Veterinarians and horse owners might be administering medications made from an illegally obtained drug (active ingredient) manufactured with no Food and Drug Administration (FDA) inspection or oversight as to purity, potency, or safety. Representatives from Boehringer-Ingelheim Vetmedica, Inc., recently shed light on the increasing numbers of “clones” of their FDA-approved medication Ventipulmin, which contains clenbuterol hydrochloride (HCl). Veterinarians and horse owners buy the off-brand formulations from pharmacies with the assumption that they are legitimate and efficacious, but instead purchase concoctions that could range anywhere from completely ineffective to harmful to the horse–and ultimately unsafe to humans.

Ventipulmin is a prescription-only drug for treating horses affected with airway obstruction, that was approved by the FDA in May of 1998. Boehringer is the only FDA-approved source of clenbuterol. According to Don Buss, Director of Regulatory Affairs at Boehringer, the company alerted the FDA of the first illegal compounding of the drug in June of 1999, but since then there has been little if any compliance action by the FDA to discourage this activity.

Responsible compounding pharmacies provide a helpful and necessary service by making available medications for special unique needs in the absence of an FDA-approved pharmaceutical. Unfortunately, with illegal clenbuterol, not all compounding pharmacies recognize and follow responsible practices, and some are putting patients and their own laboratories at risk. Since pharmacies are essentially providing illegal material, their activity is considered “renegade” drug manufacturing.

“To be legal compounding, (a pharmaceutical company) must have a FDA-approved source of active ingredient (clenbuterol),” said Bob Stenbom, DVM, a veterinarian at Boehringer-Ingelheim Vetmedica, Inc.” The only FDA-approved source of clenbuterol hydrochloride is from Boehringer-Ingelheim, who does not provide this material to compounders, as it is only used in the manufacture of Ventipulmin Syrup,” he added