Notice of amendment: Carisoprodol removed from the Prescription Drug List

April 14, 2025
Our file number: 25-102589-951

The purpose of this Notice of Amendment is to announce that Health Canada has removed carisoprodol from the Prescription Drug List (PDL) since its addition to Schedule V of the Controlled Drugs and Substances Act (CDSA) is now in effect. Both the Human and Veterinary parts of the PDL were revised.

Rationale

Carisoprodol is a sedative drug used in some countries as a muscle relaxant indicated for the relief of acute, painful musculoskeletal conditions. It produces effects similar to central nervous system depressants such as barbiturates and benzodiazepines. There are currently no marketed health products in Canada that contain carisoprodol.

Health Canada indicated its intent to remove carisoprodol from the PDL in the Notice of Intent published on March 26, 2025. Effective April 14, 2025, carisoprodol is no longer listed on the PDL as the drug has been added to Schedule V of the 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 Controlled Drugs and Substances Act (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.

For more information about the rationale for scheduling carisoprodol under the CDSA, please refer to the Regulatory Impact Analysis Statement that was published in conjunction with the Ministerial Order. An additional Ministerial Order was also made to amend Part J of the Food and Drug Regulations adding carisoprodol to Part III of its schedule. This was done to facilitate research and clinical testing with the drug while it is temporarily controlled under the CDSA.

Next steps

As of this date, carisoprodol is considered a controlled substance subject to the CDSA. Therefore, it is 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

During the period in which carisoprodol is temporarily scheduled under Schedule V of the CDSA, Health Canada intends to advance a regulatory package that would permanently control carisoprodol under Schedule IV of the CDSA and the Schedule to the Benzodiazepines and Other Targeted Substances Regulations.

Should a sponsor wish to apply for market authorization of a health product that contains carisoprodol, please contact the Bureau of Cardiology, Allergy and Neurological Sciences in the Pharmaceutical Drugs Directorate at bcansenquiries@hc-sc.gc.ca.

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