Forward Regulatory Plan 2023-2025: Order Amending Schedule I and VI to the Controlled Drugs and Substances Act and Regulations Amending the Narcotic Control Regulations and the Precursor Control Regulations (Novel Synthetic Opioids and Novel Fentanyl Precursors)
Title of Regulatory Initiative
Order Amending Schedule I and VI to the Controlled Drugs and Substances Act and Regulations Amending the Narcotic Control Regulations and the Precursor Control Regulations (Novel Synthetic Opioids and Novel Fentanyl Precursors)
Enabling Act
Controlled Drugs and Substances Act
Description
In March 2023, the United Nations Commission on Narcotic Drugs voted in favour of adding the synthetic opioid 2-methyl-AP-237 to Schedule I of the Single Convention on Narcotic Drugs, 1961. As a party to the United Nations drug control conventions, Canada is expected to take measures to ensure the control of 2-methyl-AP-237 domestically by scheduling it under the Controlled Drugs and Substances Act (CDSA). Health Canada is proposing to proceed with a class approach to scheduling by adding AP-237 and its derivatives and analogues, including 2-methyl-AP-237, to Schedule I of the CDSA and to the Schedule to the Narcotic Control Regulations.
In addition, there is evidence to suggest that substances that are chemically related to the controlled fentanyl precursor 4-piperidone (i.e., analogues and derivatives of 4-piperidone) are being illegally imported into Canada and used in the illegal production of fentanyl and fentanyl analogues. These substances have been chemically engineered by illegal drug producers to circumvent existing control measures. In response, Health Canada is proposing to move forward with a class approach to scheduling these substances that would expand the existing listings of 4-piperidone in Schedule VI to the CDSA and the Schedule to the Precursor Control Regulations.
Regulatory cooperation efforts (domestic and international)
Canada is committed to working with international partners to strengthen the coordinated global response to the international public health and public safety challenges posed by synthetic drugs. The proposed amendments would fulfill Canada's obligations as a party to the United Nations drug control conventions, including the Single Convention on Narcotic Drugs, 1961 and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.
Potential impacts on people in Canada, including businesses
The proposed regulatory amendments are expected to have positive impacts on people in Canada, as they would allow law enforcement to act against the illegal importation, distribution, and use of these synthetic opioids and fentanyl precursors. As these substances have no known industrial, commercial, or medical uses in Canada, the potential impacts of the amendments on stakeholders are expected to be minimal.
Consultations
On August 26, 2023, Health Canada published a Notice of Intent in the Canada Gazette, Part I for a 30-day consultation period.
On October 28, 2023, Health Canada published a Notice of Intent to control the derivatives and analogues of the fentanyl precursor 4-piperidone and its salts under the Controlled Drugs and Substances Act in the Canada Gazette, Part I, for a 30-day public comment period ending on November 27, 2023.
Health Canada plans to seek an exemption from pre-publication in the Canada Gazette, Part I, and if approved, plans to publish the amended regulations in the Canada Gazette, Part II, in spring 2024.
Further information
Additional information can be requested from the departmental contact.
Departmental contact information
Jennifer Pelley
Director
Office of Legislative and Regulatory Affairs
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada
Telephone: 613-410-1829
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory Plan November 2023
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