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HHS/FDA RIN: 0910-AH29 Publication ID: Fall 2015 
Title: ●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  

FDA is developing a list of bulk drug substances that may be used to compound drug products under section 503A of the Food, Drug, and Cosmetic Act. This list will identify 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 may be used in compounding under section 503A. This proposed rule will identify the criteria for evaluating bulk drug substances for inclusion on the list. It will propose an initial set of substances for inclusion on, and exclusion from, the list.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 216.23   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353a    21 U.S.C. 353b    21 U.S.C. 355    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/00/2016 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
James Flahive
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 51, Room 5197, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-9293