{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.","action":"Notice.","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/2026/05/01/2026-08552.html","cfr_references":[],"citation":"91 FR 23431","comment_url":"http://www.regulations.gov/commenton/FDA-2018-N-3240-0377","comments_close_on":"2026-06-30","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the notice must be submitted by June 30, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-3240"],"dockets":[{"supporting_documents":[{"title":"Reference 3 - 503B Liraglutide Evaluation","document_id":"FDA-2018-N-3240-0380"},{"title":"Reference 2 - 503B Tirzepatide Evaluation","document_id":"FDA-2018-N-3240-0379"},{"title":"Reference 1 - FDA Proposal Not to Include Ephedrine Sulfate on the 503B Bulks List RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","document_id":"FDA-2018-N-3240-0376"},{"title":"Reference 3 - Part 1 Evaluation for Hydroxychloroquine Sulfate RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","document_id":"FDA-2018-N-3240-0375"},{"title":"Reference 2 - Supplemental clinical need evaluation for ephedrine sulfate in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","document_id":"FDA-2018-N-3240-0374"},{"title":"Reference 4 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Prescription Requirements Under Section 503 A Under the Federal Food Drug and Cosmetic Act","document_id":"FDA-2018-N-3240-0372"},{"title":"Reference 8 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic","document_id":"FDA-2018-N-3240-0368"},{"title":"Reference 7 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic","document_id":"FDA-2018-N-3240-0367"},{"title":"Reference 4 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic","document_id":"FDA-2018-N-3240-0364"},{"title":"Reference 3 re List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic","document_id":"FDA-2018-N-3240-0363"}],"agency_name":"FDA","documents":[{"comment_count":173,"comment_start_date":"2026-05-01","updated_at":"2026-05-02T01:56:46.133-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-N-3240-0377","allow_late_comments":false,"id":"FDA-2018-N-3240-0377","comment_end_date":"2026-07-01","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":28,"id":"FDA-2018-N-3240","title":"List of Bulk Drug Substances For Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Notice"}],"document_number":"2026-08552","effective_on":null,"end_page":23444,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/01/2026-08552.xml","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-08552?publication_date=2026-05-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-01/2026-08552/mods.xml","not_received_for_publication":null,"page_length":14,"page_views":{"count":1515,"last_updated":"2026-05-03 10:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08552.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08552.pdf?1777553125","publication_date":"2026-05-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/01/2026-08552.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 3 - 503B Liraglutide Evaluation","document_id":"FDA-2018-N-3240-0380"},{"title":"Reference 2 - 503B Tirzepatide Evaluation","document_id":"FDA-2018-N-3240-0379"},{"title":"Reference 1 - FDA Proposal Not to Include Ephedrine Sulfate on the 503B Bulks List RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","document_id":"FDA-2018-N-3240-0376"},{"title":"Reference 3 - Part 1 Evaluation for Hydroxychloroquine Sulfate RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","document_id":"FDA-2018-N-3240-0375"},{"title":"Reference 2 - Supplemental clinical need evaluation for ephedrine sulfate in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","document_id":"FDA-2018-N-3240-0374"},{"title":"Reference 4 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Prescription Requirements Under Section 503 A Under the Federal Food Drug and Cosmetic Act","document_id":"FDA-2018-N-3240-0372"},{"title":"Reference 8 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic","document_id":"FDA-2018-N-3240-0368"},{"title":"Reference 7 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic","document_id":"FDA-2018-N-3240-0367"},{"title":"Reference 4 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic","document_id":"FDA-2018-N-3240-0364"},{"title":"Reference 3 re List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic","document_id":"FDA-2018-N-3240-0363"}],"comments_count":173,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-3240","supporting_documents_count":28,"docket_id":"FDA-2018-N-3240","document_id":"FDA-2018-N-3240-0377","regulation_id_number":null,"title":"List of Bulk Drug Substances For Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; 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