Pharmacists in much of Canada will be able to swap one controlled substance for another during a shortage starting Oct. 1, when Health Canada’s new Controlled Substances Regulations take effect — but pharmacists in Ontario, the country’s most populous province, will not be able to use that power at all.
The regulations, registered as SOR/2025-242 and published in the Canada Gazette, Part II on Dec. 17, 2025, fold several separate federal drug regulations and a pandemic-era exemption into a single framework. Health Canada’s subsection 56(1) class exemption — the temporary order that has let pharmacists renew prescriptions, transfer them between pharmacies and accept verbal prescriptions for controlled substances since the early months of the COVID-19 pandemic — expires Sept. 30. On Oct. 1 those authorities stop being temporary and become permanent regulation.
The headline change is therapeutic substitution. Under the new rules, a pharmacist can substitute one controlled substance for another within two years of the date the original prescription was received, provided a practitioner issued it and provincial or territorial scope of practice permits the substitution. The Canadian Pharmacists Association, which lobbied for the change, said it will “better support continuity of care during drug shortages and other urgent care situations,” and pointed to the prolonged shortages of oxycodone and acetaminophen with codeine that ran through 2025 as the reason it pressed Health Canada on the issue.
That last condition — where provincial legislation permits — is where the change stops short. The Ontario College of Pharmacists, in guidance updated Sept. 2, states plainly that Ontario pharmacists cannot therapeutically substitute one controlled substance for another, because the authority is not written into provincial legislation and therefore sits outside their scope of practice. Ontario pharmacists will be able to adapt a controlled-substance prescription — changing the dose, dosage form, regimen or route of administration — and to de-prescribe or part-fill it. They will not be able to switch a patient to a different drug.
The gap is not theoretical. The Canadian Society of Hospital Pharmacists lists immediate-release hydromorphone tablets, a controlled substance, among Canada’s active supply problems, with constraints on the 1 mg and 2 mg strengths tied to manufacturing and supply challenges at multiple manufacturers and expected to persist through September or beyond. CSHP notes the 4 mg and 8 mg strengths remain stable but that demand is concentrated in the lower strengths, so the stronger tablets will not fully offset the gap. A patient who cannot fill a hydromorphone prescription in a province that allows substitution could, in principle, have a pharmacist make the change at the counter. In Ontario, that patient goes back to the prescriber.
The rest of the package is narrower but real. Pharmacy technicians will be able to accept verbal prescriptions for controlled substances, transfer prescriptions to another technician or pharmacist anywhere in Canada, and destroy controlled stock or witness its destruction. Central fill pharmacies will be able to fill controlled-substance prescriptions without holding a dealer’s licence. Hospitals will be able to authorize employees, including pharmacy staff, to administer, transport and deliver controlled substances. Prescriptions can be extended or transferred within two years of the date they were received.
With less than a month to go, Health Canada has not published its implementation guidance. The Canadian Pharmacists Association said the department is still drafting the document and will share it with the National Association of Pharmacy Regulatory Authorities and provincial regulatory bodies for input before it is released.
The association also flagged what the regulations do not do. Pharmacists are still not recognized as practitioners under the Controlled Drugs and Substances Act, which the group calls a continuing advocacy priority precisely because that status would let pharmacists respond faster when a patient cannot access a prescribed therapy.
The practical takeaway for patients is narrower than the federal announcement suggests. What a pharmacist can do about a missing controlled substance on Oct. 2 will depend on which province the patient is standing in — and Ontario, with roughly two in five Canadians, is on the wrong side of that line for the change that matters most during a shortage.
via the Canadian Pharmacists Association and the Ontario College of Pharmacists. The regulations themselves are published as SOR/2025-242 in the Canada Gazette, Part II. Shortage details from the Canadian Society of Hospital Pharmacists.
