Guidance on controlled substances for community pharmacists and pharmacy technicians (CS-GD-022): Overview
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Foreword
Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing laws and regulations. Guidance documents also assist Health Canada officials, so that the legislation is administered in a manner that is fair, consistent, and effective. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
Any questions of interpretation concerning this guidance document should be directed to the National Compliance Section within the Office of Controlled Substances at compliance-conformite@hc-sc.gc.ca.
Preface
The Controlled Substances Regulations (CSR), made under the Controlled Drugs and Substances Act (the Act), set out authorizations and outline various regulatory requirements for pharmacists and pharmacy technicians handling controlled substances.
The CSR covers the following categories of controlled substances:
- Narcotics
- Controlled drugs
- Targeted substances
- Restricted drugs
For the purpose of this guidance document, the term “controlled substance” refers to narcotics, controlled drugs, and targeted substances set out in schedules 1, 2, and 3 of the CSR. Pharmacists and pharmacy technicians are generally not authorized to conduct activities with restricted drugs, which is the one category of controlled substances that do not have authorized medical uses.
This document provides guidance and recommendations to pharmacists and pharmacy technicians working in community pharmacies on how they can meet regulatory requirements for controlled substances. Pharmacists and pharmacy technicians working in a hospital or other healthcare settings are outside the scope of this guidance document.
The words "must" and "should" are used throughout the document. The word "must" represents a regulatory requirement, while the word "should" represents a recommendation on how to meet a regulatory requirement. There may be more than one way to meet a regulatory requirement.
Important: Provincial or territorial regulatory requirements may be stricter than what is outlined in this document. It is the responsibility of pharmacy professionals to consult with the relevant provincial or territorial professional regulatory authority for further guidance.
How to use this document
Each section of this document describes an activity that pharmacists or pharmacy technicians are authorized to conduct under the CSR, and the regulatory requirements associated with that activity.
The document uses text boxes marked ‘Important’ to highlight a key piece of information that you should know. Use it as a way for you to best comply with the CSR.
Important: Key or cautionary information to know.
Guidance documents are administrative tools that do not have the force of law. Should any information in this guidance document conflict with the legislation (the Act or the regulations), the legislation prevails.