September 1, 2004
FDA to Revise Its Compliance Policy Guide on Veterinary Compounding
FDA is announcing its intention to draft and publish for public comment a revised Compliance Policy Guide (CPG) on veterinary pharmaceutical compounding. FDA anticipates that the draft CPG will be available for comment in the Fall of 2004.
The current CPG, published in July 2003, describes FDA's present thinking on what types of veterinary compounding might be subject to enforcement action. FDA has received numerous letters from veterinarians, pet owners, compounding pharmacists, and associations expressing concern that the CPG lacks sufficient clarity on the circumstances in which veterinary compounding, particularly from bulk drugs, would be permitted. Many of the letters also disagreed with the current policy, stating that it was not within FDA's legal authority, and complained about the lack of prior public comment. After meeting with several groups and considering the comments in the letters it has received FDA concluded that issuing a revised CPG is appropriate.
When it is available, the draft CPG will be posted on FDA's Center for Veterinary Medicine (CVM) Website and a notice of availability will be published in the Federal Register .
Questions on veterinary pharmaceutical compounding or the existing CPG may be directed to Gloria Dunnavan, Director, Division of Compliance, FDA/CVM, 301-827-1168, or gdunnavan@cvm.fda.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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