By: Samantha Bartlett
The FDA released a draft guidance similar to the guidance issued in 2015, which was subsequently withdrawn after the FDA received significant pushback from the veterinary industry. While compounded animal drugs are not reviewed by the FDA as safe or effective for the intended use, the FDA acknowledges that, where there is no FDA-approved medically appropriate drug to treat the animal, a drug may be compounded from bulk drug substances. The guidance also states in these instances the FDA will not take action against licensed pharmacies and veterinarians compounding drugs for violations of the FD&C Act requirements for animal drug approval.
The new guidance only allows the use of 7 bulk active pharmaceutical ingredients (APIs) for compounding because there are currently no approved finished pharmaceutical equivalents. These bulk ingredients include: apomorphine hydrochloride, cisapride, guaifenesin, metronidazole benzoate, miconazole nitrate, potassium bromide, and tacrolimus. Specifically prohibited bulk APIs include: amlodipine, budesonide, chloramphenicol, dexamethasone, dipyrone, doxycycline, enrofloxacin, gabapentin, idoxuridine, itraconazole with DMSO, and voriconazole.
The new guidance would require that compounded medications be created from finished pharmaceuticals instead of bulk APIs except those 7 ingredients stated above. Veterinarians would also be required to document the clinical need for compounded medications on every prescription and in every medical record. This new guidance would significantly increase the price of compounded medications by increasing the price of ingredients and the amount of paperwork required, making some medications cost-prohibitive for pet owners. This guidance may also have an impact on availability of compounding when approved drugs containing APIs on the prohibited list are in short supply.
The FDA is still accepting public comments on the guidance as well as nominations for approved APIs through June 17, 2020. Information on the guidance as well as how to submit comments and ingredient proposals can be found at https://www.fda.gov/animal-veterinary/cvm-updates/fda-releases-revised-draft-guidance-compounding-animal-drugs-bulk-drug-substances.
