Takhar v. Kessler

Extra-label drug use is the practice of using a drug in a way not indicated on the drug’s label. Under the federal Food, Drug, and Cosmetic Act (the act), extra-label drug use in animals by veterinarians was technically illegal. However, beginning in the late 1970s, the Food and Drug Administration’s (FDA) Bureau of Veterinary Medicine took the position that a veterinarian could engage in extra-label drug use in non-food-producing animals provided (1) the veterinarian had legally obtained the drug, (2) no approved alternative drug was available, and (3) the extra-label use was not an obvious health hazard to the animal. At that time, the FDA did not allow extra-label drug use in food-producing animals and had told veterinarians that the FDA would take regulatory action against a veterinarian if the veterinarian’s extra-label drug use resulted in illegal drug residue in edible animal tissue. In 1984, the FDA issued Compliance Policy Guide (CPG) 7125.06, which revised the FDA’s earlier position regarding extra-label drug use in food-producing animals. The CPG stated that illegal drug residue in edible tissue was no longer a prerequisite to a regulatory action against a veterinarian for extra-label drug use. However, the CPG also indicated that veterinarians could consider extra-label drug use in food-producing animals if the animals’ health was immediately threatened and failure to treat the animals would result in the animals’ suffering or death. The CPG listed criteria and precautions for extra-label drug use that, if followed, ordinarily would not result in regulatory action against a veterinarian. The criteria and precautions included: (1) a medical diagnosis by an attending veterinarian in the context of a veterinarian-client-patient relationship, (2) an absence of approved drugs available to treat the animal’s condition effectively, (3) careful identification of the treated animal, (4) observance of an extended withdrawal period before marketing food produced by the treated animal, (5) an absence of illegal drug residue in edible tissue from the treated animal, and (6) adequate labeling of the extra-label drug by the prescribing veterinarian. The CPG indicated that some specific drugs could not be used in food-producing animals even if these criteria and precautions had been followed. In 1991, the FDA issued CPG 7125.35, which addressed the use of human drugs in veterinary practice. The CPG indicated that most human-drug use occurred in nonfood animals (e.g., pets) and explained that human drugs were sometimes necessary to treat pets’ illnesses because many human drugs did not have veterinary versions. The CPG incorporated the criteria and precautions from CPG 7125.06 to guide enforcement of human-drug use in nonfood animals.