Regulatory Counsel

0910-AI70 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act

FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act, although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drug products (the 503A Bulks List). The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Section 610 Review 21 CFR 216.23 21 U.S.C. 353a 21 U.S.C. 351 21 U.S.C. 371(a) 21 U.S.C. 352 21 U.S.C. 355 No NPRM 10/00/2023 Yes Businesses None No No Yes No Rosilend Lawson Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-6223 rosilend.lawson@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 5197, Silver Spring MD 20993