Exemptions from provisions of the Controlled Drugs and Substances Act
Health Canada manages exemption requests under the Controlled Drugs and Substances Act (CDSA). An exemption may be granted to allow a controlled substance or precursor to be used for specific scientific or medical purposes, or when it is determined to be in the public interest.
On this page:
- About exemptions
- Compliance and enforcement
- Request an exemption
- Timelines for processing exemption requests
About exemptions
The CDSA is one of Canada's federal drug control laws. It provides the framework for the control of drugs and precursor chemicals that can result in harm when misused or diverted to an illegal market.
Under the CDSA, most activities with controlled substances and precursor chemicals are illegal, unless specifically allowed through:
- regulations or
- an exemption granted by the Minister of Health
An exemption is a formal document issued to a person or group. It authorizes specific activities with controlled substances or precursor chemicals that would otherwise be illegal. For example, a researcher can request an exemption to conduct studies with a controlled substance such as ketamine, buprenorphine, sodium pentobarbital, or other controlled substances. The exemption usually specifies the duration for which it is valid and includes terms and conditions for the types of activities that it authorizes.
Health Canada reviews each request for an exemption under the CDSA on a case-by-case basis. The department considers all relevant information, including:
- potential benefits (for example, whether the research will benefit the health of Canadians)
- potential risks or harms to the health and safety of Canadians (for example, certain substances, such as fentanyl, are very dangerous if misused)
- evidence that the controlled substance or precursor chemical is necessary for the activity
- safeguards for the use and storage of the controlled substance or precursor chemical to prevent theft or misuse (for example, limitations on who can handle the substance)
Note that applying to operate supervised consumption sites and services falls under a separate process. Please see supervised consumption sites and services for more information.
Class exemptions
Health Canada also issues class exemptions, which authorize groups of people to conduct specific activities with controlled substances or precursor chemicals. These exemptions could apply to people in a geographic area (for example, a provincial class exemption) or a profession (for example, pharmacists).
For more examples, refer to the list of class exemptions and related guidance.
Compliance and enforcement
Exemption holders must comply with the terms and conditions set out in the exemption. Health Canada can revoke an exemption at any time if the exemption holder is not in compliance with the terms and conditions of their exemption.
Health Canada monitors compliance through a number of mechanisms, including verifying that:
- record-keeping is complete
- losses and thefts of controlled substances and precursor chemicals are promptly reported to Health Canada
Health Canada inspectors may visit exemption holders at any point to verify compliance.
Learn more about compliance and enforcement actions.
Request an exemption
Complete the relevant form based on the purpose of the exemption you are requesting.
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Privacy notice
The personal information you provide to Health Canada will be collected by the Office of Controlled Substances under the Controlled Drugs and Substances Act and its regulations, and Parts G and J of the Food and Drug Regulations, and handled in accordance with the Privacy Act.
Why are we collecting your personal information?
We require your personal information to review and process your application for a subsection 56(1) exemption under the Controlled Drugs and Substances Act.
Will we use or share your personal information for any other reason?
Personal information may be used or disclosed for the purposes of compliance and enforcement, program administration, program evaluation, audit and statistical purposes, and reporting to senior management. Personal information may be shared with Justice Canada or other government departments for the purposes of validating aspects of the application, and to ensure an exemption decision is not in potential conflict with relevant legislation. Personal information may be shared with Provinces/Territories, and local authorities or law enforcement authorities for the purposes of protecting public health or public safety, enforcing compliance or preventing non-compliance with the Controlled Drugs and Substances Act or its regulations, or for the purposes of an investigation and the administration or enforcement of the Act or its regulations.
What happens if you don't want to provide your personal information?
If you choose to not provide the requested personal information, this may result in a refusal to process or grant your application for a subsection 56(1) exemption under the Controlled Drugs and Substances Act.
What are your rights?
You have the right to access and request a correction and/or notation to your personal information. For privacy-related questions, you may contact the Office of Controlled Substances at exemption@hc-sc.gc.ca. If you have been unable to resolve a privacy issue with us, you may file a formal complaint with the Privacy Commissioner of Canada about how we have handled your personal information. Visit Report a concern for more information.
For more information: The collection of your personal information is described in Info Source. Refer to the personal information bank HC PPU 040 - Subsection 56(1) Exemptions under the Controlled Drugs and Substances Act.
Scientific research involving in vitro or animal studies
Human clinical trials
All other exemption requests
- For non-routine requests that do not fall under the categories listed above, please contact the Exemptions Section at exemption@hc-sc.gc.ca. Only include a brief description of what you are seeking to do, without including detailed personal information. If further information or an exemption is needed, instructions will be provided.
- Detailed information for individuals, patients, health practitioners, researchers or health care professionals seeking to access psilocybin is available on the psilocybin and psilocin page.
Other situations
Methadone
- Exemptions are no longer required for practitioners to prescribe, administer, sell or provide methadone to their patients.
Timelines for processing exemption requests
We strive to assess requests in a timely fashion.
- For clinical studies, Health Canada aims to process exemption requests within 45 calendar days of receipt of all required documents.
- For scientific research, Health Canada aims to process exemption requests within 70 calendar days of receipt of all required documents.
- For non-routine exemptions, there is no set time period for receiving decisions. The review time varies depending on the complexity and completeness of the request.