Forward Regulatory Plan 2023-2025: Order Amending Schedule VI to the Controlled Drugs and Substances Act and Regulations Amending the Precursor Control Regulations (Novel Fentanyl Precursors)
Title of Regulatory Initiative
Order Amending Schedule VI to the Controlled Drugs and Substances Act and Regulations Amending the Precursor Control Regulations (Novel Fentanyl Precursors)
There is evidence that substances that are chemically related (i.e., analogues and derivatives) to the fentanyl precursor, N-Phenyl-4-piperidinamine (4-AP) and its salts, are being imported into Canada and used in the illegal production of fentanyl. On August 31, 2022, the analogues and derivatives of 4-AP were added to Schedule V to the Controlled Drugs and Substances Act (CDSA) for a period of one year through a Ministerial Order made by the Minister of Mental Health and Addictions and Associate Minister of Health. Health Canada has since concluded that longer-term control of these novel fentanyl precursors is needed because they will continue to pose a risk to the health and safety of People in Canada following expiry of the Ministerial Order on August 30, 2023. The proposed regulatory amendments would schedule the analogues and derivatives of 4-AP as precursors under Schedule VI to the CDSA and would add these substances to the Schedule to the Precursor Control Regulations.
Regulatory cooperation efforts (domestic and international)
This initiative is not part of a formal regulatory cooperation work plan.
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 continue to act against the illegal importation, distribution and use of these novel fentanyl precursors, which are being used in the illegal production of fentanyl and fentanyl analogues. Most accidental apparent opioid toxicity deaths in Canada involve fentanyl and fentanyl analogues. As these precursor substances have no known industrial, commercial, or medical uses, apart from their use in activities supporting enforcement of the CDSA (e.g., reference standards used in laboratories), the potential impacts of the proposed regulatory amendments on businesses, licence holders, and researchers are expected to be minimal.
In 2022-23, Health Canada conducted targeted stakeholder consultations with stakeholders impacted by the August 2022 Ministerial Order and proposed regulatory changes (including law enforcement and the Canada Border Services Agency).
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 2023.
Additional information on this proposal may be requested from the departmental contact.
Departmental contact information
Office of Legislative and Regulatory Affairs
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Date the regulatory initiative was first included in the Forward Regulatory
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