Frequently Asked Questions - Benzodiazepines and Other Targeted Substances Regulations

This document is an unofficial summary of the Regulations. It is not intended to substitute for, supersede or limit the requirements under the applicable legislation. In case of any discrepancy between this summary and the legislation, the legislation will prevail.

What is the purpose of this regulation?

The  Benzodiazepines and Other Targeted Substances Regulations (BOTSR) fall under the authority of the  Controlled Drugs and Substances Act (CDSA).  The CDSA and its regulations provide a framework for the control of substances that can alter mental processes and that may produce harm to an individual or to society when diverted to an illicit market.  Scheduling substances under the CDSA provides law enforcement agencies with the authority to take action against illicit activities with those substances.

The BOTSR outline the circumstances under which activities with substances listed in the Regulations are permitted. Examples of substances regulated under the BOTSR include benzodiazepines, zolpidem, and meprobamate.

What are the key elements of this regulation?

The BOTSR describe the circumstances and requirements in which persons (including businesses), pharmacists, practitioners and hospitals may conduct regulated activities including possession, sale, distribution, importation and exportation, and production of benzodiazepines and other targeted substances.

How does this regulation affect Canadian businesses?

Prior to engaging in an activity with substances controlled under the CDSA, persons, including businesses, may be required to submit an application to Health Canada.  Authorizations may be provided in the form of a licence and, for importation and exportation activities, a permit. There are also requirements related to storage, reporting, record-keeping, and disposal.

Compliance with the Regulations is monitored by Health Canada and authorized places such as licensed businesses and pharmacies may be subject to on-site inspections.

What is the timeline for implementation?

The BOTSR came into force under the CDSA on September 1, 2000, with the exception of certain provisions which came into force on September 1, 2001.

Where can I get more information on the Benzodiazepines and Other Targeted Substances Regulations?

Please visit the Health Canada website for additional information or contact the Office of Controlled Substances to request a licence or permit application form or to make an enquiry.

For More Information

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

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