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Monday, April 19, 2010
An Interesting Judgement-(no more animals for you- JUST HUMANS)
Do you remember when this happened last year? It turned out that a tech (although a trusted 12 year veteran) compounded 10x the selenium, and it went unchecked by the RPh. It just gives me chills, thinking that it might have been on MY watch, being a little too trusting of my senior tech, and this might have been something for a hospital. Sorry to sound so abraisive, all of our excellent techs out there, but this is an unforgettable example as to why we need to double check EVERYTHING.
The U.S. Food and Drug Administration wants a Florida pharmacy to stop making animal drugs after it mixed a brew of supplements that killed 21 elite polo horses as they prepared for a championship match last year.
The FDA has asked a federal judge to issue an injunction against the pharmacy, Franck's Compounding Lab in Ocala.
However, the FDA has accused Franck's of illegally creating copies of similar drugs. The agency also says the pharmacy is mixing brews outside of federal guidelines and is compounding animal products from drugs that have not been approved for use in the U.S.
Franck's disputed the FDA's allegations.
"The business of Franck's Compounding Lab is both legal and medically vital," the pharmacy said in a statement Monday, adding that it would fight the FDA's filing.
Bernadette Dunham, director of the FDA's Center for Veterinary Medicine, said in a statement Monday that the agency recognizes the benefits compounders can provide for patients.
"But when compounders like Franck's circumvent, and thus undermine, the statutory drug approval process by manufacturing drugs under the guise of pharmacy compounding, we are concerned that poorly compounded drugs can jeopardize the health of animals," she said.
The International Academy of Compounding Pharmacists also takes issue with the FDA's stance.
The group says there is nothing in federal law that specifically regulates the use of bulk ingredients in the compounding of drugs for animals not used in food production.
"Their assertion doesn't hold the weight of law," said Sarah Dodge, the group's vice president of government affairs.
The FDA's complaint was filed April 16 in federal court in Ocala by the U.S. Justice Department.
Franck's came under intense scrutiny last year after 21 polo horses died before a championship match near West Palm Beach. The horses from the Venezuelan-owned Lechuza Caracas team had just been given a cocktail of vitamins and minerals compounded by the pharmacy on order from the team's veterinarian.
Franck's later acknowledged using too much selenium in the mix. Florida's top veterinarian blamed the deaths on an overdose of the mineral often used to help horses recover from fatigue.
The horses' owners have since sued the pharmacy.
The FDA says Franck's was warned in 2005, four years before the horses' deaths, that it was compounding animal drugs illegally. The agency warned the pharmacy again in December 2009, according to the complaint. Franck's first promised to "comply immediately and completely with any and all FDA and other legal requirements," but later said it disagreed with the FDA's interpretation of the law.
In response to the horses' deaths, the United States Polo Association has since begun random drug tests for horses in polo matches in the U.S