{"abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled \"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.\" The guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).","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/2016/06/10/2016-13798.html","cfr_references":[{"chapter":0,"citation_url":null,"part":null,"title":21}],"citation":"81 FR 37500","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-3539"],"dockets":[],"document_number":"2016-13798","effective_on":null,"end_page":37502,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/06/10/2016-13798.xml","html_url":"https://www.federalregister.gov/documents/2016/06/10/2016-13798/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/2016-13798?publication_date=2016-06-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-06-10/2016-13798/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":713,"last_updated":"2026-04-21 10:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-06-10/pdf/2016-13798.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-13798.pdf?1465476612","publication_date":"2016-06-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/06/10/2016-13798.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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","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":"2016-06-30T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":37500,"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 for Industry:","topics":[],"type":"Rule","volume":81}