Amendments
2022—Subsec. (b)(8). 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”.
Subsec. (c)(6). Pub. L. 117–328, § 2513(b)(2), added cl. (6).
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).
2011—Subsec. (f)(2)(A). 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”.
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 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). Pub. 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). Pub. L. 111–31, § 103(c)(1)(D), added subpar. (D).
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.”
Subsec. (f)(8), (9). Pub. L. 111–31, § 103(c)(3), added pars. (8) and (9).
2007—Subsec. (f). Pub. L. 110–85, § 226(b)(1), redesignated subsec. (g) as (f).
Subsec. (f)(1)(B)(ii). Pub. L. 110–85, § 226(b)(2), substituted “360i(g)” for “360i(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)(4). Pub. L. 110–85, § 902(b)(1), added par. (4).
Pub. L. 110–85, § 801(b)(2)(A), redesignated par. (4) as (6).
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.
Subsec. (g). Pub. L. 110–85, § 901(d)(4), added subsec. (g).
Pub. L. 110–85, § 226(b)(1), redesignated subsec. (g) as (f).
2003—Subsec. (b)(6). 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.
2002—Subsec. (g)(1)(A). 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 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. (b)(6). Pub. 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, 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. (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 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 intent to defraud or mislead” after “advertising”.
1990—Subsec. (e). Pub. 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 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). 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 stimulant drugs. See section 801 et seq. of this title.
1968—Subsecs. (a), (b). 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 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). 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.
Subsec. (b). Pub. L. 89–74, § 7(b), inserted parenthetical exception provision.
Subsec. (c)(5). Pub. L. 89–74, § 9(d), added cl. (5).
1960—Subsec. (c)(3). 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”.
1951—Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).