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. 381 D09002ee180df8153-USCODE-2010-title21-chap9-subchapVIII-sec381.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapVIII-sec381.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapVIII-sec381 21USC381 http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapVIII-sec381/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapVIII-sec381.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapVIII-sec381.htm 21 U.S.C. 381 21 USC 381 21 U.S.C. 381 21 USC 381; FOOD AND DRUGS; Imports and exports 315 LEAF USCODE-2010-title21-chap9-subchapVIII-sec381 Sec. 381 section standard June 25, 1938, ch. 675, §801, 52 Stat. 1058; Oct. 18, 1949, ch. 696, §§1-3, 63 Stat. 882; Pub. L. 87-781, title III, §306, Oct. 10, 1962, 76 Stat. 796; Pub. L. 90-399, §106, July 13, 1968, 82 Stat. 353; Pub. L. 91-513, title II, §701(h), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 94-295, §§3(f), 4(b)(3), May 28, 1976, 90 Stat. 578, 580; Pub. L. 100-293, §3, Apr. 22, 1988, 102 Stat. 96; Pub. L. 102-300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 102-353, §5, Aug. 26, 1992, 106 Stat. 943; Pub. L. 103-80, §3(cc), (dd)(1), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 104-134, title II, §2102(a)-(c), Apr. 26, 1996, 110 Stat. 1321-313, 1321-314; Pub. L. 104-180, title VI, §603(a), (b), Aug. 6, 1996, 110 Stat. 1594, 1595; Pub. L. 105-115, title I, §125(a)(2)(D), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 106-387, §1(a) [title VII, §§745(c)(1), <!-- PDFPage:389 -->746(c)], Oct. 28, 2000, 114 Stat. 1549, 1549A-36, 1549A-40; Pub. L. 107-188, title III, §§302(a)-(d), 303(c), 304(e), 305(c), 307(a), 308(a), 321(b)(1), 322(a), June 12, 2002, 116 Stat. 662, 663, 665, 667, 668, 670, 672, 676; Pub. L. 109-462, §5(a), Dec. 22, 2006, 120 Stat. 3475; Pub. L. 110-85, title IX, §912(b)(2), Sept. 27, 2007, 121 Stat. 952; Pub. L. 111-31, div. A, title I, §103(<em>l</em>), June 22, 2009, 123 Stat. 1837; Pub. L. 111-353, title I, §§102(b)(3), 107(b), title II, §204(j)(2), title III, §§301(c), 303(a)-(c), 304(a), Jan. 4, 2011, 124 Stat. 3889, 3910, 3937, 3955-3957. futureAmend Pub. L. 111-353, title III, §301(c), (d), Jan. 4, 2011, 124 Stat. 3955, provided that, effective 2 years after Jan. 4, 2011, subsection (a) of this section is amended by inserting “or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title” after “or in violation of section 355 of this title”. referencesInText The Controlled Substances Import and Export Act, referred to in subsec. (a), is title III of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1285, which is classified principally to subchapter II (§951 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 951 of this title and Tables.The Federal Meat Inspection Act, referred to in subsec. (m)(3)(B), is titles I to IV of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90-201, Dec. 15, 1967, 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.The Poultry Products Inspection Act, referred to in subsec. (m)(3)(B), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, 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 Egg Products Inspection Act, referred to in subsec. (m)(3)(B), is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to chapter 15 (§1031 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables. amendments <b>2011</b>-Subsec. (a). Pub. L. 111-353, §§204(j)(2), 303(a), inserted “or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article,” in the third sentence before “then such article shall be refused admission” and inserted after the third sentence “With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission.”Subsec. (b). Pub. L. 111-353, §303(c), substituted “with respect to an article described in subsection (a) relating to the requirements of sections 379aa or 379aa-1 of this title,” for “with respect to an article included within the provision of the fourth sentence of subsection (a)” in second sentence.Subsec. (e)(4)(A). Pub. L. 111-353, §107(b)(1)(A), substituted “a food, drug” for “a drug” in introductory provisions.Subsec. (e)(4)(A)(i). Pub. L. 111-353, §107(b)(1)(B), substituted “exported food, drug” for “exported drug”.Subsec. (e)(4)(A)(ii). Pub. L. 111-353, §107(b)(1)(C), substituted “the food, drug” for “the drug” in two places.Subsec. (e)(4)(C). Pub. L. 111-353, §107(b)(2), added subpar. (C).Subsec. (e)(4)(D). Pub. L. 111-353, §107(b)(3), added subpar. (D).Subsec. (<em>l</em>). Pub. L. 111-353, §102(b)(3), inserted “(or for which a registration has been suspended under such section)” after “section 350d of this title”.Subsec. (m)(1). Pub. L. 111-353, §304(a), inserted “any country to which the article has been refused entry;” after “the country from which the article is shipped;”.Subsec. (q). Pub. L. 111-353, §303(b), added subsec. (q).<b>2009</b>-Subsec. (a). Pub. L. 111-31, §103(<em>l</em>)(1)(C), which directed substitution of “drugs, devices, or tobacco products” for “drugs or devices” wherever appearing, was executed by making the substitution for “drugs and devices” in two places in second sentence, to reflect the probable intent of Congress.Pub. L. 111-31, §103(<em>l</em>)(1)(A), (B), inserted “tobacco products,” after “devices,” in first sentence and “or section 387e(h)” after “section 360” in second sentence.Subsec. (e)(1). Pub. L. 111-31, §103(<em>l</em>)(2), in introductory provisions, inserted “tobacco product” after “drug, device,” and “,and a tobacco product intended for export shall not be deemed to be in violation of section 387f(e), 387g, 387k, or 387t(a) of this title,” after “chapter”.Subsec. (p). Pub. L. 111-31, §103(<em>l</em>)(3), added subsec. (p).<b>2007</b>-Subsec. (a). Pub. L. 110-85 substituted “is adulterated, misbranded, or in violation of section 355 of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(<em>ll</em>) of this title,” for “is adulterated, misbranded, or in violation of section 355 of this title,”.<b>2006</b>-Subsec. (a). Pub. L. 109-462, §5(a)(1), inserted after third sentence “If such article is subject to a requirement under section 379aa or 379aa-1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 379aa or 379aa-1 of this title) has not complied with a requirement of such section 379aa or 379aa-1 of this title with respect to any such article, or has not allowed access to records described in such section 379aa or 379aa-1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section.”Subsec. (b). Pub. L. 109-462, §5(a)(2), in second sentence, inserted “(1)” before “an article included”, “or (2) with respect to an article included within the provision of the fourth sentence of subsection (a), the responsible person (as defined in section 379aa or 379aa-1 of this title) can take action that would assure that the responsible person is in compliance with section 379aa or 379aa-1 of this title, as the case may be,” before “final determination”, and “,or, with respect to clause (2), the responsible person,” before “to perform”.<b>2002</b>-Subsec. (d)(3). Pub. L. 107-188, §322(a), amended par. (3) generally. Prior to amendment, par. (3) read as follows: “No component of a drug, no component part or accessory of a device, or other article of device requiring further processing, which is ready or suitable for use for health-related purposes, and no food additive, color additive, or dietary supplement, including a product in bulk form, shall be excluded from importation into the United States under subsection (a) of this section if-Subsec. (h). Pub. L. 107-188, §302(a)-(c), added subsec. (h).Subsec. (i). Pub. L. 107-188, §302(d), added subsec. (i).Subsec. (j). Pub. L. 107-188, §303(c), added subsec. (j).Subsec. (k). Pub. L. 107-188, §304(e), added subsec. (k).Subsec. (<em>l</em>). Pub. L. 107-188, §305(c), added subsec. (<em>l</em>).Subsec. (m). Pub. L. 107-188, §307(a), added subsec. (m).Subsec. (n). Pub. L. 107-188, §308(a), added subsec. (n).Subsec. (<em>o</em>). Pub. L. 107-188, §321(b)(1), added subsec. (<em>o</em>).<b>2000</b>-Subsec. (d)(1). Pub. L. 106-387, §1(a) [title VII, §745(c)(1)], inserted “and section 384 of this title” after “paragraph (2)”.Subsec. (g). Pub. L. 106-387, §1(a) [title VII, §746(c)], added subsec. (g).<b>1997</b>-Subsec. (d)(1). Pub. L. 105-115 inserted “or composed wholly or partly of insulin” after “353(b) of this title”.<b>1996</b>-Subsec. (d)(3). Pub. L. 104-180, §603(a), substituted “accessory of a device, or other article of device requiring further processing, which is ready” for “accessory of a device which is ready” in introductory provisions, inserted “further processed by the initial owner or consignee, or” after “is intended to be” in subpar. (A), and inserted “article,” after “part,” and “or further processed” after “incorporated” in subpar. (C).Pub. L. 104-134, §2102(a)(1), added par. (3)Subsec. (d)(4). Pub. L. 104-134, §2102(a)(1), added par. (4).Subsec. (e)(1). Pub. L. 104-134, §2102(b)(1), struck out concluding provisions which read as follows: “This paragraph does not authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title.”Subsec. (e)(2). Pub. L. 104-134, §2102(b)(2), in concluding provisions, substituted “either (i) the Secretary” for “the Secretary” and added cl. (ii).Subsec. (e)(3), (4). Pub. L. 104-134, §2102(b)(3), added pars. (3) and (4).Subsec. (f). Pub. L. 104-180, §603(b), inserted “(other than insulin, an antibiotic drug, an animal drug, or a drug exported under section 382 of this title)” after “If a drug” in par. (1) and “A drug exported under section 382 of this title is exempt from this section.” at end of par. (2).Pub. L. 104-134, §2102(c), added subsec. (f).<b>1993</b>-Subsec. (a). Pub. L. 103-80, §3(dd)(1), substituted “Health and Human Services” for “Agriculture” after “Secretary of” in two places in first sentence.Subsec. (b). Pub. L. 103-80, §3(cc), substituted “Secretary of Health and Human Services” for “Administrator” after “If it appears to the”, “Secretary” for “Administrator” after “provisions of this subsection, the”, “Secretary's” for “Administrator's” after “as may be specified in the”, “Department of Health and Human Services” for “Federal Security Agency”, and “Secretary” for “Administrator” after “designated by the”.<b>1992</b>-Subsecs. (a), (b). Pub. L. 102-300, which directed the substitution of “Health and Human Services” for “Health, Education, and Welfare” wherever appearing, was executed in second sentence of subsec. (a), but could not be executed in first sentence of subsec. (a) or in subsec. (b) because such words did not appear. See 1993 Amendment note above and Transfer of Functions note below.Subsec. (d)(1). Pub. L. 102-353 substituted “manufacturer of” for “person who manufactured”.<b>1988</b>-Subsecs. (d), (e). Pub. L. 100-293 added subsec. (d) and redesignated former subsec. (d) as (e).<b>1976</b>-Subsec. (a). Pub. L. 94-295, §§3(f)(2), 4(b)(3), expanded provisions requiring the Secretary of Health, Education, and Welfare to request that the Secretary of the Treasury deliver to the Secretary of Health, Education, and Welfare items imported or offered for import into the United States that were manufactured, prepared, propagated, compounded, or processed in non-registered establishments by extending the provisions to include devices imported or offered for import, and, in cl. (1), inserted reference to devices which were manufactured, packed, stored, or installed using methods, facilities, or controls not conforming to the requirements of section 360j(f) of this title.Subsec. (d). Pub. L. 94-295, §3(f)(1), designated existing provisions as par. (1) and added par. (2).<b>1970</b>-Subsec. (a). Pub. L. 91-513 substituted “Clause (2) of the third sentence of this paragraph” for “This paragraph” and “the Controlled Substances Import and Export Act” for “section 173 of this title” in last sentence.<b>1968</b>-Subsec. (d). Pub. L. 90-399 provided that nothing in subsec. (d) shall authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title.<b>1962</b>-Subsec. (a). Pub. L. 87-781 inserted provisions requiring the Secretary of Health, Education, and Welfare to furnish the Secretary of the Treasury a list of establishments registered under section 360(i) of this title, and to request that samples of any drugs from any establishments not so registered be delivered to the Secretary of Health, Education, and Welfare, with notice of delivery to the consignee who may appear before the Secretary to testify.<b>1949</b>-Subsec. (a). Act Oct. 18, 1949, §1, inserted before period at end of second sentence “,except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury within ninety days of the notice of such refusal or within such additional time as may be permitted pursuant to such regulations”.Subsec. (b). Act Oct. 18, 1949, §2, provided for express statutory authority for the long-standing administrative practice of releasing imported articles that do not comply with the requirements of the law so that they may be relabeled or given appropriate treatment to bring them into compliance.Subsec. (c). Act Oct. 18, 1949, §3, charged all costs, including salaries and travel and subsistence expenses of officers and employees, against importers. effectiveDate amendments Amendment by section 301(c) of Pub. L. 111-353 effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111-353, set out as a note under section 331 of this title.Pub. L. 111-353, title III, §304(c), Jan. 4, 2011, 124 Stat. 3958, provided that: “The amendment made by this section [amending this section] shall take effect 180 days after the date of enactment of this Act [Jan. 4, 2011].”Pub. L. 109-462, §5(b), Dec. 22, 2006, 120 Stat. 3476, provided that: “The amendments made by this section [amending this section] shall take effect 1 year after the date of enactment of this Act [Dec. 22, 2006].”Amendment by section 321(b)(1) of Pub. L. 107-188 effective upon the expiration of the 180-day period beginning June 12, 2002, see section 321(c) of Pub. L. 107-188, set out as a note under section 331 of this title.Amendment by section 322(a) of Pub. L. 107-188 effective upon the expiration of the 90-day period beginning June 12, 2002, see section 322(c) of Pub. L. 107-188, set out as a note under section 331 of this title.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. 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 of subsec. (d) 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. regulations Pub. L. 111-353, title III, §304(b), Jan. 4, 2011, 124 Stat. 3958, provided that: “Not later than 120 days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall issue an interim final rule amending subpart I of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section [amending this section].”Pub. L. 107-188, title III, §307(c), June 12, 2002, 116 Stat. 672, provided that:“(1) <cap-smallcap>In general</cap-smallcap>.-Not later than 18 months after the date of the enactment of this Act [June 12, 2002], the Secretary of Health and Human Services shall promulgate proposed and final regulations for the requirement of providing notice in accordance with section 801(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 381(m)] (as added by subsection (a) of this section). Such requirement of notification takes effect-“(2) <cap-smallcap>Default; minimum period of advance notice</cap-smallcap>.-If under paragraph (1) the requirement for providing notice in accordance with section 801(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 381(m)] takes effect without final regulations having been made effective, then for purposes of such requirement, the specified period of time that the notice is required to be made in advance of the time of the importation of the article of food involved or the offering of the food for import shall be not fewer than eight hours and not more than five days, which shall remain in effect until the final regulations are made effective.” savingsProvision Amendment by Pub. L. 91-513 not to affect or abate any prosecutions for violation of law or any civil seizure or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotic and Dangerous Drugs [now 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. construction amendments Pub. L. 111-353, title III, §303(d), Jan. 4, 2011, 124 Stat. 3957, provided that: “Nothing in the amendments made by this section [amending this section] shall limit the authority of the Secretary to conduct inspections of imported food or to take such other steps as the Secretary deems appropriate to determine the admissibility of imported food.”Nothing in amendments by sections 107(b), 204(j)(2), 301(c), and 303(a)-(c) of Pub. L. 111-353 to be construed to apply to certain alcohol-related facilities, see section 2206 of this title.Nothing in amendments 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.Pub. L. 107-188, title III, §308(c), June 12, 2002, 116 Stat. 673, provided that: “With respect to articles of food that are imported or offered for import into the United States, nothing in this section [amending this section and section 343 of this title] shall be construed to limit the authority of the Secretary of Health and Human Services or the Secretary of the Treasury to require the marking of refused articles of food under any other provision of 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.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

Title 21 Section 1031et seq. Title 21 Section 451et seq. Title 21 Section 601et seq. Title 21 Section 951et seq. 21 U.S.C. 1031et seq. 21 U.S.C. 451et seq. 21 U.S.C. 601et seq. 21 U.S.C. 951et seq. Title 21 Section 1031et seq. Title 21 Section 301et seq. Title 21 Section 381(a) Title 21 Section 381(m) Title 21 Section 451et seq. Title 21 Section 601et seq. Title 21 Section 951et seq. 21 U.S.C. 1031et seq. 21 U.S.C. 301et seq. 21 U.S.C. 381(a) 21 U.S.C. 381(m) 21 U.S.C. 451et seq. 21 U.S.C. 601et seq. 21 U.S.C. 951et seq. Volume 52 Page 1058 52 Stat. 1058 Volume 63 Page 882 63 Stat. 882 Volume 71 Page 441 71 Stat. 441 Volume 76 Page 796 76 Stat. 796 Volume 81 Page 584 81 Stat. 584 Volume 82 Page 353 82 Stat. 353 Volume 84 Page 1282 84 Stat. 1282 Volume 84 Page 1285 Volume 84 Page 1620 84 Stat. 1285 84 Stat. 1620 Volume 90 Page 578 90 Stat. 578 Volume 93 Page 695 93 Stat. 695 Volume 102 Page 96 102 Stat. 96 Volume 106 Page 240 Volume 106 Page 943 106 Stat. 240 106 Stat. 943 Volume 107 Page 778 107 Stat. 778 Volume 110 Page 1321-313 Volume 110 Page 1594 110 Stat. 1321-313 110 Stat. 1594 Volume 111 Page 2325 111 Stat. 2325 Volume 114 Page 1549 114 Stat. 1549 Volume 114 Page 1549 114 Stat. 1549 Volume 116 Page 662 116 Stat. 662 Volume 116 Page 672 Volume 116 Page 673 116 Stat. 672 116 Stat. 673 Volume 117 Page 2469 117 Stat. 2469 Volume 120 Page 3475 120 Stat. 3475 Volume 120 Page 3476 120 Stat. 3476 Volume 121 Page 952 121 Stat. 952 Volume 123 Page 1837 123 Stat. 1837 Volume 124 Page 3889 124 Stat. 3889 Volume 124 Page 3922 Volume 124 Page 3955 Volume 124 Page 3957 Volume 124 Page 3958 124 Stat. 3922 124 Stat. 3955 124 Stat. 3957 124 Stat. 3958 Public Law 85-172 Public Law 87-781 Public Law 87-781 Public Law 90-201 Public Law 90-399 Public Law 90-399 Public Law 91-513 Public Law 91-513 Public Law 91-597 Public Law 94-295 Public Law 94-295 Public Law 96-88 Public Law 100-293 Public Law 100-293 Public Law 102-300 Public Law 102-300 Public Law 102-353 Public Law 102-353 Public Law 103-80 Public Law 103-80 Public Law 104-134 Public Law 104-134 Public Law 104-180 Public Law 104-180 Public Law 105-115 Public Law 105-115 Public Law 106-387 Public Law 106-387 Public Law 107-188 Public Law 107-188 Public Law 108-173 Public Law 109-462 Public Law 109-462 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