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HHS/FDA RIN: 0910-AH10 Publication ID: Fall 2014 
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: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 216   
Legal Authority: 42 USC 353a    42 USC 353b   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2015 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Kalah Auchincloss
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6208,
Silver Spring, MD 20993
Phone:301 796-0659
Email: kalah.auchincloss@fda.hhs.gov