August 15, 2010

 
news update

 Court hearings continue in complaint against Florida compounder

 
posted August 1, 2010
 
 

A Florida drug compounder and the Food and Drug Administration will continue litigation over the legality of compounding veterinary drugs from bulk pharmaceutical ingredients.

Franck's Compounding Lab, of Ocala, Fla., filed a motion July 1 seeking dismissal of a complaint by the Food and Drug Administration, which is asking a federal judge to permanently bar the company from compounding animal-use pharmaceuticals from bulk drug ingredients. The FDA filed the complaint April 16 in the U.S. District Court for the Middle District of Florida.

An FDA guidance document, "Compounding of Drugs for Use in Animals," indicates that, without a new animal drug application, it is illegal to compound pharmaceuticals from bulk or unapproved drug substances. The document expresses a concern about veterinarians and pharmacies that compound pharmaceuticals with the intent of mass marketing them outside the drug approval process.

On July 2, the FDA filed a motion for a preliminary injunction, which would more quickly but temporarily prohibit such compounding and sales.

Franck's had voluntarily suspended its operations associated with compounding of veterinary-use drugs in mid-May and agreed to negotiate with the FDA over the matter. But the FDA's motion states that a preliminary injunction is needed to make sure the company complies with the agreement.

FDA officials argue that Franck's Compounding Lab has illegally compounded and shipped drugs that are considered to be adulterated, misbranded, and unsafe. Officials with Franck's Compounding Lab contend that the company's practices are legal and medically necessary.

U.S. District Judge Timothy J. Corrigan is scheduled to hear arguments Aug. 18 on the motion to dismiss the case and the motion for a preliminary injunction.