United States Government Printing Office printer prt distributor dst United States Congress House of Representatives Office of the Law Revision Counsel author aut Government Organization text government publication eng USCODE Bills and Statutes 2006_uscode_suppl_4 legislative 2011-09-06 Sec. 333 D09002ee180df8153-USCODE-2010-title21-chap9-subchapIII-sec333.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapIII-sec333.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapIII-sec333 21USC333 http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapIII-sec333/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapIII-sec333.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapIII-sec333.htm 21 U.S.C. 333 21 USC 333 21 U.S.C. 333 21 USC 333; FOOD AND DRUGS; Penalties 137 LEAF USCODE-2010-title21-chap9-subchapIII-sec333 Sec. 333 section standard 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. futureAmend Pub. L. 111-31, div. A, title I, §103(c)(2), (3), (q)(3), June 22, 2009, 123 Stat. 1835, 1840, provided that, effective upon the issuance of guidance described in section 103(q)(1) of Pub. L. 111-31, set out as a Guidance note below, subsection (f) of this section is amended:(1) in paragraph (6), by (A) inserting “or the imposition of a no-tobacco-sale order” after “penalty” wherever appearing, and (B) substituting “issued, or on which the no-tobacco-sale order was imposed, as the case may be.” for “issued.”; and(2) by adding paragraphs (8) and (9) at the end to read as follows: referencesInText 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. amendments <b>2011</b>-Subsec. (f)(2)(A). Pub. L. 111-353 inserted “or any person who does not comply with a recall order under section 350<em>l</em> of this title” after “section 342(a)(2)(B) of this title”.<b>2009</b>-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).<b>2007</b>-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).<b>2003</b>-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.<b>2002</b>-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.”<b>2000</b>-Subsec. (b)(6). Pub. L. 106-387 added par. (6).<b>1996</b>-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.<b>1994</b>-Subsec. (e). Pub. L. 103-322 amended directory language of Pub. L. 101-647. See 1990 Amendment note below.<b>1993</b>-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.<b>1992</b>-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 <!-- PDFPage:55 -->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”.<b>1990</b>-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).<b>1988</b>-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).<b>1976</b>-Subsec. (d). Pub. L. 94-278 added subsec. (d).<b>1970</b>-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.<b>1968</b>-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.<b>1965</b>-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).<b>1960</b>-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”.<b>1951</b>-Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4). effectiveDate amendments Pub. L. 111-31, div. A, title I, §103(q)(3), (4), June 22, 2009, 123 Stat. 1840, provided that:“(3) <cap-smallcap>General effective date</cap-smallcap>.-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) <cap-smallcap>Special effective date</cap-smallcap>.-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.Section 330015 of Pub. L. 103-322 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.Section 17(b) of Pub. L. 101-629 provided that:“(b) <cap-smallcap>Effective Date of Application to Device User Facilities.-</cap-smallcap>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.Section 3 of act Oct. 26, 1951, 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].” savingsProvision 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 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 Pub. L. 91-513, set out as a note under section 321 of this title. transferOfFunctions 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. construction amendments Nothing in amendment by Pub. 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. false false false

Title 18 Section 3623 18 U.S.C. 3623 Title 21 Section 801et seq. Title 21 Section 853 21 U.S.C. 801et seq. 21 U.S.C. 853 Title 21 Section 333 Title 21 Section 333(f) Title 21 Section 333(f)(8) Title 21 Section 360i(b) Title 21 Section 387f(d) Title 21 Section 801et seq. Title 21 Section 853 21 U.S.C. 333 21 U.S.C. 333(f) 21 U.S.C. 333(f)(8) 21 U.S.C. 360i(b) 21 U.S.C. 387f(d) 21 U.S.C. 801et seq. 21 U.S.C. 853 Volume 52 Page 1043 52 Stat. 1043 Volume 65 Page 649 65 Stat. 649 Volume 74 Page 403 74 Stat. 403 Volume 79 Page 233 79 Stat. 233 Volume 82 Page 1361 82 Stat. 1361 Volume 84 Page 1281 84 Stat. 1281 Volume 84 Page 1242 84 Stat. 1242 Volume 90 Page 411 90 Stat. 411 Volume 100 Page 3751 100 Stat. 3751 Volume 102 Page 99 Volume 102 Page 4230 102 Stat. 99 102 Stat. 4230 Volume 104 Page 4526 Volume 104 Page 4853 104 Stat. 4526 104 Stat. 4853 Volume 106 Page 941 106 Stat. 941 Volume 107 Page 775 107 Stat. 775 Volume 108 Page 2146 108 Stat. 2146 Volume 110 Page 1535 110 Stat. 1535 Volume 114 Page 1549 114 Stat. 1549 Volume 116 Page 1609 116 Stat. 1609 Volume 117 Page 2469 117 Stat. 2469 Volume 121 Page 854 121 Stat. 854 Volume 123 Page 1835 123 Stat. 1835 Volume 123 Page 1835 Volume 123 Page 1838 Volume 123 Page 1840 123 Stat. 1835 123 Stat. 1838 123 Stat. 1840 Volume 124 Page 3943 124 Stat. 3943 Public Law 86-618 Public Law 86-618 Public Law 89-74 Public Law 89-74 Public Law 90-639 Public Law 90-639 Public Law 91-513 Public Law 91-513 Public Law 94-278 Public Law 94-278 Public Law 99-660 Public Law 100-293 Public Law 100-293 Public Law 100-690 Public Law 100-690 Public Law 101-629 Public Law 101-629 Public Law 101-647 Public Law 101-647 Public Law 102-353 Public Law 102-353 Public Law 103-80 Public Law 103-80 Public Law 103-322 Public Law 103-322 Public Law 104-170 Public Law 104-170 Public Law 106-387 Public Law 106-387 Public Law 107-250 Public Law 107-250 Public Law 108-173 Public Law 108-173 Public Law 110-85 Public Law 110-85 Public Law 111-31 Public Law 111-31 Public Law 111-353 Public Law 111-353 U.S. Government Printing Office 2010-12-31 monographic 2010 annual deposited born digital 711 p. Y 1.2/5: http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21 P0b002ee180df746e 000645501 21USC DGPO 2011-09-06 2011-09-06 USCODE-2010-title21 machine generated eng fdlp USCODE USCODE-2010-title21 21 true 4 2006 false false 2011-01-07 false false USCODE-title21 Title 21 http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21.htm http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21.pdf U.S.C. Title 21, 2010