Members-only Site   |   Print Page   |   Contact Us   |   Sign In   |   Register
News & Press: Breaking News

PCAC Votes 8-0 in Favor of Placing Glycolic Acid on the Positive List

Thursday, November 3, 2016   (0 Comments)
Posted by: Dagmar Anderson
Share |




PCAC Meeting - November 3, 2016, 8:30 am - 4:30 pm 


Voting Results - Live from Meeting


Glycolic Acid


FDA's Pharmacy Compounding Advisory Committee (PCAC) voted this morning 8-0 on Glycolic Acid in favor of placing it on the positive list. PCAC voted whether to add this bulk substance to the positive list and thus allow compounding with these bulk substances. IACP's Executive Vice President John Voliva, RPh made a nominator presentation for Glycolic Acid.


Also, FDA’s acting lead on compounding, Emily Gebbia, publicly said that items voted to be placed on the positive list can have restrictions for the drug’s use. The PCAC is concerned with the use of this drug via subcutaneous injection. The committee, in their comments after the vote recommend this item to be placed on the positive list for positive use only.

PLEASE NOTE: These votes are NOT final. FDA must release final guidance for this to be FINAL. These are the Committee’s votes on FDA’s recommendations.


Click here for Notice of Meeting


Click here for Meeting Briefing Information


PCAC Live Webcast Information


Click here for the November 3rd meeting webcast access information.


PCAC Meeting Materials


Click here for all 2016 PCAC Meeting Materials.


Click here for all 2015 PCAC Meeting Materials.


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”



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.


Association Management Software Powered by YourMembership  ::  Legal