Consultation on the regulatory proposal to control U-47700
From Health Canada
Current status: The public consultation is now closed. Thank you for your interest.
You are invited to provide comments on the proposal to control U-47700 under the Controlled Drugs and Substances Act (CDSA)and Part J of the Food and Drug Regulations (FDR).
Why
U-47700 is a synthetic opioid. It has never been developed for use as a medicine. In Canada and around the world, U-47700 is being misused as a recreational drug. In Canada, from April to June 2016, 3 non-fatal overdoses were associated with U-47700.
The CDSA lists controlled substances that:
- can alter mental processes
- may cause harm to the health of an individual or to society when misused
We are proposing to control U-47700 under the CDSA and Part J of the FDR because U-47700:
- is being used recreationally in Canada and internationally, and has been linked to over 40 overdoses, which have been both fatal and non-fatal
- appears to be used by illicit drug manufacturers in counterfeit prescription medications to replace opioids and other illegal drug mixtures, such as:
- heroin
- cocaine
- fentanyl
- oxycodone
- is controlled internationally under the United Nations Single Convention on Narcotic Drugs, 1961. As a signatory to this convention, Canada has an obligation to control U-47700
Controlling this substance under the CDSA would limit its availability and exposure. Only authorized people under the CDSA and Part J of the FDR will be able to possess, produce, package, import, export, sell, provide, transport, send, or deliver U-47700.
Health Canada is also considering controlling substances that are structurally related to and have similar pharmacology to U-47700. This would include the salts, isomers, derivatives and analogues of U-47700, as well as the salts of these substances, including:
- bromadoline
- U-47109
- U-48520
- U-50211
- U-77891
Health Canada is also considering controlling N1,N1,N2-trimethylcyclohexane-1,2-diamine and its salts, which is used to create U-47700. N1,N1,N2-trimethylcyclohexane-1,2-diamine and its salts, would be regulated under the Precursor Control Regulations (PCR). Under the PCR, a licensing and permits framework can allow people to conduct certain activities with precursors.
Who
Comments from all interested persons and organizations are welcome.
What
The purpose of this consultation is to ask for comments on our intent to control U-47700 under the CDSA and Part J of the FDR.
When and where
Between June 3 and July 3, 2017, we will be engaging with Canadians and stakeholders regarding the above, proposed changes.
A Notice to Interested Parties, providing more details on the proposal, is available at the Canada Gazette.
How to participate
You are encouraged to read the Notice to Interested Parties.
Send us your comments by:
- mail to the address listed below in the “Contact us” section
Related information
- Controlled Substances and Precursor Chemicals
- Controlled Drugs and Substances Act
- Part J of the Food and Drug Regulations
Contact us
Office of Legislative and Regulatory Affairs, Controlled Substances Directorate, Healthy Environments and Consumer Safety Branch, Health Canada
150 Tunney’s Pasture Driveway, Main Stats Building, Address Locator: 0301A
Ottawa ON K1A 0K9
Email: ocs_regulatorypolicy-bsc_politiquereglementaire@hc-sc-gc.ca