Every year many of us are captivated by the Triple Crown in horse racing and this year was no different. Many of us were hoping for California Chrome to become the first horse to win all three races since Affirmed accomplished this remarkable feat back in 1978. Well, the Triple Crown races are now over, but a compounding pharmacy in the horse racing industry has been generating a lot of press and news recently.
In early May of this year eight thoroughbred racehorses got sick or died when given an anti-protozoal drug compounded by a specialty pharmacy located in Kentucky. The horses were given a combination of toltrazuril/pyrimethamine, frequently used to treat or prevent equine protozoal myeloencephalitis, which affects the central nervous system in horses. Lexington based Wickliffe Pharmaceutical is now being sued by the owners of the promising race horses. The owners are suing for negligence, claiming Wickliffe allegedly compounded and dispensed the wrong dosages of the drugs, plus for the compounding pharmacy trying to then conceal the error. In addition, the FDA is now investigating! No FDA approved drug exists for the combination of toltrazuril and pyrimethamine for the treatment of EPM (plus the fact that toltrazuril is not approved for equine use). However, the pharmacy did compound the mixture with a veterinarian’s prescription.
This is not the first time that a compounding pharmacy has been in the news involving horses. A few years back, Franck’s Pharmacy in Ocala, Florida was accused of negligence when twenty-one polo horses died due to selenium poisoning from improper compounding of an equine nutritional product. that resulted in the FDA trying to stop Franck’s from compounding veterinary medicine and supplements.
If you own or operate a compounding pharmacy, do you have your policies and procedures up to date? Do you have documentation for your business practices in proper order? Are you compliant to USP 797? Keep in mind that proposed new legislation in the Michigan Senate includes additional compliance regulations for compounding pharmacies that even includes increased criminal penalties for many violations. Particulars of the proposed bill include:
- Increased record keeping requirements
- Mandatory bi-annual inspections
- Designated Pharmacist In Charge at the facility
- Ongoing licensing and accreditation requirements
If you are a compounding pharmacy, the time to act is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding your policies and procedures for compounding and dispensing preparations. Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete review of your existing policies and procedures. Reach us online or call today at 800-642-1652.