Tuesday, April 2, 2013

Question of the Day: 4/2/2013 Are FDA and State Inspectors Knowledgeable Enough and Consistent Enough Throughout the Nation to Inspect Compounding Pharmacies?

By consistent I mean at the FDA it appears that perhaps each district office is inspecting and writing compounding pharmacies up in an inconsistent manner.  For example, while a pharmacy in Oklahoma might be violating the rules and regulations in the same manner as a pharmacy in South Carolina, the one in South Carolina gets cited for the violation while the one in Oklahoma does not.   Do the inspectors have a clear understanding of all the issues they should be looking for at each compounding pharmacy?  Did they all receive the same training?

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