21 U.S.C. § 960 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter II: IMPORT AND EXPORT / Section 960: Prohibited acts A
Prohibited acts A
Status: in_force

(a) Unlawful acts

Any person who—

(1) contrary to section 825, 952, 953, or 957 of this title, knowingly or intentionally imports or exports a controlled substance,

(2) contrary to section 955 of this title, knowingly or intentionally brings or possesses on board a vessel, aircraft, or vehicle a controlled substance, or

(3) contrary to section 959 of this title, manufactures, possesses with intent to distribute, or distributes a controlled substance,

shall be punished as provided in subsection (b).

(b) Penalties

(1) In the case of a violation of subsection (a) of this section involving—

(A) 1 kilogram or more of a mixture or substance containing a detectable amount of heroin;

(B) 5 kilograms or more of a mixture or substance containing a detectable amount of—

(i) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed;

(ii) cocaine, its salts, optical and geometric isomers, and salts or isomers;

(iii) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or

(iv) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in clauses (i) through (iii);

(C) 280 grams or more of a mixture or substance described in subparagraph (B) which contains cocaine base;

(D) 100 grams or more of phencyclidine (PCP) or 1 kilogram or more of a mixture or substance containing a detectable amount of phencyclidine (PCP);

(E) 10 grams or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD);

(F) 400 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [1- ( 2-phenylethyl ) -4-piperidinyl] propanamide or 100 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;

(G) 1000 kilograms or more of a mixture or substance containing a detectable amount of marihuana; or

(H) 50 grams or more of methamphetamine, its salts, isomers, and salts of its isomers or 500 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers.1

the person committing such violation shall be sentenced to a term of imprisonment of not less than 10 years and not more than life and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than 20 years and not more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $10,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment of not less than 15 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $20,000,000 if the defendant is an individual or $75,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, any sentence under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 5 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 10 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under this paragraph. No person sentenced under this paragraph shall be eligible for parole during the term of imprisonment imposed therein.

(2) In the case of a violation of subsection (a) of this section involving—

(A) 100 grams or more of a mixture or substance containing a detectable amount of heroin;

(B) 500 grams or more of a mixture or substance containing a detectable amount of—

(i) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed;

(ii) cocaine, its salts, optical and geometric isomers, and salts or isomers;

(iii) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or

(iv) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in clauses (i) through (iii);

(C) 28 grams or more of a mixture or substance described in subparagraph (B) which contains cocaine base;

(D) 10 grams or more of phencyclidine (PCP) or 100 grams or more of a mixture or substance containing a detectable amount of phencyclidine (PCP);

(E) 1 gram or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD);

(F) 40 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [1- ( 2-phenylethyl ) -4-piperidinyl] propanamide or 10 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide;

(G) 100 kilograms or more of a mixture or substance containing a detectable amount of marihuana; or

(H) 5 grams or more of methamphetamine, its salts, isomers, and salts of its isomers or 50 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers.1

the person committing such violation shall be sentenced to a term of imprisonment of not less than 5 years and not more than 40 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than twenty years and not more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $5,000,000 if the defendant is an individual or $25,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment of not less than 10 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $8,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, any sentence imposed under this paragraph shall, in the absence of such a prior conviction, include a term of supervised release of at least 4 years in addition to such term of imprisonment and shall, if there was such a prior conviction, include a term of supervised release of at least 8 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under this paragraph. No person sentenced under this paragraph shall be eligible for parole during the term of imprisonment imposed therein.

(3) In the case of a violation under subsection (a) of this section involving a controlled substance in schedule I or II, gamma hydroxybutyric acid (including when scheduled as an approved drug product for purposes of section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000), or flunitrazepam, the person committing such violation shall, except as provided in paragraphs (1), (2), and (4), be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than twenty years and not more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18 or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 30 years and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18 or $2,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 3 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 6 years in addition to such term of imprisonment. Notwithstanding the prior sentence, and notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under the provisions of this paragraph which provide for a mandatory term of imprisonment if death or serious bodily injury results.

(4) In the case of a violation under subsection (a) with respect to less than 50 kilograms of marihuana, except in the case of 100 or more marihuana plants regardless of weight, less than 10 kilograms of hashish, or less than one kilogram of hashish oil, the person committing such violation shall be sentenced in accordance with section 841(b)(1)(D) of this title.

(5) In the case of a violation of subsection (a) involving a controlled substance in schedule III, such person shall be sentenced in accordance with section 841(b)(1) of this title.

(6) In the case of a violation of subsection (a) involving a controlled substance in schedule IV, such person shall be sentenced in accordance with section 841(b)(2) of this title.

(7) In the case of a violation of subsection (a) involving a controlled substance in schedule V, such person shall be sentenced in accordance with section 841(b)(3) of this title.

(c) Repealed. Pub. L. 98–473, title II, §225, formerly §225(a), Oct. 12, 1984, 98 Stat. 2030, as amended by Pub. L. 99–570, title I, §1005(c), Oct. 27, 1986, 100 Stat. 3207–6

(d) Penalty for importation or exportation

A person who knowingly or intentionally—

(1) imports or exports a listed chemical with intent to manufacture a controlled substance in violation of this subchapter or subchapter I;

(2) exports a listed chemical in violation of the laws of the country to which the chemical is exported or serves as a broker or trader for an international transaction involving a listed chemical, if the transaction is in violation of the laws of the country to which the chemical is exported;

(3) imports or exports a listed chemical knowing, or having reasonable cause to believe, that the chemical will be used to manufacture a controlled substance in violation of this subchapter or subchapter I;

(4) exports a listed chemical, or serves as a broker or trader for an international transaction involving a listed chemical, knowing, or having reasonable cause to believe, that the chemical will be used to manufacture a controlled substance in violation of the laws of the country to which the chemical is exported;

(5) imports or exports a listed chemical, with the intent to evade the reporting or recordkeeping requirements of section 971 of this title applicable to such importation or exportation by falsely representing to the Attorney General that the importation or exportation qualifies for a waiver of the 15-day notification requirement granted pursuant to paragraph (2) or (3) of section 971(f) of this title by misrepresenting the actual country of final destination of the listed chemical or the actual listed chemical being imported or exported;

(6) imports a listed chemical in violation of section 952 of this title, imports or exports such a chemical in violation of section 957 or 971 of this title, or transfers such a chemical in violation of section 971(d) of this title; or

(7) manufactures, possesses with intent to distribute, or distributes a listed chemical in violation of section 959 of this title.2

shall be fined in accordance with title 18, imprisoned not more than 20 years in the case of a violation of paragraph (1) or (3) involving a list I chemical or not more than 10 years in the case of a violation of this subsection other than a violation of paragraph (1) or (3) involving a list I chemical, or both.

(Pub. L. 91–513, title III, §1010, Oct. 27, 1970, 84 Stat. 1290; Pub. L. 98–473, title II, §§225, formerly §225(a), 504, Oct. 12, 1984, 98 Stat. 2030, 2070; Pub. L. 99–570, title I, §§1004(a), 1005(c), 1302, 1866(e), Oct. 27, 1986, 100 Stat. 3207–6, 3207–15, 3207–55; Pub. L. 100–690, title VI, §§6053(c), 6475, Nov. 18, 1988, 102 Stat. 4315, 4380; Pub. L. 101–647, title XII, §1204, title XXXV, §3599J, Nov. 29, 1990, 104 Stat. 4830, 4932; Pub. L. 103–200, §§4(b), 5(b), Dec. 17, 1993, 107 Stat. 2338, 2339; Pub. L. 103–322, title IX, §90105(a), title XXXIII, §330024(d)(2), Sept. 13, 1994, 108 Stat. 1987, 2151; Pub. L. 104–237, title I, §102(c), title III, §302(b), Oct. 3, 1996, 110 Stat. 3100, 3105; Pub. L. 104–305, §2(b)(2)(B), (C), Oct. 13, 1996, 110 Stat. 3807; Pub. L. 105–277, div. E, §2(b), Oct. 21, 1998, 112 Stat. 2681–759; Pub. L. 106–172, §3(b)(2), Feb. 18, 2000, 114 Stat. 9; Pub. L. 107–273, div. B, title III, §3005(b), Nov. 2, 2002, 116 Stat. 1806; Pub. L. 109–177, title VII, §§716(b)(1)(A), 717, Mar. 9, 2006, 120 Stat. 267; Pub. L. 110–425, §3(i), Oct. 15, 2008, 122 Stat. 4832; Pub. L. 111–220, §§2(b), 4(b), Aug. 3, 2010, 124 Stat. 2372; Pub. L. 113–260, §3(b), Dec. 18, 2014, 128 Stat. 2931; Pub. L. 115–391, title IV, §401(b), Dec. 21, 2018, 132 Stat. 5221.)

Editorial Notes

References in Text

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

Section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Prohibition Act of 2000, referred to in subsec. (b)(3), is section 3(a)(1)(B) of Pub. L. 106–172, which is set out in a note under section 812 of this title.

Amendments

2018—Subsec. (b)(1). Pub. L. 115–391, §401(b)(1), in concluding provisions, substituted "If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment of not less than 15 years" for "If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not less than 20 years".

Subsec. (b)(2). Pub. L. 115–391, §401(b)(2), substituted "serious drug felony or serious violent felony" for "felony drug offense" in concluding provisions.

2014—Subsec. (a)(1). Pub. L. 113–260 inserted "825," before "952".

2010—Subsec. (b)(1). Pub. L. 111–220, §4(b)(1), in concluding provisions, substituted "$10,000,000" for "$4,000,000", "$50,000,000" for "$10,000,000", "$20,000,000" for "$8,000,000", and "$75,000,000" for "$20,000,000".

Subsec. (b)(1)(C). Pub. L. 111–220, §2(b)(1), substituted "280 grams" for "50 grams".

Subsec. (b)(2). Pub. L. 111–220, §4(b)(2), in concluding provisions, substituted "$5,000,000" for "$2,000,000", "$25,000,000" for "$5,000,000", "$8,000,000" for "$4,000,000", and "$50,000,000" for "$10,000,000".

Subsec. (b)(2)(C). Pub. L. 111–220, §2(b)(2), substituted "28 grams" for "5 grams".

2008—Subsec. (b)(3). Pub. L. 110–425, §3(i)(3), struck out before period at end ", nor shall a person so sentenced be eligible for parole during the term of such a sentence".

Subsec. (b)(4). Pub. L. 110–425, §3(i)(1), inserted "or" after "hashish,", struck out "or any quantity of a controlled substance in schedule III, IV, or V, (except a violation involving flunitrazepam and except a violation involving gamma hydroxybutyric acid)" after "hashish oil,", and substituted "sentenced in accordance with section 841(b)(1)(D) of this title" for "imprisoned not more than five years, or be fined not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both. If a sentence under this paragraph provides for imprisonment, the sentence shall, notwithstanding section 3583 of title 18, in addition to such term of imprisonment, include (A) a term of supervised release of not less than two years if such controlled substance is in schedule I, II, III, or (B) a term of supervised release of not less than one year if such controlled substance is in schedule IV".

Subsec. (b)(5) to (7). Pub. L. 110–425, §3(i)(2), added pars. (5) to (7).

2006—Subsec. (d)(5). Pub. L. 109–177, §716(b)(1)(A), substituted "paragraph (2) or (3) of section 971(f) of this title" for "section 971(e)(2) or (3) of this title".

Subsec. (d)(6). Pub. L. 109–177, §717, amended par. (6) generally. Prior to amendment, par. (6) read as follows: "imports or exports a listed chemical in violation of section 957 or 971 of this title; or".

2002—Subsec. (b)(1), (2). Pub. L. 107–273, §3005(b)(1), substituted "Notwithstanding section 3583 of title 18, any sentence" for "Any sentence" in concluding provisions.

Subsec. (b)(3). Pub. L. 107–273, §3005(b)(1), substituted "Notwithstanding section 3583 of title 18, any sentence" for "Any sentence".

Subsec. (b)(4). Pub. L. 107–273, §3005(b)(2), inserted "notwithstanding section 3583 of title 18," before "in addition to such term of imprisonment".

2000—Subsec. (b)(3). Pub. L. 106–172, §3(b)(2)(A), inserted "gamma hydroxybutyric acid (including when scheduled as an approved drug product for purposes of section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000)," after "schedule I or II," in first sentence.

Subsec. (b)(4). Pub. L. 106–172, §3(b)(2)(B), substituted "flunitrazepam and except a violation involving gamma hydroxybutyric acid)" for "flunitrazepam)".

1998—Subsec. (b)(1)(H). Pub. L. 105–277, §2(b)(1), substituted "50 grams" and "500 grams" for "100 grams" and "1 kilogram", respectively.

Subsec. (b)(2)(H). Pub. L. 105–277, §2(b)(2), substituted "5 grams" and "50 grams" for "10 grams" and "100 grams", respectively.

1996—Subsec. (b)(3). Pub. L. 104–305, §2(b)(2)(B), inserted "or flunitrazepam," after "schedule I or II,".

Subsec. (b)(4). Pub. L. 104–305, §2(b)(2)(C), inserted "(except a violation involving flunitrazepam)" after "schedule III, IV, or V,".

Subsec. (d). Pub. L. 104–237, §302(b), in closing provisions, substituted "not more than 20 years in the case of a violation of paragraph (1) or (3) involving a list I chemical or not more than 10 years in the case of a violation of this subsection other than a violation of paragraph (1) or (3) involving a list I chemical," for "not more than 10 years,".

Subsec. (d)(7). Pub. L. 104–237, §102(c), added par. (7).

1994—Subsec. (b)(1), (2). Pub. L. 103–322, §90105(a), in sentence in concluding provisions beginning "If any person commits", substituted "a prior conviction for a felony drug offense has become final" for "one or more prior convictions for an offense punishable under this subsection, or for a felony under any other provision of this subchapter or subchapter I of this chapter or other law of a State, the United States, or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final".

Subsec. (b)(3). Pub. L. 103–322, §90105(a), in sentence beginning "If any person commits", substituted "a prior conviction for a felony drug offense has become final" for "one or more prior convictions for an offense punishable under this subsection, or for a felony under any other provision of this subchapter or subchapter I of this chapter or other law of a State, the United States or a foreign country relating to narcotic drugs, marihuana, or depressant or stimulant substances, have become final".

Subsec. (d)(5), (6). Pub. L. 103–322, §330024(d)(2), amended directory language of Pub. L. 103–200, §5(b)(3). See 1993 Amendment note below.

1993—Subsec. (d). Pub. L. 103–200, §5(b), as amended by Pub. L. 103–322, §330024(d)(2), added pars. (5) and (6).

Pub. L. 103–200, §4(b), amended subsec. (d) generally. Prior to amendment, subsec. (d) read as follows: "Any person who knowingly or intentionally—

"(1) imports or exports a listed chemical with intent to manufacture a controlled substance in violation of this subchapter or, in the case of an exportation, in violation of the law of the country to which the chemical is exported; or

"(2) imports or exports a listed chemical knowing, or having reasonable cause to believe, that the listed chemical will be used to manufacture a controlled substance in violation of this subchapter or, in the case of an exportation, in violation of the law of the country to which the chemical is exported;

shall be fined in accordance with title 18, or imprisoned not more than 10 years, or both."

1990—Subsec. (b)(1)(H). Pub. L. 101–647, §1204(a), added subpar. (H).

Subsec. (b)(2). Pub. L. 101–647, §3599J, substituted "supervised" for "suspervised" in two places in concluding provisions.

Subsec. (b)(2)(H). Pub. L. 101–647, §1204(b), added subpar. (H).

1988—Subsec. (a)(3). Pub. L. 100–690, §6475, substituted "manufactures, possesses with intent to distribute, or distributes a controlled substance" for "manufactures or distributes a controlled substance".

Subsec. (d). Pub. L. 100–690, §6053(c), added subsec. (d).

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

Subsec. (b)(1), (2). Pub. L. 99–570, §1302(a)(2), added pars. (1) and (2) and struck out former pars. (1) and (2) which read as follows:

"(1) In the case of a violation under subsection (a) of this section involving—

"(A) 100 grams or more of a mixture or substance containing a detectable amount of a narcotic drug in schedule I or II other than a narcotic drug consisting of—

"(i) coca leaves;

"(ii) a compound, manufacture, salt, derivative, or preparation of coca leaves; or

"(iii) a substance chemically identical thereto;

"(B) a kilogram or more of any other narcotic drug in schedule I or II;

"(C) 500 grams or more of phencyclidine (PCP);

"(D) 5 grams or more of lysergic acid diethylamide (LSD);

the person committing such violation shall be imprisoned for not more than twenty years, or fined not more than $250,000, or both.

"(2) In the case of a violation under subsection (a) of this section with respect to a controlled substance in schedule I or II, the person committing such violation shall, except as provided in paragraphs (1) and (3), be imprisoned not more than fifteen years, or fined not more than $125,000, or both. If a sentence under this paragraph provides for imprisonment, the sentence shall include a special parole term of not less than three years in addition to such term of imprisonment."

Subsec. (b)(3). Pub. L. 99–570, §1302(a)(2), added par. (3). Former par. (3) redesignated (4).

Subsec. (b)(4). Pub. L. 99–570, §1302(a)(1), (3), (b)(2), (3), redesignated former par. (3) as (4), inserted "except in the case of 100 or more marihuana plants regardless of weight," and substituted "fined not to exceed the greater of that authorized in accordance with the provisions of title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual" for "fined not more than $50,000".

Pub. L. 99–570, §§1302(b)(1), 1866(e), made identical amendment striking out ", except as provided in paragraph (4)" after "such violation shall".

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

Subsec. (c). Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term" wherever appearing, effective Nov. 1, 1987, the effective date of the repeal of subsec. (c) by Pub. L. 98–473, §225. See 1984 Amendment note below.

1984—Subsec. (b). Pub. L. 98–473, §225(a), which directed amendment of this subsection effective Nov. 1, 1987 (see section 235(a)(1) of Pub. L. 98–473 set out as an Effective Date note under section 3551 of Title 18, Crimes and Criminal Procedure) was omitted in the general amendment of section 225 of Pub. L. 98–473 by Pub. L. 99–570, §1005(c).

Subsec. (b)(1). Pub. L. 98–473, §504(1), added par. (1). Former par. (1) redesignated (2).

Subsec. (b)(2). Pub. L. 98–473, §504(1), (2), redesignated former par. (1) as (2), inserted provisions excepting pars. (1) and (3), and substituted reference to controlled substance for reference to narcotic drug, and "$125,000" for "$25,000". Former par. (2) redesignated (3).

Subsec. (b)(3). Pub. L. 98–473, §504(1), (3), redesignated former par. (2) as (3) and substituted "less than 50 kilograms of marihuana, less than 10 kilograms of hashish, less than one kilogram of hashish oil, or any quantity of a controlled substance in schedule III, IV, or V, the person committing such violation shall, except as provided in paragraph (4)" for "a controlled substance other than a narcotic drug in schedule I or II, the person committing such violation shall", and "$50,000" for "$15,000".

Subsec. (c). Pub. L. 98–473, §225, as amended by Pub. L. 99–570, §1005(c), struck out subsec. (c) which related to special parole terms imposed under this section or section 962 of this title. Notwithstanding directory language that the amendment be made to "Section 1515 of the Controlled Substances Import and Export Act (21 U.S.C. 960)", the amendment was executed to this section as the probable intent of Congress.

Statutory Notes and Related Subsidiaries

Effective Date of 2018 Amendment

Amendment by Pub. L. 115–391 applicable to any offense that was committed before Dec. 21, 2018, if a sentence for the offense has not been imposed as of Dec. 21, 2018, see section 401(c) of Pub. L. 115–391, set out as a note under section 802 of this title.

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.

Effective Date of 1994 Amendment

Amendment by section 330024(d)(2) of Pub. L. 103–322 effective 120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103–322, set out as a note under section 802 of this title.

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.

Effective Date of 1988 Amendment

Amendment by section 6053(c) of Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Effective Date of 1986 Amendment

Amendment by section 1004(a) of Pub. L. 99–570 effective on date of taking effect of section 3583 of Title 18, Crimes and Criminal Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99–570 set out as a note under section 841 of this title.

Effective Date of 1984 Amendment

Amendment by section 225 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 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title.

1 So in original. The period probably should be a semicolon.

2 So in original. The period probably should be a comma.
21 U.S.C. § 387p (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387p: Preservation of State and local authority
Preservation of State and local authority
Status: in_force

(a) In general

(1) Preservation

Except as provided in paragraph (2)(A), nothing in this subchapter, or rules promulgated under this subchapter, shall be construed to limit the authority of a Federal agency (including the Armed Forces), a State or political subdivision of a State, or the government of an Indian tribe to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to tobacco products that is in addition to, or more stringent than, requirements established under this subchapter, including a law, rule, regulation, or other measure relating to or prohibiting the sale, distribution, possession, exposure to, access to, advertising and promotion of, or use of tobacco products by individuals of any age, information reporting to the State, or measures relating to fire safety standards for tobacco products. No provision of this subchapter shall limit or otherwise affect any State, tribal, or local taxation of tobacco products.

(2) Preemption of certain State and local requirements

(A) In general

No State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this subchapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products.

(B) Exception

Subparagraph (A) does not apply to requirements relating to the sale, distribution, possession, information reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco products by individuals of any age, or relating to fire safety standards for tobacco products. Information disclosed to a State under subparagraph (A) that is exempt from disclosure under section 552(b)(4) of title 5 shall be treated as a trade secret and confidential information by the State.

(b) Rule of construction regarding product liability

No provision of this subchapter relating to a tobacco product shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.

(June 25, 1938, ch. 675, §916, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1823.)
21 U.S.C. § 348 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 348: Food additives
Food additives
Status: in_force

(a) Unsafe food additives; exception for conformity with exemption or regulation

A food additive shall, with respect to any particular use or intended use of such additives, be deemed to be unsafe for the purposes of the application of clause (2)(C) of section 342(a) of this title, unless—

(1) it and its use or intended use conform to the terms of an exemption which is in effect pursuant to subsection (j) of this section;

(2) there is in effect, and it and its use or intended use are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or

(3) in the case of a food additive as defined in this chapter that is a food contact substance, there is—

(A) in effect, and such substance and the use of such substance are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or

(B) a notification submitted under subsection (h) that is effective.

While such a regulation relating to a food additive, or such a notification under subsection (h)(1) relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i), a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or notification, be considered adulterated under section 342(a)(1) of this title.

(b) Petition for regulation prescribing conditions of safe use; contents; description of production methods and controls; samples; notice of regulation

(1) Any person may, with respect to any intended use of a food additive, file with the Secretary a petition proposing the issuance of a regulation prescribing the conditions under which such additive may be safely used.

(2) Such petition shall, in addition to any explanatory or supporting data, contain—

(A) the name and all pertinent information concerning such food additive, including, where available, its chemical identity and composition;

(B) a statement of the conditions of the proposed use of such additive, including all directions, recommendations, and suggestions proposed for the use of such additive, and including specimens of its proposed labeling;

(C) all relevant data bearing on the physical or other technical effect such additive is intended to produce, and the quantity of such additive required to produce such effect;

(D) a description of practicable methods for determining the quantity of such additive in or on food, and any substance formed in or on food, because of its use; and

(E) full reports of investigations made with respect to the safety for use of such additive, including full information as to the methods and controls used in conducting such investigations.

(3) Upon request of the Secretary, the petitioner shall furnish (or, if the petitioner is not the manufacturer of such additive, the petitioner shall have the manufacturer of such additive furnish, without disclosure to the petitioner) a full description of the methods used in, and the facilities and controls used for, the production of such additive.

(4) Upon request of the Secretary, the petitioner shall furnish samples of the food additive involved, or articles used as components thereof, and of the food in or on which the additive is proposed to be used.

(5) Notice of the regulation proposed by the petitioner shall be published in general terms by the Secretary within thirty days after filing.

(c) Approval or denial of petition; time for issuance of order; evaluation of data; factors

(1) The Secretary shall—

(A) by order establish a regulation (whether or not in accord with that proposed by the petitioner) prescribing, with respect to one or more proposed uses of the food additive involved, the conditions under which such additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or in which such additive may be used, the maximum quantity which may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use), and shall notify the petitioner of such order and the reasons for such action; or

(B) by order deny the petition, and shall notify the petitioner of such order and of the reasons for such action.

(2) The order required by paragraph (1)(A) or (B) of this subsection shall be issued within ninety days after the date of filing of the petition, except that the Secretary may (prior to such ninetieth day), by written notice to the petitioner, extend such ninety-day period to such time (not more than one hundred and eighty days after the date of filing of the petition) as the Secretary deems necessary to enable him to study and investigate the petition.

(3) No such regulation shall issue if a fair evaluation of the data before the Secretary—

(A) fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe: Provided, That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal, except that this proviso shall not apply with respect to the use of a substance as an ingredient of feed for animals which are raised for food production, if the Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and (ii) that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (f) and (g)) in any edible portion of such animal after slaughter or in any food yielded by or derived from the living animal; or

(B) shows that the proposed use of the additive would promote deception of the consumer in violation of this chapter or would otherwise result in adulteration or in misbranding of food within the meaning of this chapter.

(4) If, in the judgment of the Secretary, based upon a fair evaluation of the data before him, a tolerance limitation is required in order to assure that the proposed use of an additive will be safe, the Secretary—

(A) shall not fix such tolerance limitation at a level higher than he finds to be reasonably required to accomplish the physical or other technical effect for which such additive is intended; and

(B) shall not establish a regulation for such proposed use if he finds upon a fair evaluation of the data before him that such data do not establish that such use would accomplish the intended physical or other technical effect.

(5) In determining, for the purposes of this section, whether a proposed use of a food additive is safe, the Secretary shall consider among other relevant factors—

(A) the probable consumption of the additive and of any substance formed in or on food because of the use of the additive;

(B) the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet; and

(C) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.

(d) Regulation issued on Secretary's initiative

The Secretary may at any time, upon his own initiative, propose the issuance of a regulation prescribing, with respect to any particular use of a food additive, the conditions under which such additive may be safely used, and the reasons therefor. After the thirtieth day following publication of such a proposal, the Secretary may by order establish a regulation based upon the proposal.

(e) Publication and effective date of orders

Any order, including any regulation established by such order, issued under subsection (c) or (d) of this section, shall be published and shall be effective upon publication, but the Secretary may stay such effectiveness if, after issuance of such order, a hearing is sought with respect to such order pursuant to subsection (f).

(f) Objections and public hearing; basis and contents of order; statement

(1) Within thirty days after publication of an order made pursuant to subsection (c) or (d) of this section, any person adversely affected by such an order may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections. The Secretary shall, after due notice, as promptly as possible hold such public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public.

(2) Such order shall be based upon a fair evaluation of the entire record at such hearing, and shall include a statement setting forth in detail the findings and conclusions upon which the order is based.

(3) The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication, unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions.

(g) Judicial review

(1) In a case of actual controversy as to the validity of any order issued under subsection (f), including any order thereunder with respect to amendment or repeal of a regulation issued under this section, any person who will be adversely affected by such order may obtain judicial review by filing in the United States Court of Appeals for the circuit wherein such person resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit, within sixty days after the entry of such order, a petition praying that the order be set aside in whole or in part.

(2) A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary, or any officer designated by him for that purpose, and thereupon the Secretary shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28. Upon the filing of such petition the court shall have jurisdiction, which upon the filing of the record with it shall be exclusive, to affirm or set aside the order complained of in whole or in part. Until the filing of the record the Secretary may modify or set aside his order. The findings of the Secretary with respect to questions of fact shall be sustained if based upon a fair evaluation of the entire record at such hearing.

(3) The court, on such judicial review, shall not sustain the order of the Secretary if he failed to comply with any requirement imposed on him by subsection (f)(2) of this section.

(4) If application is made to the court for leave to adduce additional evidence, the court may order such additional evidence to be taken before the Secretary and to be adduced upon the hearing in such manner and upon such terms and conditions as to the court may seem proper, if such evidence is material and there were reasonable grounds for failure to adduce such evidence in the proceedings below. The Secretary may modify his findings as to the facts and order by reason of the additional evidence so taken, and shall file with the court such modified findings and order.

(5) The judgment of the court affirming or setting aside, in whole or in part, any order under this section shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28. The commencement of proceedings under this section shall not, unless specifically ordered by the court to the contrary, operate as a stay of an order.

(h) Notification relating to food contact substance

(1) Subject to such regulations as may be promulgated under paragraph (3), a manufacturer or supplier of a food contact substance may, at least 120 days prior to the introduction or delivery for introduction into interstate commerce of the food contact substance, notify the Secretary of the identity and intended use of the food contact substance, and of the determination of the manufacturer or supplier that the intended use of such food contact substance is safe under the standard described in subsection (c)(3)(A). The notification shall contain the information that forms the basis of the determination and all information required to be submitted by regulations promulgated by the Secretary.

(2)(A) A notification submitted under paragraph (1) shall become effective 120 days after the date of receipt by the Secretary and the food contact substance may be introduced or delivered for introduction into interstate commerce, unless the Secretary makes a determination within the 120-day period that, based on the data and information before the Secretary, such use of the food contact substance has not been shown to be safe under the standard described in subsection (c)(3)(A), and informs the manufacturer or supplier of such determination.

(B) A decision by the Secretary to object to a notification shall constitute final agency action subject to judicial review.

(C) In this paragraph, the term "food contact substance" means the substance that is the subject of a notification submitted under paragraph (1), and does not include a similar or identical substance manufactured or prepared by a person other than the manufacturer identified in the notification.

(3)(A) The process in this subsection shall be utilized for authorizing the marketing of a food contact substance except where the Secretary determines that submission and review of a petition under subsection (b) is necessary to provide adequate assurance of safety, or where the Secretary and any manufacturer or supplier agree that such manufacturer or supplier may submit a petition under subsection (b).

(B) The Secretary is authorized to promulgate regulations to identify the circumstances in which a petition shall be filed under subsection (b), and shall consider criteria such as the probable consumption of such food contact substance and potential toxicity of the food contact substance in determining the circumstances in which a petition shall be filed under subsection (b).

(4) The Secretary shall keep confidential any information provided in a notification under paragraph (1) for 120 days after receipt by the Secretary of the notification. After the expiration of such 120 days, the information shall be available to any interested party except for any matter in the notification that is a trade secret or confidential commercial information.

(5)(A)(i) Except as provided in clause (ii), the notification program established under this subsection shall not operate in any fiscal year unless—

(I) an appropriation equal to or exceeding the applicable amount under clause (iv) is made for such fiscal year for carrying out such program in such fiscal year; and

(II) the Secretary certifies that the amount appropriated for such fiscal year for the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to in subclause (I)) equals or exceeds the amount appropriated for the Center for fiscal year 1997, excluding any amount appropriated for new programs.

(ii) The Secretary shall, not later than April 1, 1999, begin accepting and reviewing notifications submitted under the notification program established under this subsection if—

(I) an appropriation equal to or exceeding the applicable amount under clause (iii) is made for the last six months of fiscal year 1999 for carrying out such program during such period; and

(II) the Secretary certifies that the amount appropriated for such period for the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (exclusive of the appropriation referred to in subclause (I)) equals or exceeds an amount equivalent to one-half the amount appropriated for the Center for fiscal year 1997, excluding any amount appropriated for new programs.

(iii) For the last six months of fiscal year 1999, the applicable amount under this clause is $1,500,000, or the amount specified in the budget request of the President for the six-month period involved for carrying out the notification program in fiscal year 1999, whichever is less.

(iv) For fiscal year 2000 and subsequent fiscal years, the applicable amount under this clause is $3,000,000, or the amount specified in the budget request of the President for the fiscal year involved for carrying out the notification program under this subsection, whichever is less.

(B) For purposes of carrying out the notification program under this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1999 through fiscal year 2003, except that such authorization of appropriations is not effective for a fiscal year for any amount that is less than the applicable amount under clause (iii) or (iv) of subparagraph (A), whichever is applicable.

(C) Not later than April 1 of fiscal year 1998 and February 1 of each subsequent fiscal year, the Secretary shall submit a report to the Committees on Appropriations of the House of Representatives and the Senate, the Committee on Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate that provides an estimate of the Secretary of the costs of carrying out the notification program established under this subsection for the next fiscal year.

(6) In this section, the term "food contact substance" means any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.

(i) Amendment or repeal of regulations

The Secretary shall by regulation prescribe the procedure by which regulations under the foregoing provisions of this section may be amended or repealed, and such procedure shall conform to the procedure provided in this section for the promulgation of such regulations. The Secretary shall by regulation prescribe the procedure by which the Secretary may deem a notification under subsection (h) to no longer be effective.

(j) Exemptions for investigational use

Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

(k) Food additives intended for use in animal food

(1) In taking action on a petition under subsection (c) for, or for recognition of, a food additive intended for use in animal food, the Secretary shall review reports of investigations conducted in foreign countries, provided by the petitioner.

(2) Not later than 12 months after August 14, 2018, the Secretary shall post on the internet website of the Food and Drug Administration—

(A) the number of petitions for food additives intended for use in animal food filed under subsection (b) that are pending;

(B) how long each such petition submitted under subsection (b) has been pending, including such petitions the Secretary has extended under subsection (c)(2); and

(C) the number of study protocols that have been pending review for over 50 days, and the number that have received an extension.

(3) In the case of a food additive petition intended for use in animal food, the Secretary shall provide information to the petitioner on the required contents of such petition. If the Secretary requires additional studies beyond what the petitioner proposed, the Secretary shall provide the scientific rationale for such requirement.

(June 25, 1938, ch. 675, §409, as added Pub. L. 85–929, §4, Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86–546, §2, June 29, 1960, 74 Stat. 255; Pub. L. 87–781, title I, §104(f)(1), Oct. 10, 1962, 76 Stat. 785; Pub. L. 98–620, title IV, §402(25)(B), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 105–115, title III, §309, Nov. 21, 1997, 111 Stat. 2354; Pub. L. 115–234, title III, §306(a), Aug. 14, 2018, 132 Stat. 2440.)

Editorial Notes

Amendments

2018—Subsec. (k). Pub. L. 115–234 added subsec. (k).

1997—Subsec. (a). Pub. L. 105–115, §309(a)(4), in closing provisions, substituted "While such a regulation relating to a food additive, or such a notification under subsection (h)(1) relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i), a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or notification, be considered adulterated under section 342(a)(1) of this title." for "While such a regulation relating to a food additive is in effect, a food shall not, by reason of bearing or containing such an additive in accordance with the regulation, be considered adulterated within the meaning of clause (1) of section 342(a) of this title."

Subsec. (a)(1). Pub. L. 105–115, §309(a)(1), substituted "subsection (j)" for "subsection (i)".

Subsec. (a)(3). Pub. L. 105–115, §309(a)(1)(B), (2), (3), added par. (3).

Subsec. (h). Pub. L. 105–115, §309(b)(2), added subsec. (h). Former subsec. (h) redesignated (i).

Subsec. (i). Pub. L. 105–115, §309(b)(1), (3), redesignated subsec. (h) as (i) and inserted at end "The Secretary shall by regulation prescribe the procedure by which the Secretary may deem a notification under subsection (h) to no longer be effective."

Subsec. (j). Pub. L. 105–115, §309(b)(1), (4), redesignated subsec. (i) as (j) and substituted "subsections (b) to (i)" for "subsections (b) to (h)".

1984—Subsec. (g)(2). Pub. L. 98–620 struck out provision that required the court to advance on the docket and expedite the disposition of all causes filed therein pursuant to this section.

1962—Subsec. (c)(3)(A). Pub. L. 87–781 excepted proviso from applying to use of a substance as an ingredient of feed for animals raised for food production, if under conditions of use specified in proposed labeling, and which conditions are reasonably certain to be followed in practice, such additive will not adversely affect the animals and no residue will be found in any edible portion of such animal after slaughter, or in any food from the living animal.

1960—Subsec. (g)(2). Pub. L. 86–546 substituted "forthwith transmitted by the clerk of the court to the Secretary, or any officer" for "served upon the Secretary, or upon any officer", "shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28" for "shall certify and file in the court a transcript of the proceedings and the record on which he based his order", and "Upon the filing of such petition the court shall have jurisdiction, which upon the filing of the record with it shall be exclusive," for "Upon such filing, the court shall have exclusive jurisdiction", and inserted sentence authorizing the Secretary to modify or set aside his order until the filing of the record.

Statutory Notes and Related Subsidiaries

Change of Name

Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Effective Date of 1997 Amendment

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

Effective Date of 1984 Amendment

Amendment by Pub. L. 98–620 not applicable to cases pending on Nov. 8, 1984, see section 403 of Pub. L. 98–620, set out as an Effective Date note under section 1657 of Title 28, Judiciary and Judicial Procedure.

Effective Date of 1962 Amendment; Exceptions

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as an Effective Date of 1962 Amendment note under section 321 of this title.

Effective Date

Section effective Sept. 6, 1958, see section 6(a) of Pub. L. 85–929, set out as an Effective Date of 1958 Amendment note under section 342 of this title.

Guidance on Pre-Petition Consultation Process for Animal Food Additives

Pub. L. 115–234, title III, §306(c), Aug. 14, 2018, 132 Stat. 2441, provided that:

"(1) In general.—Not later than 18 months after the date of enactment of this Act [Aug. 14, 2018], the Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall publish draft guidance relating to the voluntary pre-petition consultation process for food additives intended for use in animal food.

"(2) Contents.—The guidance under paragraph (1) shall include—

"(A) the recommended format to submit to the Food and Drug Administration existing data, including any applicable foreign data, for assessment prior to submission of a food additive petition for animal food under section 409(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 348(b)];

"(B) the manner and the number of days by which the Food and Drug Administration intends to review and respond to such existing data, including with respect to providing a scientific rationale for any additional data request;

"(C) circumstances under which the submission of study protocols is recommended prior to submission of a food additive petition under such section 409(b);

"(D) the manner in which the Secretary intends to inform the person submitting a study protocol for a food additive if the review of such study protocol will take longer than 50 days; and

"(E) best practices for communication between the Food and Drug Administration and industry on the development of pre-petition submissions of study protocols and existing data for food additives.

"(3) Final guidance.—The guidance under paragraph (1) shall be finalized, withdrawn, or reissued not later than 1 year after the close of the comment period on the draft guidance."

Glass and Ceramic Ware

Pub. L. 105–115, title III, §308, Nov. 21, 1997, 111 Stat. 2353, provided that:

"(a) In General.—The Secretary may not implement any requirement which would ban, as an unapproved food additive, lead and cadmium based enamel in the lip and rim area of glass and ceramic ware before the expiration of one year after the date such requirement is published.

"(b) Lead and Cadmium Based Enamel.—Unless the Secretary determines, based on available data, that lead and cadmium based enamel on glass and ceramic ware—

"(1) which has less than 60 millimeters of decorating area below the external rim, and

"(2) which is not, by design, representation, or custom of usage intended for use by children,

is unsafe, the Secretary shall not take any action before January 1, 2003, to ban lead and cadmium based enamel on such glass and ceramic ware. Any action taken after January 1, 2003, to ban such enamel on such glass and ceramic ware as an unapproved food additive shall be taken by regulation and such regulation shall provide that such products shall not be removed from the market before 1 year after publication of the final regulation."

Moratorium on Authority of Secretary With Respect to Saccharin

Pub. L. 95–203, §3, Nov. 23, 1977, 91 Stat. 1452, as amended by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96–273, June 17, 1980, 94 Stat. 536; Pub. L. 97–42, §2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98–22, §2, Apr. 22, 1983, 97 Stat. 173; Pub. L. 99–46, May 24, 1985, 99 Stat. 81; Pub. L. 100–71, title I, §101, July 11, 1987, 101 Stat. 431; Pub. L. 102–142, title VI, Oct. 28, 1991, 105 Stat. 910; Pub. L. 104–180, title VI, §602, Aug. 6, 1996, 110 Stat. 1594, provided that: "During the period ending May 1, 2002, the Secretary—

"(1) may not amend or revoke the interim food additive regulation of the Food and Drug Administration of the Department of Health and Human Services applicable to saccharin and published on March 15, 1977 (section 180.37 of part 180, subchapter B, chapter 1, title 21, Code of Federal Regulations (42 Fed. Reg. 14638)), or

"(2) may, except as provided in section 4 [enacting section 343a of this title, amending sections 321 and 343 of this title, and enacting provisions set out as notes under section 343 of this title] and the amendments made by such section, not take any other action under the Federal Food, Drug, and Cosmetic Act [this chapter] to prohibit or restrict the sale or distribution of saccharin, any food permitted by such interim food additive regulation to contain saccharin, or any drug or cosmetic containing saccharin,

solely on the basis of the carcinogenic or other toxic effect of saccharin as determined by any study made available to the Secretary before the date of the enactment of this Act [Nov. 23, 1977] which involved human studies or animal testing, or both."

[Definition of "saccharin" as used in section 3 of Pub. L. 95–203, set out above, to include calcium saccharin, sodium saccharin, and ammonium saccharin, see Pub. L. 95–203, §2(d), Nov. 23, 1997, 91 Stat. 1452.]
21 U.S.C. § 832 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 832: Suspicious orders
Suspicious orders
Status: in_force

(a) Reporting

Each registrant shall—

(1) design and operate a system to identify suspicious orders for the registrant;

(2) ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and

(3) upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business.

(b) Suspicious order database

(1) In general

Not later than 1 year after October 24, 2018, the Attorney General shall establish a centralized database for collecting reports of suspicious orders.

(2) Satisfaction of reporting requirements

If a registrant reports a suspicious order to the centralized database established under paragraph (1), the registrant shall be considered to have complied with the requirement under subsection (a)(3) to notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business.

(c) Sharing information with the States

(1) In general

The Attorney General shall prepare and make available information regarding suspicious orders in a State, including information in the database established under subsection (b)(1), to the point of contact for purposes of administrative, civil, and criminal oversight relating to the diversion of controlled substances for the State, as designated by the Governor or chief executive officer of the State.

(2) Timing

The Attorney General shall provide information in accordance with paragraph (1) within a reasonable period of time after obtaining the information.

(3) Coordination

In establishing the process for the provision of information under this subsection, the Attorney General shall coordinate with States to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescriptions for controlled substances that will assist in enforcing Federal law.

(Pub. L. 91–513, title II, §312, as added Pub. L. 115–271, title III, §3292(b), Oct. 24, 2018, 132 Stat. 3956.)
21 U.S.C. § 350a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 350a: Infant formulas
Infant formulas
Status: in_force

(a) Adulteration

An infant formula, including an infant formula powder, shall be deemed to be adulterated if—

(1) such infant formula does not provide nutrients as required by subsection (i),

(2) such infant formula does not meet the quality factor requirements prescribed by the Secretary under subsection (b)(1), or

(3) the processing of such infant formula is not in compliance with the good manufacturing practices and the quality control procedures prescribed by the Secretary under subsection (b)(2).

(b) Requirements for quality factors, good manufacturing practices, and retention of records

(1) The Secretary shall by regulation establish requirements for quality factors for infant formulas to the extent possible consistent with current scientific knowledge, including quality factor requirements for the nutrients required by subsection (i).

(2)(A) The Secretary shall by regulation establish good manufacturing practices for infant formulas, including quality control procedures that the Secretary determines are necessary to assure that an infant formula provides nutrients in accordance with this subsection and subsection (i) and is manufactured in a manner designed to prevent adulteration of the infant formula.

(B) The good manufacturing practices and quality control procedures prescribed by the Secretary under subparagraph (A) shall include requirements for—

(i) the testing, in accordance with paragraph (3) and by the manufacturer of an infant formula or an agent of such manufacturer, of each batch of infant formula for each nutrient required by subsection (i) before the distribution of such batch,

(ii) regularly scheduled testing, by the manufacturer of an infant formula or an agent of such manufacturer, of samples of infant formulas during the shelf life of such formulas to ensure that such formulas are in compliance with this section,

(iii) in-process controls including, where necessary, testing required by good manufacturing practices designed to prevent adulteration of each batch of infant formula, and

(iv) the conduct by the manufacturer of an infant formula or an agent of such manufacturer of regularly scheduled audits to determine that such manufacturer has complied with the regulations prescribed under subparagraph (A).

In prescribing requirements for audits under clause (iv), the Secretary shall provide that such audits be conducted by appropriately trained individuals who do not have any direct responsibility for the manufacture or production of infant formula.

(3)(A) At the final product stage, each batch of infant formula shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E to ensure that such infant formula is in compliance with the requirements of this subsection and subsection (i) relating to such vitamins.

(B) Each nutrient premix used in the manufacture of an infant formula shall be tested for each relied upon nutrient required by subsection (i) which is contained in such premix to ensure that such premix is in compliance with its specifications or certifications by a premix supplier.

(C) During the manufacturing process or at the final product stage and before distribution of an infant formula, an infant formula shall be tested for all nutrients required to be included in such formula by subsection (i) for which testing has not been conducted pursuant to subparagraph (A) or (B). Testing under this subparagraph shall be conducted to—

(i) ensure that each batch of such infant formula is in compliance with the requirements of subsection (i) relating to such nutrients, and

(ii) confirm that nutrients contained in any nutrient premix used in such infant formula are present in each batch of such infant formula in the proper concentration.

(D) If the Secretary adds a nutrient to the list of nutrients in the table in subsection (i), the Secretary shall by regulation require that the manufacturer of an infant formula test each batch of such formula for such new nutrient in accordance with subparagraph (A), (B), or (C).

(E) For purposes of this paragraph, the term "final product stage" means the point in the manufacturing process, before distribution of an infant formula, at which an infant formula is homogenous and is not subject to further degradation.

(4)(A) The Secretary shall by regulation establish requirements respecting the retention of records. Such requirements shall provide for—

(i) the retention of all records necessary to demonstrate compliance with the good manufacturing practices and quality control procedures prescribed by the Secretary under paragraph (2), including records containing the results of all testing required under paragraph (2)(B),

(ii) the retention of all certifications or guarantees of analysis by premix suppliers,

(iii) the retention by a premix supplier of all records necessary to confirm the accuracy of all premix certifications and guarantees of analysis,

(iv) the retention of—

(I) all records pertaining to the microbiological quality and purity of raw materials used in infant formula powder and in finished infant formula, and

(II) all records pertaining to food packaging materials which show that such materials do not cause an infant formula to be adulterated within the meaning of section 342(a)(2)(C) of this title,

(v) the retention of all records of the results of regularly scheduled audits conducted pursuant to the requirements prescribed by the Secretary under paragraph (2)(B)(iv), and

(vi) the retention of all complaints and the maintenance of files with respect to, and the review of, complaints concerning infant formulas which may reveal the possible existence of a hazard to health.

(B)(i) Records required under subparagraph (A) with respect to an infant formula shall be retained for at least one year after the expiration of the shelf life of such infant formula. Except as provided in clause (ii), such records shall be made available to the Secretary for review and duplication upon request of the Secretary.

(ii) A manufacturer need only provide written assurances to the Secretary that the regularly scheduled audits required by paragraph (2)(B)(iv) are being conducted by the manufacturer, and need not make available to the Secretary the actual written reports of such audits.

(c) Registration of persons distributing new infant formula

(1) No person shall introduce or deliver for introduction into interstate commerce any new infant formula unless—

(A) such person has, before introducing such new infant formula, or delivering such new infant formula for introduction, into interstate commerce, registered with the Secretary the name of such person, the place of business of such person, and all establishments at which such person intends to manufacture such new infant formula, and

(B) such person has at least 90 days before marketing such new infant formula, made the submission to the Secretary required by subsection (d)(1).

(2) For purposes of paragraph (1), the term "new infant formula" includes—

(A) an infant formula manufactured by a person which has not previously manufactured an infant formula, and

(B) an infant formula manufactured by a person which has previously manufactured infant formula and in which there is a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer.

For purposes of this paragraph, the term "major change" has the meaning given to such term in section 106.30(c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986), and guidelines issued thereunder.

(d) Submission of information about new infant formula required

(1) A person shall, with respect to any infant formula subject to subsection (c), make a submission to the Secretary which shall include—

(A) the quantitative formulation of the infant formula,

(B) a description of any reformulation of the formula or change in processing of the infant formula,

(C) assurances that the infant formula will not be marketed unless it meets the requirements of subsections (b)(1) and (i), as demonstrated by the testing required under subsection (b)(3), and

(D) assurances that the processing of the infant formula complies with subsection (b)(2).

(2) After the first production of an infant formula subject to subsection (c), and before the introduction into interstate commerce of such formula, the manufacturer of such formula shall submit to the Secretary, in such form as may be prescribed by the Secretary, a written verification which summarizes test results and records demonstrating that such formula complies with the requirements of subsections (b)(1), (b)(2)(A), (b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i).

(3) If the manufacturer of an infant formula for commercial or charitable distribution for human consumption determines that a change in the formulation of the formula or a change in the processing of the formula may affect whether the formula is adulterated under subsection (a), the manufacturer shall, before the first processing of such formula, make the submission to the Secretary required by paragraph (1).

(4) The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission.

(e) Additional notice requirements for manufacturer

(1) If the manufacturer of an infant formula has knowledge which reasonably supports the conclusion that an infant formula which has been processed by the manufacturer and which has left an establishment subject to the control of the manufacturer—

(A) may not provide the nutrients required by subsection (i), or

(B) may be otherwise adulterated or misbranded,

the manufacturer shall promptly notify the Secretary of such knowledge. If the Secretary determines that the infant formula presents a risk to human health, the manufacturer shall immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary.

(2) For purposes of paragraph (1), the term "knowledge" as applied to a manufacturer means (A) the actual knowledge that the manufacturer had, or (B) the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care.

(f) Procedures applicable to recalls by manufacturer; regulatory oversight

(1) If a recall of infant formula is begun by a manufacturer, the recall shall be carried out in accordance with such requirements as the Secretary shall prescribe under paragraph (2) and—

(A) the Secretary shall, not later than the 15th day after the beginning of such recall and at least once every 15 days thereafter until the recall is terminated, review the actions taken under the recall to determine whether the recall meets the requirements prescribed under paragraph (2), and

(B) the manufacturer shall, not later than the 14th day after the beginning of such recall and at least once every 14 days thereafter until the recall is terminated, report to the Secretary the actions taken to implement the recall.

(2) The Secretary shall by regulation prescribe the scope and extent of recalls of infant formulas necessary and appropriate for the degree of risks to human health presented by the formula subject to the recall.

(3) The Secretary shall by regulation require each manufacturer of an infant formula who begins a recall of such formula because of a risk to human health to request each retail establishment at which such formula is sold or available for sale to post at the point of purchase of such formula a notice of such recall at such establishment for such time that the Secretary determines necessary to inform the public of such recall.

(g) Recordkeeping requirements for manufacturer; regulatory oversight and enforcement

(1) Each manufacturer of an infant formula shall make and retain such records respecting the distribution of the infant formula through any establishment owned or operated by such manufacturer as may be necessary to effect and monitor recalls of the formula. Such records shall be retained for at least one year after the expiration of the shelf life of the infant formula.

(2) To the extent that the Secretary determines that records are not being made or maintained in accordance with paragraph (1), the Secretary may by regulation prescribe the records required to be made under paragraph (1) and requirements respecting the retention of such records under such paragraph. Such regulations shall take effect on such date as the Secretary prescribes but not sooner than the 180th day after the date such regulations are promulgated. Such regulations shall apply only with respect to distributions of infant formulas made after such effective date.

(h) Exemptions; regulatory oversight

(1) Any infant formula which is represented and labeled for use by an infant—

(A) who has an inborn error of metabolism or a low birth weight, or

(B) who otherwise has an unusual medical or dietary problem,

is exempt from the requirements of subsections (a), (b), and (c). The manufacturer of an infant formula exempt under this paragraph shall, in the case of the exempt formula, be required to provide the notice required by subsection (e)(1) only with respect to adulteration or misbranding described in subsection (e)(1)(B) and to comply with the regulations prescribed by the Secretary under paragraph (2).

(2) The Secretary may by regulation establish terms and conditions for the exemption of an infant formula from the requirements of subsections (a), (b), and (c). An exemption of an infant formula under paragraph (1) may be withdrawn by the Secretary if such formula is not in compliance with applicable terms and conditions prescribed under this paragraph.

(i) Nutrient requirements

(1) An infant formula shall contain nutrients in accordance with the table set out in this subsection, which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table.

(2) The Secretary may by regulation—

(A) revise the list of nutrients in the table in this subsection, and

(B) revise the required level for any nutrient required by the table.

NUTRIENTS

Nutrient Minimum aMaximum a

Protein (gm)
1.8 b

 4.5.

Fat:

gm
3.3

 6.0.

percent cal
30.0

 54.0.

Essential fatty acids   (linoleate):

percent cal
2.7

mg
300.0

Vitamins:

A (IU)
250.0 
(75 µg)c
750.0 (225 µg).c

D (IU)
40.0

100.0.

K (µg)
4.0

E (IU)
0.7 
(with 0.7 IU/gm linoleic acid)

C (ascorbic acid) (mg)
8.0

B1 (thiamine) (µg)
40.0

B2 (riboflavin) (µg)
60.0

B6 (pyridoxine) (µg)
35.0 
(with 15 µg/gm of protein in formula)

B12 (µg)
0.15

Niacin (µg)
250.0

Folic acid (µg)
4.0

Pantothenic acid (µg)
300.0

Biotin (µg)
1.5 d

Choline (mg)
7.0 d

Inositol (mg)
4.0 d

Minerals:

Calcium (mg)
50.0 e

Phosphorus (mg)
25.0 e

Magnesium (mg)
6.0

Iron (mg)
0.15

Iodine (µg)
5.0

Zinc (mg)
0.5

Copper (µg)
60.0

Manganese (µg)
5.0

Sodium (mg)
20.0

 60.0.

Potassium (mg)
80.0

200.0.

Chloride (mg)
55.0

150.0.

a Stated per 100 kilocalories.

b The source of protein shall be at least nutritionally equivalent to casein.

c Retinol equivalents.

d Required to be included in this amount only in formulas which are not milk-based.

e Calcium to phosphorus ratio must be no less than 1.1 nor more than 2.0.

(j) Premarket submissions to address shortages

(1) In general

The Secretary shall waive the 90-day premarket submission requirement under subsection (c) and apply a 30-day premarket submission requirement for any person who intends to introduce or deliver for introduction into interstate commerce any new infant formula.

(2) Effective period

The waiver authority under this subsection shall remain in effect—

(A) for 90 days beginning on the date that the Secretary distributes information under section 350m(a)(2) of this title with respect to a shortage of infant formula; or

(B) such longer period as the Secretary determines appropriate, to prevent or mitigate a shortage of infant formula.

(k) Congressional notification of recall

(1) In general

Not later than 24 hours after the initiation of a recall of infant formula as described in subsection (e), the Secretary shall 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 notification of such recall.

(2) Contents

A notification under paragraph (1) shall include the following:

(A) If the recall is required by the Food and Drug Administration, a summary of the information supporting a determination that the adulterated or misbranded infant formula presents a risk to human health.

(B) If the recall is voluntarily initiated by the manufacturer, a summary of the information provided to the Food and Drug Administration by the manufacturer regarding infant formula that has left the control of the manufacturer that may be adulterated or misbranded.

(C) Specification of when the Food and Drug Administration was first made aware of the instance or circumstances surrounding the recall.

(D) An initial estimate of the disruption in domestic production that may result from the recall.

(l) Annual report to Congress

(1) In general

Not later than March 30 of each year, the Secretary shall submit a report to Congress containing, with respect to the preceding calendar year, the following information:

(A) The number of submissions received by the Secretary under subsection (d).

(B) The number of such submissions that included any new ingredients that were not included in any infant formula already on the market.

(C) The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with the requirements for infant formulas under subsection (b).

(D) The time between any inspection referred to in subparagraph (C) and any necessary reinspection to evaluate compliance with the requirements for infant formulas under subsection (b).

(E) A breakdown of the information described in subparagraphs (A) through (D) between foreign and domestic manufacturers and facilities.

(2) Confidentiality

The Secretary shall ensure that the reports under paragraph (1) do not include any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(m) Waiver of requirements for importation of specialty infant formula

(1) In general

The Secretary may, during a shortage of specialty infant formula as determined by the Secretary, waive any requirement under this chapter applicable to facilitate the importation of specialty infant formula. Such a waiver may be applicable to—

(A) the importation of specialty infant formula from any country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of this chapter; or

(B) the distribution and sale of such imported specialty infant formula.

(2) Rule of construction

Nothing in paragraph (1) shall be construed to limit the authority of the Secretary to require a recall of, or otherwise impose restrictions and requirements under this chapter with respect to, specialty infant formula that is subject to a waiver under paragraph (1).

(3) Definition of specialty infant formula

In this subsection, the term "specialty infant formula" means infant formula described in subsection (h)(1).

(June 25, 1938, ch. 675, §412, as added Pub. L. 96–359, §2, Sept. 26, 1980, 94 Stat. 1190; amended Pub. L. 99–570, title IV, §4014(a), (b)(1), Oct. 27, 1986, 100 Stat. 3207–116, 3207–120; Pub. L. 103–80, §3(l), Aug. 13, 1993, 107 Stat. 777; Pub. L. 117–328, div. FF, title III, §3401(c), (g)(1)–(4), (6), (l), Dec. 29, 2022, 136 Stat. 5838, 5840, 5841, 5845.)

Editorial Notes

Amendments

2022—Subsec. (c)(1)(B). Pub. L. 117–328, §3401(g)(6), substituted "subsection (d)(1)" for "subsection (c)(1)".

Subsec. (d)(4). Pub. L. 117–328, §3401(g)(3), added par. (4).

Subsec. (i)(1). Pub. L. 117–328, §3401(g)(4), substituted ", which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table" for "or, if revised by the Secretary under paragraph (2), as so revised".

Subsec. (j). Pub. L. 117–328, §3401(c), added subsec. (j).

Subsec. (k). Pub. L. 117–328, §3401(g)(1), added subsec. (k).

Subsec. (l). Pub. L. 117–328, §3401(g)(2), added subsec. (l).

Subsec. (m). Pub. L. 117–328, §3401(l), added subsec. (m).

1993—Subsec. (h)(1). Pub. L. 103–80 substituted "(e)(1)(B)" for "(c)(1)(B)," in concluding provisions.

1986—Subsecs. (a) to (d). Pub. L. 99–570, §4014(a)(7), added subsecs. (a) to (d) and struck out former subsecs. (a) relating to adulteration and regulatory oversight, (b) relating to notice to the Secretary by a manufacturer and requirements and scope of that notice, (c) relating to additional notice requirements for the manufacturer, and (d) relating to procedures applicable to recalls by a manufacturer.

Subsecs. (e), (f). Pub. L. 99–570, §4014(a)(1), (7), added subsecs. (e) and (f) and redesignated former subsecs. (e) and (f) as (g) and (h), respectively.

Subsec. (g). Pub. L. 99–570, §4014(a)(1), (2), redesignated subsec. (e) as (g) and substituted "Such records shall be retained for at least one year after the expiration of the shelf life of the infant formula" for "No manufacturer shall be required under this subsection to retain any record respecting the distribution of an infant formula for a period of longer than 2 years from the date the record was made". Former subsec. (g) redesignated (i).

Subsec. (h). Pub. L. 99–570, §4014(a)(1), redesignated subsec. (f) as (h).

Subsec. (h)(1). Pub. L. 99–570, §4014(a)(3), (4), substituted "(a), (b), and (c)" for "(a) and (b)" and "(e)(1)" for "(c)(1)".

Pub. L. 99–570, §4014(a)(5), which directed that "(d)(1)(B)" be substituted for "(e)(1)(B)" in second sentence could not be executed because "(e)(1)(B)" did not appear. See 1993 Amendment note above.

Subsec. (h)(2). Pub. L. 99–570, §4014(a)(6), substituted "(a), (b), and (c)" for "(a) and (b)".

Subsec. (i). Pub. L. 99–570, §4014(a)(1), (b)(1), redesignated subsec. (g) as (i), designated existing provisions as par. (1), substituted "paragraph (2)" for "subsection (a)(2) of this section", substituted a period for the colon after "as so revised", and added par. (2).

Statutory Notes and Related Subsidiaries

Effective Date of 1980 Amendment

Pub. L. 96–359, §6, Sept. 26, 1980, 94 Stat. 1193, provided that: "Section 412 of the Federal Food, Drug, and Cosmetic Act (added by section 2) [this section] shall apply with respect to infant formulas manufactured on or after the 90th day after the date of the enactment of this Act [Sept. 26, 1980]."
21 U.S.C. § 883 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 883: Enforcement proceedings
Enforcement proceedings
Status: in_force

Before any violation of this subchapter is reported by the Administrator of the Drug Enforcement Administration to any United States attorney for institution of a criminal proceeding, the Administrator may require that the person against whom such proceeding is contemplated is given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding.

(Pub. L. 91–513, title II, §513, Oct. 27, 1970, 84 Stat. 1278; Pub. L. 96–132, §16(c), Nov. 30, 1979, 93 Stat. 1049.)

Editorial Notes

Amendments

1979—Pub. L. 96–132 substituted "Administrator of the Drug Enforcement Administration" for "Director of the Bureau of Narcotics and Dangerous Drugs" and "Administrator may" for "Director may".
21 U.S.C. § 830 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 830: Regulation of listed chemicals and certain machines
Regulation of listed chemicals and certain machines
Status: in_force

(a) Record of regulated transactions

(1) Each regulated person who engages in a regulated transaction involving a listed chemical, a tableting machine, or an encapsulating machine shall keep a record of the transaction for two years after the date of the transaction.

(2) A record under this subsection shall be retrievable and shall include the date of the regulated transaction, the identity of each party to the regulated transaction, a statement of the quantity and form of the listed chemical, a description of the tableting machine or encapsulating machine, and a description of the method of transfer. Such record shall be available for inspection and copying by the Attorney General.

(3) It is the duty of each regulated person who engages in a regulated transaction to identify each other party to the transaction. It is the duty of such other party to present proof of identity to the regulated person. The Attorney General shall specify by regulation the types of documents and other evidence that constitute proof of identity for purposes of this paragraph.

(b) Reports to Attorney General

(1) Each regulated person shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regulation—

(A) any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this subchapter;

(B) any proposed regulated transaction with a person whose description or other identifying characteristic the Attorney General furnishes in advance to the regulated person;

(C) any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person; and

(D) any regulated transaction in a tableting machine or an encapsulating machine.

Each report under subparagraph (A) shall be made at the earliest practicable opportunity after the regulated person becomes aware of the circumstance involved. A regulated person may not complete a transaction with a person whose description or identifying characteristic is furnished to the regulated person under subparagraph (B) unless the transaction is approved by the Attorney General. The Attorney General shall make available to regulated persons guidance documents describing transactions and circumstances for which reports are required under subparagraph (A) and subparagraph (C).

(2) A regulated person that manufactures a listed chemical shall report annually to the Attorney General, in such form and manner and containing such specific data as the Attorney General shall prescribe by regulation, information concerning listed chemicals manufactured by the person. The requirement of the preceding sentence shall not apply to the manufacture of a drug product that is exempted under section 802(39)(A)(iv) of this title.

(3) Mail order reporting.—(A) As used in this paragraph:

(i) The term "drug product" means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act 1 [21 U.S.C. 301 et seq.] for distribution in the United States.

(ii) The term "valid prescription" means a prescription which is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner's professional practice.

(B) Each regulated person who engages in a transaction with a nonregulated person or who engages in an export transaction which—

(i) involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals); and

(ii) uses or attempts to use the Postal Service or any private or commercial carrier;

shall, on a monthly basis, submit a report of each such transaction conducted during the previous month to the Attorney General in such form, containing such data, and at such times as the Attorney General shall establish by regulation.

(C) The data required for such reports shall include—

(i) the name of the purchaser;

(ii) the quantity and form of the ephedrine, pseudoephedrine, or phenylpropanolamine purchased; and

(iii) the address to which such ephedrine, pseudoephedrine, or phenylpropanolamine was sent.

(D) Except as provided in subparagraph (E), the following distributions to a nonregulated person, and the following export transactions, shall not be subject to the reporting requirement in subparagraph (B):

(i) Distributions of sample packages of drug products when such packages contain not more than two solid dosage units or the equivalent of two dosage units in liquid form, not to exceed 10 milliliters of liquid per package, and not more than one package is distributed to an individual or residential address in any 30-day period.

(ii) Distributions of drug products by retail distributors that may not include face-to-face transactions to the extent that such distributions are consistent with the activities authorized for a retail distributor as specified in section 802(49) of this title, except that this clause does not apply to sales of scheduled listed chemical products at retail.

(iii) Distributions of drug products to a resident of a long term care facility (as that term is defined in regulations prescribed by the Attorney General) or distributions of drug products to a long term care facility for dispensing to or for use by a resident of that facility.

(iv) Distributions of drug products pursuant to a valid prescription.

(v) Exports which have been reported to the Attorney General pursuant to section 954 or 971 of this title or which are subject to a waiver granted under section 971(f)(2) of this title.

(vi) Any quantity, method, or type of distribution or any quantity, method, or type of distribution of a specific listed chemical (including specific formulations or drug products) or of a group of listed chemicals (including specific formulations or drug products) which the Attorney General has excluded by regulation from such reporting requirement on the basis that such reporting is not necessary for the enforcement of this subchapter or subchapter II.

(E) The Attorney General may revoke any or all of the exemptions listed in subparagraph (D) for an individual regulated person if he finds that drug products distributed by the regulated person are being used in violation of this subchapter or subchapter II. The regulated person shall be notified of the revocation, which will be effective upon receipt by the person of such notice, as provided in section 971(c)(1) of this title, and shall have the right to an expedited hearing as provided in section 971(c)(2) of this title.

(c) Confidentiality of information obtained by Attorney General; non-disclosure; exceptions

(1) Except as provided in paragraph (2), any information obtained by the Attorney General under this section which is exempt from disclosure under section 552(a) of title 5, by reason of section 552(b)(4) of such title, is confidential and may not be disclosed to any person.

(2) Information referred to in paragraph (1) may be disclosed only—

(A) to an officer or employee of the United States engaged in carrying out this subchapter, subchapter II, or the customs laws;

(B) when relevant in any investigation or proceeding for the enforcement of this subchapter, subchapter II, or the customs laws;

(C) when necessary to comply with an obligation of the United States under a treaty or other international agreement; or

(D) to a State or local official or employee in conjunction with the enforcement of controlled substances laws or chemical control laws.

(3) The Attorney General shall—

(A) take such action as may be necessary to prevent unauthorized disclosure of information by any person to whom such information is disclosed under paragraph (2); and

(B) issue guidelines that limit, to the maximum extent feasible, the disclosure of proprietary business information, including the names or identities of United States exporters of listed chemicals, to any person to whom such information is disclosed under paragraph (2).

(4) Any person who is aggrieved by a disclosure of information in violation of this section may bring a civil action against the violator for appropriate relief.

(5) Notwithstanding paragraph (4), a civil action may not be brought under such paragraph against investigative or law enforcement personnel of the Drug Enforcement Administration.

(d) Scheduled listed chemicals; restrictions on sales quantity; requirements regarding nonliquid forms

With respect to ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product—

(1) the quantity of such base sold at retail in such a product by a regulated seller, or a distributor required to submit reports by subsection (b)(3) may not, for any purchaser, exceed a daily amount of 3.6 grams, without regard to the number of transactions; and

(2) such a seller or distributor may not sell such a product in nonliquid form (including gel caps) at retail unless the product is packaged in blister packs, each blister containing not more than 2 dosage units, or where the use of blister packs is technically infeasible, the product is packaged in unit dose packets or pouches.

(e) Scheduled listed chemicals; behind-the-counter access; logbook requirement; training of sales personnel; privacy protections

(1) Requirements regarding retail transactions

(A) In general

Each regulated seller shall ensure that, subject to subparagraph (F), sales by such seller of a scheduled listed chemical product at retail are made in accordance with the following:

(i) In offering the product for sale, the seller places the product such that customers do not have direct access to the product before the sale is made (in this paragraph referred to as "behind-the-counter" placement). For purposes of this paragraph, a behind-the-counter placement of a product includes circumstances in which the product is stored in a locked cabinet that is located in an area of the facility involved to which customers do have direct access.

(ii) The seller delivers the product directly into the custody of the purchaser.

(iii) The seller maintains, in accordance with criteria issued by the Attorney General, a written or electronic list of such sales that identifies the products by name, the quantity sold, the names and addresses of purchasers, and the dates and times of the sales (which list is referred to in this subsection as the "logbook"), except that such requirement does not apply to any purchase by an individual of a single sales package if that package contains not more than 60 milligrams of pseudoephedrine.

(iv) In the case of a sale to which the requirement of clause (iii) applies, the seller does not sell such a product unless the sale is made in accordance with the following:

(I) The prospective purchaser—

(aa) presents an identification card that provides a photograph and is issued by a State or the Federal Government, or a document that, with respect to identification, is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of title 8, Code of Federal Regulations (as in effect on or after March 9, 2006); and

(bb) signs the written logbook and enters in the logbook his or her name, address, and the date and time of the sale, or for transactions involving an electronic logbook, the purchaser provides a signature using one of the following means:

(AA) Signing a device presented by the seller that captures signatures in an electronic format. Such device shall display the notice described in clause (v). Any device used shall preserve each signature in a manner that clearly links that signature to the other electronically-captured logbook information relating to the prospective purchaser providing that signature.

(BB) Signing a bound paper book. Such bound paper book shall include, for such purchaser, either (aaa) a printed sticker affixed to the bound paper book at the time of sale which either displays the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale, or a unique identifier which can be linked to that electronic information, or (bbb) a unique identifier which can be linked to that information and which is written into the book by the seller at the time of sale. The purchaser shall sign adjacent to the printed sticker or written unique identifier related to that sale. Such bound paper book shall display the notice described in clause (v).

(CC) Signing a printed document that includes, for such purchaser, the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale. Such document shall be printed by the seller at the time of the sale. Such document shall contain a clearly identified signature line for a purchaser to sign. Such printed document shall display the notice described in clause (v). Each signed document shall be inserted into a binder or other secure means of document storage immediately after the purchaser signs the document.

(II) The seller enters in the logbook the name of the product and the quantity sold. Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.

(III) The logbook maintained by the seller includes the prospective purchaser's name, address, and the date and time of the sale, as follows:

(aa) If the purchaser enters the information, the seller must determine that the name entered in the logbook corresponds to the name provided on such identification and that the date and time entered are correct.

(bb) If the seller enters the information, the prospective purchaser must verify that the information is correct.

(cc) Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.

(v) The written or electronic logbook includes, in accordance with criteria of the Attorney General, a notice to purchasers that entering false statements or misrepresentations in the logbook, or supplying false information or identification that results in the entry of false statements or misrepresentations, may subject the purchasers to criminal penalties under section 1001 of title 18, which notice specifies the maximum fine and term of imprisonment under such section.

(vi) Regardless of whether the logbook entry is written or electronic, the seller maintains each entry in the logbook for not fewer than 2 years after the date on which the entry is made.

(vii) In the case of individuals who are responsible for delivering such products into the custody of purchasers or who deal directly with purchasers by obtaining payments for the products, the seller has submitted to the Attorney General a self-certification that all such individuals have, in accordance with criteria under subparagraph (B)(ii), undergone training provided by the seller to ensure that the individuals understand the requirements that apply under this subsection and subsection (d).

(viii) The seller maintains a copy of such certification and records demonstrating that individuals referred to in clause (vii) have undergone the training.

(ix) If the seller is a mobile retail vendor:

(I) The seller complies with clause (i) by placing the product in a locked cabinet.

(II) The seller does not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.

(B) Additional provisions regarding certifications and training

(i) In general

A regulated seller may not sell any scheduled listed chemical product at retail unless the seller has submitted to the Attorney General the self-certification referred to in subparagraph (A)(vii). The certification is not effective for purposes of the preceding sentence unless, in addition to provisions regarding the training of individuals referred to in such subparagraph, the certification includes a statement that the seller understands each of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements.

(ii) Issuance of criteria; self-certification

The Attorney General shall by regulation establish criteria for certifications under this paragraph. The criteria shall—

(I) provide that the certifications are self-certifications provided through the program under clause (iii);

(II) provide that a separate certification is required for each place of business at which a regulated seller sells scheduled listed chemical products at retail; and

(III) include criteria for training under subparagraph (A)(vii).

(iii) Program for regulated sellers

The Attorney General shall establish a program regarding such certifications and training in accordance with the following:

(I) The program shall be carried out through an Internet site of the Department of Justice and such other means as the Attorney General determines to be appropriate.

(II) The program shall inform regulated sellers that section 1001 of title 18 applies to such certifications.

(III) The program shall make available to such sellers an explanation of the criteria under clause (ii).

(IV) The program shall be designed to permit the submission of the certifications through such Internet site.

(V) The program shall be designed to automatically provide the explanation referred to in subclause (III), and an acknowledgement that the Department has received a certification, without requiring direct interactions of regulated sellers with staff of the Department (other than the provision of technical assistance, as appropriate).

(iv) Availability of certification to State and local officials

Promptly after receiving a certification under subparagraph (A)(vii), the Attorney General shall make available a copy of the certification to the appropriate State and local officials.

(v) Publication of list of self-certified persons

The Attorney General shall develop and make available a list of all persons who are currently self-certified in accordance with this section. This list shall be made publicly available on the website of the Drug Enforcement Administration in an electronically downloadable format.

(C) Privacy protections

In order to protect the privacy of individuals who purchase scheduled listed chemical products, the Attorney General shall by regulation establish restrictions on disclosure of information in logbooks under subparagraph (A)(iii). Such regulations shall—

(i) provide for the disclosure of the information as appropriate to the Attorney General and to State and local law enforcement agencies; and

(ii) prohibit accessing, using, or sharing information in the logbooks for any purpose other than to ensure compliance with this subchapter or to facilitate a product recall to protect public health and safety.

(D) False statements or misrepresentations by purchasers

For purposes of section 1001 of title 18, entering information in the logbook under subparagraph (A)(iii) shall be considered a matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States.

(E) Good faith protection

A regulated seller who in good faith releases information in a logbook under subparagraph (A)(iii) to Federal, State, or local law enforcement authorities is immune from civil liability for such release unless the release constitutes gross negligence or intentional, wanton, or willful misconduct.

(F) Inapplicability of requirements to certain sales

Subparagraph (A) does not apply to the sale at retail of a scheduled listed chemical product if a report on the sales transaction is required to be submitted to the Attorney General under subsection (b)(3).

(G) Certain measures regarding theft and diversion

A regulated seller may take reasonable measures to guard against employing individuals who may present a risk with respect to the theft and diversion of scheduled listed chemical products, which may include, notwithstanding State law, asking applicants for employment whether they have been convicted of any crime involving or related to such products or controlled substances.

(2) Mail-order reporting; verification of identity of purchaser; 30-day restriction on quantities for individual purchasers

Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General is subject to the following:

(A) The person shall, prior to shipping the product, confirm the identity of the purchaser in accordance with procedures established by the Attorney General. The Attorney General shall by regulation establish such procedures.

(B) The person may not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.

(C) Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General may not sell any scheduled listed chemical product at retail unless such regulated person has submitted to the Attorney General a self-certification including a statement that the seller understands each of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements. The Attorney General shall by regulation establish criteria for certifications of mail-order distributors that are consistent with the criteria established for the certifications of regulated sellers under paragraph (1)(B).

(3) Exemptions for certain products

Upon the application of a manufacturer of a scheduled listed chemical product, the Attorney General may by regulation provide that the product is exempt from the provisions of subsection (d) and paragraphs (1) and (2) of this subsection if the Attorney General determines that the product cannot be used in the illicit manufacture of methamphetamine.

(Pub. L. 91–513, title II, §310, as added Pub. L. 95–633, title II, §202(a), Nov. 10, 1978, 92 Stat. 3774; amended Pub. L. 100–690, title VI, §6052(a), Nov. 18, 1988, 102 Stat. 4312; Pub. L. 103–200, §§2(c), 10, Dec. 17, 1993, 107 Stat. 2336, 2341; Pub. L. 104–237, title II, §208, title IV, §402, Oct. 3, 1996, 110 Stat. 3104, 3111; Pub. L. 106–310, div. B, title XXXVI, §3652, Oct. 17, 2000, 114 Stat. 1239; Pub. L. 109–177, title VII, §§711(a)(2)(B), (b)(1), (c)(1), (2), (d), 716(b)(2), Mar. 9, 2006, 120 Stat. 257, 261, 267; Pub. L. 110–415, §2, Oct. 14, 2008, 122 Stat. 4349; Pub. L. 111–268, §§2, 3, Oct. 12, 2010, 124 Stat. 2847.)

Editorial Notes

References in Text

The Food, Drug, and Cosmetic Act, referred to in subsec. (b)(3)(A)(i), probably means the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This subchapter, referred to in subsecs. (b)(3)(D)(vi), (E) and (e)(1)(C)(ii), 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.

Subchapter II, referred to in subsecs. (b)(3)(D)(iv), (E) and (c)(2)(A), (B), was in the original "title III", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

Amendments

2010—Subsec. (e)(1)(B)(v). Pub. L. 111–268, §3, added cl. (v).

Subsec. (e)(2)(C). Pub. L. 111–268, §2, added subpar. (C).

2008—Subsec. (e)(1)(A)(iv) to (vi). Pub. L. 110–415 added cls. (iv) to (vi) and struck out former cls. (iv) to (vi) which related to procedures for sales subject to the logbook requirement.

2006—Subsec. (b)(3)(D)(ii). Pub. L. 109–177, §711(c)(2), inserted ", except that this clause does not apply to sales of scheduled listed chemical products at retail" before period at end.

Pub. L. 109–177, §711(a)(2)(B), substituted "section 802(49)" for "section 802(46)".

Subsec. (b)(3)(D)(v). Pub. L. 109–177, §716(b)(2), substituted "section 971(f)(2)" for "section 971(e)(2)".

Subsec. (d). Pub. L. 109–177, §711(b)(1), added subsec. (d).

Subsec. (e)(1). Pub. L. 109–177, §711(b)(1), added subsec. heading and par. (1).

Subsec. (e)(2). Pub. L. 109–177, §711(c)(1), added par. (2).

Subsec. (e)(3). Pub. L. 109–177, §711(d), added par. (3).

2000—Subsec. (b)(3). Pub. L. 106–310 added subpars. (A), (D), and (E), redesignated former subpars. (A) and (B) as (B) and (C), respectively, and inserted "or who engages in an export transaction" after "nonregulated person" in introductory provisions of subpar. (B).

1996—Subsec. (a)(1). Pub. L. 104–237, §208, substituted "for two years after the date of the transaction." for the dash after "record of the transaction" and struck out subpars. (A) and (B) which read as follows:

"(A) for 4 years after the date of the transaction, if the listed chemical is a list I chemical or if the transaction involves a tableting machine or an encapsulating machine; and

"(B) for 2 years after the date of the transaction, if the listed chemical is a list II chemical."

Subsec. (b)(3). Pub. L. 104–237, §402, added par. (3).

1993—Subsec. (a)(1). Pub. L. 103–200, §2(c)(1), substituted "list I chemical" for "precursor chemical" in subpar. (A) and "a list II chemical" for "an essential chemical" in subpar. (B).

Subsec. (b). Pub. L. 103–200, §10, designated existing provisions as par. (1), redesignated former pars. (1) to (4) as subpars. (A) to (D), respectively, in concluding provisions, substituted "subparagraph (A)" for "paragraph (1)" in two places, "subparagraph (B)" for "paragraph (2)", and "subparagraph (C)" for "paragraph (3)", and added par. (2).

Subsec. (c)(2)(D). Pub. L. 103–200, §2(c)(2), substituted "chemical control laws" for "precursor chemical laws".

1988—Pub. L. 100–690 amended section generally, substituting provisions relating to regulation of listed chemicals and certain machines for provisions relating to reporting by any person who distributes, sells, or imports any piperidine.

Statutory Notes and Related Subsidiaries

Effective Date of 2010 Amendment

Pub. L. 111–268, §6(a), Oct. 12, 2010, 124 Stat. 2848, provided that: "This Act [amending this section and section 842 of this title and enacting provisions set out as notes under this section and section 801 of this title] and the amendments made by this Act shall take effect 180 days after the date of enactment of this Act [Oct. 12, 2010]."

Effective Date of 2006 Amendment

Pub. L. 109–177, title VII, §711(b)(2), Mar. 9, 2006, 120 Stat. 261, provided that: "With respect to subsections (d) and (e)(1) of section 310 of the Controlled Substances Act [21 U.S.C. 830(d), (e)(1)], as added by paragraph (1) of this subsection:

"(A) Such subsection (d) applies on and after the expiration of the 30-day period beginning on the date of the enactment of this Act [Mar. 9, 2006].

"(B) Such subsection (e)(1) applies on and after September 30, 2006."

Pub. L. 109–177, title VII, §711(c)(3), Mar. 9, 2006, 120 Stat. 261, provided that: "The amendments made by paragraphs (1) and (2) [amending this section] apply on and after the expiration of the 30-day period beginning on the date of the enactment of this Act [Mar. 9, 2006]."

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 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; Time To Submit Piperidine Report; Required Information

Pub. L. 95–633, title II, §203(a), Nov. 10, 1978, 92 Stat. 3776, provided that:

"(1) Except as provided under paragraph (2), the amendments made by this title [enacting this section and amending sections 841 to 843 of this title] shall take effect on the date of the enactment of this Act [Nov. 10, 1978].

"(2) Any person required to submit a report under section 310(a)(1) of the Controlled Substances Act [subsec. (a)(1) of this section] respecting a distribution, sale, or importation of piperidine during the 90 days after the date of the enactment of this Act [Nov. 10, 1978] may submit such report any time up to 97 days after such date of enactment.

"(3) Until otherwise provided by the Attorney General by regulation, the information required to be reported by a person under section 310(a)(1) of the Controlled Substances Act (as added by section 202(a)(2) of this title) [subsec. (a)(1) of this section] with respect to the person's distribution, sale, or importation of piperidine shall—

"(A) be the information described in subparagraphs (A) and (B) of such section, and

"(B) except as provided in paragraph (2) of this subsection, be reported not later than seven days after the date of such distribution, sale, or importation."

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 this section effective Jan. 1, 1981.

Regulations

Pub. L. 111–268, §6(b), Oct. 12, 2010, 124 Stat. 2848, provided that: "In promulgating the regulations authorized by section 2 [amending this section], the Attorney General may issue regulations on an interim basis as necessary to ensure the implementation of this Act by the effective date [see Effective Date of 2010 Amendment note above]."

Pub. L. 95–633, title II, §203(b), Nov. 10, 1978, 92 Stat. 3777, required the Attorney General to publish proposed interim regulations for piperidine reporting under section 830(a) of this title not later than 30 days after enactment, and final interim regulations not later than 75 days after enactment, such final interim regulations to be effective on and after the ninety-first day after enactment.

Report to President and Congress on Effectiveness of Title II of Pub. L. 95–633

Pub. L. 95–633, title II, §203(c), Nov. 10, 1978, 92 Stat. 3777, required the Attorney General to analyze and evaluate the impact and effectiveness of the amendments made by title II of Pub. L. 95–633, and report to the President and Congress not later than Mar. 1, 1980.

1 See References in Text note below.
21 U.S.C. § 355h (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 355h: Regulation of certain nonprescription drugs that are marketed without an approved drug application
Regulation of certain nonprescription drugs that are marketed without an approved drug application
Status: in_force

(a) Nonprescription drugs marketed without an approved application

Nonprescription drugs marketed without an approved drug application under section 355 of this title, as of March 27, 2020, shall be treated in accordance with this subsection.

(1) Drugs subject to a final monograph; category I drugs subject to a tentative final monograph

A drug is deemed to be generally recognized as safe and effective under section 321(p)(1) of this title, not a new drug under section 321(p) of this title, and not subject to section 353(b)(1) of this title, if—

(A) the drug is—

(i) in conformity with the requirements for nonprescription use of a final monograph issued under part 330 of title 21, Code of Federal Regulations (except as provided in paragraph (2)), the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and

(ii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title; or

(B) the drug is—

(i) classified in category I for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations;

(ii) in conformity with the proposed requirements for nonprescription use of such tentative final monograph, any applicable subsequent determination by the Secretary, the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and

(iii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title.

(2) Treatment of sunscreen drugs

With respect to sunscreen drugs subject to this section, the applicable requirements in terms of conformity with a final monograph, for purposes of paragraph (1)(A)(i), shall be the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.

(3) Category III drugs subject to a tentative final monograph; category I drugs subject to proposed monograph or advance notice of proposed rulemaking

A drug that is not described in paragraph (1), (2), or (4) is not required to be the subject of an application approved under section 355 of this title, and is not subject to section 353(b)(1) of this title, if—

(A) the drug is—

(i) classified in category III for safety or effectiveness in the preamble of a proposed rule establishing a tentative final monograph that is the most recently applicable proposal or determination for such drug issued under part 330 of title 21, Code of Federal Regulations;

(ii) in conformity with—

(I) the conditions of use, including indication and dosage strength, if any, described for such category III drug in such preamble or in an applicable subsequent proposed rule;

(II) the proposed requirements for drugs classified in such tentative final monograph in category I in the most recently proposed rule establishing requirements related to such tentative final monograph and in any final rule establishing requirements that are applicable to the drug; and

(III) the general requirements for nonprescription drugs and conditions or requirements under subsection (b) or (k); and

(iii) in a dosage form that, immediately prior to March 27, 2020, had been used to a material extent and for a material time under section 321(p)(2) of this title; or

(B) the drug is—

(i) classified in category I for safety and effectiveness under a proposed monograph or advance notice of proposed rulemaking that is the most recently applicable proposal or determination for such drug issued under part 330 of title 21, Code of Federal Regulations;

(ii) in conformity with the requirements for nonprescription use of such proposed monograph or advance notice of proposed rulemaking, any applicable subsequent determination by the Secretary, the general requirements for nonprescription drugs, and conditions or requirements under subsection (b) or (k); and

(iii) in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title.

(4) Category II drugs deemed new drugs

A drug that is classified in category II for safety or effectiveness under a tentative final monograph or that is subject to a determination to be not generally recognized as safe and effective in a proposed rule that is the most recently applicable proposal issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a new drug under section 321(p) of this title, misbranded under section 352(ee) of this title, and subject to the requirement for an approved new drug application under section 355 of this title beginning on the day that is 180 calendar days after March 27, 2020, unless, before such day, the Secretary determines that it is in the interest of public health to extend the period during which the drug may be marketed without such an approved new drug application.

(5) Drugs not GRASE deemed new drugs

A drug that the Secretary has determined not to be generally recognized as safe and effective under section 321(p)(1) of this title under a final determination issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a new drug under section 321(p) of this title, misbranded under section 352(ee) of this title, and subject to the requirement for an approved new drug application under section 355 of this title.

(6) Other drugs deemed new drugs

Except as provided in subsection (m), a drug is deemed to be a new drug under section 321(p) of this title and misbranded under section 352(ee) of this title if the drug—

(A) is not subject to section 353(b)(1) of this title; and

(B) is not described in paragraph (1), (2), (3), (4), or (5), or subsection (b)(1)(B).

(b) Administrative orders

(1) In general

(A) Determination

The Secretary may, on the initiative of the Secretary or at the request of one or more requestors, issue an administrative order determining whether there are conditions under which a specific drug, a class of drugs, or a combination of drugs, is determined to be—

(i) not subject to section 353(b)(1) of this title; and

(ii) generally recognized as safe and effective under section 321(p)(1) of this title.

(B) Effect

A drug or combination of drugs shall be deemed to not require approval under section 355 of this title if such drug or combination of drugs—

(i) is determined by the Secretary to meet the conditions specified in clauses (i) and (ii) of subparagraph (A);

(ii) is marketed in conformity with an administrative order under this subsection;

(iii) meets the general requirements for nonprescription drugs; and

(iv) meets the requirements under subsections (c) and (k).

(C) Standard

The Secretary shall find that a drug is not generally recognized as safe and effective under section 321(p)(1) of this title if—

(i) the evidence shows that the drug is not generally recognized as safe and effective under section 321(p)(1) of this title; or

(ii) the evidence is inadequate to show that the drug is generally recognized as safe and effective under section 321(p)(1) of this title.

(2) Administrative orders initiated by the Secretary

(A) In general

In issuing an administrative order under paragraph (1) upon the Secretary's initiative, the Secretary shall—

(i) make reasonable efforts to notify informally, not later than 2 business days before the issuance of the proposed order, the sponsors of drugs who have a listing in effect under section 360(j) of this title for the drugs or combination of drugs that will be subject to the administrative order;

(ii) after any such reasonable efforts of notification—

(I) issue a proposed administrative order by publishing it on the website of the Food and Drug Administration and include in such order the reasons for the issuance of such order; and

(II) publish a notice of availability of such proposed order in the Federal Register;

(iii) except as provided in subparagraph (B), provide for a public comment period with respect to such proposed order of not less than 45 calendar days; and

(iv) if, after completion of the proceedings specified in clauses (i) through (iii), the Secretary determines that it is appropriate to issue a final administrative order—

(I) issue the final administrative order, together with a detailed statement of reasons, which order shall not take effect until the time for requesting judicial review under paragraph (3)(D)(ii) has expired;

(II) publish a notice of such final administrative order in the Federal Register;

(III) afford requestors of drugs that will be subject to such order the opportunity for formal dispute resolution up to the level of the Director of the Center for Drug Evaluation and Research, which initially must be requested within 45 calendar days of the issuance of the order, and, for subsequent levels of appeal, within 30 calendar days of the prior decision; and

(IV) except with respect to drugs described in paragraph (3)(B), upon completion of the formal dispute resolution procedure, inform the persons which sought such dispute resolution of their right to request a hearing.

(B) Exceptions

When issuing an administrative order under paragraph (1) on the Secretary's initiative proposing to determine that a drug described in subsection (a)(3) is not generally recognized as safe and effective under section 321(p)(1) of this title, the Secretary shall follow the procedures in subparagraph (A), except that—

(i) the proposed order shall include notice of—

(I) the general categories of data the Secretary has determined necessary to establish that the drug is generally recognized as safe and effective under section 321(p)(1) of this title; and

(II) the format for submissions by interested persons;

(ii) the Secretary shall provide for a public comment period of no less than 180 calendar days with respect to such proposed order, except when the Secretary determines, for good cause, that a shorter period is in the interest of public health; and

(iii) any person who submits data in such comment period shall include a certification that the person has submitted all evidence created, obtained, or received by that person that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the drug is generally recognized as safe and effective under section 321(p)(1) of this title.

(3) Hearings; judicial review

(A) In general

Only a person who participated in each stage of formal dispute resolution under subclause (III) of paragraph (2)(A)(iv) of an administrative order with respect to a drug may request a hearing concerning a final administrative order issued under such paragraph with respect to such drug. If a hearing is sought, such person must submit a request for a hearing, which shall be based solely on information in the administrative record, to the Secretary not later than 30 calendar days after receiving notice of the final decision of the formal dispute resolution procedure.

(B) No hearing required with respect to orders relating to certain drugs

(i) In general

The Secretary shall not be required to provide notice and an opportunity for a hearing pursuant to paragraph (2)(A)(iv) if the final administrative order involved relates to a drug—

(I) that is described in subsection (a)(3)(A); and

(II) with respect to which no human or non-human data studies relevant to the safety or effectiveness of such drug have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such drug.

(ii) Human data studies and non-human data defined

In this subparagraph:

(I) The term "human data studies" means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies.

(II) The term "non-human data" means data from testing other than with human subjects which provides information concerning safety or effectiveness.

(C) Hearing procedures

(i) Denial of request for hearing

If the Secretary determines that information submitted in a request for a hearing under subparagraph (A) with respect to a final administrative order issued under paragraph (2)(A)(iv) does not identify the existence of a genuine and substantial question of material fact, the Secretary may deny such request. In making such a determination, the Secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies.

(ii) Single hearing for multiple related requests

If more than one request for a hearing is submitted with respect to the same administrative order under subparagraph (A), the Secretary may direct that a single hearing be conducted in which all persons whose hearing requests were granted may participate.

(iii) Presiding officer

The presiding officer of a hearing requested under subparagraph (A) shall—

(I) be designated by the Secretary;

(II) not be an employee of the Center for Drug Evaluation and Research; and

(III) not have been previously involved in the development of the administrative order involved or proceedings relating to that administrative order.

(iv) Rights of parties to hearing

The parties to a hearing requested under subparagraph (A) shall have the right to present testimony, including testimony of expert witnesses, and to cross-examine witnesses presented by other parties. Where appropriate, the presiding officer may require that cross-examination by parties representing substantially the same interests be consolidated to promote efficiency and avoid duplication.

(v) Final decision

(I) At the conclusion of a hearing requested under subparagraph (A), the presiding officer of the hearing shall issue a decision containing findings of fact and conclusions of law. The decision of the presiding officer shall be final.

(II) The final decision may not take effect until the period under subparagraph (D)(ii) for submitting a request for judicial review of such decision expires.

(D) Judicial review of final administrative order

(i) In general

The procedures described in section 355(h) of this title shall apply with respect to judicial review of final administrative orders issued under this subsection in the same manner and to the same extent as such section applies to an order described in such section except that the judicial review shall be taken by filing in an appropriate district court of the United States in lieu of the appellate courts specified in such section.

(ii) Period to submit a request for judicial review

A person eligible to request a hearing under this paragraph and seeking judicial review of a final administrative order issued under this subsection shall file such request for judicial review not later than 60 calendar days after the latest of—

(I) the date on which notice of such order is published;

(II) the date on which a hearing with respect to such order is denied under subparagraph (B) or (C)(i);

(III) the date on which a final decision is made following a hearing under subparagraph (C)(v); or

(IV) if no hearing is requested, the date on which the time for requesting a hearing expires.

(4) Expedited procedure with respect to administrative orders initiated by the Secretary

(A) Imminent hazard to the public health

(i) In general

In the case of a determination by the Secretary that a drug, class of drugs, or combination of drugs subject to this section poses an imminent hazard to the public health, the Secretary, after first making reasonable efforts to notify, not later than 48 hours before issuance of such order under this subparagraph, sponsors who have a listing in effect under section 360(j) of this title for such drug or combination of drugs—

(I) may issue an interim final administrative order for such drug, class of drugs, or combination of drugs under paragraph (1), together with a detailed statement of the reasons for such order;

(II) shall publish in the Federal Register a notice of availability of any such order; and

(III) shall provide for a public comment period of at least 45 calendar days with respect to such interim final order.

(ii) Nondelegation

The Secretary may not delegate the authority to issue an interim final administrative order under this subparagraph.

(B) Safety labeling changes

(i) In general

In the case of a determination by the Secretary that a change in the labeling of a drug, class of drugs, or combination of drugs subject to this section is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug, the Secretary may—

(I) make reasonable efforts to notify informally, not later than 48 hours before the issuance of the interim final order, the sponsors of drugs who have a listing in effect under section 360(j) of this title for such drug or combination of drugs;

(II) after reasonable efforts of notification, issue an interim final administrative order in accordance with paragraph (1) to require such change, together with a detailed statement of the reasons for such order;

(III) publish in the Federal Register a notice of availability of such order; and

(IV) provide for a public comment period of at least 45 calendar days with respect to such interim final order.

(ii) Content of order

An interim final order issued under this subparagraph with respect to the labeling of a drug may provide for new warnings and other information required for safe use of the drug.

(C) Effective date

An order under subparagraph (A) or (B) shall take effect on a date specified by the Secretary.

(D) Final order

After the completion of the proceedings in subparagraph (A) or (B), the Secretary shall—

(i) issue a final order in accordance with paragraph (1);

(ii) publish a notice of availability of such final administrative order in the Federal Register; and

(iii) afford sponsors of such drugs that will be subject to such an order the opportunity for formal dispute resolution up to the level of the Director of the Center for Drug Evaluation and Research, which must initially be within 45 calendar days of the issuance of the order, and for subsequent levels of appeal, within 30 calendar days of the prior decision.

(E) Hearings

A sponsor of a drug subject to a final order issued under subparagraph (D) and that participated in each stage of formal dispute resolution under clause (iii) of such subparagraph may request a hearing on such order. The provisions of subparagraphs (A), (B), and (C) of paragraph (3), other than paragraph (3)(C)(v)(II), shall apply with respect to a hearing on such order in the same manner and to the same extent as such provisions apply with respect to a hearing on an administrative order issued under paragraph (2)(A)(iv).

(F) Timing

(i) Final order and hearing

The Secretary shall—

(I) not later than 6 months after the date on which the comment period closes under subparagraph (A) or (B), issue a final order in accordance with paragraph (1); and

(II) not later than 12 months after the date on which such final order is issued, complete any hearing under subparagraph (E).

(ii) Dispute resolution request

The Secretary shall specify in an interim final order issued under subparagraph (A) or (B) such shorter periods for requesting dispute resolution under subparagraph (D)(iii) as are necessary to meet the requirements of this subparagraph.

(G) Judicial review

A final order issued pursuant to subparagraph (F) shall be subject to judicial review in accordance with paragraph (3)(D).

(5) Administrative order initiated at the request of a requestor

(A) In general

In issuing an administrative order under paragraph (1) at the request of a requestor with respect to certain drugs, classes of drugs, or combinations of drugs—

(i) the Secretary shall, after receiving a request under this subparagraph, determine whether the request is sufficiently complete and formatted to permit a substantive review;

(ii) if the Secretary determines that the request is sufficiently complete and formatted to permit a substantive review, the Secretary shall—

(I) file the request; and

(II) initiate proceedings with respect to issuing an administrative order in accordance with paragraphs (2) and (3); and

(iii) except as provided in paragraph (6), if the Secretary determines that a request does not meet the requirements for filing or is not sufficiently complete and formatted to permit a substantive review, the requestor may demand that the request be filed over protest, and the Secretary shall initiate proceedings to review the request in accordance with paragraph (2)(A).

(B) Request to initiate proceedings

(i) In general

A requestor seeking an administrative order under paragraph (1) with respect to certain drugs, classes of drugs, or combinations of drugs, shall submit to the Secretary a request to initiate proceedings for such order in the form and manner as specified by the Secretary. Such requestor may submit a request under this subparagraph for the issuance of an administrative order—

(I) determining whether a drug is generally recognized as safe and effective under section 321(p)(1) of this title, exempt from section 353(b)(1) of this title, and not required to be the subject of an approved application under section 355 of this title; or

(II) determining whether a change to a condition of use of a drug is generally recognized as safe and effective under section 321(p)(1) of this title, exempt from section 353(b)(1) of this title, and not required to be the subject of an approved application under section 355 of this title, if, absent such a changed condition of use, such drug is—

(aa) generally recognized as safe and effective under section 321(p)(1) of this title in accordance with subsection (a)(1), (a)(2), or an order under this subsection; or

(bb) subject to subsection (a)(3), but only if such requestor initiates such request in conjunction with a request for the Secretary to determine whether such drug is generally recognized as safe and effective under section 321(p)(1) of this title, which is filed by the Secretary under subparagraph (A)(ii).

(ii) Exception

The Secretary is not required to complete review of a request for a change described in clause (i)(II) if the Secretary determines that there is an inadequate basis to find the drug is generally recognized as safe and effective under section 321(p)(1) of this title under paragraph (1) and issues a final order announcing that determination.

(iii) Withdrawal

The requestor may withdraw a request under this paragraph, according to the procedures set forth pursuant to subsection (d)(2)(B). Notwithstanding any other provision of this section, if such request is withdrawn, the Secretary may cease proceedings under this subparagraph.

(C) Exclusivity

(i) In general

A final administrative order issued in response to a request under this section shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such order), for a period of 18 months following the effective date of such final order and beginning on the date the requestor may lawfully market such drugs pursuant to the order, to market drugs—

(I) incorporating changes described in clause (ii); and

(II) subject to the limitations under clause (iv).

(ii) Changes described

A change described in this clause is a change subject to an order specified in clause (i), which—

(I) provides for a drug to contain an active ingredient (including any ester or salt of the active ingredient) not previously incorporated in a drug described in clause (iii); or

(II) provides for a change in the conditions of use of a drug, for which new human data studies conducted or sponsored by the requestor (or for which the requestor has an exclusive right of reference) were essential to the issuance of such order.

(iii) Drugs described

The drugs described in this clause are drugs—

(I) specified in subsection (a)(1), (a)(2), or (a)(3);

(II) subject to a final order issued under this section;

(III) subject to a final sunscreen order (as defined in section 360fff(2)(A) of this title); or

(IV) described in subsection (m)(1), other than drugs subject to an active enforcement action under subchapter III of this chapter.

(iv) Limitations on exclusivity

(I) In general

Only one 18-month period under this subparagraph shall be granted, under each order described in clause (i), with respect to changes (to the drug subject to such order) which are either—

(aa) changes described in clause (ii)(I), relating to active ingredients; or

(bb) changes described in clause (ii)(II), relating to conditions of use.

(II) No exclusivity allowed

No exclusivity shall apply to changes to a drug which are—

(aa) the subject of a Tier 2 OTC monograph order request (as defined in section 379j–71 of this title);

(bb) safety-related changes, as defined by the Secretary, or any other changes the Secretary considers necessary to assure safe use; or

(cc) changes related to methods of testing safety or efficacy.

(v) New human data studies defined

In this subparagraph, the term "new human data studies" means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies, the results of which—

(I) have not been relied on by the Secretary to support—

(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 321(p)(1) of this title; or

(bb) approval of a drug that was approved under section 355 of this title; and

(II) do not duplicate the results of another study that was relied on by the Secretary to support—

(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 321(p)(1) of this title; or

(bb) approval of a drug that was approved under section 355 of this title.

(vi) Notification of drug not available for sale

A requestor that is granted exclusivity with respect to a drug under this subparagraph shall notify the Secretary in writing within 1 year of the issuance of the final administrative order if the drug that is the subject of such order will not be available for sale within 1 year of the date of issuance of such order. The requestor shall include with such notice the—

(I) identity of the drug by established name and by proprietary name, if any;

(II) strength of the drug;

(III) date on which the drug will be available for sale, if known; and

(IV) reason for not marketing the drug after issuance of the order.

(6) Information regarding safe nonprescription marketing and use as condition for filing a generally recognized as safe and effective request

(A) In general

In response to a request under this section that a drug described in subparagraph (B) be generally recognized as safe and effective, the Secretary—

(i) may file such request, if the request includes information specified under subparagraph (C) with respect to safe nonprescription marketing and use of such drug; or

(ii) if the request fails to include information specified under subparagraph (C), shall refuse to file such request and require that nonprescription marketing of the drug be pursuant to a new drug application as described in subparagraph (D).

(B) Drug described

A drug described in this subparagraph is a nonprescription drug which contains an active ingredient not previously incorporated in a drug—

(i) specified in subsection (a)(1), (a)(2), or (a)(3);

(ii) subject to a final order under this section; or

(iii) subject to a final sunscreen order (as defined in section 360fff(2)(A) of this title).

(C) Information demonstrating prima facie safe nonprescription marketing and use

Information specified in this subparagraph, with respect to a request described in subparagraph (A)(i), is—

(i) information sufficient for a prima facie demonstration that the drug subject to such request has a verifiable history of being marketed and safely used by consumers in the United States as a nonprescription drug under comparable conditions of use;

(ii) if the drug has not been previously marketed in the United States as a nonprescription drug, information sufficient for a prima facie demonstration that the drug was marketed and safely used under comparable conditions of marketing and use in a country listed in section 382(b)(1)(A) of this title or designated by the Secretary in accordance with section 382(b)(1)(B) of this title—

(I) for such period as needed to provide reasonable assurances concerning the safe nonprescription use of the drug; and

(II) during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the Secretary for such monitoring purposes, including for adverse events associated with nonprescription use of the drug; or

(iii) if the Secretary determines that information described in clause (i) or (ii) is not needed to provide a prima facie demonstration that the drug can be safely marketed and used as a nonprescription drug, such other information the Secretary determines is sufficient for such purposes.

(D) Marketing pursuant to new drug application

In the case of a request described in subparagraph (A)(ii), the drug subject to such request may be resubmitted for filing only if—

(i) the drug is marketed as a nonprescription drug, under conditions of use comparable to the conditions specified in the request, for such period as the Secretary determines appropriate (not to exceed 5 consecutive years) pursuant to an application approved under section 355 of this title; and

(ii) during such period, 1,000,000 retail packages of the drug, or an equivalent quantity as determined by the Secretary, were distributed for retail sale, as determined in such manner as the Secretary finds appropriate.

(E) Rule of application

Except in the case of a request involving a drug described in section 360fff(9) of this title, as in effect on January 1, 2017, if the Secretary refuses to file a request under this paragraph, the requestor may not file such request over protest under paragraph (5)(A)(iii).

(7) Packaging

An administrative order issued under paragraph (2), (4)(A), or (5) may include requirements for the packaging of a drug to encourage use in accordance with labeling. Such requirements may include unit dose packaging, requirements for products intended for use by pediatric populations, requirements to reduce risk of harm from unsupervised ingestion, and other appropriate requirements. This paragraph does not authorize the Food and Drug Administration to require standards or testing procedures as described in part 1700 of title 16, Code of Federal Regulations.

(8) Final and tentative final monographs for category I drugs deemed final administrative orders

(A) In general

A final monograph or tentative final monograph described in subparagraph (B) shall be deemed to be a final administrative order under this subsection and may be amended, revoked, or otherwise modified in accordance with the procedures of this subsection.

(B) Monographs described

For purposes of subparagraph (A), a final monograph or tentative final monograph is described in this subparagraph if it—

(i) establishes conditions of use for a drug described in paragraph (1) or (2) of subsection (a); and

(ii) represents the most recently promulgated version of such conditions, including as modified, in whole or in part, by any proposed or final rule.

(C) Deemed orders include harmonizing technical amendments

The deemed establishment of a final administrative order under subparagraph (A) shall be construed to include any technical amendments to such order as the Secretary determines necessary to ensure that such order is appropriately harmonized, in terms of terminology or cross-references, with the applicable provisions of this chapter (and regulations thereunder) and any other orders issued under this section.

(c) Procedure for minor changes

(1) In general

Minor changes in the dosage form of a drug that is described in paragraph (1) or (2) of subsection (a) or the subject of an order issued under subsection (b) may be made by a requestor without the issuance of an order under subsection (b) if—

(A) the requestor maintains such information as is necessary to demonstrate that the change—

(i) will not affect the safety or effectiveness of the drug; and

(ii) will not materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product; and

(B) the change is in conformity with the requirements of an applicable administrative order issued by the Secretary under paragraph (3).

(2) Additional information

(A) Access to records

A sponsor shall submit records requested by the Secretary relating to such a minor change under section 374(a)(4) of this title, within 15 business days of receiving such a request, or such longer period as the Secretary may provide.

(B) Insufficient information

If the Secretary determines that the information contained in such records is not sufficient to demonstrate that the change does not affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to the active ingredient, the Secretary—

(i) may so inform the sponsor of the drug in writing; and

(ii) if the Secretary so informs the sponsor, shall provide the sponsor of the drug with a reasonable opportunity to provide additional information.

(C) Failure to submit sufficient information

If the sponsor fails to provide such additional information within a time prescribed by the Secretary, or if the Secretary determines that such additional information does not demonstrate that the change does not—

(i) affect the safety or effectiveness of the drug; or

(ii) materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product,

the drug as modified is a new drug under section 321(p) of this title and shall be deemed to be misbranded under section 352(ee) of this title.

(3) Determining whether a change will affect safety or effectiveness

(A) In general

The Secretary shall issue one or more administrative orders specifying requirements for determining whether a minor change made by a sponsor pursuant to this subsection will affect the safety or effectiveness of a drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product, together with guidance for applying those orders to specific dosage forms.

(B) Standard practices

The orders and guidance issued by the Secretary under subparagraph (A) shall take into account relevant public standards and standard practices for evaluating the quality of drugs, and may take into account the special needs of populations, including children.

(d) Confidentiality of information submitted to the Secretary

(1) In general

Subject to paragraph (2), any information, including reports of testing conducted on the drug or drugs involved, that is submitted by a requestor in connection with proceedings on an order under this section (including any minor change under subsection (c)) and is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18 shall not be disclosed to the public unless the requestor consents to that disclosure.

(2) Public availability

(A) In general

Except as provided in subparagraph (B), the Secretary shall—

(i) make any information submitted by a requestor in support of a request under subsection (b)(5)(A) available to the public not later than the date on which the proposed order is issued; and

(ii) make any information submitted by any other person with respect to an order requested (or initiated by the Secretary) under subsection (b), available to the public upon such submission.

(B) Limitations on public availability

Information described in subparagraph (A) shall not be made public if—

(i) the information pertains to pharmaceutical quality information, unless such information is necessary to establish standards under which a drug is generally recognized as safe and effective under section 321(p)(1) of this title;

(ii) the information is submitted in a requestor-initiated request, but the requestor withdraws such request, in accordance with withdrawal procedures established by the Secretary, before the Secretary issues the proposed order;

(iii) the Secretary requests and obtains the information under subsection (c) and such information is not submitted in relation to an order under subsection (b); or

(iv) the information is of the type contained in raw datasets.

(e) Updates to drug listing information

A sponsor who makes a change to a drug subject to this section shall submit updated drug listing information for the drug in accordance with section 360(j) of this title within 30 calendar days of the date when the drug is first commercially marketed, except that a sponsor who was the order requestor with respect to an order subject to subsection (b)(5)(C) (or a licensee, assignee, or successor in interest of such requestor) shall submit updated drug listing information on or before the date when the drug is first commercially marketed.

(f) Approvals under section 355 of this title

The provisions of this section shall not be construed to preclude a person from seeking or maintaining the approval of an application for a drug under sections 355(b)(1), 355(b)(2), and 355(j) of this title. A determination under this section that a drug is not subject to section 353(b)(1) of this title, is generally recognized as safe and effective under section 321(p)(1) of this title, and is not a new drug under section 321(p) of this title shall constitute a finding that the drug is safe and effective that may be relied upon for purposes of an application under section 355(b)(2) of this title, so that the applicant shall be required to submit for purposes of such application only information needed to support any modification of the drug that is not covered by such determination under this section.

(g) Public availability of administrative orders

The Secretary shall establish, maintain, update (as determined necessary by the Secretary but no less frequently than annually), and make publicly available, with respect to orders issued under this section—

(1) a repository of each final order and interim final order in effect, including the complete text of the order; and

(2) a listing of all orders proposed and under development under subsection (b)(2), including—

(A) a brief description of each such order; and

(B) the Secretary's expectations, if resources permit, for issuance of proposed orders over a 3-year period.

(h) Development advice to sponsors or requestors

The Secretary shall establish procedures under which sponsors or requestors may meet with appropriate officials of the Food and Drug Administration to obtain advice on the studies and other information necessary to support submissions under this section and other matters relevant to the regulation of nonprescription drugs and the development of new nonprescription drugs under this section.

(i) Participation of multiple sponsors or requestors

The Secretary shall establish procedures to facilitate efficient participation by multiple sponsors or requestors in proceedings under this section, including provision for joint meetings with multiple sponsors or requestors or with organizations nominated by sponsors or requestors to represent their interests in a proceeding.

(j) Electronic format

All submissions under this section shall be in electronic format.

(k) Effect on existing regulations governing nonprescription drugs

(1) Regulations of general applicability to nonprescription drugs

Except as provided in this subsection, nothing in this section supersedes regulations establishing general requirements for nonprescription drugs, including regulations of general applicability contained in parts 201, 250, and 330 of title 21, Code of Federal Regulations, or any successor regulations. The Secretary shall establish or modify such regulations by means of rulemaking in accordance with section 553 of title 5.

(2) Regulations establishing requirements for specific nonprescription drugs

(A) The provisions of section 310.545 of title 21, Code of Federal Regulations, as in effect on the day before March 27, 2020, shall be deemed to be a final order under subsection (b).

(B) Regulations in effect on the day before March 27, 2020, establishing requirements for specific nonprescription drugs marketed pursuant to this section (including such requirements in parts 201 and 250 of title 21, Code of Federal Regulations), shall be deemed to be final orders under subsection (b), only as they apply to drugs—

(i) subject to paragraph (1), (2), (3), or (4) of subsection (a); or

(ii) otherwise subject to an order under this section.

(3) Withdrawal of regulations

The Secretary shall withdraw regulations establishing final monographs and the procedures governing the over-the-counter drug review under part 330 and other relevant parts of title 21, Code of Federal Regulations (as in effect on the day before March 27, 2020), or make technical changes to such regulations to ensure conformity with appropriate terminology and cross references. Notwithstanding subchapter II of chapter 5 of title 5, any such withdrawal or technical changes shall be made without public notice and comment and shall be effective upon publication through notice in the Federal Register (or upon such date as specified in such notice).

(l) Guidance

The Secretary shall issue guidance that specifies—

(1) the procedures and principles for formal meetings between the Secretary and sponsors or requestors for drugs subject to this section;

(2) the format and content of data submissions to the Secretary under this section;

(3) the format of electronic submissions to the Secretary under this section;

(4) consolidated proceedings for appeal and the procedures for such proceedings where appropriate; and

(5) for minor changes in drugs, recommendations on how to comply with the requirements in orders issued under subsection (c)(3).

(m) Rule of construction

(1) In general

This section shall not affect the treatment or status of a nonprescription drug—

(A) that is marketed without an application approved under section 355 of this title as of March 27, 2020;

(B) that is not subject to an order issued under this section; and

(C) to which paragraph (1), (2), (3), (4), or (5) of subsection (a) do not apply.

(2) Treatment of products previously found to be subject to time and extent requirements

(A) Notwithstanding subsection (a), a drug described in subparagraph (B) may only be lawfully marketed, without an application approved under section 355 of this title, pursuant to an order issued under this section.

(B) A drug described in this subparagraph is a drug which, prior to March 27, 2020, the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review (as such phrase "OTC drug review" was used in section 330.14 of title 21, Code of Federal Regulations, as in effect on the day before March 27, 2020).

(3) Preservation of authority

(A) Nothing in paragraph (1) shall be construed to preclude or limit the applicability of any provision of this chapter other than this section.

(B) Nothing in subsection (a) shall be construed to prohibit the Secretary from issuing an order under this section finding a drug to be not generally recognized as safe and effective under section 321(p)(1) of this title, as the Secretary determines appropriate.

(n) Investigational new drugs

A drug is not subject to this section if an exemption for investigational use under section 355(i) of this title is in effect for such drug.

(o) Inapplicability of Paperwork Reduction Act

Chapter 35 of title 44 shall not apply to collections of information made under this section.

(p) Inapplicability of notice and comment rulemaking and other requirements

The requirements of subsection (b) shall apply with respect to orders issued under this section instead of the requirements of subchapter II of chapter 5 of title 5.

(q) Definitions

In this section:

(1) The term "nonprescription drug" refers to a drug not subject to the requirements of section 353(b)(1) of this title.

(2) The term "sponsor" refers to any person marketing, manufacturing, or processing a drug that—

(A) is listed pursuant to section 360(j) of this title; and

(B) is or will be subject to an administrative order under this section of the Food and Drug Administration.

(3) The term "requestor" refers to any person or group of persons marketing, manufacturing, processing, or developing a drug.

(June 25, 1938, ch. 675, §505G, as added Pub. L. 116–136, div. A, title III, §3851(a), Mar. 27, 2020, 134 Stat. 435.)

Statutory Notes and Related Subsidiaries

Drugs Excluded From the Over-the-Counter Drug Review

Pub. L. 116–136, div. A, title III, §3853, Mar. 27, 2020, 134 Stat. 454, provided that:

"(a) In General.—Nothing in this Act [probably should be "this subtitle", meaning subtitle F (§§3851–3862) of title III of div. A of Pub. L. 116–136, enacting this section, section 360fff–8 of this title, and subpart 10 of part C of subchapter VII of this chapter, amending sections 352, 360fff–3, 379j–52, 379r, and 381 of this title, repealing section 360fff–5 of this title, and enacting provisions set out as notes under this section and sections 360fff–3, 360fff–6, 379j–52, and 379j–71 of this title] (or the amendments made by this Act) shall apply to any nonprescription drug (as defined in section 505G(q) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(q)], as added by section 3851 of this subtitle) which was excluded by the Food and Drug Administration from the Over-the-Counter Drug Review in accordance with the paragraph numbered 25 on page 9466 of volume 37 of the Federal Register, published on May 11, 1972.

"(b) Rule of Construction.—Nothing in this section shall be construed to preclude or limit the applicability of any other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)."

Treatment of Authority Regarding Finalization of Sunscreen Monograph

Pub. L. 116–136, div. A, title III, §3854(c), Mar. 27, 2020, 134 Stat. 456, provided that:

"(1) In general.—

"(A) Revision of final sunscreen order.—The Secretary of Health and Human Services (referred to in this subsection as the 'Secretary') shall amend and revise the final administrative order concerning nonprescription sunscreen (referred to in this subsection as the 'sunscreen order') for which the content, prior to the date of enactment of this Act [Mar. 27, 2020], was represented by the final monograph for sunscreen drug products set forth in part 352 of title 21, Code of Federal Regulations (as in effect on May 21, 1999).

"(B) Issuance of revised sunscreen order; effective date.—A revised sunscreen order described in subparagraph (A) shall be—

"(i) issued in accordance with the procedures described in section 505G(b)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(b)(2)];

"(ii) issued in proposed form not later than 18 months after the date of enactment of this Act; and

"(iii) issued by the Secretary at least 1 year prior to the effective date of the revised order.

"(2) Reports.—If a revised sunscreen order issued under paragraph (1) does not include provisions related to the effectiveness of various sun protection factor levels, and does not address all dosage forms known to the Secretary to be used in sunscreens marketed in the United States without a new drug application approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), the Secretary shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the rationale for omission of such provisions from such order, and a plan and timeline to compile any information necessary to address such provisions through such order."

Annual Update to Congress on Appropriate Pediatric Indication for Certain OTC Cough and Cold Drugs

Pub. L. 116–136, div. A, title III, §3855, Mar. 27, 2020, 134 Stat. 457, provided that:

"(a) In General.—Subject to subsection (c), the Secretary of Health and Human Services shall, beginning not later than 1 year after the date of enactment of this Act [Mar. 27, 2020], annually submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a letter describing the progress of the Food and Drug Administration—

"(1) in evaluating the cough and cold monograph described in subsection (b) with respect to children under age 6; and

"(2) as appropriate, revising such cough and cold monograph to address such children through the order process under section 505G(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(b)], as added by section 3851 of this subtitle.

"(b) Cough and Cold Monograph Described.—The cough and cold monograph described in this subsection consists of the conditions under which nonprescription drugs containing antitussive, expectorant, nasal decongestant, or antihistamine active ingredients (or combinations thereof) are generally recognized as safe and effective, as specified in part 341 of title 21, Code of Federal Regulations (as in effect immediately prior to the date of enactment of this Act), and included in an order deemed to be established under section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle.

"(c) Duration of Authority.—The requirement under subsection (a) shall terminate as of the date of a letter submitted by the Secretary of Health and Human Services pursuant to such subsection in which the Secretary indicates that the Food and Drug Administration has completed its evaluation and revised, in a final order, as applicable, the cough and cold monograph as described in subsection (a)(2)."
21 U.S.C. § 880 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 880: Administrative inspections and warrants
Administrative inspections and warrants
Status: in_force

(a) "Controlled premises" defined

As used in this section, the term "controlled premises" means—

(1) places where original or other records or documents required under this subchapter are kept or required to be kept, and

(2) places, including factories, warehouses, and other establishments, and conveyances, where persons registered under section 823 of this title (or exempt from registration under section 822(d) of this title or by regulation of the Attorney General) or regulated persons may lawfully hold, manufacture, distribute, dispense, administer, or otherwise dispose of controlled substances or listed chemicals or where records relating to those activities are maintained.

(b) Grant of authority; scope of inspections

(1) For the purpose of inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under this subchapter and otherwise facilitating the carrying out of his functions under this subchapter, the Attorney General is authorized, in accordance with this section, to enter controlled premises and to conduct administrative inspections thereof, and of the things specified in this section, relevant to those functions.

(2) Such entries and inspections shall be carried out through officers or employees (hereinafter referred to as "inspectors") designated by the Attorney General. Any such inspector, upon stating his purpose and presenting to the owner, operator, or agent in charge of such premises (A) appropriate credentials and (B) a written notice of his inspection authority (which notice in the case of an inspection requiring, or in fact supported by, an administrative inspection warrant shall consist of such warrant), shall have the right to enter such premises and conduct such inspection at reasonable times.

(3) Except as may otherwise be indicated in an applicable inspection warrant, the inspector shall have the right—

(A) to inspect and copy records, reports, and other documents required to be kept or made under this subchapter;

(B) to inspect, within reasonable limits and in a reasonable manner, controlled premises and all pertinent equipment, finished and unfinished drugs, listed chemicals, and other substances or materials, containers, and labeling found therein, and, except as provided in paragraph (4) of this subsection, all other things therein (including records, files, papers, processes, controls, and facilities) appropriate for verification of the records, reports, and documents referred to in clause (A) or otherwise bearing on the provisions of this subchapter; and

(C) to inventory any stock of any controlled substance or listed chemical therein and obtain samples of any such substance or chemical.

(4) Except when the owner, operator, or agent in charge of the controlled premises so consents in writing, no inspection authorized by this section shall extend to—

(A) financial data;

(B) sales data other than shipment data; or

(C) pricing data.

(c) Situations not requiring warrants

A warrant under this section shall not be required for the inspection of books and records pursuant to an administrative subpena issued in accordance with section 876 of this title, nor for entries and administrative inspections (including seizures of property)—

(1) with the consent of the owner, operator, or agent in charge of the controlled premises;

(2) in situations presenting imminent danger to health or safety;

(3) in situations involving inspection of conveyances where there is reasonable cause to believe that the mobility of the conveyance makes it impracticable to obtain a warrant;

(4) in any other exceptional or emergency circumstance where time or opportunity to apply for a warrant is lacking; or

(5) in any other situations where a warrant is not constitutionally required.

(d) Administrative inspection warrants; issuance; execution; probable cause

Issuance and execution of administrative inspection warrants shall be as follows:

(1) Any judge of the United States or of a State court of record, or any United States magistrate judge, may, within his territorial jurisdiction, and upon proper oath or affirmation showing probable cause, issue warrants for the purpose of conducting administrative inspections authorized by this subchapter or regulations thereunder, and seizures of property appropriate to such inspections. For the purposes of this section, the term "probable cause" means a valid public interest in the effective enforcement of this subchapter or regulations thereunder sufficient to justify administrative inspections of the area, premises, building, or conveyance, or contents thereof, in the circumstances specified in the application for the warrant.

(2) A warrant shall issue only upon an affidavit of an officer or employee having knowledge of the facts alleged, sworn to before the judge or magistrate judge and establishing the grounds for issuing the warrant. If the judge or magistrate judge is satisfied that grounds for the application exist or that there is probable cause to believe they exist, he shall issue a warrant identifying the area, premises, building, or conveyance to be inspected, the purpose of such inspection, and, where appropriate, the type of property to be inspected, if any. The warrant shall identify the items or types of property to be seized, if any. The warrant shall be directed to a person authorized under subsection (b)(2) to execute it. The warrant shall state the grounds for its issuance and the name of the person or persons whose affidavit has been taken in support thereof. It shall command the person to whom it is directed to inspect the area, premises, building, or conveyance identified for the purpose specified, and, where appropriate, shall direct the seizure of the property specified. The warrant shall direct that it be served during normal business hours. It shall designate the judge or magistrate judge to whom it shall be returned.

(3) A warrant issued pursuant to this section must be executed and returned within ten days of its date unless, upon a showing by the United States of a need therefor, the judge or magistrate judge allows additional time in the warrant. If property is seized pursuant to a warrant, the person executing the warrant shall give to the person from whom or from whose premises the property was taken a copy of the warrant and a receipt for the property taken or shall leave the copy and receipt at the place from which the property was taken. The return of the warrant shall be made promptly and shall be accompanied by a written inventory of any property taken. The inventory shall be made in the presence of the person executing the warrant and of the person from whose possession or premises the property was taken, if they are present, or in the presence of at least one credible person other than the person making such inventory, and shall be verified by the person executing the warrant. The judge or magistrate judge, upon request, shall deliver a copy of the inventory to the person from whom or from whose premises the property was taken and to the applicant for the warrant.

(4) The judge or magistrate judge who has issued a warrant under this section shall attach to the warrant a copy of the return and all papers filed in connection therewith and shall file them with the clerk of the district court of the United States for the judicial district in which the inspection was made.

(Pub. L. 91–513, title II, §510, Oct. 27, 1970, 84 Stat. 1274; Pub. L. 101–647, title XXXV, §3599M, Nov. 29, 1990, 104 Stat. 4932; Pub. L. 101–650, title III, §321, Dec. 1, 1990, 104 Stat. 5117; Pub. L. 103–200, §6, Dec. 17, 1993, 107 Stat. 2339.)

Editorial Notes

Amendments

1993—Subsec. (a)(2). Pub. L. 103–200, §6(1), amended par. (2) generally. Prior to amendment, par. (2) read as follows: "places, including factories, warehouses, or other establishments, and conveyances, where persons registered under section 823 of this title (or exempted from registration under section 822(d) of this title) may lawfully hold, manufacture, or distribute, dispense, administer, or otherwise dispose of controlled substances."

Subsec. (b)(3)(B). Pub. L. 103–200, §6(2)(A), inserted ", listed chemicals," after "unfinished drugs".

Subsec. (b)(3)(C). Pub. L. 103–200, §6(2)(B), inserted "or listed chemical" after "controlled substance" and "or chemical" after "such substance".

1990—Subsec. (b)(3)(B). Pub. L. 101–647 substituted "paragraph (4)" for "paragraph (5)".

Statutory Notes and Related Subsidiaries

Change of Name

"United States magistrate judge" and "magistrate judge" substituted for "United States magistrate" and "magistrate", respectively, wherever appearing in subsec. (d) pursuant to section 321 of Pub. L. 101–650, set out as a note under section 631 of Title 28, Judiciary and Judicial Procedure.

Effective Date of 1993 Amendment

Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title.