Regulatory Counsel

0910-AI77 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness

This proposed rule would amend the regulation regarding the list of drug products that were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective and may not be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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined No 21 CFR 216.24 secs. 503A, 503B, and 701 (a) of the FD&C Act (21 U.S.C. 353a, 353b, and 371a) No NPRM 08/00/2023 Undetermined None No No No No Mariestela Buhay Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-7313 mariestela.buhay@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 5519, Silver Spring MD 20993