{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.\" This draft guidance describes procedures to obtain a National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would provide an additional avenue through which drugs could be sold at a lower cost in the U.S. market. This draft guidance is intended to address certain challenges in the private market faced by manufacturers seeking to sell their drugs at lower costs.","action":"Notice of availability.","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/2019/12/23/2019-27475.html","cfr_references":[],"citation":"84 FR 70557","comment_url":null,"comments_close_on":"2020-02-21","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 21, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-5743"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":10,"comment_start_date":"2019-12-23","updated_at":"2023-02-28T13:52:41.626-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-5743-0001","allow_late_comments":null,"id":"FDA-2019-D-5743-0001","comment_end_date":"2020-02-22","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-D-5743","title":"Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry; Availability"}],"document_number":"2019-27475","effective_on":null,"end_page":70559,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/12/23/2019-27475.xml","html_url":"https://www.federalregister.gov/documents/2019/12/23/2019-27475/importation-of-certain-food-and-drug-administration-approved-human-prescription-drugs-including","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-27475?publication_date=2019-12-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-12-23/2019-27475/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1413,"last_updated":"2026-07-28 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-12-23/pdf/2019-27475.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-27475.pdf?1576676728","publication_date":"2019-12-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/12/23/2019-27475.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":10,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-D-5743","supporting_documents_count":0,"docket_id":"FDA-2019-D-5743","document_id":"FDA-2019-D-5743-0001","regulation_id_number":null,"title":"Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-02-28T18:52:40Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":70557,"subtype":null,"title":"Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability","toc_doc":"Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":84}