(6) studies or special projects to develop information necessary to carry out his functions under section 811 of this title.

(b) Contracts

The Attorney General may enter into contracts for such educational and research activities without performance bonds and without regard to section 6101 of title 41.

(c) Identification of research populations; authorization to withhold

The Attorney General may authorize persons engaged in research to withhold the names and other identifying characteristics of persons who are the subjects of such research. Persons who obtain this authorization may not be compelled in any Federal, State, tribal, or local civil, criminal, administrative, legislative, or other proceeding to identify the subjects of research for which such authorization was obtained.

(d) Affect of treaties and other international agreements on confidentiality

Nothing in the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, or other treaties or international agreements shall be construed to limit, modify, or prevent the protection of the confidentiality of patient records or of the names and other identifying characteristics of research subjects as provided by any Federal, State, or local law or regulation.

(e) Use of controlled substances in research

The Attorney General, on his own motion or at the request of the Secretary, may authorize the possession, distribution, and dispensing of controlled substances by persons engaged in research. Persons who obtain this authorization shall be exempt from State or Federal prosecution for possession, distribution, and dispensing of controlled substances to the extent authorized by the Attorney General.

(f) Program to curtail diversion of precursor and essential chemicals

The Attorney General shall maintain an active program, both domestic and international, to curtail the diversion of precursor chemicals and essential chemicals used in the illicit manufacture of controlled substances.

(Pub. L. 91–513, title II, §502, Oct. 27, 1970, 84 Stat. 1271; Pub. L. 95–633, title I, §108(a), Nov. 10, 1978, 92 Stat. 3773; Pub. L. 100–690, title VI, §6060, Nov. 18, 1988, 102 Stat. 4320; Pub. L. 111–211, title II, §232(a), July 29, 2010, 124 Stat. 2278.)

Editorial Notes

Codification

In subsec. (b), "section 6101 of title 41" substituted for "section 3709 of the Revised Statutes (41 U.S.C. 5)" on authority of Pub. L. 111–350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Amendments

2010—Subsecs. (a)(1), (c). Pub. L. 111–211 inserted "tribal," after "State,".

1988—Subsec. (f). Pub. L. 100–690 added subsec. (f).

1978—Subsecs. (d), (e). Pub. L. 95–633 added subsec. (d) and redesignated former subsec. (d) as (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

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.

Effect of Grants

Pub. L. 111–211, title II, §232(e), July 29, 2010, 124 Stat. 2279, provided that: "Nothing in this section [amending this section and sections 872a, 873, and 878 of this title] or any amendment made by this section—

"(1) allows the grant to be made to, or used by, an entity for law enforcement activities that the entity lacks jurisdiction to perform; or

"(2) has any effect other than to authorize, award, or deny a grant of funds to a federally recognized Indian tribe for the purposes described in the relevant grant program."

[For definition of "Indian tribe" as used in section 232(e) of Pub. L. 111–211, set out above, see section 203(a) of Pub. L. 111–211, set out as a note under section 2801 of Title 25, Indians.]

Training for Drug Enforcement Administration and State and Local Law Enforcement Personnel Relating to Clandestine Laboratories

Pub. L. 106–310, div. B, title XXXVI, §3623, Oct. 17, 2000, 114 Stat. 1231, provided that:

"(a) In General.—

"(1) Requirement.—The Administrator of the Drug Enforcement Administration shall carry out the programs described in subsection (b) with respect to the law enforcement personnel of States and localities determined by the Administrator to have significant levels of methamphetamine-related or amphetamine-related crime or projected by the Administrator to have the potential for such levels of crime in the future.

"(2) Duration.—The duration of any program under that subsection may not exceed 3 years.

"(b) Covered Programs.—The programs described in this subsection are as follows:

"(1) Advanced mobile clandestine laboratory training teams.—A program of advanced mobile clandestine laboratory training teams, which shall provide information and training to State and local law enforcement personnel in techniques utilized in conducting undercover investigations and conspiracy cases, and other information designed to assist in the investigation of the illegal manufacturing and trafficking of amphetamine and methamphetamine.

"(2) Basic clandestine laboratory certification training.—A program of basic clandestine laboratory certification training, which shall provide information and training—

"(A) to Drug Enforcement Administration personnel and State and local law enforcement personnel for purposes of enabling such personnel to meet any certification requirements under law with respect to the handling of wastes created by illegal amphetamine and methamphetamine laboratories; and

"(B) to State and local law enforcement personnel for purposes of enabling such personnel to provide the information and training covered by subparagraph (A) to other State and local law enforcement personnel.

"(3) Clandestine laboratory recertification and awareness training.—A program of clandestine laboratory recertification and awareness training, which shall provide information and training to State and local law enforcement personnel for purposes of enabling such personnel to provide recertification and awareness training relating to clandestine laboratories to additional State and local law enforcement personnel.

"(c) Authorization of Appropriations.—There are authorized to be appropriated for each of fiscal years 2000, 2001, and 2002 amounts as follows:

"(1) $1,500,000 to carry out the program described in subsection (b)(1).

"(2) $3,000,000 to carry out the program described in subsection (b)(2).

"(3) $1,000,000 to carry out the program described in subsection (b)(3)."

Educational Program for Police Departments

Pub. L. 104–305, §4, Oct. 13, 1996, 110 Stat. 3809, provided that: "The Attorney General may—

"(1) create educational materials regarding the use of controlled substances (as that term is defined in section 102 of the Controlled Substances Act [21 U.S.C. 802]) in the furtherance of rapes and sexual assaults; and

"(2) disseminate those materials to police departments throughout the United States."

Study and Report on Measures To Prevent Sales of Agents Used in Methamphetamine Production

Pub. L. 104–237, title II, §202, Oct. 3, 1996, 110 Stat. 3101, required the Attorney General of the United States to conduct a study on measures to effectively prevent the diversion of red phosphorous, iodine, hydrochloric gas, and other agents for use in the production of methamphetamine, and to submit to Congress no later than Jan. 1, 1998, a report of the findings pursuant to the study on the need for and advisability of preventive measures.
21 U.S.C. § 952 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 952: Importation of controlled substances
Importation of controlled substances
Status: in_force

(a) Controlled substances in schedule I or II and narcotic drugs in schedule III, IV, or V; exceptions

It shall be unlawful to import into the customs territory of the United States from any place outside thereof (but within the United States), or to import into the United States from any place outside thereof, any controlled substance in schedule I or II of subchapter I, or any narcotic drug in schedule III, IV, or V of subchapter I, or ephedrine, pseudoephedrine, or phenylpropanolamine, except that—

(1) such amounts of crude opium, poppy straw, concentrate of poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and phenylpropanolamine, as the Attorney General finds to be necessary to provide for medical, scientific, or other legitimate purposes, and

(2) such amounts of any controlled substance in schedule I or II or any narcotic drug in schedule III, IV, or V that the Attorney General finds to be necessary to provide for the medical, scientific, or other legitimate needs of the United States—

(A) during an emergency in which domestic supplies of such substance or drug are found by the Attorney General to be inadequate,

(B) in any case in which the Attorney General finds that competition among domestic manufacturers of the controlled substance is inadequate and will not be rendered adequate by the registration of additional manufacturers under section 823 of this title, or

(C) in any case in which the Attorney General finds that such controlled substance is in limited quantities exclusively for scientific, analytical, or research uses,

may be so imported under such regulations as the Attorney General shall prescribe. No crude opium may be so imported for the purpose of manufacturing heroin or smoking opium.

(b) Nonnarcotic controlled substances in schedule III, IV, or V

It shall be unlawful to import into the customs territory of the United States from any place outside thereof (but within the United States), or to import into the United States from  any  place  outside  thereof,  any  nonnarcotic controlled substance in schedule III, IV, or V, unless such nonnarcotic controlled substance—

(1) is imported for medical, scientific, or other legitimate uses, and

(2) is imported pursuant to such notification, or declaration, or in the case of any nonnarcotic controlled substance in schedule III, such import permit, notification, or declaration, as the Attorney General may by regulation prescribe, except that if a nonnarcotic controlled substance in schedule IV or V is also listed in schedule I or II of the Convention on Psychotropic Substances it shall be imported pursuant to such import permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention.

(c) Coca leaves

In addition to the amount of coca leaves authorized to be imported into the United States under subsection (a), the Attorney General may permit the importation of additional amounts of coca leaves. All cocaine and ecgonine (and all salts, derivatives, and preparations from which cocaine or ecgonine may be synthesized or made) contained in such additional amounts of coca leaves imported under this subsection shall be destroyed under the supervision of an authorized representative of the Attorney General.

(d) Application for increased importation of ephedrine, pseudoephedrine, or phenylpropanolamine

(1) With respect to a registrant under section 958 of this title who is authorized under subsection (a)(1) to import ephedrine, pseudoephedrine, or phenylpropanolamine, at any time during the year the registrant may apply for an increase in the amount of such chemical that the registrant is authorized to import, and the Attorney General may approve the application if the Attorney General determines that the approval is necessary to provide for medical, scientific, or other legitimate purposes regarding the chemical.

(2) With respect to the application under paragraph (1):

(A) Not later than 60 days after receiving the application, the Attorney General shall approve or deny the application.

(B) In approving the application, the Attorney General shall specify the period of time for which the approval is in effect, or shall provide that the approval is effective until the registrant involved is notified in writing by the Attorney General that the approval is terminated.

(C) If the Attorney General does not approve or deny the application before the expiration of the 60-day period under subparagraph (A), the application is deemed to be approved, and such approval remains in effect until the Attorney General notifies the registrant in writing that the approval is terminated.

(e) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine

Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.

(Pub. L. 91–513, title III, §1002, Oct. 27, 1970, 84 Stat. 1285; Pub. L. 95–633, title I, §105, Nov. 10, 1978, 92 Stat. 3772; Pub. L. 98–473, title II, §§519–521, Oct. 12, 1984, 98 Stat. 2075; Pub. L. 109–177, title VII, §715, Mar. 9, 2006, 120 Stat. 264.)

Editorial Notes

References in Text

Schedules I, II, III, IV, and V, referred to in subsecs. (a) and (b), are set out in section 812(c) of this title.

Amendments

2006—Subsec. (a). Pub. L. 109–177, §715(1)(A), inserted "or ephedrine, pseudoephedrine, or phenylpropanolamine," after "schedule III, IV, or V of subchapter I," in introductory provisions.

Subsec. (a)(1). Pub. L. 109–177, §715(1)(B), inserted ", and of ephedrine, pseudoephedrine, and phenylpropanolamine," after "coca leaves".

Subsecs. (d), (e). Pub. L. 109–177, §715(2), added subsecs. (d) and (e).

1984—Subsec. (a)(1). Pub. L. 98–473, §519, amended par. (1) generally, inserting references to poppy straw and concentrate of poppy straw.

Subsec. (a)(2)(C). Pub. L. 98–473, §520, added subpar. (C).

Subsec. (b)(2). Pub. L. 98–473, §521, substituted "is imported pursuant to such notification, or declaration, or in the case of any nonnarcotic controlled substance in schedule III, such import permit, notification, or declaration, as the Attorney General may by regulation prescribe, except that if a nonnarcotic controlled substance in schedule IV or V is also listed in schedule I or II of the Convention on Psychotropic Substances it shall be imported pursuant to such import permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention" for "is imported pursuant to such notification or declaration requirements as the Attorney General may by regulation prescribe, except that if a nonnarcotic controlled substance in schedule III, IV, or V is also listed in schedule I or II of the Convention on Psychotropic Substances it shall be imported pursuant to such import permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention".

1978—Subsec. (b)(2). Pub. L. 95–633 inserted provision relating to exception for nonnarcotic controlled substances listed in schedule I or II of the Convention on Psychotropic Substances.

Statutory Notes and Related Subsidiaries

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.

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. § 332 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter III: PROHIBITED ACTS AND PENALTIES / Section 332: Injunction proceedings
Injunction proceedings
Status: in_force

(a) Jurisdiction of courts

The district courts of the United States and the United States courts of the Territories shall have jurisdiction, for cause shown 1 to restrain violations of section 331 of this title, except paragraphs (h), (i), and (j).

(b) Violation of injunction

In case of violation of an injunction or restraining order issued under this section, which also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the accused, by a jury.

(June 25, 1938, ch. 675, §302, 52 Stat. 1043; Pub. L. 87–781, title I, §103(d), title II, §201(c), Oct. 10, 1962, 76 Stat. 784, 793; Pub. L. 103–80, §3(d), Aug. 13, 1993, 107 Stat. 775.)

Editorial Notes

Amendments

1993—Subsec. (a). Pub. L. 103–80, §3(d)(1), struck out ", and subject to the provisions of section 17 (relating to notice to opposite party) of the Act entitled 'An Act to supplement existing laws against unlawful restraints and monopolies, and for other purposes', approved October 15, 1914, as amended (U.S.C., 1934 ed., title 28, sec. 381)," after "for cause shown".

Subsec. (b). Pub. L. 103–80, §3(d)(2), struck out at end "Such trial shall be conducted in accordance with the practice and procedure applicable in the case of proceedings subject to the provisions of section 22 of such Act of October 15, 1914, as amended (U.S.C., 1934 ed., title 28, sec. 387)."

1962—Subsec. (a). Pub. L. 87–781, §103(d), struck out "(e)," after "paragraphs".

Pub. L. 87–781, §201(c), struck out "(f)," after "paragraphs".

Statutory Notes and Related Subsidiaries

Effective Date of 1962 Amendment

Amendment by section 103(c) of Pub. L. 87–781 effective on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Pub. L. 87–781, title II, §203, Oct. 10, 1962, 76 Stat. 793, provided that: "The amendments made by this title [amending this section and section 374 of this title and enacting provisions set out as notes under sections 321 and 374 of this title] shall take effect on the date of enactment of this Act [Oct. 10, 1962]."

1 So in original. Probably should be followed by a comma.
21 U.S.C. § 360ddd (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360ddd: Definitions
Definitions
Status: in_force

In this part:

(1) The term "designated medical gas" means any of the following:

(A) Oxygen that meets the standards set forth in an official compendium.

(B) Nitrogen that meets the standards set forth in an official compendium.

(C) Nitrous oxide that meets the standards set forth in an official compendium.

(D) Carbon dioxide that meets the standards set forth in an official compendium.

(E) Helium that meets the standards set forth in an official compendium.

(F) Carbon monoxide that meets the standards set forth in an official compendium.

(G) Medical air that meets the standards set forth in an official compendium.

(H) Any other medical gas deemed appropriate by the Secretary, after taking into account any investigational new drug application or investigational new animal drug application for the same medical gas submitted in accordance with regulations applicable to such applications in title 21 of the Code of Federal Regulations, unless any period of exclusivity for a new drug under section 355(c)(3)(E)(ii) of this title or section 355(j)(5)(F)(ii) of this title, or the extension of any such period under section 355a of this title, or any period of exclusivity for a new animal drug under section 360b(c)(2)(F) of this title, applicable to such medical gas has not expired.

(2) The term "medical gas" means a drug that—

(A) is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; and

(B) is administered as a gas.

(June 25, 1938, ch. 675, §575, as added Pub. L. 112–144, title XI, §1111, July 9, 2012, 126 Stat. 1108; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(R), Dec. 13, 2016, 130 Stat. 1155.)

Editorial Notes

Amendments

2016—Par. (1)(H). Pub. L. 114–255 inserted "for a new drug" after "any period of exclusivity" and "or any period of exclusivity for a new animal drug under section 360b(c)(2)(F) of this title," after "section 355a of this title,".

Statutory Notes and Related Subsidiaries

Changes to Regulations

Pub. L. 112–144, title XI, §1112, July 9, 2012, 126 Stat. 1111, provided that:

"(a) Report.—Not later than 18 months after the date of the enactment of this Act [July 9, 2012], the Secretary, after obtaining input from medical gas manufacturers and any other interested members of the public, shall—

"(1) determine whether any changes to the Federal drug regulations are necessary for medical gases; and

"(2) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report regarding any such changes.

"(b) Regulations.—If the Secretary determines under subsection (a) that changes to the Federal drug regulations are necessary for medical gases, the Secretary shall issue final regulations revising the Federal drug regulations with respect to medical gases not later than 48 months after the date of the enactment of this Act [July 9, 2012].

"(c) Definitions.—In this section:

"(1) The term 'Federal drug regulations' means regulations in title 21 of the Code of Federal Regulations pertaining to drugs.

"(2) The term 'medical gas' has the meaning given to such term in section 575 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ddd], as added by section 1111 of this Act.

"(3) The term 'Secretary' means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs."

Rules of Construction

Pub. L. 112–144, title XI, §1113, July 9, 2012, 126 Stat. 1112, provided that: "Nothing in this subtitle [subtitle B (§§1111–1113) of title XI of Pub. L. 112–144, enacting this section and sections 360ddd–1 and 360ddd–2 of this title and provisions set out as notes under this section] and the amendments made by this subtitle applies with respect to—

"(1) a drug that is approved prior to May 1, 2012, pursuant to an application submitted under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b);

"(2) any gas listed in subparagraphs (A) through (G) of section 575(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360ddd(1)], as added by section 1111 of this Act, or any combination of any such gases, for an indication that—

"(A) is not included in, or is different from, those specified in subclauses (I) through (VII) of section 576(a)(3)(A)(i) of such Act [21 U.S.C. 360ddd–1(a)(3)(A)(i)]; and

"(B) is approved on or after May 1, 2012, pursuant to an application submitted under section 505 or 512 [21 U.S.C. 355, 360b]; or

"(3) any designated medical gas added pursuant to subparagraph (H) of section 575(1) of such Act [21 U.S.C. 360ddd(1)] for an indication that—

"(A) is not included in, or is different from, those originally added pursuant to subparagraph (H) of section 575(1) [21 U.S.C. 360ddd(1)(H)] and section 576(a)(3)(A)(i)(VIII) [21 U.S.C. 360ddd–1(a)(3)(A)(i)(VIII)]; and

"(B) is approved on or after May 1, 2012, pursuant to an application submitted under section 505 or 512 of such Act [21 U.S.C. 355, 360b]."