For the first time, the U.S. Food and Drug Administration (FDA) is attempting to end a veterinary compounding operation, accusing Franck’s Pharmacy in Florida of selling adulterated and misbranded drugs in violation of federal law.

The agency is asking U.S. District Court in the Ocala Division of the Middle District of Florida for a permanent injunction against Franck’s Compounding Lab, a part of the pharmacy that bills itself as “the nation’s premier compounder.”

In a written statement, Franck’s Pharmacy said, in part: “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.”

The FDA filed the legal complaint on Friday. In an announcement today about the action, the agency said it is “concerned that the company’s continued compounding practices pose a significant health risk.” It cited as evidence the deaths of 21 polo horses that were given a drug compounded by Franck’s just before a match in the U.S. Open Polo Championships. The horses died one year ago today.

Despite the reference to the high-profile polo incident, FDA Center for Veterinary Medicine spokeswoman Laura Alvey said the legal action does not stem from that specific case. “This action deals with the practice of compounding animal drugs from bulk API (active pharmaceutical ingredients),” she told the VIN News Service by e-mail.

Compounding — when, why and how it is done — has been the subject of a long-running legal tussle between the FDA and compounding pharmacies. Compounding is the practice of preparing medications for individual patients whose unique needs cannot be met by commercially available FDA-approved drugs. Compounded drugs are not subject to the FDA drug-approval process, an extensive, expensive undertaking through which drugs are tested for safety and efficacy.

Compounding is a growing business in human and veterinary medicine alike. Veterinarians lean heavily on compounding because relatively few medications are made specifically for non-human species — especially exotic pets such as birds and rabbits.

Under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), compounders of veterinary medications are prohibited from using “bulk” ingredients as their starting material; products must be compounded instead from FDA-approved finished drugs.

Nevertheless, veterinary compounders widely admit to using bulk ingredients, saying they cannot compound properly otherwise. (A two-part series on the complicated and confused state of veterinary compounding was published last fall by the VIN News Service.)

Apart from sending warning letters to some compounders, the FDA appeared to be looking the other way — until now.

According to the complaint against Franck’s Pharmacy, the FDA inspected the compounding facility in the fall of 2004. In January 2005, it sent Franck’s a warning letter advising it of the following violations:

• Compounding veterinary drugs from API (bulk ingredients) and distributing them in interstate commerce--Compounding veterinary drugs outside the context of a valid veterinarian-client-patient relationship

• Not compounding for individual patients, but rather, compounding for third-parties who resell to individual patients

• Compounding drugs for use when an approved drug, in available dosage form and concentration, exist to treat the animal

Franck’s responded with a letter from its lawyer promising “ ‘to comply immediately and completely with any and all FDA and other legal requirements’...” the complaint states.

Following the deaths of the polo horses in April 2009, the FDA inspected Franck’s Pharmacy again, visiting it on May 5-20, June 18-23 and Dec. 1-4.

“These inspections revealed that Defendants continue to unlawfully compound drugs from API for use in animals,” the complaint reads. It also states, “FDA investigators informed Defendants of their continuing violation during the December 2009 inspection, to which Defendant Paul W. Franck [the pharmacy owner] responded that he understood that under the FDA’s interpretation of the law, Defendants’ activities are illegal, but disagreed with that interpretation.”

Gigi Davidson, director of clinical pharmacy services at North Carolina State University’s College of Veterinary Medicine, said the FDA appears with this case to be taking a stand against a too-liberal use of compounding in veterinary medicine overall.

“FDA seems to be using Franck’s to make a generalized, broad sweep of veterinary compounding,” Davidson said.

According to the FDA complaint, Franck’s employs about 67 people, has annual gross sales of about $8 million — $3.5 million is from veterinary products — and filled more than 37,600 prescriptions for animal use between Feb. 1 and Dec. 4, 2009.

In addition to its legal trouble with the FDA, Franck’s is being sued by owners of nine of the dead polo horses; and by Diamond State Group, an insurer that reportedly paid out $1.3 million for the loss of the remaining 12 ponies. The parties are seeking damages worth more than $4 million.

The horses died after being injected with a compounded version of Biodyl, a vitamin supplement made by Merial that is not approved by the FDA but is used in other countries.

Franck’s Pharmacy later admitted that it made a mistake in preparing the compound. An investigation led by the Florida Department of Agriculture and Consumer Services determined that the horses likely died of an overdose of selenium, a component of Biodyl.

The FDA also investigated the case; the status of that investigation is unclear. Last October, spokeswoman Alvey told the VIN News Service that the investigation was active and ongoing. On Monday, she said by e-mail, “The FDA cannot confirm or deny if we are actively conducting an investigation.”