SOURCE: King & Spalding

King & Spalding

September 15, 2011 10:51 ET

King & Spalding Wins Landmark Veterinary 'Compounding' Victory Against Food and Drug Administration

JACKSONVILLE, FL--(Marketwire - Sep 15, 2011) - King & Spalding obtained a significant victory in the U.S. District Court for the Middle District of Florida in a ruling against the U.S. Food and Drug Administration. For the first time in the 70-year history of its controlling statute, the FDA had tried to bar a licensed pharmacy from the "traditional practice" of compounding animal drugs in accordance with state law. Federal Judge Timothy J. Corrigan ruled in favor of Ocala, Fla.-based Franck's Lab, Inc., on September 12, granting its motion for summary judgment and denying the FDA's request for an injunction.

In an 80-page decision, Judge Corrigan sided with Franck's Lab, saying the Food, Drug and Cosmetic Act does not give the FDA the authority to prohibit state-licensed veterinary compounding from bulk drug ingredients. He held that the FDA lacked the authority "to enjoin the long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian's prescription for a non food-producing animal by compounding from bulk substances."

To view the decision, click here.

In April 2010, without prior notice, the FDA filed a highly publicized complaint seeking to enjoin Franck's veterinary compounding practice based on the novel legal theory that animal medications compounded from bulk ingredients constitute "new animal drugs" that cannot be distributed without an FDA-approved new animal drug application. Franck's argued that the traditional, state-licensed pharmacy practice of compounding commercially unavailable veterinary medications from bulk ingredients is lawful and a practice followed by hundreds of licensed pharmacies throughout the nation.

The King & Spalding Washington-based litigation team representing Franck's Lab was led by partner Mark S. Brown and consisted of partners Jeffrey S. Bucholtz, Alan R. Dial, Ashley C. Parrish, associate Amanda J. Klingler and former associate Candice Chiu. Also representing Franck's were Edward L. Birk and Jeptha F. Barbour of Marks Gray, of Jacksonville, Fla., and Michael E. Dean and Timothy S. Dean of the Dean Law Firm, of Ocala, Fla.

About King & Spalding
Celebrating more than 125 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with 800 lawyers in 17 offices in the United States, Europe, the Middle East and Asia. The firm has handled matters in over 160 countries on six continents and is consistently recognized for the results it obtains, uncompromising commitment to quality and dedication to understanding the business and culture of its clients. More information is available at www.kslaw.com.

Contact Information