0910-AH35 201610 The Regulatory Plan and the 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of Health and Human Services HHS Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness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 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compounded under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act, because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.

 

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 216.24 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 No NPRM 10/18/2016 81 FR 71648 NPRM Comment Period End 01/03/2017 No None No No No Edisa Gozun Consumer Safety Officer 0910 Food and Drug Administration FDA 301 796-3775 301 847-8745 edisa.gozun@fda.hhs.gov Building 51, Room 5199, 10903 New Hampshire Avenue, Silver Spring MD 20993