REQUIREMENTS FOR ELDU | en Español
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).
- 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
- 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