--- In EquineCushings@yahoogroups.com, "Ian Hudgings"
>
>
> The reason the wholesalers can't get Pergolide is because it is on an
> FDA hold and will be seized by customs at the border. Even if I could
> find a source for bulk Pergolide and convince them to ship it to me,
> it would likely get seized and we would still be in the same
> situation.
The last I heard from a wholesaler (and this information is a week old
so maybe things have changed), the FDA has not taken any action to stop
movement of pergolide, and really would have no reason to do that since
the legal demand for the drug is gone. The finished product (pergolide
pills) manufacturers have ceased production.
The FDA theoretically could seize pergolide or ban importation, but as
far as I know that has not occurred. The reason the wholesalers are no
longer wanting to carry it is simply that there is no legal avenue for
them to sell it.
The compounding of veterinary drugs from bulk powder like this is
considered illegal by the FDA. There is one court decision that
disagrees with that stance, two that uphold it. The only reason it's
even a point of contention is that the original legislation permitting
veterinary compounding did not specifically mention compounding from
bulk drugs. However, a later Compliance Guideline policy statement by
the FDA specifically prohibits compounding from bulk drugs. To put it
another way, even if the human manufacturers hadn't withdrawn the drug
from the market, it could still be illegal for compounding pharmacies
to make pergolide for equine use from bulk drugs. The reason for this
policy is that compounded drugs are not checked for potency and purity
the way manufactured drugs are. We've already seen multiple times on
this list how that can cause problems.
The wholesalers are caught in the middle. They can't legally sell bulk
pergolide to compounding pharmacies.
The only way around this would be for the FDA to make an exception in
the case of pergolide for Cushing's horses. They might also decide to
try to encourage one of the previous pill manufacturers to start
production again. Until this is sorted out, the other option you and
your vets all have individually is to submit a MNVD request as I
outlined yesterday. Post 90108.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
The sooner they start getting these requests, the sooner they'll
realize there's a problem.
Eleanor
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