Wednesday, April 16, 2014

Question of the Day April 16,, 2014 What is or will be the FDA's position regarding providing samples of compounding preparations under the DQSA? Does it matter if the samples are being provided under 503A or 503b? Are samples allowed if a compounding pharmacy is an outsourcing facility? How can samples be provided if compounded preparations are suppose to be patient specific under 503A? Should compounding pharmacies receive warning letters from the FDA if they hand out samples or should states regulate this area?


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