The Food and Drug Administration has issued a warning letter to Pennsylvania-based Rapid Equine Solutions following its inspection of the facility last summer, asking the pharmacy to provide more information about what its employees are doing to prevent serious problems at the facility.
The letter, dated June 12 of this year, describes observations made by federal inspectors between July 22 and Aug. 9, 2019 that include “insanitary conditions,” “potency issues,” and misbranding. Inspectors described “an unknown white film on the floor in the sterile production room and debris in the corners of the room” as well as several bugs lingering around the sterile and non-sterile preparation areas, while fly tape hung from the ceiling above the laboratory sink.
Further, the letter notes that a batch of toltrazuril/pyrimethamine paste compounded for the treatment of horses with Equine Protozoal Myeloencephalitis (EPM) was found to have incorrect amounts of both ingredients in it per its labeling. There was only 3 percent of the declared amount of toltrazuril in the paste, but 2,122 percent the amount of pyrimethamine declared on the label. The investigation followed the deaths of three horses in Maine and Ohio who were given the paste.
The drug combination, which has proven a popular choice for treating EPM, is the same one that was formulated incorrectly in 2014 by a Kentucky compounder which released batches with too much pyrimethamine in them. At least four horses died and several more fell ill in that case.
Rapid Equine provided the FDA with responses outlining its plans for eliminating the problems identified by investigators, but the agency writes in its warning letter this month those responses don't include enough specific information about what the facility is doing to improve their processes.
In 2019, Maine regulators suspended Rapid Equine's license after they say they discovered the mail-order facility was acting as a wholesaler for compounded drugs and was selling large amounts of compounds to a harness veterinarian who sold them without a prescription. Compounded drugs are not FDA-approved and are not intended to be produced and sold or stored in bulk; rather, they should be formulated to order for a specific patient to treat a diagnosed condition as prescribed by a veterinarian.
According to the online license verification system for the Pennsylvania State Board of Pharmacy, regulators there have taken no disciplinary action against Rapid Equine's license, which was renewed in August 2019 — on the same day FDA inspectors concluded their observation of the pharmacy's unsanitary conditions.
Read the June 2020 FDA warning letter here.
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