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How To
Obtain Domperidone
On June 7, 2004, the Food and Drug
Administration (FDA) warned compounding pharmacies and firms that
supply domperidone for use in compounding that it is illegal to
compound domperidone and issued an import alert advising FDA field
personnel that they may detain shipments of finished drug products
and bulk ingredients containing domperidone. These actions were the
result of the Agency's concern about the potential public health
risks associated with the use of domperidone by lactating women.
Although FDA has determined that domperidone should not be
compounded or used to enhance breast milk production in lactating
women, there are some patients with severe gastrointestinal
disorders, such as severe gastroparesis or severe GI motility
disorders that are refractory to standard therapy, who may benefit
from the drug and in whom the drug’s benefits outweigh its risks.
FDA encourages physicians who would like to prescribe domperidone
for their patients with severe gastrointestinal disorders that are
refractory to standard therapy to open an Investigational New Drug
Application (IND). An IND is a request
for FDA authorization to administer an investigational drug to
humans. Such authorization would allow the importation, interstate
shipment, and administration of the drug even though it is not
approved for sale in the U.S.
For questions relating to domperidone
INDs contact Ms. Maureen Dewey, Regulatory Health Project Manager,
Division of Gastroenterology Products. Ms. Dewey can be reached at
(301) 796-0845 or
maureen.dewey@fda.hhs.gov.
Background Information
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Date created: May 18, 2005, updated September
6, 2006 |
