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. 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.

Seven Uses That Are ELDU

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

 

Prohibited Drugs

Some drugs and drug classes are prohibited from any ELDU in food-producing animals.
  ELDU Resources

See FARAD resources to understand and comply with ELDU requirements and regulations.
  Restricted Drugs

Some drugs and drug classes are limited with respect to ELDU in food-producing animals.