{"description":"Documents matching '\"bulk drug substances\" 503A', published on or after 01/01/2025, and from Food and Drug Administration","count":3,"total_pages":1,"results":[{"title":"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.\" This guidance describes FDA's interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.","document_number":"2024-31546","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31546/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503a-of-the-federal-food-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31546.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31546.pdf?1736171123","publication_date":"2025-01-07","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"}],"excerpts":"industry entitled “Interim Policy on Compounding Using <span class=\"match\">Bulk Drug Substances</span> Under Section <span class=\"match\">503A</span> of the Federal Food, Drug, and Cosmetic Act” (2024 <span class=\"match\">503A</span> Interim Policy Guidance). This guidance finalizes the draft guidance entitled “Interim Policy on Compounding Using <span class=\"match\">Bulk Drug Substances</span> Under Section <span class=\"match\">503A</span> of the Federal Food, Drug, and Cosmetic Act” issued on December 7, 2023 (88 FR 85296), and replaces the guidance of the same title issued in January 2017 (2017 <span class=\"match\">503A</span> Interim Policy Guidance). \n Section <span class=\"match\">503A</span> of the FD&amp;C Act (21 U.S.C. 353a) sets forth"},{"title":"Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2026-07361","html_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07361.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07361.pdf?1776257113","publication_date":"2026-04-16","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"}],"excerpts":"BPC-157-related <span class=\"match\">bulk drug substances</span> (BPC-157 (free base)/BPC-157 acetate), KPV-related <span class=\"match\">bulk drug substances</span> (KPV (free base)/KPV acetate), TB-500-related <span class=\"match\">bulk drug substances</span> (TB-500 (free base)/TB-500 acetate), and MOTs-C-related <span class=\"match\">bulk drug substances</span> (MOTs-C (free base)/MOTs-C acetate). The chart below identifies the use(s) FDA reviewed for each of the <span class=\"match\">bulk drug substances</span> being discussed at this advisory committee meeting. For nominated <span class=\"match\">bulk drug substances</span>, the nominators of these substances will be invited to make a short presentation supporting"},{"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","type":"Notice","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.","document_number":"2026-08552","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","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08552.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08552.pdf?1777553125","publication_date":"2026-05-01","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"}],"excerpts":"for the <span class=\"match\">bulk drug substances</span> we are addressing in this notice. Accordingly, as explained below, we did not proceed further in our evaluation of these substances and are proposing not to include these <span class=\"match\">bulk drug substances</span> on the 503B Bulks List. \n \n In this notice, FDA evaluated certain nominated <span class=\"match\">bulk drug substances</span> for potential inclusion on the 503B Bulks List either alone or in combination with other <span class=\"match\">bulk drug substances</span>. FDA does not intend to consider comments raising different <span class=\"match\">bulk drug substances</span> or combinations of <span class=\"match\">bulk drug substances</span> other"}]}