controlled Substance regulations

Background

On October 1, 2026, Health Canada’s new Controlled Substances Regulations (CSR) will come into force, replacing several existing federal regulations with a single, modernized framework for controlled substances. The new regulations consolidate the Narcotic Control Regulations, the Benzodiazepines and Other Targeted Substances Regulations, Parts G and J of the Food and Drug Regulations, and the New Classes of Practitioners Regulations. The regulations were published in December 2025 following Health Canada’s 2024 public consultations. To read the Regulatory Impact Analysis Statement, refer to the Canada Gazette, Part II, Volume 159, Number 26.

What are the Changes?

The CSR largely reflect how pharmacists have been practising under the federal subsection 56(1) exemptions introduced during the COVID-19 pandemic. Health Canada’s subsection 56 (1) exemption for patients, practitioners and pharmacists prescribing and providing controlled substances in Canada remains in effect until September 30, 2026. On October 1 the exemptions become part of the permanent regulatory framework. The CSR also permit certain activities with controlled substances by pharmacy technicians.

The new federal regulations do not automatically permit PEI pharmacists and pharmacy technicians to undertake every activity that may be authorized elsewhere in Canada. Registrants may only perform activities that are authorized in the province.

Prescription Transfers

Under the new regulations, transfers of prescriptions for controlled substances continue to be permitted between pharmacies in Canada for two years from the date of receipt. Pharmacy technicians may also give or receive prescription transfers for controlled substances on October 1st.

Verbal Prescriptions

Pharmacists may continue to accept verbal prescriptions for controlled substances from authorized prescribers. Pharmacy technicians may also accept verbal prescriptions on October 1st.

Prescription Renewals, Adaptation and Therapeutic Substitution

The CSR establish federal authority for pharmacists to extend, renew, adapt or de-prescribe controlled substance prescriptions where permitted under provincial law. However, the Pharmacist and Pharmacy Technician Regulations do not permit adaptation or therapeutic substitution of controlled substances by pharmacists in PEI.

The College has submitted a request to the Department of Health and Wellness to amend the regulations, removing this prohibition. The amendment, if approved, will authorize pharmacists to perform adaptation and therapeutic substitution of controlled substance in line with the CSR. However, until these amendments to the Pharmacist and Pharmacy Technician Regulations are approved by the government, the prohibition on adaptation and therapeutic substitution of controlled substances remains.  The College will provide updates on the status of any amendments as they are approved. 

Resources

Health Canada’s Controlled Substances Program is offering information sessions on the Controlled Substances Regulations, which come into force on October 1, 2026. These sessions are intended for pharmacists and pharmacy technicians working in a community pharmacy setting.

To register for a session, use the links below.

Any questions can be directed to Health Canada at CSP-Inspections-PSC@hc-sc.gc.ca.

English Information Sessions:

Monday, October 5, 2026 at 11AM EST (8AM PT/12PM AT)

Monday, October 5, 2026 at 8PM EST (5PM PT/9PM AT)

Tuesday, October 6, 2026 at 6PM EST (3PM PT/7PM AT)

Wednesday, October 7, 2026 at 1PM EST (10AM PT/2PM AT)

Wednesday, October 7, 2026 at 4PM EST (1PM PT/5PM AT)

Thursday, October 8, 2026 at 12PM EST (9AM PT/1PM AT)

Thursday, October 8, 2026 at 3PM EST (12PM PT/4PM AT)

Friday, October 9, 2026 at 6PM EST (3PM PT/7PM AT)

Tuesday, October 13, 2026 at 11AM EST (8AM PT/12PM AT)