Active Pharmaceutical Ingredients (API) for Veterinary Use - Position Statement
August 18, 2014
The Canadian Veterinary Medical Association (CVMA) holds that public health, food safety, animal health, and animal welfare are the priority considerations for determining which veterinary products can be imported and used in Canada.
The CVMA supports the licensing and approval process for the sale and distribution of veterinary pharmaceuticals through Health Canada’s Veterinary Drug Directorate (VDD).
The CVMA does not support active pharmaceutical ingredients (APIs) being sold for use as veterinary drugs in dosage form without approval by the VDD. The representation of APIs as veterinary drugs is illegal in Canada. The direct administration of APIs to animals carries inherent food safety and animal health risks as well as trade risks for food animal products. The direct administration of APIs to animals avoids the oversight provided by the Health Canada’s drug regulatory system. The CVMA supports regulatory change that is intended to stop the direct use of APIs in animals/livestock production by animal owners/caregivers without the direction and supervision of a veterinarian within the confines of a valid veterinary-client-patient relationship (VCPR).
The CVMA recognizes that the legitimate compounding of veterinary products pursuant to a valid prescription with appropriate veterinary oversight is an important part of the practice of veterinary medicine that protects animal health and welfare.
- Active pharmaceutical ingredients (APIs) are defined as bulk, pharmaceutically active substances (‘chemicals’) that are purchased as such from chemical suppliers and used in the formulation of drugs in dosage form. APIs are intended for modification prior to use by a licensed drug manufacturer, pharmacist, or veterinary practitioner.
- Health Canada requires that all veterinary pharmaceuticals have a valid Drug Identification Number (DIN) which permits the manufacturer to market the drug in Canada. APIs are not subject to Health Canada’s market authorization requirements, do not have a DIN and are not intended to be administered directly to animals. Currently, their administration to animals is not illegal. The CVMA holds that the administration of APIs to animals by end users (direct use, on farm mixing, etc.) should be considered to be the use of a drug in dosage form. As such, this use should require compliance with Health Canada’s VDD requirements for registration (1).
- The federal regulatory void and the associated administration of APIs to animals can result in issues with food safety, environmental, worker, and animal safety, and ‘product’ (drug) efficacy. The CVMA supports regulatory change that would provide oversight for the importation, sale, and distribution of APIs, and would stop their purchase and direct administration to animals by owners/caregivers. Such regulatory oversight would contribute to public health, food safety, animal health and welfare, and the viability of Canada’s export markets.
- The CVMA holds that compounding is both necessary and beneficial for veterinary patients but there are potential risks to animal health, public health, and food safety if the standards of practice for compounding are not adhered to. No person other than a licensed pharmacist or veterinarian may compound products for use in animals. The CVMA recommends veterinarians follow the CVMA Guidelines for the Legitimate Use of Compounded Drugs in Veterinary Medicine and its Decision Cascade and choose the level of least risk to animal health, public health, and food safety. Veterinarians should only prescribe and dispense products compounded from API if other options in the Decision Cascade are not available or appropriate. Cost is not a defensible reason for prescribing a compounded product (3,4).
- Health Canada Policy for the Importation or Sale of Active Pharmaceutical Ingredients for Veterinary Use POL-0018. (Health Canada website). Available from: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/import-export/pol_0018_tc-tm-eng.php. Last accessed August 1, 2014.
- Uses of Antimicrobials in Food Animals in Canada: Impact of Resistance and Animal Health. (Health Canada website). Available from: http://www.hc-sc.gc.ca/dhp-mps/pubs/vet/amr-ram_final_report-rapport_06-27_cp-pc-eng.php. Last accessed August 1, 2014.
- CVMA Guidelines For the Legitimate Use of Compounded Drugs in Veterinary Practice 2006. (CVMA website). Available from: http://www.canadianveterinarians.net/documents/cvma-guidelines-for-legitimate-use-of-compounded-drugs-in-veterinary-practice-2006. Last accessed August 1, 2014.
- Therapeutic Decision Cascade for Animal and Public Safety 2013. (CVMA website). Available from: http://www.canadianveterinarians.net/documents/therapeutic-decision-cascade. Last accessed August 1, 2014.