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

The term “importer” means a pharmacist or wholesaler. The term “pharmacist” means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs. a controlled substance (as defined in section 802 of this title ); a biological product (as defined in section 262 of title 42 ); an infused drug (including a peritoneal dialysis solution); an intravenously injected drug; a drug that is inhaled during surgery; or 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. The term “qualifying laboratory” means a laboratory in the United States that has been approved by the Secretary for the purposes of this section. The term “wholesaler” means a person licensed as a wholesaler or distributor of prescription drugs in the United States under section 353(e)(2)(A) of this title . The term “wholesaler” does not include a person authorized to import drugs under section 381(d)(1) of this title . The Secretary, after consultation with the United States Trade Representative and the Commissioner of U.S. Customs and Border Protection, shall promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States. require that safeguards be in place to ensure 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 requirements of this chapter; require that an importer of a prescription drug under the regulations comply with subsections (d)(1) and (e); and contain any additional provisions determined by the Secretary to be appropriate as a safeguard to protect the public health or as a means to facilitate the importation of prescription drugs. The name and quantity of the active ingredient of the prescription drug. A description of the dosage form of the prescription drug. The date on which the prescription drug is shipped. The quantity of the prescription drug that is shipped. The point of origin and destination of the prescription drug. The price paid by the importer for the prescription drug. the original source of the prescription drug; and the quantity of each lot of the prescription drug originally received by the seller from that source. The lot or control number assigned to the prescription drug by the manufacturer of the prescription drug. The name, address, telephone number, and professional license number (if any) of the importer. Documentation demonstrating that the prescription drug was received by the recipient from the manufacturer and subsequently shipped by the first foreign recipient to the importer. Documentation of the quantity of each lot of the prescription drug received by the first foreign recipient demonstrating that the quantity being imported into the United States is not more than the quantity that was received by the first foreign recipient. In the case of an initial imported shipment, documentation demonstrating that each batch of the prescription drug in the shipment was statistically sampled and tested for authenticity and degradation. In the case of any subsequent shipment, documentation demonstrating that a statistically valid sample of the shipment was tested for authenticity and degradation. 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 demonstrating that each batch in each shipment offered for importation into the United States was statistically sampled and tested for authenticity and degradation. is approved for marketing in the United States and is not adulterated or misbranded; and meets all labeling requirements under this chapter. Laboratory records, including complete data derived from all tests necessary to ensure that the prescription drug is in compliance with established specifications and standards. Documentation demonstrating that the testing required by subparagraphs (J) and (L) was conducted at a qualifying laboratory. Any other information that the Secretary determines is necessary to ensure the protection of the public health. The Secretary shall maintain information and documentation submitted under paragraph (1) for such period of time as the Secretary determines to be necessary. 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; authenticate the prescription drug being tested; and confirm that the labeling of the prescription drug complies with labeling requirements under this chapter; that the information supplied under subparagraph (A) be kept in strict confidence and used only for purposes of testing or otherwise complying with this chapter; and 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. 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 establishment and the name of the United States agent for the establishment. 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 pattern of importation of that specific prescription drug or by that specific importer of drugs that are counterfeit or in violation of any requirement under this section, until an investigation is completed and the Secretary determines that the public is adequately protected from counterfeit and violative prescription drugs being imported under subsection (b). The manufacturer of a prescription drug shall provide an importer written authorization for the importer to use, at no cost, the approved labeling for the prescription drug. 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 manufacturer of the drug to a charitable or humanitarian organization (including the United Nations and affiliates) or to a government of a foreign country. focus enforcement on cases in which the importation by an individual poses a significant threat to public health; and the importation is clearly for personal use; and the prescription drug or device imported does not appear to present an unreasonable risk to the individual. 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 prescription drugs or devices, under such conditions as the Secretary determines to be appropriate. The Secretary shall publish, and update as necessary, guidance that accurately describes circumstances in which the Secretary 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 personal use will be permitted. is imported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supply; is accompanied by a copy of a valid prescription; is imported from Canada, from a seller registered with the Secretary; is a prescription drug approved by the Secretary under subchapter V; is in the form of a final finished dosage that was manufactured in an establishment registered under section 360 of this title ; and is imported under such other conditions as the Secretary determines to be necessary to ensure public safety. Nothing in this section limits the authority of the Secretary relating to the importation of prescription drugs, other than with respect to section 381(d)(1) of this title as provided in this section. pose no additional risk to the public’s health and safety; and result in a significant reduction in the cost of covered products to the American consumer. If, after the date that is 1 year after the effective date of the regulations under subsection (b) and before the date that is 18 months after the effective date, the Secretary submits to Congress a certification that, in the opinion of the Secretary, based on substantial evidence obtained after the effective date, the benefits of implementation of this section do not outweigh any detriment 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 certification. determines that it is more likely than not that implementation of this section would result in an increase in the risk to the public health and safety; identifies specifically, in qualitative and quantitative terms, the nature of the increased risk; identifies specifically the causes of the increased risk; and considers whether any measures can be taken to avoid, reduce, or mitigate the increased risk; and if the Secretary determines that any measures described in item (aa) would require additional statutory authority, submits to Congress a report describing the legislation that would be required; 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 consumers in the United States, allowing consumers to procure needed medication that consumers might not otherwise be able to procure without foregoing other necessities of life); and compares in specific terms the detriment identified under clause (i) with the benefits identified under clause (ii); and determines that the benefits do not outweigh the detriment. There are authorized to be appropriated such sums as are necessary to carry out this section.