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PCAC Resource Guide
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Pharmacy Compounding Advisory Committee (PCAC)

 

Upcoming Meetings

 

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

 

 

Voting Results - Live from Meeting

 

Transdermal Delivery Systems

 

PCAC Final Vote of the Day: The committee voted unanimously to place transdermal delivery systems on the demonstrably difficult list.

Reminder: The discussion of transdermal delivery systems was relegated to “drug products that employ matrix or reservoir type transdermal or topical delivery systems, which are designed to deliver active ingredient through the skin either systemically or locally.” “For the purposes of this review, FDA does not consider transdermal delivery systems to be liquid or semisolids, such as gels, creams, lotions, foams, ointments or sprays, that are intended for use without a matrix or reservoir type transdermal or topical delivery systems.” The committee stayed true to this statement and only transdermal delivery systems using reservoir or matrix types systems were voted to be placed on the demonstrably difficult list.

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.

 

Vasoactive Intestinal Peptide

 

FDA's Pharmacy Compounding Advisory Committee (PCAC) voted 8-0 to NOT place Vasoactive Intestinal Peptide on the Positive List.

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.

 

Diindolylmethane 

  

Diindolylmethane was voted to NOT be placed on the positive list in an 8-1 vote. Gigi S. Davidson, BSPh, DICVP, Director, Clinical Pharmacy Services, North Carolina State University College of Veterinary Medicine, was the sole Committee member to vote to add the item to the list.

 

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.

 

Kojic Acid

  

FDA's Pharmacy Compounding Advisory Committee (PCAC) voted to not place Kojic Acid on the positive list in a 3 Yes, 4 No, 1 Abstain. Major issue with the committee was stability of the drug.

 

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.

 

Trichloroacetic Acid

 

FDA's Pharmacy Compounding Advisory Committee (PCAC) voted this morning 7-1 in favor of placing Trichloroacetic Acid on the positive list and thus allow compounding with this bulk substance. The only dissenting vote came from Public Citizen.

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.

 

 

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, recommended this item to be placed on the positive list for topical 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.

 

Drug

Use(s) Reviewed

Diindolylmethane

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.

 

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