Yes, I am saying that page is incorrect when it says current legal precedent
supports the assertion that compounding of an unapproved drug is legal in
the U.S.  I don't have any opinion about the rest of it.

I am not saying what I think the law should be - just what the latest
federal decision (last year in the 5th Circuit) is. And thank you Arly for
supplying the FDA quote.

As for prosecution of a compounding pharmacy, the 5th Circuit case held that
compounding pharmacies could be prosecuted. I don't know whether
prosecutions have been brought.  

When I was first asked to research this (last year just after the 5th
Circuit decision), I tried to find out more about the history of domperidone
in the U.S.   Why did the original manufacturer (it is now generic) seek
approval in other countries but not in the U.S.?  Was approval ever sought
in the U.S.? Did anyone ever seek approval for this use (which could have
led to patent extension) either in the U.S. or elsewhere?  I couldn't find
the answers to any of these questions so if anyone knows, I'd be curious.
Conspiracy theories aside, it was probably just never worth it economically
for a pharmaceutical company to invest the money. 

I believe I've reached my daily post limit. :)

Yours,
Jake
  

On Fri, 3 Jul 2009 12:55:33 -0500, Kershaw Jane
<[log in to unmask]> wrote:

>Please take at the following article
http://www.breastfeeding.org/articles/domperidone.html for more information
on this subject.   Are you stating that the information in this article is
incorrect?  Please show evidence of a successful prosecution of a
compounding pharmacist for this.  I think FDA uses scare tactics.  It is
absolutely ridiculous to me that a product such as VIAGRA with known health
risks is allowed to be on the market because it helps with the production of
a bodily fluid from a male that on occasion results in births of babies that
we are trying to help, but tries to prevent another pharamaceutical that has
been shown to help with production of a bodily fluid from a female that
sustains the life of babies produced (at times) by the use of the other! 
Maybe that's because the largest profit margin for pharmaceutical companies
is the formula industry?
>
>-----Original Message-----
>From: Lactation Information and Discussion
[mailto:[log in to unmask]] On Behalf Of Jake Marcus
>Sent: Friday, July 03, 2009 6:30 AM
>Subject: Re: Domperidone
>
>No. Domperidone is not approved for any use in the U.S.  Manufacture
(including by a compounding pharmacist) is illegal. Importation via an
Internet pharmacy (from Canada, for example) is also illegal.
>
>Hope that helps. :) There is a great deal of inaccurate information
floating around there about the legality of obtaining domperidone in the U.S.
>
>Yours,
>Jake Marcus, J.D.
>
>On Thu, 2 Jul 2009 22:31:50 EDT, [log in to unmask] wrote:
>
>>Is there any way for a mother to obtain  Domperidone legally in the U.S?
>>Mother went 7 weeks trying to nurse a  posterior tongue tied baby who 
>>was not up to birth weight at 7 weeks.  I  saw them Tues., tongue was 
>>lasered yesterday and baby will go for CST  ASAP.  Milk supply is way 
>>down and she is supplementing with ABM.  Was  pumping with used PINS, but
now has Symphony.
>>She is on Fenugreek, red  raspberry tea,milk thistle and oatmeal.  She 
>>asked me about use of  Domperidone.  What is the latest info?  TIA
>>
>>Alice Ernest IBCLC, RLC
>>Sunny hot Simpsonville,SC
>
>             ***********************************************

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