AMDUCA

AMDUCA (Animal Medicinal Drug Use Clarification Act) is a United States federal law enacted in 1996 to regulate the use of animal drugs, particularly in food-producing animals. The law provides a legal framework for the use of veterinarian-approved or conditionally approved drugs that are not specifically labeled for a particular species, allowing for extra-label drug use (ELDU) under certain conditions.

AMDUCA aims to ensure the efficacy and safety of animal drugs while protecting public health by preventing drug residues in meat, milk, and other animal-based products. The legislation grants veterinarians the authority to prescribe extralabel uses of approved drugs when necessary for animal health, provided they observe guidelines to minimize drug residues in food products and follow withdrawal periods.

Key provisions of AMDUCA include the requirement that extralabel drug use must be based on valid veterinarian-client-patient relationships, and drugs must be used in a manner consistent with approved labeling unless approved otherwise. The law also stipulates record-keeping and reporting requirements to monitor drug usage and ensure compliance.

The Food and Drug Administration (FDA) oversees and enforces AMDUCA regulations, working closely with the U.S. Department of Agriculture (USDA) and state regulatory agencies. Violations of AMDUCA can result in legal penalties, including fines and sanctions.

Overall, AMDUCA plays a crucial role in balancing animal health management with food safety and public health concerns, providing veterinarians with necessary flexibility while maintaining regulatory oversight to prevent drug residues in human food supplies.