{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. If the rule is finalized as proposed, States or certain other non-federal governmental entities would be able to submit importation program proposals to FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another State or non-federal governmental entity. The rule, when finalized, would contain all requirements necessary for a State or other non-federal governmental entity and its co-sponsors, if any, to demonstrate that their importation program will pose no additional risk to the public's health and safety. In addition, the proposed rule would require that the State or non-federal governmental entity and its co-sponsors, if any, explain why their program would be expected to result in a significant reduction in the cost of covered products to the American consumer.","action":"Proposed 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/2019/12/23/2019-27474.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1,"title":21},{"chapter":null,"citation_url":null,"part":251,"title":21}],"citation":"84 FR 70796","comment_url":null,"comments_close_on":"2020-03-09","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by March 9, 2020. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by January 22, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-N-5711"],"dockets":[{"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"}],"agency_name":"FDA","documents":[{"comment_count":1211,"comment_start_date":"2019-12-23","updated_at":"2023-03-01T00:26:10.703-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-N-5711-0001","allow_late_comments":null,"id":"FDA-2019-N-5711-0001","comment_end_date":"2020-03-10","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":54,"id":"FDA-2019-N-5711","title":"Importation of Prescription Drugs"}],"document_number":"2019-27474","effective_on":null,"end_page":70839,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/12/23/2019-27474.xml","html_url":"https://www.federalregister.gov/documents/2019/12/23/2019-27474/importation-of-prescription-drugs","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-27474?publication_date=2019-12-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-12-23/2019-27474/mods.xml","not_received_for_publication":null,"page_length":44,"page_views":{"count":15911,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-12-23/pdf/2019-27474.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-27474.pdf?1576676728","publication_date":"2019-12-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/12/23/2019-27474.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":1211,"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-5711-0001","regulation_id_number":null,"title":"Importation of Prescription Drugs","checked_regulationsdotgov_at":"2023-03-01T05:26:09Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":70796,"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":"Proposed Rule","volume":84}