Domperidone Not FDA Approved, Should Not be Marketed in the US, FDA Stresses

Quoted From NABP

July 31, 2013 2:10 pm Topics: Compounding and Patient Safety

Food and Drug Administration (FDA) stresses that domperidone is not an FDA-approved drug, and that it may not be legally marketed in the US. In June 2004, FDA warned compounding pharmacies and 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 arrest, 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 in whom the benefits of the drug may outweigh its risks. Domperidone is available to these patients through an Expanded Access to Investigational Drugs 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. According to FDA, currently the only authorized supplier of the drug is Dougherty’s Pharmacy in Dallas, TX.

Boards observing that an entity may be obtaining or compounding domperidone under circumstances not in compliance with FDA regulations are encouraged by the agency to report any concerns. Pharmacists may direct any questions to the FDA Division of Drug Information by sending an e-mail todruginfo@fda.hhs.gov or by calling 855/543-3784 or 301/796-3400.