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

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 methylphenidate and its salts to include its isomers, derivatives and analogues, as well as salts of the derivatives, isomers and analogues. In addition, these substances will be added to the Schedule to Part J of the Food and Drug Regulations (FDR).

Methylphenidate is a stimulant currently listed with its salts in Schedule III to the CDSA. Activities with methylphenidate and its salts are authorized under Part G to the FDR, where they are scheduled as controlled drugs.

In recent years, there has been a significant increase in the emergence of new psychoactive substances which mimic the effects of controlled substances, but which are created to circumvent existing drug legislation. Several substances related to methylphenidate have been identified as new psychoactive substances with similar effects to methylphenidate, but with no approved therapeutic uses. As the derivatives, isomers and analogues of methylphenidate (as well as salts of derivatives, isomers and analogues) have no approved therapeutic uses, Health Canada is proposing to list them under Part J to the FDR. Research or scientific use of these substances can be authorized under Part J of the FDR.

Health Canada is seeking input to determine whether expanding the scope of the scheduling entry for methylphenidate and its salts is warranted.

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 February 27, 2016, initiating a 30-day comment period ending on March 28, 2016.

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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