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 pharmacists

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 pharmacists

Enabling Act

Controlled Drugs and Substances Act

Description

Canada's regulatory framework for controlled substances has evolved over decades. This has resulted in a set of regulations that do not account for some of the newer operational realities of pharmacies, which in turn has created barriers to the adoption of new and emerging service delivery models and does not reflect the expanding roles of other registered and qualified pharmacy professionals. It has also created inconsistencies across the regulations.

Proposed amendments to the Narcotic Control Regulations, the Benzodiazepines and Other Targeted Substances Regulations, and the Food and Drug Regulations – Part G, would respond to these issues and update the regulations to enable pharmacy innovation in Canada and continue to prevent diversion while bringing greater clarity and consistency across the regulations.

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 enable pharmacy innovation in Canada and continue to prevent diversion, while bringing greater clarity and consistency across the regulations.

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

Consultations

Canadians will have the opportunity to provide comments on the regulatory proposal on the 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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