21 U.S.C. 381: Imports and exports

2022

• 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 sectio… (Consolidated Appropriations Act, 2023) Law text · (a)
• 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 tit… (Consolidated Appropriations Act, 2023) Law text · (b)
• 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 whethe… (Consolidated Appropriations Act, 2023) Law text · (e)
• Pub. L. 117–328, §3304(2), added subpar. (F). (Consolidated Appropriations Act, 2023) Law text · (e)

2021

• 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 … (Safeguarding Therapeutics Act) Law text · (a)

2020

• Pub. L. 116–136 substituted "paragraph" for "subparagraph" in subcls. (I) and (II). (Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act) Law text · (e)

2018

• 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 … (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (a)
• 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 re… (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (a)
• 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. (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (a)
• Pub. L. 115–271, §3013, added subsec. (t). (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (t)
• Pub. L. 115–271, §3022(d), added subsec. (u). (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (u)

2017

• Pub. L. 115–52, §604(a), designated existing provisions as subpar. (A) and added subpar. (B). (FDA Reauthorization Act of 2017) Law text · (d)
• Pub. L. 115–52, §704(2), realigned margins. (FDA Reauthorization Act of 2017) Law text · (e), (D)
• Pub. L. 115–52, §704(1), added subpar. (E). (FDA Reauthorization Act of 2017) Law text · (e)

2016

• Pub. L. 114–255 added subpar. (D). (21st Century Cures Act) Law text · (s)

2012

• 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 … (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• 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 Trea… (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §713(1), struck out "drug or" after "If an article that is a". (Food and Drug Administration Safety and Innovation Act) Law text · (o)
• Pub. L. 112–144, §713(2), added subsec. (r). (Food and Drug Administration Safety and Innovation Act) Law text · (r)
• Pub. L. 112–144, §714(b), added subsec. (s). (Food and Drug Administration Safety and Innovation Act) Law text · (s)

2011

• 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". (FDA Food Safety Modernization Act) Law text · (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 ref… (FDA Food Safety Modernization Act) Law text · (a)
• 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 sent… (FDA Food Safety Modernization Act) Law text · (b)
• Pub. L. 111–353, §107(b)(1)(A), substituted "a food, drug" for "a drug" in introductory provisions. (FDA Food Safety Modernization Act) Law text · (e)
• Pub. L. 111–353, §107(b)(1)(B), substituted "exported food, drug" for "exported drug". (FDA Food Safety Modernization Act) Law text · (e)
• Pub. L. 111–353, §107(b)(1)(C), substituted "the food, drug" for "the drug" in two places. (FDA Food Safety Modernization Act) Law text · (e)
• Pub. L. 111–353, §107(b)(2), added subpar. (C). (FDA Food Safety Modernization Act) Law text · (e)
• Pub. L. 111–353, §107(b)(3), added subpar. (D). (FDA Food Safety Modernization Act) Law text · (e)
• 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". (FDA Food Safety Modernization Act) Law text · (l)
• 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;". (FDA Food Safety Modernization Act) Law text · (m)
• Pub. L. 111–353, §303(b), added subsec. (q). (FDA Food Safety Modernization Act) Law text · (q)

2009

• 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. Law text · (a)
• 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. Law text · (a)
• 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". Law text · (e)
• Pub. L. 111–31, §103(l)(3), added subsec. (p). Law text · (p)

2007

• 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 … (Food and Drug Administration Amendments Act of 2007) Law text · (a)

2006

• 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… (Dietary Supplement and Nonprescription Drug Consumer Protection Act) Law text · (a)
• 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 … (Dietary Supplement and Nonprescription Drug Consumer Protection Act) Law text · (b)

2002

• 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 pur… (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (d)
• Pub. L. 107–188, §302(a)–(c), added subsec. (h). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (h)
• Pub. L. 107–188, §302(d), added subsec. (i). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (i)
• Pub. L. 107–188, §303(c), added subsec. (j). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (j)
• Pub. L. 107–188, §304(e), added subsec. (k). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (k)
• Pub. L. 107–188, §305(c), added subsec. (l). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (l)
• Pub. L. 107–188, §307(a), added subsec. (m). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (m)
• Pub. L. 107–188, §308(a), added subsec. (n). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (n)
• Pub. L. 107–188, §321(b)(1), added subsec. (o). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (o)

2000

• Pub. L. 106–387, §1(a) [title VII, §745(c)(1)], inserted "and section 384 of this title" after "paragraph (2)". (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001) Law text · (d)
• Pub. L. 106–387, §1(a) [title VII, §746(c)], added subsec. (g). (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001) Law text · (g)

1997

• Pub. L. 105–115 inserted "or composed wholly or partly of insulin" after "353(b) of this title". (Food and Drug Administration Modernization Act of 1997) Law text · (d)

1996

• 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 … (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 1997) Law text · (d)
• Pub. L. 104–134, §2102(a)(1), added par. (3) (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1996.) Law text · (d)
• Pub. L. 104–134, §2102(a)(1), added par. (4). (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1996.) Law text · (d)
• 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 titl… (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1996.) Law text · (e)
• Pub. L. 104–134, §2102(b)(2), in concluding provisions, substituted "either (i) the Secretary" for "the Secretary" and added cl. (ii). (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1996.) Law text · (e)
• Pub. L. 104–134, §2102(b)(3), added pars. (3) and (4). (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1996.) Law text · (e), (4)
• 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). (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 1997) Law text · (f)
• Pub. L. 104–134, §2102(c), added subsec. (f). (Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1996.) Law text · (f)

1993

• Pub. L. 103–80, §3(dd)(1), substituted "Health and Human Services" for "Agriculture" after "Secretary of" in two places in first sentence. · (a)
• 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… · (b)

1992

• 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… · (a), (b)
• Pub. L. 102–353 substituted "manufacturer of" for "person who manufactured". · (d)

1988

• Pub. L. 100–293 added subsec. (d) and redesignated former subsec. (d) as (e). · (d), (e)

1976

• 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 we… · (a)
• Pub. L. 94–295, §3(f)(1), designated existing provisions as par. (1) and added par. (2). · (d)

1970

• 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. · (a)

1968

• 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. · (d)

1962

• 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 register… · (a)