{"abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled \"Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.\" To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. This guidance sets forth FDA policies regarding this provision of section 503A, including the terms \"commercially available,\" \"essentially a copy of a commercially available drug,\" and \"regularly or in inordinate amounts.\"","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/2016/07/11/2016-16361.html","cfr_references":[],"citation":"81 FR 44881","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work to finalize the guidance, submit either electronic or written comments on this draft guidance by October 11, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-1309"],"dockets":[],"document_number":"2016-16361","effective_on":null,"end_page":44883,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/11/2016-16361.xml","html_url":"https://www.federalregister.gov/documents/2016/07/11/2016-16361/compounded-drug-products-that-are-essentially-copies-of-a-commercially-available-drug-product-under","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-16361?publication_date=2016-07-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-11/2016-16361/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":927,"last_updated":"2026-09-20 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-11/pdf/2016-16361.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-16361.pdf?1467982199","publication_date":"2016-07-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/11/2016-16361.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-2016-D-1309","supporting_documents_count":0,"docket_id":"FDA-2016-D-1309","regulation_id_number":null,"title":"Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2016-10-12T05:00:32Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44881,"subtype":null,"title":"Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability","toc_doc":"Compounded Drug Products that are Essentially Copies of Commercially Available Drug Products under the Federal Food, Drug, and Cosmetic Act","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}