§382. Exports of certain unapproved products

(a) Drugs intended for human or animal use which require approval or licensing

A drug (including a biological product) intended for human or animal use-

(1) which-

(A) requires approval by the Secretary under section 355 of this title or section 360b of this title, or

(B) requires licensing by the Secretary under section 262 of title 42 or by the Secretary of Agriculture under the Act of March 4, 1913 [21 U.S.C. 151 et seq.] (known as the Virus Serum Toxin Act),

before it may be introduced or delivered for introduction into interstate commerce to a country, and

(2) which does not have such approval or license, which is not exempt from such sections or Act, and which is introduced or delivered for introduction into interstate commerce to a country,

is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug is authorized under subsection (b) of this section.

(b) Conditions for export; active pursuit of drug approval or licensing; application for export, contents, approval or disapproval; list of eligible countries for export; criteria for list change

(1) A drug (including a biological product) may, upon approval of an application submitted under paragraph (3), be exported if-

(A) the drug contains the same active ingredient as a-

(i) new drug-

(I) which has an exemption under section 355(i) of this title, and

(II) for which approval is actively being pursued by the person who has the exemption,

(ii) biological product for human use-

(I) which has an exemption under section 355(i) of this title, and

(II) for which licensing of the biological product under section 262 of title 42 is actively being pursued by the person who has the exemption,

(iii) biological product for animal use-

(I) for which authority has been granted under the Virus-Serum Toxin Act [21 U.S.C. 151 et seq.] for the preparation of an experimental drug product, and

(II) for which the licensing of the biological product under such Act is actively being pursued by the person who has the authority, or

(iv) new animal drug-

(I) which has an exemption under section 360b(j) of this title, and

(II) for which approval is actively being pursued by the person who has the exemption,

(B) except as provided in paragraph (2), the drug is exported to a country which is listed under paragraph (4) and in which the drug is approved and has not been withdrawn from sale,

(C) an application for the drug under section 355 or 360b of this title, section 262 of title 42, or the Virus-Serum Toxin Act [21 U.S.C. 151 et seq.] has not been disapproved by an order of the Secretary under section 355(d) or 360b(d) of this title or section 262 of title 42 or by the Secretary of Agriculture in the case of an application under the Virus-Serum Toxin Act,

(D) the drug is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and is not adulterated under paragraph (a)(1), (a)(2)(A), (a)(3), (c), or (d) of section 351 of this title,

(E) the outside of the shipping package is labeled with the following statement: "This drug may be sold or offered for sale only in the following countries:       ", the blank space being filled with a list of the countries to which export of the drug is authorized under this subsection,

(F) the drug is not the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the manufacture of the drug in the United States for export to a country is contrary to the public health and safety of the United States,

(G) the requirements of subparagraphs (A) through (D) of section 381(d)(1) of this title have been met.

The Secretary shall determine that an applicant is actively pursuing the approval or licensing of a drug if the applicant has demonstrated that degree of attention and continuous directed effort as may reasonably be expected from, and are ordinarily exercised by, a person before approval or licensing of a drug, such as the preparation for and the conduct of preclinical or clinical investigations, the analysis of the results of such investigations, conferences on such investigations with government officials, and the preparation of an application of approval or licensing for the drug.

(2) The Secretary may permit the export of a drug under paragraph (1) to a country which is listed under paragraph (4) and in which the drug is not approved if the drug is exported to such country solely for the purpose of further export to a country listed in paragraph (4) in which the drug is approved.

(3)(A) Any person may apply to have a drug exported under paragraph (1). Such an application shall be filed at least 90 days before the date the applicant proposes to export the drug for which the application is submitted. Before the expiration of 10 days from the date of the submission of such an application, the Secretary shall publish a notice in the Federal Register which identifies the applicant under such application, the drug proposed to be exported under such application, and the country to which the drug is proposed to be exported.

(B) An application for the export of a drug shall-

(i) identify the drug to be exported,

(ii) list each country to which the drug is to be exported and list the persons in each such country to which the drug is to be exported,

(iii) contain a certification by the applicant that-

(I) the applicant will export the drug only to a country which is listed in paragraph (4) and in which the drug is approved unless the drug is authorized to be exported under paragraph (2) and will export only those quantities of the drug which may reasonably be sold in each country to which it is to be exported,

(II) the drug is approved by each country to which it is to be exported unless the drug is authorized to be exported under paragraph (2) and the drug has not been withdrawn from sale in such country,

(III) the drug meets the requirements of paragraph (1)(D),

(IV) the drug will be labeled in accordance with paragraph (1)(E), and

(V) the drug meets the requirements of paragraphs (1)(C) and (1)(G),

(iv) contain a certification by the holder of the exemption or authority for such drug described in paragraph (1)(A) that the holder will actively pursue the approval or licensing of the drug,

(v) identify the exemption or authority for an experimental drug product in effect for such drug under the laws referred to in paragraph (1)(A),

(vi) identify the establishments in which the drug is manufactured, and

(vii) include a written agreement from each importer to whom the drug is to be exported from the United States that such importer will not export the drug to a country which is not listed under paragraph (4) and will provide notice to the applicant of any knowledge of an export of the drug to such a country by any person and will maintain records of the drug wholesale distributors to which the drug is sold.

(C)(i) Before the expiration of 30 days after the date an application is submitted to the Secretary, the Secretary shall review the application to determine if the application meets the requirements of clauses (i), (ii), (iv), (v), (vi), and (vii) of subparagraph (B) and contains the certifications described in clauses (iii) (other than the certification required by clause (iii)(II)) and (iv). If the Secretary determines that the application meets such requirements and contains such certifications the Secretary shall conditionally approve the application. An application which is so conditionally approved shall be finally approved within 5 days of the submission of the certification required by clause (iii)(II).

(ii) If the Secretary proposes to disapprove an application, the Secretary shall provide the applicant with a written statement specifying-

(I) the deficiencies which the applicant must correct in order to enable the Secretary to approve the application, and

(II) that the applicant has 60 days after receiving the statement to correct such deficiencies.

(D) If the holder of an application approved under subparagraph (C) for the export of a drug intends to export such drug to a country listed in paragraph (4) which is not listed in such application, such holder shall submit an amendment to such application to the Secretary not later than 30 days before the date of the proposed export to such country identifying the country to which the holder intends to export such drug and containing information sufficient to show that the drug is approved by such country and has not been withdrawn from sale in such country. The Secretary shall approve or disapprove the export of such drug to such country within 15 days of the receipt of the notice required by this subparagraph.

(4)(A) The countries to which a drug may be exported under paragraph (1) are-

(i) Australia,

(ii) Austria,

(iii) Belgium,

(iv) Canada,

(v) Denmark,

(vi) Federal Republic of Germany,

(vii) Finland,

(viii) France,

(ix) Iceland,

(x) Ireland,

(xi) Italy,

(xii) Japan,

(xiii) Luxembourg,

(xiv) The Netherlands,

(xv) New Zealand,

(xvi) Norway,

(xvii) Portugal,

(xviii) Spain,

(xix) Sweden,

(xx) Switzerland, and

(xxi) The United Kingdom,

(B) Changes in the list contained in subparagraph (A) shall be based on the following criteria:

(i) Statutory or regulatory requirements which require the review of drugs for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs which have been determined to be safe 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 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.

(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of drugs 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 and procedures to withdraw approval and remove drugs found not to be safe or effective.

(iv) Statutory or regulatory requirements that the labeling and promotion of drugs must be in accordance with the approval of the drug.

(c) Report to Secretary by holder of approved application; events requiring report; annual report to Secretary on pursuit of approval of drug

(1) The holder of an approved application under subsection (b) of this section authorizing the export of a drug shall report to the Secretary-

(A) any withdrawal of an approval of the drug by any country to which it has been exported,

(B) any withdrawal of the drug from sale in any such country,

(C) the withdrawal of an application by the holder under section 355 or 360b of this title, section 262 of title 42, or the Virus-Serum Toxin Act [21 U.S.C. 151 et seq.], and

(D) the receipt of any credible information indicating that the drug is being or may have been exported from a country listed under subsection (b)(4) of this section to a country which is not listed under such subsection.

The reporting of an event described in subparagraph (A), (B), or (C) shall be made within 15 days of the occurrence of the event and the reporting of the receipt of information under subparagraph (D) shall be made within 15 days of the receipt of such information.

(2) The holder of an approved application under subsection (b) of this section authorizing the export of a drug shall report annually to the Secretary after the date of the approval of the application of the actions taken by the holder in pursuit of the approval of such drug during the year reported on. Not later than 90 days from the date of the receipt of a report under this paragraph the Secretary shall determine if the holder is actively pursuing the approval of such drug.

(d) Export of drug under approved application prohibited

A drug authorized to be exported to a country under an application approved under subsection (b) of this section may not be exported to such country if-

(1) an approval of such drug is withdrawn by such country,

(2) the drug is withdrawn from sale in such country,

(3) the Secretary issues an order refusing to approve an application of the holder of such application under section 355 or 360b of this title, section 262 of title 42, or the Virus-Serum Toxin Act [21 U.S.C. 151 et seq.], or

(4) an application for such drug under such section or Act is withdrawn or if an exemption for such drug under section 355(i) or 360b(j) of this title or the authority granted for such drug to prepare an experimental drug product under the Virus-Serum Toxin Act [21 U.S.C. 151 et seq.] is withdrawn and no application for approval of such drug has been submitted under section 355 or 360b of this title, section 262 of title 42, or the Virus-Serum Toxin Act.

(e) 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 and hearings; prohibition on exportation of drug

(1) If the Secretary determines that-

(A) a drug for which an application was approved under subsection (b) of this section no longer complies with subparagraphs (A), (D), (E), and (G) of paragraph (1) of such subsection or with paragraph (2) of such subsection or the holder of such application has not made the reports required by subsection (c) of this section, or

(B) the manufacture of a drug in the United States for export is contrary to the public health and safety of the United States and an application for the export of such drug has been approved under subsection (b) of this section,

then before taking action against the holder of an application for which a determination was made under subparagraph (A) or (B), the Secretary shall notify the holder in writing of the determination and provide the holder 30 days to take such action as may be required so that the Secretary would be unable to make such determination. When the Secretary takes action against such holder because of such a determination, the Secretary shall provide the holder a written statement specifying the reasons for such determination and provide the person, on request, an opportunity for an informal hearing with respect to such determination.

(2) If the Secretary determines that the approval of a drug is not being actively pursued as required by subsection (b)(1)(A) of this section, the Secretary shall give the holder of the application authorizing the export of such drug 60 days to assure that actions are taken to actively pursue such approval. During the 60-day period the Secretary shall give the holder an opportunity for an informal hearing on the determination of the Secretary. If upon the expiration of such 60-day period the Secretary determines that approval of such drug is not being actively pursued, the Secretary shall prohibit the export of such drug.

(3)(A) If at any time the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that-

(i) the holder of an approved application under subsection (b) of this section is exporting a drug from the United States to an importer,

(ii) such importer is exporting the drug to a country which is not listed under subsection (b)(4) of this section, and

(iii) such export presents an imminent hazard to the public health in such country,

the Secretary shall immediately prohibit the export of the drug to such importer, give the person exporting the drug from the United States prompt notice of the determination, and afford such person an opportunity for an expedited hearing.

(B) The authority conferred by subparagraph (A) shall not be delegated by the Secretary. A determination by the Secretary under subparagraph (A) may not be stayed pending final action by a reviewing court.

(4)(A) If the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that the holder of an approved application under subsection (b) of this section is exporting a drug to a country which is not listed under subsection (b)(4) of this section and that the export of the drug presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug to such country, give the holder prompt notice of the determination, and afford the holder an opportunity for an expedited hearing.

(B) The authority conferred by subparagraph (A) shall not be delegated by the Secretary. A determination by the Secretary under subparagraph (A) may not be stayed pending final action by a reviewing court.

(5) If the Secretary receives credible evidence that the holder of an application approved under subsection (b) of this section is exporting a drug to a country which is not listed under subsection (b)(4) of this section, the Secretary shall give the holder 60 days to provide information to the Secretary respecting such evidence and shall provide the holder an opportunity for an informal hearing on such evidence. Upon the expiration of such 60 days the Secretary shall prohibit the export of such drug to such country if the Secretary determines that the holder of the application is exporting the drug to a country which is not listed under subsection (b)(4) of this section.

(6) If the Secretary receives credible evidence that an importer is exporting a drug to a country which is not listed under subsection (b)(4) of this section, the Secretary shall notify the holder of the application authorizing the export of such drug of such evidence and shall require the holder to investigate the export by such importer and to report to the Secretary within 14 days of the receipt of such notice the findings of the holder. If the Secretary determines that the importer has exported a drug to such a country, the Secretary shall prohibit such holder from exporting such drug to the importer unless the Secretary determines that the export by the importer was unintentional.

(f) Drugs used in prevention or treatment of tropical disease

(1) A drug (including a biological product) which is to be used in the prevention or treatment of a tropical disease may, upon approval of an application submitted under paragraph (2), be exported if-

(A) the Secretary finds, based on credible scientific evidence, including clinical investigations, that the drug is safe and effective in the country to which it is to be exported in the prevention or treatment of a tropical disease in such country,

(B) the drug is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and is not adulterated under paragraph (a)(1), (a)(2)(A), (a)(3), (c), or (d) of section 351 of this title,

(C) the outside of the shipping package is labeled with the following statement: "This drug may be sold or offered for sale only in the following countries:       ", the blank space being filled with a list of the countries to which export of the drug is authorized under this subsection,

(D) the drug is not the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the manufacture of the drug in the United States for export to a country is contrary to the public health and safety of the United States, and

(E) the requirements of subparagraphs (A) through (D) of section 381(d)(1) of this title have been met.

(2) Any person may apply to have a drug exported under paragraph (1). The application shall-

(A) describe the drug to be exported,

(B) list each country to which the drug is to be exported,

(C) contain a certification by the applicant that the drug will not be exported to a country for which the Secretary cannot make a finding described in paragraph (1)(A),

(D) identify the establishments in which the drug is manufactured, and

(E) demonstrate to the Secretary that the drug meets the requirements of paragraph (1).

(3) The holder of an approved application for the export of a drug under this subsection shall report to the Secretary-

(A) the receipt of any information indicating that the drug is being or may have been exported from a country for which the Secretary made a finding under paragraph (1)(A) to a country for which the Secretary cannot make such a finding, and

(B) the receipt of any information indicating any adverse reactions to such drug.

(4)(A) If the Secretary determines that-

(i) a drug for which an application is approved under paragraph (2) does not continue to meet the requirements of paragraph (1),

(ii) the holder of such application has not made the report required by paragraph (3), or

(iii) the manufacture of such drug in the United States for export is contrary to the public health and safety of the United States and an application for the export of such drug has been approved under paragraph (2),

then before taking action against the holder of an application for which a determination was made under clause (i), (ii), or (iii), the Secretary shall notify the holder in writing of the determination and provide the holder 30 days to take such action as may be required so that the Secretary would be unable to make such determination. When the Secretary takes action against such holder because of such a determination, the Secretary shall provide the holder a written statement specifying the reasons for such determination and provide the person, on request, an opportunity for an informal hearing with respect to such determination.

(B) If at any time the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that-

(i) the holder of an approved application under paragraph (2) is exporting a drug from the United States to an importer,

(ii) such importer is exporting the drug to a country for which the Secretary cannot make a finding under paragraph (1)(A), and

(iii) such export presents an imminent hazard to the public health in such country,

the Secretary shall immediately prohibit the export of the drug to such importer, give the person exporting the drug from the United States prompt notice of the determination, and afford such person an opportunity for an expedited hearing. A determination by the Secretary under this subparagraph may not be stayed pending final action by a reviewing court. The authority conferred by this subparagraph shall not be delegated by the Secretary.

(C) If the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that the holder of an approved application under paragraph (2) is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (1)(A), and that the export of the drug presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug to such country, give the holder prompt notice of the determination, and afford the holder an opportunity for an expedited hearing. A determination by the Secretary under this subparagraph may not be stayed pending final action by a reviewing court. The authority conferred by this subparagraph shall not be delegated by the Secretary.

(D) If the Secretary receives credible evidence that the holder of an application approved under paragraph (2) is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (1)(A), the Secretary shall give the holder 60 days to provide information to the Secretary respecting such evidence and shall provide the holder an opportunity for an informal hearing on such evidence. Upon the expiration of such 60 days the Secretary shall prohibit the export of such drug to such country if the Secretary determines the holder is exporting the drug to a country for which the Secretary cannot make a finding under paragraph (1)(A).

(E) If the Secretary receives credible evidence that an importer is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (1)(A), the Secretary shall notify the holder of the application authorizing the export of such drug of such evidence and shall require the holder to investigate the export by such importer and to report to the Secretary within 14 days of the receipt of such notice the findings of the holder. If the Secretary determines that the importer has exported a drug to such a country, the Secretary shall prohibit such holder from exporting such drug to the importer unless the Secretary determines that the export by the importer was unintentional.

(g) Reference to Secretary and holder of application

For purposes of this section-

(1) a reference to the Secretary shall in the case of a biological product which is required to be licensed under the Virus-Serum Toxin Act [21 U.S.C. 151 et seq.] be considered to be a reference to the Secretary of Agriculture, and

(2) a reference in paragraph (3), (4), (5), or (6) of subsection (e) of this section and in subparagraph (B), (C), (D), or (E) of subsection (f)(4) of this section to the holder of an application shall be considered a reference to any person which is under common control with holder, is controlled by the holder, controls the holder, is owned by the holder, or owns the holder.

(June 25, 1938, ch. 675, §802, as added Nov. 14, 1986, Pub. L. 99–660, title I, §102(2), 100 Stat. 3743 .)

References in Text

Act of March 4, 1913 (known as the Virus Serum Toxin Act), referred to in subsecs. (a)(1)(B), (b)(1)(A)(iii)(I), (C), (c)(1)(C), (d)(3), (4), and (g)(1), is act Mar. 4, 1913, ch. 145, 37 Stat. 828 , as amended, 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.

Section Referred to in Other Sections

This section is referred to in section 321 of this title; title 42 section 262.