Notice of Intent to Amend the Prescription Drug List (PDL): Betaine

July 6, 2022
Our file number: 21-108009-981

The purpose of this Notice of Intent to Amend is to announce that Health Canada will remove "Betaine or its salts" from the Veterinary part of the Prescription Drug List (PDL). Only the Veterinary part of the PDL will be revised.

Consultation summary

The proposal for this amendment to the PDL was communicated through a Notice of Consultation. The Notice of Consultation was posted on the Health Canada website on December 22, 2021, followed by a 75-day comment period. No comments were received during the consultation period.

Based on the results of this consultation, the Minister of Health intends to go forward with the proposed removal of "Betaine or its salts" from the Veterinary part of the PDL.

Rationale

A review of the safety and efficacy evidence submitted to Health Canada determined that betaine for veterinary use does not warrant its current prescription status due to the drug not meeting the principles and factors underlying the need for prescription status. A summary of how betaine for veterinary use does not meet any of the prescription criteria can be found in the consultation notice.

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. This resulted in betaine for veterinary use inadvertently becoming a prescription drug as it was listed 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.

Next steps

This PDL amendment will take effect 6 months after the posting of this notice. The amendment will be communicated to stakeholders through the publication of a Notice of Amendment. No currently marketed product will be affected by this amendment.

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.

Should you have any questions on this update to the Prescription Drug List, please contact:

Health Canada
Pharmaceutical Drugs Directorate
Office of Science
E-mail: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca

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