Part IIFinal RegulationVolume 159, Number 6Published: March 12, 2025

Carisoprodol Added to Food and Drug Schedule

Order Amending Part III of the Schedule to Part J of the Food and Drug Regulations (Carisoprodol): SOR/2025-65

The order adds carisoprodol to Part III of the schedule to Part J of the Food and Drug Regulations for a one-year period beginning April 14, 2025, and deletes the previous Item 1. The order generally comes into force on April 14, 2025, while the deletion (section 2) will come into force on the earlier of a related CDSA scheduling order or April 14, 2026 (not earlier than April 15, 2025).

Published
March 12, 2025
Department
Unavailable
Section
Order Amending Part III of the Schedule to Part J of the Food and Drug Regulations (Carisoprodol)
Comment deadline
Unavailable
Effective date
April 14, 2025
Publication part
Part II

Summary

Summary#

The Canada Gazette published the Order Amending Part III of the Schedule to Part J of the Food and Drug Regulations (Carisoprodol): SOR/2025-65. It adds carisoprodol to Part III of that schedule for a one‑year period from April 14, 2025 to April 13, 2026, and removes the previous Item 1. The order mostly takes effect on April 14, 2025, with a specific part tied to possible changes under the Controlled Drugs and Substances Act.

What it does#

  • Adds carisoprodol (2-((carbamoyloxy)methyl)-2-methylpentyl isopropylcarbamate) to Part III of the schedule to Part J of the Food and Drug Regulations for the period April 14, 2025 to April 13, 2026.
  • Deletes the existing Item 1 of Part III of that schedule.
  • Sets the coming-into-force dates:
    • The order generally comes into force on April 14, 2025.
    • The deletion (section 2) comes into force on the earlier of:
      • the day a provision of an order under the Controlled Drugs and Substances Act adds carisoprodol to any of Schedules I, II, III, IV or VI; and
      • April 14, 2026.
        The deletion will not come into force earlier than April 15, 2025.

Who's affected#

  • Likely to be noticed by people and organizations that make, import, sell, prescribe, dispense, or study prescription drugs that contain carisoprodol (manufacturers, distributors, pharmacies, hospitals, researchers).
  • Regulators and law enforcement may also be affected because the change is coordinated with listing under the Controlled Drugs and Substances Act.
  • The source does not spell out specific operational steps for each group, so exactly who will see direct regulatory changes is not fully clear from the notice.

Why it matters#

  • A formal listing in the Food and Drug Regulations for a fixed period signals tighter regulatory attention on carisoprodol at the federal level.
  • Because the timing is linked to possible scheduling under the Controlled Drugs and Substances Act, this could lead to new controls on how the drug is handled, imported, prescribed, or sold — depending on later orders and rules.
  • For patients, health providers, and businesses that deal with the drug, this may affect availability, paperwork, or legal requirements once the related orders take effect. The exact practical effects depend on the companion measures under the Controlled Drugs and Substances Act and other guidance that regulators may issue.

Key topics

Food and Drug RegulationsPart J of the Food and Drug RegulationsPart III of the schedule to Part JControlled Drugs and Substances ActCDSAcarisoprodol (2-((carbamoyloxy)methyl)-2-methylpentyl isopropylcarbamate)carisoprodolSchedule ISchedule IISchedule IIISchedule IVSchedule VIHealth Canadaprescription drugsdrug scheduling

Source: Canada Gazette

Official source