Regulatory Brief

 U.S. Food and Drug Administration versus Franck's Lab, Inc.

Complaint for Permanent Injunction


Brief Description:

The Food and Drug Administration (FDA) filed a complaint in the U.S. District Court for the Middle District of Florida seeking injunctive relief against Franck's Pharmacy. The FDA's complaint alleges that Franck's has been engaging in "compounding, manufacturing, processing, packing, labeling, holding, and distributing drugs within the meaning of 21 U.S.C. § 321(g), which are new animal drugs within the meaning of 21 U.S.C. § 321(v)."

AVMA Response:

The AVMA applauds the FDA's enforcement of illegal manufacturing activities. The AVMA asserts that large-scale manufacturing of animal drugs under the guise of compounding does not serve to benefit animal health; rather, circumvention of the drug approval process yields substances with questionable safety and efficacy, potentially both allowing disease to progress and harming animal health. In addition, considering the wide scope of species and disease conditions veterinarians treat, illegal manufacturing of drugs only serves to divert resources away from FDA-approved drugs manufactured legally and can potentially result in a supply/demand disincentive for new FDA-approved drugs.

The AVMA continues to ensure veterinarians are made aware of the Animal Medicinal Drug Use Clarification Act (AMDUCA) and related FDA regulations addressing the issue of compounding, through educational materials published in the Journal of the AVMA and our other regular communication vehicles. The AVMA continues to maintain active dialog with relevant stakeholders on the issues surrounding compounding, including our member veterinarians, regulators, animal health industry, and pharmacists. The AVMA applauds the FDA for its efforts to promote animal health through prohibition of illegal drug manufacturing activities, thereby promoting assurance of pharmacologic and legal soundness of drugs manufactured for the health of our nation's animals. 

Status:

The AVMA responded on May 25, 2010. (PDF)