Forward Regulatory Plan 2019-2021: Amendments to the regulations made under the Controlled Drugs and Substances Act regarding the return and destruction of controlled substances and travel with controlled substances, as well as to facilitate access to controlled substances for testing, scientific analysis and other legitimate purposes

Title of Regulatory Initiative

Amendments to the regulations made under the Controlled Drugs and Substances Act regarding the return and destruction of controlled substances and travel with controlled substances, as well as to facilitate access to controlled substances for testing, scientific analysis and other  legitimate purposes.

Enabling Act

Controlled Drugs and Substances Act

Description

The regulatory proposal would address several gaps and inconsistencies in Controlled Drugs and Substances Act (CDSA) regulations including: lack of explicit authorities for individuals to return controlled substances to a pharmacy for disposal, and to travel with controlled substances for personal medical use; and inconsistencies with respect to how regulated parties (hospitals, pharmacists and practitioners) collect, handle and dispose of unserviceable stock containing a controlled substance.

Regulations pertaining to test kits are inconsistent between regulations and are somewhat inflexible with regard to the type of products eligible for registration. These proposed amendments would align, streamline and modernize the authorization of test kits.

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

Regulatory cooperation efforts (domestic and international)

Not Applicable

Potential impacts on Canadians, including businesses

The proposed regulatory amendments apply to the health care sector and will clarify the rules regarding the collection, and disposition of unserviceable stock containing a controlled substance and streamline and modernize the authorization of test kits.

Stakeholders that may be impacted by the change include: hospitals, pharmacies, Canadians and health practitioners.

Consultations

A Notice to Interested Parties was published in Canada Gazette, Part I October 28, 2017 for a 60 day public comment period, to obtain feedback on regulatory amendments pertaining to the return, destruction of, and travel with a controlled substance.

A Notice to Interested Parties was published on March 31, 2018 in Canada Gazette, Part I for a 60 day public comment period, to obtain feedback on regulatory amendments pertaining to test kits.

Canadians will have the opportunity to further provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which is expected to take place winter 2020 and last 70 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

Jennifer Geduld
Manager
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada
Telephone: 613-316-2624
Email: hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca

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

October 1, 2016

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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