---
kind: "section"
citation: "21 U.S.C. § 382"
title: "21"
title_heading: "Food and Drugs"
number: "382"
heading: "Exports of certain unapproved products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/382"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VIII — Imports and Exports"
---

# §382. Exports of certain unapproved products

- (a) **Drugs or devices intended for human or animal use which require approval or licensing—** A [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1)—
  - (1) which, in the case of a [drug](/usc/21/321.md?p=g-1)—
    - (A)
      - (i) requires approval by the [Secretary](/usc/21/321.md?p=d) under [section 355 of this title](/usc/21/355.md) before such [drug](/usc/21/321.md?p=g-1) may be introduced or delivered for introduction into [interstate commerce](/usc/21/321.md?p=b); or
      - (ii) requires licensing by the [Secretary](/usc/21/321.md?p=d) under [section 262 of title 42](/usc/42/262.md) or by the [Secretary](/usc/21/321.md?p=d) of Agriculture under the Act of March 4, 1913 [[21 U.S.C. 151](/usc/21/151.md) et seq.] (known as the Virus-Serum Toxin Act) before it may be introduced or delivered for introduction into [interstate commerce](/usc/21/321.md?p=b);
    - (B) does not have such approval or license; and
    - (C) is not exempt from such sections or Act; and
  - (2) which, in the case of a [device](/usc/21/321.md?p=h-1)—
    - (A) does not comply with an applicable requirement under section [360d](/usc/21/360d.md) or [360e](/usc/21/360e.md) of this title;
    - (B) under [section 360j(g) of this title](/usc/21/360j.md?p=g) is exempt from either such section; or
    - (C) is a banned [device](/usc/21/321.md?p=h-1) under [section 360f of this title](/usc/21/360f.md), is adulterated, misbranded, and in violation of such sections or Act unless the export of the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) is, except as provided in [subsection (f)](#f), [authorized](/usc/21/360eee.md?p=2) under subsection [(b)](#b), [(c)](#c), [(d)](#d), or [(e)](#e) or [section 381(e)(2) of this title](/usc/21/381.md?p=e-2). If a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) described in paragraphs [(1)](#a-1) and [(2)](#a-2) may be exported under [subsection (b)](#b) and if an application for such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) under section [355](/usc/21/355.md) or [360e](/usc/21/360e.md) of this title or [section 262 of title 42](/usc/42/262.md) was disapproved, the [Secretary](/usc/21/321.md?p=d) shall notify the appropriate public health official of the country to which such [drug](/usc/21/321.md?p=g-1) will be exported of such disapproval.
- (b) **List of eligible countries for export; criteria for addition to list; direct export; petition for exemption—**
  - (1)
    - (A) A [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) described in [subsection (a)](#a) may be exported to any country, if the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) complies with the laws of that country and has valid marketing authorization by the appropriate authority—
      - (i) in Australia, Canada, Israel, Japan, New Zealand, Switzerland, or South Africa; or
      - (ii) in the European Union or a country in the European Economic Area (the countries in the European Union and the European Free Trade Association) if the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) is marketed in that country or the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) is [authorized](/usc/21/360eee.md?p=2) for general marketing in the European Economic Area.
    - (B) The [Secretary](/usc/21/321.md?p=d) may designate an additional country to be included in the list of countries described in clauses [(i)](#b-1-A-i) and [(ii)](#b-1-A-ii) of subparagraph (A) if all of the following requirements are met in such country:
      - (i) Statutory or regulatory requirements which require the review of [drugs](/usc/21/321.md?p=g-1) and [devices](/usc/21/321.md?p=h-1) for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those [drugs](/usc/21/321.md?p=g-1) and [devices](/usc/21/321.md?p=h-1) which have been determined to be [safe](/usc/21/321.md?p=u) and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of [drugs](/usc/21/321.md?p=g-1) and [devices](/usc/21/321.md?p=h-1) on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of [drugs](/usc/21/321.md?p=g-1) and [devices](/usc/21/321.md?p=h-1).
      - (ii) Statutory or regulatory requirements that the methods used in, and the [facilities](/usc/21/364.md?p=3-A) and controls used for—
        - (I) the manufacture, processing, and packing of [drugs](/usc/21/321.md?p=g-1) in the country are adequate to preserve their identity, quality, purity, and strength; and
        - (II) the manufacture, preproduction design validation, packing, storage, and installation of a [device](/usc/21/321.md?p=h-1) are adequate to assure that the [device](/usc/21/321.md?p=h-1) will be [safe](/usc/21/321.md?p=u) and effective.
      - (iii) Statutory or regulatory requirements for the reporting of adverse reactions to [drugs](/usc/21/321.md?p=g-1) and [devices](/usc/21/321.md?p=h-1) and procedures to withdraw approval and remove [drugs](/usc/21/321.md?p=g-1) and [devices](/usc/21/321.md?p=h-1) found not to be [safe](/usc/21/321.md?p=u) or effective.
      - (iv) Statutory or regulatory requirements that the [labeling](/usc/21/321.md?p=m) and promotion of [drugs](/usc/21/321.md?p=g-1) and [devices](/usc/21/321.md?p=h-1) must be in accordance with the approval of the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1).
      - (v) The valid marketing authorization system in such country or countries is equivalent to the systems in the countries described in clauses [(i)](#b-1-A-i) and [(ii)](#b-1-A-ii) of subparagraph (A).

      The [Secretary](/usc/21/321.md?p=d) shall not delegate the authority granted under this subparagraph.

    - (C) An appropriate country official, [manufacturer](/usc/21/360hh.md?p=3), or exporter may request the [Secretary](/usc/21/321.md?p=d) to take action under [subparagraph (B)](#b-1-B) to designate an additional country or countries to be added to the list of countries described in clauses [(i)](#b-1-A-i) and [(ii)](#b-1-A-ii) of subparagraph (A) by submitting documentation to the [Secretary](/usc/21/321.md?p=d) in support of such designation. Any [person](/usc/21/321.md?p=e) other than a country requesting such designation shall include, along with the request, a letter from the country indicating the desire of such country to be designated.
  - (2) A [drug](/usc/21/321.md?p=g-1) described in [subsection (a)](#a) may be directly exported to a country which is not listed in clause [(i)](#b-1-A-i) or [(ii)](#b-1-A-ii) of paragraph (1)(A) if—
    - (A) the [drug](/usc/21/321.md?p=g-1) complies with the laws of that country and has valid marketing authorization by the responsible authority in that country; and
    - (B) the [Secretary](/usc/21/321.md?p=d) determines that all of the following requirements are met in that country:
      - (i) Statutory or regulatory requirements which require the review of [drugs](/usc/21/321.md?p=g-1) for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those [drugs](/usc/21/321.md?p=g-1) which have been determined to be [safe](/usc/21/321.md?p=u) and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of [drugs](/usc/21/321.md?p=g-1) on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of [drugs](/usc/21/321.md?p=g-1).
      - (ii) Statutory or regulatory requirements that the methods used in, and the [facilities](/usc/21/364.md?p=3-A) and controls used for the manufacture, processing, and packing of [drugs](/usc/21/321.md?p=g-1) in the country are adequate to preserve their identity, quality, purity, and strength.
      - (iii) Statutory or regulatory requirements for the reporting of adverse reactions to [drugs](/usc/21/321.md?p=g-1) and procedures to withdraw approval and remove [drugs](/usc/21/321.md?p=g-1) found not to be [safe](/usc/21/321.md?p=u) or effective.
      - (iv) Statutory or regulatory requirements that the [labeling](/usc/21/321.md?p=m) and promotion of [drugs](/usc/21/321.md?p=g-1) must be in accordance with the approval of the [drug](/usc/21/321.md?p=g-1).
  - (3) The exporter of a [drug](/usc/21/321.md?p=g-1) described in [subsection (a)](#a) which would not meet the conditions for approval under this chapter or conditions for approval of a country described in clause [(i)](#b-1-A-i) or [(ii)](#b-1-A-ii) of paragraph (1)(A) may petition the [Secretary](/usc/21/321.md?p=d) for authorization to export such [drug](/usc/21/321.md?p=g-1) to a country which is not described in clause [(i)](#b-1-A-i) or [(ii)](#b-1-A-ii) of paragraph (1)(A) or which is not described in [paragraph (2)](#b-2). The [Secretary](/usc/21/321.md?p=d) shall permit such export if—
    - (A) the [person](/usc/21/321.md?p=e) exporting the [drug](/usc/21/321.md?p=g-1)—
      - (i) certifies that the [drug](/usc/21/321.md?p=g-1) would not meet the conditions for approval under this chapter or the conditions for approval of a country described in clause [(i)](#b-1-A-i) or [(ii)](#b-1-A-ii) of paragraph (1)(A); and
      - (ii) provides the [Secretary](/usc/21/321.md?p=d) with credible scientific evidence, acceptable to the [Secretary](/usc/21/321.md?p=d), that the [drug](/usc/21/321.md?p=g-1) would be [safe](/usc/21/321.md?p=u) and effective under the conditions of use in the country to which it is being exported; and
    - (B) the appropriate health authority in the country to which the [drug](/usc/21/321.md?p=g-1) is being exported—
      - (i) requests approval of the export of the [drug](/usc/21/321.md?p=g-1) to such country;
      - (ii) certifies that the health authority understands that the [drug](/usc/21/321.md?p=g-1) is not approved under this chapter or in a country described in clause [(i)](#b-1-A-i) or [(ii)](#b-1-A-ii) of paragraph (1)(A); and
      - (iii) concurs that the scientific evidence provided pursuant to [subparagraph (A)](#b-3-A) is credible scientific evidence that the [drug](/usc/21/321.md?p=g-1) would be reasonably [safe](/usc/21/321.md?p=u) and effective in such country.

    The [Secretary](/usc/21/321.md?p=d) shall take action on a request for export of a [drug](/usc/21/321.md?p=g-1) under this paragraph within 60 days of receiving such request.

- (c) **Investigational use exemption—** A [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) intended for investigational use in any country described in clause [(i)](#b-1-A-i) or [(ii)](#b-1-A-ii) of subsection (b)(1)(A) may be exported in accordance with the laws of that country and shall be exempt from regulation under section [355(i)](/usc/21/355.md?p=i) or [360j(g)](/usc/21/360j.md?p=g) of this title.
- (d) **Anticipation of market authorization—** A [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) intended for formulation, filling, [packaging](/usc/21/364.md?p=3-C), [labeling](/usc/21/321.md?p=m), or further processing in anticipation of market authorization in any country described in clause [(i)](#b-1-A-i) or [(ii)](#b-1-A-ii) of subsection (b)(1)(A) may be exported for use in accordance with the laws of that country.
- (e) **Diagnosis, prevention, or treatment of tropical disease—**
  - (1) A [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) which is used in the diagnosis, prevention, or treatment of a tropical disease or another disease not of significant prevalence in the United States and which does not otherwise qualify for export under this section shall, upon approval of an application, be permitted to be exported if the [Secretary](/usc/21/321.md?p=d) finds that the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) will not expose patients in such country to an unreasonable risk of illness or injury and the probable benefit to health from the use of the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) (under conditions of use prescribed, recommended, or suggested in the [labeling](/usc/21/321.md?p=m) or proposed [labeling](/usc/21/321.md?p=m) of the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1)) outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) treatment.
  - (2) The holder of an approved application for the export of a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) under this subsection shall report to the [Secretary](/usc/21/321.md?p=d)—
    - (A) the receipt of any credible information indicating that the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) is being or may have been exported from a country for which the [Secretary](/usc/21/321.md?p=d) made a finding under paragraph (1)(A) to a country for which the [Secretary](/usc/21/321.md?p=d) cannot make such a finding; and
    - (B) the receipt of any information indicating adverse reactions to such [drug](/usc/21/321.md?p=g-1).
  - (3)
    - (A) If the [Secretary](/usc/21/321.md?p=d) determines that—
      - (i) a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) for which an application is approved under [paragraph (1)](#e-1) does not continue to meet the requirements of such paragraph; or
      - (ii) the holder of an approved application under [paragraph (1)](#e-1) has not made the report required by [paragraph (2)](#e-2),

      the [Secretary](/usc/21/321.md?p=d) may, after providing the holder of the application an opportunity for an [informal hearing](/usc/21/321.md?p=x), withdraw the approved application.

    - (B) If the [Secretary](/usc/21/321.md?p=d) determines that the holder of an approved application under [paragraph (1)](#e-1) or an importer is exporting a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) from the United States to an importer and such importer is exporting the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) to a country for which the [Secretary](/usc/21/321.md?p=d) cannot make a finding under [paragraph (1)](#e-1) and such export presents an imminent hazard, the [Secretary](/usc/21/321.md?p=d) shall immediately prohibit the export of the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) to such importer, provide the [person](/usc/21/321.md?p=e) exporting the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) from the United States prompt notice of the prohibition, and afford such [person](/usc/21/321.md?p=e) an opportunity for an expedited hearing.
- (f) **Prohibition of export of drug or device—** A [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) may not be exported under this section—
  - (1) if the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) is not manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practice requirements or does not meet international standards as certified by an international standards organization recognized by the [Secretary](/usc/21/321.md?p=d);
  - (2) if the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) is adulterated under clause [(1)](/usc/21/351.md?p=a-1), [(2)(A)](/usc/21/351.md), or [(3)](/usc/21/351.md) of section 351(a) or subsection (c) or (d) of [section 351 of this title](/usc/21/351.md);
  - (3) if the requirements of subparagraphs (A) through (D) of [section 381(e)(1) of this title](/usc/21/381.md?p=e-1) have not been met;
  - (4)
    - (A) if the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) is the subject of a notice by the [Secretary](/usc/21/321.md?p=d) or the [Secretary](/usc/21/321.md?p=d) of Agriculture of a determination that the probability of reimportation of the exported [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) would present an imminent hazard to the public health and safety of the United States and the only means of limiting the hazard is to prohibit the export of the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1); or
    - (B) if the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) presents an imminent hazard to the public health of the country to which the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) would be exported;
  - (5) if the [labeling](/usc/21/321.md?p=m) of the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) is not—
    - (A) in accordance with the requirements and conditions for use in—
      - (i) the country in which the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) received valid marketing authorization under [subsection (b)](#b); and
      - (ii) the country to which the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) would be exported; and
    - (B) in the language and units of measurement of the country to which the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) would be exported or in the language designated by such country; or
  - (6) if the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) is not promoted in accordance with the [labeling](/usc/21/321.md?p=m) requirements set forth in [paragraph (5)](#f-5).

  In making a finding under paragraph [(4)(B)](#f-4-B), [(5)](#f-5), or [(6)](#f-6) the [Secretary](/usc/21/321.md?p=d) shall consult with the appropriate public health official in the affected country.

- (g) **Notification of Secretary—** The exporter of a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) exported under [subsection (b)(1)](#b-1) shall provide a simple notification to the [Secretary](/usc/21/321.md?p=d) identifying the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) when the exporter first begins to export such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) to any country listed in clause [(i)](#b-1-A-i) or [(ii)](#b-1-A-ii) of subsection (b)(1)(A). When an exporter of a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) first begins to export a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) to a country which is not listed in clause (i) or (ii) of subsection (b)(1)A),[^1] the exporter shall provide a simple notification to the [Secretary](/usc/21/321.md?p=d) identifying the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) and the country to which such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) is being exported. Any exporter of a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) shall maintain records of all [drugs](/usc/21/321.md?p=g-1) or [devices](/usc/21/321.md?p=h-1) exported and the countries to which they were exported.
- (h) **References to Secretary and term “drug”—** For purposes of this section—
  - (1) a reference to the [Secretary](/usc/21/321.md?p=d) shall in the case of a biological [product](/usc/21/360eee.md?p=13) which is required to be [licensed](/usc/21/360eee.md?p=9) under the Act of March 4, 1913 [[21 U.S.C. 151](/usc/21/151.md) et seq.] (37 Stat. 832–833) (commonly known as the Virus-Serum Toxin Act) be considered to be a reference to the [Secretary](/usc/21/321.md?p=d) of Agriculture, and
  - (2) the term “[drug](/usc/21/321.md?p=g-1)” includes [drugs](/usc/21/321.md?p=g-1) for human use as well as biologicals under [section 262 of title 42](/usc/42/262.md) or the Act of March 4, 1913 (37 Stat. 832–833) (commonly known as the Virus-Serum Toxin Act).
- (i) **Exportation—** Insulin and [antibiotic drugs](/usc/21/321.md?p=jj) may be exported without regard to the requirements in this section if the insulin and [antibiotic drugs](/usc/21/321.md?p=jj) meet the requirements of [section 381(e)(1) of this title](/usc/21/381.md?p=e-1).

## Footnotes

[^1]: So in original. Probably should be subsection “(b)(1)(A),”.

## Source credit

(June 25, 1938, ch. 675, § 802, as added Pub. L. 99–660, title I, § 102(2), Nov. 14, 1986, 100 Stat. 3743; amended Pub. L. 104–134, title III, § 2102(d)(1), Apr. 26, 1996, 110 Stat. 1321–315; Pub. L. 104–180, title VI, § 603(c), Aug. 6, 1996, 110 Stat. 1595; Pub. L. 105–115, title I, § 125(c), Nov. 21, 1997, 111 Stat. 2326.)

## Notes

### Editorial Notes

### References in Text

Act of March 4, 1913 (known as the Virus-Serum Toxin Act), referred to in subsecs. (a)(1)(A)(ii), (C), (2)(C) and (h), is the eighth paragraph under the heading “Bureau of Animal Industry” of act Mar. 4, 1913, ch. 145, 37 Stat. 832, which is classified generally to chapter 5 (§ 151 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 151 of this title and Tables.

### Amendments

1997—Subsec. (i). Pub. L. 105–115 added subsec. (i).

1996—Pub. L. 104–134 reenacted section catchline without change and amended text generally. Prior to amendment, text related to exports of certain unapproved products, including provisions relating to drugs intended for human or animal use which required approval or licensing, conditions for export, active pursuit of drug approval or licensing, application for export, contents, approval or disapproval, list of eligible countries for export, and criteria for list change, report to Secretary by holder of approved application, events requiring report, and annual report to Secretary on pursuit of approval of drug, export of drug under approved application prohibited under certain conditions, determination by Secretary of noncompliance, failure of active pursuit of drug approval, imminent hazard of drug to public health, or exportation of drug to noneligible country, notices, hearings, and prohibition on exportation of drug under certain circumstances, drugs used in prevention or treatment of tropical disease, and reference to Secretary and holder of application.

Subsec. (f)(5). Pub. L. 104–180 substituted “if the labeling of the drug or device is not” for “if the drug or device is not labeled”.