Veterinary compounding is a growing market, and ranges from simply flavoring medications to customized cancer prescriptions. It also introduces a distinct set of legal issues, as while some practices are covered by existing laws governing human compounding, others fall into grey areas, in which no clear guidance is apparent. One of these issues is that of compounding for “office use” – in which a medication is compounded and sold to the practitioner, who then administers and sells directly to the patient.
While compounding for in-office use for human drugs is permitted if a facility is registered as an “Outsourcing Facility” under 503B of the Drug Quality and Security Act (DQSA), which was enacted in 2013, the FDA has stated that the DQSA does not apply to veterinary compounding. Additionally, the Draft Guidance for Industry Compounding Animal Drugs from Bulk Drug Substances (“Draft Guidance”) published May 20, 2015 states that while 503A and 503B provide certain statutory exemptions for compounded human drugs, these sections do not provide exemptions for drugs compounded for animal use. Therefore, there is no current 503B “Outsourcing Facility” equivalent for in-office use of veterinary drugs.
Prior to the Draft Guidance, the main source of information on the legality of veterinary compounding practices was the FDA’s “Compliance Policy Guideline” (CPG) on the subject, which clarified when the FDA would use “enforcement discretion” to permit various forms of animal compounding. The CPG provided that the FDA would “defer” to state authorities regarding the day-to-day regulation of compounding by veterinarians and pharmacies of animal drugs; however, the CPG has now been superseded by the Draft Guidance and is thus no longer applicable.
Like the CPG, the Draft Guidance does not directly address office use of compounded drugs for animals, but does specify that 503B’s exceptions, which include office use compounding for humans, do not apply. The Draft Guidance states, for both state-licensed pharmacies and outsourcing facilities, that the FDA does not intend to take action if the drug is compounded pursuant to certain conditions. While there are multiple conditions listed, germane to the topic of office use compounding is the one that specifies that “The drug is not sold or transferred by an entity other than the entity that compounded such drug. For purposes of this condition, a sale or transfer does not include administration of a compounded drug by a veterinarian to a patient under his or her care.” The Draft Guidance therefore could arguably be construed to allow in office administration of compounded drugs, but would not appear to allow the veterinarian to dispense compounded drugs.
On the other hand, there are issues with conflicting state and federal laws, with some states allowing practitioners to administer and dispense, some allowing only administration, while other states expressly prohibit compounding for office use. Still other states are silent on the subject, leaving the permissibility of office use ambiguous. Taken together, the lack of an express prohibition on office use at the federal level suggests that, in states that permit it, practitioners may keep a limited supply of routinely needed medications on hand to administer, either drugs that are solely for office use or for office use while a compounded prescription is concurrently filled. Ultimately, the permissibility of veterinary compounding for in-office use is currently a state-by-state determination, but veterinary compounders would be prudent to pay attention to developments in federal compounding law, as it likely that the industry will be subject to increased scrutiny in the future.
