21 U.S.C. § 384 — Importation of prescription drugs

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); Page 653 TITLE 21—FOOD AND DRUGS § 384 (B) a biological product (as defined in sec- tion 262 of title 42); (C) an infused drug (including a peritoneal dialysis solution); (D) an intravenously injected drug; (E) a drug that is inhaled during surgery; or (F) a drug which is a parenteral drug, the importation of which pursuant to subsection (b) is determined by the Secretary to pose a threat to the public health, in which case section 381(d)(1) of this title shall continue to apply. (4) Qualifying laboratory The term ‘‘qualifying laboratory’’ means a laboratory in the United States that has been approved by the Secretary for the purposes of this section. (5) Wholesaler (A) In general The term ‘‘wholesaler’’ means a person li- censed as a wholesaler or distributor of pre- scription drugs in the United States under section 353(e)(2)(A) of this title. (B) Exclusion The term ‘‘wholesaler’’ does not include a person authorized to import drugs under sec- tion 381(d)(1) of this title. (b) Regulations The Secretary, after consultation with the United States Trade Representative and the Commissioner of U.S. Customs and Border Pro- tection, shall promulgate regulations permit- ting pharmacists and wholesalers to import pre- scription drugs from Canada into the United States. (c) Limitation The regulations under subsection (b) shall— (1) require that safeguards be in place to en- sure that each prescription drug imported under the regulations complies with section 355 of this title (including with respect to being safe and effective for the intended use of the prescription drug), with sections 351 and 352 of this title, and with other applicable re- quirements of this chapter; (2) require that an importer of a prescription drug under the regulations comply with sub- sections (d)(1) and (e); and (3) contain any additional provisions deter- mined by the Secretary to be appropriate as a safeguard to protect the public health or as a means to facilitate the importation of pre- scription drugs. (d) Information and records (1) In general The regulations under subsection (b) shall require an importer of a prescription drug under subsection (b) to submit to the Sec- retary the following information and docu- mentation: (A) The name and quantity of the active ingredient of the prescription drug. (B) A description of the dosage form of the prescription drug. (C) The date on which the prescription drug is shipped. (D) The quantity of the prescription drug that is shipped. (E) The point of origin and destination of the prescription drug. (F) The price paid by the importer for the prescription drug. (G) Documentation from the foreign seller specifying— (i) the original source of the prescription drug; and (ii) the quantity of each lot of the pre- scription drug originally received by the seller from that source. (H) The lot or control number assigned to the prescription drug by the manufacturer of the prescription drug. (I) The name, address, telephone number, and professional license number (if any) of the importer. (J)(i) In the case of a prescription drug that is shipped directly from the first for- eign recipient of the prescription drug from the manufacturer: (I) Documentation demonstrating that the prescription drug was received by the recipient from the manufacturer and sub- sequently shipped by the first foreign re- cipient to the importer. (II) Documentation of the quantity of each lot of the prescription drug received by the first foreign recipient dem- onstrating that the quantity being im- ported into the United States is not more than the quantity that was received by the first foreign recipient. (III)(aa) In the case of an initial im- ported shipment, documentation dem- onstrating that each batch of the prescrip- tion drug in the shipment was statistically sampled and tested for authenticity and degradation. (bb) In the case of any subsequent ship- ment, documentation demonstrating that a statistically valid sample of the ship- ment was tested for authenticity and deg- radation. (ii) In the case of a prescription drug that is not shipped directly from the first foreign recipient of the prescription drug from the manufacturer, documentation dem- onstrating that each batch in each shipment offered for importation into the United States was statistically sampled and tested for authenticity and degradation. (K) Certification from the importer or manufacturer of the prescription drug that the prescription drug— (i) is approved for marketing in the United States and is not adulterated or misbranded; and (ii) meets all labeling requirements under this chapter. (L) Laboratory records, including com- plete data derived from all tests necessary to ensure that the prescription drug is in compliance with established specifications and standards. (M) Documentation demonstrating that the testing required by subparagraphs (J) and (L) was conducted at a qualifying lab- oratory. Page 654 TITLE 21—FOOD AND DRUGS § 384 (N) Any other information that the Sec- retary determines is necessary to ensure the protection of the public health. (2) Maintenance by the Secretary The Secretary shall maintain information and documentation submitted under para- graph (1) for such period of time as the Sec- retary determines to be necessary. (e) Testing The regulations under subsection (b) shall re- quire— (1) that testing described in subparagraphs (J) and (L) of subsection (d)(1) be conducted by the importer or by the manufacturer of the prescription drug at a qualified laboratory; (2) if the tests are conducted by the im- porter— (A) that information needed to— (i) authenticate the prescription drug being tested; and (ii) confirm that the labeling of the pre- scription drug complies with labeling re- quirements under this chapter; be supplied by the manufacturer of the pre- scription drug to the pharmacist or whole- saler; and (B) that the information supplied under subparagraph (A) be kept in strict con- fidence and used only for purposes of testing or otherwise complying with this chapter; and (3) may include such additional provisions as the Secretary determines to be appropriate to provide for the protection of trade secrets and commercial or financial information that is privileged or confidential. (f) Registration of foreign sellers Any establishment within Canada engaged in the distribution of a prescription drug that is imported or offered for importation into the United States shall register with the Secretary the name and place of business of the establish- ment and the name of the United States agent for the establishment. (g) Suspension of importation The Secretary shall require that importations of a specific prescription drug or importations by a specific importer under subsection (b) be immediately suspended on discovery of a pat- tern of importation of that specific prescription drug or by that specific importer of drugs that are counterfeit or in violation of any require- ment under this section, until an investigation is completed and the Secretary determines that the public is adequately protected from counter- feit and violative prescription drugs being im- ported under subsection (b). (h) Approved labeling The manufacturer of a prescription drug shall provide an importer written authorization for the importer to use, at no cost, the approved la- beling for the prescription drug. (i) Charitable contributions Notwithstanding any other provision of this section, section 381(d)(1) of this title continues to apply to a prescription drug that is donated or otherwise supplied at no charge by the manu- facturer of the drug to a charitable or humani- tarian organization (including the United Na- tions and affiliates) or to a government of a for- eign country. (j) Waiver authority for importation by individ- uals (1) Declarations Congress declares that in the enforcement against individuals of the prohibition of im- portation of prescription drugs and devices, the Secretary should— (A) focus enforcement on cases in which the importation by an individual poses a sig- nificant threat to public health; and (B) exercise discretion to permit individ- uals to make such importations in cir- cumstances in which— (i) the importation is clearly for per- sonal use; and (ii) the prescription drug or device im- ported does not appear to present an un- reasonable risk to the individual. (2) Waiver authority (A) In general The Secretary may grant to individuals, by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of pre- scription drugs or devices, under such condi- tions as the Secretary determines to be ap- propriate. (B) Guidance on case-by-case waivers The Secretary shall publish, and update as necessary, guidance that accurately de- scribes circumstances in which the Sec- retary will consistently grant waivers on a case-by-case basis under subparagraph (A), so that individuals may know with the greatest practicable degree of certainty whether a particular importation for per- sonal use will be permitted. (3) Drugs imported from Canada In particular, the Secretary shall by regula- tion grant individuals a waiver to permit indi- viduals to import into the United States a pre- scription drug that— (A) is imported from a licensed pharmacy for personal use by an individual, not for re- sale, in quantities that do not exceed a 90- day supply; (B) is accompanied by a copy of a valid prescription; (C) is imported from Canada, from a seller registered with the Secretary; (D) is a prescription drug approved by the Secretary under subchapter V; (E) is in the form of a final finished dosage that was manufactured in an establishment registered under section 360 of this title; and (F) is imported under such other condi- tions as the Secretary determines to be nec- essary to ensure public safety. (k) Construction Nothing in this section limits the authority of the Secretary relating to the importation of pre- scription drugs, other than with respect to sec- Page 655 TITLE 21—FOOD AND DRUGS § 384 tion 381(d)(1) of this title as provided in this sec- tion. (l) Effectiveness of section (1) Commencement of program This section shall become effective only if the Secretary certifies to the Congress that the implementation of this section will— (A) pose no additional risk to the public’s health and safety; and (B) result in a significant reduction in the cost of covered products to the American consumer. (2) Termination of program (A) In general If, after the date that is 1 year after the ef- fective date of the regulations under sub- section (b) and before the date that is 18 months after the effective date, the Sec- retary submits to Congress a certification that, in the opinion of the Secretary, based on substantial evidence obtained after the effective date, the benefits of implementa- tion of this section do not outweigh any det- riment of implementation of this section, this section shall cease to be effective as of the date that is 30 days after the date on which the Secretary submits the certifi- cation. (B) Procedure The Secretary shall not submit a certifi- cation under subparagraph (A) unless, after a hearing on the record under sections 556 and 557 of title 5, the Secretary— (i)(I) determines that it is more likely than not that implementation of this sec- tion would result in an increase in the risk to the public health and safety; (II) identifies specifically, in qualitative and quantitative terms, the nature of the increased risk; (III) identifies specifically the causes of the increased risk; and (IV)(aa) considers whether any measures can be taken to avoid, reduce, or mitigate the increased risk; and (bb) if the Secretary determines that any measures described in item (aa) would re- quire additional statutory authority, sub- mits to Congress a report describing the legislation that would be required; (ii) identifies specifically, in qualitative and quantitative terms, the benefits that would result from implementation of this section (including the benefit of reductions in the cost of covered products to con- sumers in the United States, allowing con- sumers to procure needed medication that consumers might not otherwise be able to procure without foregoing other neces- sities of life); and (iii)(I) compares in specific terms the detriment identified under clause (i) with the benefits identified under clause (ii); and (II) determines that the benefits do not outweigh the detriment. (m) Authorization of appropriations There are authorized to be appropriated such sums as are necessary to carry out this section. (June 25, 1938, ch. 675, § 804, as added Pub. L. 108–173, title XI, § 1121(a), Dec. 8, 2003, 117 Stat. 2464; amended Pub. L. 114–125, title VIII, § 802(d)(2), Feb. 24, 2016, 130 Stat. 210.) Editorial Notes PRIOR PROVISIONS A prior section 384, act June 25, 1938, ch. 675, § 804, as added Pub. L. 106–387, § 1(a) [title VII, § 745(c)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A–36, related to importation of covered products, prior to repeal by Pub. L. 108–173, title XI, § 1121(a), Dec. 8, 2003, 117 Stat. 2464. Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Commissioner of U.S. Customs and Border Protec- tion’’ substituted for ‘‘Commissioner of Customs’’ in subsec. (b) on authority of section 802(d)(2) of Pub. L. 114–125, set out as a note under section 211 of Title 6, Domestic Security. EFFECTIVE DATE For certification by Secretary of Health and Human Services pursuant to subsec. (l)(1) of this section, see 85 F.R. 62094, 62096 (Oct. 1, 2020); 166 Cong. Rec. S6652 (daily ed. Nov. 10, 2020) (citing Executive Communication EC–5822); 166 Cong. Rec. H5866 (daily ed. Nov. 17, 2020) (citing Executive Communication EC–5624). TRANSFER OF FUNCTIONS For transfer of functions, personnel, assets, and li- abilities of the United States Customs Service of the Department of the Treasury, including functions of the Secretary of the Treasury relating thereto, to the Sec- retary of Homeland Security, and for treatment of re- lated references, see sections 203(1), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of Novem- ber 25, 2002, as modified, set out as a note under section 542 of Title 6. For establishment of U.S. Customs and Border Protection in the Department of Homeland Se- curity, treated as if included in Pub. L. 107–296 as of Nov. 25, 2002, see section 211 of Title 6, as amended gen- erally by Pub. L. 114–125, and section 802(b) of Pub. L. 114–125, set out as a note under section 211 of Title 6. STUDY AND REPORT ON IMPORTATION OF DRUGS Pub. L. 108–173, title XI, § 1122, Dec. 8, 2003, 117 Stat. 2469, directed the Secretary of Health and Human Serv- ices to conduct a study on the importation of drugs into the United States pursuant to this section and to submit to Congress, not later than 12 months after Dec. 8, 2003, a report providing the findings of such study. Executive Documents EX. ORD. NO. 13938. INCREASING DRUG IMPORTATION TO LOWER PRICES FOR AMERICAN PATIENTS Ex. Ord. No. 13938, July 24, 2020, 85 F.R. 45757, pro- vided: By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: SECTION 1. Purpose. Americans spend more per capita on pharmaceutical drugs than residents of any other developed country. Americans often pay more for the exact same drugs, even when they are produced and shipped from the exact same facilities. One way to minimize international disparities in price is to increase the trade of prescription drugs be- tween nations with lower prices and those with persist- ently higher ones. Over time, reducing trade barriers and increasing the exchange of drugs will likely result in lower prices for the country that is paying more for drugs. For example, in the European Union, a market Page 656 TITLE 21—FOOD AND DRUGS § 384a 1 So in original. characterized by price controls and significant barriers to entry, the parallel trade of drugs has existed for dec- ades and has been estimated to reduce the price of cer- tain drugs by up to 20 percent. Accordingly, my Admin- istration supports the goal of safe importation of pre- scription drugs. SEC. 2. Permitting the Importation of Safe Prescription Drugs from Other Countries. The Secretary of Health and Human Services shall, as appropriate and consistent with applicable law, take action to expand safe access to lower-cost imported prescription drugs by: (a) facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, pro- vided such importation poses no additional risk to pub- lic safety and results in lower costs to American pa- tients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2); (b) authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care pursuant to section 801(d) of the FDCA, 21 U.S.C. 381(d); and (c) completing the rulemaking process regarding the proposed rule to implement section 804(b) through (h) of the FDCA, 21 U.S.C. 384(b) through (h), to allow im- portation of certain prescription drugs from Canada. SEC. 3. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appro- priations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforce- able at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. DONALD J. TRUMP. § 384a. Foreign supplier verification program (a) In general (1) Verification requirement Except as provided under subsections (e) and (f), each importer shall perform risk-based for- eign supplier verification activities for the purpose of verifying that the food imported by the importer or agent of an importer is— (A) produced in compliance with the re- quirements of section 350g of this title or section 350h of this title, as appropriate; and (B) is not adulterated under section 342 of this title or misbranded under section 343(w) of this title. (2) Importer defined For purposes of this section, the term ‘‘im- porter’’ means, with respect to an article of food— (A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or (B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or con- signee of the article of food at the time of entry of such article into the United States. (b) Guidance Not later than 1 year after January 4, 2011, the Secretary shall issue guidance to assist import- ers in developing foreign supplier verification programs. (c) Regulations (1) In general Not later than 1 year after January 4, 2011, the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under sub- section (a). (2) Requirements The regulations promulgated under para- graph (1)— (A) shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported food in compliance with— (i) processes and procedures, including reasonably appropriate risk-based preven- tive controls, that provide the same level of public health protection as those re- quired under section 350g of this title or section 350h of this title (taking into con- sideration variances granted under section 350h of this title), as appropriate; and (ii) section 342 of this title and section 343(w) of this title.1 (B) shall include such other requirements as the Secretary deems necessary and appro- priate to verify that food imported into the United States is as safe as food produced and sold within the United States. (3) Considerations In promulgating regulations under this sub- section, the Secretary shall, as appropriate, take into account differences among importers and types of imported foods, including based on the level of risk posed by the imported food. (4) Activities Verification activities under a foreign sup- plier verification program under this section may include monitoring records for ship- ments, lot-by-lot certification of compliance, annual on-site inspections, checking the haz- ard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments. (d) Record maintenance and access Records of an importer related to a foreign supplier verification program shall be main- tained for a period of not less than 2 years and shall be made available promptly to a duly au- thorized representative of the Secretary upon request. (e) Exemption of seafood, juice, and low-acid canned food facilities in compliance with HACCP This section shall not apply to a facility if the owner, operator, or agent in charge of such facil- ity is required to comply with, and is in compli- ance with, 1 of the following standards and regu- lations with respect to such facility: (1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.