Veterinary Compounding: For "Office Use"

As the veterinary compounding market continues to grow and expand, new legal issues arise and, in some instances, the current federal and/or state laws may be in conflict with one another or they may not provide clear guidance on specific topics.

Veterinary compounding for ‘office use,’ where a medication is compounded and then sold to a veterinarian, who then administers (or sells) directly to the patient (or owner) remains a hot topic since state authorities continue to regulate compounding and the compounding laws of one state may be completely different from the compounding laws of another state. Thus, it is critical that each veterinary compounding pharmacy familiarize itself with the laws of each state where they do business or face potentially severe disciplinary actions.

Historically, the Food and Drug Administration (FDA), used enforcement discretion that allowed various forms of animal compounding and would defer to state authorities the day-to-day regulation of veterinary compounding by pharmacists, pharmacies and veterinarians. However, the New England Compounding Center (NECC) tragedy of 2012 dramatically changed compounding and, ever since, all aspects of compounding have remained under increased scrutiny.

In response to the NECC compounding tragedy, the FDA stepped in and passed the Drug Quality and Security Act (DQSA) in 2013, which allowed compounding for office use of human drugs if a compounding facility is registered as an outsourcing facility under 503B of the DQSA. In May 2015, the FDA published the Draft Guidance for Industry Compounding Animal Drugs from Bulk Substances (Draft Guidance) which states that while 503A and 503B provide certain statutory exemptions for compounded human drugs these sections do not provide exemptions for drugs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. Unfortunately, neither has sufficiently addressed office use of compounded medications for animals and, thus, the regulation of veterinarian compounding remains under state authorities.

For veterinary compounding pharmacies, issues with individual state law regulation remain as one state may expressly prohibit compounding for ‘office use’ or make no distinction between human drugs and animal drugs, while others laws simply do not address ‘office use.’

In conclusion, veterinary compounding pharmacies should continue to pay close attention to the specific ‘office use’ laws of each state where they send compounded veterinary medications as it is highly likely that their actions will continue to be closely monitored and scrutinized.