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Date: | Sat, 5 Feb 2005 09:23:10 EST |
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In response to someone's question this morning, I ran a google search. I
could not locate anything more recent than June 2004 about Domperidone. From
what I found, it seems that it is illegal to "compound, import or distribute"
it. Hope this helps
Kathy R in NJ
The following was from the FDA in June, 2004. The paper talked about warning
women and pharmacies about the use of domperidone. It also noted that an
Import Alert was issued:
"The letters issued by FDA today stated that all drug products containing
domperidone (whether compounded or not) violate the Federal Food, Drug, and
Cosmetic Act (the Act) because they are unapproved new drugs and misbranded. In
addition, distribution within the U.S., or importation of
domperidone-containing products, violates the law. FDA informed the warning letter recipients
that further violations of the Act may result in enforcement actions including
seizure and injunction." FDA Talk Paper, June 7, 2004
_http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01292.html_
(http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01292.html)
Other info can be obtained from:
A letter issued by a local branch of FDA sent to a pharmacy who was
compounding domperidone:
_www.fda.gov/cder/warn/2004/Line%20Ave%20Letter.pdf_
(http://www.fda.gov/cder/warn/2004/Line%20Ave%20Letter.pdf)
International Academy of Compounding Pharmacists (who knew??), June 04
_http://www.iacprx.org/Domperidone.html_
(http://www.iacprx.org/Domperidone.html)
"This drug is not approved in the United States for any indication and it is
illegal to compound, import, or distribute this product in the United
States." from an unofficial transcript of the FDA warning as reported by
BreastfeedingOnline:_http://www.breastfeedingonline.com/DomperidoneFDATranscript.shtml_
(http://www.breastfeedingonline.com/DomperidoneFDATranscript.shtml)
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