Apr
28
2010

A Florida compounding pharmacy is denying that it broke the law, following a suit filed against it by the federal government.

Last week the U.S. Food and Drug Administration (FDA) filed a complaint for permanent injunction against compounding pharmacy Franck’s Compounding Lab of Ocala, Fla. The case is a milestone in the long and complex history of compounding regulation.

“This is the first time FDA has sought a permanent injunction to end compounding activities by a veterinary compounding pharmacy,” said Laura Alvey, a spokesperson for the FDA’a Center for Veterinary Medicine.

The injunction would permanently bar Franck’s Compounding Lab and CEO Paul W. Franck from compounding or distributing drugs without FDA approval, and award “just and proper” costs to the FDA.

Last year, Franck’s drew attention from the media when 21 polo horses from the Lechuza Caracas polo team died at the U.S. Open Polo Championships after they were given a compounded formula of Biodyl. Franck’s was the pharmacy that prepared the formula, and admitted shortly after the incident that it incorrectly prepared the formula.

The FDA may or may not be investigating this particular incident. Alvey said the agency could “neither confirm nor deny the existence of an investigation” into the polo horses’ deaths.

Although the FDA says the action is not directly related to the deaths of the polo horses, the announcement about the filing came exactly one year to the day after the horses died on April 19, 2009.

“This case is not focused on the deaths of the horses, but on the continued and prolonged practice of compounding animal drugs in violation of the law,” Alvey said.

The FDA says that the pharmacy is using bulk ingredients to create new animal drugs without receiving FDA approval, a process it says is illegal.

Legal quagmire
The legalities of compounding are covered on a federal level in the Animal Medicinal Drug Use Clarification Act (AMDUCA) and the FDA’s Compliance Policy Guide (CPG). AMDUCA permits compounding if certain conditions are met, but does not discuss bulk ingredients. The CPG lays out guidelines for FDA inspectors to help them decide when to take any enforcement action against a compounding pharmacy. The focus of the CPG is to prevent veterinarians or pharmacies from making and distributing non-FDA-approved new animal drugs in violation of the Food, Drug and Cosmetic Act, which is what the FDA is accusing Franck’s of doing.

“Animal drugs compounded from bulk ingredients do not undergo FDA review and are not approved by the agency,” the FDA said in a statement. “Many of Franck’s illegal products are copies very similar to available drugs that have been approved by FDA."

Franck’s issued its own statement declaring the pharmacy’s innocence.

“The business of Franck’s Compounding Lab is both legal and medically vital,” the statement says. “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 International Academy of Compounding Pharmacists (IACP) a nonprofit association that represents compounding pharmacists and technicians, also weighed in on the matter after the FDA’s announcement of the complaint.

“As expressed most recently in its injunction against Franck’s Pharmacy, the FDA’s misguided assertion that compounding from bulk ingredients for non-food animals is illegal would rob veterinarians of critical treatment options,” the IACP said. “FDA’s position on bulk ingredients is contrary to the long-standing and generally accepted practice of pharmacy.”

Paul Levesque, RPh., CEO of the IACP, said that prohibiting the use of bulk APIs would harm patients, because they will be denied the custom medications prescribed by the veterinarian.

“The message from FDA is not a new message, they have simply been trying to gain control of the compounding industry,” Levesque said. “The patients, in this case, the domestic animals, are the ones that are going to be harmed here, as well as compounding pharmacies or small businesses that will be closed if defined as manufacturers.”

Levesque disputes the FDA’s claim that pharmacies that compound from bulk APIs are breaking the law. He said that the state boards of pharmacy regulate compounding pharmacies, not the FDA, and almost all compounding pharmacies compound using bulk ingredients. It is necessary, he said, in order to meet the needs of specific patients.

“We are not creating and selling a product for an unnamed end user,” Levesque said. “A compounding pharmacy makes a specific product and tailors it for a specific end user.”

The CPG says that “generally, FDA will defer to state authorities regarding the day-to-day regulation of compounding by veterinarians and pharmacists of animal and human drugs that are intended for use in animals.” However, the legal line becomes clearer if a pharmacy is compounding a drug that is a copy of an FDA-approved drug. In that case, the compounding pharmacy may be violating the law.

“We typically do not compound or copy a commercially available product. If something is commercially available in a certain strength, that is not a standard practice that compounding pharmacies will engage in,” Levesque said. “But we are allowed to tailor them into a different form or flavor.”

The Pharmaceutical Compounding Accreditation Board (PCAB) accredits compounders who apply for accreditation and comply with certain standards. Currently about 75 pharmacies are accredited with another 85 in the accreditation process. Franck’s is not currently listed as a PCAB-accredited pharmacy.

The FDA investigated Franck’s in 2004 and issued a warning letter alerting the pharmacy that it had committed violations, including compounding copies of existing drugs and compounding outside of a valid veterinarian-client-patient relationship. The agency investigated Franck’s again after the polo horse deaths and said it told the pharmacy that it was still in violation of the law.

“FDA investigators informed Defendants of their continuing violation during the December 2009 inspection, to which Defendant Paul W. Franck responded that he understood that under FDA’s interpretation of the law, Defendants’ activities are illegal, but disagreed with that interpretation,” the injunction complaint reads.

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