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News & Press: Breaking News

LIVE REPORT PART TWO - FDA PCAC Votes on Bulk Drug Substance Nominations

Tuesday, October 27, 2015   (0 Comments)
Posted by: Dagmar Anderson
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IACP's David G. Miller, RPh, files this additional report from today's Pharmacy Compounding Advisory Committee (PCAC) meeting.

This afternoon, after hearing presentations from FDA staff and nominators, PCAC voted on the three more of nine submitted bulk substances to be added to a pending "positive list." That makes five APIs reviewed today with an additional two tomorrow on October 28, 2015. 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.

The 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 PCAC 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.

It's important to remember that although the PCAC voted today, 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 prohibitions on using these two APIs in fulfilling a compounded prescription for an individual patient.


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