Order Amending Schedules I and VI to the Controlled Drugs and Substances Act (Synthetic Opioids and Emerging Fentanyl Precursors): SOR/2024-98

Canada Gazette, Part II, Volume 158, Number 12

Registration
SOR/2024-98 May 27, 2024

CONTROLLED DRUGS AND SUBSTANCES ACT

P.C. 2024-574 May 24, 2024

Her Excellency the Governor General in Council, on the recommendation of the Minister of Mental Health and Addictions and Associate Minister of Health, considering that it is necessary in the public interest, makes the annexed Order Amending Schedules I and VI to the Controlled Drugs and Substances Act (Synthetic Opioids and Emerging Fentanyl Precursors) under section 60footnote a of the Controlled Drugs and Substances Act footnote b.

Order Amending Schedules I and VI to the Controlled Drugs and Substances Act (Synthetic Opioids and Emerging Fentanyl Precursors)

Amendments

1 Schedule I to the Controlled Drugs and Substances Act footnote b is amended by adding the following after item 27:

2 Item 27 of Part 1 of Schedule VI to the Act is replaced by the following:

Coming into Force

3 (1) This Order, except section 2, comes into force on the day on which it is published in the Canada Gazette, Part II.

(2) Section 2 comes into force on the 90th day after the day on which is published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order or the regulations.)

Issues

Opioid-related harms, including deaths, remain a significant public health crisis in Canada. While Canada strictly controls synthetic opioids and the precursor chemicals used to produce them, the illegal drug market is constantly evolving in an attempt to evade these controls.

In March 2023, the United Nations (UN) Commission on Narcotic Drugs voted in favour of scheduling the novel synthetic opioid 2-methyl-AP-237 under Schedule I of the Single Convention on Narcotic Drugs of 1961 (1961 Single Convention). As a party to this convention, Canada is expected to take measures to ensure the control of 2-methyl-AP-237 domestically under the Controlled Drugs and Substances Act (CDSA). Further, based on Health Canada’s review of the scientific evidence, substances related to 2-methyl-AP-237 (i.e. AP-237 and its analogues and derivatives) also have significant potential to be misused and illegally imported for sale on the illegal market.

The fentanyl precursor 4-piperidone and its salts are listed in Schedule VI (precursors) to the CDSA. Emerging evidence suggests that certain chemically related substances (i.e. analogues and derivatives) of 4-piperidone, including 1-boc-4-piperidone,1-benzyl-4-piperidone and 3-methyl-4-piperidone, are being illegally imported into Canada and used in the illegal production of fentanyl. In March 2024, the UN Commission on Narcotic Drugs voted in favour of scheduling 4-piperidone and 1-boc-4-piperidone under Table I of the UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 (1988 Convention).

Until these substances are scheduled under the CDSA, the Canada Border Services Agency (CBSA) and law enforcement have fewer tools available to them to prevent their importation, distribution, and use. Further, 2-methyl-AP-237 and 1-boc-4-piperidone must be scheduled on a long-term basis under the CDSA for Canada, as a party to the 1961 Single Convention and the 1988 Convention, to meet its international obligations.

Background

Between January 2016 and September 2023, there were a total of 42 494 apparent opioid toxicity deaths in Canada. Fentanyl and fentanyl analogues continue to be major drivers of the opioid overdose crisis, with 82% of all accidental apparent opioid toxicity deaths from January 2023 to September 2023 involving fentanyl.footnote 1 In addition to the devastating public health and social harms associated with the consumption of illegal synthetic opioids such as fentanyl, Canada is also concerned with the impact of illegal synthetic opioids on public safety, including security challenges associated with their illegal production, diversion, trafficking, and related crimes.

Methods used by illegal drug producers to evade controls include creating novel psychoactive substances and novel precursors to avoid detection by law enforcement and border control agencies.

2-Methyl-AP-237 and related substances (synthetic opioids)

2-Methyl-AP-237 is an analogue of AP-237, which is also known as bucinnazine. AP-237 and its derivatives and analogues, including 2-methyl-AP-237, AP-238, and para-methyl-AP-237, are all synthetic opioids. These substances demonstrate acute analgesic (pain-relieving) effects, similar to other known opioids. Clinical studies in humans involving AP-237 show that it has analgesic properties similar to, but not as potent as, morphine. Human studies have not been conducted on 2-methyl-AP-237, para-methyl-AP-237, or AP-238, but preclinical (i.e. animal) studies involving these three substances have indicated that the potency of 2-methyl-AP-237 may be comparable to fentanyl. There are also case reports of non-medical use or dependence involving AP-237 and related substances.

While none of these substances have approved medical uses in Canada, AP-237 is approved for use as an analgesic (i.e. for pain relief) in China. There are no known legitimate commercial or industrial uses of these substances in Canada or internationally, and no research (including clinical trials) with these substances is currently being conducted in Canada. The use of these substances as reference standards in analytical chemistry, including by Health Canada’s Drug Analysis Service, is one legitimate use of these substances that can continue provided the persons conducting those activities first obtain appropriate authorizations from Health Canada (e.g. a licence, licence amendment, or exemption) once these substances have been scheduled.

2-Methyl-AP-237 has been detected in Canada

2-Methyl-AP-237 has been detected at the Canadian border and in samples seized by Canadian law enforcement. The packages of 2-methyl-AP-237 intercepted by the CBSA were mis-declared, suggesting that their intended end-use may be illegal. Health Canada’s Drug Analysis Service has detected 2-methyl-AP-237 in samples seized by law enforcement. This substance has also been seized internationally.

Analogues and derivatives of 4-piperidone and its salts (emerging fentanyl precursors)

Fentanyl and fentanyl analogues are highly potent synthetic opioids that are controlled in Canada under Schedule I of the CDSA. Class A precursors are chemicals that are essential to the production of a controlled substance. While some precursor chemicals have legitimate uses, they can also be used in the illegal production of controlled substances, like fentanyl and fentanyl analogues. In Canada, precursors are controlled under Schedule VI of the CDSA and subject to the Precursor Control Regulations (PCR).

One precursor known to be used in the illegal production of fentanyl and fentanyl analogues is 4-piperidone. 4-Piperidone is used in the initial stages of illegal fentanyl production to create other precursors, which are in turn used to synthesize fentanyl. 4-Piperidone and its salts are currently controlled as Class A precursors (essential chemical compounds) under Schedule VI of the CDSA and regulated under the PCR.

A scientific assessment by Health Canada found that derivatives or analogues of 4-piperidone can also be used to produce fentanyl and fentanyl analogues. The available evidence suggests that these substances have few known legitimate industrial, commercial, or medical uses in Canada. Current legitimate uses include research and analysis, including forensic analysis in support of law enforcement. Some of these substances may also be used in the legal manufacture of pharmaceutical drugs. Other possible uses include pharmaceutical drug discovery, medical imaging and diagnostic testing.

Certain derivatives and analogues of 4-piperidone have been detected in Canada

Three substances which are either derivatives or analogues of 4-piperidone, i.e. 1-boc-4-piperidone, 1-benzyl-4-piperidone, and 3-methyl-4-piperidone, are of particular concern. These three substances have all either been intercepted by the CBSA at the border for suspected use in illegal fentanyl production or found in samples seized from illegal drug laboratories by law enforcement. Additionally, there is evidence that other derivatives and analogues of 4-piperidone can be used to produce fentanyl and fentanyl analogues. However, data about the extent to which these substances are being used to illegally produce fentanyl in Canada is not currently available.

Legislative framework for controlled substances

The CDSA is the federal statute that provides a framework for the control of substances that can alter mental processes and may produce harm to health or society when diverted to an illegal market or misused. Unless otherwise authorized by regulations or exempted in accordance with section 56, the trafficking, possession for the purposes of trafficking, import, export, and production of all controlled substances and possession of controlled substances listed in Schedules I through III are prohibited. The CDSA specifies the offences and penalties associated with prohibited activities with controlled substances (substances listed in Schedule I to V of the CDSA) and precursors (Schedule VI). The CDSA also authorizes the Governor in Council to make regulations as required and to amend the Schedule to the CDSA by order.

Made under the CDSA, the Narcotic Control Regulations (NCR) set out a framework within which legitimate activities with narcotics are regulated. The term “narcotic” refers to any substance set out in the schedule to the NCR. The NCR describe the requirements that apply to persons (including organizations), pharmacists, practitioners, and hospitals conducting regulated activities with narcotics, including possession, sale, distribution, importation/exportation, and production. To engage in these activities with narcotics, persons other than pharmacists, practitioners and hospitals must first obtain appropriate authorizations from Health Canada. This means they need a licence (i.e. dealer’s licence) and, for importation and exportation activities, a permit. The NCR also sets out requirements related to the storage, security, and record-keeping of narcotics. Researchers conducting research with narcotics must obtain a subsection 56(1) exemption from Health Canada.

Made under the CDSA, the Precursor Control Regulations (PCR) provide a framework for the regulation of certain legitimate activities with precursors. Class A precursors are chemicals that are essential to the production of a controlled substance. While some precursor chemicals have legitimate uses, they can also be used in the illegal production of controlled substances, like fentanyl and fentanyl analogues. In Canada, precursors are controlled under Schedule VI of the CDSA and subject to the PCR. For Class A precursors, which include substances that can be used to illegally produce fentanyl, a person requires authorization from Health Canada (i.e. a Class A precursor dealer’s licence and/or import permit) to produce, package, sell, provide, import, export, and possess for the purpose of such regulated activities with the precursor. The Schedule to the PCR also includes specified thresholds, in absolute quantities or package size, for each Class A precursor. Any licensed dealer who conducts certain regulated activities (e.g. to sell, send, transport or deliver) with amounts of the Class A precursor above the listed threshold must also comply with certain record-keeping provisions.

It should be noted that neither the PCR nor the CDSA prohibits possession of a precursor (other than possession for the purposes of trafficking), including a Class A precursor. As a result, any person who procures a Class A precursor as an “end user” (i.e. a person who purchases a Class A precursor from a licensed dealer and signs an “end-use declaration”) can possess, transport, send and deliver a Class A precursor without additional authorization. For example, research activities with Class A precursors typically fall within the scope of permitted end-user activities (e.g. possession); as a result, researchers rarely need to seek additional authorization from Health Canada to be able to use such substances.

Canada’s approach to scheduling controlled substances and precursors

In Canada and internationally, there are a variety of approaches that have been taken to scheduling controlled substances and precursors. These include individual substance listings, class listings, and expanding existing listings to include related substances. Class listings and the expansion of existing listings to include related substances are strategies that are used to cast a wider net to try to stay ahead of illegal drug producers.

Objective

The objective of the Order Amending Schedules I and VI to the Controlled Drugs and Substances Act (Synthetic Opioids and Emerging Fentanyl Precursors), the Regulations Amending the Precursor Control Regulations (Emerging Fentanyl Precursors) and the Regulations Amending the Narcotic Control Regulations (Synthetic Opioids) [the amendments] is to protect public health and public safety by strictly controlling activities with these substances, thereby minimizing the risk that they will be diverted to the illegal market. Controlling 2-methyl-AP-237 and related substances as controlled substances and the derivatives and analogues of 4-piperidone as precursors under the CDSA will allow law and border enforcement to act against any illegal importation, production, distribution and sale of these substances in Canada. This action will assist in addressing the production and supply of toxic illegal drugs, particularly synthetic opioids like fentanyl, that are contributing to substance use harms and to the overdose crisis.

Description

2-Methyl-AP-237 and related substances (synthetic opioids)

Schedule I of the CDSA is amended by adding, as item 28, AP-237 and its salts, derivatives and analogues, and salts of derivatives and analogues. The Schedule to the NCR is also amended by adding, as item 20, AP-237 and its salts, derivatives and analogues, and salts of derivatives and analogues.

For both Schedule I of the CDSA and the Schedule to the NCR, the amended listing is as follows:

AP-237 (1-(4-cinnamylpiperazin-1-yl)butan-1-one), its salts, derivatives and analogues and salts of derivatives and analogues, including:

Analogues and derivatives of 4-piperidone (emerging fentanyl precursors)

Schedule VI to the CDSA is amended by expanding, in item 27, the existing listing of 4-piperidone and its salts to include its derivatives and analogues. Item 28 on the Schedule to the PCR is also amended.

The amended listing for 4-piperidone and its salts in Schedule VI to the CDSA and the Schedule to the PCR is as follows:

4-piperidone (piperidin-4-one), and its salts, derivatives, analogues and salts of derivatives and analogues, including

The listing is also amended to include the International Union of Pure and Applied Chemistry (IUPAC) name of 4-piperidone and its derivatives and analogues. The IUPAC naming system provides an international standard of nomenclature for chemical compounds. This addition will increase transparency by better ensuring accurate interpretation of the listing and standardization with international chemical naming guidelines.

The maximum quantity threshold (Column 2 to the Schedule to the PCR) for these precursors remains at “0.”

Regulatory development

Consultation

Notices of Intent were published to seek input from interested parties about the proposed scheduling of 2-methyl-AP-237 and related substances and the expanded listing for 4-piperidone and its salts. These consultations took place in the summer/fall of 2023 and were open for comment for 30 days. Targeted emails were sent to key stakeholders who may be impacted by these amendments, including licensed dealers, law enforcement, and federal forensic laboratories (i.e. Health Canada’s Drug Analysis Service and the CBSA’s laboratories).

The Notice of Intent for the proposal to schedule 2-methyl-AP-237 and related substances only received one comment. The comment was provided by a health care practitioner who was supportive of the proposed scheduling as part of Canada’s continuing efforts to address the opioid overdose crisis.

The Notice of Intent for the proposal to expand the listing for 4-piperidone and its salts received four comments. One comment was received from an association of pharmacists and was supportive of the proposed scheduling. One comment was out of scope, from an individual concerned about the criminalization of people who use drugs and requesting changes to the laws allowing animal testing. The third comment was from a drug policy organization advocating for alternative approaches to the prohibition of controlled substances (including legal access to all controlled substances), explaining that the scheduling of substances does not stop people from using them, creates incentives for illegal drug producers to develop more harmful substances, and increases challenges and costs for law enforcement.

The final comment was provided by a licensed dealer stating that while they supported adding 1-boc-4-piperidone, 3-methyl-4-piperidone and 1-benzyl-4-piperidone to the schedule, they had concerns about expanding the listing to capture all derivatives and analogues and their salts. The commenter explained that their company currently uses isotopes of these substances in chemical analytical testing, and raised the possibility that these substances may be used for other legitimate purposes, particularly in pharmaceutical drug discovery.

After receiving this response, Health Canada conducted an additional targeted consultation with registered and licensed dealers, as well as drug establishment licence holders, on the proposal to expand the listing for 4-piperidone and its salts to seek feedback about possible impacts on pharmaceutical drug development. Feedback received from the additional consultation indicated that most stakeholders will be unaffected by scheduling, although a few stakeholders stated they will need to either amend or apply for a Class A precursor licence. Only one organization was not supportive of the scheduling amendment, stating that because their company uses some of these substances for analytical testing, they are concerned that controlling these derivatives may have significant negative impacts on pharmaceutical research and drug discovery in Canada.

Based on feedback received from both sets of consultations, Health Canada has determined that very few industry organizations will be affected by scheduling these substances. Additionally, while some of the derivatives and analogues of 4-piperidone and its salts may be used in legitimate pharmaceutical manufacturing, research or drug discovery in Canada, all the responses received from members of these industries indicated that they will either be unaffected by the scheduling, or that the effects will be relatively minor. This is because scheduling these substances does not prevent them from being used for legitimate purposes; an organization wanting to use these substances for legitimate purposes can apply to Health Canada to amend an existing Class A precursor licence or apply for a new Class A precursor Licence (this is the case for any organization wanting to conduct controlled activities with any Class A precursor).

The impacts of the amendments on people who use drugs and legitimate industry were given serious consideration. It is acknowledged that these amendments will have a minimal impact on industry, but given that these amendments are designed to strictly control the use of these substances in order to protect public health and public safety by minimizing the risk that they will be diverted to the illegal market, it is in the public interest to schedule these substances.

Modern treaty obligations and Indigenous engagement and consultation

As required by the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, an assessment of modern treaty implications was conducted on the amendments. The assessment did not identify any modern treaty implications or obligations.

Instrument choice

Scheduling these synthetic opioids and emerging fentanyl precursors provides law enforcement with the authority to take action in relation to activities that contravene the CDSA for these substances. Without these amendments, law enforcement would not have the tools needed to take action to halt the importation, distribution, and use of these potentially harmful substances. In addition, these amendments are the means by which Canada complies with its international obligation under the 1961 Single Convention to schedule 2-methyl-AP-237 and the 1988 Convention to schedule 1-boc-4-piperidone. As a result, controlling these substances under the CDSA was the most appropriate option.

Regulatory analysis

Benefits and costs

Benefits

Scheduling these synthetic opioids and emerging fentanyl precursors under the CDSA helps protect public health and public safety by restricting their importation, production, and distribution in Canada. Controlling these substances strengthens oversight of legitimate activities conducted with these substances; it also facilitates their detection in illegal activities and the taking of enforcement actions. Further, controlling 2-methyl-AP-237 and 1-boc-4 piperidone under the CDSA also allows Canada to meet its international obligations under the 1961 Single Convention and the 1988 Convention.

Given that fentanyl and fentanyl analogues continue to be major drivers of the opioid overdose crisis, any action to disrupt sources of illegal production of fentanyl and fentanyl analogues also assists with the Government of Canada’s comprehensive approach to addressing substance use-related harms and the overdose crisis. Scheduling these substances under the CDSA demonstrates Canada’s commitment to addressing the illegal production and trafficking of fentanyl.

Costs
Costs to industry

Costs associated with scheduling the derivatives and analogues of 4-piperidone

With the scheduling of the derivatives and analogues of 4-piperidone, the administrative and compliance requirements under the PCR would apply to activities involving these substances. Based on feedback received through the Notice of Intent and targeted stakeholder engagement, it is assumed that three companies will need to apply for a licence under the PCR and five existing licensed dealers under the PCR will need to amend their licences in order to continue their activities with these substances.

The responsible person in charge (RPIC) from the five existing licensed dealers will spend 30 minutes each on preparing an application for licence amendment. Similarly, the RPIC from each of the three companies that will be required to apply for a new license under the PCR will spend eight hours on preparing an application for a Class A precursor licence (upfront) and one hour every three years on preparing an application to renew their licences. In addition, responsible personnel (three RPIC and one senior person in charge [SPIC]) at each of the three businesses will spend eight hours and pay a $70 fee (per person) to apply for a criminal record check as part of the process of applying for a new licence or to renew their licences. Further, the RPIC from the three companies will spend an additional eight hours on record-keeping activities and submission of annual reports to Health Canada.

All eight companies will need to apply for permits should they need to import or export these substances. It is assumed that these companies would submit 16 permits per year, on average, and 30 minutes will be spent by the RPIC on submitting one permit application.

Completing the various activities mentioned above would result in compliance and administrative burden to these businesses. Using the hourly wage of $34.40 for RPIC and an average hourly wage of $40.68 for the responsible personnel (adjusted for overhead and in 2022 dollars), respectively, the total incremental cost to businesses is estimated to amount to $13,911 in present value (PV) or $1,981 in annualized value.

Costs associated with scheduling the synthetic opioids

There are currently no known medical, commercial, or industrial uses of these synthetic opioids in Canada. While AP-237 is approved for use as an analgesic (i.e. for pain relief) in China, there are no other known legitimate uses of these synthetic opioids in other international jurisdictions. Consequently, the likelihood of these synthetic opioids being imported into Canada for legitimate activities, other than for research or forensic analysis, is extremely low. However, in the unlikely event that a business decides to conduct activities with substances related to AP-237 in the future, the business would need to meet the requirements (i.e. apply for a new licence or amend their licence, apply for import and/or export permits and meet reporting and record-keeping requirements) under the NCR and incur any associated costs. While the potential for these costs to be incurred is acknowledged, they are not being estimated given the very low likelihood of activities with the newly scheduled synthetic opioids taking place in the foreseeable future.

Costs to researchers

Currently, results from stakeholder consultations and other available information do not indicate any research being done with these substances in Canada, including through clinical trials.

With respect to the synthetic opioids being scheduled, should a researcher wish to conduct research with any of them in the future, they would need to apply for a subsection 56(1) exemption under the CDSA. This is the case for any researcher wishing to conduct research with any narcotic. While Health Canada does not expect to receive any requests in the foreseeable future, should a researcher decide to apply for an exemption, they would need to spend time to prepare and submit an application.

Regarding the derivatives and analogues of 4-piperidone, if a researcher wishes to conduct activities with these precursors, they would incur small costs to comply with the applicable regulatory requirements. To purchase these precursors from a licensed dealer, a researcher would need to submit a signed end-use declaration to the licensed dealer. In addition, a researcher may incur costs to apply for an authorization from Health Canada in the event they want to produce a controlled substance as part of research involving these precursors.

The effort to prepare and submit these documents is very low; thus, any potential costs to researchers are expected to be very limited, if any.

Costs to government

The small number of federal government organizations that possess a dealer’s licence under the NCR and/or the PCR may incur costs associated with submitting requests to amend their dealer’s licences and/or apply for an import permit to import reference standards containing these substances. The overall cost to these affected entities is expected to be limited.

Additional but small costs will also be incurred by Health Canada for processing licence applications, licence amendments, import permits for importation, and subsection 56(1) exemptions.

Minimal incremental costs related to implementation and compliance and enforcement activities will be incurred by Health Canada and federal government partners. They include updating guidance documents, preparing compliance promotion materials, and responding to stakeholders’ enquiries. These costs are expected to be minimal.

Small business lens

Analysis under the small business lens concluded that the regulations will impact small businesses as four of the companies that are conducting activities with the derivatives and analogues of 4-piperidone are small businesses. Three of the four impacted small businesses are existing PCR licensed dealers and will need to amend their licences and the fourth will need to apply for a new licence, renew its licence every three years, including applying for a criminal record check, and start to conduct record-keeping activities as well as submitting annual reports to Health Canada. All four companies will need to apply for permits should they need to import or export the derivatives and analogues of 4-piperidone. The total costs to small businesses for meeting the requirements under the PCR are estimated to be $4,497 (PV) or $640 annually. Cost per small business is estimated at $1,124 (PV) over ten years or $160 annually. Scheduling the derivatives and analogues of 4-piperidone will subject these substances to all the requirements set out in the PCR, including requiring companies to be licensed and to submit an annual report. These activities are essential to the effective administration of the PCR. Considering the relatively low cost imposed on business, providing additional flexibility to small businesses was not considered necessary.

Small business lens summary
Compliance costs
Activity Annualized value Present value
Payment of fees to obtain criminal record checks $113 $792
Total compliance cost $113 $792
Administrative costs
Activity Annualized value Present value
Applying for new licences $37 $257
Renewing licences $9 $65
Applying for a criminal record checks $131 $921
Keeping records and preparing and submitting annual reports $275 $1,932
Amending licences $7 $48
Applying for import/export permits $69 $483
Total administrative cost $528 $3,705
Total compliance and administrative costs
Totals Annualized value Present value
Total cost (all impacted small businesses) $640 $4,497
Cost per impacted small business $160 $1,124

One-for-one rule

The amendments will result in incremental administrative burden to businesses. The one-for-one rule applies and the amendments are considered an “IN” under the rule.

In order to conduct activities with the derivatives and analogues of 4-piperidone, each of the three businesses that will need to become licensed under the PCR will spend

All these activities will be completed by the RPIC.

In addition, responsible personnel (RPIC and SPIC) at each of these businesses will spend eight hours to apply for a criminal record check as part of the process for applying for a new licence or to renew their licence.

The other five companies will incur one-time costs associated with 30 minutes spent by the RPIC applying for amendments to their licence under the PCR to include activities with the derivatives and analogues of 4-piperidone.

The RPIC from all eight companies will spend 30 minutes on preparing a permit application in order to import or export the substances. It is estimated that 16 import or export permit applications will be submitted each year.

The time spent on these activities by the relevant personnel is valued using the hourly wage rate of $27.70 (RPIC) and average hourly wage rate of $32.70 (responsible personnel) [adjusted for overhead and in 2012 dollars, as per the Red Tape Reduction Regulations], respectively.

As per the requirements of the Red Tape Reduction Act and the Red Tape Reduction Regulations, the administrative burden costs on all affected businesses are estimated over a 10-year period and discounted to 2012 using a 7% discount rate. The present value of the total incremental administrative burden cost to all affected businesses is estimated to be $4,094 or $583 in annualized value. The annualized incremental cost to each affected business is estimated to be about $72.90.

Regulatory cooperation and alignment

In March 2023, the UN Commission on Narcotic Drugs voted in favour of scheduling the novel synthetic opioid 2-methyl-AP-237 under Schedule I of the 1961 Single Convention and, in March 2024, voted in favour of scheduling 4-piperidone and 1-boc-4-piperidone under Table I of the 1988 Convention. As a signatory to these conventions, Canada is obligated to take measures to control these substances domestically. In addition to scheduling these chemicals, the decision was made to also schedule all chemically related substances when listing substances in the schedules to the CDSA. This proactive approach has historically been a highly effective strategy for Canada, particularly in instances like this where those substances have no known or limited legitimate medical, commercial, or industrial uses.

In May 2023, the United States finalized its control of 4-piperidone and related substances, such as 1-boc-4-piperidone.

Scheduling these substances is also in line with Canada’s commitment to strengthen the coordinated global response to the international public health and public safety challenges posed by synthetic drugs, as outlined in the Ministerial Declaration on Accelerating and Strengthening the Global Response to Synthetic Drugs.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan was conducted which concluded that there will be no expected important environmental effects, positive or negative. As such, a strategic environmental assessment was not required.

Gender-based analysis plus

Canada continues to face an unprecedented opioid overdose crisis affecting individuals of all walks of life, including across sex/gender, geography or socioeconomic status. Opioid-related harms are distributed unevenly among subgroups of affected Canadians based on sex/gender or other factors. For example,

Actions to prevent the introduction of any new substances into the illegal drug supply and to disrupt the illegal importation of fentanyl precursor chemicals into Canada are expected to benefit groups affected by the overdose crisis. These benefits are expected to be experienced by all potentially impacted groups or subgroups. Although there are sex/gender differences in adverse health outcomes associated with the consumption of opioids, there is no evidence indicating that the amendments will result in any potential for disproportionate impacts to any affected groups or subgroups based on sex/gender, socioeconomic, or any other such characteristics.

Implementation, compliance and enforcement, and service standards

Implementation

The amendments in respect of 2-methyl-AP-237 come into force upon publication in the Canada Gazette, Part II.

The amendments expanding the listing for 4-piperidone and its salts will come into force three months (90 days) after publication in the Canada Gazette, Part II. This delay in coming into force will provide sufficient time for affected stakeholders to apply for a Class A precursor licence, a licence amendment, or an authorization or exemption, as required. Any requests for new or amended precursor licences to add these substances will be prioritized by Health Canada staff to ensure that any impacts on legitimate industry are minimized. Health Canada will also notify stakeholders, including licensed dealers, federal and other law enforcement partners, and federal laboratories of the changes. Health Canada will also reply to stakeholder inquiries as needed.

Compliance and enforcement

Health Canada is responsible for authorizing (through licences, permits, and exemptions) legitimate activities with substances scheduled under the CDSA and its regulations and for monitoring compliance with regulatory requirements.

The CBSA supports compliance monitoring for controlled substances and precursors at the border. Federal, provincial and local law enforcement are responsible for taking enforcement action in response to contraventions of the CDSA and its regulations. Under the CDSA, a range of penalties apply to the offences associated with the substances covered by these amendments. The maximum penalty for indictable offences with respect to substances listed in Schedule VI to the CDSA is imprisonment for a term not exceeding 10 years and life imprisonment for certain offences with respect to substances listed in Schedule I of the CDSA.

Service standards

No additional service standards are being created. Service standards already exist for issuing licences and permits under the CDSA.

Contact

Office of Legislative and Regulatory Affairs
Controlled Substances and Overdose Response Directorate
Health Canada
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca.