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. 352 D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partA-sec352.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partA-sec352.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec352 21USC352 http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec352/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec352.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec352.htm 21 U.S.C. 352 21 USC 352 21 U.S.C. 352 21 USC 352; FOOD AND DRUGS; Misbranded drugs and devices 181 LEAF USCODE-2010-title21-chap9-subchapV-partA-sec352 Sec. 352 section standard June 25, 1938, ch. 675, §502, 52 Stat. 1050; June 23, 1939, ch. 242, §3, 53 Stat. 854; Dec. 22, 1941, ch. 613, §2, 55 Stat. 851; July 6, 1945, ch. 281, §2, 59 Stat. 463; Mar. 10, 1947, ch. 16, §2, 61 Stat. 11; July 13, 1949, ch. 305, §1, 63 Stat. 409; Aug. 5, 1953, ch. 334, §1, 67 Stat. 389; Pub. L. 86-618, title I, §102(b)(2), July 12, 1960, 74 Stat. 398; Pub. L. 87-781, title I, §§105(c), 112(a), (b), 131(a), title III, §305, Oct. 10, 1962, 76 Stat. 785, 790, 791, 795; Pub. L. 90-399, §105(a), July 13, 1968, 82 Stat. 352; Pub. L. 91-601, §6(d), formerly §7(d), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97-35, title XII, §1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 94-295, §§3(e), 4(b)(2), 5(a), 9(b)(2), May 28, 1976, 90 Stat. 577, 580, 583; Pub. L. 95-633, title I, §111, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 102-300, §3(a)(2), June 16, 1992, 106 Stat. 239; Pub. L. 102-571, title I, §107(9), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, §3(m), Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, §§114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, §412(c), Nov. 21, 1997, 111 Stat. 2312, 2325, 2327, 2375; Pub. L. 107-250, title II, §206, title III, §§301(a), 302(a)(1), Oct. 26, 2002, 116 Stat. 1613, 1616; Pub. L. 108-214, §2(b)(2)(B), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108-282, title I, §102(b)(5)(E), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109-43, §2(c)(1), Aug. 1, 2005, 119 Stat. 441; Pub. L. 109-462, §2(d), Dec. 22, 2006, 120 Stat. 3472; Pub. L. 110-85, title IX, §§901(d)(3)(A), (6), 902(a), 906(a), Sept. 27, 2007, 121 Stat. 940, 942, 943, 949. amendments <b>2007</b>-Par. (n). Pub. L. 110-85, §906(a), inserted “and in the case of published direct-to-consumer advertisements the following statement printed in conspicuous text: ‘You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.’,” after “section 371(a) of this title,”.Pub. L. 110-85, §901(d)(6), substituted “section 371(a) of this title” for “the procedure specified in section 371(e) of this title”.Pub. L. 110-85, §901(d)(3)(A), inserted at end “In the case of an advertisement for a drug subject to section 353(b)(1) of this title presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner.”Pars. (y), (z). Pub. L. 110-85, §902(a), added pars. (y) and (z).<b>2006</b>-Par. (x). Pub. L. 109-462 added par. (x).<b>2005</b>-Par. (u). Pub. L. 109-43 amended par. (u) generally. Prior to amendment, par. (u) read as follows: “If it is a device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, except that the Secretary may waive any requirement under this paragraph for the device if the Secretary determines that compliance with the requirement is not feasible for the device or would compromise the provision of reasonable assurance of the safety or effectiveness of the device.”<b>2004</b>-Par. (f). Pub. L. 108-214, in last sentence, inserted “or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments” after “in health care facilities”, inserted <!-- PDFPage:147 -->comma after “means”, substituted “requirements of law, and that the manufacturer affords such users the opportunity” for “requirements of law and, that the manufacturer affords health care facilities the opportunity”, and struck out “the health care facility” after “promptly provides”.Par. (w). Pub. L. 108-282 added par. (w).<b>2002</b>-Par. (f). Pub. L. 107-250, §206, inserted at end “Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.”Par. (u). Pub. L. 107-250, §301(a), which directed amendment of section by adding par. (u) at end, was executed by adding par. (u) before par. (v) to reflect the probable intent of Congress.Par. (v). Pub. L. 107-250, §302(a)(1), added par. (v).<b>1997</b>-Par. (a). Pub. L. 105-115, §114(a), inserted at end “Health care economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be considered to be false or misleading under this paragraph if the health care economic information directly relates to an indication approved under section 355 of this title or under section 262(a) of title 42 for such drug and is based on competent and reliable scientific evidence. The requirements set forth in section 355(a) of this title or in section 262(a) of title 42 shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request. In this paragraph, the term ‘health care economic information’ means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention.”Par. (d). Pub. L. 105-115, §126(b), struck out par. (d) which read as follows: “If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha eucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane; or any chemical derivative of such substance, which derivative has been by the Secretary, after investigation, found to be, and by regulations designated as, habit forming; unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement ‘Warning-May be habit forming.’”Par. (e)(1). Pub. L. 105-115, §412(c), amended subpar. (1) generally. Prior to amendment, subpar. (1) read as follows: “If it is a drug, unless (A) its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula), (i) the established name (as defined in subparagraph (3)) of the drug, if such there be, and (ii), in case it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury ouabain strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein; <em>Provided</em>, That the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this paragraph, shall apply only to prescription drugs; and (B) for any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient: <em>Provided</em>, That to the extent that compliance with the requirements of clause (A)(ii) or clause (B) of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary.”Par. (k). Pub. L. 105-115, §125(a)(2)(B), struck out par. (k) which read as follows: “If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 356 of this title, and (2) such certificate or release is in effect with respect to such drug.”Par. (<em>l</em>). Pub. L. 105-115, §125(b)(2)(D), struck out par. (<em>l</em>) which read as follows: “If it is, or purports to be, or is represented as a drug (except a drug for use in animals other than man) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 357 of this title, and (2) such certificate or release is in effect with respect to such drug: <em>Provided</em>, That this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under section 357(c) or (d) of this title.”<b>1993</b>-Par. (e)(3). Pub. L. 103-80, §3(m)(1), substituted “of such ingredient, except that” for “of such ingredient: <em>Provided</em>, That”.Par. (f). Pub. L. 103-80, §3(m)(2), substituted “users, except that where” for “users: <em>Provided</em>, That where”.Par. (g). Pub. L. 103-80, §3(m)(3), substituted “prescribed therein. The method” for “prescribed therein: <em>Provided</em>, That the method” and “Pharmacopoeia, except that” for “Pharmacopoeia: <em>Provided further</em>, That,”.Par. (n). Pub. L. 103-80, §3(m)(4), substituted “,except that (A)” for “:<em>Provided</em>, That (A)”.<b>1992</b>-Par. (m). Pub. L. 102-571 substituted “379e” for “376”.Par. (t)(3). Pub. L. 102-300 added cl. (3).<b>1978</b>-Par. (n). Pub. L. 95-633 inserted provision relating to the construction of the Convention on Psychotropic Substances.<b>1976</b>-Par. (e). Pub. L. 94-295, §5(a), substituted “subparagraph (3)” for “subparagraph (2)” in subpar. (1), added subpar. (2), redesignated former subpar. (2) as (3) and in subpar. (3) as so redesignated substituted “subparagraph (1)” for “this paragraph (e)”, and added subpar. (4).Par. (j). Pub. L. 94-295, §3(e)(2), substituted “dosage or manner,” for “dosage,”.Par. (m). Pub. L. 94-295, §9(b)(2), substituted “the intended use of which is for” for “the intended use of which in or on drugs is for”.Par. (<em>o</em>). Pub. L. 94-295, §4(b)(2), substituted “If it was manufactured” for “If it is a drug and was manufactured” and inserted “,if it was not included in a list required by section 360(j) of this title, if a notice or other information respecting it was not provided as required by such section or section 360(k) of this title, or if it does not bear such symbols from the uniform system for identification of devices prescribed under section 360(e) of this title as the Secretary by regulation requires”.Pars. (q) to (t). Pub. L. 94-295, §3(e)(1), added pars. (q) to (t).<b>1970</b>-Par. (p). Pub. L. 91-601 added par. (p).<b>1968</b>-Par. (<em>l</em>). Pub. L. 90-399 inserted “(except a drug for use in animals other than man)” after “represented as a drug”.<b>1962</b>-Par. (e). Pub. L. 87-781, §112(a), designated existing provisions as subpar. (1), substituted “,unless (A) <!-- PDFPage:148 -->its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula), (i) the established name (as defined in subparagraph (2) of this subsection) of the drug, if such there be, and (ii), in case it is fabricated from two or more ingredients, the established name and quantity” for “and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug, if such there be; and (2), in case it is fabricated from two or more ingredients, the common or usual name”, and “the established name” for “the name”, provided that the requirement for stating the quantity of active ingredients, other than those specified in this par., applies only to prescription drugs, and that the established name of a drug on a label is to be printed prominently and in type at least half as large as used for any proprietary designation, and added subpar. (2) defining “established name”.Par. (g). Pub. L. 87-781, §112(b), provided that if there is an inconsistency between the provisions of this par. and those of par. (e), as to the name of a drug, the requirements of par. (e) should prevail.Par. (<em>l</em>). Pub. L. 87-781, §105(c), substituted “bacitracin, or any other antibiotic drug” for “or bacitracin.”Par. (n). Pub. L. 87-781, §131(a), added par. (n).Par. (<em>o</em>). Pub. L. 87-781, §305, added par. (<em>o</em>).<b>1960</b>-Par. (m). Pub. L. 86-618 added par. (m).<b>1953</b>-Par. (<em>l</em>). Act Aug. 5, 1953, substituted “chlortetracycline” for “aureomycin”.<b>1949</b>-Par. (<em>l</em>). Act July 13, 1949, inserted “,aureomycin, chloramphenicol, or bacitracin” after “streptomycin”.<b>1947</b>-Par. (<em>l</em>). Act Mar. 10, 1947, inserted “or streptomycin” after “penicillin”.<b>1945</b>-Par. (<em>l</em>). Act July 6, 1945, added par. (<em>l</em>).<b>1941</b>-Par. (k). Act Dec. 22, 1941, added par. (k).<b>1939</b>-Par. (d). Act June 29, 1939, substituted “name, and quality or proportion” for “name, quantity, and percentage”. effectiveDate amendments Amendment by 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.Pub. L. 109-462, §2(e)(1), (2), Dec. 22, 2006, 120 Stat. 3472, provided that:“(1) <cap-smallcap>In general</cap-smallcap>.-Except as provided in paragraph (2), the amendments made by this section [enacting section 379aa of this title and amending this section and section 331 of this title] shall take effect 1 year after the date of enactment of this Act [Dec. 22, 2006].“(2) <cap-smallcap>Misbranding</cap-smallcap>.-Section 502(x) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(x)] (as added by this section) shall apply to any nonprescription drug (as defined in such section 502(x)) labeled on or after the date that is 1 year after the date of enactment of this Act [Dec. 22, 2006].”Pub. L. 107-250, title III, §301(b), Oct. 26, 2002, 116 Stat. 1616, as amended by Pub. L. 108-214, §2(c)(1), Apr. 1, 2004, 118 Stat. 575; Pub. L. 109-43, §2(d), Aug. 1, 2005, 119 Stat. 441, provided that: “Section 502(u) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(u)] (as amended by section 2(c) of the Medical Device User Fee Stabilization Act of 2005 [Pub. L. 109-43])-Pub. L. 107-250, title III, §302(a)(2), Oct. 26, 2002, 116 Stat. 1616, provided that: “The amendment made by paragraph (1) [amending this section] takes effect 15 months after the date of the enactment of this Act [Oct. 26, 2002], and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date.”Amendment by sections 114(a), 126(b), and 412(c) of Pub. L. 105-115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105-115, set out as a note under section 321 of this title.Amendment by Pub. L. 95-633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an Effective Date note under section 801a of this title.Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91-601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade.Amendment by Pub. L. 90-399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90-399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.Section 112(c) of Pub. L. 87-781 provided that: “This section [amending this section] shall take effect on the first day of the seventh calendar month following the month in which this Act is enacted [October 1962].”Section 131(b) of Pub. L. 87-781 provided that: “No drug which was being commercially distributed prior to the date of enactment of this Act [Oct. 10, 1962] shall be deemed to be misbranded under paragraph (n) of section 502 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(n)], as added by this section, until the earlier of the following dates: (1) the first day of the seventh month following the month in which this Act is enacted; or (2) the effective date of regulations first issued under clause (3) of such paragraph (n) in accordance with the procedure specified in section 701(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 371(e)].”Amendment by Pub. L. 87-781 effective on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87-781, 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. effectiveDate Pars. (b) and (d) to (h) effective Jan. 1, 1940, and such paragraphs effective July 1, 1940, as provided by regulations for certain lithographed labeling and containers bearing certain labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date: Postponement in Certain Cases note under section 301 of this title. regulations Pub. L. 110-85, title IX, §901(d)(3)(B), Sept. 27, 2007, 121 Stat. 940, provided that: “Not later than 30 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 [Sept. 27, 2007], the Secretary of Health and Human Services shall by regulation establish standards for determining whether a major statement relating to side effects and contraindications of a drug, described in section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) is presented in the manner required under such section.” 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. false false false

Part A Drugs and Devices Title 21 Section 352(i) Title 21 Section 352(n) Title 21 Section 352(u) Title 21 Section 352(x) Title 21 Section 360bbb-6 Title 21 Section 371(e) 21 U.S.C. 352(i) 21 U.S.C. 352(n) 21 U.S.C. 352(u) 21 U.S.C. 352(x) 21 U.S.C. 360bbb-6 21 U.S.C. 371(e) Volume 52 Page 1050 52 Stat. 1050 Volume 53 Page 854 53 Stat. 854 Volume 53 Page 853 53 Stat. 853 Volume 55 Page 851 55 Stat. 851 Volume 59 Page 463 59 Stat. 463 Volume 61 Page 11 61 Stat. 11 Volume 63 Page 409 63 Stat. 409 Volume 67 Page 389 67 Stat. 389 Volume 74 Page 398 74 Stat. 398 Volume 76 Page 785 76 Stat. 785 Volume 79 Page 234 79 Stat. 234 Volume 82 Page 352 82 Stat. 352 Volume 84 Page 1673 84 Stat. 1673 Volume 90 Page 577 90 Stat. 577 Volume 92 Page 3773 92 Stat. 3773 Volume 95 Page 716 95 Stat. 716 Volume 106 Page 239 Volume 106 Page 4499 106 Stat. 239 106 Stat. 4499 Volume 107 Page 777 107 Stat. 777 Volume 111 Page 2325 Volume 111 Page 2327 111 Stat. 2325 111 Stat. 2327 Volume 111 Page 2312 111 Stat. 2312 Volume 116 Page 1613 116 Stat. 1613 Volume 116 Page 1616 116 Stat. 1616 Volume 117 Page 2171 117 Stat. 2171 Volume 118 Page 575 Volume 118 Page 902 118 Stat. 575 118 Stat. 902 Volume 118 Page 575 118 Stat. 575 Volume 119 Page 441 119 Stat. 441 Volume 119 Page 441 119 Stat. 441 Volume 120 Page 3472 120 Stat. 3472 Volume 120 Page 3472 120 Stat. 3472 Volume 121 Page 940 121 Stat. 940 Volume 121 Page 940 Volume 121 Page 950 121 Stat. 940 121 Stat. 950 Volume 124 Page 530 124 Stat. 530 Public Law 86-618 Public Law 86-618 Public Law 87-781 Public Law 87-781 Public Law 89-74 Public Law 90-399 Public Law 90-399 Public Law 91-601 Public Law 91-601 Public Law 94-295 Public Law 94-295 Public Law 95-633 Public Law 95-633 Public Law 97-35 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 105-115 Public Law 105-115 Public Law 107-250 Public Law 107-250 Public Law 108-173 Public Law 108-214 Public Law 108-214 Public Law 108-282 Public Law 108-282 Public Law 109-43 Public Law 109-43 Public Law 109-462 Public Law 109-462 Public Law 110-85 Public Law 110-85 Public Law 111-148 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