E-DRUG: U.S. FDA's policy on drug donations

[snightin@bangate.fda.gov]

E-DRUG: U.S. FDA's policy on drug donations
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FDA, as an agency within the Department of Health and Human 
Services within the U.S. Government, has a position consistent 
with the position taken about drug donations by the U.S. 
Government at the World Health Assembly (WHA) in May 1996--that 
is, endorsing the WHO guidelines on drug donations.  Specifically, 
the U.S. endorsed the guidelines on a "trial" basis requesting 
that these guidelines be reviewed in one year.  However, since 
implementation has been slow, WHO did not bring this issue back 
to the WHA in 1997, but is expected to do so at the 1998 World 
Health Assembly. WHO is supposed to discuss its experience with 
relevant parties and bring those views to the WHA so that any 
revision needed in the guidelines can be made.

FDA, as a regulatory agency, has not issued specific advice to 
physicians, pharmacists, or hospitals about drug donations. On 
the other hand, FDA does have specific regulations covering 
pharmaceutical exports. For examle, FDA does have requirements 
for Good Manufacturing Practices which apply to drugs used 
domestically, as well as to drugs exported from the United
States for any purpose.  

Should anyone be interested in any specific regulations or 
guidelines, please let me know.  FDA's World Wide Web site 
(www.fda.gov) contains information on our regulations, 
guidelines, and guidances. Please let me know if I can be of 
any further assistance.

Stuart L. Nightingale, M.D.
 Associate Commissioner for Health Affairs
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857, USA
Email: snightin@bangate.fda.gov

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