The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) made ELDU an FDA-regulated veterinary medical activity, allowing veterinarians to prescribe extra-label uses of approved animal and human drugs when the health of an animal is threatened, or when suffering or death may result from failure to treat animals. Prior to the passage of the AMDUCA, ELDU of animal drugs was illegal. AMDUCA amended the Federal Food, Drug, and Cosmetic Act to legalize ELDU under a valid VCPR as well as certain other conditions describing requirements for use, record requirements, and label requirements according to FDA regulations.
