21 U.S.C. § 381

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 V of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and Pub. L. 110–246, title XI, § 11015(a), June 18, 2008, 122 Stat. 2124, which are classified generally to subchapters I to IV–A (§ 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.

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.

2025—Subsec. (a). Pub. L. 119–37 substituted “drug, device, or tobacco product” for “drug or device” wherever appearing.

2022—Subsec. (a). Pub. L. 117–328, § 3503(a)(4)(C), substituted “under section 364a, 379aa, or 379aa–1 of this title” for “under section 379aa or 379aa–1 of this title”, “defined in section 364, 379aa, or 379aa–1 of this title” for “defined in such section 379aa or 379aa–1 of this title”, “of such section 364a, 379aa, or 379aa–1 of this title” for “of such section 379aa or 379aa–1 of this title”, and “described in such section 364a, 379aa, or 379aa–1 of this title” for “described in such section 379aa or 379aa–1 of this title”.

Subsec. (b). Pub. L. 117–328, § 3503(a)(4)(D), substituted “requirements of section 364a, 379aa, or 379aa–1 of this title” for “requirements of sections 379aa or 379aa–1 of this title,”, “as defined in section 364, 379aa, or 379aa–1 of this title” for “defined in section 379aa or 379aa–1 of this title”, and “with section 364a, 379aa, or 379aa–1 of this title” for “with section 379aa or 379aa–1 of this title”.

Subsec. (e)(4)(E)(iii). Pub. L. 117–328, § 3304(1), struck out cl. (iii) which applied to requests for certification on behalf of any device establishment registered under section 360 of this title, whether the establishment is located inside or outside of the United States, and regardless of whether such devices are to be exported from the United States.

Subsec. (e)(4)(F). Pub. L. 117–328, § 3304(2), added subpar. (F).

2021—Subsec. (a). Pub. L. 116–304 inserted “or counterfeit device” after “counterfeit drug” in fourth sentence, and substituted “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 90 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 or device refused admission under this section, if such drug or device 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). 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 or device under the seventh 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 or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).” for “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).. 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).”

2020—Subsec. (e)(4)(E)(iii). Pub. L. 116–136 substituted “paragraph” for “subparagraph” in subcls. (I) and (II).

2018—Subsec. (a). Pub. L. 115–271, § 3022(c)(2), (3), inserted “If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission.” after third sentence, and substituted “Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act.” for “Clause (2) of the third sentence of this paragraph shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances Import and Export Act.”

Pub. L. 115–271, § 3022(c)(1), which directed substitution of “or (5) such article is being imported or offered for import in violation of section 331(cc) of this title, then any such article described in any of clauses (1) through (5) shall be refused admission” for “, then such article shall be refused admission”, was executed by making the substitution only in the third sentence, to reflect the probable intent of Congress.

Pub. L. 115–271, § 3012(c), inserted “, or is a controlled substance subject to an order under section 360bbb–8d of this title” before “or (4)” in third sentence.

Subsec. (t). Pub. L. 115–271, § 3013, added subsec. (t).

Subsec. (u). Pub. L. 115–271, § 3022(d), added subsec. (u).

2017—Subsec. (d)(1). Pub. L. 115–52, § 604(a), designated existing provisions as subpar. (A) and added subpar. (B).

Subsec. (e)(4)(C), (D). Pub. L. 115–52, § 704(2), realigned margins.

Subsec. (e)(4)(E). Pub. L. 115–52, § 704(1), added subpar. (E).

2016—Subsec. (s)(2)(D). Pub. L. 114–255 added subpar. (D).

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 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.

Amendment by section 3503(a)(4)(C), (D) of Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.

Pub. L. 112–144, title VII, § 708(c), July 9, 2012, 126 Stat. 1069, provided that: “The amendment made by subsection (a) [amending this section] shall apply beginning on the effective date of the regulations promulgated pursuant to the amendment made by subsection (b) [amending this section].”

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.

Pub. L. 112–144, title VII, § 708(d), July 9, 2012, 126 Stat. 1069, provided that:“(1)In general.—Not later than 2 years after the date of enactment of this Act [July 9, 2012], the Secretary of Health and Human Services shall adopt final regulations implementing the amendments made this section [amending this section].“(2)Procedure.—In promulgating a regulation implementing the amendments made by this section, the Secretary of Health and Human Services shall—“(A) issue a notice of proposed rulemaking that includes a copy of the proposed regulation;“(B) provide a period of not less than 60 days for comments on the proposed regulation; and“(C) publish the final regulation not less than 30 days before the effective date of the regulation.“(3)Restrictions.—Notwithstanding any other provision of law, the Secretary of Health and Human Services shall promulgate regulations implementing the amendments made by this section only as described in paragraph (2).”

Pub. L. 112–144, title VII, § 714(d), July 9, 2012, 126 Stat. 1074, provided that, within 36 months after July 9, 2012, the Secretary of Homeland Security acting through U.S. Customs and Border Protection, was to promulgate regulations required to carry out subsection (s) of this section relating to registration of commercial importers and specified procedures for promulgating regulations and their effective date, prior to repeal by Pub. L. 114–255, div. A, title III, § 3101(a)(2)(W)(ii), Dec. 13, 2016, 130 Stat. 1156.

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)In general.—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—“(A) upon the effective date of such final regulations; or“(B) upon the expiration of such 18-month period if the final regulations have not been made effective as of the expiration of such period, subject to compliance with the final regulations when the final regulations are made effective.“(2)Default; minimum period of advance notice.—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.”

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.

Nothing in amendment made by section 3503(a)(4)(C), (D) of Pub. L. 117–328 to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

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.”

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.

Pub. L. 111–353, title I, § 115, Jan. 4, 2011, 124 Stat. 3922, as amended by Pub. L. 114–125, title VIII, § 802(d)(2), Feb. 24, 2016, 130 Stat. 210, provided that: “Until the date on which the Secretary promulgates a final rule that implements the amendments made by section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (Public Law 107–188) [amending this section and section 343 of this title], the Secretary shall notify the Secretary of Homeland Security of all instances in which the Secretary refuses to admit a food into the United States under section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) so that the Secretary of Homeland Security, acting through the Commissioner of U.S. Customs and Border Protection, may prevent food refused admittance into the United States by a United States port of entry from being admitted by another United States port of entry, through the notification of other such United States ports of entry.”

[“Commissioner of U.S. Customs and Border Protection” substituted for “Commissioner of Customs and Border Protection” in section 115 of Pub. L. 111–353, set out above, to reflect the probable intent of section 802(d)(2) of Pub. L. 114–125, set out as a note under section 211 of Title 6, Domestic Security, which provided that on or after Feb. 24, 2016, any reference to the “Commissioner of Customs” or the “Commissioner of the Customs Service” would be deemed to be a reference to the Commissioner of U.S. Customs and Border Protection.]

With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

Pub. L. 108–173, title XI, § 1123, Dec. 8, 2003, 117 Stat. 2469, provided that: “The President’s designees shall conduct a study and report on issues related to trade and pharmaceuticals.”

Pub. L. 106–387, § 1(a) [title VII, § 746(b)], Oct. 28, 2000, 114 Stat. 1549, 1549A–40, provided that: “The Congress finds as follows:“(1) Patients and their families sometimes have reason to import into the United States drugs that have been approved by the Food and Drug Administration (‘FDA’).“(2) There have been circumstances in which—“(A) an individual seeking to import such a drug has received a notice from FDA that importing the drug violates or may violate the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]; and“(B) the notice failed to inform the individual of the reasons underlying the decision to send the notice.“(3) FDA should not send a warning notice regarding the importation of a drug without providing to the individual involved a statement of the underlying reasons for the notice.”

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.