Saturday, March 9, 2013

FDA With 14 Compounding Pharmacies Nationwide Inspected and Reports Filed It is Starting to Appear That It is Capable and Ready If Clearly Assigned the Task

Before the NECC outbreak it was not clear when the FDA had jurisdiction to inspect compounding pharmacies.  The FDA has some jurisdiction to go in and inspect along with state boards of pharmacies in some case.  However, at least one federal district court in Florida in the Frank's veterinary compounding case involving the death of polo ponies had said the FDA did not have jurisdiction over the compounding pharmacy and that only the state did.

Since NECC, the debate has been ongoing about the current state of the law and the future state of the law.  One thing is now becoming clear: If Congress tasks the FDA with primary jurisdiction over all or part of inspecting compounding pharmacies, both human and veterinary, the FDA, even with its current budget and staff is up to the task, and has gotten more done in 2013  than all the states combined in the last several years.  See here for names and inspection reports of the 14 compounding pharmacies inspected so far. The states have picked up the pace in their inspections and enforcement of their rules and regulations relating to compounding pharmacies since the beginning of 2013 but it in no way compares yet to what the FDA has accomplished.  Could both the FDA and the states have done more so far. Yes.  Are both at least doing more than they were before the NECC outbreak. Yes.  So at least both the FDA and the states are moving in the right direction, but the FDA is definitely by all appearances making the stronger attempt to clean up the bad compounders who pose potential risk to the heath and safety of the general public.  We'll keep watching to see what happens in the coming weeks.