Veterinarians Voice Concern over FDA Compounding Rule
Almost a year after the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) issued a revision of its Compliance Policy Guide (CPG) for compound drugs, at least 500 veterinarians have written letters of concern about the revision, said L.D. King, executive director of the International Academy of Compounding Pharmacists (IACP).
In April 2004, the FDA issued a notice to the state boards of pharmacy to request assistance with the inspection of 20 pharmacies to “…determine the extent of illegal veterinary compounding activities.” The notice explains that “while some compounded drugs may have a place in veterinary practice, compounding of drugs for use in animals, except in limited circumstances, is not permitted under federal law.”
The IACP is lobbying the FDA to change the revised CPG. Some veterinarians are concerned about the following language in the July 2003 revision: “The Act does not permit veterinarians to compound unapproved finished drug products from bulk drug substances, unless the finished drug is not a new animal drug.”
Veterinarians are just now realizing the implications of the 2003 revisions, said Jeffrey Brown, DVM, president of the Arizona VMA, who sent a letter to the CVM in April. The “guideline does a real disservice to veterinarians,” he said. “Ideally we’d like the FDA to sit down with veterinarians to hammer out drugs that we would like to keep on the market.”
At press time the CVM was not prepared to answer questions about the revised CPG, but a spokesperson said, “We recognize that there has been a great deal of confusion and concern about our policy on compounding. [The] FDA is working to more clearly articulate our policy.”
Some veterinarians worry that they will not be able to use drugs that are available in compounded version but not in a branded form. For example, both Brown and King mentioned potassium bromide, a seizure drug for which there is no brand substitute, that is not approved for use in the United States. “I’m not sure why the FDA put its clamps down, because the compounded versions with their possible flaws are better than no drug at all,” Brown said.
In the CPG document, the CVM cites safety concerns about the use of compounded drugs that have not gone through the FDA approval process. It explains that the guidance was updated to “describe what factors FDA will consider in exercising its enforcement discretion regarding compounding of drugs intended for use in animals...”
In addition to concerns about the policy, industry members have voiced concern that the CVM issued the 2003 revision without offering the traditional public comment period, said King. The IACP, a Houston, Texas-based organization with 1,800 members, would like the FDA to withdraw the 2003 CPG revision, and reissue the guide with a public comment period.
“These kind of huge, drastic, very significant changes [to the CPG] warrant a comment period,” King said.