Requirements for ELDU

Extra-label drug use 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:

  • Only a licensed veterinarian, with a valid veterinarian-client-patient relationship (VCPR), can use and prescribe a drug in an extra label manner.
    • This means it is considered illegal extra label drug use if a producer initiates use of a drug extra label without the supervision or direction of a veterinarian.
  • Only animal or human FDA approved drugs may be used in an extra label manner.
    • This includes both Over The Counter (OTC) and prescription (Rx) only drugs.
    • This also means that pesticides, which are approved by the Environmental Protection Agency (EPA), not FDA, may not be used in an extra label manner.
  • Drugs are not allowed to be used in an extra label manner in feed.
  • The use of a drug extra label is only for therapeutic purposes or where suffering or death may result from failure to treat.
    • This means a drug may not be used in an extra label manner for the purpose of increasing production (i.e. increasing milk production, weight gain of the animal, or for reproduction).

 

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