Sunday, April 29, 2007

April 13, 2007 Clarification of Pergolide Supply

>Do you have email correspondence from these
> wholesalers that you can share, as you have letters from the FDA?

Yes, I do, but they're private e-mails (not government agencies) and
I don't have permission to broadcast them...

Without identifying the sender, here is an excerpt:

"...Here is what we know and/or what we suspect might happen.
- the FDA has not told us we cannot import the material so far
- the FDA issued a Human Compliance Policy Guideline (CPG)
about 4 years ago that specifically identified 20+ chemicals that
were banned or restricted for use in compounding due to safety
reasons. Presumably the withdrawal of pergolide for safety reasons
would fall under this CPG due to precedent.
- the FDA issued at Veterinary CPG shortly after the Human
CPG that stated all compounding from bulk chemicals for vet purposes
was illegal. There was talk at the time that they would issue a
short list of approved chemicals but according to people that saw the
list it was limited to chemicals commonly used to treat poisoning.
The FDA frequently cites AMDUCA as the rational for why bulk
chemicals are illegal.
- the judge in the Midland case did rule that vet compounding
from bulk chemicals is legal with the restriction that it be done for
non-food chain animals. Unfortunately, the way the federal district
courts operate this ruling only applies to the states within that
- the FDA routinely asks us to provide intended use (and
names of likely customers) in writing for chemicals we import before
they will allow the chemical to clear customs. Given the withdrawal
for safety reasons in humans and the ban on the use of bulk chemicals
in vet practice it is entirely possible that they could refuse to let
this material into the country or into our hands."

If there was no issue here, why would the FDA be working on a
solution? You can review some of the controversies here:

Maybe large pharmacies with big stockpiles are saying no problem,
maybe some pharmacies import drug directly in quantity and haven't
been stopped (yet). Maybe pharmacies are operating under the
impression that they won't be stopped because they haven't been in
the past (as in the link above), but if suppliers don't stock and
ship, there won't be an issue about whether what they are doing is
legal or not. There will be no supply.

We just have to wait and see what the FDA press release says next


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