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News & Press: Breaking News

LIVE REPORT - 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, Executive Vice President/CEO is attending the FDA's Pharmacy Compounding Advisory Committee (PCAC) meetings. He files this live report.

 

This afternoon, after hearing presentations from FDA staff and nominators, the PCAC voted on the first two of nine submitted bulk substances to be added to a pending "positive list." Three more drugs are being 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 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. The Committee members expressed concerns about safety, routes of administration, and the lack of evidence of efficacy.

 

The PCAC 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.

 

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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