Schedule IX: Tablet and Capsule Equipment

Summary#

This is a proposed Order from the Department of Health, published in the Canada Gazette on June 28, 2025, that would change Schedule IX of the Controlled Drugs and Substances Act. It replaces the existing listing for tablet presses and capsule fillers and adds three related parts. The government is asking for public comments within 45 days.

What it does#

• Replaces the current items in Schedule IX that describe machines for making tablets and filling capsules with a clearer list of five entries:
  • devices (manual, semi‑automatic or fully automatic) that compact powders, granules or semi‑solid material into tablets, whether assembled, partly assembled, unassembled or disassembled;
  • devices (manual, semi‑automatic or fully automatic) that fill capsules with powdered, granular, semi‑solid or liquid material, whether assembled, partly assembled, unassembled or disassembled;
  • dies suitable for use in, but not already part of, the tablet-press or capsule-filling devices above;
  • moulds suitable for use in, but not already part of, those devices;
  • punches suitable for use in, but not already part of, those devices.
• This is a proposed Order (Part I notice). If finalized, the Order would come into force on the day it is published in Canada Gazette, Part II.

Who's affected#

• Manufacturers and suppliers of tablet presses and capsule-filling machines and of dies, moulds and punches.
• Importers, exporters and distributors who buy or sell these machines or parts.
• Laboratories, compounding pharmacies, universities, and other institutions that use or acquire tablet- or capsule-making equipment.
• It is not fully clear from this short notice what new permits, reporting or restrictions would apply; the detailed impacts are described in the linked Regulatory Impact Analysis Statement.

Why it matters#

• The change narrows and clarifies exactly which machines and parts are listed in Schedule IX, which is the list the government uses to identify equipment tied to controlled substances.
• If the Order is finalized, people or businesses that make, sell, import or buy these machines or parts could face new rules or oversight. The notice links this change to broader proposed rules called the Regulations Amending the Precursor Control Regulations (Increased Regulatory Oversight), which explain the practical effects in more detail.
• Anyone affected or interested has a 45-day window to comment while the proposal is under consideration.