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News & Press: Breaking News

IACP Live Report: FDA Pharmacy Compounding Advisory Committee Says NO to Domperidone

Wednesday, October 28, 2015   (1 Comments)
Posted by: Dagmar Anderson
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Reporting from the FDA's Pharmacy Compounding Advisory Committee (PCAC) meeting, today, IACP's David Miller, RPh, EVP/CEO sends the following news.

This afternoon, PCAC 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 IND is still available to meet individual patient needs and 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.

Although the Committee's vote was taken today, no decision of the PCAC is final until the recommendations are reviewed by the Secretary of Health and Human Services and published through the Federal Register.  

Comments...

Chris Coleman says...
Posted Wednesday, October 28, 2015
Foreign outsourcing is a better option than the patient-doctor-pharmacist triad? I'm curious if the members of PCAC are aware of how well versed U.S. physicians and pharmacists are at managing patients taking Rx's that prolong QT interval? Rationale like this, from the highest drug regulatory agency in our country, does help explain why our health system is one of the worst in the developed world.

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