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HHS/FDA RIN: 0910-AH29 Publication ID: Fall 2016 
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  

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.


Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 216.23   
Legal Authority: 21 U.S.C. 353a    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  11/00/2016 
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