An attorney who handled a prominent negligence case against a Kentucky compounder advises veterinarians and horse owners to make sure they are acting legally when administering a compounded drug to a horse, because without such care they could lose out on legal protections should anything go wrong with the treatment.

During the National Conference on Equine Law May 4 at Keeneland, Tom Nicholl, an attorney and veterinarian in Orlando, Fla., advised vets and horsemen who treat a horse with a compounded drug to acquire in writing from the compounder that the administration of the substance is legal.

Nicholl outlined some of the gray areas that compounders operate under, specifically in the horse industry. He noted that while there has been some added oversight of compounded drugs, most of that focus has been on compounds for human use, and to a lesser extent compounded drugs in animals to be sold for meat. He said the lowest of regulatory concern is the use of compounded drugs in animals not sold for human consumption, like horses.

He said this environment has allowed compounding pharmacies, which are supposed to be used to mix two or more FDA-approved drugs to suit a specific patient, wide latitude in operations and has led to misconceptions.

Nicholl said while compounders are supposed to address specific patients, some have been found to make large batches of product, which blurs the line between a compounder and drug manufacturer. A drug manufacturer, whether a brand name or generic, is subject to FDA oversight. Compounders are largely regulated at the state level, although some federal restrictions have been added in recent years.

A patient who needs a specific dose—say a large or small animal—that may not be available in that dosage size would likely be a candidate for a compounded version of the medication. Or a patient who cannot receive an injection of a drug may have to have an oral version of the drug compounded.

If an FDA-approved drug is no longer manufactured, a compounded alternative is allowed to be made and substituted. Nicholl noted that this situation comes up frequently in animals.

Also, a valid client-patient relationship is required that documents why the patient, in this case a horse, needs a compounded medication as opposed to the FDA-approved drug.

Nicholl cautioned that some sellers try to equate compounded drugs with generic drugs. He said that sales pitch is not accurate, as generic drugs do receive FDA oversight but compounded drugs do not.

“Compounded drugs are not FDA approved,” Nicholl advised. “There’s no quality standards, no stability standards, no consistency standards.”

In using compounded drugs in racing, this can put a horse in danger of a positive drug test, as withdrawal standards are based on FDA-approved drugs, but compounded medications can see fluctuation in the concentration of the drug from batch to batch. Such a post-race positive, of course, would impact a vet, trainer, and owner.

Furthermore, compounded drugs can be a danger to the health of horses as well. Nicholl is familiar with that situation, as he represented horse owners who sued Wickliffe Pharmaceutical Inc. (also known as Wickliffe Veterinary Pharmacy) and some of its board members, after alleging that six horses became sick and two others died at an Ocala training center after receiving a compounded drug to treat equine protozoal myeloencephalitis from the Lexington, Ky., pharmacy. 

The 2014 lawsuit alleged a Wickliffe compound of toltrazuril and pyrimethamine had more than 13 times the amount of pyrimethamine that was supposed to be in the product, as listed on the label. The FDA reported a similar finding in the Wickliffe product in question, noting that adverse events associated with high doses of pyrimethamine include seizure, fever, and death.

The case was settled out of court in early 2015. Nicholl believes by filing the case in federal court, his clients were in a better settlement negotiating position, because in that court Wickliffe also was subject to punitive damages should the case go forward. Nicholl said the dosage levels and documentation of the mixture did not match what testing revealed to actually be in the compounded medication.

Nicholl noted that, had the horses involved received a compounded drug that didn’t meet legal standards of administration, it’s doubtful any court would have recognized their case. He said the compounded drug administered in this case met legal standards, because there was a valid vet-patient relationship, the medication was properly prescribed, the compound was a mix of FDA-approved drugs, the vet involved noted that an FDA-approved drug had not been effective as some patients had relapsed, and it was properly labeled.

He said it’s not valid to call for use of a compound because the treatment is cheaper. He also said saying its use is “common practice” will not meet legal standards.