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HHS/FDA RIN: 0910-AH81 Publication ID: Spring 2018 
Title: 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.

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 
EO 13771 Designation: Regulatory 
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. 355    21 U.S.C. 371    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  11/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Rosilend Lawson
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 5197,
Silver Spring, MD 20993
Phone:240 402-6223