Not all veterinary groups agree on the issue. As reported in DVM Newsmagazine, the American Association of Equine Practitioners (AAEP) formed a task force to confront the issue of compounding, and the American Association of Bovine Practitioners banned bulk drug compounders from exhibiting at its meeting.

History of regulationFDA aims for more regulatory control of an industry Brakke Consulting, Inc., estimates is comprised of dozens of national veterinary compounding pharmacies and likely many more at local and regional levels. The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) grants FDA power to regulate and enforce drug manufacturing, marketing and distribution of any product approved by the agency.

But compounded drugs aren't FDA-approved, and although the agency generally left oversight of compounding to state pharmacy boards for the first 50 years of FDCA, regulators now are concerned some pharmacists are manufacturing and selling drugs under the guise of compounding, allegedly avoiding FDCA's drug approval requirements. In 1996, FDA responded, issuing its CPG, stating the agency would not ordinarily take action against bulk product compounding for nonfood animals if a medical need was identified and no market drug was approved to treat the condition.

In July 2003, the agency issued a more restrictive CPG, rescinding the bulk compounding permit of its predecessor. While compounders and veterinarians were concerned, it wasn't until the April 2 letter that FDA threatened enforcement, Riddell says.

"People were still compounding from bulk drugs, even after last year's CPG," he says. "The truth of the matter is FDA knows there needs to be change. In its strictest sense, it's against the law."

No jurisdictionThat's not true, says Howard Hoffmann, a Chicago attorney representing some of the nation's largest compounders. According to Hoffmann, any regulation FDA adopts is unenforceable against a compounding pharmacy because the agency has no power to enact it.

"FDA is not intended to govern compounding pharmacy; there is no law that gives them that authority," Hoffmann says. "In the absence of an act of Congress that would authorize the CPG as law, it has no enforcement value and is more like a wish list. As the FDA provides all this really bad propaganda about compounders, they sort of gloss over that very important fact."

FDA officials did not respond by presstime to DVM Newsmagazine inquiries seeking comment. Hoffmann speculates that the "sudden attention" FDA is giving to compounding pharmacies is disguising a turf war derived from the agency's desire to wrestle jurisdiction over the compounding market away from the states. If not, the issue is manufacturer derived, he says.

"Why go after compounding now?" Hoffmann asks. "There has never been one patent suit against compounders for making clones, and it's because it doesn't happen. It's possible that manufacturers believe compounding pharmacies are a threat to their business and put the buzz in the ear of FDA, but I don't believe that. To me, this looks like a power grab."

That's nothing but an argument in favor of illegal manufacturing, says Ron Phillips, spokesman for the Animal Health Institute (AHI), which represents pharmaceutical manufacturers.

"There are certainly people who believe there is widespread abuse by compounders," he says. "The veterinary community in general is concerned about safety and efficacy questions. Right now we have a regulated system and an unregulated system. That's not right. It cuts to the heart of why we even have an FDA."

Regulatory loopholesStill, Riddell says he understands the agency's decision to come down on the manufacture and sale of compounded products. The products are not required to undergo safety and efficacy testing, and the manufacture and sale of copycat products does occur, he says, because copycat drugs are cheaper and practitioners can sell compounded versions for higher profit.