Forward Regulatory Plan 2021-2023: Proposed New Controlled Substances Regulations

Title of Regulatory Initiative

Proposed New Controlled Substances Regulations

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

This regulatory initiative will consolidate the Narcotic Control Regulations, the Benzodiazepines and Other Targeted Substances Regulations and Parts G and J of the Food and Drug Regulations into a single new Controlled Substances Regulations. This consolidation will result in a modernization of regulatory language throughout the proposed new regulation.

Additional changes

Provisions pertaining to licences and permits were recently modernized. As part of the planned consolidation, changes to regulatory provisions pertaining to pharmacists, individuals, destruction and test kits will also be made in order to:

No substantive changes to provisions pertaining to hospitals or practitioners are expected to be made until such a time as the regulatory consolidation has been completed and further consultation with stakeholders has been done.

Coordinating amendments will also be made to other federal regulations, including the Precursor Control Regulations, Cannabis Regulations, and the Food and Drug Regulations.

Note: The pharmacist component of this initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap and is also associated with Health Canada’s Stock Review Plan.

Regulatory cooperation efforts (domestic and international)

Not applicable

Potential impacts on Canadians, 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 change include pharmacies and pharmacists, licensed dealers, patients, health practitioners and individual Canadians.

Consultations

Canadians 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 winter/spring 2022 and last 60 days.

Certain aspects of this regulatory package have been consulted upon previously, as follows:

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.

Further information

Additional information can be requested from the departmental contact.

Departmental contact information

Jennifer Pelley
Acting Director
Office of Legislative and Regulatory Affairs
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada

Telephone: 613-410-1829
Email: hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 1, 2018

Consult Health Canada's acts and regulations web page for:

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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