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HHS/FDA RIN: 0910-AH08 Publication ID: Fall 2016 
Title: Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness  

This rule would update and amend the list of drug products to add entries to or modify existing entries the list of drug products that may not be compounded because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.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: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
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:
Action Source Description Date
Final  Statutory  Not more than 18 months following publication of the proposed rule.   

Overall Description of Deadline: Section 104 of the Drug Quality and Security Act (DQSA) requires that in promulgating any regulations to implement the DQSA (e.g., section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA)), at least 60 days be provided for comments on a proposed regulation and the final regulation be published not more than 18 months following publication of the proposed rule and not less than 30 calendar days before the effective date of such final regulation.

Action Date FR Cite
NPRM  07/02/2014  79 FR 37687   
NPRM Comment Period End  09/02/2014 
Final Action  10/07/2016  81 FR 69668   
Final Action Effective  11/07/2016 
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