Policy document on inspection strategy for licensed dealers of controlled substances and Class A precursors (CSP-POL-002): Overview

On this page

• Scope
• Purpose
• Introduction

Scope

The Controlled Drugs and Substances Act (the Act) is the federal statute that provides a framework for control of substances that can alter mental processes and that pose risks to public health and public safety when used inappropriately or diverted to an illegal market. This applies to all controlled substances and Class A and B precursors (precursors) listed in the schedules to the Act.

Schedule VI of the Act includes a list of controlled Class A and Class B precursors that are commonly used in clandestine production processes. Both Class A and Class B precursors are regulated under the Precursor Control Regulations (PCR). Class A precursors are essential chemical compounds, while Class B precursors are common essential reagents, such as solvents, acids, and bases.   

Controlled substances are defined as substances that are included in Schedules I-V of the Act and are regulated under the Controlled Substances Regulations (CSR). Controlled substances include:

• narcotics, such as morphine, oxycodone, and fentanyl, listed in Schedule 1 of the CSR
• controlled drugs, such as testosterone and amphetamine, listed in Schedule 2 of the CSR
• targeted substances, such as clonazepam and lorazepam, listed in Schedule 3 of the CSR
• restricted drugs, such as lysergic acid diethylamide and psilocybin (commonly known as magic mushrooms), listed in Schedule 4 of the CSR

Restricted drugs generally have no approved medical uses but may be used for scientific or research purposes, such as in clinical trials.   

Purpose

Companies require a controlled substance (dealer’s) licence or a Class A precursor licence (precursor) to be authorized to conduct regulated activities with those substances. Health Canada inspects licensed dealers of controlled substances and precursors to assess their compliance with the Act and its associated regulations. By enforcing the Act and its associated regulations, it helps minimize the risk of diversion of precursors and controlled substances to the illegal market. 

This policy will help you understand Health Canada’s inspection strategy for precursors and controlled substances. It also describes the inspection process we use to assess whether the activities performed comply with the Act and its associated regulations. Health Canada’s authority to inspect places where activities with these substances take place comes from section 31 of the Act. Health Canada inspectors are designated under section 30 of the Act.

The main objectives of Health Canada’s inspection strategy are to:

• minimize the risk of diversion of precursors and controlled substances within the legal supply chain
• assess through inspections the compliance of establishments that conduct activities with controlled substances or precursors
• take compliance and enforcement actions when needed
• support national consistency
• foster transparency with industry, the people of Canada, international regulatory authorities and other global stakeholders.

Introduction

Health Canada is committed to maintaining and improving the health of the people of Canada. Part of that commitment involves protecting the health and safety of Canadians from risks associated with controlled substances and precursors. Controlled substances and precursors can pose a risk to the people of Canada when used inappropriately or diverted out of the legal supply chain.

To meet these commitments, Health Canada operates a Controlled Substances Program (CSP) to enforce the applicable regulations and verify industry compliance. Companies that conduct activities with controlled substances or precursors are required to have in place specific security requirements, operational controls, and record keeping practices that minimize the risk of these products being diverted.

Health Canada has developed a series of guides that outline how to comply with the associated regulations. See Guidance Document: Inspection Guide for Licensed Dealers of Controlled Substances (CSP-GD-016) and Guidance for licensed dealers on conducting activities with Class A precursors (CSP-GD-018) for more information.