The Animal Medicinal Drug Use Clarification Act of 1994 states that it is illegal to produce a compounded drug designed to treat a disease or condition when an FDA-approved drug for the disease or condition is available. As an exception to this rule, compounding a particular drug is legal when the approved drug is not available in the required dosage, form, or concentration. That lets horses take advantage of medications created for humans or other species.

There has been a rash of renegade compounders. One problem with compounds is when the amount of active ingredient in the product doesn’t match the label. Compounded drugs have been found with as little as 6% of the active ingredient claimed on the label. Some products have higher amounts; toxicity could be worse than ineffectiveness.

Luitpold Animal Health sponsored a roundtable on compounding on Aug. 30 in New York. In attendance were Gary White, DVM (Luitpold Pharmaceuticals); C. Wayne McIlwraith, BVSc, PhD, FRCVS, Dipl. ACVS, ECVS (representing the American Association of Equine Practitioners); Richard Mitchell, DVM (clinician who focuses on lameness issues); Robert Stenbom, DVM (Boehringer-Ingelheim); and Joe Bertone, DVM, MS, Dipl. ACVIM (professor of equine medicine at Western University’s veterinary school). Representatives from compounding companies and the FDA were invited, but didn’t attend.

The discussions included the value of compounded drugs, risks, quality issues, safety, compounding versus manufacturing, common illegal compounding practices, regulation enforcement, and the role of the AAEP