Monday, November 24, 2014

Question of the Day November 24, 2014 IACP proposes that " That the inspection of compounders by the FDA must be based upon the standards required by the states. Too many compounders are being inspected using CGMPs (Current Good Manufacturing Practices) which are neither required nor appropriate for a pharmacy practice regulated by a state Board of Pharmacy." Is this logical? Why would a federal agency go inspect compounding pharmacies based upon each state's standards? Isn't this just an argument against the FDA having any authority over compounding pharmacies? Isn't the real issue that these compounding pharmacies are manufacturing and unwilling to register as outsourcing facilities? And isn't this the real reason compounders are against patient-specific compounding? It prohibits them from mass producing compounds which is where the huge profits are made

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