Notice of Amendment: Betaine removed from the Prescription Drug List (PDL)

January 6, 2023
Our file number: 22-113665-91

The purpose of this Notice of Amendment is to announce that Health Canada has removed “Betaine or its salts” from the Veterinary part of the Prescription Drug List (PDL). Only the Veterinary part of the PDL has been be revised.

Rationale

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.

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 that indicate the need for prescription status.

Health Canada published a Notice of Intent to Amend on July 6th 2022 to announce the Minister’s intent to remove betaine from the veterinary part of the PDL following a public consultation.

Next steps

As a result of this PDL amendment, a veterinary product containing betaine or its salts will be considered a non-prescription drug subject to the Food and Drug Regulations (FDR). To date, there are no marketed products in Canada that 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