Canada Gazette, Part I, Volume 157, Number 34: GOVERNMENT NOTICES
August 26, 2023
DEPARTMENT OF HEALTH
CONTROLLED DRUGS AND SUBSTANCES ACT
Notice of intent to control 2-methyl-AP-237 and related substances under the Controlled Drugs and Substances Act
This notice provides interested parties with the opportunity to comment on Health Canada’s proposal to add 2-methyl-AP-237 and related substances to Schedule I to the Controlled Drugs and Substances Act (CDSA) and to the Schedule to the Narcotic Control Regulations (NCR).
In October 2022, the World Health Organization Expert Committee on Drug Dependence (WHO ECDD) released a Critical review report (PDF) for 2-methyl-AP-237. In March 2023, based on the recommendation of the WHO ECDD, the United Nations Commission on Narcotic Drugs voted in favour of controlling 2-methyl-AP-237 under Schedule I of the Single Convention on Narcotic Drugs, 1961 (1961 Convention). As a party to the UN drug control conventions, Canada is expected to take measures to ensure the control of 2-methyl-AP-237 domestically under the CDSA. The CDSA is the federal statute through which the Government of Canada fulfills its international obligations under UN drug control conventions.
In support of this proposed scheduling action, Health Canada has completed a scientific assessment of substances chemically related to 2-methyl-AP-237. 2-Methyl-AP-237 is an analogue of AP-237, also known as bucinnazine. AP-237 and its related substances, including 2-methyl-AP-237, AP-238, and para-methyl-AP-237, are all synthetic opioids. 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.
On the basis of this scientific assessment, Health Canada is proposing to move forward with a class approach to scheduling that would include AP-237 and its analogues and derivatives, including 2-methyl-AP-237, para-methyl-AP-237, and AP-238.
More specifically, it is proposed that the following new listing would be added to Schedule I to the CDSA and to the Schedule to the NCR:
AP-237 (1-(4-cinnamylpiperazin-1-yl)butan-1-one), and its salts, derivatives and analogues and salts of derivatives and analogues, including:
- (1) 2-methyl-AP-237 (1-(4-cinnamyl-2-methylpiperazin1-yl)butan-1-one)
- (2) para-methyl-AP-237 ((E)-1-(4-(3-(p-tolyl)allyl)piperazin-1-yl)butan-1-one)
- (3) AP-238 (1-(4-cinnamyl-2,6-dimethylpiperazin-1-yl)propan-1-one)
Based on the available evidence, these substances have no known legitimate industrial, commercial, or medical uses in Canada. There are limited circumstances in which they may be used, including for forensic analysis in support of law enforcement activities.
Although no human clinical studies have been conducted on 2-methyl-AP-237, para-methyl-AP-237, or AP-238, animal studies have demonstrated similar effects as observed for other opioids, such as morphine and fentanyl.
Only 2-methyl-AP-237 has been detected at the Canadian border or in samples seized by Canadian law enforcement. From 2018 to March 2023, three packages of 2-methyl-AP-237 were intercepted by the Canada Border Services Agency at the border; all were misdeclared and in bulk powder form. From 2019 to March 2023, Health Canada’s Drug Analysis Service detected 2-methyl-AP-237 in 31 samples seized by Canadian law enforcement. This substance has also been seized internationally and is currently controlled in Germany and Sweden. As noted above, it has also recently been scheduled internationally. As of March 2023, no data from Health Canada’s Drug Analysis Service or the Canada Border Services Agency was available for AP-237, para-methyl-AP-237, or AP-238.
If, as proposed, these substances are scheduled under Schedule I to the CDSA, the possession, trafficking, possession for the purposes of trafficking, importation, exportation, and production of these substances would become prohibited. An authorization from Health Canada, such as a licence or exemption, would be required to legally conduct activities with the substances in Canada.
Health Canada welcomes comments from interested parties on this scheduling proposal, including comments on whether there are any legitimate uses for these substances in Canada.
Public comment period
Any person may, within 30 days of publication of this notice, submit written comments to Health Canada on the proposal to control 2-methyl-AP-237 and related substances under the CDSA. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Office of Legislative and Regulatory Affairs, Controlled Substances Directorate, Controlled Substances and Cannabis Branch, Health Canada. Comments can be sent by email to firstname.lastname@example.org.
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
PRIVY COUNCIL OFFICE
We know that our country is stronger — and our government more effective — when decision-makers reflect Canada’s diversity. The Government of Canada has implemented an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous peoples and minority groups are properly represented in positions of leadership. We continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.
We are equally committed to providing a healthy workplace that supports one’s dignity, self-esteem and the ability to work to one’s full potential. With this in mind, all appointees will be expected to take steps to promote and maintain a healthy, respectful and harassment-free work environment.
The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.
The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council appointments website.
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