Saturday, August 31, 2013

Second Question of the Day August 30, 2013 If IACP's claim is that the FDA only has jurisdiction to inspect compounders acting like manufacturers, then isn't the FDA applying the correct standards when it inspects "compounders acting like manufacturers" by applying cGMPs?

Alternatively, if states and not the FDA have the authority to inspect traditional compounders, as the IACP argues, then why would the FDA inspect "compounders acting as manufacturers"  and apply standards such as 797?  Again, it seems like IACP's argument is illogical.  

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