Guidance on reporting loss or theft of controlled substances and precursors (CS-GD-005): Overview

On this page

• Purpose
• Scope
• Background
• General remarks
• Contact Information

Purpose

This document provides guidance in reporting a loss or theft of controlled substances and precursors. It applies to regulated parties and exemptees under the Controlled Drugs and Substances Act (CDSA) and its associated regulations.

Regulated parties as well as exemptees under section 56 of the CDSA must notify Health Canada of the loss or theft of controlled substances or precursors. This is in accordance with any of the following:

• the Narcotic Control Regulations (NCR)
• Parts G and J of the Food and Drugs Regulations (FDR-G or FDR-J)
• the Benzodiazepines and Other Targeted Substances Regulations (BOTSR)
• the Precursor Control Regulations (PCR)
• the terms and conditions of their exemption

Reports of any loss or theft of controlled substances or precursors must be submitted to Health Canada's Office of Controlled Substances (OCS).

For those who deal with post-consumer returns, please refer to the guidance document Handling and destruction of post-consumer returns containing controlled substances (CS-GD-021). It explains the roles and responsibilities of stakeholders on post-consumer returns.

The following table shows the 3 types of flags used in this document.

Direct any questions about this guidance document to the Monitoring Section of the Office of Controlled Substances (OCS) at ocs.reporting-rapporter.bsc@hc-sc.gc.ca.

Scope

This document provides guidance to regulated parties for meeting the regulatory requirements to report losses or thefts of controlled substances and precursors, including preparations containing these substances.

Under the CDSA, regulated parties include but are not limited to:

• licensed or registered dealers
• pharmacists
• practitioners as defined in the CDSA and New Classes of Practitioners Regulations
• hospitals

This document also applies to exemptees under section 56 of the CDSA who must report any losses or thefts as per the terms and conditions of their exemptions.

Background

Canada is a signatory to:

• the Single Convention on Narcotic Drugs (1961)
• the Convention on Psychotropic Substances (1971)
• the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988)

Canada is also party to the resolutions set by the International Narcotics Control Board (INCB). Part of the INCB's mandate is to prevent controlled substances and precursors from being diverted to the illegal market.

The OCS works in collaboration with Canadian and international stakeholders in the public and private sectors to ensure that controlled substances and precursors are used for legal purposes. The OCS supports this effort through its administration of laws pertaining to the possession, import, export, production, packaging and sale or provision of controlled substances and precursors listed in the Schedules of the CDSA.

General remarks

Guidance documents provide assistance to industry and healthcare professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety and security of controlled substances and precursors. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

Contact Information

Reporting losses and thefts of controlled substances and precursors:
National Monitoring Section
Email: ocs.reporting-rapporter.bsc@hc-sc.gc.ca

Health Canada E-Services Portal for Controlled Substances Services:
Controlled Substances and Cannabis Branch Call Centre
Email: csps-spsc@hc-sc.gc.ca
Phone: 1-866-337-7705 (option 5)

General queries:
Office of Controlled Substances
Email: ocs-bsc@hc-sc.gc.ca
Phone: 613-952-2177