Regulatory Counsel

0910-AH81 201804 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 Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act

This proposed rule proposes to add additional bulk drug substances to the list of bulk drug substances that may be used to compound drug products that qualify for the exemptions in section 503A of the FD&C Act (the List). Currently, the only bulk drug substances that may be used to compound drugs that qualify for the section 503A exemptions are those that are the subject of an applicable United States Pharmacopeia or National Formulary monograph, a component of an FDA-approved drug, or those that FDA has already placed on the List. This proposed rule will identify approximately 30 additional bulk drug substances nominated by stakeholders for the List and explain whether FDA proposes the substance be included on the List.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No Regulatory 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 11/00/2018 No No None No No 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