Extra-label drug use refers to the use of a drug that is not in accordance with the approved label or the package insert of the drug licensed by Health Canada. Extra-label drug use encompasses a broad range of activities. Extra-label drug use can be a significant component of a veterinarian’s practice, and can be essential for certain animal species.
As a drug used in an extra-label manner has not undergone the drug review process at Health Canada that ensures that a drug product has received rigorous scientific scrutiny and satisfies all requirements and criteria that are prescribed by the Food and Drug Regulations, a drug used in an extra-label manner does not have proven safety or efficacy characteristics based on its intended use. According to Health Canada, extra-label drug use presents a number of potential public health and food safety risks, including violative drug residues being present in food products derived from ELDU-treated animals, the emergence and/or aggravation of antimicrobial resistance, and potential adverse reactions to an animal or group of animals since these products may not have been tested appropriately for the intended condition.
Veterinarians must ensure that they meet the practice expectations when prescribing and dispensing a drug in an extra-label manner.
Extra-Label Drug Use: Extra-label drug use (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 with respect to species, indication, dose, duration, and route of administration. It also includes the use of all unapproved drugs, including unapproved bulk active pharmaceutical ingredients (APIs) and compounded drugs.
Guide to the Standard
A separate Guide to the Professional Practice Standard: Extra-Label Drug Use has been developed
by the College and can be found on the Colleges’ website www.cvo.org.
Food and Drugs Act and Regulations (Federal)
Feeds Act and Regulations (Federal)
Controlled Drugs and Substances Act and Regulations (Federal)
Drug and Pharmacies Regulation Act and Regulations (Provincial)
Drug Interchangeability and Dispensing Fee Act (Provincial)
Veterinarians Act (Provincial)
Regulation 1093, s. 1, 18, 23-33 (Veterinarians Act) (Provincial)
The following can be found at the College’s website at cvo.org:
Professional Practice Standard: Prescribing a Drug
Guide to the Professional Practice Standard: Prescribing a Drug
Professional Practice Standard: Dispensing a Drug
Guide to the Professional Practice Standard: Dispensing a Drug
Professional Practice Standard: Use of Compounded Drugs in Veterinary Practice
Guide to the Professional Practice Standard: Use of Compounded Drugs in Veterinary Practice
Professional Practice Standard: Management and Disposal of Controlled Drugs
Guide to the Professional Practice Standard: Management and Disposal of Controlled Drugs
Professional Practice Standard: Informed Client Consent
Guide to the Professional Practice Standard: Informed Client Consent
Professional Practice Standard: Medical Records
Guide to the Professional Practice Standard: Medical Records
Professional Practice Standard: Establishing, Maintaining, and Discontinuing a Veterinarian-Client-Patient Relationship (VCPR)
Guide to the Professional Practice Standard: Establishing, Maintaining, and Discontinuing a Veterinarian-Client-Patient Relationship (VCPR)
The following additional resources are also applicable:
Health Canada Policy on Extra-Label Drug Use (ELDU) in Food Producing Animals
Health Canada Categorization of Antimicrobial Drugs Based on their Importance in Human Medicine Health Canada, Extra-Label Drug Use (ELDU) in Animals
Alberta Veterinary Medical Association Council Guidelines regarding Prescribing, Dispensing, Compounding and Selling Pharmaceuticals