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 ELDU

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

 

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.