Domperidone and Boards of Pharmacy: Further Scrutiny?
In a July issue of their electronic newsletter, the National Association of Boards of Pharmacy
published an article entitled "Domperidone Not FDA Approved, Should Not be Marketed in the US, FDA Stresses." Click here for the NABP article
The article references the June 2004 FDA warning to compounding pharmacies and suppliers that it is illegal to compound domperidone because the product has never been reviewed or approved for marketing within the US. It also includes information about the access to compounded domperidone for GI motility disorders through the agency's Expanded Access to Investigational Drugs program - click here to view
The FDA requires that domperidone only be obtained from certain specific suppliers and authorization must be approved by them in advance prior to the importation, shipment or administration of the drug. According to the agency, the only authorized supplier of domperidone is Dougherty's Pharmacy in Dallas, Texas.
For compounders, this information is not new. What is concerning about the NABP article is the following statement: "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." IACP members who currently provide compounded domperidone to patients and prescribers should be aware that Board inspectors may be following this federal policy during inspections and should contact their Boards to determine whether or not the state has a different interpretation or position than that of the FDA.
For additional information on the FDA position, pharmacists may direct any questions to the FDA Division of Drug Information by sending an e-mail to email@example.com
or by calling (855) 543-3784.