Abstract
Pharmacy compounding of drugs for companion animals and humans is as old as time. For hundreds of years, pharmacists created these drugs using active pharmaceutical ingredients, otherwise known as bulk drug substances, to address the medical needs of these patients. Congress recognized this longstanding practice when it enacted the Food, Drug, and Cosmetic Act (“FDCA”), with lawmakers then noting that while pharmacists, physicians, and veterinarians were already highly regulated by the states, mass-producing drug manufacturers were not regulated. The FDCA would regulate such manufacturers.
Thereafter, pharmacy compounding from bulk drug substances continued for decades after the FDCA’s enactment and without any attempted interference by the Food and Drug Administration (“FDA”). But, approximately fifty years after Congress enacted the FDCA, the FDA began to change its tune. The FDA’s policy guides first proclaimed such compounding to be illegal under the FDCA in relation to human drugs. Congress pushed back and, in 1997, created the Food and Drug Administration Modernization Act (“FDAMA”), which expressly permits pharmacy compounding from bulk drug substances for human use. Despite this congressional statement, the FDA persisted in its position that using bulk drug substances to compound drugs for companion animals is illegal per se. Its latest 2022 policy guide adheres to this position, stating that the FDA, “in its discretion,” will permit such compounding only in limited, delineated circumstances. But in that same year, the Supreme Court officially recognized the “major questions doctrine,” which attempts to rein in overzealous agency assertions of power beyond that which Congress likely granted. In West Virginia v. EPA, the Court announced that, when faced with dramatic claims of agency authority that have political or economic significance, are novel or unprecedented, or impact traditionally state-regulated areas, the Court will look for a “clear statement” from Congress that it delegated such authority to the agency.
This Note analyzes the legality of the FDA’s 2022 policy guide for pharmacy compounding from bulk drug substances for companion, nonfood animals. For several reasons, the “major questions doctrine” should apply to curtail the FDA’s claimed authority. The FDA’s position ignores centuries of history, several FDCA textual provisions, the FDA’s own inconsistent policy positions, and traditional state regulation over pharmacy and medical practices. And, at bottom, the FDA’s policy jeopardizes companion animals’ medical needs and runs counter to the FDCA’s mission. If the FDA’s 2022 policy guide is allowed to stand, it will have a substantial and unnecessary negative impact on the health and wellbeing of nonfood companion animals—who, for many of us, are beloved members of our families.
Recommended Citation
Ross C. Reggio, FDA Overreach: Is Your Pet’s Health a “Major Question” to You?, 81 Wash. & Lee L. Rev. 907 (2024).Available at: https://scholarlycommons.law.wlu.edu/wlulr/vol81/iss2/9
Included in
Administrative Law Commons, Animal Law Commons, Food and Drug Law Commons, Legislation Commons