Re: getting vet to prescribe pergolide #legalityofpergolide


Nancy C
 
Edited

Though it is a common reason used, I would disagree with her assessment about her license, but that is just me.  As outlined in the other posts, this falls on the pharmacy.

https://ecir.groups.io/g/main/topic/more_posts_on_legality_of/6059689

Again, the legality has nothing to do with writing a prescription for a compounded drug. Prescriptions don't have to specify the source of the drug. That's on the compounder. A veterinarian selling a compounded drug is another story but if all they do is write a prescription for pergolide they are not involved in any legal issues - although I'd bet the BI reps visiting practices tell them something different.
Eleanor in PA
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I would submit you and your vet are not exceeding the VCPR - the veterinarian-client-patient-relationship.

You and/or your vet are not mass marketing this.

This one is more complicated --  "Compounded product mimics equivalent FDA approved product available on market" 

From message  206354  (emphasis mine)

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 that 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

www.drkellon.com 


from

On Fri, Mar 24, 2017 at 07:50 am, Barbara Rosensteel wrote:

- The FDA has ruled that compounded pergolide must be made using BI's prascend.  But, in two federal court districts, the FDA has been ruled against which means that compounding pharmacies in those districts can compound from bulk pergolide.  Unless I am wrong, district court decisions apply only to the districts in which they are made, and some pharmacies might make the decision to use prascend regardless of the court ruling,  so the only way to know for sure is to ask the pharmacy if they use bulk pergolide or prascend.

 That is all correct.
--
Eleanor in PA


I've found over the years that, sometimes, offering to sign a waiver of liability for your vet, absolving them of harm  for a protocol you wish to follow, gives them a little more courage.  I've never had to actually sign anything, but usually have been able to move them to try new things out.

Hope this helps.
--
Nancy C in NH
ECIR Moderator 2003

 

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