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HHS/FDA RIN: 0910-AH08 Publication ID: Spring 2014 
Title: ●Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness  
Abstract: This rule would update and amend the list of drug products to add to or modify the list of drug products that may not be compounded because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.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: First time 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 USC 351    21 USC 352    21 USC 353a    PL 113-54, 127 Stat 587    21 USC 355    21 USC 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 FD&C Act), 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  05/00/2014 
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:
Olivia Ziolkowski
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6210,
Silver Spring, MD 20993
Phone:301 796-2888
Fax:301 847-8440

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