U.S. District Court Judge Donald Walter denied a motion earlier this month to dismiss federal charges against Louisiana veterinarian Dr. Kyle J. Hebert and Essential Pharmacy Compounding. Hebert is accused of providing trainers with injectable vials of dermorphin, a synthetic opioid said to be 30 times more powerful than morphine and which he allegedly obtained from web-based retailer Essential.
Dermorphin, listed as a Class 1 drug by the Association of Racing Commissioners International, in its natural state is extracted from tree frogs found in the Amazon region of South America, thus its nickname “frog juice.”
Kohll's Pharmacy, which operates the online storefront Essential Pharmacy Compounding, was charged with conspiracy and introduction of adulterated or misbranded drug for its role in providing what prosecutors considered mislabeled product.
Hebert was charged with conspiracy, misbranding, and delivery and receipt of adulterated or misbranded drug in interstate commerce for his role. Trainers allegedly were not informed what was in the syringes Hebert provided, but were told to inject the substance one hour prior to a horse's race. It is illegal for non-veterinarians to possess hypodermic needles on the racetrack, and illegal for anyone to inject a substance other than specifically-listed bleeder medications on race day.
Attorneys for the defense argued the Food, Drug and Cosmetic Act (FDCA), which sets standards for what constitutes misbranding of drugs, doesn't apply to veterinary compounding, and that a compounded drug for veterinary use doesn't qualify under the act because it's not a “new drug.”
Kohll's argument centered around dermorphin's status according to the FDCA; the pharmacy argued FDCA has no authority over veterinary compounding, while prosecutors disagreed, saying compounded animal drugs are “new drugs,” to which the FDCA's requirements regarding labeling do apply.
In his order denying the defense motion, Walter wrote, “The FDCA's application hinges on the substance in question, not who created the substance. Therefore, if a compounded animal drug exception existed under the FDCA, the exception would only apply when the drug in question was actually compounded.”
An indictment against Hebert and Kohll's Pharmacy filed earlier this year stated Essential Pharmacy Compounding did not make the dermorphin itself but ordered the drug from an unnamed chemical company in California and simply changed the label. According to the indictment, the pharmacy's labeling allegedly “made it appear that the product was a compounded drug created by Kohll's, doing business as Essential Pharmacy Compounding, for a specific horse owned by a specific person upon the prescription of defendant, Kyle James Hebert, DVM.”
Further, Walter stated in his order denying the motion to dismiss that earlier court decisions have set a precedent that compounded drugs are indeed new drugs to which the FDCA applies, with limited exceptions. Dermorphin qualified as a new animal drug because it “has not been ‘recognized, among experts … as safe and effective for use' with racehorses,” according to the judge's opinion.
All told, the indictment stated Hebert spent about $25,140 on 815 milligrams of dermorphin between November 2010 and May 2012. Prosecutors state the patient information on the vials of dermorphin remained the same for nearly a year of that time, even when patient names on the invoices for the drug changed. Syringes Hebert allegedly provided to trainers bore no labels, only a handwritten “1.”
Kohll's/Essential Compounding have been the target of an investigation from the Food and Drug Administration, which sent the pharmacy a warning letter in 2016 stating that an FDA inspection had turned up findings of sterile drugs prepared, packed, or held in “insanitary conditions,” rendering them adulterated, along with other sanitation and equipment-related concerns. In a response letter, Justin Kohll, vice president of the company, asserted the FDA's Good Manufacturing Practices did not apply to Essential Compounding because it participated in compounding and was therefore exempt from the guidelines. Kohll also disputed the FDA's claims regarding cleaning procedures and equipment safety testing.
The case is set to go to a jury on Oct. 30 in the 14th Judicial District Court in Lake Charles, La.
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