FDA Allows Compounded FIP Drug in Certain Cases

01Sep '24

FDA Allows Compounded FIP Drug in Certain Cases

BY: SAMANTHA BARTLETT, DVM

Remdesivir is an antiviral drug used primarily to treat COVID-19 and SARS-CoV-2 infections in people. Researchers at the University of California Davis School of Veterinary Medicine have found success using both Remdesivir and its metabolite GS-441524 in treating case of Feline Infectious Peritonitis (FIP). Unfortunately the drug has been almost impossible for veterinarians to acquire and cat owners have relied on black market sources until recently. Stokes Pharmacy announced its partnership with Bova Group to produce an FDA-approved compounded GS-441524 product for the treatment of FIP in cats.

In response to social media posts incorrectly stating that GS-441524 will be “legally” available for the treatment of Feline Infectious Peritonitis (FIP) in the U.S., the Food and Drug Administration (FDA) has issued clarification on compounding guidelines. The clarification states that because there is no FDA approved drug to treat FIP in cats, the agency does not intend to enforce requirements for new animal drug approval regarding compounding of GS-441524. However, the FDA reminds compounders they must still follow Guidance for Industry (GFI) #256, Compounding Animal Drugs from Bulk Substances. GFI #256 states that products must be compounded for patient specific prescriptions and can not be kept as office stock. 

Because many cats presenting with FIP are sick enough they cannot wait for a compounded prescription to be filled, the American Veterinary Medical Association (AVMA) and the American Association of Feline Practitioners (AAFP) are collaborating to submit nominations to the FDA to allow office stock for both Remdesivir and its metabolite, GS-441524.

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