Regulatory Counsel

0910-AH29 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS List of Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act

As required under section 503A of the Food, Drug, and Cosmetic Act (FD&C Act), FDA is developing a list of bulk drug substances that are not the subject of an applicable United States Pharmacopeia or National Formulary monograph, or a component of an FDA-approved drug, that can be used to compound drug products eligible for the exemptions identified in section 503A of the FD&C Act. This proposed rule will identify the criteria proposed for evaluating bulk drug substances for inclusion on the list and the first 10 substances considered. It will identify those substances FDA proposes for inclusion on, the list and those substances FDA proposes not be placed on the list.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 216.23 21 U.S.C. 353a 21 U.S.C. 371 No NPRM 11/00/2016 No None No No No James Flahive Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-9293 james.flahive@fda.hhs.gov Center for Drug Evaluation and Research, Building 51, Room 5197, 10903 New Hampshire Avenue, Silver Spring MD 20993