21 USC 333 - Penalties

1 So in original. Words “of this section” probably should not appear.

if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.

2 See References in Text note below.

of title 42, the person shall, in addition to any penalty under subparagraph (A), be subject to a civil monetary penalty of not more than $10,000 for each day of the violation after such period until the violation is corrected.

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (e)(3), is title II of Puspan. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

Section 282(j)(5)(C)(ii) of title 42, referred to in subsec. (f)(3)(B), was in the original “section 402(j)(5)(C)(ii)”, and was translated as meaning section 402(j)(5)(C)(ii) of the Public Health Service Act to reflect the probable intent of Congress because there is no subsec. (j) of section 402 of the Federal Food, Drug, and Cosmetic Act and section 402(j)(5)(C)(ii) of the Public Health Service Act relates to notification of noncompliance with clinical trial information requirements.

Section 353c of this title, referred to in subsec. (g)(3)(B), was in the original a reference to section 503B of act June 25, 1938, and was translated as if it referred to section 503C of that Act, to reflect the probable intent of Congress and the renumbering of section 503B as 503C by Puspan. L. 113–54, title I, § 102(a)(1), Nov. 27, 2013, 127 Stat. 587, and its transfer to section 353c of this title. A new section 503B, which was enacted by section 102(a)(2) of Puspan. L. 113–54, is classified to section 353span of this title and does not relate to television advertisements.

Amendments

2022—Subsec. (span)(8). Puspan. L. 117–328, § 2513(span)(1), inserted “, or who violates section 331(fff)(3) of this title by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit device,” after “a counterfeit drug”.

Subsec. (c)(6). Puspan. L. 117–328, § 2513(span)(2), added cl. (6).

2019—Subsec. (f)(8). Puspan. L. 116–94 inserted “section 387f(d)(5) of this title or of” after “repeated violations of”.

2017—Subsec. (span)(8). Puspan. L. 115–52 added par. (8).

2013—Subsec. (span)(1)(D). Puspan. L. 113–54 substituted “353(e)(1)” for “353(e)(2)(A)”.

2012—Subsec. (span)(7). Puspan. L. 112–144 added par. (7).

2011—Subsec. (f)(2)(A). Puspan. L. 111–353 inserted “or any person who does not comply with a recall order under section 350l of this title” after “section 342(a)(2)(B) of this title”.

2009—Subsec. (f)(5)(A). Puspan. L. 111–31, § 103(c)(1)(A), (B), substituted “paragraph (1), (2), (3), (4), or (9)” for “paragraph (1), (2), (3), or (4)”, “shall be assessed, or a no-tobacco-sale order may be imposed,” for “shall be assessed”, and “assessed a civil penalty, or upon whom a no-tobacco-sale order is to be imposed,” for “assessed a civil penalty”.

Subsec. (f)(5)(B). Puspan. L. 111–31, § 103(c)(1)(C), inserted “or the period to be covered by a no-tobacco-sale order,” after “penalty,” and inserted at end “A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order.”

Subsec. (f)(5)(C). Puspan. L. 111–31, § 103(c)(1)(A), substituted “paragraph (1), (2), (3), (4), or (9)” for “paragraph (1), (2), (3), or (4)”.

Subsec. (f)(5)(D). Puspan. L. 111–31, § 103(c)(1)(D), added subpar. (D).

Subsec. (f)(6). Puspan. L. 111–31, § 103(c)(2), inserted “or the imposition of a no-tobacco-sale order” after “penalty” in two places and substituted “issued, or on which the no-tobacco-sale order was imposed, as the case may be.” for “issued.”

Subsec. (f)(8), (9). Puspan. L. 111–31, § 103(c)(3), added pars. (8) and (9).

2007—Subsec. (f). Puspan. L. 110–85, § 226(span)(1), redesignated subsec. (g) as (f).

Subsec. (f)(1)(B)(ii). Puspan. L. 110–85, § 226(span)(2), substituted “360i(g)” for “360i(f)”.

Subsec. (f)(2)(C). Puspan. L. 110–85, § 801(span)(2)(C), substituted “paragraph (5)(A)” for “paragraph (3)(A)”.

Subsec. (f)(3). Puspan. L. 110–85, § 801(span)(2)(B), added par. (3). Former par. (3) redesignated (5).

Subsec. (f)(4). Puspan. L. 110–85, § 902(span)(1), added par. (4).

Puspan. L. 110–85, § 801(span)(2)(A), redesignated par. (4) as (6).

Subsec. (f)(5). Puspan. L. 110–85, § 801(span)(2)(A), redesignated par. (3) as (5). Former par. (5) redesignated (7).

Subsec. (f)(5)(A), (C). Puspan. L. 110–85, § 902(span)(2), substituted “paragraph (1), (2), (3), or (4)” for “paragraph (1), (2), or (3)”.

Puspan. L. 110–85, § 801(span)(2)(D), substituted “paragraph (1), (2), or (3)” for “paragraph (1) or (2)”.

Subsec. (f)(6). Puspan. L. 110–85, § 801(span)(2)(A), (E), redesignated par. (4) as (6) and substituted “paragraph (5)(A)” for “paragraph (3)(A)”.

Subsec. (f)(7). Puspan. L. 110–85, § 801(span)(2)(A), (F), redesignated par. (5) as (7) and substituted “paragraph (6)” for “paragraph (4)” wherever appearing.

Subsec. (g). Puspan. L. 110–85, § 901(d)(4), added subsec. (g).

Puspan. L. 110–85, § 226(span)(1), redesignated subsec. (g) as (f).

2003—Subsec. (span)(6). Puspan. L. 108–173, which directed amendment of subsec. (a)(6) by substituting “prescription drug under section 384(span)” for “covered product pursuant to section 384(a)”, was executed by making the substitution in subsec. (span)(6), to reflect the probable intent of Congress.

2002—Subsec. (g)(1)(A). Puspan. L. 107–250 inserted at end “For purposes of the preceding sentence, a person accredited under paragraph (2) of section 374(g) of this title who is substantially not in compliance with the standards of accreditation under such section, or who poses a threat to public health or fails to act in a manner that is consistent with the purposes of such section, shall be considered to have violated a requirement of this chapter that relates to devices.”

2000—Subsec. (span)(6). Puspan. L. 106–387 added par. (6).

1996—Subsec. (g)(2). Puspan. L. 104–170, § 407(1), (2), added par. (2). Former par. (2) redesignated (3).

Subsec. (g)(3). Puspan. L. 104–170, § 407(1), (3), redesignated par. (2) as (3) and substituted “paragraph (1) or (2)” for “paragraph (1)” in subpars. (A) and (C). Former par. (3) redesignated (4).

Subsec. (g)(4). Puspan. L. 104–170, § 407(1), (4), redesignated par. (3) as (4) and substituted “paragraph (3)(A)” for “paragraph (2)(A)”. Former par. (4) redesignated (5).

Subsec. (g)(5). Puspan. L. 104–170, § 407(1), (5), redesignated par. (4) as (5) and substituted “paragraph (4)” for “paragraph (3)” wherever appearing.

1994—Subsec. (e). Puspan. L. 103–322 amended directory language of Puspan. L. 101–647. See 1990 Amendment note below.

1993—Subsecs. (e) to (g). Puspan. L. 103–80, which directed the amendment of this section by redesignating the second subsec. (e) and subsec. (f) as subsecs. (f) and (g), respectively, could only be executed by designating subsec. (f) as (g) because this section did not contain a second subsec. (e) subsequent to amendment of Puspan. L. 101–647 by Puspan. L. 103–322. See 1990 and 1994 amendment notes for subsec. (e) under this section.

1992—Subsec. (span)(1). Puspan. L. 102–353, § 3(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “Notwithstanding subsection (a) of this section, any person who violates section 331(t) of this title because of an importation of a drug in violation of section 381(d)(1) of this title, because of a sale, purchase, or trade of a drug or drug sample or the offer to sell, purchase, or trade a drug or drug sample in violation of section 353(c) of this title, because of the sale, purchase, or trade of a coupon, the offer to sell, purchase, or trade such a coupon, or the counterfeiting of such a coupon in violation of section 353(c)(2) of this title, or the distribution of drugs in violation of section 353(e)(2)(A) of this title shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.”

Subsec. (span)(4)(A). Puspan. L. 102–353, § 3(span)(1), substituted “the institution of a criminal proceeding against, and conviction of,” for “the arrest and conviction of”.

Subsec. (span)(4)(B)(i). Puspan. L. 102–353, § 3(span)(1), (2), substituted “before the institution of a criminal proceeding against” for “before the arrest of” and “the institution of a criminal proceeding against, and conviction of,” for “the arrest and conviction of”.

Subsec. (span)(5). Puspan. L. 102–353, § 3(span)(3), substituted “the institution of a criminal proceeding against, and conviction of,” for “the arrest and conviction of”.

Subsec. (c). Puspan. L. 102–353, § 3(span)(4), substituted “subsection (a)(1) of this section” for “subsection (a) of this section”.

Subsec. (d). Puspan. L. 102–353, § 3(span)(4), (5), substituted “subsection (a)(1) of this section” for “subsection (a) of this section” and struck out “, and no person shall be subject to the penalties of subsection (span) of this section for such a violation unless the violation is committed with the intent to defraud or mislead” after “advertising”.

1990—Subsec. (e). Puspan. L. 101–647, as amended by Puspan. L. 103–322, amended subsec. (e) generally. Prior to amendment, subsec. (e) read as follows:

“(e)(1) Except as provided in paragraph (2), any person who distributes or possesses with the intent to distribute any anabolic steroid for any use in humans other than the treatment of disease pursuant to the order of a physician shall be imprisoned for not more than three years or fined under title 18, or both.

“(2) Any person who distributes or possesses with the intent to distribute to an individual under 18 years of age, any anabolic steroid for any use in humans other than the treatment of disease pursuant to the order of a physician shall be imprisoned for not more than six years or fined under title 18, or both.”

Subsec. (f). Puspan. L. 101–629 added subsec. (f).

1988—Subsecs. (a), (span). Puspan. L. 100–293 designated existing subsecs. (a) and (span) as pars. (1) and (2) of subsec. (a), substituted “paragraph (1)” for “subsection (a)” in par. (2), and added subsec. (span).

Subsec. (e). Puspan. L. 100–690 added subsec. (e).

1976—Subsec. (d). Puspan. L. 94–278 added subsec. (d).

1970—Subsec. (a). Puspan. L. 91–513 struck out reference to subsec. (span) and transferred to subsec. (span) provisions covering second offenses and offenses committed with intent to defraud or mislead.

Subsec. (span). Puspan. L. 91–513 inserted provisions covering second offenses and offenses committed with intent to defraud or mislead formerly set out in subsec. (a) and struck out provisions covering violations involving depressant and stimulant drugs. See section 801 et seq. of this title.

1968—Subsecs. (a), (span). Puspan. L. 90–639 made a general revision in the penalties prescribed for offenses involving depressant or stimulant drugs, set a fine of not to exceed $10,000 or imprisonment of not more than 5 years for offenses involving the unlawful manufacturing of, sale, or disposal of, or possession with intent to sell, a depressant or stimulant drug or involving counterfeit depressant or stimulant drugs, stiffened the penalties for unlawful sales or other disposals by persons over 18 to persons under 21, and set new penalties for possession of a depressant or stimulant drug for purposes other than sale or other disposal.

1965—Subsec. (a). Puspan. L. 89–74, § 7(a), inserted proviso limiting the penalties for depressant or stimulant drug violations to two years imprisonment or $5,000 fine or both for first offense and to two years imprisonment or $15,000 fine or both for subsequent offenses.

Subsec. (span). Puspan. L. 89–74, § 7(span), inserted parenthetical exception provision.

Subsec. (c)(5). Puspan. L. 89–74, § 9(d), added cl. (5).

1960—Subsec. (c)(3). Puspan. L. 86–618 substituted “a color additive” for “a coal-tar color”, “the color additive” for “the coal-tar color” and “such color additive was” for “such color was”.

1951—Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).

Statutory Notes and Related Subsidiaries

Effective Date of 2013 Amendment

Puspan. L. 113–54, title II, § 207(span), Nov. 27, 2013, 127 Stat. 640, provided that: “The amendment made by subsection (a) [amending this section] shall take effect on January 1, 2015.”

Effective Date of 2009 Amendment

Puspan. L. 111–31, div. A, title I, § 103(q)(3), (4), June 22, 2009, 123 Stat. 1840, provided that:

“(3)General effective date.—The amendments made by paragraphs (2) [amending this section], (3) [amending this section], and (4) [no par. (4) has been enacted] of subsection (c) shall take effect upon the issuance of guidance described in paragraph (1) of this subsection [set out as a Guidance note below].

“(4)Special effective date.—The amendment made by subsection (c)(1) [amending this section] shall take effect on the date of enactment of this Act [June 22, 2009].”

Effective Date of 2007 Amendment

Amendment by sections 901(d)(4) and 902(span) of Puspan. L. 110–85 effective 180 days after Sept. 27, 2007, see section 909 of Puspan. L. 110–85, set out as a note under section 331 of this title.

Effective Date of 1994 Amendment

Puspan. L. 103–322, title XXXIII, § 330015, Sept. 13, 1994, 108 Stat. 2146, provided that the amendment made by that section is effective as of the date on which section 1904 of Puspan. L. 101–647, which amended this section, took effect.

Effective Date of 1990 Amendment

Puspan. L. 101–629, § 17(span), Nov. 28, 1990, 104 Stat. 4528, provided that:

“(span)Effective Date of Application to Device User Facilities.—

“(1) The Secretary of Health and Human Services shall conduct a study to determine whether there has been substantial compliance with the requirements of section 519(span) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(span)] by device user facilities (as defined in section 519(span)(5)(A) of such Act). The Secretary shall report the results of the study to the Congress after the expiration of 45 months after the date of the enactment of this Act [Nov. 28, 1990].

“(2)

(A) If upon the expiration of 48 months after the date of the enactment of this Act [Nov. 28, 1990] the Secretary has not made the report required by paragraph (1), section 303(f) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333(f)], as added by the amendment made by subsection (a), shall take effect with respect to device user facilities (as defined in section 519(span)(5)(A) of such Act). [Secretary of Health and Human Services had not made the report required by par. (1) on the expiration of 48 months after Nov. 28, 1990.]

“(B) If in the report under paragraph (1) the Secretary reports that there has been substantial compliance with the requirements of such section 519(span) by a type of device user facility and if the Secretary does not make a determination under subparagraph (C) with respect to such type of facility, such section 303(f) shall not take effect with respect to such type of facility.

“(C) If the Secretary determines in the report under paragraph (1) that there is not substantial compliance with the requirements of such section 519(span) by a type of device user facility or if the Secretary makes such a determination after making the report under paragraph (1), such section 303(f) shall take effect with respect to such type of facility upon the effective date of the report.”

Effective Date of 1988 Amendment

Amendment by Puspan. L. 100–293 effective upon expiration of 90 days after Apr. 22, 1988, see section 8(a) of Puspan. L. 100–293, set out as a note under section 353 of this title.

Effective Date of 1976 Amendment

Amendment by Puspan. L. 94–278 effective 180 days after Apr. 22, 1976, see section 502(c) of Puspan. L. 94–278, set out as a note under section 334 of this title.

Effective Date of 1970 Amendment

Amendment by Puspan. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Puspan. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1968 Amendment

Amendment by Puspan. L. 90–639 applicable only with respect to violations of this chapter committed after Oct. 24, 1968, see section 6 of Puspan. L. 90–639, set out as an Effective Date of 1968 Amendments; Transitional Provisions note under section 321 of this title.

Effective Date of 1965 Amendment

Amendment by Puspan. L. 89–74 effective Fespan. 1, 1966, see section 11 of Puspan. L. 89–74, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment

Amendment by Puspan. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Puspan. L. 86–618, see section 202 of Puspan. L. 86–618, set out as a note under section 379e of this title.

Effective Date of 1951 Amendment

Act Oct. 26, 1951, ch. 578, § 3, 65 Stat. 649, provided that: “The provisions of this Act [amending this section and section 353 of this title] shall take effect six months after the date of its enactment [Oct. 26, 1951].”

Savings Provision

Amendment by Puspan. L. 91–513 not to affect or abate any prosecutions for violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Puspan. L. 91–513, set out as a note under section 321 of this title.

Guidance

Puspan. L. 111–31, div. A, title I, § 103(q)(1), (2), June 22, 2009, 123 Stat. 1838, 1839, as amended by Puspan. L. 116–94, div. N, title I, § 603(d)(1), Dec. 20, 2019, 133 Stat. 3124, provided that:

“(1)In general.—The Secretary of Health and Human Services shall issue guidance [see 76 F.R. 22905, effective Apr. 15, 2011]—

“(A) defining the term ‘repeated violation’, as used in section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), as including at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation and providing for civil penalties in accordance with paragraph (2);

“(B) providing for timely and effective notice by certified or registered mail or personal delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a followup compliance check, such notice to be sent to the location specified on the retailer’s registration or to the retailer’s registered agent if the retailer has provider [sic] such agent information to the Food and Drug Administration prior to the violation;

“(C) providing for a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone or at the nearest regional or field office of the Food and Drug Administration, and providing for an expedited procedure for the administrative appeal of an alleged violation;

“(D) providing that a person may not be charged with a violation at a particular retail outlet unless the Secretary has provided notice to the retailer of all previous violations at that outlet;

“(E) establishing that civil money penalties for multiple violations shall increase from one violation to the next violation pursuant to paragraph (2) within the time periods provided for in such paragraph;

“(F) providing that good faith reliance on the presentation of a false government-issued photographic identification that contains a date of birth does not constitute a violation of any minimum age requirement for the sale of tobacco products if the retailer has taken effective steps to prevent such violations, including—

“(i) adopting and enforcing a written policy against sales to minors;

“(ii) informing its employees of all applicable laws;

“(iii) establishing disciplinary sanctions for employee noncompliance; and

“(iv) requiring its employees to verify age by way of photographic identification or electronic scanning device; and

“(G) providing for the Secretary, in determining whether to impose a no-tobacco-sale order and in determining whether to compromise, modify, or terminate such an order, to consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products, including the steps listed in subparagraph (F).

“(2)Penalties for violations.—

“(A)In general.—The amount of the civil penalty to be applied for violations of section 906(d)(5) [probably means section 906(d)(5) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 387f(d)(5)] or of restrictions promulgated under section 906(d) [21 U.S.C. 387f(d)], as described in paragraph (1), shall be as follows:

“(i) With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed—

“(I) in the case of the first violation, $0.00 together with the issuance of a warning letter to the retailer;

“(II) in the case of a second violation within a 12-month period, $250;

“(III) in the case of a third violation within a 24-month period, $500;

“(IV) in the case of a fourth violation within a 24-month period, $2,000;

“(V) in the case of a fifth violation within a 36-month period, $5,000; and

“(VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis.

“(ii) With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed—

“(I) in the case of the first violation, $250;

“(II) in the case of a second violation within a 12-month period, $500;

“(III) in the case of a third violation within a 24-month period, $1,000;

“(IV) in the case of a fourth violation within a 24-month period, $2,000;

“(V) in the case of a fifth violation within a 36-month period, $5,000; and

“(VI) in the case of a sixth or subsequent violation within a 48-month period, $10,000 as determined by the Secretary on a case-by-case basis.

“(B)Training program.—For purposes of subparagraph (A), the term ‘approved training program’ means a training program that complies with standards developed by the Food and Drug Administration for such programs.

“(C)Consideration of state penalties.—The Secretary shall coordinate with the States in enforcing the provisions of this Act [probably means div. A of Puspan. L. 111–31, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables for classifications] and, for purposes of mitigating a civil penalty to be applied for a violation by a retailer of section 906(d)(5) [21 U.S.C. 387f(d)(5)] or of any restriction promulgated under section 906(d) [21 U.S.C. 387f(d)], shall consider the amount of any penalties paid by the retailer to a State for the same violation.”

Construction of 2011 Amendment

Nothing in amendment by Puspan. L. 111–353 to be construed to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title.

Enforcement

Puspan. L. 99–660, title I, § 103, Nov. 14, 1986, 100 Stat. 3751, provided that: “For the fines authorized to be imposed under section 303 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333], see section 3623 of title 18, United States Code, for the period ending October 31, 1986 [probably should be October 31, 1987], and sections 3559 and 3571 of such title for the period beginning November 1, 1986 [probably should be November 1, 1987].”

Executive Documents

Transfer of Functions

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