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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