{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.\" This guidance describes FDA's interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.","action":"Notice of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/2025/01/07/2024-31545.html","cfr_references":[],"citation":"90 FR 1130","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on January 7, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-3539"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2025-01-07T13:56:33.961-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-D-3539-0030","allow_late_comments":false,"id":"FDA-2015-D-3539-0030","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2015-D-3539","title":"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act"}],"document_number":"2024-31545","effective_on":null,"end_page":1132,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/01/07/2024-31545.xml","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31545/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503b-of-the-federal-food-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-31545?publication_date=2025-01-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-01-07/2024-31545/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":655,"last_updated":"2026-06-24 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31545.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31545.pdf?1736171123","publication_date":"2025-01-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/01/07/2024-31545.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2015-D-3539","supporting_documents_count":0,"docket_id":"FDA-2015-D-3539","document_id":"FDA-2015-D-3539-0030","regulation_id_number":null,"title":"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act","checked_regulationsdotgov_at":"2025-01-08T18:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":1130,"subtype":null,"title":"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability","toc_doc":"Interim Policy on Compounding Using Bulk Drug Substances under the Federal Food, Drug, and Cosmetic Act","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}