The FDA filed a complaint for injunction through the Department of Justice April 16 in the U.S. District Court for the Middle District of Florida that would permanently bar Franck’s Compounding Lab in Ocala, Fla., from compounding animal drugs from bulk ingredients without FDA approval.
“FDA recognizes the benefit of the traditional practice of pharmacy compounding -- providing a service in response to a valid prescription to accommodate the specialized needs of a particular patient,” says Bernadette Dunham, DVM, PhD, director of the FDA Center for Veterinary Medicine. “But when compounders like Franck’s circumvent, and, thus, undermine the statutory drug approval process by manufacturing drugs under the guise of pharmacy compounding, we are concerned that poorly compounded drugs can jeopardize the health of animals.”
The FDA claims many of Franck’s “illegal products” are copies of drugs available and approved by the FDA; and says the pharmacy has been warned, as recently as December 2009, about its “illegal behavior.” Despite the warning, Franck’s has continued the practices. The injunction would prevent Franck’s from introducing any “adulterated, misbranded, and unsafe animal drugs into interstate commerce,” according to FDA. “The business of Franck’s Compounding Lab is both legal and medically vital. Customized human and veterinary medicines -- which we prepare pursuant to a verified prescription -- meet the critical needs of doctors, veterinarians and their patients that are otherwise unmet by off-the-shelf manufactured products,” states an April 19 statement released by Franck’s. “Franck’s has been preparing customized medicines for more than 27 years. We will defend ourselves against FDA’s action so that we can continue to make prescription medicines that improve the quality of our patients’ lives. Our quality control procedures are strong and fully comply with regulatory requirements.”
After the death of 21 horses at the U.S. Polo Open last year, Franck’s released a statement saying, "The strength of an ingredient in the medication was incorrect.” Franck’s had prepared medication for the horses that died based on an order from a polo team veterinarian. The Florida-licensed veterinarians for the Venezuelan Lechuza Caracas Polo team wrote a prescription for a compounded substitute vitamin supplement for BIODYL containing vitamin B, potassium, magnesium and selenium. Horses treated with the compound became sick and died within three hours of treatment. The horses that were not treated remain healthy and normal, according to a team statement.
The horses reportedly appeared dizzy and disoriented while being unloaded from their trailers and seven died at the scene. The others died during treatment elsewhere or while being moved to a medical facility.
Almost immediately, officials indicated it appeared the horses died of heart failure caused by a toxin that could have tainted their food, vitamins, supplements or all three. High levels of selenium were ultimately suspected as the cause in the deaths, according to necropsy reports.