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. 321 D09002ee180df8153-USCODE-2010-title21-chap9-subchapII-sec321.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapII-sec321.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapII-sec321 21USC321 http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapII-sec321/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapII-sec321.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapII-sec321.htm 21 U.S.C. 321 21 USC 321 21 U.S.C. 321 21 USC 321; FOOD AND DRUGS; Definitions; generally 129 LEAF USCODE-2010-title21-chap9-subchapII-sec321 Sec. 321 section standard June 25, 1938, ch. 675, §201, 52 Stat. 1040; July 22, 1954, ch. 559, §1, 68 Stat. 511; Pub. L. 85-929, §2, Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86-618, title I, §101, July 12, 1960, 74 Stat. 397; Pub. L. 87-781, title I, §102(a), title III, §307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89-74, §§3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90-399, §102, July 13, 1968, 82 Stat. 351; Pub. L. 90-639, §§1, 4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91-513, title II, §701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92-516, §3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94-278, title V, §502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-295, §3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L. 95-203, §4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96-359, §3, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100-670, title I, §107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101-535, §5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101-629, §16(b), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-282, §6, May 13, 1992, 106 Stat. 161; Pub. L. 102-300, §6(a), (b), June 16, 1992, 106 Stat. 240; Pub. L. 102-571, title I, §107(1), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, §§3(b), (dd)(1), 4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103-417, §§3(a), (b), 10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104-170, title IV, §402, Aug. 3, 1996, 110 Stat. 1513; Pub. L. 105-115, title I, §§121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111 Stat. 2320, 2325, 2327; Pub. L. 105-324, §2(a), (c), Oct. 30, 1998, 112 Stat. 3035, 3037; Pub. L. 107-109, §5(b)(1), Jan. 4, 2002, 115 Stat. 1413; Pub. L. 107-250, title III, §302(d), Oct. 26, 2002, 116 Stat. 1619; Pub. L. 108-282, title I, §102(b)(1), (5)(A), (B), title II, §203(c)(1), Aug. 2, 2004, 118 Stat. 891, 902, 908; Pub. L. 110-85, title X, §1005(c), Sept. 27, 2007, 121 Stat. 968; Pub. L. 111-31, div. A, title I, §101(a), June 22, 2009, 123 Stat. 1783. referencesInText The Food and Drugs Act of June 30, 1906, as amended, referred to in par. (p)(1), and the Food and Drug Act of June 30, 1906, as amended, referred to in par. (v)(1), is act June 30, 1906, ch. 3915, 34 Stat. 768, which was classified to subchapter I (§1 et seq.) of chapter 1 of this title, was repealed (except for section 14a which was transferred to section 376 of this title) by act June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111-31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chapter.The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in par. (q)(1), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to sub<!-- PDFPage:37 -->chapter II (§136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.The Poultry Products Inspection Act, referred to in par. (s)(4), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which is classified generally to chapter 10 (§451 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 451 of this title and Tables.The Meat Inspection Act of March 4, 1907, as amended and extended, referred to in par. (s)(4), is act Mar. 4, 1907, ch. 2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81 Stat. 584, which are classified generally to subchapters I to IV (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.Section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in par. (kk), is section 101(4) of Pub. L. 105-115, which is set out as a note under section 379g of this title. amendments <b>2009</b>-Par. (rr). Pub. L. 111-31 added par. (rr).<b>2007</b>-Par. (ff). Pub. L. 110-85 substituted “paragraph (g) and section 350f of this title” for “paragraph (g)” in concluding provisions.2004-Par. (u). Pub. L. 108-282, §102(b)(5)(A), substituted “360b, 360ccc” for “360b”.Par. (v). Pub. L. 108-282, §102(b)(5)(B), inserted concluding provisions.Pars. (nn) to (pp). Pub. L. 108-282, §102(b)(1), added pars. (nn) to (pp).Par. (qq). Pub. L. 108-282, §203(c)(1), added par. (qq).<b>2002</b>-Par. (kk). Pub. L. 107-109 added par. (kk).Pars. (<em>ll</em>), (mm). Pub. L. 107-250 added pars. (<em>ll</em>) and (mm).<b>1998</b>-Par. (q)(1). Pub. L. 105-324, §2(a), added subpar. (1) and struck out former subpar. (1) which read as follows: “The term ‘pesticide chemical’ means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingredients of such pesticide.”Par. (q)(3). Pub. L. 105-324, §2(c), substituted “subparagraphs (1) and (2)” for “paragraphs (1) and (2)” in introductory provisions.<b>1997</b>-Par. (aa). Pub. L. 105-115, §125(b)(2)(A), struck out “or 357” after “section 355(j)”.Par. (dd). Pub. L. 105-115, §125(b)(2)(A), struck out “357,” after “section 355,”.Par. (ff)(3)(A). Pub. L. 105-115, §125(b)(2)(A), struck out “,certified as an antibiotic under section 357 of this title,” before “or licensed as a biologic”.Par. (ii). Pub. L. 105-115, §121(a), added par. (ii).Par. (jj). Pub. L. 105-115, §125(e), added par. (jj).<b>1996</b>-Par. (q). Pub. L. 104-170, §402(a), amended par. (q) generally. Prior to amendment, par. (q) read as follows: “The term ‘pesticide chemical’ means any substance which, alone, in chemical combination or in formulation with one or more other substances, is ‘a pesticide’ within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act as now in force or as hereafter amended, and which is used in the production, storage, or transportation of raw agricultural commodities.”Par. (s)(1), (2). Pub. L. 104-170, §402(b), amended subpars. (1) and (2) generally. Prior to amendment, subpars. (1) and (2) read as follows:“(1) a pesticide chemical in or on a raw agricultural commodity; or“(2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; or”.Pars. (gg), (hh). Pub. L. 104-170, §402(c), added pars. (gg) and (hh).<b>1994</b>-Par. (g)(1). Pub. L. 103-417, §10(a), amended last sentence generally. Prior to amendment, last sentence read as follows: “A food for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug under clause (B) solely because the label or labeling contains such a claim.”Par. (s)(6). Pub. L. 103-417, §3(b), added subpar. (6).Par. (ff). Pub. L. 103-417, §3(a), added par. (ff).<b>1993</b>-Pars. (c), (d). Pub. L. 103-80, §3(dd)(1), substituted “Health and Human Services” for “Agriculture”.Par. (h). Pub. L. 103-80, §4(b), amended directory language of Pub. L. 102-300, §6(a)(1). See 1992 amendment note below.Pars. (v) to (ff). Pub. L. 103-80, §3(b), redesignated pars. (w) to (ff) as (v) to (ee), respectively.<b>1992</b>-Pars. (c), (d). Pub. L. 102-300, §6(b)(1), which directed the substitution of “Health and Human Services” for “Health, Education, and Welfare”, could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions notes below.Par. (h). Pub. L. 102-300, §6(a)(1), as amended by Pub. L. 103-80, §4(b), substituted “its primary” for “any of its principal” in two places in concluding provisions.Par. (u). Pub. L. 102-571 substituted “379e” for “376”.Par. (y)(1). Pub. L. 102-300, §6(b)(2), struck out “of Health, Education, and Welfare” after “employees of the Department”.Pars. (bb) to (ee). Pub. L. 102-282 added pars. (bb) to (ee).Par. (ff). Pub. L. 102-300, §6(a)(2), added par. (ff).<b>1990</b>-Par. (g)(1). Pub. L. 101-629, §16(b)(1), struck out “;but does not include devices or their components, parts, or accessories” after “clause (A), (B), or (C)”.Pub. L. 101-535 inserted at end “A food for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug under clause (B) solely because the label or labeling contains such a claim.”Par. (h)(3). Pub. L. 101-629, §16(b)(2), which directed the amendment of subpar. (3) by substituting “its primary” for “any of its principal”, could not be executed because “any of its principal” did not appear in subpar. (3).<b>1988</b>-Par. (w)(3). Pub. L. 100-670 struck out subpar. (3) which read as follows: “which drug is composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative thereof, except when there is in effect a published order of the Secretary declaring such drug not to be a new animal drug on the grounds that (A) the requirement of certification of batches of such drug, as provided for in section 360b(n) of this title, is not necessary to insure that the objectives specified in paragraph (3) thereof are achieved and (B) that neither subparagraph (1) nor (2) of this paragraph (w) applies to such drug.”<b>1980</b>-Par. (aa). Pub. L. 96-359 added par. (aa).<b>1977</b>-Par. (z). Pub. L. 95-203 added par. (z).<b>1976</b>-Par. (h). Pub. L. 94-295, §3(a)(1)(A), expanded definition of “device” to include implements, machines, implants, in vitro reagents, and other similar or related articles, added recognition in the National Formulary or the United States Pharmacopeia, or any supplement to the Formulary or Pharmacopeia, to the enumeration of conditions under which a device may qualify for inclusion under this chapter, and inserted requirements that a device be one which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.Par. (n). Pub. L. 94-278 inserted “or advertising” after “labeling” wherever appearing.Par. (y). Pub. L. 94-295, §3(a)(2), added par. (y).<b>1972</b>-Par. (q). Pub. L. 92-516 substituted reference to pesticide for reference to economic poison.<b>1970</b>-Par. (a)(2). Pub. L. 91-513, §701(g), struck out reference to sections 321, 331(i), 331(p), 331(q), 332, 333, 334, 337, 360, 360a, 372, 373, 374, and 375 of this title as they apply to depressant or stimulant drugs.Par. (v). Pub. L. 91-513, §701(a), struck out par. (v) which defined “depressant or stimulant drug”.<b>1968</b>-Par. (a)(2). Pub. L. 90-639, §4(a), extended provisions to cover depressant and stimulant drugs, the containers thereof, and equipment used in manufacturing, compounding, or processing such drugs, to the Canal Zone.Par. (p). Pub. L. 90-399, §102(a), (b), inserted “(except a new animal drug or an animal feed bearing or containing a new animal drug)” after “Any drug” in subpars. (1) and (2), respectively.Par. (s)(5). Pub. L. 90-399, §102(c), added subpar. (5).Par. (u). Pub. L. 90-399, §102(d), inserted reference to section 360b of this title.Par. (v)(3). Pub. L. 90-639, §1, inserted reference to lysergic acid diethylamide.Pars. (w), (x). Pub. L. 90-399, §102(e), added pars. (w) and (x).<b>1965</b>-Par. (g). Pub. L. 89-74, §9(b), designated existing provisions as subpar. (1), redesignated cls. (1) to (4) thereof as (A) to (D), substituted “(A), (B), or (C)” for “(1), (2), or (3)” and added subpar. (2).Par. (v). Pub. L. 89-74, §3(a), added par. (v).<b>1962</b>-Par. (a). Pub. L. 87-781, §307(a), designated existing provisions as subpar. (2), inserted “Commonwealth of Puerto Rico and the”, and added subpar. (1).Par. (p)(1). Pub. L. 87-781, §102(a)(1), inserted “and effectiveness” after “to evaluate the safety”, and “and effective” after “as safe”.Par. (p)(2). Pub. L. 87-781, §102(a)(2), inserted “and effectiveness” after “safety”.<b>1960</b>-Par. (s). Pub. L. 86-618, §101(a), excluded color additives from definition of “food additive”.Par. (t). Pub. L. 86-618, §101(c), added par. (t). Former par. (t) redesignated (u).Par. (u). Pub. L. 86-618, §101(b), redesignated par. (t) as (u) and inserted reference to section 376 of this title.<b>1958</b>-Pars. (s), (t). Pub. L. 85-929 added pars. (s) and (t).<b>1954</b>-Pars. (q), (r). Act July 22, 1954, added pars. (q) and (r). effectiveDate amendments Pub. L. 108-282, title II, §203(d), Aug. 2, 2004, 118 Stat. 908, provided that: “The amendments made by this section [amending this section and sections 343 and 343-1 of this title] shall apply to any food that is labeled on or after January 1, 2006.”Section 501 of Pub. L. 105-115 provided that: “Except as otherwise provided in this Act [see Short Title of 1997 Amendment note set out under section 301 of this title], this Act and the amendments made by this Act, other than the provisions of and the amendments made by sections 111, 121, 125, and 307 [enacting section 355a of this title, amending this section and sections 331, 335a, 351, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381, and 382 of this title, section 45C of Title 26, Internal Revenue Code, section 156 of Title 35, Patents, and section 8126 of Title 38, Veterans’ Benefits, repealing sections 356 and 357 of this title, and enacting provisions set out as notes under sections 351 and 355 of this title], shall take effect 90 days after the date of enactment of this Act [Nov. 21, 1997].”Amendment by Pub. L. 101-535 effective six months after the date of the promulgation of final regulations to implement section 343(r) of this title, or if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations (Nov. 8, 1992), with exception for persons marketing food the brand name of which contains a term defined by the Secretary under section 343(r)(2)(A)(i) of this title, see section 10(a) of Pub. L. 101-535, set out as a note under section 343 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. 92-516 effective at the close of Oct. 21, 1972, except if regulations are necessary for the implementation of any provision that becomes effective on Oct. 21, 1972, and continuation in effect of subchapter I of chapter 6 of Title 7, and regulations thereunder, relating to the control of economic poisons, as in existence prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92-516, and regulations thereunder, see section 4 of Pub. L. 92-516, set out as an Effective Date note under section 136 of Title 7, Agriculture.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.Section 6 of Pub. L. 90-639 provided that: “The amendments made by this Act [amending this section, sections 331, 333, 334, and 360a of this title, and provisions set out as a note under section 289a of Title 42, The Public Health and Welfare] shall apply only with respect to violations of the Federal Food, Drug, and Cosmetic Act [this chapter] committed after the date of the enactment of this Act [Oct. 24, 1968].”Amendment by Pub. L. 90-399 effective on first day of thirteenth calendar month after July 13, 1968, except that in the case of a drug (other than one subject to section 360b(n) of this title) intended for use in animals other than man which, on Oct. 9, 1962, was commercially used or sold in the United States, was not a new drug as defined in par. (p) of this section then in force, and was not covered by an effective application under section 355 of this title, the words “effectiveness” and “effective” contained in par. (v) of this section not applicable to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day, see section 108(a), (b)(3) of Pub. L. 90-399, as amended, set out as an Effective Date and Transitional Provisions note under section 360b of this title.Section 11 of Pub. L. 89-74 provided that: “The foregoing provisions of this Act [see Short Title of 1965 Amendment note set out under section 301 of this title] shall take effect on the first day of the seventh calendar month [Feb. 1, 1966] following the month in which this Act is enacted [July 15, 1965]; except that (1) the Secretary shall permit persons, owning or operating any establishment engaged in manufacturing, preparing, propagating, compounding, processing, wholesaling, jobbing, or distributing any depressant or stimulant drug, as referred to in the amendments made by section 4 of this Act to section 510 of the Federal Food, Drug, and Cosmetic Act [section 360 of this title], to register their name, places of business, and establishments, and other information prescribed by such amendments, with the Secretary prior to such effective date, and (2) sections 201(v) and 511(g) of the Federal Food, Drug, and Cosmetic Act, as added by this act [par. (v) of this section and par. (g) of section 360a of this title], and the provisions of sections 8 [amending section 372 of this title and section 1114 of Title 18, Crimes and Criminal Procedure] and 10 [set out as a note under this section] shall take effect upon the date of enactment of this Act [July 15, 1965].”Section 107 of Pub. L. 87-781 provided that:“(a) Except as otherwise provided in this section, the amendments made by the foregoing sections of this part A [amending this section and sections 331, 332, 348, 351 to 353, 355, 357, 379e of this title, and enacting provisions set out as a note under section 355 of this title] shall take effect on the date of enactment of this Act [Oct. 10, 1962].“(b) The amendments made by sections 101, 103, 105, and 106 of this part A [amending sections 331, 332, 351, 352, 355, and 357 of this title] shall, with respect to any drug, take effect on the first day of the seventh calendar month following the month in which this Act is enacted [Oct. 1962].“(c)(1) As used in this subsection, the term ‘enactment date’ means the date of enactment of this Act; and the term ‘basic Act’ means the Federal Food, Drug, and Cosmetic Act [this chapter].“(2) An application filed pursuant to section 505(b) of the basic Act [section 355(b) of this title] which was ‘effective’ within the meaning of that Act on the day immediately preceding the enactment date shall be deemed as of the enactment date, to be an application ‘approved’ by the Secretary within the meaning of the basic Act as amended by this Act.“(3) In the case of any drug with respect to which an application filed under section 505(b) of the basic Act is deemed to be an approved application on the enactment date by virtue of paragraph (2) of this subsection-“(4) In the case of any drug which, on the day immediately preceding the enactment date, (A) was commercially used or sold in the United States, (B) was not a new drug as defined by section 201(p) of the basic Act as then in force [par. (p) of this section], and (C) was not covered by an effective application under section 505 of that Act [section 355 of this title], the amendments to section 201(p) [par. (p) of this section] made by this Act shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day.”Amendment by Pub. L. 86-618 effective July 12, 1960, subject to 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.Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section 6(a) of Pub. L. 85-929, set out as a note under section 342 of this title.For effective date of amendment by act July 22, 1954, see section 5 of that act, set out as a note under section 342 of this title. construction amendments Amendment by Pub. L. 102-282 not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-282, set out as a note under section 335a of this title.Amendments by Pub. L. 101-535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101-535, set out as a note under section 343 of this title. savingsProvision Section 702 of Pub. L. 91-513, as amended by Pub. L. 93-481, §2, Oct. 26, 1974, 88 Stat. 1455, provided that:“(a) Prosecutions for any violation of law occurring prior to the effective date [see Effective Date of 1970 Amendment note above] of section 701 [repealing section 360a of this title, and amending sections 321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114 and 1952 of Title 18, Crimes and Criminal Procedure, and section 242 of Title 42, The Public Health and Welfare] shall not be affected by the repeals or amendments made by such section, or abated by reason thereof.“(b) Civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of section 701 shall not be affected by the repeals or amendments made by such section, or abated by reason thereof.“(c) All administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on the date of enactment of this Act [Oct. 27, 1970] shall be continued and brought to final determination in accord with laws and regulations in effect prior to such date of enactment. Where a drug is finally determined under such proceedings to be a depressant or stimulant drug, as defined in section 201(v) of the Federal Food, Drug, and Cosmetic Act [par. (v) of this section], such drug shall automatically be controlled under this title [subchapter I of chapter 13 of this title] by the Attorney General without further proceedings and listed in the appropriate schedule after he has obtained the recommendation of the Secretary. Any drug with respect to which such a final determination has been made prior to the date of enactment of this Act which is not listed in section 202 [section 812 of this title] within schedules I through V shall automatically be controlled under this title [subchapter I of chapter 13 of this title] by the Attorney General without further proceedings, and be listed in the appropriate schedule, after he has obtained the recommendations of the Secretary.“(d) Notwithstanding subsection (a) of this section or section 1103 [of Pub. L. 91-513, set out as a note under <!-- PDFPage:40 -->sections 171 to 174 of this title], section 4202 of title 18, United States Code, shall apply to any individual convicted under any of the laws repealed by this title or title III [subchapter I or subchapter II of chapter 13 of this title] without regard to the terms of any sentence imposed on such individual under such law.” transferOfFunctions Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96-88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.Functions of Secretary of Health, Education, and Welfare [now Health and Human Services] under Federal Food, Drug, and Cosmetic Act, to the extent such functions related to administration and enforcement of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), transferred to Consumer Product Safety Commission by section 2079 of Title 15, Commerce and Trade.Functions of Secretary of Health, Education, and Welfare [now Health and Human Services] under Drug Abuse Control Amendments of 1965 [see Short Title of 1965 Amendment note set out under section 301 of this title] transferred to Attorney General except function of regulating counterfeiting of those drugs which are not “depressant or stimulant” drugs, see section 2 of Reorg. Plan No. 1 of 1968, set out in the Appendix to Title 5, Government Organization and Employees.Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out in the Appendix to Title 5, Government Organization and Employees. Federal Security Agency and office of Administrator abolished by section 8 of Reorg. Plan No. 1 of 1953.Food and Drug Administration in Department of Agriculture and its functions, except those functions relating to administration of Insecticide Act of 1910 and Naval Stores Act, transferred to Federal Security Agency, to be administered under direction and supervision of Federal Security Administrator, by Reorg. Plan No. IV of 1940, set out in the Appendix to Title 5. amendments Section 10 of Pub. L. 89-74 provided that:“(a) Nothing in this Act [enacting section 360a of this title, amending sections 321, 331, 333, 334, 360, and 372 of this title and section 1114 of Title 18, Crimes and Criminal Procedure, and enacting provisions set out as notes under sections 321, 352, and 360a of this title] shall be construed as authorizing the manufacture, compounding, processing, possession, sale, delivery, or other disposal of any drug in any State in contravention of the laws of such State.“(b) No provision of this Act nor any amendment made by it shall be construed as indicating an intent on the part of the Congress to occupy the field in which such provision or amendment operates to the exclusion of any State law on the same subject matter, unless there is a direct and positive conflict between such provision or amendment and such State law so that the two cannot be reconciled or consistently stand together.“(c) No amendment made by this Act shall be construed to prevent the enforcement in the courts of any State of any statute of such State prescribing any criminal penalty for any act made criminal by any such amendment.”Section 202 of Pub. L. 87-781 provided that: “Nothing in the amendments made by this Act [enacting sections 358 to 360, amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e, and 381 of this title, and enacting provisions set out as notes under sections 321, 331, 332, 352, 355, 360, and 374 of this title] to the Federal Food, Drug, and Cosmetic Act [this chapter] shall be construed as invalidating any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law.” crossReferences Section 2 of Pub. L. 105-115 provided that: “In this Act [see Short Title of 1997 Amendment note set out under section 301 of this title], the terms ‘drug’, ‘device’, ‘food’, and ‘dietary supplement’ have the meaning given such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).” false false false

Title 7 Section 136et seq. 7 U.S.C. 136et seq. Title 15 Section 1471et seq. 15 U.S.C. 1471et seq. Title 18 Section 4202 18 U.S.C. 4202 Title 21 Section 451et seq. Title 21 Section 601et seq. 21 U.S.C. 451et seq. 21 U.S.C. 601et seq. Title 21 Section 1031et seq. Title 21 Section 301et seq. Title 21 Section 321 Title 21 Section 451et seq. Title 21 Section 601et seq. 21 U.S.C. 1031et seq. 21 U.S.C. 301et seq. 21 U.S.C. 321 21 U.S.C. 451et seq. 21 U.S.C. 601et seq. Volume 34 Page 768 34 Stat. 768 Volume 52 Page 1040 52 Stat. 1040 Volume 52 Page 1059 52 Stat. 1059 Volume 68 Page 511 68 Stat. 511 Volume 71 Page 441 71 Stat. 441 Volume 72 Page 1784 72 Stat. 1784 Volume 74 Page 397 74 Stat. 397 Volume 76 Page 781 76 Stat. 781 Volume 79 Page 227 79 Stat. 227 Volume 81 Page 584 81 Stat. 584 Volume 82 Page 351 Volume 82 Page 1361 82 Stat. 351 82 Stat. 1361 Volume 84 Page 1281 84 Stat. 1281 Volume 86 Page 998 86 Stat. 998 Volume 86 Page 973 86 Stat. 973 Volume 88 Page 1455 88 Stat. 1455 Volume 90 Page 411 Volume 90 Page 575 90 Stat. 411 90 Stat. 575 Volume 91 Page 1453 91 Stat. 1453 Volume 93 Page 695 93 Stat. 695 Volume 94 Page 1193 94 Stat. 1193 Volume 102 Page 3984 102 Stat. 3984 Volume 104 Page 2362 Volume 104 Page 4526 104 Stat. 2362 104 Stat. 4526 Volume 106 Page 161 Volume 106 Page 240 Volume 106 Page 4499 106 Stat. 161 106 Stat. 240 106 Stat. 4499 Volume 107 Page 775 107 Stat. 775 Volume 108 Page 4327 108 Stat. 4327 Volume 110 Page 1513 110 Stat. 1513 Volume 111 Page 2298 111 Stat. 2298 Volume 111 Page 2320 111 Stat. 2320 Volume 112 Page 3035 112 Stat. 3035 Volume 115 Page 1413 115 Stat. 1413 Volume 116 Page 1619 116 Stat. 1619 Volume 118 Page 891 118 Stat. 891 Volume 118 Page 908 118 Stat. 908 Volume 121 Page 968 121 Stat. 968 Volume 123 Page 1783 123 Stat. 1783 Volume 123 Page 1784 123 Stat. 1784 Public Law 85-172 Public Law 85-929 Public Law 85-929 Public Law 86-618 Public Law 86-618 Public Law 87-781 Public Law 87-781 Public Law 89-74 Public Law 89-74 Public Law 90-201 Public Law 90-399 Public Law 90-399 Public Law 90-639 Public Law 90-639 Public Law 91-513 Public Law 91-513 Public Law 92-516 Public Law 92-516 Public Law 93-481 Public Law 94-278 Public Law 94-278 Public Law 94-295 Public Law 94-295 Public Law 95-203 Public Law 95-203 Public Law 96-88 Public Law 96-359 Public Law 96-359 Public Law 100-670 Public Law 100-670 Public Law 101-535 Public Law 101-535 Public Law 101-629 Public Law 101-629 Public Law 102-282 Public Law 102-282 Public Law 102-300 Public Law 102-300 Public Law 102-571 Public Law 102-571 Public Law 103-80 Public Law 103-80 Public Law 103-417 Public Law 103-417 Public Law 104-170 Public Law 104-170 Public Law 105-115 Public Law 105-115 Public Law 105-324 Public Law 105-324 Public Law 107-109 Public Law 107-109 Public Law 107-250 Public Law 107-250 Public Law 108-282 Public Law 108-282 Public Law 110-85 Public Law 110-85 Public Law 111-31 Public Law 111-31 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