21 U.S.C. 333: Penalties

2022

• Pub. L. 117–328, §2513(b)(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". (Consolidated Appropriations Act, 2023) Law text · (b)
• Pub. L. 117–328, §2513(b)(2), added cl. (6). (Consolidated Appropriations Act, 2023) Law text · (c)

2019

• Pub. L. 116–94 inserted "section 387f(d)(5) of this title or of" after "repeated violations of". (Further Consolidated Appropriations Act, 2020) Law text · (f)

2017

• Pub. L. 115–52 added par. (8). (FDA Reauthorization Act of 2017) Law text · (b)

2013

• Pub. L. 113–54 substituted "353(e)(1)" for "353(e)(2)(A)". Law text · (b)

2012

• Pub. L. 112–144 added par. (7). (Food and Drug Administration Safety and Innovation Act) Law text · (b)

2011

• Pub. 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". (FDA Food Safety Modernization Act) Law text · (f)

2009

• 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 ord… Law text · (f)
• 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 selling tobacco products shall include provisions that allow th… Law text · (f)
• Pub. L. 111–31, §103(c)(1)(A), substituted "paragraph (1), (2), (3), (4), or (9)" for "paragraph (1), (2), (3), or (4)". Law text · (f)
• Pub. L. 111–31, §103(c)(1)(D), added subpar. (D). Law text · (f)
• 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." Law text · (f)
• Pub. L. 111–31, §103(c)(3), added pars. (8) and (9). Law text · (f), (9)

2007

• Pub. L. 110–85, §226(b)(1), redesignated subsec. (g) as (f). (Food and Drug Administration Amendments Act of 2007) Law text · (f)
• Pub. L. 110–85, §226(b)(2), substituted "360i(g)" for "360i(f)". (Food and Drug Administration Amendments Act of 2007) Law text · (f)
• Pub. L. 110–85, §801(b)(2)(C), substituted "paragraph (5)(A)" for "paragraph (3)(A)". (Food and Drug Administration Amendments Act of 2007) Law text · (f)
• Pub. L. 110–85, §801(b)(2)(B), added par. (3). Former par. (3) redesignated (5). (Food and Drug Administration Amendments Act of 2007) Law text · (f)
• Pub. L. 110–85, §902(b)(1), added par. (4). (Food and Drug Administration Amendments Act of 2007) Law text · (f)
• Pub. L. 110–85, §801(b)(2)(A), redesignated par. (4) as (6). (Food and Drug Administration Amendments Act of 2007) Law text · (f)
• Pub. L. 110–85, §801(b)(2)(A), redesignated par. (3) as (5). Former par. (5) redesignated (7). (Food and Drug Administration Amendments Act of 2007) Law text · (f)
• Pub. L. 110–85, §902(b)(2), substituted "paragraph (1), (2), (3), or (4)" for "paragraph (1), (2), or (3)". (Food and Drug Administration Amendments Act of 2007) Law text · (f), (C)
• Pub. L. 110–85, §801(b)(2)(D), substituted "paragraph (1), (2), or (3)" for "paragraph (1) or (2)". (Food and Drug Administration Amendments Act of 2007) Law text · (f), (C)
• Pub. L. 110–85, §801(b)(2)(A), (E), redesignated par. (4) as (6) and substituted "paragraph (5)(A)" for "paragraph (3)(A)". (Food and Drug Administration Amendments Act of 2007) Law text · (f)
• Pub. L. 110–85, §801(b)(2)(A), (F), redesignated par. (5) as (7) and substituted "paragraph (6)" for "paragraph (4)" wherever appearing. (Food and Drug Administration Amendments Act of 2007) Law text · (f)
• Pub. L. 110–85, §901(d)(4), added subsec. (g). (Food and Drug Administration Amendments Act of 2007) Law text · (g)
• Pub. L. 110–85, §226(b)(1), redesignated subsec. (g) as (f). (Food and Drug Administration Amendments Act of 2007) Law text · (g)

2003

• Pub. L. 108–173, which directed amendment of subsec. (a)(6) by substituting "prescription drug under section 384(b)" for "covered product pursuant to section 384(a)", was executed by making the substitution in subsec. (b)(6), to reflect the probable intent of Congress. (Medicare Prescription Drug, Improvement, and Modernization Act of 2003) Law text · (b)

2002

• Pub. 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 o… (Medical Device User Fee and Modernization Act of 2002) Law text · (g)

2000

• Pub. L. 106–387 added par. (6). (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001) Law text · (b)

1996

• Pub. L. 104–170, §407(1), (2), added par. (2). Former par. (2) redesignated (3). (Food Quality Protection Act of 1996) Law text · (g)
• 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). (Food Quality Protection Act of 1996) Law text · (g)
• 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). (Food Quality Protection Act of 1996) Law text · (g)
• Pub. L. 104–170, §407(1), (5), redesignated par. (4) as (5) and substituted "paragraph (4)" for "paragraph (3)" wherever appearing. (Food Quality Protection Act of 1996) Law text · (g)

1994

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

1993

• 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) subsequ… · (e), (f), (g)

1992

• Pub. 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… · (b)
• Pub. L. 102–353, §3(b)(1), substituted "the institution of a criminal proceeding against, and conviction of," for "the arrest and conviction of". · (b)
• 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". · (b)
• Pub. L. 102–353, §3(b)(3), substituted "the institution of a criminal proceeding against, and conviction of," for "the arrest and conviction of". · (b)
• Pub. L. 102–353, §3(b)(4), substituted "subsection (a)(1) of this section" for "subsection (a) of this section". · (c)
• 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 no person shall be subject to the penalties of subsection (b) of this section for such a violation unless the violation is committed with the inten… · (d)

1990

• Pub. L. 101–647, as amended by Pub. L. 103–322, amended subsec. (e) generally. Prior to amendment, subsec. (e) read as follows: · (e)
• Pub. L. 101–629 added subsec. (f). · (f)

1988

• 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). · (a), (b)
• Pub. L. 100–690 added subsec. (e). · (e)

1976

• Pub. L. 94–278 added subsec. (d). · (d)

1970

• 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. · (a)
• 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 stimulant drugs. See section 801 et seq. of this title. · (b)

1968

• Pub. 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 pos… · (a), (b)

1965

• Pub. 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. · (a)
• Pub. L. 89–74, §7(b), inserted parenthetical exception provision. · (b)
• Pub. L. 89–74, §9(d), added cl. (5). · (c)

1960

• Pub. 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". · (c)