Briefing Summary: US FDA Posts Advisory Committee Materials for a Review of Drugs Not Allowed List and Bulk Substances Allowed List for Pharmacy Compounding – FEB 23-24, 2015 (PCAC)
The US FDA has posted details, including Briefing Materials, for the Monday-Tuesday, February 23-24, 2015 Pharmacy Compounding Advisory Committee (PCAC) Meeting. On February 23, during the morning session, the Committee will discuss FDA’s proposed revisions to the list of drug products that may not be compounded under the exemptions provided by the FD&C Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The list of products is currently codified at 21 CFR 216.24. FDA proposes to revise and update the list for purposes of both sections 503A and 503B of the FD&C Act, based on its July 2, 2014 Federal Register publication of a proposed rule that would add 25 drug products to this list and modify the description of one drug product on this list to add an exception.
During the February 23 afternoon session, and on February 24, the Committee will discuss FDA’s proposed criteria for developing the list of bulk drug substances that may be used to compound drug products in accordance with section 503A of the FD&C Act and will discuss six substances nominated for inclusion on the list. On December 4, 2013, and July 2, 2014, FDA published FR notices (78 FR 72841 and 79 FR 37747) soliciting nominations for this list. FDA intends to discuss the following nominated bulk drug substances: Cantharidin, diphenylcyclopropenone, piracetam, silver protein mild, squaric acid dibutyl ester, and thymol iodide.