JUN 17-18 PCAC

Briefing Summary: US FDA Posts Advisory Committee Materials for Review of Drugs on the Not Allowed List and Bulk Substances for the Allowed List for Pharmacy Compounding – JUN 17-18, 2015 (PCAC)

The US FDA has posted details, including FDA Briefing Materials, for the Wednesday and Thursday, June 17-18, 2015 Pharmacy Compounding Advisory Committee (PCAC) meeting, for the discussion of specific drugs that are proposed to be included on the withdrawn or removed list, based on sections 503A and 503B of the Food, Drug, and Cosmetic Act (FD&C Act); and other drugs that are proposed for the section 503A bulk drug substances list. The Committee will also be asked to discuss the criteria FDA proposes to use to evaluate those drugs identified as difficult to compound, based on sections 503A and 503B, and will hear the FDA present on expanded access to investigational drug for treatment use.

See the SAC Tracker report