May 17, 2024

FDA to exercise enforcement discretion on compounded FIP treatment

This week, FDA announced that it 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 GFI #256. There is currently no FDA-approved drug available to treat FIP. 

Just because FDA is exercising enforcement discretion doesn’t mean your marketing language doesn’t matter, though. If you are compounding GS-441524 for FIP under the circumstances described above, you can’t say that it is now “legally available.” Animal drugs compounded from bulk drug substances are unapproved drugs (and therefore not legal), but in this specific case, FDA is exercising its enforcement discretion since no other treatment option exists.