New guidance from the FDA Center for Veterinary Medicine on the compounding of animal drugs from bulk drug substances—termed GFI 256—will go into effect on April 1, 2023.

These “nonbinding recommendations” are a summary of the FDA’s current thinking on the compounding of animal drugs from bulk substances; they do not recommend taking enforcement action against against those who compound animal drugs from bulk drugs when no other medically appropriate treatment options are available.

Compounded animal drugs are not FDA-approved and therefore violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). With GFI 256, the FDA wants to reduce the amount of compounded drugs kept in clinics for potential later use and encourage more individual prescriptions of some of these substances.

“In a nutshell, “what is changing is how you can order a medication, but not what you can order,” said Marcy Bliss, CEO of Wedgewood Pharmacy. When GFI 256 takes effect, “certain compounded medications will no longer be available for veterinarians to keep on-hand for administration from their office, and they will instead need to be prescribed to an individual patient,” she said.

The recommendations were written in April 2022, but the FDA delayed implementation until now to give veterinary professionals time to be educated about the changes and provide a comment period to nominate compounded medications that should be permissible to keep for clinic use.

Ultimately, the FDA’s position is that the appropriate use of compounded animal drugs in nonfood-producing animals is up to the veterinarian—with the caveat that FDA-approved drugs should be used first when available.

There may be instances, Bliss said, in which an approved commercial medication may not be the best choice. A veterinarian may reach for a compounded drug when the strength, dosage form, or flavor is not suited to their patient(s). The FDA is pushing for more of these compounded medications to be prescribed for a specific patient rather than purchased for in-hospital use.

Currently, the FDA has three categories for bulk drugs:

• Drugs that can be compounded for office stock (including gabapentin 50 mg/ml solution and tacrolimus ophthalmic drops);
• Compounded drugs that are still under review (including doxycycline and potassium bromide);
• Drugs that have been reviewed but not listed as appropriate to keep for in-office use (including apomorphine subconjunctival solution and tablets, and various otic preparations of ketoconazole, triamcinolone, and an antibiotic).

What does the GFI 256 guidance mean?

Since these guidelines are not legally binding and the FDA recognizes the veterinarian’s expertise and discretion, what do these recommendations really mean?

Pharmacies who choose to comply with GFI 256 could now require veterinarians to write individual prescriptions for certain compounded medications instead of ordering them for in-house use.

Pharmacies will also need to limit the amount of medication they dispense to a reasonable amount for the patient’s needs. This may increase the cost-per-dose for some medications, since smaller quantities of medication tend to cost more per dose.

Veterinarians may need to provide a rationale for compounding a medication versus using an FDA-approved drug, and they will need to report any adverse events or product defects to the FDA using a specific reporting tool.  

Unless prohibited by state law, medications listed as “under review” can still be ordered for in-office use until the FDA makes a decision on it, Bliss said.

Let the FDA know which compounded drugs you need in-clinic

Bliss is concerned that the FDA seems to be moving more compounded drugs to the “not listed” category, meaning these medications will not be available to order for in-hospital use. She stressed that veterinarians can make a big difference by sharing their opinions.

The FDA wants to hear from you about which compounded medications are best kept in stock versus prescribing them for individual patients. Veterinarians can visit the FDA docket to comment on drugs that are under review or are not listed. Bliss explains that comments should include the name of the bulk drug substance (BDS) and include examples of how having a particular medication in the clinic has impacted patient health.

“You have to convince them,” Bliss said. “They want to hear from you.”

To comment on which drugs are important to you, follow Wedgewood Pharmacy’s instructions on how to submit a comment to the FDA: https://info.wedgewoodpharmacy.com/gfi-comments.  

Further reading

GFI 256:
https://www.fda.gov/media/132567/download

Bulk Drug Substances Currently Under Review:
https://www.fda.gov/animal-veterinary/animal-drug-compounding/bulk-drug-substances-currently-under-review

Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals:
https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-office-stock-drugs-use-nonfood-producing-animals

Bulk Drug Substances Reviewed and Not Listed:
https://www.fda.gov/animal-veterinary/animal-drug-compounding/bulk-drug-substances-reviewed-and-not-listed

Emily Singler, VMD, is a 2001 graduate of Penn State University and a 2005 graduate of University of Pennsylvania School of Veterinary Medicine. She has worked in shelter medicine, private practice, and as a relief veterinarian. She currently works as a veterinary writer and consultant and has her own blog, www.vetmedbaby.com.   

Photo credit: © Vadim Sazhniev E+ via Getty Images Plus  

Disclaimer: The views expressed, and topics discussed, in any NEWStat column or article are intended to inform, educate, or entertain, and do not represent an official position by the American Animal Hospital Association (AAHA) or its Board of Directors.