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United States Code (Last Updated: May 24, 2014) |
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Title 21. FOOD AND DRUGS |
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Chapter 9. FEDERAL FOOD, DRUG, AND COSMETIC ACT |
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SubChapter VIII. IMPORTS AND EXPORTS |
§ 381. Imports and exports
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(a) Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or section 387e(h) of this title and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 360j(f) of this title, or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 355 of this title or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title, 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, then such article shall be refused admission, except as provided in subsection (b) of this section. 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. 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. 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 date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b).. of this title.
(B) In promulgating the regulations under subparagraph (A), the Secretary— (i) may, as appropriate, take into account differences among importers and types of imports, and, based on the level of risk posed by the imported drug, provide for expedited clearance for those importers that volunteer to participate in partnership programs for highly compliant companies and pass a review of internal controls, including sourcing of foreign manufacturing inputs, and plant inspections; and (ii) shall— (I) issue a notice of proposed rulemaking that includes the proposed regulation; (II) provide a period of not less than 60 days for comments on the proposed regulation; and (III) publish the final regulation not less than 30 days before the effective date of the regulation. (C) Notwithstanding any other provision of law, the Secretary shall promulgate regulations implementing this subsection only as described in subparagraph (B). (s) Registration of commercial importers (1) Registration The Secretary shall require a commercial importer of drugs— (A) to be registered with the Secretary in a form and manner specified by the Secretary; and (B) subject to paragraph (4), to submit, at the time of registration, a unique identifier for the principal place of business for which the importer is required to register under this subsection. (2) Regulations (A) In general The Secretary, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, shall promulgate regulations to establish good importer practices that specify the measures an importer shall take to ensure imported drugs are in compliance with the requirements of this chapter and the Public Health Service Act [42 U.S.C. 201 et seq.].
(B) Procedure In promulgating a regulation under subparagraph (A), the Secretary shall— (i) issue a notice of proposed rulemaking that includes the proposed regulation; (ii) provide a period of not less than 60 days for comments on the proposed regulation; and (iii) publish the final regulation not less than 30 days before the regulation’s effective date. (C) Restrictions Notwithstanding any other provision of Federal law, in implementing this subsection, the Secretary shall only promulgate regulations as described in subparagraph (B).
(3) Discontinuance of registration The Secretary shall discontinue the registration of any commercial importer of drugs that fails to comply with the regulations promulgated under this subsection.
(4) Unique facility identifier The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.
(5) Exemptions The Secretary, by notice in the Federal Register, may establish exemptions from the requirements of this subsection.
References In Text
The Controlled Substances Import and Export Act, referred to in subsec. (a), is title III of Pub. L. 91–513,
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,
The Poultry Products Inspection Act, referred to in subsec. (m)(3)(B), is Pub. L. 85–172,
The Egg Products Inspection Act, referred to in subsec. (m)(3)(B), is Pub. L. 91–597,
The Public Health Service Act, referred to in subsec. (s)(2)(A), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
Amendments
2012—Subsec. (a). Pub. L. 112–144, § 708(b), inserted “The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug under the sixth sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee.” after “described under subsection (b)..”
Pub. L. 112–144, § 708(a), inserted “, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug refused admission under this section, if such drug is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19 and was not brought into compliance as described under subsection (b).” after “pursuant to such regulations”.
Subsec. (o). Pub. L. 112–144, § 713(1), struck out “drug or” after “If an article that is a”.
Subsec. (r). Pub. L. 112–144, § 713(2), added subsec. (r).
Subsec. (s). Pub. L. 112–144, § 714(b), added subsec. (s).
2011—Subsec. (a). Pub. L. 111–353, § 301(c), inserted “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”.
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. (l). 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).
2009—Subsec. (a). Pub. L. 111–31, § 103(l)(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(l)(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(l)(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(l)(3), added subsec. (p).
2007—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(ll) of this title,” for “is adulterated, misbranded, or in violation of section 355 of this title,”.
2006—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”.
2002—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—
“(A) the importer of such article of a drug or device or importer of the food additive, color additive, or dietary supplement submits a statement to the Secretary, at the time of initial importation, that such article of a drug or device, food additive, color additive, or dietary supplement is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by such owner or consignee from the United States in accordance with subsection (e) of this section or section 382 of this title or section 262(h) of title 42;
“(B) the initial owner or consignee responsible for such imported article maintains records that identify the use of such imported article and upon request of the Secretary submits a report that provides an accounting of the exportation or the disposition of the imported article, including portions that have been destroyed, and the manner in which such person complied with the requirements of this paragraph; and
“(C) any imported component, part, article, or accessory of a drug or device and any food additive, color additive, or dietary supplement not incorporated or further processed as described in subparagraph (A) is destroyed or exported by the owner or consignee.”
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. (l). Pub. L. 107–188, § 305(c), added subsec. (l).
Subsec. (m). Pub. L. 107–188, § 307(a), added subsec. (m).
Subsec. (n). Pub. L. 107–188, § 308(a), added subsec. (n).
Subsec. (o). Pub. L. 107–188, § 321(b)(1), added subsec. (o).
2000—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).
1997—Subsec. (d)(1). Pub. L. 105–115 inserted “or composed wholly or partly of insulin” after “353(b) of this title”.
1996—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).
1993—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”.
1992—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”.
1988—Subsecs. (d), (e). Pub. L. 100–293 added subsec. (d) and redesignated former subsec. (d) as (e).
1976—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).
1970—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.
1968—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.
1962—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.
1949—Subsec. (a). Act
Subsec. (b). Act
Subsec. (c). Act
Effective Date Of Amendment
Pub. L. 112–144, title VII, § 708(c),
Amendment by section 301(c) of Pub. L. 111–353 effective 2 years after
Pub. L. 111–353, title III, § 304(c),
Pub. L. 109–462, § 5(b),
Amendment by section 321(b)(1) of Pub. L. 107–188 effective upon the expiration of the 180-day period beginning
Amendment by section 322(a) of Pub. L. 107–188 effective upon the expiration of the 90-day period beginning
Amendment by Pub. L. 100–293 effective upon expiration of 90 days after
Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after
Amendment of subsec. (d) by Pub. L. 90–399 effective on first day of thirteenth calendar month after
Miscellaneous
Pub. L. 112–144, title VII, § 708(d),
Pub. L. 112–144, title VII, § 714(d),
Pub. L. 111–353, title III, § 304(b),
Pub. L. 107–188, title III, § 307(c),
Savings
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
Miscellaneous
Pub. L. 111–353, title III, § 303(d),
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),
Transfer Of Functions
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),
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.
Miscellaneous
Pub. L. 111–353, title I, § 115,
With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on
Pub. L. 108–173, title XI, § 1123,
Pub. L. 106–387, § 1(a) [title VII, § 746(b)],