Consultation - Regulatory amendments, the salts of apomorphine, cyprenorphine, narcotine, papaverine, carbamethidine, oxpheneridine, ethoheptazine, metethoheptazine, metheptazine, dextromethorphan, dextrorphan, levallorphan, levargorphan, cyclazocine
Notice to the reader:
The Order and Regulations with respect to the above regulatory amendments have been finalized. They were published in Canada Gazette, Part II on February 22, 2017. 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 amendments to exclude the salts of the above 14 substances from the Controlled Drugs and Substances Act (CDSA) and its regulations.
The salts of these 14 substances are not captured within the current exclusions which explicitly capture only the parent substance. Under this regulatory proposal, the scope of the exclusions for these 14 substances would be extended to include their salts.
The salts of these substances are used for a wide variety of purposes and do not pose a threat to public health or public safety. For many of these substances, the salt form is the most commonly commercially available form of the substance. Salt forms can often have improved chemical and physical stability (e.g. for storage and transport), and can be easier to process (e.g. forming a salt can turn a sticky oil into a free flowing powder) and so they are used in lieu of the parent substance. The salts of these substances are contained within a variety of products currently sold in Canada (e.g. cough syrups commonly contain the salt of dextromethorphan).
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 July 25, 2015, initiating a 30-day comment period ending on August 23, 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,
Ottawa, Ontario, K1A 0K9.
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