June 01, 2004


 Compliance policy guide has flaws, but also teeth

Posted May 15, 2004

The International Academy of Compounding Pharmacists and various local pharmacists are urging veterinarians and pet owners to lobby the Food and Drug Administration to withdraw its compliance policy guide on compounding of drugs.

Even though the AVMA Council on Biologic and Therapeutic Agents acknowledges that the CPG is not perfect, it does not favor withdrawal of the guide.

The CPG, which the FDA Center for Veterinary Medicine issued in its current form in 2003, regulates the compounding of drugs by veterinarians and pharmacists for use in animals. A task force comprising veterinarians, pharmacists, and regulators offered concepts that the CVM incorporated in the original version in 1996.

One of the reasons the IACP is pursuing rescission of the 2003 CPG is that the guide does not reflect the regulatory discretion found in the 1996 guide. The academy would prefer to go back to the 1996 CPG.

But for that very same reason, the AVMA council would rather have the industry continue to operate under the 2003 CPG while refinements are made than return to the lack of enforcement that characterized the 1996 CPG.

The council is also pleased the new CPG is facilitating enforcement against piracy of approved drugs in circumstances involving food animals and other animals.

On one point, the AVMA council and IACP do agree—that compounding from bulk drugs is sometimes necessary for nonfood animals. The IACP wants its pharmacist members to be able to compound from bulk drugs for companion animal, equine, and exotic animals.

Similarly, the AVMA council acknowledges that drugs compounded from bulk for nonfood animals are occasionally medically necessary within a veterinarian-client-patient relationship, when no FDA-approved drug exists. The council supports changes to reconcile the CPG with such practice realities.

Council chairman, Dr. Gatz Riddell of Auburn University, said, "First and foremost, from a food animal perspective, considering the issue of human food safety, the current compliance policy guide is very good in that it gives FDA some teeth to stop illegal compounding, which could be a threat to our national cattle herd and/or the human food chain.

"However, it's got to be understood that for nonfood and companion animals, there are some situations where compounding from bulk drugs—medically necessary drugs—is an important part of preventing pain and suffering."