Part IIOrderVolume 159, Number 26Published: December 17, 2025

Schedule IX: Tablet and Capsule Equipment

Order Amending Schedule IX to the Controlled Drugs and Substances Act: SOR/2025-261

This order amends Schedule IX to the Controlled Drugs and Substances Act to list specific machines and parts used to make tablets and fill capsules, including tablet-press and capsule-filling devices and associated dies, moulds and punches. It came into force on 2025-12-17 and will affect manufacturers, suppliers, importers/exporters and enforcement officials who deal with this equipment.

Published
December 17, 2025
Department
Unavailable
Section
Order Amending Schedule IX to the Controlled Drugs and Substances Act
Comment deadline
Unavailable
Effective date
December 17, 2025
Publication part
Part II

Summary

Summary#

The Order Amending Schedule IX to the Controlled Drugs and Substances Act: SOR/2025-261 updates the list of machines and parts tied to making tablets and filling capsules. It replaces earlier entries with a clearer set of items and came into force on December 17, 2025.

What it does#

This order replaces items in Schedule IX to the Controlled Drugs and Substances Act with a more detailed list. The new entries cover:

  • A manual, semi‑automatic or fully automatic device (whether unassembled, partially or fully assembled, or disassembled) that can compact or mould powdered, granular or semi‑solid material to produce solid tablets.
  • A manual, semi‑automatic or fully automatic device (whether unassembled, partially or fully assembled, or disassembled) that can fill capsules with powdered, granular, semi‑solid or liquid material.
  • A die that is suitable for use in, but not already part of, a device described above.
  • A mould that is suitable for use in, but not already part of, a device described above.
  • A punch that is suitable for use in, but not already part of, a device described above.

The order states it comes into force on the day it was published in the Canada Gazette, Part II (see December 17, 2025).

Who's affected#

Most likely to notice this change are:

  • Businesses that make, sell, import, export, repair or service tablet‑press and capsule‑filling machines.
  • Suppliers of dies, moulds and punches used with those machines.
  • Pharmaceutical, nutraceutical, and chemical companies that use such equipment.
  • Law enforcement, customs and regulatory officials who reference Schedule IX when identifying covered equipment.

If it is unclear who else will be affected (for example, small tool shops or hobbyists), the source does not say.

Why it matters#

The order clarifies exactly which machines and spare parts are listed in Schedule IX. That matters because the list is what regulators and enforcement agencies use when deciding which equipment to watch, control, or restrict. In practice, the change could affect trade, import/export checks, sales and compliance practices for firms that handle tablet‑making and capsule‑filling equipment. The government’s Regulatory Impact Analysis Statement for related precursor controls is published alongside a related instrument (see the Canada Gazette entry for context).

Key topics

Controlled Drugs and Substances ActCDSASchedule IXtablet-press machinescapsule-filling machinesdie (machine part)mould (machine part)punch (machine part)Precursor Control RegulationsHealth CanadaMinister of Healthimport-export controlscontrolled substances enforcementpharmaceutical manufacturing

Source: Canada Gazette

Official source