Extralabel
Extralabel refers to the use of a drug or medical product in a manner not specified on the product’s label. In veterinary medicine, extralabel use, often called off-label use, involves treating animals with a drug for a species, indication, dosage, route of administration, or duration that is not included on the label. It is governed in the United States by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), which allows veterinarians to authorize extralabel use when no approved treatment exists and it is in the animal’s best interest, provided certain conditions are met. These conditions typically include a valid veterinarian–client–patient relationship, use only when necessary and supported by professional judgment, avoidance of unsafe practices, and thorough recordkeeping. For food-producing animals, withdrawal times and residue considerations are emphasized to protect public health.
Outside veterinary medicine, extralabel use mirrors the broader concept of off-label use in humans, where a
Regulatory landscapes vary by country. In the United States, AMDUCA governs veterinary extralabel use, while in