Guidance for licensed dealers on conducting activities with controlled substances (CS-GD-016): Overview
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Foreword
Guidance documents are meant to provide assistance to industry and health care 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.
Scope
This guidance document is for people (licensed dealers) who conduct the following activities with controlled substances:
- possess
- produce
- package
- sell or provide
- send, transport and deliver
- import
- export
- destroy
A controlled substance can change someone’s mental state and may cause harm to personal and public health and safety when misused or diverted to the illegal market. Controlled substances include:
- Narcotics, such as morphine, oxycodone, and fentanyl, listed in Schedule 1 of the Controlled Substances Regulations
- Controlled drugs, such as testosterone and amphetamine, listed in Schedule 2 of the Controlled Substances Regulations
- Targeted substances, such as clonazepam and lorazepam, listed in Schedule 3 of the Controlled Substances Regulations
- Restricted drugs, such as lysergic acid diethylamide and psilocybin (found in magic mushrooms), which are not approved in Canada, but may be used for specific authorized purposes such as clinical testing and research, listed in Schedule 4 of the Controlled Substances Regulations
Purpose
The Controlled Drugs and Substances Act (the act) is the federal drug control statute. It has 2 purposes: to protect public health and maintain public safety. Under the act, 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 (the regulations) under the act is to allow legitimate activities with controlled substances and precursors (for example, their use in approved prescription drugs or for research projects), while minimizing the risk of their diversion to illegal markets.
As a licensed dealer, many provisions of the act and the regulations pertain to your work. This means you have an important role to play in minimizing the risk of diversion of controlled substances to the illegal market.
This guidance document will help you understand and comply with the act and the regulations. The document is not intended to cover every possible scenario. Other ways of complying with the regulations may be considered with proper justification. As new technologies emerge, different approaches may be called for.
Health Canada is a signatory to 3 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. Your compliance with the regulatory requirements listed in this document fulfills some of these international obligations.
Health Canada inspects licensed dealers to verify that you have complied with the act and the regulations. When we conduct an inspection, we will use this document as a guide in assessing your compliance with the regulatory requirements.
How to use this document
Each section in this document starts with a table giving the exact text from the regulations, followed by an explanation and how to comply.
The document uses text boxes marked ‘Important’ to highlight a key piece of information that you should know, such as updates to processes or parts of the regulations that are often missed or misunderstood. Use it as a way for you to best comply with the regulations.
Important: Key or cautionary information to know.
The Office of Controlled Substances will occasionally communicate directly with all licensed dealers to supplement this guidance document and clarify expectations.
Guidance documents are administrative tools that do not have the force of law. Should any information in this guidance document conflict with the legislation (the act or the regulations), the legislation prevails.