Compounders tow line at AAEP
DENVER—Two-thirds of registered compounders did not exhibit at the 50th-annual American Association of Equine Practitioners (AAEP) Convention compared to last year. Though no exhibitors were thrown off the trade show floor in the first event policed by the U.S. Food and Drug Administration (FDA), the regulatory presence prompted an unplanned discussion.
The show welcomed six compounding pharmacies, compared to 21 in 2003, according to Dr. James P. Morehead, chairman of AAEP's Compounding Task Force. This year, AAEP required that compounders sign a letter of assurance that exhibit booths, product offerings and operations fell within FDA guidelines, and they invited the FDA to enforce the rules just to be sure.
Julia Punderson, DVM, of FDA's Center for Veterinary Medicine, conducted the inspections during the four-day trade show in Denver.She says she was looking at product listings to make sure that compounding pharmacies were altering FDA-approved drugs instead of creating new products from bulk ingredients.
"The FDA does appreciate the need for these drugs," Punderson says. "We have a changing industry, but we must maintain the consistency of products to protect the health of the animal."
Morehead, who practices at Equine Medical Associates in Lexington, Ky., and Punderson held a spontaneous session Dec. 6 to discuss the finer points of the government's compounding guidelines. The talks proved to put a heavy onus on practitioners to know what compounding pharmacies are selling, how their products are produced and how long those drugs stay in the stock room.
"The shelf life is one issue; the fact that you have it on your shelf is another issue," Morehead says. "It's a needed part of our practice life, but we've changed the way we stock them. If the veterinary practitioners set the pace on this, then it is going to be helpful for everybody."
The Animal Medicinal Drug Use Clarification Act (AMDUCA) authorizes veterinarians to prescribe extra-label uses of approved animal drugs and approved human drugs for animals. Although a strict interpretation of AMDUCA still is being hashed out in courtrooms and around policy-making tables, the current internal regulatory guidelines allow compounding to exist only from FDA-approved drugs as long as there is no FDA-approved veterinary alternative.
That means that a compounder that begins with bulk ingredients that were not purchased from a FDA-inspected and approved pharmaceutical manufacturer is in violation of the government's rules, according to the government agency. Only FDA-approved name-brand or generic pharmaceuticals can be altered to meet the needs of a veterinarian for individual clients, officials contend.
Two lawsuits have emerged accusing the FDA of overstepping its regulatory bounds and unfairly targeting the compounding industry. The lawsuits, one filed on behalf of 10 compounding pharmacies and the other by Kentucky-based Bet Pharm LLC, challenge the agency's jurisdiction.
Court dates for both cases were not scheduled at presstime.