What is considered Extra-label 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 ELDU:

Any of the following drug uses constitutes ELDU in food-producing animal species:

  1. Administration to a different SPECIES or Animal Use Class than listed on the label
  2. Administration of a different DOSE than listed on the label
  3. Administration of a different VOLUME per injection site than listed on the label
  4. Administration via a different ROUTE than listed on the label
  5. Administration at a different INTERVAL (frequency) than listed on the label
  6. Administration for a different DURATION than what listed on the label
  7. Administration for a different INDICATION or purpose than listed on the label
More information on ELDU:
Requirements for ELDU
Learn about the general requirements for ELDU as well as veterinarian requirements and producer responsibilities for ELDU.
Drugs and Drug Classes Prohibited from ELDU
Learn about human safety concerns with ELDU and the extended withdrawal interval.
ELDU and Withdrawal Time
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.