March 24, 2023
Racehorses, compounding and confusion
In recent weeks there’s been a persistent rumor that the governing body for horse-racing has banned compounded drugs because they are not FDA approved. But that’s not the case.
While the syntax is a bit convoluted, the Horseracing Integrity and Safety Authority’s new Rule 4111 states that compounded drugs are clearly permissible:
Rule 4111. S0 Non-Approved Substances
Any pharmacological substance that (i) is not addressed by Rules 4112 through 4117, (ii) has no current approval by any governmental regulatory health authority for veterinary or human use, and (iii) is not universally recognized by veterinary regulatory authorities as a valid veterinary use, is prohibited at all times. For the avoidance of doubt, compounded products compliant with the Animal Medicinal Drug Use Clarification Act (AMDUCA) and the FDA Guidance for Industry (GFI) #256 (also known as Compounding Animal Drugs from Bulk Drug Substances) are not prohibited under this section S0.
We repeat: HISA’s rules allow compounded medications for equine patients from pharmacies that are compliant with the Animal Medicinal Drug Use Clarification Act and the FDA Guidance for Industry (GFI) #256.
It’s worth noting that HISA’s Anti-Doping and Medication Control [ADMC] Program takes effect this Monday, March 27.