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

Pursuant to subsection 56(1) of the Controlled Drugs and Substances Act (CDSA), the Person in Charge of a hospital and or pharmacist is 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;
• Subsections 8(1), 31(1), 65(1) and section 69 of the Narcotic Control Regulations (NCR) with respect to any narcotic listed in the schedule to the NCR; and
• Section G.02.001, section G.03.002 subsection G.05.003 (1) and section 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.

Health care service provider

means the government of Canada, provincial or territorial government or 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 to administer medication to patients.

Person in Charge

means the person responsible for overseeing activities (e.g., possession, administration, sale) and conditions related to this exemption (e.g., record-keeping, security and reporting) conducted with controlled substances at a hospital, as well as for supervising employees (e.g. pharmacists, pharmacy technicians) at a hospital.

Pharmacist

means a person who is registered or otherwise entitled under the laws of a province to practise pharmacy and to operate a pharmacy or dispensary and who is practising pharmacy in that province.

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 any class of persons designated as a practitioner under the New Classes of Practitioners Regulations.

Conditions

This exemption provides the Person in Charge of a hospital and/or a pharmacist with the authority to possess, sell, provide, send, transport and deliver controlled substances to a community health facility, subject to the terms and conditions of this exemption.

This exemption is only applicable if the following conditions are met. The Person in Charge of a hospital or pharmacist must:

1. Sell, provide, send, transport or deliver controlled substances only upon receipt of an order signed and dated by both a nurse working at a community health facility and a practitioner/pharmacist, and where the signatures are not known to the Person in Charge, verify them;
2. Record the following information about any transactions involving the sale, provision, sending, receiving, transportation and delivery of controlled substances:
   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 sale, receipt, provision, sending, transportation and delivery of the controlled substance;
   4. the name of the person who sold, received, provided, sent, transported or delivered the controlled substance;
   5. the name and address of the person who ordered or sent the controlled substance; and
   6. the name and address of the community health facility that will receive or sent the controlled substance.
3. Retain records identified in paragraph 2 for a period of at least two (2) years from the date the record was made;
4. Provide any records with respect to activities conducted with controlled substances at the hospital and/or pharmacy to the Minister on request;
5. Take necessary steps to protect controlled substances against loss or theft at the hospital and/or pharmacy and during transportation to and from the hospital and/or pharmacy, including the use of a chain of signature system that records signatures, full names and dates of receipt for each shipment;
6. The person in charge of a hospital or pharmacist should accept the transfer of any controlled substances from a closing community health facility and keep a record of the transfer; and
7. Report any loss or theft of 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.

This exemption replaces "Section 56 Class Exemption for the Person in Charge of a Hospital who Supplies Controlled Substances to a Health Facility in a Remote and/or Isolated Community".

This exemption will remain in effect until the date on which this exemption has been replaced or the date on which the exemption is revoked.

Original signed by

Michelle Boudreau, Director General
Opioid Response Branch
Health Canada

Effective Date: September 5, 2018

Amended on: January 9, 2019