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HHS/FDA RIN: 0910-AH34 Publication ID: Fall 2016 
Title: Second 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 

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 a 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 that section (List). In fall 2016, we expect to publish an NPRM proposing the criteria for evaluating bulk drug substances for the List, identifying 10 substances nominated for the list and whether FDA proposes the substance be placed on the List. This proposed rule will identify 15-20 additional bulk drug substances nominated for the List and whether FDA proposes the substance be included on the List, or not included 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: Undetermined  Unfunded Mandates: No 
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