Briefing Summary: Pharmacy Compounding Advisory Committee to Review Nominees for the “Bulk Substances Allowed” and “Demonstrably Difficult” Lists– MAR 8-9, 2016 (PCAC)

The US FDA has posted Briefing Materials for the Pharmacy Compounding Advisory Committee (PCAC) meeting on Tuesday and Wednesday, March 8-9, 2016. The PCAC will weigh in on two topics:

1) Whether to add six bulk drug substances to the list of allowed substances; and

2) Whether to add two drug product categories to the list of drug products that present demonstrable difficulties for compounding.

See the SAC Tracker report