Forward Regulatory Plan 2019-2021: Proposed Regulations Amending the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, and the Food and Drug Regulations – Part G in order to modernize regulations with respect to hospitals 

Title of Regulatory Initiative

Proposed Regulations Amending the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, and the Food and Drug Regulations – Part G in order to modernize regulations with respect to hospitals

Enabling Act

Controlled Drugs and Substances Act

Description

Amendments are to be made to the Benzodiazepines and Other Targeted Substances Regulations, the Narcotic Control Regulations and Part G (Controlled Drugs) of the Food and Drug Regulations.

The regulatory initiative would address several gaps and inconsistencies in Controlled Drugs and Substances Act regulations 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. This makes activities with controlled substances and compliance with enforcement challenging.  These gaps can present undesirable opportunities for diversion of controlled substances.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap.

This regulatory initiative is associated with Health Canada’s stock review plan.

Regulatory cooperation efforts (domestic and international)

Not Applicable

Potential impacts on Canadians, including businesses

The proposed regulatory amendment applies to the health care sector and would clarify the definition of health care facilities to facilitate compliance and enforcement activities.

Stakeholders that may be impacted by the change include: hospitals, health care facilities, pharmacies, industry, health professionals.

Consultations

Canadians will have the opportunity to provide comments on a Notice to Interested Parties during the Canada Gazette, Part I public comment period, which is expected to take place in fall 2020 and last 60 days.

Information on previous consultations and details on upcoming opportunities for consultation in the area of Controlled Substances can be found on the Canada.ca website.

Further information

Additional information can be requested from the Departmental contact.

Departmental contact information

Office of Legislative and Regulatory Affairs
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada
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

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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