Pharmacy Professionals > Controlled Substances Regulations

Controlled Substances Regulations

Page Updated: October 2, 2026

Latest Updates: 

Background 

On October 1, 2026, Health Canada’s Controlled Substances Regulations came into effect, creating a single, modernized framework for regulating controlled substances. Multiple federal regulations and exemptions were consolidated into one framework to improve clarity, consistency and harmonization across substance categories. 

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.

The authorities granted by Health Canada’s subsection 56 (1) exemption from the Controlled Drugs and Substances Act exemption are now permanently established under the Controlled Substances Regulations. 

Summary of Key Changes  

As of October 1, 2026:  

Pharmacists and interns can: 

  • Accept verbal prescriptions for controlled substances from a practitioner
  • Order and receive controlled substances
  • Transfer prescriptions for controlled substances to another pharmacist or pharmacy technician in Canada within two years of the date of receipt
  • Extend (renew) or adapt prescriptions for controlled substances within two years of the date of receipt
  • De-prescribe controlled substance prescriptions as an adaptation, or part-fill them in accordance with the Drug Interchangeability and Dispensing Fee Act 

Pharmacy technicians and intern technicians can: 

  • Accept verbal prescriptions for controlled substances from a practitioner
  • Receive controlled substances
  • Transfer prescriptions for controlled substances to another pharmacy technician or pharmacist in Canada within two years of the date of receipt
  • Destroy controlled substances or serve as a witness during their destruction at the pharmacy 

Central fill pharmacies can: 

  • Fill controlled substance prescriptions without needing a dealer’s license 

Persons in charge of a hospital can permit an employee, including a pharmacy professional, to conduct activities with controlled substances:  

  • Administer, sell, provide, send, deliver, and transport  

Resources

Health Canada Guidance

Health Canada Information Sessions

Charts

Articles

Policies

Guidelines

Fact Sheets

Frequently Asked Questions 

Do all aspects of the Controlled Substances Regulations apply to Ontario pharmacy professionals?  
No. Not all aspects of the Controlled Substances Regulations apply in Ontario. While the Controlled Substances Regulations are federal, some authorities require enabling provincial legislation.  

For example, Ontario pharmacists cannot therapeutically substitute one controlled substance for another because this authority is not included in provincial legislation (i.e., it is not within the scope of practice for Ontario pharmacists).  

Ontario pharmacists can adapt prescriptions for controlled substances, such as by changing the dose, dosage form or regimen.     

 
Will the subsection 56 (1) class exemption from the Controlled Drugs and Substances Act become permanent under the new Controlled Substances Regulations?   
Yes. Health Canada’s subsection 56 (1) exemption from the Controlled Drugs and Substances Act remains in effect until September 30, 2026. After that date, the authorities granted by the exemption, including pharmacists’ ability to extend (renew) and transfer prescriptions for controlled substances, will be permanently established under the Controlled Substances Regulations. 

 
What are considered controlled substances under the Controlled Substances Regulations? 
Controlled substances include narcotics, controlled drugs, targeted substances and restricted drugs. The definition of a controlled substance is not changing. What is changing is where these substances are listed. As of October 1, 2026, controlled substances will be listed in Schedules 1 to 4 of the Controlled Substances Regulations instead of in schedules across three separate regulations. 


Are pharmacy professionals required to notify Health Canada about moving or selling their controlled substance inventory? 
Under the Controlled Substances Regulations, effective October 1, 2026, pharmacy professionals are no longer required to notify Health Canada when transferring controlled substance inventory after a pharmacy permanently closes. 


With the introduction of the Controlled Substances Regulations, what federal policy tools will no longer be in effect?
When the Controlled Substances Regulations come into effect on October 1, 2026, certain federal regulations, exemptions and guidance documents will be repealed and no longer in effect.

The following federal items will no longer be in effect as of October 1, 2026. Note this is not an exhaustive list and only captures items relevant to pharmacy practice.  

Federal Regulations

  • Narcotic Control Regulations
  • Benzodiazepines and Other Targeted Substances Regulations
  • Parts G and J of the Food and Drug Regulations
  • New Classes of Practitioners Regulations

The authorities granted by these regulations will be incorporated into the Controlled Substances Regulations on October 1, 2026.  

Federal Exemptions

The authorities granted by these exemptions, including pharmacists’ ability to extend (renew) and transfer prescriptions for controlled substances, will be permanently established under the Controlled Substances Regulations as of October 1, 2026. 

For a detailed analysis and explanation, please refer to the Regulatory Impact Analysis Statement published in the Canada Gazette, Part II, Volume 159, Number 26. Questions about these regulatory changes may be directed to the Office of Legislative and Regulatory Affairs within the Controlled Substances and Overdose Response Directorate at Health Canada: [email protected].


With the introduction of the Controlled Substances Regulations, what impact will there be on Ontario regulations?
When the Controlled Substances Regulations come into effect on October 1, 2026, certain elements of provincial regulations, including exemptions, definitions and clauses, will be impacted.

The following changes to O. Reg. 256/24 under the Pharmacy Act will take effect on October 1, 2026:

  • The “coronavirus exemption” will be revoked (O. Reg. 256/24, s. 47).
    • Defining this exemption was required to enable pharmacists to adapt and renew prescriptions for controlled substances under Health Canada’s exemption. It is no longer needed because this authority will be permanently established under the Controlled Substances Regulations. 

  • The definition of “adapt” will no longer include “de-prescribing of the prescribed drug” or “part-filling of the prescription” (O. Reg. 256/24, s. 47).
    • Although the definition is changing back to the original definition, pharmacists can continue to make these types of modifications to a controlled substance prescription.
    • Please note that:
      • De-prescribing, tapering or discontinuing a medication are not controlled acts in Ontario and therefore do not require authorization through legislation.
      • De-prescribing, tapering or discontinuing a medication may be used to resolve drug therapy problems and meet a patient’s medication therapy needs.
      • Pharmacists may recommend changes to the prescriber or adapt the dosage and/or instructions for use (e.g., dose regime) and communicate clinically significant changes to the prescriber. 
      • Part-filling remains permitted in accordance with the Drug Interchangeability and Dispensing Fee Act and is described in the College’s Prescription Refills, Part-Fills and Intervals Fact Sheet.
  • The clause permitting a pharmacist to “be satisfied as to the existence and details of the prescription from an alternative source” to renew or adapt a prescription will be revoked (O. Reg. 256/24, s. 52(5), para. 1(iv)). 
    • This clause provided additional options in the event the original prescription was not in the pharmacist’s possession, such as using the prescription label, the prescription receipt with medication history, or a picture or copy of the prescription.
    • Similar guidance was provided by the College at the start of the pandemic, before it was in the regulation, reminding pharmacists of the importance of exercising professional judgment, especially in urgent or emergency situations.
    • Although this clause will be revoked from legislation, it remains an expectation of the College. Pharmacists must continue to make decisions in the best interest and safety of the patient, documenting their therapeutic assessment and rationale.   


What are the provincial and federal limits on renewing a prescription for a controlled substance?

Provincial limits
Provincially, pharmacists can “renew” a controlled substance for a quantity that does not exceed the lesser of:

  • The quantity that was originally prescribed, including any refills; or
  • A 12-month supply.

These provincial limits also apply to non-controlled substance prescriptions.

Federal limits
Federally, pharmacists can “extend” a prescription if the quantity prescribed does not exceed a days’ supply that would last more than two years after the day the pharmacist or pharmacy technician first received the prescription (or if not known, the date the prescription was issued).

To reconcile the difference between these quantity limits when renewing a controlled substance prescription, the maximum amount that can be prescribed for the renewed prescription is the quantity or days’ supply that is the shortest.

There is no limit on the number of times a prescription can be renewed within the two-year period. The decision to renew is a matter of professional judgment. However, only the original prescription issued by the practitioner can be renewed.

To comply with Ontario regulations, the pharmacist’s name is recorded as the prescriber on the renewed prescription and its dispensing record. Although this does not meet the federal definition of a prescription because pharmacists are not practitioners, a pharmacist-issued prescription can still be dispensed by, or transferred to, another pharmacy professional in Canada for dispensing.

If the patient decides to present a prescription to the pharmacy well after the date it was issued, the written date of the prescription should be considered as part of the pharmacist’s overall assessment and decision to dispense.

For example:
A practitioner issues a controlled substance prescription for a 3-month supply with no refills and sends it electronically to the pharmacy on October 30, 2026. 

A pharmacist may renew the prescription for up to a 3-month supply (i.e., the quantity originally prescribed) until July 30, 2028, regardless of when the patient finishes the medication. The July 30, 2028 date is calculated by taking the prescription ‘expiry’ date of October 30, 2028 (two years from the date the pharmacy received the prescription) and subtracting the 3-month quantity being renewed.

If the practitioner provides the written prescription directly to the patient on October 30, 2026, and the pharmacy receives the prescription from the patient on December 1, 2026, the two-year renewal window can begin on December 1, 2026.

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