{"abstract":"The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled \"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act\" that appeared in the Federal Register of May 1, 2026. In the Federal Register notice, FDA requested comments on FDA's proposal not to include semaglutide, tirzepatide, or liraglutide 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). The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.","action":"Notice; extension of comment period.","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/2026/06/26/2026-12937.html","cfr_references":[],"citation":"91 FR 38719","comment_url":null,"comments_close_on":"2026-05-01","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period on the notice published in the Federal Register of May 1, 2026 (91 FR 23431). Either electronic or written comments must be submitted by July 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":0,"comment_start_date":"2026-06-26","updated_at":"2026-06-26T13:56:39.774-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-N-3240-1006","allow_late_comments":false,"id":"FDA-2018-N-3240-1006","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"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"},{"supporting_documents":[{"title":"Guidance: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements","document_id":"FDA_FRDOC_0001-12016"},{"title":"Meetings: Patient-Focused Drug Development for Long COVID","document_id":"FDA_FRDOC_0001-12015"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-06-26","updated_at":"2026-06-26T09:01:12.918-04:00","comment_url":"https://www.regulations.gov/commenton/FDA_FRDOC_0001-14313","allow_late_comments":false,"id":"FDA_FRDOC_0001-14313","comment_end_date":"2026-05-02","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA_FRDOC_0001","title":"Recently Posted FDA Rules and Notices."}],"document_number":"2026-12937","effective_on":null,"end_page":38720,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/26/2026-12937.xml","html_url":"https://www.federalregister.gov/documents/2026/06/26/2026-12937/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/2026-12937?publication_date=2026-06-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-26/2026-12937/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":728,"last_updated":"2026-09-20 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12937.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12937.pdf?1782391517","publication_date":"2026-06-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/26/2026-12937.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":0,"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-3240-1006","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; Notice","checked_regulationsdotgov_at":"2026-06-27T19:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":38719,"subtype":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; Extension of Comment Period","toc_doc":"List of Bulk Drug Substances for which there Is a Clinical Need the Federal Food, Drug, and Cosmetic Act","toc_subject":null,"topics":[],"type":"Notice","volume":91}