Virginia Board of Pharmacy August 2013 Newsletter Discusses Domperidone

Domperidone
Domperidone is not a Food and Drug Administration
(FDA)-approved drug, and it is not legally marketed in the
United States. In June 2004, FDA warned compounding
pharmacies, as well as firms that supply domperidone for use
in compounding that it is illegal to compound domperidone.
In addition, FDA put into place an import alert permitting
FDA personnel to detain domperidone shipments of bulk
ingredients and shipments of finished drug products offered
for importation without an active investigational new drug
application. These actions resulted from FDA’s concern
about the potential health risks associated with the use of
domperidone in lactating women. These risks include cardiac
arrhythmias, cardiac death, and sudden death.
Although domperidone is not FDA approved, FDA recognizes
there are some patients with severe gastrointestinal
motility disorders that are refractory to standard therapy who
may benefit from the use of domperidone and for whom the
benefits of the drug may outweigh its risks. Domperidone is
available to these patients through an Expanded Access to
Investigational Drugs for Treatment Use program. Under this
program, domperidone may be obtained only from certain
specified suppliers and authorization must be obtained prior
to the importation, interstate shipment, and administration
of the drug. It is the Board’s understanding that as of July
1, 2013, there are currently no pharmacies in Virginia with
FDA approval to possess domperidone.
Obtaining or compounding domperidone not in compliance
with FDA requirements may result in an investigation
by the Board and FDA. Deficiencies that may be cited during
an inspection include Major Deficiency 27 and/or Major
Deficiency 25 as listed in Guidance Document 110-9.
Questions regarding FDA’s standards for domperidone
may be directed to FDA Division of Drug Information at
www.fda.gov/AboutFDA/CentersOffices/OfficeofMedical
ProductsandTobacco/CDER/ucm082585.htm, 855/543-
3784, 301/796-3400, or druginfo@fda.hss.gov.
quoted from Virginia Board of Pharmacy August 2013 Newsletter