Re: True or false? Compounding pharmacies can only use Prascend, not bulk pergolide

Eleanor Kellon, VMD

On Sun, Mar 26, 2017 at 09:04 am, LeeAnne Bloye wrote:

As I understood how it works currently: Compounding pharmacies purchase bulk pergolide from offshore producers the same as BI. The pharmacies legally can  make capsules (or pills or whatever) that has any dosage except 1mg of pergolide.  Only BI can sell pergolide in a 1mg dosage.   

Now some new(?) ruling has changed that so that compounding pharmacies must buy Prascend tablets from BI for making capsules?  Or must they only purchase bulk pergolide from BI?  

 Dosage has nothing to do with it.  It has never been legal to compound from bulk drug when there is an FDA approved drug available. We had to get a special exemption, which was actually a statement the FDA would look the other way, when pergolide was pulled off the market for humans and there was no veterinary FDA approved drug. Now that Prascend is available, they are supposed to be compounding using that.  Before Prascend and the human pergolide ban they were supposed to be compounding using Permax - but weren't.  This is why the compounded drug is less expensive.

The legality is complicated. The FDA has no power to rule on anything. They can propose that certain things be made law but only Congress can make them a law.  The FDA also issues "position statements" which basically state how they interpret the law and how they will enforce it. However, position statements have no legal standing. There are existing laws against compounding from bulk drugs. However, two federal district courts have ruled that either that does not apply to animal drugs and/or the FDA is infringing on the rights of the states to oversee pharmacies.
Eleanor in PA 

EC Owner 2001

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