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Extralabel drug use encompasses the use of a drug in an animal in a manner that is not in accordance with the FDA-approved label. This includes use in a species or for a disease or condition not listed on the label; use at dosages, frequencies, or routes of administration that differ from those stated on the label; or deviation from the labeled withdrawal time. Extralabel drug use in veterinary species was made legal by the passage of AMDUCA in 1994.
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