The U.S. Food and Drug Administration is allowing products compounded from the antiviral drug GS-441524 when they are prescribed by a veterinarian to treat some feline infectious peritonitis patients.
The agency responded after Stokes Pharmacy announced that its compounded oral treatment for FIP would be available starting June 1.
The FDA announcement also served to remind compounding pharmacies, veterinarians and pet owners that animal drugs compounded from bulk drug substances are unapproved.
“However,” the agency added, “in Guidance for Industry (GFI) #256, the FDA has described certain conditions where the agency does not intend to take enforcement actions for compounded products for use in animals.”
According to the FDA, veterinarians who want to obtain animal drugs compounded from a bulk drug substance for office stock must nominate the bulk drug substance, including justification for its use.
Stokes Pharmacy’s compounded preparation is based on the Bova Group’s drug formula, which is available from Bova Aus and Bova UK. The 50 mg tuna-flavored tablets are meant for the treatment of:
- Wet feline infectious peritonitis.
- Dry FIP.
- FIP with ocular involvement.
- FIP with neurologic involvement.
The compounded GS-441524 is available by veterinary prescription for individual patients and office use in all states except Arkansas, Maine, Massachusetts, New Mexico, New York, Oregon, Rhode Island and West Virginia. Veterinarians in states that don’t allow compounded medications for office use can prescribe the drug in a patient’s name.