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Maryland Department of Agriculture

Information Regarding compounded FIP treatment GS-441524

Veterinary News |

As many of you may be aware, information about the use of GS-441524 to treat FIP is being circulated by many sources. The Maryland Board of Veterinary Medical Examiners wants to make you aware of the current status of GS-441524 with the FDA.

The FDA made the following statement on May 10th, 2024.

Because no FDA approved drug is available to treat Feline Infectious Peritonitis in cats, the U.S. Food and Drug Administration does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, when prescribed by a veterinarian for a specific cat patient for the treatment of Feline Infectious Peritonitis under the conditions listed in Guidance for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances.

Please see the following link for the full FDA announcement. FDA Announces Position on Use of Compounded GS-441524 to Treat FIP | FDA

Though it is our understanding that the AVMA and other organizations have (or plan to submit) the compounded drug for consideration to be allowable for office stock, at this time it has not been approved.

If you believe that a prescription for GS-441524 for the off-label treatment of FIP is appropriate in a patient you should ensure that you are sufficiently educated on the implementation, risks, and benefits of the medication. These should be thoroughly discussed with clients and documented in the medical records.