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IACP's David Miller Reports from PCAC Two-day Meeting
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For the past two days, IACP's David G. Miller, RPh, Executive Vice President/CEO has sat through the Pharmacy Compounding Advisory Committee (PCAC) meeting. He has sent a series of live reports as PCAC members have debated, hotly at times, various pharmacy compounding issues.

 

QUOTE HERE FROM DAVE

 

Yesterday afternoon, after hearing presentations from FDA staff and nominators, PCAC voted on the first two of nine submitted bulk substances to be added to a pending "positive list." This list is intended to include Active Pharmaceutical Ingredients (APIs) which do not have a USP/NF monograph or which are not components of an FDA-approved drug product.

The PCAC considered the addition of methylsulfonylmethane (MSM) to a list of bulk ingredient/APIs that 503A traditional compounders may use and voted 10 to 1 NOT to permit its use in compounding. Committee members expressed concerns about safety, routes of administration, and the lack of evidence of efficacy.

The PCAC also considered the addition of curcumin to a list of bulk ingredients/APIs that 503A traditional compounders may use and voted 6 to 4 with 1 abstention to NOT permit its use in compounding for drug therapy.

Later Tuesday afternoon, after hearing presentations from FDA staff and nominators, PCAC voted on three more of nine submitted bulk substances to be added to a pending "positive list."  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.

The PCAC considered the addition of germanium sesquioxide to a list of bulk ingredient/APIs that 503A traditional compounders may use and voted 11 to 0 NOT to permit its use in compounding. The Committee members commented on their concerns about safety and the availability of other approved treatments. That vote against adding germanium to the bulk ingredient "positive list" was what had been recommended by FDA.

PCAC considered the addition of rubidium chloride to a list of bulk ingredients/APIs that 503A traditional compounders may use and voted 11 to 0 to NOT permit its use in compounding for drug therapy. That vote was based upon a lack of convincing data and evidence and was consistent with FDA's internal review and recommendations to the Committee.

The Committee considered the addition of deoxy-D-glucose to a list of bulk ingredients/APIs that 503A traditional compounders may use and voted 9 to 3 to NOT permit its use in compounding for drug therapy. Several Committee members pointed out lack of evidence for its use in antiviral or malignancies, a lack of efficacy, and concerns about safety. FDA's background information presented to the Committee recommended that deoxy-D-glucose not be used in compounding.

This morning, the second day of its open meeting, PCAC voted on three more of nine submitted bulk substances to be added to a pending "positive list."  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.

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. The resulting vote 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.

This afternoon, the Committee received presentations from FDA, representatives from the compounding community, physicians, and other members of the public on whether or not domperidone should be included on the list of drugs that a 503A traditional compounder can use in fulfilling prescriptions.

The Committee voted 8 to 3 to NOT include or permit compounding with bulk domperidone. While Committee representatives recognized that the product is approved in other countries and has a long-standing track record of safety and efficacy, there were also concerns raised about the changes in recommended dosing as well as safety reports on QT prolongation. An Investigational New Drug (IND) application is still available to meet individual patient needs. That was noted by several of the Committee members as a rationale why compounding is unnecessary when the finished manufactured product can be obtained from foreign producers.

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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