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News & Press: Breaking News

Pharmacy Compounding Advisory Committee List Clarification

Wednesday, October 19, 2016   (0 Comments)
Posted by: Dagmar Anderson
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FDA has recently announced the agenda and briefing materials for the third and final 2016 Pharmacy Compounding Advisory Committee meeting, which will be held on November 3rd. For this meeting, FDA will discuss five drugs for inclusion or exclusion for the “positive list” as well as a new class of drugs for the demonstrably difficult list. 

For more information on the “lists”, please click here.

The five drugs FDA will discuss are:

- Glycolic Acid – FDA is recommending to include on the positive list
- Trichloroacetic Acid – FDA is recommending to include on the positive list
- Kojic Acid – FDA is recommending to NOT include on the positive list
- Diindolylmerhane (DIM) – FDA is recommending to NOT include on the positive list
- Vasoactive Intestinal Peptide (VIP) – FDA is recommend to NOT include on the positive list

Additionally, FDA is proposing for “drug products that employ transdermal or topical delivery systems” to be included on the demonstrably difficult list. However, per the briefing materials published by FDA, the only drug products to be considered will be “drug products that employ matrix or reservoir type transdermal or topical delivery systems..” and will not include a discussion on “liquid or semisolids, such as gels, creams, lotions, foams, ointments or sprays, that are intended for use without matrix or reservoir type transdermal or topical delivery systems.” (page 189 of the briefing materials). 

IACP is aware of some confusion in the industry regarding this discussion and the belief that transdermal pain creams or topical hormone creams will be discussed. At this point, this is not the case. IACP will be in attendance at the PCAC meeting and will be prepared to defend these (and other compounds) if the discussion regarding transdermal or topical delivery systems deviates from what is outlined in the briefing materials. Based on the history of discussions held at previous PCAC meetings, IACP believes the vote will solely be based on those products which use matrix or reservoir systems.

Please email your questions to iacpinfo@iacprx.org.

John Voliva, RPh/IACP Executive Vice President

 

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