On Sept. 25, U.S. District Judge Karl Forester filed a consent decree in a civil case between the United States and the Lexington, Ky., pharmacy BET Pharm LLC. The two sides settled a dispute over compounded drugs for use in horses.
In August 2004, the United States filed a complaint in the U.S. District Court for the Eastern District of Kentucky alleging that compounded drugs from BET Pharm were adulterated because they were new animal drugs that were not approved as required by the Federal Food, Drug, and Cosmetic Act. The complaint also alleged that the compounded drugs were misbranded because they failed to bear adequate directions for use.
The U.S. marshal for the district seized the compounded drugs from BET Pharm shortly after the complaint was filed (see JAVMA, Oct. 1, 2004).
Without admitting or denying the allegations in the complaint, BET Pharm agreed to the consent decree, which requires the pharmacy to pay all court costs, along with other expenses, and to destroy the seized compounded drugs under the supervision of a Food and Drug Administration representative.
At least one other case involving compounded drugs recently played out in the courts. In August, the U.S. District Court for the Western District of Texas, Midland-Odessa Division, ruled that compounded drugs, when created for an individual patient following a prescription from a licensed practitioner, are implicitly exempt from the "new drugs" definitions in the FFDCA (see JAVMA, Oct. 15, 2006).