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Extra Label Drug Use FAQs

Extra Label Drug Use (ELDU) describes the use of an approved drug in a manner that is not in accordance with the approved labeling, yet meets the conditions set forth by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and U.S. Food and Drug Administration (FDA) regulations.

Deviations from FDA-approved labeling include use in another species, use for a different indication, use at a different dose or frequency, and use via a different route of administration.

Extra label drug use (ELDU) is frequently required to treat small ruminants and maintain acceptable levels of flock and herd health. For example, most of the dewormers recommended for goats and camelids are not FDA-approved for use in these species. Administering a higher dosage of an approved product requires ELDU.

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