{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.\" For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it must not be essentially a copy of one or more approved drug products and must meet other conditions in section 503B. This guidance sets forth FDA's policies concerning the \"essentially a copy\" provision of section 503B of 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/2018/01/19/2018-00914.html","cfr_references":[],"citation":"83 FR 2786","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 19, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-1267"],"dockets":[],"document_number":"2018-00914","effective_on":null,"end_page":2787,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/01/19/2018-00914.xml","html_url":"https://www.federalregister.gov/documents/2018/01/19/2018-00914/compounded-drug-products-that-are-essentially-copies-of-approved-drug-products-under-section-503b-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-00914?publication_date=2018-01-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-01-19/2018-00914/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":683,"last_updated":"2026-08-24 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-01-19/pdf/2018-00914.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-00914.pdf?1516283188","publication_date":"2018-01-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/01/19/2018-00914.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-1267","supporting_documents_count":0,"docket_id":"FDA-2016-D-1267","regulation_id_number":null,"title":"Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act","checked_regulationsdotgov_at":"2018-02-08T06:00:22Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":2786,"subtype":null,"title":"Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability","toc_doc":"Compounded Drug Products That Are Essentially Copies of Approved Drug Products","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}