Destruction of controlled substances by licensed dealers (CSP-GUI-020): Overview

On this page

• Foreword
• Scope
• Purpose

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 staff, so that the laws and regulations are 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 Health Canada to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

Scope

This guidance document applies to licensed dealers who destroy controlled substances listed under the Controlled Drugs and Substances Act (the Act) and the Controlled Substances Regulations (CSR).

It covers the destruction of:

• Unserviceable stock: controlled substances that are unused, expired and/or can no longer be dispensed; and
• Post-consumer returns: finished products containing a controlled substance that have been returned by an individual for the purpose of destruction to a pharmacist, pharmacy technician, practitioner, hospital, or particular person.

A controlled substance can change someone’s mental state and may cause harm to personal and public health when misused or diverted to the illegal market. Controlled substances include:

• Narcotics, such as morphine, oxycodone, and fentanyl, listed in Schedule 1 of the CSR;
• Controlled drugs, such as testosterone and amphetamine, listed in Schedule 2 of the CSR;
• Targeted substances, such as clonazepam and lorazepam, listed in Schedule 3 of the CSR;
• Restricted drugs, such as lysergic acid diethylamide and psilocybin (found in magic mushrooms), which are not approved in Canada, but may be used for specific authorized purposes such as clinical testing and research, listed in Schedule 4 of the CSR.

This guidance document does not apply to the destruction of controlled substances subject to voluntary forfeiture.

Purpose

The destruction of controlled substances is an important control measure for preventing diversion and protecting public health and safety. Controlled substances must be destroyed to such an extent that consumption is rendered impossible or improbable. To ensure that destructions are conducted securely and in compliance with regulatory requirements, you must obtain authorization from Health Canada prior to destroying controlled substances held as unserviceable stock and products received as post-consumer returns.

This guidance explains the requirements for the destruction of controlled substances and post-consumer returns under the Act and CSR. It also outlines Health Canada's expectations regarding:

• obtaining authorization to destroy controlled substances;
• destruction methods and procedures;
• witness requirements; and
• record-keeping requirements.