Subsection 56(1) Class Exemption for Designated Administrators of Ambulance Service Operators in Newfoundland and Labrador

Pursuant to subsection 56(1) of the Controlled Drugs and Substances Act (CDSA), Designated Administrators of regulated ambulance service operators in the province of Newfoundland and Labrador 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 fentanyl, hydromorphone, ketamine, morphine and pethidine;
• Subsections 5(1) and 5(2) of the CDSA with respect to diazepam, fentanyl, hydromorphone, ketamine, lorazepam, midazolam, morphine and pethidine; and
• Subsection 8(1) of the Narcotic Control Regulations (NCR) with respect to fentanyl, hydromorphone, ketamine, morphine and pethidine

In respect of this exemption,

• Controlled substance means one of the following substances: diazepam, fentanyl, hydromorphone, ketamine, lorazepam, midazolam, morphine, and pethidine.
• Designated Administrator means a person who is in a managerial position and is ultimately responsible for ordering, transporting, storing and providing controlled substances to paramedics for an ambulance service operator governed under the Motor Carrier Act and the Motor Carrier Regulations (Newfoundland and Labrador), the relevant policies established by the Department of Health and Community Services of Newfoundland and Labrador and its Provincial Medical Oversight Program.
• Paramedic means a person who is registered and entitled under the Provincial Medical Oversight Program in accordance with the Health and Community Services Act (Newfoundland and Labrador) and Regional Health Authorities Act (Newfoundland and Labrador) to practice as an Advanced Care Paramedic or Critical Care Paramedic in that province and to administer controlled substances as part of the practice of paramedicine, and who is employed by ambulance service operators governed under the Motor Carrier Act and the Motor Carrier Regulations (Newfoundland and Labrador), the relevant policies established by the Newfoundland and Labrador Department of Health and Community Services and its Provincial Medical Oversight Program.
• Unserviceable stock means drug product containing a controlled substance that is unusable, expired and/or that cannot be dispensed. 

This exemption provides the aforementioned Designated Administrators with the authority to possess, transport and provide controlled substances required by the aforementioned paramedics employed by regulated ambulance service operators with which Designated Administrators are affiliated.

The exemption is only applicable if the following conditions are met. Designated Administrators must:

1. Take necessary steps, in accordance with guidelines established by the Department of Health and Community Services of Newfoundland and Labrador, to ensure the security of controlled substances in storage and during transportation;
2. Order controlled substances only from the hospital pharmacy with which the ambulance service operator is affiliated, and return any unserviceable stock for destruction to that pharmacy;
3. Record all transactions involving controlled substances, i.e., date, name and quantity of controlled substances ordered, received, stored in ambulances or aircrafts, provided to paramedics (to be carried on their person) and returned to originating hospital pharmacy for destruction;
4. Maintain all records submitted by paramedics working for their regulated ambulance service operator;
5. 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; and
6. Keep information specified in (3) and (4) for at least two (2) years from the date the record was made and make it available to Health Canada upon request.

This exemption replaces the “Section 56 Class Exemption for Designated Administrators of Ambulance Service Operators in Newfoundland and Labrador” that was issued on July 12, 2010. This exemption will remain in effect until the date on which this exemption has been replaced or the date on which this exemption is revoked.

Failure to comply with the terms and conditions of this exemption may, among other things, result in immediate suspension of this exemption, and ultimately, in its revocation

Signed for and on the behalf of the Minister of Health,

Michelle Boudreau
Director General
Controlled Substances Directorate
Health Canada

Effective Date:  April 8, 2019