A Kentucky-based pharmacy has received a warning letter from the US Food and Drug Administration (FDA) following the agency’s testing of samples from two prescriptions compounded for horses.
The drugs were found by the agency to be adulterated and misbranded under the Federal Food, Drug and Cosmetic Act.
The warning letter was sent to Wickliffe Pharmaceutical in Lexington and its president and owner, Jacqueline Bernard, from Paul Teitell, who is the FDA’s district director in Cincinnati.
The letter arose from an investigation launched by the FDA late in April following the deaths of two horses in Kentucky after an application of an oral paste containing toltrazuril and pyrimethamine that was compounded by the pharmacy.
While the investigation was ongoing, the FDA received a report that eight horses in Florida had suffered adverse reactions after they were treated with a suspension drug product compounded by the pharmacy that also contained toltrazuril and pyrimethamine. Two of those horses died.
It is understood the medication was compounded to treat or prevent equine protozoal myeloencephalitis.
The pharmacy, which provides customized medicinal solutions for veterinarians, issued a statement following the release of the FDA letter. It said it had cooperated fully with inquiries into the matter by federal health officials.
“We took prompt action last spring in response to the incident to reinforce our high safety and quality standards for Wickliffe’s compounded product,” the statement said.
“We are preparing a response to the FDA that outlines the steps that we have taken and the quality assurance program that we maintain.”
The FDA letter described how samples of the paste and the suspension product were collected by the FDA for testing.
Teitell said the FDA’s investigation revealed that animal drug products compounded by the firm were adulterated and misbranded under the Federal Food, Drug and Cosmetic Act.
The FDA investigation revealed that on March 25, 2014, the firm compounded a paste, the label of which stated that it contained toltrazuril at a concentration of 227 milligrams per milliliter (mg/ml) and pyrimethamine at 340mg/ml.
The agency analyzed two samples of the paste to determine the concentration of each drug.
The results for the first sample showed:
- Toltrazuril at 182 mg/ml, which is 80 percent of the declared concentration.
- Pyrimethamine at 277 mg/ml, which is 82 percent of the declared concentration.
The results for the second sample showed:
- Toltrazuril at 184 mg/ml, which is 81 percent of the declared concentration.
- Pyrimethamine at 283 mg/ml, which is 83 percent of the declared concentration.
The investigation also revealed that on April 2 the firm compounded a suspension drug product, the label of which stated it contained toltrazuril at 416 mg/ml and pyrimethamine at 17 mg/ml.
However, FDA analyzed a sample of the product to determine the concentration of each drug and found that it contained:
- Toltrazuril at 15.5 mg/ml, which is 3.74 percent of the declared concentration.
- Pyrimethamine at 405 mg/ml, which is 2380 percent of the declared concentration.
Deviations of the actual concentrations of the drugs from their labeled concentrations caused the suspension product and the paste to be considered adulterated under the act, Teitell said, because their strength differed from that which they were represented to possess.
Additionally, the suspension product and the paste were considered misbranded because their labeling was false and misleading. “As discussed above, product samples indicate that the suspension product and paste were sub-potent and/or super-potent in comparison with their labeled potency, which makes their labeling false,” he wrote.
He continued: “As a pharmacy engaged in distributing drugs in interstate commerce you are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.
“It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.”
Teitell said the pharmacy should take prompt action to correct the violations described and to establish procedures to ensure that these violations did not recur.
The pharmacy must, with 15 working days of receiving the letter, outline in writing the steps it had taken to correct the violations.
The full letter can be read here.