Forward Regulatory Plan 2021-2023: Regulations Amending Certain Regulations under the Controlled Drugs and Substances Act to modernize provisions with respect to hospitals, other health care facilities, and health care professionals
Title of Regulatory Initiative
Regulations Amending Certain Regulations under the Controlled Drugs and Substances Act to modernize provisions with respect to hospitals, other health care facilities, and health care professionals
Enabling Act
Controlled Drugs and Substances Act
Description
The proposed amendments would address several gaps and inconsistencies in regulations under the Controlled Drugs and Substances Act (CDSA) with respect to the definition and regulatory requirements for hospitals.
Currently, many health care facilities that do not meet the definition of a hospital are not appropriately captured.
Further, certain health care professionals (such as nurses and paramedics) are not explicitly authorized to perform activities with controlled substances outside of a hospital. In some cases, section 56 exemptions have been issued and are in use to address these gaps. This makes activities with controlled substances and compliance of the regulations challenging. These gaps can also present opportunities for diversion of controlled substances.
A modernization of regulatory language pertaining to hospitals and practitioners will be completed as part of the planned new Controlled Substances Regulations, however no substantive changes are expected to be made until such a time as the regulatory consolidation and further consultations with stakeholders have been completed.
This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap.
This regulatory initiative is a part of Health Canada’s stock review plan.
Regulatory cooperation efforts (domestic and international)
Not Applicable
Potential impacts on Canadians, including businesses
The proposed regulatory amendment apply to the health care sector.
Stakeholders that may be impacted by the change include hospitals, health care facilities, health care professionals.
Consultations
Canadians will have the opportunity to provide comments on a Notice of Intent during the Canada Gazette, Part I.
Given the stakeholders who would be impacted by this proposal, consultation on a Notice of Intent is on hold due the COVID-19 pandemic. In light of this, no substantive changes to provisions pertaining to hospitals and practitioners in the regulations under the CDSA will be undertaken until such a time as the consolidation of regulations for controlled substances has been completed.
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: 613-410-3793
Email: hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca
Date the regulatory initiative was first included in the Forward Regulatory Plan
May 27, 2019
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