Consultation - Regulatory Amendments Regarding Barbituric Acid, Naloxegol, Methylnaltrexone, Catha edulis Forsk, Cathine and Cathinone and the Salts of Nalmefene, Naloxone and Naltrexone

Notice to the reader:

The Order and Regulations with respect to the above substances have been finalized and published in Canada Gazette, Part II on February 22, 2017. Please, go to the Canada Gazette ( Order) and ( Regulations) for further details.

The purpose of this Notice of Consultation is to provide an opportunity to comment on proposed regulatory changes to facilitate legitimate access to certain substances.

Health Canada has determined that several substances that do not pose risks to public health and safety are captured under the schedules to the Controlled Drugs and Substances Act (CDSA). They are: barbituric acid, naloxegol and its salts, methylnaltrexone and its salts as well as the salts of nalmefene, naloxone and naltrexone. Heath Canada is proposing amendments to the schedules of the CDSA and its regulations to exclude these substances from the application of the Act.

In addition, certain substances scheduled under the Act (Catha edulis Forsk, cathine and cathinone) are not listed under any of its regulations.  Health Canada is proposing to make amendments to Part J of the Food and Drug Regulations (FDR) to include these substances in its Schedule. Substances scheduled under Part J to the FDR are defined as “restricted drugs” and can only be used for scientific and research purposes and in the manufacture of test kits.

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 May 23, 2015, initiating a 30-day comment period ending on June 21, 2015.

Consult 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:

Regulatory Policy Division,
Controlled Substances and Tobacco Directorate,
Healthy Environments and Consumer Safety Branch,
Health Canada,
Address Locator: 0302A, 150 Tunney’s Pasture Driveway,
Ottawa, Ontario, K1A 0K9.

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