FDA’s recent announcement that it is “withdrawing draft Guidance for Industry (GFI) #230, ‘Compounding Animal Drugs from Bulk Drug Substances’” reminded me that pet owners can become confused about what type of medications are available for treating their pets. For example, while serving on the New Jersey State Board of Veterinary Medicine, I recall a fair number of consumer complaints that alleged that a veterinarian provided substandard medical care because the medication prescribed to a pet was labeled “for human use only.” Consumers therefore concluded that the medication harmed their pet.
However, the fact that medication is not specifically approved for use in animals does not mean that it would necessarily be harmful to those animals.
In fact, the use of an approved drug in a manner that is different than stated on the label, has been a fundamental tool used in veterinary medicine since drugs were first labeled. This “extralabel” drug use was memorialized by Congress in the Animal Medicinal Drug Clarification Act of 1994 (AMDUCA). See AVMA’s description of AMDUCA.
As AVMA describes on it’s website, “Compounding: FAQ for Veterinarians,” “compounding for animal patients . . . [is] a subpart of [the] Extralabel Drug Use (ELDU) Rules.”
The ability to use approved drugs in species, for treatments, or at dosages, frequencies, or routes of administration that are not included on the label, is a tool that veterinarians use on a daily basis. Since obtaining drug approvals for all uses in all types of animal species is cost-prohibitive, the only way some animals can be treated is through the use of drugs in an extra-labeled fashion.
When used properly and pursuant to the standard of care in veterinary medicine, such use should be considered legal.
While FDA has stated that “[c]urrent law does not permit compounding of animal drugs from bulk drug substances,” whether, and to what extent FDA governs compounding in the veterinary space has been the subject of legal debate.
However, FDA’s withdrawal of its guidance document related to compounding animal drugs from bulk substances creates even more confusion and uncertainty for the regulated community. The now withdrawn guidance document, Guidance #230, had set forth the situations in which FDA had indicated that it would not take regulatory action against a pharmacy or veterinarian when “an animal drug compounded from bulk substances may be an appropriate treatment option.”
Now, instead of finalizing the draft guidance based on comments received, “FDA intends to publish the new draft in early 2018 for public comment.”
So, the regulated community will be without guidance for a short period of time.
Hopefully FDA’s new guidance will continue to permit compounding from bulk substances when needed to provide adequate medical care for animals in need thereof.