EXTRALABEL DRUG USE
Extra Label Drug Use (ELDU or “Off-Label Use”) is any use of an FDA-approved drug that differs from instructions on the approved product label.
Seven Uses that are ELDUAny of the following drug uses constitutes ELDU in food-producing animal species:
- Administration to a different SPECIES or Animal Use Class than listed on the label
- Administration of a different DOSE than listed on the label
- Administration of a different VOLUME per injection site than listed on the label
- Administration via a different ROUTE than listed on the label
- Administration at a different INTERVAL (frequency) than listed on the label
- Administration for a different DURATION than what listed on the label
- Administration for a different INDICATION or purpose than listed on the label
|ELDU Requirements Learn about the general requirements for ELDU as well as veterinarian requirements and producer responsibilities for ELDU.||Withdrawal Time Considerations Learn about human safety concerns with ELDU and the extended withdrawal interval.||Prohibited Drugs Learn about which drugs are prohibited from ELDU and why they are prohibited.|
While ELDU in non-human species is permissible under the Animal Medicinal Drug Use Clarification Act (AMDUCA), it is vitally important that ELDU in food-producing animal species is consistent with FDA requirements as outlined in the Code of Federal Regulations 21 CFR 530.