FDA tightens reins on equine compounding companies

The FDA continues to tighten the reins on animal drug compounding, most recently by sending three companies warning letters targeted at equine products they allegedly marketed without first getting regulatory approval.

Tri-Star Equine, HorsePreRace and Horse Gold all received warning letters from the federal agency this week that accused them of marketing their compounds in a manner "intended for use in the mitigation, treatment or prevention of disease in animals." That makes them fall under the Federal Food, Drug and Cosmetic Act (FD&C), which defines the compounds as drug products.

The agency's action is just the latest salvo in its campaign against compounders--both for human and animal compound medications. The agency began issuing more warning letters to compounders in the aftermath of a meningitis outbreak linked to the New England Compounding Center in 2012, which resulted in FDA Commissioner Margaret Hamburg coming under fire for not exercising enough oversight with compounders.

The warning letters claim all three companies were marketing drugs aimed at treating equine ulcers, which are a common ailment for horses, notably racehorses. The agency said in all three warnings that none of the companies cited sought or received FDA approval, making the drugs automatically considered both "adulterated" and "unsafe" under the FD&C Act.

Additionally, last week, the FDA sent a warning letter to a company alleged to be marketing an unapproved oncology drug for dogs.

- read the warning letters for Tri-Star Equine, HorsePreRace, and Horse Gold
- check out the RAPS take

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