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HHS/FDA RIN: 0910-AH10 Publication ID: Spring 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: First time 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  10/00/2014   
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
10903 New Hampshire Avenue, Building 51, Room 6208,
Silver Spring, MD 20993
Phone:301 796-0659
Email: kalah.auchincloss@fda.hhs.gov

 
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