Members-only Site   |   Print Page   |   Contact Us   |   Sign In   |   Register
PCAC Resource Guide
Share |


Pharmacy Compounding Advisory Committee (PCAC)



PCAC Purpose and Role


The Pharmacy Compounding Advisory Committee (PCAC) advises the Food & Drug Administration (FDA) Commissioner or designee in discharging responsibilities as they relate to compounding drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.

The Committee shall provide advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, and, as required, any other product for which the FDA has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs.



PCAC Charter


Click here to view the Charter.



PCAC Roster


Click here to view the current Roster.



PCAC Meeting Materials


Click here for all 2016 PCAC Meeting Materials.


Click here for all 2015 PCAC Meeting Materials.



Upcoming Meetings


Date: November 3, 2016, 8:30 am - 4:30 pm 


Click here for Notice of Meeting


Click here for Meeting Briefing Information


Agenda: The committee intends to discuss five bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Glycolic acid, trichloroacetic acid, kojic acid, diindolylmethane, and vasoactive intestinal peptide. The chart in this document describes which use(s) FDA reviewed for each of the five bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination.


The committee also intends to discuss drug products that employ transdermal and topical delivery systems, which were nominated for the Difficult to Compound List. The nominators will be invited to make a short presentation supporting the nomination.



Use(s) Reviewed


Treatment of cancer

Glycolic acid

Hyperpigmentation (including melasma) and photodamaged skin

Trichloroacetic acid

Common warts and genital warts

Kojic acid

Hyperpigmentation and as a chelating agent to promote wound healing

Vasoactive intestinal peptide

A condition described as “chronic inflammatory response syndrome”

Association Management Software Powered by®  ::  Legal