Regulating Chemicals in the Opioid Crisis

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The “Regulations Amending the Precursor Control Regulations (Novel Fentanyl Precursors): SOR/2023-102” introduces new measures to combat the growing issue of fentanyl and its analogues in Canada. These regulations, implemented under the Controlled Drugs and Substances Act (CDSA), aim to strengthen control over specific chemical substances involved in fentanyl production.

Fentanyl is a potent synthetic opioid that has significantly contributed to Canada’s ongoing opioid crisis, with over 34,000 reported opioid toxicity deaths between January 2016 and September 2022, of which approximately 81% involved fentanyl. The newly regulated substances include derivatives and analogues of N-Phenyl-4-piperidinamine (4-AP), a known fentanyl precursor frequently used in illicit drug production.

Although 4-AP was already regulated, its derivatives were only temporarily controlled through a Ministerial Order set to expire. If not permanently scheduled, law enforcement would lose the authority to act against the illegal importation and use of these substances. Furthermore, one specific derivative, 4-anilino-1-boc-piperidine, was recognized under international agreements, necessitating Canada’s compliance.

The amendments to the Precursor Control Regulations now permanently include the derivatives and analogues of 4-AP under the CDSA. This action ensures ongoing control over these substances, which have no legitimate industrial, commercial, or medical uses in Canada. The updated regulations add these derivatives and their salts to Schedule VI of the CDSA, allowing law enforcement to effectively monitor and respond to illegal activities involving them.

Several specific derivatives of 4-AP identified in the amendments include 4-anilino-1-boc-piperidine, 4-fluoro anilino-1-boc-piperidine, N-(4-fluorophenyl)-4-piperidinamine, and 4-bromo anilino-1-boc-piperidine. Canadian authorities have intercepted these substances, indicating their use in illicit drug production, and by controlling them, the government aims to decrease the production and distribution of dangerous opioids.

The CDSA provides a comprehensive legal framework for controlling substances that pose risks to public health and safety, while the Precursor Control Regulations (PCR) specify how precursor chemicals necessary for producing controlled substances can be legally managed. Licenses are required for any activities involving Class A precursors, including production, sale, or import.

The primary objective of these amendments is to ensure that derivatives and analogues of 4-AP are permanently controlled under the CDSA, enabling law enforcement to effectively tackle illegal trafficking. This initiative is part of broader efforts to mitigate the opioid crisis by reducing the availability of toxic illegal drugs.

Canada (SOR/2023-102) June 7, 2023