{"description":"Documents matching '\"bulk drug substances\"' and published on or after 06/01/2026","count":3,"total_pages":1,"results":[{"title":"Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled \"Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities.\" This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding of animal drug products from bulk drug substances (BDS) when done in accordance with Current Good Manufacturing Practice (CGMP) at drug production facilities that are registered with FDA.","document_number":"2026-17580","html_url":"https://www.federalregister.gov/documents/2026/08/28/2026-17580/compounding-animal-drugs-from-bulk-drug-substances-compounding-under-cgmp-in-federally-registered","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-28/pdf/2026-17580.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17580.pdf?1787834714","publication_date":"2026-08-28","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":"we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled “Compounding Animal Drugs from <span class=\"match\">Bulk Drug Substances</span>: Compounding under CGMP in Federally-Registered Facilities.” This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding of animal drug products from <span class=\"match\">bulk drug substances</span> (BDS) when done in accordance with Current Good Manufacturing Practice (CGMP) at drug production facilities that are registered"},{"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","type":"Notice","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.","document_number":"2026-12937","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","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12937.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12937.pdf?1782391517","publication_date":"2026-06-26","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":"Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled “List of <span class=\"match\">Bulk Drug Substances</span> for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act” that appeared in the \n Federal Register \n of May 1, 2026. In the \n Federal Register \n notice, FDA requested comments on FDA's proposal not to include semaglutide, tirzepatide, or liraglutide on a list of <span class=\"match\">bulk drug substances</span> (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.","document_number":"2026-17676","html_url":"https://www.federalregister.gov/documents/2026/08/31/2026-17676/agency-information-collection-activities-proposed-collection-comment-request-registration-of-human","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17676.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17676.pdf?1787921110","publication_date":"2026-08-31","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":"indicate: (1) whether it intends to compound, within the next calendar year, a drug that appears on our drug shortage list in effect under section 506E of the FD&amp;C Act (21 U.S.C. 356e); and (2) whether it compounds from <span class=\"match\">bulk drug substances</span> and, if so, whether it compounds sterile or nonsterile drugs from <span class=\"match\">bulk drug substances</span>. Registered outsourcing facilities must submit a drug product report upon initial registration under section 503B and twice each year in June and December for drug products produced during the previous 6-month period. We require"}]}