I hardly ever post on Lactnet but whenever Domperidone (or a state
breastfeeding law) comes up I quickly use up my daily post allotment. :)

Morgan, there has historically been very sketchy enforcement of state and
federal law against compounding pharmacies so in many places in the US
obtaining Domperidone has been easy.  Not legal, but easy.

Lara, there was a federal court case out of Texas concerning FDA regulation
of compounding pharmacies which many non-lawyers were citing for the
proposition that Domperidone compounding was legal.  The article at KellyMom
as well as articles at other breastfeeding sites reflect that misplaced
optimism. The same Texas federal court case was reversed on appeal
(technically vacated and remanded - Medical Center Pharmacy v. Mukasey, 5th
Circuit Court of Appeals, July 2008, for anyone who would like to read it).
Not only may the FDA regulate compounding pharmacies but the legality of
compounding and/or sale of drugs that are *not approved* by the FDA was
never even an issue in the case.  Compounding pharmacies may under some
circumstances create drugs in different forms (liquid when only commercially
manufactured as a pill) or in different doses (smaller doses than
commercially manufactured) but can not legally do so for drugs that have not
been approved for any use by the FDA. Domperidone has not been approved for
any use in the US therefore it is not legal to sell it here. 

Some doctors have been prosecuted for writing prescriptions for Domperidone
and many have not. Lack of prosecution does not alter illegality.

Hope that helps.

Yours,
Jake

On Fri, 3 Jul 2009 21:27:02 +0800, Lara <[log in to unmask]> wrote:

>Morgan Gallagher <[log in to unmask]> wrote:
>
>> Jake Marcus wrote:
>> > 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.
>
>> This really confuses me.  I know women in the USA who have not only got
>> scripts for it from their Doctor but the compounding pharmacy has then
>> billed the insurance company, who are paying for it happily.
>
>The FDA have claimed jurisdiction and attempted to ban domperidone
>altogether. However, Compounding Pharmacies lie in curious area of the
>law which isn't necessarily under FDA jurisdiction - and furthermore,
>there is recent judicial precedent in this area supporting compounding
>pharmacies.
>
>The links here are useful.
>
><http://www.kellymom.com/health/meds/prescript_galactagogue.html>
>
>Lara Hopkins

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