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

On this page

• Foreword
• Scope
• Purpose
• How to use this document
• Contact information

Foreword

Guidance documents are meant to provide assistance to industry and healthcare professionals on how to comply with governing laws and regulations. Guidance documents also assist Health Canada staff, so that the laws and regulations are administered in a manner that is fair, consistent and effective. Guidance documents are administrative instruments not having force of law and, as such allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches 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.

Any questions of interpretation concerning this guidance document should be directed to the National Monitoring Section at ocs.reporting-rapporter.bsc@hc-sc.gc.ca.

Scope

This document provides guidance to regulated parties on how to meet the regulatory requirements for reporting losses or thefts of controlled substances or precursors, including preparations containing these substances, to Health Canada.

Under the Controlled Drugs and Substances Act (CDSA), regulated parties include but are not limited to:

• licensed or registered dealers
• pharmacists
• practitioners as defined in the CDSA
• hospitals

This document also applies to holders of an exemption under subsection 56(1) or section 56.1 of the CDSA who must report any losses or thefts as per the terms and conditions of their exemptions.

Purpose

The CDSA is one of Canada's federal drug control statutes. It has two purposes: to protect public health and maintain public safety. Under the CDSA, activities with controlled substances are generally prohibited (for example, possession, production, importing, exporting, and trafficking) unless authorized through regulations or exemptions.

The objective of the Controlled Substances Regulations and the Precursor Control Regulations under the CDSA is to allow legitimate activities with controlled substances and precursors (for example, their use in approved prescription drugs), while minimizing the risk of their diversion to illegal markets.

As a regulated party, the loss or theft reporting provisions outlined in the regulations pertain to your work. This means you have an important role to play in minimizing the risk of diversion of controlled substances or precursors to the illegal markets.

This guidance document will help you understand and comply with the loss or theft reporting requirements for controlled substances or precursors.

Health Canada is a signatory to three international conventions to protect health and safety by ensuring access to controlled substances for medical and scientific purposes while preventing diversion to illegal channels. Health Canada meets its international obligations by managing and monitoring the movement of controlled substances and other chemicals in and out of Canada. Your compliance with the regulatory requirements listed in this document fulfills some of these international obligations.

How to use this document

The following table shows the 2 types of flags used in this document.

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

Contact information

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

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