21 U.S.C. § 382 — Exports of certain unapproved products

Page 649 TITLE 21—FOOD AND DRUGS § 382 387s of this title, and the Secretary may extend or re- duce the duration of one or more such time periods, ex- cept 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: ‘‘(1) Patients and their families sometimes have reason to import into the United States drugs that have been approved by the Food and Drug Adminis- tration (‘FDA’). ‘‘(2) There have been circumstances in which— ‘‘(A) 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 ‘‘(B) the notice failed to inform the individual of the reasons underlying the decision to send the no- tice. ‘‘(3) FDA should not send a warning notice regard- ing 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 Admin- istrator 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. § 382. Exports of certain unapproved products (a) Drugs or devices intended for human or ani- mal use which require approval or licensing A drug or device— (1) which, in the case of a drug— (A)(i) requires approval by the Secretary under section 355 of this title before such drug may be introduced or delivered for in- troduction into interstate commerce; or (ii) requires licensing by the Secretary under section 262 of title 42 or by the Sec- retary 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 in- troduced or delivered for introduction into interstate commerce; (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— (A) does not comply with an applicable re- quirement under section 360d or 360e of this title; (B) under section 360j(g) of this title is ex- empt from either such section; or (C) is a banned device under section 360f of this title, is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug or device is, except as pro- vided in subsection (f), authorized under sub- section (b), (c), (d), or (e) or section 381(e)(2) of this title. If a drug or device described in paragraphs (1) and (2) may be exported under subsection (b) and if an application for such drug or device under section 355 or 360e of this title or section 262 of title 42 was dis- approved, the Secretary shall notify the ap- propriate public health official of the coun- try to which such drug 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 or device described in subsection (a) may be exported to any country, if the drug or device 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 or device is marketed in that country or the drug or de- vice is authorized for general marketing in the European Economic Area. (B) The Secretary may designate an additional country to be included in the list of countries described in clauses (i) and (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 and devices for safety and effectiveness by an entity of the government of such country and which author- ize the approval of only those drugs and de- vices which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by sci- entific training and experience to evaluate the safety and effectiveness of drugs and devices on the basis of adequate and well-controlled investigations, including clinical investiga- tions, conducted by experts qualified by sci- entific training and experience to evaluate the safety and effectiveness of drugs and devices. (ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for— (I) the manufacture, processing, and pack- ing of drugs in the country are adequate to preserve their identity, quality, purity, and strength; and (II) the manufacture, preproduction design validation, packing, storage, and installa- tion of a device are adequate to assure that the device will be safe and effective. (iii) Statutory or regulatory requirements for the reporting of adverse reactions to drugs and devices and procedures to withdraw ap- proval and remove drugs and devices found not to be safe or effective. (iv) Statutory or regulatory requirements that the labeling and promotion of drugs and devices must be in accordance with the ap- proval of the drug or device. (v) The valid marketing authorization sys- tem in such country or countries is equivalent Page 650 TITLE 21—FOOD AND DRUGS § 382 to the systems in the countries described in clauses (i) and (ii) of subparagraph (A). The Secretary shall not delegate the authority granted under this subparagraph. (C) An appropriate country official, manufac- turer, or exporter may request the Secretary to take action under subparagraph (B) to designate an additional country or countries to be added to the list of countries described in clauses (i) and (ii) of subparagraph (A) by submitting docu- mentation to the Secretary in support of such designation. Any person other than a country requesting such designation shall include, along with the request, a letter from the country indi- cating the desire of such country to be des- ignated. (2) A drug described in subsection (a) may be directly exported to a country which is not list- ed in clause (i) or (ii) of paragraph (1)(A) if— (A) the drug complies with the laws of that country and has valid marketing authoriza- tion by the responsible authority in that coun- try; and (B) the Secretary determines that all of the following requirements are met in that coun- try: (i) Statutory or regulatory requirements which require the review of drugs for safety and effectiveness by an entity of the govern- ment 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 train- ing 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 ef- fectiveness of drugs. (ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for the manufacture, proc- essing, 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 ef- fective. (iv) Statutory or regulatory requirements that the labeling and promotion of drugs must be in accordance with the approval of the drug. (3) The exporter of a drug described in sub- section (a) which would not meet the conditions for approval under this chapter or conditions for approval of a country described in clause (i) or (ii) of paragraph (1)(A) may petition the Sec- retary for authorization to export such drug to a country which is not described in clause (i) or (ii) of paragraph (1)(A) or which is not described in paragraph (2). The Secretary shall permit such export if— (A) the person exporting the drug— (i) certifies that the drug would not meet the conditions for approval under this chap- ter or the conditions for approval of a coun- try described in clause (i) or (ii) of paragraph (1)(A); and (ii) provides the Secretary with credible scientific evidence, acceptable to the Sec- retary, that the drug would be safe and effec- tive under the conditions of use in the coun- try to which it is being exported; and (B) the appropriate health authority in the country to which the drug is being exported— (i) requests approval of the export of the drug to such country; (ii) certifies that the health authority un- derstands that the drug is not approved under this chapter or in a country described in clause (i) or (ii) of paragraph (1)(A); and (iii) concurs that the scientific evidence provided pursuant to subparagraph (A) is credible scientific evidence that the drug would be reasonably safe and effective in such country. The Secretary shall take action on a request for export of a drug under this paragraph within 60 days of receiving such request. (c) Investigational use exemption A drug or device intended for investigational use in any country described in clause (i) or (ii) of subsection (b)(1)(A) may be exported in ac- cordance with the laws of that country and shall be exempt from regulation under section 355(i) or 360j(g) of this title. (d) Anticipation of market authorization A drug or device intended for formulation, fill- ing, packaging, labeling, or further processing in anticipation of market authorization in any country described in clause (i) or (ii) of sub- section (b)(1)(A) may be exported for use in ac- cordance with the laws of that country. (e) Diagnosis, prevention, or treatment of trop- ical disease (1) A drug or device which is used in the diag- nosis, prevention, or treatment of a tropical dis- ease or another disease not of significant preva- lence in the United States and which does not otherwise qualify for export under this section shall, upon approval of an application, be per- mitted to be exported if the Secretary finds that the drug or device 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 or device (under condi- tions of use prescribed, recommended, or sug- gested in the labeling or proposed labeling of the drug or device) outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently avail- able drug or device treatment. (2) The holder of an approved application for the export of a drug or device under this sub- section shall report to the Secretary— (A) the receipt of any credible information indicating that the drug or device 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 adverse reactions to such drug. (3)(A) If the Secretary determines that— Page 651 TITLE 21—FOOD AND DRUGS § 382 1 So in original. Probably should be subsection ‘‘(b)(1)(A),’’. (i) a drug or device for which an application is approved under paragraph (1) does not con- tinue to meet the requirements of such para- graph; or (ii) the holder of an approved application under paragraph (1) has not made the report required by paragraph (2), the Secretary may, after providing the holder of the application an opportunity for an informal hearing, withdraw the approved application. (B) If the Secretary determines that the hold- er of an approved application under paragraph (1) or an importer is exporting a drug or device from the United States to an importer and such importer is exporting the drug or device to a country for which the Secretary cannot make a finding under paragraph (1) and such export pre- sents an imminent hazard, the Secretary shall immediately prohibit the export of the drug or device to such importer, provide the person ex- porting the drug or device from the United States prompt notice of the prohibition, and af- ford such person an opportunity for an expedited hearing. (f) Prohibition of export of drug or device A drug or device may not be exported under this section— (1) if the drug or device is not manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practice requirements or does not meet inter- national standards as certified by an inter- national standards organization recognized by the Secretary; (2) if the drug or device is adulterated under clause (1), (2)(A), or (3) of section 351(a) or sub- section (c) or (d) of section 351 of this title; (3) if the requirements of subparagraphs (A) through (D) of section 381(e)(1) of this title have not been met; (4)(A) if the drug or device is the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the prob- ability of reimportation of the exported drug or device would present an imminent hazard to the public health and safety of the United States and the only means of limiting the haz- ard is to prohibit the export of the drug or de- vice; or (B) if the drug or device presents an immi- nent hazard to the public health of the coun- try to which the drug or device would be ex- ported; (5) if the labeling of the drug or device is not— (A) in accordance with the requirements and conditions for use in— (i) the country in which the drug or de- vice received valid marketing authoriza- tion under subsection (b); and (ii) the country to which the drug or de- vice would be exported; and (B) in the language and units of measure- ment of the country to which the drug or de- vice would be exported or in the language designated by such country; or (6) if the drug or device is not promoted in accordance with the labeling requirements set forth in paragraph (5). In making a finding under paragraph (4)(B), (5), or (6) the Secretary shall consult with the ap- propriate public health official in the affected country. (g) Notification of Secretary The exporter of a drug or device exported under subsection (b)(1) shall provide a simple no- tification to the Secretary identifying the drug or device when the exporter first begins to ex- port such drug or device to any country listed in clause (i) or (ii) of subsection (b)(1)(A). When an exporter of a drug or device first begins to ex- port a drug or device 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 identifying the drug or device and the country to which such drug or device is being exported. Any exporter of a drug or device shall maintain records of all drugs or devices ex- ported and the countries to which they were ex- ported. (h) References to Secretary and term ‘‘drug’’ 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 Act of March 4, 1913 [21 U.S.C. 151 et seq.] (37 Stat. 832–833) (com- monly known as the Virus-Serum Toxin Act) be considered to be a reference to the Sec- retary of Agriculture, and (2) the term ‘‘drug’’ includes drugs for human use as well as biologicals under section 262 of title 42 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 may be exported without regard to the requirements in this sec- tion if the insulin and antibiotic drugs meet the requirements of section 381(e)(1) of this title. (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.) 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 head- ing ‘‘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 unap- proved products, including provisions relating to drugs intended for human or animal use which required ap- proval or licensing, conditions for export, active pur- Page 652 TITLE 21—FOOD AND DRUGS § 383 suit of drug approval or licensing, application for ex- port, 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 ap- proved 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 non- eligible 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 la- beling of the drug or device is not’’ for ‘‘if the drug or device is not labeled’’. § 383. Office of International Relations (a) Establishment There is established in the Department of Health and Human Services an Office of Inter- national Relations. (b) Agreements with foreign countries In carrying out the functions of the office under subsection (a), the Secretary may enter into agreements with foreign countries to facili- tate commerce in devices between the United States and such countries consistent with the requirements of this chapter. In such agree- ments, the Secretary shall encourage the mu- tual recognition of— (1) good manufacturing practice regulations promulgated under section 360j(f) of this title, and (2) other regulations and testing protocols as the Secretary determines to be appropriate. (c) Harmonizing regulatory requirements (1) The Secretary shall support the Office of the United States Trade Representative, in con- sultation with the Secretary of Commerce, in meetings with representatives of other countries to discuss methods and approaches to reduce the burden of regulation and harmonize regulatory requirements if the Secretary determines that such harmonization continues consumer protec- tions consistent with the purposes of this chap- ter. (2) The Secretary shall support the Office of the United States Trade Representative, in con- sultation with the Secretary of Commerce, in ef- forts to move toward the acceptance of mutual recognition agreements relating to the regula- tion of drugs, biological products, devices, foods, food additives, and color additives, and the regu- lation of good manufacturing practices, between the European Union and the United States. (3)(A) The Secretary shall regularly partici- pate in meetings with representatives of other foreign governments to discuss and reach agree- ment on methods and approaches to harmonize regulatory requirements. (B) In carrying out subparagraph (A), the Sec- retary may participate in appropriate fora, in- cluding the International Medical Device Regu- lators Forum, and may— (i) provide guidance to such fora on strate- gies, policies, directions, membership, and other activities of a forum as appropriate; (ii) to the extent appropriate, solicit, review, and consider comments from industry, aca- demia, health care professionals, and patient groups regarding the activities of such fora; and (iii) to the extent appropriate, inform the public of the Secretary’s activities within such fora, and share with the public any docu- mentation relating to a forum’s strategies, policies, and other activities of such fora. (4) With respect to devices, the Secretary may, when appropriate, enter into arrangements with nations regarding methods and approaches to harmonizing regulatory requirements for activi- ties, including inspections and common inter- national labeling symbols. (5) Paragraphs (1) through (4) shall not apply with respect to products defined in section 321(ff) of this title. (June 25, 1938, ch. 675, § 803, as added Pub. L. 101–629, § 15(a), Nov. 28, 1990, 104 Stat. 4525; amended Pub. L. 105–115, title IV, § 410(b), Nov. 21, 1997, 111 Stat. 2373; Pub. L. 112–144, title VI, §§ 609, 610, July 9, 2012, 126 Stat. 1059.) Editorial Notes AMENDMENTS 2012—Subsec. (c)(3). Pub. L. 112–144, § 610, designated existing provisions as subpar. (A) and added subpar. (B). Subsec. (c)(4). Pub. L. 112–144, § 609, amended par. (4) generally. Prior to amendment, par. (4) read as follows: ‘‘The Secretary shall, not later than 180 days after No- vember 21, 1997, make public a plan that establishes a framework for achieving mutual recognition of good manufacturing practices inspections.’’ 1997—Subsec. (c). Pub. L. 105–115 added subsec. (c). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1997 AMENDMENT Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title. REPORT ON ACTIVITIES OF OFFICE OF INTERNATIONAL RELATIONS Pub. L. 101–629, § 15(b), Nov. 28, 1990, 104 Stat. 4525, di- rected Secretary of Health and Human Services, not later than 2 years after Nov. 28, 1990, to prepare and submit to the appropriate committees of Congress a re- port on the activities of the Office of International Re- lations under 21 U.S.C. 383. § 384. Importation of prescription drugs (a) Definitions In this section: (1) Importer The term ‘‘importer’’ means a pharmacist or wholesaler. (2) Pharmacist The term ‘‘pharmacist’’ means a person li- censed by a State to practice pharmacy, in- cluding the dispensing and selling of prescrip- tion drugs. (3) Prescription drug The term ‘‘prescription drug’’ means a drug subject to section 353(b) of this title, other than— (A) a controlled substance (as defined in section 802 of this title);