Forward Regulatory Plan 2023-2025: Modernization of Regulations for Controlled Substances
Title of Regulatory Initiative
Modernization of Regulations for Controlled Substances
Enabling Act
Controlled Drugs and Substances Act
Description
Canada's regulatory framework for controlled substances has evolved over decades to address emerging issues. This evolution has resulted in a set of regulations that, while containing broadly similar provisions, also feature issues, gaps and inconsistencies, causing undue burden for the administration of and compliance with these regulations.
Consolidation and Modernization
Health Canada is proposing to consolidate the Narcotic Control Regulations, the Benzodiazepines and Other Targeted Substances Regulations. Parts G and J of the Food and Drug Regulations, and the New Classes of Practitioners Regulations into a single new regulation for controlled substances. This consolidation would result in a modernization of regulatory language throughout the proposed new regulation. Health Canada also intends to repeal the Regulations Exempting Certain Precursors and Controlled Substances from the Application of the Controlled Drugs and Substances Act.
Additional changes
Provisions pertaining to licences and permits were modernized in 2019. As part of the planned consolidation, changes to regulatory provisions pertaining to pharmacists, individuals, destruction, and test kits would also be made to:
- Support pharmacy innovation in Canada, and enable pharmacists to more fully use their expertise and contribute to Canada's responses to urgent and non-urgent health-related situations, while maintaining stewardship over the movement of controlled substances;
- Allow individuals to travel with prescription drugs containing controlled substances for personal medical use and to return prescription drugs containing controlled substances to a pharmacy for disposal;
- Allow pharmacists, pharmacy technicians, practitioners and persons in charge of a hospital to destroy controlled substances or provide them to licensed dealers for the purpose of destruction; and
- Update provisions in relation to test kits.
Coordinating amendments would also be made to other federal regulations, including the Precursor Control Regulations, Cannabis Regulations, and the Food and Drug Regulations.
This initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap and is a part of Health Canada's Regulatory Stock Review Plan.
Regulatory cooperation efforts (domestic and international)
This initiative is not part of a formal regulatory cooperation work plan.
Potential impacts on people in Canada, including businesses
Modernization and consolidation of these regulations is expected to enable pharmacy innovation in Canada, improve clarity and consistency, and contribute to improved administration of and compliance with the regulations.
Stakeholders that may be impacted by the proposal include pharmacies, pharmacists and pharmacy technicians, licensed dealers, patients, health practitioners and individual people in Canada.
Consultations
A Notice to Interested Parties seeking feedback on proposed regulatory changes pertaining to the return, destruction of, and travel with controlled substances was published in the Canada Gazette, Part I, on October 28, 2017 for a 60-day public comment period.
A Notice to Interested Parties seeking feedback on proposed regulatory changes pertaining to test kits was published in the Canada Gazette, Part I, on March 31, 2018 for a 60-day public comment period.
A Notice to Interested Parties seeking feedback on proposed regulatory changes pertaining to pharmacists was published in the Canada Gazette, Part I, on March 9, 2019 for a 60-day public comment period.
People in Canada will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which is expected to take place in spring 2024 and last 70 days.
Further information
Additional information can be requested from the departmental contact.
Health Canada's intent to modernize provisions pertaining to pharmacists was first signalled through its Forward Regulatory Plan (FRP) in May 2019.
Health Canada's intent to modernize provisions pertaining to individuals, destruction, and test kits was first signalled through its FRP in 2016.
Departmental contact information
Jennifer Pelley
Director
Office of Legislative and Regulatory Affairs
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada
Telephone: 613-410-1829
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory Plan
April 2021
Consult Health Canada's acts and regulations web page for:
- a list of acts and regulations administered by Health Canada
- further information on Health Canada's implementation of government-wide regulatory management initiatives
Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:
To learn about upcoming or ongoing consultations on proposed federal regulations, visit:
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