Court Ruling Keeps Compounding Legal, For Now

Horse owners who need medications compounded specifically for their horses will be able to obtain them through a licensed veterinarian, at least for the foreseeable future. A federal court ruling that has surprised some experts leaves the door open for pharmacists to fill veterinary prescriptions for medications compounded according to existing guidelines.

The ruling by Judge Robert Junell of the U.S. District Court, Western District of Texas observes that the federal Food, Drug and Cosmetic Act, which governs the U.S. Food and Drug Administration (FDA) does not prohibit compounding, and that states--rather than the FDA--have jurisdiction over pharmacy compounding.

"This court finds that pharmacies may compound drugs for non-food animals from legal bulk ingredients," said Judge Junell. "Drugs compounded from legal bulk ingredients do not violate the (FDA's) unsafe, adulterated, or misbranded provisions."

The court case, filed by 10 compounding pharmacies (five of them located in Texas), was brought in response to FDA actions that restricted compounding. An FDA Compliance Practice Guideline (CPG) revised in 2003 (http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html)

defines some compounded medications as "new drugs," thus making them subject to the lengthy and expensive FDA approval process. The plaintiffs in the court case feared an escalation of FDA restrictions that might disrupt their businesses, said one of their attorneys, Matthew T. Slimp.

Medications are compounded by pharmacists when they are not available through drug manufacturers; this means they have not been subject to the FDA approval process. Compounding gives veterinarians a tool to treat specific problems that can't be addressed with FDA-approved medications, such as converting an oral medication into an injectable, combining drugs for use in horses that aren't available elsewhere, or using a drug that is approved for another species.

Compounding has been opposed by drug manufacturers because it circumvents the long and expensive drug approval process, and it might put patients at risk since the medications are not proven safe and effective according to FDA protocol. However, pharmaceutical experts make a distinction between "legal" and "illegal" compounding. Legal compounding is performed with FDA-approved bulk ingredients, and the medications are compounded for a specific health care provider prescribing for a specific case. It's considered illegal to compound medications in large amounts to mimic an approved drug and resell them (usually at a lower price). The current court case was seeking to clarify legal compounding only.

Although the plaintiffs were pharmacists, the take-home message is positive for veterinarians and horse owners, says Mr. Slimp: "Horses occupy a sacred place in the heart of American culture, and it is imperative that veterinarians be able to employ the best science available to care for them. Unfortunately, there are very few approved FDA drugs for animals, and most of those are only approved for dogs and cats."

The American Association of Equine Practitioners (AAEP) guidelines regarding compounded medications (www.aaep.org/drug_compounding.htm) asserts: "The preparation of compounded medication from bulk drugs may be permissible in medically necessary situations when there is no approved product available or the needed compounded preparation cannot be made from an FDA-approved drug."

At the heart of legal compounding is a valid veterinarian-client-patient relationship (VCPR). Charlotte Lacroix, a veterinarian and attorney who wrote "Illegal Drug Compounding: Your Legal Nightmare Waiting to Happen" (also on the AAEP web site, as noted above) defines a valid VCPR as a case in which the veterinarian has sufficient knowledge of the animal to diagnose the condition and has assumed responsibility for making medical judgments, and the animal is readily available for follow-up in case of adverse reaction. She notes that this latest court ruling only increases the legal burden on the veterinarian.

"Any investigatory power taken from FDA shifts more risk to the veterinarian. The vet must exercise due diligence when dealing with compounding pharmacies. The vet is the end-user and they better pay attention if that compounding pharmacy is operating within the law. If that drug kills an animal, the vet will take it on the chin," says Lacroix.

She adds that horse owners must also bear their share of responsibility for medical decisions regarding their animals.

"There are a lot of diseases in animals for which there is no approved drug. Legal compounding is appropriate, but discuss with your vet why he or she is using a compounded drug, the risks involved, and any alternatives you might have," says Lacroix. "The owner has mutual decision-making responsibilities with the veterinarian, just like medical decisions you make for your children or yourself."

No comment was available from the FDA on whether an appeal is planned to the District Court ruling. Slimp says an appeal would have to be filed with the U.S. Court of Appeals for the Fifth Circuit by October 30, and the appeals process could take up to two years or more.

About the Author

Judith Lee

Judith Lee is a freelance health care writer who has written for a number of medical and health care journals and health care companies. As a long-time equestrian and horse owner, she has a particular interest in equine health care. She also operates an equestrian education program, Riding for Fun, geared toward adult beginners and returning riders.

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