---
kind: "section"
citation: "21 U.S.C. § 381"
title: "21"
title_heading: "Food and Drugs"
number: "381"
heading: "Imports and exports"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/381"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VIII — Imports and Exports"
---

# §381. Imports and exports

- (a) **Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission—** The [Secretary](/usc/21/321.md?p=d) of the Treasury shall deliver to the [Secretary](/usc/21/321.md?p=d) of Health and Human Services, upon his request, samples of [food](/usc/21/321.md?p=f), [drugs](/usc/21/321.md?p=g-1), [devices](/usc/21/321.md?p=h-1), [tobacco products](/usc/21/321.md?p=rr-1), and [cosmetics](/usc/21/321.md?p=i) 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](/usc/21/321.md?p=d) of Health and Human Services and have the right to introduce testimony. The [Secretary](/usc/21/321.md?p=d) of Health and Human Services shall furnish to the [Secretary](/usc/21/321.md?p=d) of the Treasury a list of establishments registered pursuant to [subsection (i)](/usc/21/360.md?p=i) of section 360 or [section 387e(h) of this title](/usc/21/387e.md?p=h) and shall request that if any [drugs](/usc/21/321.md?p=g-1), [devices](/usc/21/321.md?p=h-1), or [tobacco products](/usc/21/321.md?p=rr-1) 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](/usc/21/321.md?p=g-1), [devices](/usc/21/321.md?p=h-1), or [tobacco products](/usc/21/321.md?p=rr-1) be delivered to the [Secretary](/usc/21/321.md?p=d) of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=h-1), the methods used in, or the [facilities](/usc/21/364.md?p=3-A) or controls used for, the manufacture, packing, storage, or installation of the [device](/usc/21/321.md?p=h-1) do not conform to the requirements of [section 360j(f) of this title](/usc/21/360j.md?p=f), 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](/usc/21/355.md) or the importer (as defined in [section 384a of this title](/usc/21/384a.md)) is in violation of such [section 384a of this title](/usc/21/384a.md), or prohibited from introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) under [section 331(ll)](/usc/21/331.md?p=ll) of this title, or is a controlled substance subject to an order under [section 360bbb–8d of this title](/usc/21/360bbb–8d.md), or (4) the recordkeeping requirements under [section 2223 of this title](/usc/21/2223.md) (other than the requirements under [subsection (f)](/usc/21/2223.md?p=f) of such section) have not been complied with regarding such article or[^1] (5) such article is being imported or offered for import in violation of [section 331(cc) of this title](/usc/21/331.md?p=cc), then any such article described in any of clauses (1) through (5) shall be refused admission, except as provided in [subsection (b)](#b) of this section. If it appears from the examination of such samples or otherwise that the article is a [counterfeit drug](/usc/21/321.md?p=g-2) or [counterfeit device](/usc/21/321.md?p=h-2), such article shall be refused admission. With respect to an article of [food](/usc/21/321.md?p=f), if importation of such [food](/usc/21/321.md?p=f) is subject to, but not compliant with, the requirement under [subsection (q)](#q) that such [food](/usc/21/321.md?p=f) be accompanied by a certification or other assurance that the [food](/usc/21/321.md?p=f) meets applicable requirements of this chapter, then such article shall be refused admission. If such article is subject to a requirement under section [364a](/usc/21/364a.md), [379aa](/usc/21/379aa.md), or [379aa–1](/usc/21/379aa–1.md) of this title and if the [Secretary](/usc/21/321.md?p=d) has credible evidence or information indicating that the [responsible person](/usc/21/364.md?p=4) (as defined in section [364](/usc/21/364.md), [379aa](/usc/21/379aa.md), or [379aa–1](/usc/21/379aa–1.md) of this title) has not complied with a requirement of such section [364a](/usc/21/364a.md), [379aa](/usc/21/379aa.md), or [379aa–1](/usc/21/379aa–1.md) of this title with respect to any such article, or has not allowed access to records described in such section [364a](/usc/21/364a.md), [379aa](/usc/21/379aa.md), or [379aa–1](/usc/21/379aa–1.md) of this title, then such article shall be refused admission, except as provided in [subsection (b)](#b) of this section. The [Secretary](/usc/21/321.md?p=d) of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=d) of Health and Human Services may destroy, without the opportunity for export, any [drug](/usc/21/321.md?p=g-1), [device](/usc/21/321.md?p=h-1), or [tobacco product](/usc/21/321.md?p=rr-1) refused admission under this section, if such [drug](/usc/21/321.md?p=g-1), [device](/usc/21/321.md?p=h-1), or [tobacco product](/usc/21/321.md?p=rr-1) is valued at an amount that is $2,500 or less (or such higher amount as the [Secretary](/usc/21/321.md?p=d) of the Treasury may set by regulation pursuant to [section 1498(a)(1) of title 19](/usc/19/1498.md?p=a-1)) and was not brought into compliance as described under [subsection (b)](#b). The [Secretary](/usc/21/321.md?p=d) of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the [Secretary](/usc/21/321.md?p=d) of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a [drug](/usc/21/321.md?p=g-1), [device](/usc/21/321.md?p=h-1), or [tobacco product](/usc/21/321.md?p=rr-1) 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](/usc/21/321.md?p=g-1), [device](/usc/21/321.md?p=h-1), or [tobacco product](/usc/21/321.md?p=rr-1). Where the [Secretary](/usc/21/321.md?p=d) of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a [drug](/usc/21/321.md?p=g-1), [device](/usc/21/321.md?p=h-1), or [tobacco product](/usc/21/321.md?p=rr-1), the [Secretary](/usc/21/321.md?p=d) of Health and Human Services shall store and, as applicable, dispose of the [drug](/usc/21/321.md?p=g-1), [device](/usc/21/321.md?p=h-1), or [tobacco product](/usc/21/321.md?p=rr-1) after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to [subsection (c)](#c). Such process may be combined with the notice and opportunity to appear before the [Secretary](/usc/21/321.md?p=d) and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee. Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic [drugs](/usc/21/321.md?p=g-1), the importation of which is permitted under the Controlled Substances Import and Export Act [[21 U.S.C. 951](/usc/21/951.md) et seq.].
- (b) **Disposition of refused articles—** Pending decision as to the admission of an article being imported or offered for import, the [Secretary](/usc/21/321.md?p=d) of the Treasury may authorize delivery of such article to the owner or consignee upon the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the [Secretary](/usc/21/321.md?p=d) of the Treasury. If it appears to the [Secretary](/usc/21/321.md?p=d) of Health and Human Services that (1) an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be brought into compliance with this chapter or rendered other than a [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), [device](/usc/21/321.md?p=h-1), or [cosmetic](/usc/21/321.md?p=i), or (2) with respect to an article described in [subsection (a)](#a) relating to the requirements of section [364a](/usc/21/364a.md), [379aa](/usc/21/379aa.md), or [379aa–1](/usc/21/379aa–1.md) of this title, the [responsible person](/usc/21/364.md?p=4) (as defined in section [364](/usc/21/364.md), [379aa](/usc/21/379aa.md), or [379aa–1](/usc/21/379aa–1.md) of this title) can take action that would assure that the [responsible person](/usc/21/364.md?p=4) is in compliance with section [364a](/usc/21/364a.md), [379aa](/usc/21/379aa.md), or [379aa–1](/usc/21/379aa–1.md) of this title, as the case may be, final determination as to admission of such article may be deferred and, upon filing of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection, the [Secretary](/usc/21/321.md?p=d) may, in accordance with regulations, authorize the applicant, or, with respect to clause (2), the [responsible person](/usc/21/364.md?p=4), to perform such relabeling or other action specified in such authorization (including destruction or export of rejected articles or portions thereof, as may be specified in the [Secretary](/usc/21/321.md?p=d)’s authorization). All such relabeling or other action pursuant to such authorization shall in accordance with regulations be under the supervision of an officer or employee of the [Department](/usc/21/321.md?p=c) of Health and Human Services designated by the [Secretary](/usc/21/321.md?p=d), or an officer or employee of the [Department](/usc/21/321.md?p=c) of the Treasury designated by the [Secretary](/usc/21/321.md?p=d) of the Treasury.
- (c) **Charges concerning refused articles—** All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the United States) in connection with the destruction provided for in [subsection (a)](#a) of this section and the supervision of the relabeling or other action [authorized](/usc/21/360eee.md?p=2) under the provisions of [subsection (b)](#b) of this section, the amount of such expenses to be determined in accordance with regulations, and all expenses in connection with the storage, cartage, or labor with respect to any article refused admission under [subsection (a)](#a) of this section, shall be paid by the owner or consignee and, in default of such payment, shall constitute a lien against any future importations made by such owner or consignee.
- (d) **Reimportation—**
  - (1)
    - (A) Except as provided in [paragraph (2)](#d-2) and [section 384 of this title](/usc/21/384.md), no [drug](/usc/21/321.md?p=g-1) subject to [section 353(b) of this title](/usc/21/353.md?p=b) or composed wholly or partly of insulin which is manufactured in a [State](/usc/21/321.md?p=a-1) and exported may be imported into the United States unless the [drug](/usc/21/321.md?p=g-1) is imported by the [manufacturer](/usc/21/360hh.md?p=3) of the [drug](/usc/21/321.md?p=g-1).
    - (B) Except as [authorized](/usc/21/360eee.md?p=2) by the [Secretary](/usc/21/321.md?p=d) in the case of a [drug](/usc/21/321.md?p=g-1) that appears on the [drug](/usc/21/321.md?p=g-1) shortage list under [section 356e of this title](/usc/21/356e.md) or in the case of importation pursuant to [section 384 of this title](/usc/21/384.md), no [drug](/usc/21/321.md?p=g-1) that is subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1) may be imported into the United States for commercial use if such [drug](/usc/21/321.md?p=g-1) is manufactured outside the United States, unless the [manufacturer](/usc/21/360hh.md?p=3) has [authorized](/usc/21/360eee.md?p=2) the [drug](/usc/21/321.md?p=g-1) to be marketed in the United States and has caused the [drug](/usc/21/321.md?p=g-1) to be labeled to be marketed in the United States.
  - (2) The [Secretary](/usc/21/321.md?p=d) may authorize the importation of a [drug](/usc/21/321.md?p=g-1) the importation of which is prohibited by [paragraph (1)](#d-1) if the [drug](/usc/21/321.md?p=g-1) is required for emergency medical care.
  - (3)
    - (A) Subject to [subparagraph (B)](#d-3-B), no component of a [drug](/usc/21/321.md?p=g-1), no component part or accessory of a [device](/usc/21/321.md?p=h-1), or other article of [device](/usc/21/321.md?p=h-1) requiring further processing, which is ready or suitable for use for health-related purposes, and no article of a [food additive](/usc/21/321.md?p=s), [color additive](/usc/21/321.md?p=t-1), or [dietary supplement](/usc/21/321.md?p=ff), including a [product](/usc/21/360eee.md?p=13) in bulk form, shall be excluded from importation into the United States under [subsection (a)](#a) if each of the following conditions is met:
      - (i) The importer of such article of a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) or importer of such article of a [food additive](/usc/21/321.md?p=s), [color additive](/usc/21/321.md?p=t-1), or [dietary supplement](/usc/21/321.md?p=ff) submits to the [Secretary](/usc/21/321.md?p=d), at the time of initial importation, a statement in accordance with the following:
        - (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](/usc/21/321.md?p=g-1), biological [product](/usc/21/360eee.md?p=13), [device](/usc/21/321.md?p=h-1), [food](/usc/21/321.md?p=f), [food additive](/usc/21/321.md?p=s), [color additive](/usc/21/321.md?p=t-1), or [dietary supplement](/usc/21/321.md?p=ff) that will be exported by the initial owner or consignee from the United States in accordance with [subsection (e)](#e) or [section 382 of this title](/usc/21/382.md), or with section 351(h) of the Public Health Service Act [[42 U.S.C. 262(h)](/usc/42/262.md?p=h)].
        - (II) The statement identifies the [manufacturer](/usc/21/360hh.md?p=3) of such article and each processor, packer, distributor, or other entity that had possession of the article in the chain of possession of the article from the [manufacturer](/usc/21/360hh.md?p=3) to such importer of the article.
        - (III) The statement is accompanied by such certificates of analysis as are necessary to identify such article, unless the article is a [device](/usc/21/321.md?p=h-1) or is an article described in [paragraph (4)](#d-4).
      - (ii) At the time of initial importation and before the delivery of such article to the importer or the initial owner or consignee, such owner or consignee executes a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the [Secretary](/usc/21/321.md?p=d) of the Treasury.
      - (iii) Such article is used and exported by the initial owner or consignee in accordance with the intent described under [clause (i)(I)](#d-3-A-i-I), except for any portions of the article that are destroyed.
      - (iv) The initial owner or consignee maintains records on the use or destruction of such article or portions thereof, as the case may be, and submits to the [Secretary](/usc/21/321.md?p=d) any such records requested by the [Secretary](/usc/21/321.md?p=d).
      - (v) Upon request of the [Secretary](/usc/21/321.md?p=d), the initial owner or consignee submits a report that provides an accounting of the exportation or destruction of such article or portions thereof, and the manner in which such owner or consignee complied with the requirements of this subparagraph.
    - (B) Notwithstanding [subparagraph (A)](#d-3-A), the [Secretary](/usc/21/321.md?p=d) may refuse admission to an article that otherwise would be imported into the United States under such subparagraph if the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=g-1), biological [product](/usc/21/360eee.md?p=13), [device](/usc/21/321.md?p=h-1), [food](/usc/21/321.md?p=f), [food additive](/usc/21/321.md?p=s), [color additive](/usc/21/321.md?p=t-1), or [dietary supplement](/usc/21/321.md?p=ff) that will be exported by the initial owner or consignee from the United States in accordance with [subsection (e)](#e) or [section 382 of this title](/usc/21/382.md), or with section 351(h) of the Public Health Service Act [[42 U.S.C. 262(h)](/usc/42/262.md?p=h)].
    - (C) This section may not be construed as affecting the responsibility of the [Secretary](/usc/21/321.md?p=d) to ensure that articles imported into the United States under authority of [subparagraph (A)](#d-3-A) meet each of the conditions established in such subparagraph for importation.
  - (4) The importation into the United States of blood, blood components, source plasma, or source leukocytes or of a component, accessory, or part thereof is not permitted pursuant to [paragraph (3)](#d-3) unless the importation complies with section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](/usc/42/262.md?p=a)] or the [Secretary](/usc/21/321.md?p=d) permits the importation under appropriate circumstances and conditions, as determined by the [Secretary](/usc/21/321.md?p=d). The importation of tissue or a component or part of tissue is not permitted pursuant to [paragraph (3)](#d-3) unless the importation complies with section 361 of the Public Health Service Act [[42 U.S.C. 264](/usc/42/264.md)].
- (e) **Exports—**
  - (1) A [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), [device](/usc/21/321.md?p=h-1), [tobacco product](/usc/21/321.md?p=rr-1) or [cosmetic](/usc/21/321.md?p=i) intended for export shall not be deemed to be adulterated or misbranded under this chapter, and a [tobacco product](/usc/21/321.md?p=rr-1) intended for export shall not be deemed to be in violation of section [387f(e)](/usc/21/387f.md?p=e), [387g](/usc/21/387g.md), [387k](/usc/21/387k.md), or [387t(a)](/usc/21/387t.md?p=a) of this title, if it—
    - (A) accords to the specifications of the foreign purchaser,
    - (B) is not in conflict with the laws of the country to which it is intended for export,
    - (C) is labeled on the outside of the shipping [package](/usc/21/360eee.md?p=11-A) that it is intended for export, and
    - (D) is not sold or offered for sale in domestic [commerce](/usc/21/360hh.md?p=4).
  - (2) [Paragraph (1)](#e-1) does not apply to any [device](/usc/21/321.md?p=h-1)—
    - (A) which does not comply with an applicable requirement of section [360d](/usc/21/360d.md) or [360e](/usc/21/360e.md) of this title,
    - (B) which under [section 360j(g) of this title](/usc/21/360j.md?p=g) is exempt from either such section, or
    - (C) which is a banned [device](/usc/21/321.md?p=h-1) under [section 360f of this title](/usc/21/360f.md),

    unless, in addition to the requirements of [paragraph (1)](#e-1), either (i) the [Secretary](/usc/21/321.md?p=d) has determined that the exportation of the [device](/usc/21/321.md?p=h-1) 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](/usc/21/321.md?p=h-1) is eligible for export under [section 382 of this title](/usc/21/382.md).

  - (3) A [new animal drug](/usc/21/321.md?p=v) that requires approval under [section 360b of this title](/usc/21/360b.md) shall not be exported pursuant to [paragraph (1)](#e-1) if such [drug](/usc/21/321.md?p=g-1) has been banned in the United States.
  - (4)
    - (A) Any [person](/usc/21/321.md?p=e) who exports a [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), animal [drug](/usc/21/321.md?p=g-1), or [device](/usc/21/321.md?p=h-1) may request that the [Secretary](/usc/21/321.md?p=d)—
      - (i) certify in writing that the exported [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), animal [drug](/usc/21/321.md?p=g-1), or [device](/usc/21/321.md?p=h-1) meets the requirements of [paragraph (1)](#e-1) or [section 382 of this title](/usc/21/382.md); or
      - (ii) certify in writing that the [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), animal [drug](/usc/21/321.md?p=g-1), or [device](/usc/21/321.md?p=h-1) being exported meets the applicable requirements of this chapter upon a showing that the [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) meets the applicable requirements of this chapter.

      The [Secretary](/usc/21/321.md?p=d) shall issue such a certification within 20 days of the receipt of a request for such certification.

    - (B) If the [Secretary](/usc/21/321.md?p=d) issues a written export certification within the 20 days prescribed by [subparagraph (A)](#e-4-A), a fee for such certification may be charged but shall not exceed $175 for each certification. Fees collected for a fiscal year pursuant to this subparagraph shall be credited to the appropriation account for salaries and expenses of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and shall be available in accordance with appropriations Acts until expended without fiscal year limitation. Such fees shall be collected in each fiscal year in an amount equal to the amount specified in appropriations Acts for such fiscal year and shall only be collected and available for the costs of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
    - (C) For purposes of this paragraph, a certification by the [Secretary](/usc/21/321.md?p=d) shall be made on such basis, and in such form (including a publicly available listing) as the [Secretary](/usc/21/321.md?p=d) determines appropriate.
    - (D) With regard to fees pursuant to [subparagraph (B)](#e-4-B) in connection with written export certifications for [food](/usc/21/321.md?p=f):
      - (i) Such fees shall be collected and available solely for the costs of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration associated with issuing such certifications.
      - (ii) Such fees may not be retained in an amount that exceeds such costs for the respective fiscal year.
    - (E)
      - (i)
        - (I) If the [Secretary](/usc/21/321.md?p=d) denies a request for certification under [subparagraph (A)(ii)](#e-4-A-ii) with respect to a [device](/usc/21/321.md?p=h-1) manufactured in an establishment (foreign or domestic) registered under [section 360 of this title](/usc/21/360.md), the [Secretary](/usc/21/321.md?p=d) shall provide in writing to the [person](/usc/21/321.md?p=e) seeking such certification the basis for such denial, and specifically identify the finding upon which such denial is based.
        - (II) If the denial of a request as described in [subclause (I)](#e-4-E-i-I) is based on grounds other than an injunction proceeding pursuant to [section 332 of this title](/usc/21/332.md), seizure action pursuant to [section 334 of this title](/usc/21/334.md), or a recall designated Class I or Class II pursuant to part 7, [title 21](/usc/21.md), Code of Federal Regulations, and is based on the [facility](/usc/21/364.md?p=3-A) being out of compliance with part 820 of title 21, Code of Federal Regulations, the [Secretary](/usc/21/321.md?p=d) shall provide a substantive summary of the specific grounds for noncompliance identified by the [Secretary](/usc/21/321.md?p=d).
        - (III) With respect to a [device](/usc/21/321.md?p=h-1) manufactured in an establishment that has received a report under [section 374(b) of this title](/usc/21/374.md?p=b), the [Secretary](/usc/21/321.md?p=d) shall not deny a request for certification as described in [subclause (I)](#e-4-E-i-I) with respect to a [device](/usc/21/321.md?p=h-1) based solely on the issuance of that report if the owner, operator, or agent in charge of such establishment has agreed to a plan of correction in response to such report.
      - (ii)
        - (I) The [Secretary](/usc/21/321.md?p=d) shall provide a process for a [person](/usc/21/321.md?p=e) who is denied a certification as described in [clause (i)(I)](#e-4-E-i-I) to request a review that conforms to the standards of [section 360g–1(b) of this title](/usc/21/360g–1.md?p=b).
        - (II) Notwithstanding any previous review conducted pursuant to [subclause (I)](#e-4-E-ii-I), a [person](/usc/21/321.md?p=e) who has been denied a certification as described in [clause (i)(I)](#e-4-E-i-I) may at any time request a review in order to present new information relating to actions taken by such [person](/usc/21/321.md?p=e) to address the reasons identified by the [Secretary](/usc/21/321.md?p=d) for the denial of certification, including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by the [Secretary](/usc/21/321.md?p=d).
        - (III) Not later than 1 year after August 18, 2017, the [Secretary](/usc/21/321.md?p=d) shall issue guidance providing for a process to carry out this subparagraph. Not later than 1 year after the close of the comment period for such guidance, the [Secretary](/usc/21/321.md?p=d) shall issue final guidance.
    - (F)
      - (i) This paragraph applies to requests for certification under this subparagraph of a [device](/usc/21/321.md?p=h-1) manufactured by a [device](/usc/21/321.md?p=h-1) establishment located outside of the United States that is registered under [section 360 of this title](/usc/21/360.md), if the [device](/usc/21/321.md?p=h-1) is listed pursuant to [section 360(j) of this title](/usc/21/360.md?p=j), the [device](/usc/21/321.md?p=h-1) has been cleared, approved, or is not required to submit a premarket report pursuant to subsection (l) or (m) of [section 360 of this title](/usc/21/360.md), and the [device](/usc/21/321.md?p=h-1) is imported or offered for import into the United States.
      - (ii) The [Secretary](/usc/21/321.md?p=d) shall issue the certification as described in [clause (iii)](#e-4-F-iii) if the [device](/usc/21/321.md?p=h-1) or [devices](/usc/21/321.md?p=h-1) for which certification is requested under this subparagraph meet the applicable requirements of this chapter.
      - (iii)
        - (I) A certification for a [device](/usc/21/321.md?p=h-1) described in [clause (i)](#e-4-F-i) shall be subject to the fee described in [subparagraph (B)](#e-4-B).
        - (II) Notwithstanding [subparagraph (C)](#e-4-C), a certification for a [device](/usc/21/321.md?p=h-1) described in [clause (i)](#e-4-F-i) shall address and include the same material information as a “Certificate to Foreign Government” and shall have a document title including the words “Certificate to Foreign Government”.
      - (iv) The requirements and procedures of [subparagraph (E)](#e-4-E) shall apply to a denial of a certification under this subparagraph.
- (f) **Labeling of exported drugs—**
  - (1) If a [drug](/usc/21/321.md?p=g-1) (other than insulin, an [antibiotic drug](/usc/21/321.md?p=jj), an animal [drug](/usc/21/321.md?p=g-1), or a [drug](/usc/21/321.md?p=g-1) exported under [section 382 of this title](/usc/21/382.md)) being exported in accordance with [subsection (e)](#e) is being exported to a country that has different or additional [labeling](/usc/21/321.md?p=m) requirements or conditions for use and such country requires the [drug](/usc/21/321.md?p=g-1) to be labeled in accordance with those requirements or uses, such [drug](/usc/21/321.md?p=g-1) may be labeled in accordance with such requirements and conditions for use in the country to which such [drug](/usc/21/321.md?p=g-1) is being exported if it also is labeled in accordance with the requirements of this chapter.
  - (2) If, pursuant to [paragraph (1)](#f-1), the [labeling](/usc/21/321.md?p=m) of an exported [drug](/usc/21/321.md?p=g-1) includes conditions for use that have not been approved under this chapter, the [labeling](/usc/21/321.md?p=m) must [state](/usc/21/321.md?p=a-1) that such conditions for use have not been approved under this chapter. A [drug](/usc/21/321.md?p=g-1) exported under [section 382 of this title](/usc/21/382.md) is exempt from this section.
- (g) **Warning notice of importation in violation of chapter—**
  - (1) With respect to a [prescription drug](/usc/21/360eee.md?p=12) being imported or offered for import into the United States, the [Secretary](/usc/21/321.md?p=d), in the case of an individual who is not in the business of such importations, may not send a warning notice to the individual unless the following conditions are met:
    - (A) The notice specifies, as applicable to the importation of the [drug](/usc/21/321.md?p=g-1), that the [Secretary](/usc/21/321.md?p=d) has made a determination that—
      - (i) importation is in violation of [subsection (a)](#a) because the [drug](/usc/21/321.md?p=g-1) is or appears to be adulterated, misbranded, or in violation of [section 355 of this title](/usc/21/355.md);
      - (ii) importation is in violation of [subsection (a)](#a) because the [drug](/usc/21/321.md?p=g-1) is or appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported;
      - (iii) importation is or appears to be in violation of [subsection (d)(1)](#d-1); or
      - (iv) importation otherwise is or appears to be in violation of Federal law.
    - (B) The notice does not specify any provision described in [subparagraph (A)](#g-1-A) that is not applicable to the importation of the [drug](/usc/21/321.md?p=g-1).
    - (C) The notice [states](/usc/21/321.md?p=a-1) the reasons underlying such determination by the [Secretary](/usc/21/321.md?p=d), including a brief application to the principal facts involved of the provision of law described in [subparagraph (A)](#g-1-A) that is the basis of the determination by the [Secretary](/usc/21/321.md?p=d).
  - (2) For purposes of this section, the term “warning notice”, with respect to the importation of a [drug](/usc/21/321.md?p=g-1), means a communication from the [Secretary](/usc/21/321.md?p=d) (written or otherwise) notifying a [person](/usc/21/321.md?p=e), or clearly suggesting to the [person](/usc/21/321.md?p=e), that importing the [drug](/usc/21/321.md?p=g-1) for personal use is, or appears to be, a violation of this chapter.
- (h) **Protection against adulteration of food—**
  - (1) The [Secretary](/usc/21/321.md?p=d) shall give high priority to increasing the number of inspections under this section for the purpose of enabling the [Secretary](/usc/21/321.md?p=d) to inspect [food](/usc/21/321.md?p=f) offered for import at ports of entry into the United States, with the greatest priority given to inspections to detect the intentional adulteration of [food](/usc/21/321.md?p=f).
  - (2) The [Secretary](/usc/21/321.md?p=d) shall give high priority to making necessary improvements to the information management systems of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration that contain information related to [foods](/usc/21/321.md?p=f) imported or offered for import into the United States for purposes of improving the ability of the [Secretary](/usc/21/321.md?p=d) to allocate resources, detect the intentional adulteration of [food](/usc/21/321.md?p=f), and facilitate the importation of [food](/usc/21/321.md?p=f) that is in compliance with this chapter.
  - (3) The [Secretary](/usc/21/321.md?p=d) shall improve linkages with other regulatory agencies of the Federal Government that share responsibility for [food](/usc/21/321.md?p=f) safety, and shall with respect to such safety improve linkages with the [States](/usc/21/321.md?p=a-1) and Indian tribes (as defined in [section 5304(e) of title 25](/usc/25/5304.md?p=e)).
- (i) **Testing for rapid detection of adulteration of food—**
  - (1) For use in inspections of [food](/usc/21/321.md?p=f) under this section, the [Secretary](/usc/21/321.md?p=d) shall provide for research on the development of tests and sampling methodologies—
    - (A) whose purpose is to test [food](/usc/21/321.md?p=f) in order to rapidly detect the adulteration of the [food](/usc/21/321.md?p=f), with the greatest priority given to detect the intentional adulteration of [food](/usc/21/321.md?p=f); and
    - (B) whose results offer significant improvements over the available technology in terms of accuracy, timing, or costs.
  - (2) In providing for research under [paragraph (1)](#i-1), the [Secretary](/usc/21/321.md?p=d) shall give priority to conducting research on the development of tests that are suitable for inspections of [food](/usc/21/321.md?p=f) at ports of entry into the United States.
  - (3) In providing for research under [paragraph (1)](#i-1), the [Secretary](/usc/21/321.md?p=d) shall as appropriate coordinate with the Director of the Centers for Disease Control and Prevention, the Director of the National Institutes of Health, the [Administrator](/usc/21/321.md?p=hh) of the Environmental Protection Agency, and the [Secretary](/usc/21/321.md?p=d) of Agriculture.
  - (4) The [Secretary](/usc/21/321.md?p=d) shall annually submit to the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the progress made in research under [paragraph (1)](#i-1), including progress regarding [paragraph (2)](#i-2).
- (j) **Temporary holds at ports of entry—**
  - (1) If an officer or qualified employee of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration has credible evidence or information indicating that an article of [food](/usc/21/321.md?p=f) presents a threat of serious adverse health consequences or death to humans or animals, and such officer or qualified employee is unable to inspect, examine, or investigate such article upon the article being offered for import at a port of entry into the United States, the officer or qualified employee shall request the [Secretary](/usc/21/321.md?p=d) of Treasury to hold the [food](/usc/21/321.md?p=f) at the port of entry for a reasonable period of time, not to exceed 24 hours, for the purpose of enabling the [Secretary](/usc/21/321.md?p=d) to inspect, examine, or investigate the article as appropriate.
  - (2) The [Secretary](/usc/21/321.md?p=d) shall request the [Secretary](/usc/21/321.md?p=d) of Treasury to remove an article held pursuant to [paragraph (1)](#j-1) to a secure [facility](/usc/21/364.md?p=3-A), as appropriate. During the period of time that such article is so held, the article shall not be transferred by any [person](/usc/21/321.md?p=e) from the port of entry into the United States for the article, or from the secure [facility](/usc/21/364.md?p=3-A) to which the article has been removed, as the case may be. [Subsection (b)](#b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held.
  - (3) An officer or qualified employee of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration may make a request under [paragraph (1)](#j-1) only if the [Secretary](/usc/21/321.md?p=d) or an official designated by the [Secretary](/usc/21/321.md?p=d) approves the request. An official may not be so designated unless the official is the director of the district under this chapter in which the article involved is located, or is an official senior to such director.
  - (4) With respect to an article of [food](/usc/21/321.md?p=f) for which a request under [paragraph (1)](#j-1) is made, the [Secretary](/usc/21/321.md?p=d), promptly after the request is made, shall notify the [State](/usc/21/321.md?p=a-1) in which the port of entry involved is located that the request has been made, and as applicable, that such article is being held under this subsection.
- (k) **Importation by debarred persons—**
  - (1) If an article of [food](/usc/21/321.md?p=f) is being imported or offered for import into the United States, and the importer, owner, or consignee of the article is a [person](/usc/21/321.md?p=e) who has been debarred under [section 335a(b)(3) of this title](/usc/21/335a.md?p=b-3), such article shall be held at the port of entry for the article, and may not be delivered to such [person](/usc/21/321.md?p=e). [Subsection (b)](#b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure [facility](/usc/21/364.md?p=3-A), as appropriate. During the period of time that such article is so held, the article shall not be transferred by any [person](/usc/21/321.md?p=e) from the port of entry into the United States for the article, or from the secure [facility](/usc/21/364.md?p=3-A) to which the article has been removed, as the case may be.
  - (2) An article of [food](/usc/21/321.md?p=f) held under [paragraph (1)](#k-1) may be delivered to a [person](/usc/21/321.md?p=e) who is not a debarred [person](/usc/21/321.md?p=e) under [section 335a(b)(3) of this title](/usc/21/335a.md?p=b-3) if such [person](/usc/21/321.md?p=e) affirmatively establishes, at the expense of the [person](/usc/21/321.md?p=e), that the article complies with the requirements of this chapter, as determined by the [Secretary](/usc/21/321.md?p=d).
- (l) **Failure to register—**
  - (1) [^2] If an article of [food](/usc/21/321.md?p=f) is being imported or offered for import into the United States, and such article is from a foreign [facility](/usc/21/364.md?p=3-A) for which a registration has not been submitted to the [Secretary](/usc/21/321.md?p=d) under [section 350d of this title](/usc/21/350d.md) (or for which a registration has been suspended under such section), such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until the foreign [facility](/usc/21/364.md?p=3-A) is so registered. [Subsection (b)](#b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure [facility](/usc/21/364.md?p=3-A), as appropriate. During the period of time that such article is so held, the article shall not be transferred by any [person](/usc/21/321.md?p=e) from the port of entry into the United States for the article, or from the secure [facility](/usc/21/364.md?p=3-A) to which the article has been removed, as the case may be.
- (m) **Prior notice of imported food shipments—**
  - (1) In the case of an article of [food](/usc/21/321.md?p=f) that is being imported or offered for import into the United States, the [Secretary](/usc/21/321.md?p=d), after consultation with the [Secretary](/usc/21/321.md?p=d) of the Treasury, shall by regulation require, for the purpose of enabling such article to be inspected at ports of entry into the United States, the submission to the [Secretary](/usc/21/321.md?p=d) of a notice providing the identity of each of the following: The article; the [manufacturer](/usc/21/360hh.md?p=3) and shipper of the article; if known within the specified period of time that notice is required to be provided, the grower of the article; the country from which the article originates; the country from which the article is shipped; any country to which the article has been refused entry; and the anticipated port of entry for the article. An article of [food](/usc/21/321.md?p=f) imported or offered for import without submission of such notice in accordance with the requirements under this paragraph shall be refused admission into the United States. Nothing in this section may be construed as a limitation on the port of entry for an article of [food](/usc/21/321.md?p=f).
  - (2)
    - (A) Regulations under [paragraph (1)](#m-1) shall require that a notice under such paragraph be provided by a specified period of time in advance of the time of the importation of the article of [food](/usc/21/321.md?p=f) involved or the offering of the [food](/usc/21/321.md?p=f) for import, which period shall be no less than the minimum amount of time necessary for the [Secretary](/usc/21/321.md?p=d) to receive, review, and appropriately respond to such notification, but may not exceed five days. In determining the specified period of time required under this subparagraph, the [Secretary](/usc/21/321.md?p=d) may consider, but is not limited to consideration of, the effect on [commerce](/usc/21/360hh.md?p=4) of such period of time, the locations of the various ports of entry into the United States, the various modes of transportation, the types of [food](/usc/21/321.md?p=f) imported into the United States, and any other such consideration. Nothing in the preceding sentence may be construed as a limitation on the obligation of the [Secretary](/usc/21/321.md?p=d) to receive, review, and appropriately respond to any notice under [paragraph (1)](#m-1).
    - (B)
      - (i) If an article of [food](/usc/21/321.md?p=f) is being imported or offered for import into the United States and a notice under [paragraph (1)](#m-1) is not provided in advance in accordance with the requirements under [paragraph (1)](#m-1), such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such notice is submitted to the [Secretary](/usc/21/321.md?p=d), and the [Secretary](/usc/21/321.md?p=d) examines the notice and determines that the notice is in accordance with the requirements under [paragraph (1)](#m-1). [Subsection (b)](#b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure [facility](/usc/21/364.md?p=3-A), as appropriate. During the period of time that such article is so held, the article shall not be transferred by any [person](/usc/21/321.md?p=e) from the port of entry into the United States for the article, or from the secure [facility](/usc/21/364.md?p=3-A) to which the article has been removed, as the case may be.
      - (ii) In carrying out [clause (i)](#m-2-B-i) with respect to an article of [food](/usc/21/321.md?p=f), the [Secretary](/usc/21/321.md?p=d) shall determine whether there is in the possession of the [Secretary](/usc/21/321.md?p=d) any credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.
  - (3)
    - (A) This subsection may not be construed as limiting the authority of the [Secretary](/usc/21/321.md?p=d) to obtain information under any other provision of this chapter.
    - (B) This subsection may not be construed as authorizing the [Secretary](/usc/21/321.md?p=d) to impose any requirements with respect to a [food](/usc/21/321.md?p=f) to the extent that it is within the exclusive jurisdiction of the [Secretary](/usc/21/321.md?p=d) of Agriculture pursuant to the Federal Meat Inspection Act ([21 U.S.C. 601](/usc/21/601.md) et seq.), the Poultry [Products](/usc/21/360eee.md?p=13) Inspection Act ([21 U.S.C. 451](/usc/21/451.md) et seq.), or the Egg [Products](/usc/21/360eee.md?p=13) Inspection Act ([21 U.S.C. 1031](/usc/21/1031.md) et seq.).
- (n) **Labeling of food refused admission—**
  - (1) If a [food](/usc/21/321.md?p=f) has been refused admission under [subsection (a)](#a), other than such a [food](/usc/21/321.md?p=f) that is required to be destroyed, the [Secretary](/usc/21/321.md?p=d) may require the owner or consignee of the [food](/usc/21/321.md?p=f) to affix to the container of the [food](/usc/21/321.md?p=f) a [label](/usc/21/321.md?p=k) that clearly and conspicuously bears the statement: “UNITED STATES: REFUSED ENTRY”.
  - (2) All expenses in connection with affixing a [label](/usc/21/321.md?p=k) under [paragraph (1)](#n-1) shall be paid by the owner or consignee of the [food](/usc/21/321.md?p=f) involved, and in default of such payment, shall constitute a lien against future importations made by such owner or consignee.
  - (3) A requirement under [paragraph (1)](#n-1) remains in effect until the [Secretary](/usc/21/321.md?p=d) determines that the [food](/usc/21/321.md?p=f) involved has been brought into compliance with this chapter.
- (o) **Registration statement—** If an article that is a [device](/usc/21/321.md?p=h-1) is being imported or offered for import into the United States, and the importer, owner, or consignee of such article does not, at the time of offering the article for import, submit to the [Secretary](/usc/21/321.md?p=d) a statement that identifies the registration under [section 360(i) of this title](/usc/21/360.md?p=i) of each establishment that with respect to such article is required under such section to register with the [Secretary](/usc/21/321.md?p=d), the article may be refused admission. If the article is refused admission for failure to submit such a statement, the article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such a statement is submitted to the [Secretary](/usc/21/321.md?p=d). [Subsection (b)](#b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure [facility](/usc/21/364.md?p=3-A), as appropriate. During the period of time that such article is so held, the article shall not be transferred by any [person](/usc/21/321.md?p=e) from the port of entry into the United States for the article, or from the secure [facility](/usc/21/364.md?p=3-A) to which the article has been removed, as the case may be.
- (p) **Report—**
  - (1) Not later than 36 months after June 22, 2009, and annually thereafter, the [Secretary](/usc/21/321.md?p=d) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives, a report regarding—
    - (A) the nature, extent, and destination of United States [tobacco product](/usc/21/321.md?p=rr-1) exports that do not conform to [tobacco product](/usc/21/321.md?p=rr-1) standards established pursuant to this chapter;
    - (B) the public health implications of such exports, including any evidence of a negative public health impact; and
    - (C) recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports.
  - (2) The [Secretary](/usc/21/321.md?p=d) is [authorized](/usc/21/360eee.md?p=2) to establish appropriate information disclosure requirements to carry out this subsection.
- (q) **Certifications concerning imported foods—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) may require, as a condition of granting admission to an article of [food](/usc/21/321.md?p=f) imported or offered for import into the United States, that an entity described in [paragraph (3)](#q-3) provide a certification, or such other assurances as the [Secretary](/usc/21/321.md?p=d) determines appropriate, that the article of [food](/usc/21/321.md?p=f) complies with applicable requirements of this chapter. Such certification or assurances may be provided in the form of shipment-specific certificates, a listing of certified [facilities](/usc/21/364.md?p=3-A) that manufacture, process, pack, or hold such [food](/usc/21/321.md?p=f), or in such other form as the [Secretary](/usc/21/321.md?p=d) may specify.
  - (2) **Factors to be considered in requiring certification—** The [Secretary](/usc/21/321.md?p=d) shall base the determination that an article of [food](/usc/21/321.md?p=f) is required to have a certification described in [paragraph (1)](#q-1) on the risk of the [food](/usc/21/321.md?p=f), including—
    - (A) known safety risks associated with the [food](/usc/21/321.md?p=f);
    - (B) known [food](/usc/21/321.md?p=f) safety risks associated with the country, [territory](/usc/21/321.md?p=a-2), or region of origin of the [food](/usc/21/321.md?p=f);
    - (C) a finding by the [Secretary](/usc/21/321.md?p=d), supported by scientific, risk-based evidence, that—
      - (i) the [food](/usc/21/321.md?p=f) safety programs, systems, and standards in the country, [territory](/usc/21/321.md?p=a-2), or region of origin of the [food](/usc/21/321.md?p=f) are inadequate to ensure that the article of [food](/usc/21/321.md?p=f) is as [safe](/usc/21/321.md?p=u) as a similar article of [food](/usc/21/321.md?p=f) that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this chapter; and
      - (ii) the certification would assist the [Secretary](/usc/21/321.md?p=d) in determining whether to refuse or admit the article of [food](/usc/21/321.md?p=f) under [subsection (a)](#a); and
    - (D) information submitted to the [Secretary](/usc/21/321.md?p=d) in accordance with the process established in [paragraph (7)](#q-7).
  - (3) **Certifying entities—** For purposes of [paragraph (1)](#q-1), entities that shall provide the certification or assurances described in such paragraph are—
    - (A) an agency or a representative of the government of the country from which the article of [food](/usc/21/321.md?p=f) at issue originated, as designated by the [Secretary](/usc/21/321.md?p=d); or
    - (B) such other [persons](/usc/21/321.md?p=e) or entities accredited pursuant to [section 384d of this title](/usc/21/384d.md) to provide such certification or assurance.
  - (4) **Renewal and refusal of certifications—** The [Secretary](/usc/21/321.md?p=d) may—
    - (A) require that any certification or other assurance provided by an entity specified in [paragraph (2)](#q-2) be renewed by such entity at such times as the [Secretary](/usc/21/321.md?p=d) determines appropriate; and
    - (B) refuse to accept any certification or assurance if the [Secretary](/usc/21/321.md?p=d) determines that such certification or assurance is not valid or reliable.
  - (5) **Electronic submission—** The [Secretary](/usc/21/321.md?p=d) shall provide for the electronic submission of certifications under this subsection.
  - (6) **False statements—** Any statement or representation made by an entity described in [paragraph (2)](#q-2) to the [Secretary](/usc/21/321.md?p=d) shall be subject to [section 1001 of title 18](/usc/18/1001.md).
  - (7) **Assessment of food safety programs, systems, and standards—** If the [Secretary](/usc/21/321.md?p=d) determines that the [food](/usc/21/321.md?p=f) safety programs, systems, and standards in a foreign region, country, or [territory](/usc/21/321.md?p=a-2) are inadequate to ensure that an article of [food](/usc/21/321.md?p=f) is as [safe](/usc/21/321.md?p=u) as a similar article of [food](/usc/21/321.md?p=f) that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this chapter, the [Secretary](/usc/21/321.md?p=d) shall, to the extent practicable, identify such inadequacies and establish a process by which the foreign region, country, or [territory](/usc/21/321.md?p=a-2) may inform the [Secretary](/usc/21/321.md?p=d) of improvements made to such [food](/usc/21/321.md?p=f) safety program, system, or standard and demonstrate that those controls are adequate to ensure that an article of [food](/usc/21/321.md?p=f) is as [safe](/usc/21/321.md?p=u) as a similar article of [food](/usc/21/321.md?p=f) that is manufactured, processed, packed, or held in the United States in accordance with the requirements of this chapter.
- (r) **Standards for admission of imported drugs—**
  - (1) The [Secretary](/usc/21/321.md?p=d) may require, pursuant to the regulations promulgated under [paragraph (4)(A)](#r-4-A), as a condition of granting admission to a [drug](/usc/21/321.md?p=g-1) imported or offered for import into the United States, that the importer electronically submit information demonstrating that the [drug](/usc/21/321.md?p=g-1) complies with applicable requirements of this chapter.
  - (2) The information described under [paragraph (1)](#r-1) may include—
    - (A) information demonstrating the regulatory status of the [drug](/usc/21/321.md?p=g-1), such as the [new drug](/usc/21/321.md?p=p) application, abbreviated [new drug](/usc/21/321.md?p=p) application, or investigational [new drug](/usc/21/321.md?p=p) or [drug](/usc/21/321.md?p=g-1) master file number;
    - (B) [facility](/usc/21/364.md?p=3-A) information, such as proof of registration and the unique [facility](/usc/21/364.md?p=3-A) identifier;
    - (C) indication of compliance with current good manufacturing practice, testing results, certifications relating to satisfactory inspections, and compliance with the country of export regulations; and
    - (D) any other information deemed necessary and appropriate by the [Secretary](/usc/21/321.md?p=d) to assess compliance of the article being offered for import.
  - (3) Information requirements referred to in [paragraph (2)(C)](#r-2-C) may, at the discretion of the [Secretary](/usc/21/321.md?p=d), be satisfied—
    - (A) through representation by a foreign government, if an inspection is conducted by a foreign government using standards and practices as determined appropriate by the [Secretary](/usc/21/321.md?p=d);
    - (B) through representation by a foreign government or an agency of a foreign government recognized under [section 384e of this title](/usc/21/384e.md); or
    - (C) other appropriate documentation or evidence as described by the [Secretary](/usc/21/321.md?p=d).
  - (4)
    - (A) Not later than 18 months after July 9, 2012, the [Secretary](/usc/21/321.md?p=d) shall adopt final regulations implementing this subsection. Such requirements shall be appropriate for the type of import, such as whether the [drug](/usc/21/321.md?p=g-1) is for import into the United States for use in preclinical research or in a clinical investigation under an investigational [new drug](/usc/21/321.md?p=p) exemption under 355(i)[^3] of this title.
    - (B) In promulgating the regulations under [subparagraph (A)](#r-4-A), the [Secretary](/usc/21/321.md?p=d)—
      - (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](/usc/21/321.md?p=g-1), 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](/usc/21/321.md?p=d) shall promulgate regulations implementing this subsection only as described in [subparagraph (B)](#r-4-B).
- (s) **Registration of commercial importers—**
  - (1) **Registration—** The [Secretary](/usc/21/321.md?p=d) shall require a commercial importer of [drugs](/usc/21/321.md?p=g-1)—
    - (A) to be registered with the [Secretary](/usc/21/321.md?p=d) in a form and manner specified by the [Secretary](/usc/21/321.md?p=d); and
    - (B) subject to [paragraph (4)](#s-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](/usc/21/321.md?p=d), in consultation with the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=g-1) are in compliance with the requirements of this chapter and the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.].
    - (B) **Procedure—** In promulgating a regulation under [subparagraph (A)](#s-2-A), the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=d) shall only promulgate regulations as described in [subparagraph (B)](#s-2-B).
    - (D) **Effective date—** In establishing the effective date of the regulations under [subparagraph (A)](#s-2-A), the [Secretary](/usc/21/321.md?p=d) shall, in consultation with the [Secretary](/usc/21/321.md?p=d) of Homeland Security acting through U.S. Customs and Border Protection, as determined appropriate by the [Secretary](/usc/21/321.md?p=d) of Health and Human Services, provide a reasonable period of time for an importer of a [drug](/usc/21/321.md?p=g-1) to comply with good importer practices, taking into account differences among importers and types of imports, including based on the level of risk posed by the imported [product](/usc/21/360eee.md?p=13).
  - (3) **Discontinuance of registration—** The [Secretary](/usc/21/321.md?p=d) shall discontinue the registration of any commercial importer of [drugs](/usc/21/321.md?p=g-1) that fails to comply with the regulations promulgated under this subsection.
  - (4) **Unique facility identifier—** The [Secretary](/usc/21/321.md?p=d) shall specify the unique [facility](/usc/21/364.md?p=3-A) identifier system that shall be used by registrants under [paragraph (1)](#s-1). The requirement to include a unique [facility](/usc/21/364.md?p=3-A) identifier in a registration under [paragraph (1)](#s-1) shall not apply until the date that the identifier system is specified by the [Secretary](/usc/21/321.md?p=d) under the preceding sentence.
  - (5) **Exemptions—** The [Secretary](/usc/21/321.md?p=d), by notice in the Federal Register, may establish exemptions from the requirements of this subsection.
- (t) **Single source pattern of imported illegal drugs—** If the [Secretary](/usc/21/321.md?p=d) determines that a [person](/usc/21/321.md?p=e) subject to debarment as a result of engaging in a pattern of importing or offering for import controlled substances or [drugs](/usc/21/321.md?p=g-1) as described in [section 335a(b)(3)(D) of this title](/usc/21/335a.md?p=b-3-D), and such pattern is identified by the [Secretary](/usc/21/321.md?p=d) as being offered for import from the same [manufacturer](/usc/21/360hh.md?p=3), distributor, or importer, the [Secretary](/usc/21/321.md?p=d) may by order determine all [drugs](/usc/21/321.md?p=g-1) being offered for import from such [person](/usc/21/321.md?p=e) as adulterated or misbranded, unless such [person](/usc/21/321.md?p=e) can provide evidence otherwise.
- (u) **Illicit articles containing active pharmaceutical ingredients—**
  - (1) **In general—** For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the [Secretary](/usc/21/321.md?p=d) as a [drug](/usc/21/321.md?p=g-1) if the article—
    - (A) is not—
      - (i) accompanied by an electronic import entry for such article submitted using an [authorized](/usc/21/360eee.md?p=2) electronic data interchange system; and
      - (ii) designated in such a system as an article regulated by the [Secretary](/usc/21/321.md?p=d) (which may include regulation as a [drug](/usc/21/321.md?p=g-1), a [device](/usc/21/321.md?p=h-1), a [dietary supplement](/usc/21/321.md?p=ff), or other [product](/usc/21/360eee.md?p=13) that is regulated under this chapter); and
    - (B) is an ingredient that presents significant public health concern and is, or contains—
      - (i) an active ingredient in a [drug](/usc/21/321.md?p=g-1)—
        - (I) that is approved under [section 355 of this title](/usc/21/355.md) or [licensed](/usc/21/360eee.md?p=9) under section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)]; or
        - (II) for which—
          - (aa) an investigational use exemption has been [authorized](/usc/21/360eee.md?p=2) under [section 355(i) of this title](/usc/21/355.md?p=i) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](/usc/42/262.md?p=a)]; and
          - (bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or
      - (ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) described in subclause [(I)](#u-1-B-i-I) or [(II)](#u-1-B-i-II) of clause (i).
  - (2) **Effect—** This subsection shall not be construed to bear upon any determination of whether an article is a [drug](/usc/21/321.md?p=g-1) within the meaning of [section 321(g) of this title](/usc/21/321.md?p=g), other than for the purposes described in [paragraph (1)](#u-1).

## Footnotes

[^1]: So in original. Probably should be preceded by a comma.
[^2]: So in original. No par. (2) has been enacted.
[^3]: So in original. Probably should be preceded by “section”.

## Source credit

(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), 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(l), 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; Pub. L. 112–144, title VII, §§ 708(a), (b), 713, 714(b), July 9, 2012, 126 Stat. 1068, 1072, 1073; Pub. L. 114–255, div. A, title III, § 3101(a)(2)(W)(i), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 115–52, title VI, § 604(a), title VII, § 704, Aug. 18, 2017, 131 Stat. 1048, 1056; Pub. L. 115–271, title III, §§ 3012(c), 3013, 3022(c), (d), Oct. 24, 2018, 132 Stat. 3936, 3939, 3940; Pub. L. 116–136, div. A, title III, § 3856(a), Mar. 27, 2020, 134 Stat. 458; Pub. L. 116–304, § 2(a), Jan. 5, 2021, 134 Stat. 4915; Pub. L. 117–328, div. FF, title III, §§ 3304, 3503(a)(4)(C), (D), Dec. 29, 2022, 136 Stat. 5832, 5858; Pub. L. 119–37, div. B, title VII, § 772(d), Nov. 12, 2025, 139 Stat. 556.)

## Notes

### Editorial Notes

### References in Text

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.

### Amendments

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.

### Statutory Notes and Related Subsidiaries

### Effective Date of 2022 Amendment

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.

### Effective Date of 2012 Amendment; Applicability

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].”

### Effective Date of 2011 Amendment

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].”

### Effective Date of 2006 Amendment

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].”

### Effective Date of 2002 Amendment

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.

### Effective Date of 1988 Amendment

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.

### Effective Date of 1970 Amendment

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.

### Effective Date of 1968 Amendment

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. 112–144, title VII, § 708(d), July 9, 2012, 126 Stat. 1069, provided that: 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]. Procedure.—In promulgating a regulation implementing the amendments made by this section, the Secretary of Health and Human Services shall— issue a notice of proposed rulemaking that includes a copy of the proposed regulation; provide a period of not less than 60 days for comments on the proposed regulation; and publish the final regulation not less than 30 days before the effective date of the regulation. 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: 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— upon the effective date of such final regulations; or 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. 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.”

### Savings Provision

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; Confidentiality

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.

### Construction of 2011 Amendment

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.

### Construction of Amendments by Pub. L. 107–188

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.”

### 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), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.

### Port Shopping

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.]

### Modification of Deadlines for Secretarial Action

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.

### Study and Report on Trade in Pharmaceuticals

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.”

### Findings

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: 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’). There have been circumstances in which— 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 the notice failed to inform the individual of the reasons underlying the decision to send the notice. 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.”

### Executive Documents

### Transfer of Functions

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.