Consultation - Proposed Order Amending Schedule III to the Controlled Drugs and Substances Act and Regulations Amending Part G to the Food and Drug Regulations with Respect to Aminorex

Notice to the reader: The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered. Thank you for your input.

The purpose of this Notice of Consultation is to provide an opportunity to comment on Health Canada’s proposal to amend Schedule III to the Controlled Drugs and Substances Act (CDSA) in order to expand the scope of the scheduling entry for aminorex and its salts to include its derivatives, isomers and analogues, as well as salts of the derivatives, isomers and analogues. In addition, these substances will be added to the Schedule to Part G to the Food and Drug Regulations (FDR).

Aminorex and its salts are currently controlled under Schedule III to the CDSA and Part G to the FDR. The derivatives, isomers and analogues of aminorex (as well as salts of derivatives, isomers and analogues) currently have no approved therapeutic uses in Canada. However, Health Canada is proposing to also list them under Part G to the FDR, which would facilitate legitimate use in the future, should therapeutic uses emerge.

In recent years there has been a significant increase in new psychoactive substances which mimic the effects of controlled substances, but which are created to circumvent existing drug legislation. This expansion of the listing of aminorex and its salts would capture 4,4’-DMAR, an analogue of aminorex, which was added to Schedule II to the Convention on Psychotropic Substances (1971) at the 59th Commission on Narcotic Drugs in Vienna, Austria in March 2016. These amendments will ensure Canada meets its international obligations.

Health Canada is seeking input on this proposal to expand the scope of the scheduling entry for aminorex and its salts.

How to Get Involved

Proposed amendments are outlined in a Notice to Interested Parties (NTIP). The NTIP was published in the Canada Gazette, Part I, on December 24, 2016, initiating a 30-day comment period ending on January 23, 2017.

Go to the Canada Gazette for further details.

If you are interested in this process or have comments on the proposed changes, please contact:

By mail at:

Legislative and Regulatory Affairs,
Controlled Substances Directorate,
Healthy Environments and Consumer Safety Branch,
Health Canada,
Address Locator: 0302A
Ottawa, Ontario, K1A 0K9.

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