Regulatory Counsel

0910-AI31 201904 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 Section 503A and 503B of the Federal Food Drug and Cosmetic Act

Both sections 503A and 503B require compounded drug products to satisfy several conditions to qualify for the statutory exemptions from the FD&C Act. One of those conditions is that the compounded drug product is not a drug product that presents 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 Difficult to Compound List. Based on the results of its evaluation of nominated difficult to compound 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 the list.

]]> Other Significant First Time Published in The Unified Agenda Prerule Stage No No Regulatory 21 CFR 216.25 21 U.S.C. 353a 21 U.S.C. 353b 21 U.S.C. 371(a) No ANPRM 12/00/2019 No No 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