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HHS/FDA RIN: 0910-AI77 Publication ID: Fall 2023 
Title: Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness 

This proposed rule would amend the regulation regarding the list of drug products that were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective and may not be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

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: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 216.24   
Legal Authority: secs. 503A, 503B, and 701 (a) of the FD&C Act (21 U.S.C. 353a, 353b, and 371a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/00/2023 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Mariestela Buhay
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 5519,
Silver Spring, MD 20993
Phone:301 796-7313