Schedule IX: Tablet and Capsule Equipment

Summary#

This is a proposed Order Amending Schedule IX to the Controlled Drugs and Substances Act from the Department of Health. It replaces the current wording in Schedule IX with clearer descriptions of machines and parts used to make tablets and fill capsules. Interested people can comment within 45 days after publication on June 28, 2025.

What it does#

• Replaces Items 1 and 2 of Schedule IX (the list in the Controlled Drugs and Substances Act) with new, more detailed entries. The new list explicitly covers:
  • A manual, semi-automatic or fully automatic device (assembled, partly assembled, unassembled or disassembled) that can compact or mould powdered, granular or semi-solid material to make solid tablets.
  • A manual, semi-automatic or fully automatic device (assembled, partly assembled, unassembled or disassembled) that can fill capsules with powdered, granular, semi-solid or liquid material.
  • A die suitable for use in, but not already part of, a device listed above.
  • A mould suitable for use in, but not already part of, a device listed above.
  • A punch suitable for use in, but not already part of, a device listed above.
• The notice is a proposal. Comments must be sent within 45 days of the notice (published June 28, 2025).
• If approved, the Order would come into force on the day it is published in Canada Gazette, Part II.

Who's affected#

• Companies that make, sell, import or export tablet-presses, capsule-fillers, and related equipment and parts.
• Suppliers of dies, moulds and punches used with those machines.
• Pharmacies, pharmaceutical manufacturers, contract manufacturers and some laboratory suppliers — they may notice changes to how equipment is described in federal lists.
• Regulators and enforcement agencies that use Schedule IX to identify items of regulatory interest.
• If unclear: the notice does not itself spell out specific regulatory consequences, so how each group is affected will depend on follow-up rules or decisions.

Why it matters#

• The change clarifies which machines and individual parts are specifically listed. That can affect who has to follow any rules tied to Schedule IX items.
• Clearer wording may make it easier for businesses to know whether particular equipment or parts are included in the federal list.
• People and companies that buy, sell or move tablet- or capsule-making equipment should watch the proposal and, if needed, comment during the 45-day period before it is finalized.