Source: https://www.law.cornell.edu/uscode/text/21/333
Timestamp: 2016-10-28 20:30:58
Document Index: 665060412

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Notwithstanding subsection (a), any person who is a manufacturer or importer of a prescription drug under section 384(b) of this title and knowingly fails to comply with a requirement of section 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 person that knowingly and intentionally adulterates a drug such that the drug is adulterated under subsection (a)(1), (b), (c), or (d) of section 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.
Except as provided in subparagraph (B), any person who violates a requirement of this chapter which relates to devices shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. 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.
to any person who violates the requirements of section 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 any person who commits minor violations of section 360i(e) or 360i(g) of this title (only with respect to correction reports) if such person demonstrates substantial compliance with such section, or
Any person who introduces into 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 person who does not comply with a recall order under section 350l of this title shall be subject to a civil money penalty of not more than $50,000 in the case of an individual and $250,000 in the case of any other person for such introduction or delivery, not to exceed $500,000 for all such violations adjudicated in a single proceeding.
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 person who violates 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 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.
(A) Any responsible person (as such term is used in 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—
In determining the amount of a civil penalty under subparagraph (A)(ii), the Secretary shall take into consideration whether the responsible person is making efforts toward correcting the violation of the requirement of section 355(o), 355(p), or 355–1 of this title for which the responsible person is subject to such civil penalty.
If the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 387f(d) of this title at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-sale order under this paragraph, a person shall be entitled to 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, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available.
With respect to a person who is a holder of an approved application under section 355 of this title for a drug subject to section 353(b) of this title or under section 262 of title 42, any such person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent violation in any 3-year period. No other civil monetary penalties in this chapter (including the civil penalty in subsection (f)(4)) shall apply to a violation regarding direct-to-consumer advertising. For purposes of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in paragraph (2) for such advertisements shall be considered one violation. (B) On and after the date of the receipt of such a notice, all violations under this paragraph occurring in a single day shall be considered one violation. With respect to advertisements that appear in magazines or other publications that are published less frequently than daily, each issue date (whether weekly or monthly) shall be treated as a single day for the purpose of calculating the number of violations under this paragraph.
Whether the person submitted the advertisement for review if required under section 353c 2 of this title.
(June 25, 1938, ch. 675, § 303, 52 Stat. 1043; Oct. 26, 1951, ch. 578, § 2, 65 Stat. 649; Pub. L. 86–618, title I, § 105(b), July 12, 1960, 74 Stat. 403; Pub. L. 89–74, §§ 7, 9(d), July 15, 1965, 79 Stat. 233, 235; Pub. L. 90–639, § 3, Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91–513, title II, § 701(b), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 94–278, title V, § 502(a)(2)(B), Apr. 22, 1976, 90 Stat. 411; Pub. L. 100–293, § 7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100–690, title II, § 2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101–629, § 17(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 101–647, title XIX, § 1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102–353, § 3, Aug. 26, 1992, 106 Stat. 941; Pub. L. 103–80, § 3(e), Aug. 13, 1993, 107 Stat. 775; Pub. L. 103–322, title XXXIII, § 330015, Sept. 13, 1994, 108 Stat. 2146; Pub. L. 104–170, title IV, § 407, Aug. 3, 1996, 110 Stat. 1535; Pub. L. 106–387, § 1(a) [title VII, § 745(d)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A–40; Pub. L. 107–250, title II, § 201(c), Oct. 26, 2002, 116 Stat. 1609; Pub. L. 108–173, title XI, § 1121(b)(2), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 110–85, title II, § 226(b), title VIII, § 801(b)(2), title IX, §§ 901(d)(4), 902(b), Sept. 27, 2007, 121 Stat. 854, 920, 940, 943; Pub. L. 111–31, div. A, title I, § 103(c), June 22, 2009, 123 Stat. 1835; Pub. L. 111–353, title II, § 206(c), Jan. 4, 2011, 124 Stat. 3943; Pub. L. 112–144, title VII, § 716, July 9, 2012, 126 Stat. 1075; Pub. L. 113–54, title II, § 207(a), Nov. 27, 2013, 127 Stat. 640.)
[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 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.
2013—Subsec. (b)(1)(D). Pub. L. 113–54 substituted “353(e)(1)” for “353(e)(2)(A)”.
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).
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.
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”.
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).
Pub. L. 113–54, title II, § 207(b), Nov. 27, 2013, 127 Stat. 640, provided that: “The amendment made by subsection (a) [amending this section] shall take effect on January 1, 2015.”
Pub. L. 111–31, div. A, title I, § 103(q)(3), (4), June 22, 2009, 123 Stat. 1840, provided that:
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].”
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.
Pub. L. 101–629, § 17(b), Nov. 28, 1990, 104 Stat. 4528, provided that:
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(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)] by device user facilities (as defined in section 519(b)(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].
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(b)(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.]
If in the report under paragraph (1) the Secretary reports that there has been substantial compliance with the requirements of such section 519(b) 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.
If the Secretary determines in the report under paragraph (1) that there is not substantial compliance with the requirements of such section 519(b) 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.”
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].”
Pub. L. 111–31, div. A, title I, § 103(q)(1), (2), June 22, 2009, 123 Stat. 1838, 1839, provided that:
“(1)In general.—The Secretary of Health and Human Services shall issue guidance [see 76 F.R. 22905, effective Apr. 15, 2011]—
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;
“(A)In general.—The amount of the civil penalty to be applied for violations of restrictions promulgated under section 906(d) [probably means section 906(d) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 387f(d)], as described in paragraph (1), shall be as follows:
“(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 Pub. 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 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.”
Pub. 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].”
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