|PCAC Resource Guide|
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.
Click here to view the Charter.
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.
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.
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