Regulatory Counsel

0910-AH29 201804 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 Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act

This rule will establish the statutorily required list of additional bulk drug substances that may be used to compound drug products that qualify for the exemptions in section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (the section 503A exemptions). Currently, the only bulk drug substances that may be used to compound drug products that qualify for the section 503A exemptions are those that are the subject of an applicable United States Pharmacopeia or National Formulary monograph, or a component of an FDA-approved drug. This final rule will also identify the criteria for evaluating additional bulk drug substances that may be used to compound drug products that qualify for the section 503A exemptions and list substances that were considered and are not included. The rule will provide clarity to stakeholders about what bulk drug substances can be used to compound drug products that qualify for the section 503A exemptions by identifying additional bulk drug substances.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No Deregulatory 21 CFR 216.23 21 U.S.C. 351 to 353a 21 U.S.C. 355 21 U.S.C. 371 ... No NPRM 12/16/2016 81 FR 91071 NPRM Comment Period End 03/16/2017 Final Rule 08/00/2018 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