Subsection 56(1) Class Exemption for Nurses providing Health Care at a Community Health Facility

Pursuant to subsection 56(1) of the Controlled Drugs and Substances Act (CDSA), nurses providing health care at a community health facility are exempted for medical purposes from the application of the following provisions of the CDSA and its regulations:

• Subsection 4(1) of the CDSA with respect to any substance listed in Schedule I, II, or III of the CDSA;
• Subsections 5(1) and 5(2) of the CDSA with respect to any substance listed in Schedule I, II, III, or IV of the CDSA;
• Subsection 8(1) and section 69 of the Narcotic Control Regulations (NCR) with respect to any narcotic listed in the schedule to the NCR;
• Subsection 2(1) of the Benzodiazepines and Other Targeted Substances Regulations (BOTSR) with respect to any targeted substance listed in the schedules to the BOTSR; and
• Section G.02.001 and G.06.002 of Part G of the Food and Drug Regulations (Part G-FDR) with respect to any controlled drug listed in the schedule to Part G-FDR.

Definitions

In respect of this exemption and unless otherwise defined below, the terms used in this exemption have the same meaning as those provided in the CDSA and its regulations.

Community health facility

means a facility where health care services are delivered and managed by a nurse as part of the nurse's professional practice.

Controlled substance

means any substance listed in Schedule I, II, III, or IV of the CDSA.

Destroy

means to alter or denature a controlled substance to such an extent that its consumption is rendered impossible or improbable.

Health care service provider

means the government of Canada, provincial or territorial government, First Nation band council, First Nation health authority, or public, regional or community agency who delivers health care services and employs nurses to provide health care services at a community health facility.

Hospital

means a facility that is licensed, approved or designated by a province or territory under the laws of a province or territory to provide health care or treatment to persons, or is owned or operated by the government of Canada or of a province or territory and that provides health services.

Minister

means the federal Minister of Health.

Nurse

means an individual who is registered and entitled under the laws of a province/territory to practise nursing (e.g. registered nurse, licensed practical nurse, registered psychiatric nurse, etc.), and who is employed or contracted by a health care service provider to deliver health care services, and who is permitted by that province/territory authority to administer medication to patients.

Practitioner

means a person who is registered and entitled under the laws of a province/territory to practise in that province/territory the profession of medicine or dentistry and includes any class of persons designated as a practitioner under the New Classes of Practitioners Regulations.

Supplier

means either a licensed dealer who is authorized under the CDSA and its regulations to sell/provide controlled substances or the person in charge of a hospital, or a pharmacist that meets the conditions of the Subsection 56(1) Class Exemption for the Person in Charge of a Hospital and/or pharmacist who Supplies Controlled Substances to a Community Health Facility.

Unserviceable stock

means drug product containing a narcotic, controlled drug or targeted substance that is unusable, expired and/or that cannot be dispensed.

This exemption provides nurses with the authority to possess, sell, provide, administer, transport, send and deliver controlled substances in the course of providing health care services to patients in community health facilities, subject to the terms and conditions of this exemption.

Conditions

This exemption is only applicable if the following conditions are met.

1. Nurses must only provide and administer controlled substances, subject to the following conditions:
   1. the person to whom a controlled substance is being provided or administered must be a patient under the professional treatment of the nurse providing or administering the controlled substance;
   2. the controlled substance must be required for the condition for which the person is receiving treatment;
   3. before providing or administering a controlled substance, the nurse must obtain an order or a prescription signed and dated by a practitioner; and
   4. the nurse must follow the policies and procedures of the health care service provider for the handling of medications that contain controlled substances at the health facility.
2. The nurse must return to the supplier for destruction or destroy on-site any unserviceable stock of controlled substances. In the case of on-site destruction, it must be witnessed by the individual destroying the controlled substance and one other nurse, practitioner, pharmacist, pharmacy intern, pharmacy technician or a Health Canada inspector;
3. Nurses must only request and receive controlled substances stock under this exemption from a supplier.
4. A nurse who sells, provides, or administers controlled substances to a patient under this exemption must record the following information:
   1. the brand or specified name of the controlled substance;
   2. the quantity and, if applicable, the strength per unit of the controlled substance;
   3. whether or not the substance was administered to the patient onsite;
   4. the date of the sale, provision, or administration of the controlled substance;
   5. the name of the individual who received the controlled substance;
   6. the name of the person who prescribed the controlled substances; and
   7. the name of the nurse who sold, provided, or administered the controlled substances.
5. Nurses must record all transactions involving orders, receipts and returns of controlled substances. These records must contain the following information:
   1. the brand or specified name of the controlled substance;
   2. the quantity and, if applicable, the strength per unit of the controlled substance;
   3. the date of the order, receipt or return of the controlled substance;
   4. the name and address of the supplier from where the controlled substance was received/returned; and
   5. the name of the person who ordered, received or returned the controlled substance.
6. Nurses must retain records required to be kept under this exemption for a period of at least two (2) years from the date the record was made;
7. Nurses must provide records with respect to activities conducted with controlled substances at a community health facility to the Minister on request;
8. Nurses must take necessary steps to protect controlled substances against loss or theft, both in a community health facility and during transportation to and from a community health facility. This includes the use of a chain of signature system that records signatures, full names and dates of receipt for each shipment;
9. In the event of a closure of a community health facility, the nurse must transfer all controlled substances to a supplier and keep a record of the transfer;
10. Nurses must restrict access to any location where controlled substances are stored (e.g., cupboard, cabinet, refrigerator, crash cart, etc.); and
11. Nurses must immediately report any loss or theft of client-specific medication to the pharmacist that dispensed it, and report any loss or theft of other controlled substances to the Compliance and Monitoring Division, Health Canada, at hc.ocs.reporting-rapporter.bsc.sc@canada.ca within 10 days of discovery.

The Minister may at any time and for any reason revoke or change the terms and conditions of this exemption. Should this be the case, you will be informed in writing and reasons for the revocation or changes will be provided.

A suspension of this exemption without prior notice may be ordered if the Minister deems that such a suspension is necessary to protect public health, safety or security.

The Minister shall provide in writing any factual information about a nurse that has been obtained under the Act, its regulations or this exemption to the provincial/territorial professional licensing authority responsible for the registration or authorization of the person to practise their profession.

This exemption replaces "Section 56 Class Exemption for Nurses Providing Health Care at a Health Facility in a Remote and/or Isolated Community". This exemption will remain in effect until the date on which tis exemption has been replaced or the date on which this exemption is revoked.

Original signed by

Michelle Boudreau, Director General
Controlled Substances Directorate
Opioid Response Branch
Health Canada

Effective Date: September 5, 2018

Amended on January 9, 2019