Extra-Label Drug Use (ELDU) in Animals

ELDU, also referred to as "off-label use", refers to the use or intended use of a drug approved by Health Canada in an animal in a manner not in accordance with the label or package insert. It also includes the use of all unapproved drugs, including unapproved bulk active pharmaceutical ingredients (APIs) and compounded drugs.

The practice of ELDU in Animals in Canada is not confined to veterinarians and may be performed by multiple users including intermediate health professionals (e.g., pharmacists, animal health technicians, etc.) and laypersons (e.g., animal owners, livestock producers, etc.). VDD acknowledges that ELDU is an imprtant tool in the practice of veterinary medicine. Decisions to use ELDU may include a potential lack of efficacy of approved products, lack of approved products to address specific needs and economic considerations.

There are possible human health risks relating to ELDU in animals including:

• Development of antimicrobial resistance (AMR);
• Presence of drug residues in foods derived from treated animals and in the environment.

Health Canada established an ELDU Advisory Committee to provide expert advice and guidance on the issue of ELDU in animals in Canada. For more information on ELDU please see the links below.

• Policy on Extra-Label Drug Use (ELDU) in Food Producing Animals
• Extra-Label Drug Use (ELDU) in Food-producing Animals - Questions and Answers

The following information is no longer available online. If you would like to receive this information, contact the Veterinary Drugs Directorate.

• Issue Identification Paper - Extra Label Drug Use (ELDU)
• Health Canada's Veterinary Drugs Directorate Drug Use in Animals Study