In July, a federal court in Louisiana ruled that compounded preparations for veterinary use are subject to the enforcement provisions of the Federal Food, Drug, and Cosmetic Act. While the case in question alleged that a veterinarian and pharmacy worked together to provide a synthetic version of dermorphin to racehorses, this decision may have broader consequences for many veterinary practitioners.
In this particular court case, defendants argued that the synthetic version of dermorphin was a compounded animal drug for veterinarians and therefore was exempt from requirements under the Food, Drug, and Cosmetic Act. The district court disagreed, saying that the law’s application “hinges on the substances in question not who created the substance.”
For all veterinarians, this ruling means that compounded preparations for veterinary use continue to be subject to the enforcement provisions of the Food, Drug, and Cosmetic Act.
The AVMA remains committed to protecting veterinary medicine’s access to compounding, including from bulk substances. We’ve communicated frequently with Congress and federal agencies on this issue, and we also convened a task force to develop compounding legislation addressing veterinary concerns. We’re currently working with stakeholders to develop legislation from the task force’s final recommendations.
We’ll continue providing updates on changes in compounding policies for veterinarians. To learn more about compounding, including the AVMA’s compounding policies and efforts, visit the compounding page of AVMA.org.