Provision of Controlled Substances

Narcotics, Controlled Drugs, and Targeted Substances

A controlled substance is any type of drug that the federal government has categorized as having a higher-than-average potential for abuse or addiction. These substances are set out in Schedules I, II, III, IV, and V of the Controlled Drugs and Substances Act. A targeted substance is a controlled substance included in Schedule I or a product or compound that contains the controlled substance.

Pharmacy professionals must follow the Controlled Drugs and Substances Act and its associated regulations for the sale, ordering, and purchasing of controlled substances.

FAQ

What is the Health Canada Subsection 56(1) Class Exemption?

Under subsection 56(1) of the Controlled Drugs and Substances Act (“CDSA”), the federal Minister of Health has the ability to grant special permissions related to controlled substances if they feel it is in the best interest of the public to do so. In this case, Health Canada has issued a Subsection 56(1) Class Exemption (“the exemption”) that exempts practitioners and pharmacists, authorized within their scope of practice, from certain sections of the CDSA and its regulations when prescribing, selling, or providing a controlled substance to a patient or transferring a prescription for a controlled substance to a pharmacist in Canada. In addition to the information provided below, pharmacy professionals can also refer to Health Canada’s FAQ on the Subsection 56(1) Class Exemption. Per federal legislation, “controlled substances” are defined as narcotics, controlled drugs, benzodiazepines, and other targeted substances.

The exemption is in effect until the earliest of the following dates:

September 30, 2026;
the date that it is replaced by another exemption; or
the date on which it is revoked.

For the duration of the exemption, NL pharmacists CAN:

accept verbal prescriptions for controlled substances from authorized prescribers;
prescribe an interim supply or extend a prescription for a controlled substance within the framework of the Standards of Practice for Prescribing by Pharmacists as long as the prescription can be filled at the pharmacy where the prescribing pharmacist is located at the time it is written;
send or receive a prescription transfer for a narcotic or controlled drug to another pharmacist within Canada;
send or receive a prescription transfer for a benzodiazepine or targeted substance more than once; or
delegate another appropriate individual to deliver controlled substances to a patient’s home or another location.

Pharmacy technicians are NOT currently permitted to transfer prescriptions for controlled substances under the federal legislation.

Despite the exemption, NL pharmacists CANNOT:

initiate prescriptions for controlled substances;
adapt prescriptions for controlled substances; or
make a therapeutic substitution for controlled substances.
What has the Health Canada Subsection 56(1) Exemption changed regarding the delivery of controlled substances?

Typically, NL pharmacists are permitted to deliver controlled substances to patients and community health facilities when necessary, providing that the College’s delivery standards outlined in the Standards of Pharmacy Operation are met. In 2019, Health Canada issued guidance and an exemption specifically related to this issue:

Transportation of Controlled Substances in Canada
Subsection 56(1) Class Exemption for the Person in Charge of a Hospital and/or a Pharmacist who Supplies Controlled Substances to a Community Health Facility
Supplementary Information

This exemption allows pharmacists to delegate the delivery of controlled substances to pharmacy team members and other appropriate individuals. In addition to the College’s usual delivery standards, the Health Canada exemption requires that any individual delivering controlled substances carries a copy of the Health Canada exemption and a written note from a pharmacist that identifies the name of the person doing the delivery, the name of the controlled substance to be delivered and the place of delivery (drug information may be contained within the package to preserve patient confidentiality) while carrying out the delivery.

Pharmacists must ensure patients provide consent to the delivery (including the sharing of necessary personal health information); verbal consent is acceptable.

It is expected that all reasonable steps will be taken to protect against loss or theft and that there are processes in place to verify that the medication has reached the patient for which it is intended.

Additional Resources

TEMPLATE: Monthly Random Audit of CDSA Purchase Records
TEMPLATE: Monthly Random Audit of CDSA Sales Records
Controlled Substances Guidance for Community Pharmacists: Security, Inventory Reconciliation and Record-Keeping
GUIDANCE DOCUMENT: Handling and Destruction of Post-Consumer Returns Containing Narcotics, Controlled Drugs or Targeted Substances
TEMPLATE: Record of Local Destruction of Post-Consumer Returns Containing Narcotics, Controlled Drugs or Targeted Substances
GUIDANCE DOCUMENT: Handling and Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs or Targeted Substances
TEMPLATE: Record of Local Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs or Targeted Substances
Reporting Loss or Theft of Controlled Substances and Precursors
Report Losses or Thefts Using Health Canada’s E-Services Portal
Per the Standards of Pharmacy Operation, please send a copy of the report to the College of Pharmacy of Newfoundland and Labrador, as well as retain a copy in your pharmacy.
In accordance with Health Canada’s Guidance Documents, forged prescriptions are only considered thefts if a drug product containing a controlled substance or a precursor is actually dispensed, either partially or fully. The dispensed amount should be reported as the quantity stolen. Attempted forgeries where no drug products were dispensed are not to be reported.

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