Unlike licensed veterinary drugs that undergo a strict legislated approval process by the federal Veterinary Drugs Directorate, compounded drugs are not tested or approved by Health Canada and their use may be associated with greater risk to animal care and outcomes. A veterinarian who engages in the preparation of a compounded drug assumes the same responsibility for the quality, stability, safety, efficacy, potency, and any adverse reactions of the compounded drug that a pharmaceutical company assumes for its approved drugs. This accountability exists whether a veterinarian orders compounded drugs through a compounding pharmacy or when they compound independently.
Compounding is extra-label drug use. In Ontario, no individual other than a licensed veterinarian or pharmacist may dispense a compounded drug for administration to animals. Compounding is an accepted veterinary practice and, in certain circumstances, and for some species, may be the most appropriate and effective method of dispensing a drug. A veterinarian wishing to prescribe a compounded drug may compound and dispense the drug him or herself, issue a prescription for a specific compounded drug, or dispense from stock a drug that was purchased from a compounding pharmacy for in-office use.
Veterinarians must ensure that they meet the practice expectations for prescribing and dispensing a drug when compounding.
Beyond Use Date: A beyond use date is the date after which a compounded preparation should not be used; determined from the date the preparation is compounded.
Compounding: Compounding is the combining or mixing together of two or more ingredients (of which at least one is a drug or an active pharmaceutical ingredient) to create a final drug in an appropriate form for dosing. It can involve raw materials or the alteration of the form and strength of commercially available drugs. It can include reformulation to allow for a novel drug delivery (e.g., transdermal). Compounding does not include mixing, reconstituting, or any other manipulation that is performed in accordance with the directions for use on an approved drug’s labelling material.
Guide to the Standard
A separate Guide to the Professional Practice Standard: Use of Compounded Drugs in Veterinary Practice 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 references informed the development of this Professional Practice Standard:
Health Canada, Health Products and Food Branch Inspectorate, Policy on Manufacturing and Compounding Drug Products in Canada, POL-0051, January 26, 2009
ABVMA Council Guidelines Regarding Prescribing, Dispensing, Compounding and Selling Pharmaceuticals
The following can be found at the College 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: Extra-Label Drug Use
Guide to the Professional Practice Standard: Extra-Label Drug Use
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:
Trissel's Stability of Compounded Formulations (print book)