Background Analysis: US FDA Advisory Committee to Review Drugs for the Not Allowed List and Bulk Substances for the Allowed List for Pharmacy Compounding – JUN 17-18, 2015 (PCAC)
The US FDA has scheduled a meeting of the Pharmacy Compounding Advisory Committee (PCAC) for Wednesday and Thursday, June 17-18, 2015 to discuss specific drugs that are proposed to be included on the withdrawn or removed list, based on sections 503A and 503B; and other drugs that are proposed for the section 503A bulk drug substances list. They will also discuss the criteria FDA proposes to use to evaluate those drugs identified as difficult to compound, based on sections 503A and 503B.