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News & Press: Breaking News

LIVE REPORT Part III - FDA PCAC Votes on Bulk Drug Substance Nominations

Wednesday, October 28, 2015   (0 Comments)
Posted by: Dagmar Anderson
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IACP's David G. Miller, RPh, Executive Vice President/CEO is attending day two of FDA's  Pharmacy Compounding Advisory Committee (PCAC) meetings. Below is his first report of the day.


On the second day of its open meeting, the PCAC voted on the three more of nine submitted bulk substances to be added to a pending "positive list." These three plus domperidone, which will be considered this afternoon, will make a total of nine drugs reviewed at the October 27/28 meeting.  This list is intended to include APIs which do not have a USP/NF monograph or which are not components of an FDA-approved drug product. These three along with domperidone which will be presented this afternoon represent a total of nine APIs that are under consideration for the "positive list"

The PCAC considered the addition of alanyl-L-glutamine  to a list of bulk ingredient/APIs that 503A traditional compounders may use and voted 11 to 1 NOT to permit its use in compounding.  The Committee members commented on their concerns about safety in its use in IV therapy and literature citation of a randomized clinical trial that showed an increase in mortality among patients receiving treatment with the drug. That vote against adding alanyl-L-glutamine to the bulk ingredient "positive list"  was what had been recommended by FDA.

The PCAC considered the addition of gluteraldehyde to a list of bulk ingredients/APIs that 503A traditional compounders may use and voted 9 to 1 (2 individuals did not vote) to permit its use in compounding for topical uses only and to INCLUDE it on the "positive list."  That vote was based upon historic use of the product in treating warts, clinical efficacy, and a general safety profile.  That was consistent with FDA's internal review and recommendations to the Committee.

The PCAC considered the addition of glycyrrhizin to a list of bulk ingredients/APIs that 503A traditional compounders may use and voted 11 to 0 (1 individual did not vote) to NOT permit its use in compounding for drug therapy. Several Committee members pointed out lack of evidence for any efficacy in antiviral therapy, the existence of highly effective FDA approved drugs available for patients, and significant concerns about safety when using glycyrrhizin in IV therapy. FDA's background information presented to the Committee recommended that glycyrrhizin not be used in compounding.

It's important to remember that although the PCAC voted today and yesterday, their decision is only a recommendation to the Secretary of Health and Human Services. Until those recommendations are considered by the Secretary and formally published in the Federal Register, there are no current prohibitions on using these three APIs in fulfilling a compounded prescription for an individual patient. At the conclusion of this two-day meeting, the FDA PCAC will have considered and decided upon 19 APIs out of a total announced 64.

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