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HHS/FDA RIN: 0910-AH10 Publication ID: Fall 2016 
Title: Regulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act  
Abstract:

FDA will propose regulations to define and implement certain statutory conditions under which compounded products may qualify for exemptions from certain requirements.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: Undetermined  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 216   
Legal Authority: 21 U.S.C. 353a    21 U.S.C. 353b    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2017 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Sara Rothman
Consumer Safety Officer
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:301 796-3536
Email: sara.rothman@fda.hhs.gov