December 22, 2021
Our file number: 21-121823-438

This Notice of Consultation provides an opportunity to comment on the proposal to remove "Betaine or its salts" from the Veterinary part of the Prescription Drug List (PDL). Only the Veterinary part of the PDL is proposed to be revised.

Rationale

In the last year, Health Canada has received submissions to add "betaine and its salts" to the List of Permitted Substances (or List C: Veterinary Health Products). Veterinary Health Products are low risk drugs in dosage form to maintain or promote health and wellbeing in animals, including food and companion animals. As a veterinary health product betaine hydrochloride is indicated to support the maintenance of normal hydration in livestock during times of stress and is added to feed or drinking water.

Prior to the introduction of the PDL in 2013, betaine was listed on Schedule F of the Food and Drug Regulations for a specific human indication. When the products listed under Schedule F were transferred to the PDL in 2013, the Veterinary listing of betaine was erroneously modified to remove the qualification for the human disease rather than removing the ingredient entirely and betaine inadvertently became a prescription drug on the Veterinary part of the PDL. The removal of "betaine and its salts" from the Veterinary PDL would rectify this issue and permit betaine to be added to the List of Permitted Substances.

Should this PDL amendment proceed, a veterinary product containing betaine will no longer be considered a prescription drug under the Food and Drug Regulations.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Comments on this proposed change to the PDL should be provided to Health Canada in writing, preferably in electronic format, within 75 days from the date of this notice.

Please send your comments to:
Health Canada
Therapeutic Products Directorate
Office of Science
E-mail: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca

Next steps:

All comments will be reviewed and summarised. Should Health Canada proceed with the amendment, a Notice of Intent to Amend the PDL will be posted on the Health Canada website.