Extralabel Use [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 530.3 (a) [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter E Animal Drugs, Feeds, and Related Products; Part 530 Extralabel Drug use in Animals; Subpart A General Provisions], Extralabel Use means “actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses.”