Pharmacists to gain authority to therapeutically substitute controlled substances under new federal regulations
Effective October 1, 2026, pharmacists will have the authority to therapeutically substitute one controlled substance for another—where permitted by provincial or territorial regulation—following amendments to the Controlled Substances Regulations (CSR) published in the Canada Gazette, Part II in mid-December. This long-sought change will better support continuity of care during drug shortages and other urgent care situations.
CPhA has consistently advocated for expanded authorities, including therapeutic substitution and actively raised this issue with Health Canada during the prolonged shortage of acetaminophen with codeine and oxycodone we experienced throughout 2025.
CPhA engagement: Key clarifications from Health Canada
In mid-January, CPhA participated in a technical briefing with Health Canada to obtain further clarity on implementation. Key insights included:
- Permanent authorities: The subsection 56(1) class exemption for pharmacists will expire on September 30, 2026, with the amended regulations continuing to authorize pharmacists to extend, renew and transfer prescriptions for controlled substances.
- Therapeutic substitution: Pharmacists will be authorized to substitute one controlled substance for another within two years of the date the prescription was received, provided the original prescription was issued by a practitioner and substitution is permitted under provincial or territorial scope of practice.
- Central fill: Regulatory barriers to central fill services for controlled substances will be removed, allowing non-emergency, patient-specific transfers between pharmacists without the need for a dealer’s licence.
- Pharmacy technicians: Pharmacy technicians will be authorized to independently perform a range of activities involving controlled substances—including compounding, transferring prescriptions and on-site destruction—where permitted under provincial or territorial regulation.
- Implementation guidance: Health Canada is developing a guidance document with further details on the amendments, which will be shared with NAPRA and provincial regulatory bodies for input. CPhA will provide further updates once this guidance is released.
Progress, with more work ahead
While these amendments represent an important step forward, CPhA has been clear that further action is needed to modernize federal rules to reflect the realities of front-line pharmacy practice and to enable pharmacists to respond quickly when patients cannot access their prescribed therapy.
Recognizing pharmacists as practitioners under the Controlled Drugs and Substances Act (CDSA) remains an important advocacy priority to ensure pharmacists can better support patients during drug shortages, public health emergencies and urgent care situations.