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News & Press: Breaking News

IACP's Statement Regarding FDA’s recently released final rule on bulk drug substances

Wednesday, March 6, 2019  
Posted by: Jennnifer Petska
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IACP has reviewed the FDA’s recently released final rule on bulk drug substances for which there is a clinical need under the FDCA (“the 503B bulks list”).  We continue to have concerns about the restrictive criteria the agency is using to make a determination as to the “clinical need” for placing nominated substances on the 503B bulks list. By using restrictive criteria that so heavily favor compounding from FDA approved drugs as opposed to compounding from bulk ingredients, IACP is concerned that the agency is limiting the 503B bulk list in a way that will jeopardize patient access to compounded medications and stifle the outsourcing facility market from developing.  Additionally, FDA’s policies will make it less likely that 503A compounding pharmacies will choose to register as outsourcing facilities and less likely that the 503B outsourcing facilities will be able to meet the needs of patients and prescribers for compounded medications that must be administered to patient in office or clinical settings.

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