21 U.S. Code § 333 - Penalties

Any section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both.

Notwithstanding the provisions of paragraph (1) of this section,[1] if any (b) Prescription drug marketing violations

knowingly selling, purchasing, or trading aknowingly offering to sell, purchase, or trade asection 353(c)(1) of this title,

knowingly selling, purchasing, or trading a coupon, knowingly offering to sell, purchase, or trade such a coupon, or knowingly counterfeiting such a coupon, in violation of section 353(c)(2) of this title, or

(2) Any manufacturer or distributor who distributes drug samples by means other than the mail or common carrier whose representative, during the course of the representative’s employment or association with that manufacturer or distributor, violated section 331(t) of this title because of a violation of section 353(c)(1) of this title or violated anysection 353(b) of this title or the offer to sell, purchase, or trade such a (A)

A civil penalty of not more than $50,000 for each of the first two such violations resulting in a conviction of any representative of the manufacturer or distributor in any 10-year period.

A civil penalty of not more than $1,000,000 for each violation resulting in a conviction of any representative after the second conviction in any 10-year period.

For the purposes of this paragraph, multiple convictions of one or more persons arising out of the same event or transaction, or a related series of events or transactions, shall be considered as one violation.

Any manufacturer or distributor who violates section 331(t) of this title because of a failure to make a report required by section 353(d)(3)(E) of this title shall be subject to a civil penalty of not more than $100,000.

If a manufacturer or distributor or any representative of such manufacturer or distributor provides information leading to the institution of a criminal proceeding against, and conviction of, any representative of that manufacturer or distributor for a violation of section 331(t) of this title because of a sale, purchase, or trade or offer to purchase, sell, or trade asection 353(c)(1) of this title or for a violation of (B) If, in an action brought under paragraph (2) against a manufacturer or distributor relating to the conviction of a representative of such manufacturer or distributor for the sale, purchase, or trade of a drug or the offer to sell, purchase, or trade a drug, it is shown, by clear and convincing evidence—

that the manufacturer or distributor conducted, before the institution of a criminal proceeding against such representative for the violation which resulted in such conviction, an investigation of events or transactions which would have led to the reporting of information leading to the institution of a criminal proceeding against, and conviction of, such representative for such purchase, sale, or trade or offer to purchase, sell, or trade, or

that, except in the case of the conviction of a representative employed in a supervisory function, despite diligent implementation by the manufacturer or distributor of an independent audit and security system designed to detect such a violation, the manufacturer or distributor could not reasonably have been expected to have detected such violation,

the conviction of such representative shall not be considered as a conviction for purposes of paragraph (2).

If a section 331(t) of this title because of the sale, purchase, or trade of asection 353(c)(1) of this title, such (6)

Notwithstanding subsection (a), any section 384(b) of this title andsection 384(e) of this title that is applicable to such manufacturer or importer, respectively, shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.

Notwithstanding subsection (a)(2), any knowingly and intentionally adulterates asection 351 of this title and has a reasonable probability of causing serious adverse health consequences or death to humans or animals shall be imprisoned for not more than 20 years or fined not more than $1,000,000, or both.

No interstate commerce any article and delivered it or proffered delivery of it, if such delivery or proffer was made in good faith, unless he refuses to furnish on request of an officer or employee duly designated by thesection 331(a) or (d) of this title, if he establishes a guaranty or undertaking signed by, and containing the name and address of, thesection 331(a) of this title, that such article is not adulterated or misbranded, within the meaning of this chapter designating this chapter or to the effect, in case of an alleged violation of section 331(d) of this title, that such article is not an article which may not, under the provisions of section 344 or 355 of this title, be introduced into interstate commerce; or (3) for having violated section 331(a) of this title, where the violation exists because the article is adulterated by reason of containing a color additive, to the effect that suchsection 352(f) of this title in respect to an article received in interstate commerce to which neither section 353(a) nor 353(b)(1) of this title is applicable, if the delivery or proffered delivery was made in good faith and the labeling at the time thereof contained the same directions for use and warning statements as were contained in the labeling at the time of such receipt of such article; or (5) for having violated section 331(i)(2) of this title if such counterfeit drug, or for having violated section 331(i)(3) of this title if the counterfeit drug; or (6) for having violated section 331(fff)(2) of this title if suchsection 331(fff)(3) of this title if the counterfeit device.

No section 331 of this title involving misbranded food if the violation exists solely because the food is misbranded under section 343(a)(2) of this title because of its advertising.

Except as provided in paragraph (2), whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by thesection 355 of this title and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18, or both.

Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both.

Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes of forfeiture under section 413 of such Act [21 U.S.C. 853].

As used in this subsection the term “human growth hormone” means somatrem, somatropin, or an analogue of either of them.

The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.

Except as provided in subparagraph (B), any devices shall be liable to the Unitedsection 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 (B) Subparagraph (A) shall not apply—

to any 360i(a) or 360j(f) of this title unless such violation constitutes (I) a significant or knowing departure from such requirements, or (II) a risk to public health,

to violations of section 351(a)(2)(A) of this title which involve one or more devices which are not defective.

Any interstate commerce or delivers for introduction into interstate commerce an article of food that is adulterated within the meaning of section 342(a)(2)(B) of this title or any (B)

This paragraph shall not apply to any food that is adulterated. If the interstate commerce of the article of food that is adulterated. If thesection 334 of this title or the injunction authorities of section 332 of this title with respect to the article of food that is adulterated.

In a hearing to assess a civil penalty under this paragraph, the presiding officer shall have the same authority with regard to compelling testimony or production of documents as a presiding officer has under section 346a(g)(2)(B) of this title. The third sentence of paragraph (5)(A) shall not apply to any investigation under this paragraph.

Any section 331(jj) of this title shall be subject to a civil monetary penalty of not more than $10,000 for all violations adjudicated in a single proceeding.

If a violation of section 331(jj) of this title is not corrected within the 30-day period following notification under section 282(j)(5)(C)(ii) [2] of title 42, the (4)

(A) Any responsible section 355–1 of this title) that violates a requirement of section 355(o), 355(p), or 355–1 of this title shall be subject to a civil monetary penalty of—

not more than $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or

In determining the amount of a civil penalty under subparagraph (A)(ii), the 355(o), 355(p), or 355–1 of this title for which the responsible (5)

A civil penalty under paragraph (1), (2), (3), (4), or (9) shall be assessed, or a no-tobacco-sale order may be imposed, by the section 554 of title 5. Before issuing such an order, the Secretary’s proposal to issue such order and provide such (B)

In determining the amount of a civil penalty, or the period to be covered by a no-tobacco-sale order, the (C)

(i) Any 387b(5), 387b(6), 387d, 387h(c), or 387k(a) of this title, shall be subject to a civil monetary penalty of—

not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or

in the case of a violation that continues after the person, $250,000 for the first 30-day period (or any portion thereof) that the (ii) Any 387k(g)(2)(C)(ii) or 387k(i)(1) of this title, shall be subject to a civil monetary penalty of—

not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or

in the case of a violation that continues after the person, $250,000 for the first 30-day period (or any portion thereof) that the (iii)

In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the (g) Violations regarding direct-to-consumer advertising

A civil penalty under paragraph (1) shall be assessed by the section 554 of title 5. If upon receipt of the written notice, the (3) The (A)

after a court in an action brought under paragraph (6) has entered a final judgment in favor of the the Attorney General of the United States shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in paragraph (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review.

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

[2] See References in Text note below.

The Controlled Substances Act, referred to in subsec. (e)(3), is title II of Pub. 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 Pub. 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 Pub. L. 113–54, is classified to section 353b of this title and does not relate to television advertisements.

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

2017—Subsec. (b)(8). Pub. L. 115–52 added par. (8).

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

2012—Subsec. (b)(7). Pub. L. 112–144 added par. (7).

2009—Subsec. (f)(5)(A). Pub. 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). Pub. 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 sellingPub. L. 111–31, § 103(c)(1)(A), substituted “paragraph (1), (2), (3), (4), or (9)” for “paragraph (1), (2), (3), or (4)”.

Subsec. (f)(6). Pub. 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.”

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

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

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

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

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

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

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

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

2003—Subsec. (b)(6). Pub. L. 108–173, which directed amendment of subsec. (a)(6) by substituting “prescriptionCongress .

2002—Subsec. (g)(1)(A). Pub. L. 107–250 inserted at end “For purposes of the preceding sentence, asection 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 toPub. L. 106–387 added par. (6).

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

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

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

1993—Subsecs. (e) to (g). Pub. 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 Pub. L. 101–647 by Pub. L. 103–322. See 1990 and 1994 amendment notes for subsec. (e) under this section.

1992—Subsec. (b)(1). Pub. L. 102–353, § 3(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “Notwithstanding subsection (a) of this section, anysection 331(t) of this title because of an importation of asection 381(d)(1) of this title, because of a sale, purchase, or trade of asection 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 ofsection 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. (b)(4)(A). Pub. L. 102–353, § 3(b)(1), substituted “the institution of a criminal proceeding against, and conviction of,” for “the arrest and conviction of”.

Subsec. (b)(4)(B)(i). Pub. L. 102–353, § 3(b)(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. (b)(5). Pub. L. 102–353, § 3(b)(3), substituted “the institution of a criminal proceeding against, and conviction of,” for “the arrest and conviction of”.

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

Subsec. (d). Pub. L. 102–353, § 3(b)(4), (5), substituted “subsection (a)(1) of this section” for “subsection (a) of this section” and struck out “, and noPub. L. 101–647, as amended by Pub. L. 103–322, amended subsec. (e) generally. Prior to amendment, subsec. (e) read as follows:

“(e)(1) Except as provided in paragraph (2), any Pub. L. 101–629 added subsec. (f).

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

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

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

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

Subsec. (b). Pub. L. 91–513 inserted provisions covering second offenses and offenses committed with intent to defraud or mislead formerly set out in subsec. (a) and struck out provisions covering violations involving depressant and stimulantPub. L. 90–639 made a general revision in the penalties prescribed for offenses involving depressant or stimulantPub. L. 89–74, § 7(a), inserted proviso limiting the penalties for depressant or stimulantPub. L. 89–74, § 7(b), inserted parenthetical exception provision.

“The amendment made by subsection (a) [amending this section] shall take effect on January 1, 2015 .”

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].

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

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

Pub. 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 Pub. L. 101–647, which amended this section, took effect.

If upon the expiration of 48 months after the date of the enactment of this Act [ Nov. 28, 1990 ] theFederal 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 toNov. 28, 1990 .]

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

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

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

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

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

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

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 ].”

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

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);

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;

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;

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 “(i)

requiring its employees to verify age by way of photographic identification or electronic scanning “(G)

“(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—

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