Regulatory Counsel

0910-AH81 202104 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 List of Bulk Drug 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 (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs (the 503A Bulks List). FDA has proposed to amend the 503A Bulks List by placing five additional bulk drug substances on the list. FDA has also identified 26 bulk drug substances that FDA has considered and proposed not to include on the 503A Bulks List. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 216.23 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353a 21 U.S.C. 355 21 U.S.C. 371 ... No NPRM 09/05/2019 84 FR 46688 NPRM Comment Period End 12/04/2019 Final Rule 12/00/2021 Yes Businesses None 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