Requirements for ELDU

ELDU is allowed under the Animal Medicinal Drug Use Clarification Act (AMDUCA). FDA regulations addressing ELDU are covered in 21 CFR 530.

The following must be met in order to use a FDA approved drug in an extra label manner:
Extra Label Drug Use Algorithm in Food Producing Animals
*Adapted from the AVMA Extra Label Drug Use Algorithm
adapted AVMA extralabel drug use algorithm

Requirements for Veterinarians

  • Diagnose and evaluate the condition for which the drug is to be used
  • Institute procedures to ensure the identification of the treated animal(s) is maintained
  • Establish a science based and substantially extended withdrawal interval
  • Take appropriate measures to ensure the withdrawal interval is met by the clients
  • Maintain treatment records

Responsibility of Producers

  • Engage a veterinarian to develop and oversee a drug management program
  • Maintain records of treated animals
  • Maintain identification of treated animals
  • Have a control system in place to prevent contamination of the human food chain
  • Maintain storage and accounting of drugs on the premises

Search VetGRAM

Search for FDA Approved Animal Drugs and view their approved uses
  Prohibited Drugs

Learn about which drugs are prohibited from ELDU and why they are prohibited
  Submit a Withdrawal Request

Access FARAD's online withdrawal request form