§382. Exports of certain unapproved products — Inbound Citations

Code of Federal Regulations Citations

Cited by 1 regulation in the Code of Federal Regulations.

• 21 C.F.R. § 1.101(a) — Notification and recordkeeping.

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  (a) This section pertains to notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports under sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or section 351 of the Public Health Service Act (42 U.S.C. 262).

Citations to 21 U.S.C. § 382 as a whole

• 21 U.S.C. § 321(dd)

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  (dd) For purposes of sections 335a and 335b of this title, the term “drug product” means a drug subject to regulation under section 355, 360b, or 382 of this title or under section 262 of title 42.

• 21 U.S.C. § 331(w)

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  (w) The making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under section 381(d)(3) of this title; the failure to submit a certificate of analysis as required under such section; the failure to maintain records or to submit records or reports as required by such section; the release into interstate commerce of any article or portion thereof imported into the United States under such section or any finished product made from such article or portion, except for export in accordance with section 381(e) or 382 of this title, or with section 262(h) of title 42; or the failure to so export or to destroy such an article or portions thereof, or such a finished product.

• 21 U.S.C. § 381(d)(3)(A)(i)(I)

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  (I) Such statement provides that such article 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 the initial owner or consignee from the United States in accordance with subsection (e) or section 382 of this title, or with section 351(h) of the Public Health Service Act [42 U.S.C. 262(h)].

• 21 U.S.C. § 381(d)(3)(B)

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  (B) Notwithstanding subparagraph (A), the Secretary may refuse admission to an article that otherwise would be imported into the United States under such subparagraph if the Secretary determines that there is credible evidence or information indicating that such article is not 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 the initial owner or consignee from the United States in accordance with subsection (e) or section 382 of this title, or with section 351(h) of the Public Health Service Act [42 U.S.C. 262(h)].

• 21 U.S.C. § 381(e)(2)

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  (2) Paragraph (1) does not apply to any device—

  (A) which does not comply with an applicable requirement of section 360d or 360e of this title,

  (B) which under section 360j(g) of this title is exempt from either such section, or

  (C) which is a banned device under section 360f of this title,

  unless, in addition to the requirements of paragraph (1), either (i) the Secretary has determined that the exportation of the device is not contrary to public health and safety and has the approval of the country to which it is intended for export or (ii) the device is eligible for export under section 382 of this title.

• 21 U.S.C. § 381(e)(4)(A)(i)

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  (i) certify in writing that the exported food, drug, animal drug, or device meets the requirements of paragraph (1) or section 382 of this title; or

• 21 U.S.C. § 381(f)(1)

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  (1) If a drug (other than insulin, an antibiotic drug, an animal drug, or a drug exported under section 382 of this title) being exported in accordance with subsection (e) is being exported to a country that has different or additional labeling requirements or conditions for use and such country requires the drug to be labeled in accordance with those requirements or uses, such drug may be labeled in accordance with such requirements and conditions for use in the country to which such drug is being exported if it also is labeled in accordance with the requirements of this chapter.

• 21 U.S.C. § 381(f)(2)

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  (2) If, pursuant to paragraph (1), the labeling of an exported drug includes conditions for use that have not been approved under this chapter, the labeling must state that such conditions for use have not been approved under this chapter. A drug exported under section 382 of this title is exempt from this section.

Citations to §382(b)(1)(A)

• 21 U.S.C. § 355h(b)(6)(C)(ii)

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  (ii) if the drug has not been previously marketed in the United States as a nonprescription drug, information sufficient for a prima facie demonstration that the drug was marketed and safely used under comparable conditions of marketing and use in a country listed in section 382(b)(1)(A) of this title or designated by the Secretary in accordance with section 382(b)(1)(B) of this title—

  (I) for such period as needed to provide reasonable assurances concerning the safe nonprescription use of the drug; and

  (II) during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the Secretary for such monitoring purposes, including for adverse events associated with nonprescription use of the drug; or

Citations to §382(b)(1)(B)

• 21 U.S.C. § 355h(b)(6)(C)(ii)

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  (ii) if the drug has not been previously marketed in the United States as a nonprescription drug, information sufficient for a prima facie demonstration that the drug was marketed and safely used under comparable conditions of marketing and use in a country listed in section 382(b)(1)(A) of this title or designated by the Secretary in accordance with section 382(b)(1)(B) of this title—

  (I) for such period as needed to provide reasonable assurances concerning the safe nonprescription use of the drug; and

  (II) during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the Secretary for such monitoring purposes, including for adverse events associated with nonprescription use of the drug; or