Regulatory Counsel

0910-AI31 202104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act

Sections 503A and 503B of the FD&C Act require compounded drug products to satisfy several conditions to qualify for certain statutory exemptions listed under each section. Both sections 503A and 503B contain conditions that concern whether a compounded drug product is one that the Agency has identified as presenting demonstrable difficulties for compounding. FDA is proposing to establish the criteria by which drug products and categories of drug products will be evaluated for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and the Difficult to Compound List for 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. 353a 21 U.S.C. 353b 21 U.S.C. 371(a) No NPRM 12/00/2021 No Businesses None No No No No Alexandria Fujisaki Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-4078 alexandria.fujisaki@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 5169, Center for Drug Evaluation and Research, Silver Spring MD 20993