Regulating Controlled Substances and Precursors

Regulating controlled substances and precursors

Examples of controlled substances and precursors include substances explicitly listed in the Controlled Drugs and Substances Act (CDSA) such as:

• cocaine
• fentanyl
• morphine
• methamphetamine
• ephedrine

Many other substances are also captured under the CDSA as analogues, derivatives, isomers and salts of listed substances. Health Canada provides a public service to stakeholders to confirm the control status of substances. The status confirmation process includes a scientific review with respect to the heading in the Act for the relevant CDSA Schedule entry.

Controlled substances can be used improperly, resulting in harm to public health or safety. Precursors are chemicals that can be used to make controlled substances. That is why we regulate the substances and precursors listed in the CDSA.

The CDSA forbids the following activities for controlled substances and precursors, unless authorized by regulations or exempted under the CDSA:

• sale
• export
• import
• possession
• production

The regulations and exemptions authorize lawful activities for medical, scientific and industrial purposes.

Some of the regulations made under the CDSA are:

• Benzodiazepines and Other Targeted Substances Regulations
• Food and Drug Regulations - Part G
• Food and Drug Regulations - Part J
• Narcotic Control Regulations
• Precursor Control Regulations

Health Canada administers the CDSA and its regulations to:

• allow access for lawful purposes
• reduce the risk that controlled substances and precursors will be used for illegal purposes

To meet these 2 objectives, we:

• issue licences, permits and exemptions
• monitor trends of problematic substance use
• update the Schedules to the CDSA based on assessments of new or existing substances, when necessary
• work with international organizations and other countries to meet Canada's obligations regarding controlled substances

The regulations apply to a broad range of parties, including:

• manufacturers, distributors, importers and exporters who must get a licence to produce, sell, import or export controlled substances and precursors
• importers and exporters who must get a permit each time they import and export a controlled substance or precursor
• health professionals who must comply with requirements when prescribing and giving controlled substances to a patient
• researchers who must get permission to have a controlled substance for research purposes

All regulated parties must comply with requirements for:

• security
• reporting
• record-keeping

Promoting and enforcing compliance

To promote compliance with the regulations we:

• develop and publish guidance
• inform affected parties of any regulatory changes
• publish notices seeking public input on proposed regulatory changes

These actions are meant to help all regulated parties understand how to meet the requirements of the regulations.

Heath Canada also carries out inspections of regulated parties and monitors regulated activities.

Health Canada may take action when a regulated party is not following the rules of the CDSA. These actions include (but are not limited to):

• issuing warning letters
• requiring a corrective action plan
• suspending and revoking licences, permits or exemptions to stop a regulated party from conducting activities

Working with partners

Health Canada helps to protect the health of Canadians by working with a wide range of partners and stakeholders, including:

• provincial and territorial governments
• other federal departments and agencies
• law enforcement agencies
• academic, scientific and research communities
• non-government organizations, such as national, provincial and territorial health professional associations
• federal regulators in other countries
• international organizations, such as the United Nations

Our work with these groups includes:

• increasing collaboration
• getting the best advice on policies and regulations through external experts
• meeting Canada's international obligations to promote public health and safety

Engaging and informing Canadians

We speak with Canadians as part of the regulatory process. This can include seeking the views of the public through a variety of means, including:

• online consultations
• advisory committees
• meetings with stakeholders
• roundtables and focus groups

Health Canada informs Canadians about the health hazards of controlled substances through:

• news releases
• announcements
• public information materials, such as fact sheets
• responses to questions from the public and media on controlled substances and precursors
• web-posting data on controlled substances, such as results of the Canadian Tobacco, Alcohol and Drugs Survey and the Canadian Student Tobacco, Alcohol and Drugs Survey

Health Canada announced the federal government's new approach to drug policy, the Canadian Drugs and Substances Strategy (CDSS), in December 2016.

The CDSS is a comprehensive, collaborative, compassionate and evidence-based approach, which uses a public health lens to address problematic drug and substance use. The approach restores harm reduction as a key pillar, alongside prevention, treatment and enforcement.

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