Consumer Safety Officer

0910-AI31 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

Compounded drug products must satisfy the conditions of section 503A or section 503B of the FD&C Act to qualify for certain statutory exemptions listed under each section. Both sections 503A and 503B provide that a compounded drug is not eligible for those exemptions if it is identified by FDA as presenting demonstrable difficulties for compounding. FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B. Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 216.25 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353a 21 U.S.C. 353b 21 U.S.C. 355 21 U.S.C. 371 No NPRM 10/00/2023 No Businesses None No No No No Ian Reynolds Consumer Safety Officer 0910 Food and Drug Administration FDA 240 402-7079 ian.reynolds@fda.hhs.gov 10903 New Hampshire Avenue, Center for Drug Evaluation and Research, Building 51, Room 5104, Silver Spring MD 20993