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Subject:
From:
Kathy Rubin APN <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Sat, 5 Feb 2005 09:23:10 EST
Content-Type:
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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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