{"abstract":"The Secretary of Health and Human Services (Secretary) is issuing a final rule to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. Under this final rule, States and Indian Tribes, and in certain future circumstances pharmacists and wholesalers, may submit importation program proposals to the Food and Drug Administration (FDA, the Agency, or we) for review and authorization. An importation program may be cosponsored by a State, Indian Tribe, pharmacist, or wholesaler. The final rule contains all requirements necessary for a sponsor to demonstrate that their importation program will pose no additional risk to the public's health and safety. In addition, the final rule requires that the sponsor explain how they will ensure their program will result in a significant reduction in the cost of covered products to the American consumer.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2020/10/01/2020-21522.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1","title":21},{"chapter":null,"citation_url":null,"part":"251","title":21}],"citation":"85 FR 62094","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This final rule is effective November 30, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-5711"],"dockets":[],"document_number":"2020-21522","effective_on":"2020-11-30","end_page":62140,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/10/01/2020-21522.xml","html_url":"https://www.federalregister.gov/documents/2020/10/01/2020-21522/importation-of-prescription-drugs","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-21522?publication_date=2020-10-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-10-01/2020-21522/mods.xml","not_received_for_publication":null,"page_length":47,"page_views":{"count":15786,"last_updated":"2026-07-26 04:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-10-01/pdf/2020-21522.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-21522.pdf?1601064920","publication_date":"2020-10-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/10/01/2020-21522.txt","regulation_id_number_info":{"0910-AI45":{"issue":"202004","html_url":"https://www.federalregister.gov/regulations/0910-AI45/importation-of-prescription-drugs-","title":"Importation of Prescription Drugs ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202004&RIN=0910-AI45&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AI45"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"RIA_REF8 RE Final rule ref 06 Final Regulatory Impact Analysis","document_id":"FDA-2019-N-5711-1267"},{"title":"RIA_REF6 RE Final rule ref 06 Final Regulatory Impact Analysis","document_id":"FDA-2019-N-5711-1265"},{"title":"RIA_REF4 RE Final rule ref 06 Final Regulatory Impact Analysis","document_id":"FDA-2019-N-5711-1263"},{"title":"RIA_REF1 RE Final rule ref 06 Final Regulatory Impact Analysis","document_id":"FDA-2019-N-5711-1260"},{"title":"Final rule ref 05 Government of Canada, Health Canada, GMP Drug Establishment Good Manufacturing Practices Pre-Application Package Importers, Distributors and Wholesalers","document_id":"FDA-2019-N-5711-1258"},{"title":"Final rule ref 04 Government of Canada, Consultation Regulations Amending the Food and Drug Regulations 1447-Good Manufacturing Practices","document_id":"FDA-2019-N-5711-1257"},{"title":"Reference 8 Report on Prescription Drug Importation re Importation of Prescription Drugs","document_id":"FDA-2019-N-5711-0041"},{"title":"Reference 6 Pharmaceutical trends Retail Prescriptions Dispensed in Canada, 2014-2018 re Importation of Prescription Drugs","document_id":"FDA-2019-N-5711-0039"},{"title":"Reference 4 Medicine Use and Spending in the US A Review of 2018 and Outlook to 2023 re Importation of Prescription Drugs","document_id":"FDA-2019-N-5711-0037"},{"title":"Reference 3 International Prices And Availability Of Pharmaceuticals In 2005 re Importation of Prescription Drugs","document_id":"FDA-2019-N-5711-0036"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-N-5711","supporting_documents_count":54,"docket_id":"FDA-2019-N-5711","document_id":"FDA-2019-N-5711-1252","regulation_id_number":null,"title":"Importation of Prescription Drugs","checked_regulationsdotgov_at":"2020-10-03T21:30:09Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":62094,"subtype":null,"title":"Importation of Prescription Drugs","toc_doc":"Importation of Prescription Drugs","toc_subject":null,"topics":["Cosmetics","Drugs","Exports","Food labeling","Imports","Labeling","Packaging and containers","Prescription drugs","Reporting and recordkeeping requirements"],"type":"Rule","volume":85}