July 24, 2019 — The Food and Drug Administration announced this week that horses in regionally diverse parts of the country died or were euthanized as a result of the use of compounded drugs.
It’s not the first time. FDA also cited the death of four horses in 2014 as a result of an erroneously formulated compound. And in 2009, 21 polo ponies in the state of Florida died as a result of an erroneously compounded product.
The FDA release states the actual amount of one of the active ingredients in the product, pyrimethamine, was 18 to 21 times what the label claimed. How does this happen? Compounded products do not carry the assurances of quality, safety and efficacy that FDA approved products carry. There’s a lack of oversight and a lack of enforcement.
Compounding of animal drugs is legal under very limited conditions: it is the customized manipulation of an approved drug or drugs by a veterinarian or pharmacist upon the prescription of a veterinarian to meet the needs of an individual patient.
The compounding that killed these horses was illegal. The FDA release highlights key areas of concern with these continued infractions:
Compounded products should only be made for an individual patient.
The release refers to the fact that “the product lot is accounted for.” “Product lot” indicates a batch of this product had been prepared and was being marketed as an alternative to approved products. It was not being done for an individual patient. A compounder was making batches of drugs – like a drug manufacturer – and marketing the drug like a drug manufacturer, but without meeting all the FDA safety, efficacy and manufacturing standards that drug manufacturers must meet.
Compounding is only legal when an approved human or animal drug is not available
The release states that “FDA has approved several drug products for the treatment” of the condition that the compounded product was to treat. Remember, compounding is only legal when there is not an approved human or animal drug that, in the available dosage form and concentration, appropriately treats the condition diagnosed.
We commend FDA for taking this action. More needs to be done. We recognize there are limited circumstances in which compounding drugs from bulk active ingredients, rather than approved products, is necessary. FDA is working on guidance to delineate those specific circumstances and we urge them to publish that guidance as soon as possible. Once those rules are clear, FDA needs to aggressively enforce against compounders that continue to act like manufacturers and put animal health at risk.