Lexington, Ky.-the american association of equine pracitioners (aaep) is addressing the controversy surrounding compounded drugs by creating a task force and scrutinizing the business practices of pharmacies exhibiting at its annual trade show.
LEXINGTON, KY.—the american association of equine pracitioners (aaep) is addressing the controversy surrounding compounded drugs by creating a task force and scrutinizing the business practices of pharmacies exhibiting at its annual trade show.
The association follows the lead of the American Association of Bovine Practitioners, which recently barred compounding pharmacies from buying booth space at its annual convention next month. While AAEP still permits compounders to attend, it requires they sign a contract stating they abide by the Food and Drug Administration (FDA) Compliance Policy Guide (CPG).
The controversy surrounding compounding recently has come to a head as pharmacies challenge FDA's regulatory authority and the release of its revamped CPG, which deems all drug manufacturing from bulk product illegal. While most veterinarians recognize the need for regulatory oversight of the compounding of unapproved drugs and ban on copycat products, they claim the practice is often necessary for patient health. At presstime, stakeholders were meeting with FDA concerning the policy's review and possible reissue.
"The whole issue is so convoluted, we wanted to boil it down to something easily understandable," AAEP Executive Director David Foley says. "There hasn't been a lot of feedback from FDA on its CPG, and our members want to do the right thing. They look to AAEP to offer guidelines to do that."
Once finalized, the guidelines will be translated into a white paper for publication, bullet pointing the do's and don'ts of veterinary compounding and the drugs' pharmacological use. An AAEP task force has been commissioned to draft the rules, designed to educate the membership and aid in policing the association's trade show.
"I think there's a fair amount of misunderstanding with veterinarians, as I believe there's a misunderstanding among compounders," Task Force Chairman Dr. James Morehead says. "Our mission is to educate our members on how to handle the compounding issue and find a solution to our trade show exhibitors."
The guidelines also will include language to aid in scrutinizing booth applications.
"All of the other trade shows are struggling with how best to deal with this. Essentially, we're developing our own version of a compliance form," Foley says.
AAEP means business, Foley adds, and has invited FDA officials to police compounding activity at its trade show. If caught violating the contract, AAEP threatens to remove the compounding pharmacy from the show room floor.
The activity already has slowed down interest in exhibiting, he says. Since the contracts were mandated, just six compounding pharmacies have signed on for booth space, compared last year's 19 attendees.
"We're really serious about addressing this issue," Foley says. "We just have to do what we think is right for the horse and our members."