MAR 8-9 PCAC

The US FDA has scheduled a Pharmacy Compounding Advisory Committee (PCAC) meeting for Tuesday and Wednesday, March 8-9, 2016 to vote on whether to add 6 bulk drug substances to the list of allowed substances (FD&C Act Section 503A) and whether to add 2 drug product categories to the list of drug products that present demonstrable difficulties for compounding (FD& C Act 503A and 503B).

On March 8, 2016, from 8:30 a.m. to 4:30 p.m. US EST the Committee will discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances allowed list: 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 March 9, 2016, from 8:30 a.m. to 1:00 p.m. US EST the Committee will discuss two categories of drug products nominated for the list of drug products that present demonstrable difficulties for compounding, per section 503 A and B. These categories of drug products are metered dose inhalers and dry powder inhalers. The nominators who nominated the category of drugs or specific drug products in the category will be invited to make a short presentation supporting the nomination.

See the FDA Announcement