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HHS/FDA RIN: 0910-AH35 Publication ID: Fall 2016 
Title: Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness 

This rule would amend the regulation regarding the list of drug products that may not be compounded under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act, because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.


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: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 216.24   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353a    Pub. L. 113-54, 127 Stat 587    21 U.S.C. 355    21 U.S.C. 371   
Legal Deadline:  None
Action Date FR Cite
NPRM  10/18/2016  81 FR 71648   
NPRM Comment Period End  01/03/2017 
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:
Edisa Gozun
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Building 51, Room 5199, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3775
Fax:301 847-8745