Notice of intent: Removing carisoprodol from the Prescription Drug List

March 26, 2025
Our file number: 25-102221-119

The purpose of this Notice of Intent is to announce that Health Canada will remove carisoprodol from the human and veterinary parts of the Prescription Drug List (PDL) on April 14th, 2025, the date on which the Ministerial Order comes into force to add carisoprodol to Schedule V of the Controlled Drugs and Substances Act (CDSA).

The PDL is a list of medicinal ingredients that, when found in a drug, require a prescription. It doesn't include medicinal ingredients that are listed on schedules of the CDSA. Medicinal ingredients are removed from the PDL when they are scheduled under the CDSA because the prescription controls under the CDSA provide sufficient oversight for any therapeutic use.

There are currently no marketed health products that contain carisoprodol in Canada. Carisoprodol is a sedative drug used in some countries as a muscle relaxant indicated for the relief of acute, painful musculoskeletal conditions.

Consultation summary

Health Canada held a consultation on the proposal to add carisoprodol to Schedule V of the CDSA through a Canada Gazette Part I publication from February 14^th to 24^th 2025. A PDL Notice of Consultation was also published on February 18^th 2025 to coincide with the CG Part I publication. Health Canada did not receive any comments directly related to the removal of carisoprodol from the PDL.

Rationale

On February 27, 2025, the Minister of Mental Health and Addictions and Associate Minister of Health issued an Order to add carisoprodol to a temporary emergency schedule under the CDSA. The Minister also issued an Order to amend Part J of the Food and Drug Regulations to add carisoprodol to Part III of its schedule to facilitate its use in clinical testing and laboratory research. These Orders come into force on April 14, 2025, and will be in effect for one year or the day on which an Order is made adding this substance to another schedule to the CDSA. The PDL will be amended on this day (April 14, 2025) and a notice of amendment will also be posted announcing this change.

The Regulatory Impact Analysis Statement and the Orders can be found in the links below:

• Order Amending Schedule V to the Controlled Drugs and Substances Act (Fentanyl Precursors and Carisoprodol): SOR/2025-64
• Order Amending Part III of the Schedule to Part J of the Food and Drug Regulations (Carisoprodol): SOR/2025-65

Next steps

When the Orders come into force on April 14^th 2025, it would be prohibited under the CDSA (unless otherwise authorized by Health Canada) for carisoprodol to be:

• sold
• imported
• exported
• produced
• possessed for the purpose of trafficking
• possessed for the purposes of exporting

For more information about carisoprodol's scheduling under the CDSA, please contact the Office of Legislative and Regulatory Affairs in Health Canada's Controlled Substances and Overdose Response Directorate at csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca.

Questions about how to access carisoprodol for legitimate use should be directed to the Office of Controlled Substances in Health Canada's Controlled Substances and Overdose Response Directorate at cds-sdc@hc-sc.gc.ca.

Should you have any questions about this notice, please contact:

Health Canada
Prescription Drug Status Committee
6th Floor Holland Cross – Tower B
Address Locator 3106C
1600 Scott St
Ottawa ON K1A 0K9

Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca