New Controls on Tablet and Capsule Equipment

Summary#

The Order Amending Schedule IX to the Controlled Drugs and Substances Act is a proposed change published by the Department of Health on June 28, 2025. It would add detailed descriptions of tablet- and capsule-making machines and some of their parts to Schedule IX; the proposal is open for public comment for 45 days and is not law yet.

What it does#

• Replaces the existing item entries in Schedule IX to explicitly name:
  • manual, semi‑automatic or fully automatic devices that compact or mould powdered, granular or semi‑solid material to produce tablets (tablet presses);
  • manual, semi‑automatic or fully automatic devices that fill capsules with powdered, granular, semi‑solid or liquid material (capsule fillers);
  • dies, moulds and punches that are suitable for use in, but not already part of, those devices.
• The notice says the Order would come into force on the day it is published in Canada Gazette, Part II (but the text published on June 28, 2025 is a proposal, not an in‑force order).

Who's affected#

• Businesses that make, sell, import or export tablet presses, capsule fillers or the listed parts.
• Laboratories, compounding pharmacies, manufacturers and others that use these machines.
• Regulators and law enforcement agencies that oversee controlled substances.
• It could also affect people who acquire such equipment, whether for legitimate purposes or for producing controlled substances illegally.

Why it matters#

• Putting these machines and parts on Schedule IX would bring them under tighter regulatory oversight tied to the Controlled Drugs and Substances Act.
• That can change how equipment is bought, sold, shipped or reported — with potential compliance costs or paperwork for legitimate suppliers and users.
• The change is intended to make it harder for equipment to be used to produce illegal tablets or capsules, while still affecting legitimate medical, pharmaceutical and industrial uses.