Background Analysis: 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 scheduled a Pharmacy Compounding Advisory Committee (PCAC) meeting for Tuesday - Wednesday, March 8-9, 2016.
On Tuesday, the Committee will discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA will discuss the following nominated bulk drug substances: quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The nominators of these substances will be invited to make a short presentation supporting the nomination.
On Wednesday, the Committee will discuss two categories of drug products nominated for the list of drug products that present demonstrable difficulties for compounding. These categories of drug products are metered dose inhalers and dry powder inhalers. The nominators for each category of drugs or specific drug products in the category will be invited to make a short presentation supporting the nomination.
See the SAC Tracker report