Regulatory Initiative: Amendments to Schedule I to the Controlled Drugs and Substances Act, and the Schedule to the Narcotic Control Regulations to Include Tapentadol - Forward Regulatory Plan 2012-2014

Title or working title of the regulatory initiative: Amendments to Schedule I to the Controlled Drugs and Substances Act, and the Schedule to the Narcotic Control Regulations to Include Tapentadol

Description of the objective:
Tapentadol is a novel opioid analgesic marketed internationally under the trade name of NUCYNTA^®.  While opioids are safe and effective in some patients, they can lead to dependence, abuse and/or addiction in others.  Tapentadol may be abused by chewing, snorting, or injection, potentially resulting in overdose and death.  Scheduling tapentadol under the Controlled Drugs and Substances Act and regulating it under the Narcotic Control Regulations (NCR) will provide patients with access to this analgesic while introducing control mechanisms (i.e., record-keeping, reporting and security requirements), that would reduce the potential risk of diversion and/or abuse.

The Regulation will only come into force 120 days following publication in Canada Gazette, Part II.  Health Canada will, however, begin to accept applications for licence amendments under the NCR immediately following registration of this regulatory amendment.

Enabling Act:
Controlled Drugs and Substances Act

Indication of business impacts:
There may be business impacts.  The "One-for-One" Rule and/or the Small Business Lens may apply.

Public consultation opportunities:

On February 26, 2011, a  Notice to Interested Parties was published in the Canada Gazette, Part I.  A copy of the notice can be viewed online.

Departmental contact:

Johanne Beaulieu
Director
Office of Controlled Substances
Controlled Substances and Tobacco Directorate
Health Environments and Consumer Safety Branch
Health Canada

Telephone number: 613-952-2177

Email address: OCS_regulatorypolicy-BSC_politiquereglementaire@hc-sc.gc.ca

For More Information

•  Government-Wide Forward Regulatory Plans
• The  Cabinet Directive on Regulatory Management
• The  Red Tape Reduction Action Plan
• The  Canada-United States Regulatory Cooperation Council

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the  Canada Gazette and  Consulting with Canadians websites.