BY: SAMANTHA BARTLETT, DVM
The U.S. Food and Drug Administration (FDA) published new guidance on the use of bulk active pharmaceutical ingredients to compound veterinary preparations and began enforcing in April. The guidance, known as GFI #256, no longer allows veterinarians to stock compounded preparations from bulk ingredients for future use. Instead, these medications can only be prescribed to individual patients on an as-needed basis. Veterinarians may only use compounded medications when the unique needs of the patient cannot be fulfilled by FDA approved drugs. GFI #256 does not apply to compounded preparations based on FDA-approved finished drugs.
GFI #256 also requires veterinarians to give a clinical rationale for prescribing a bulk compounded medication and pharmacies must document why a finished FDA-approved drug cannot be used as an active ingredient and bulk active ingredient must be used to compound the medication.
The FDA states it does not intend to inspect veterinary practices that don’t compound from bulk substances but does plan to inspect state-licensed pharmacies. The GFI (Guidance for Industry) is not a law, but provides the basis for the FDA to investigate/inspect compounding pharmacies. Compounding pharmacies prepare the majority of medications using bulk drug substances. The FDA is still identifying which preparations from bulk drug substances may be ordered for office stock and which may only be prescribed for individual patients.
The FDA is currently creating three lists. The “listed” medications and those “under review” may currently be ordered for office stock. Medications on a “not listed” list may not be used as office stock but may be prescribed for individual patients if a medical rationale is documented. Of 200+ bulk drug substances asked to be “listed”, the FDA has only allowed about 30 to be compounded for office use. Roughly the same may not be compounded, including apomorphine hydrochloride tablets, mirtazapine oral suspension and enrofloxacin oral paste for horses.
The FDA is asking for input from veterinarians why access to these medications for office use is necessary for patient care. Veterinarians can comment and provide case examples on the FDA’s online GFI#256 commenting docket, which can be accessed at https://www.regulations.gov/document/FDA-2018-N-4626-0001.
