Guidance Document for Pharmacists and Dealers Licensed to Destroy Narcotics, Controlled Drugs or Targeted Substances: Handling and Destruction of Post-consumer Returns Containing Narcotics, Controlled Drugs or Targeted Substances

Controlled Substances Directorate
Opioid Response Team

Date Adopted :
Effective Date :

Foreword

Guidance documents are meant to provide assistance to regulated parties on how to comply with governing statutes and regulations. Guidance documents also provide assistance to departmental staff involved in administering legislation, regulations and/or policies in a manner that is fair and consistent.

Guidance documents are administrative instruments that do not have the force of law and are thus not intended to substitute for, supersede or limit the requirements set out under prevailing legislation. In the case of any discrepancy between this document and the actual text of prevailing legislation, the legislative text will prevail.

It is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document in order to allow the Department to verify compliance with relevant regulations and/or adequately mitigate the risk of diversion of controlled substances to the illegal market.

Any questions of interpretation concerning this guidance document should be directed to the Compliance and Monitoring Division within the Controlled Substances Directorate (CSD) at hc.compliance-conformite.sc@canada.ca.

Table of Contents

  1. Introduction
    1.1   Context
    1.2   Objectives
    1.3   Scope and Application
  2. Roles and Responsibilities
    2.1   Pharmacists working in a retail or community pharmacy
    2.2   Licensed Dealers including those Licensed to Destroy
  3. Record Keeping
  4. Storage
  5. Procedure for Destruction
    5.1   Local Destruction of Post-Consumer Returns
    5.2   Providing to a Dealer Licensed to Destroy
  6. Loss or Theft of Post-Consumer Returns
    Annex A: Definitions

1.0 Introduction

The Controlled Drugs and Substances Act (CDSA) provides for the control of substances that can alter mental processes and that may produce harm to health and to society when diverted or misused. Except as authorized under its related regulations or via an exemption issued under section 56 of the Act, most activities involving substances regulated under the Act, e.g., possession, import, export, trafficking, possession for the purposes of trafficking, production, etc., are prohibited.

The substances regulated under the CDSA are grouped into Schedules I to VI to the Act. Schedules I to V list controlled substances, while Schedule VI lists precursor chemicals, which can be used to make controlled substances.

At the present time, there are several sets of regulations made under the CDSA that set out the circumstances under which activities with controlled substances or precursors are permitted. Four regulations are relevant to this Guidance Document:

Post-consumer returns are unused or expired drug substances or drug products that may contain a narcotic, controlled drug or targeted substance and that are returned by an individual consumer. For the purpose of this document, post-consumer returns do not include drug products returned to a hospital pharmacy from patient wards or products returned as part of an exchange program (e.g. Ontario’s fentanyl patch-for-patch program).

1.1 Context

This guidance document is being issued in conjunction with the Guidance Document for Pharmacists, Practitioners and Persons in Charge of Hospitals: Handling and Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs, Targeted Substances to clarify the recommended procedures for the collection, handling, and destruction of post-consumer returns and unserviceable stock.

1.2 Objectives

This guidance will:

  • set out procedures for pharmacists involved in the collection, handling and destruction of unused or expired drug products containing a narcotic, controlled drug or targeted substance, that are returned by an individual consumer (post-consumer returns);
  • clarify that dealers licensed to destroy a narcotic, controlled drug or targeted substance can accept post-consumer returns as well as unserviceable stock; and,
  • set out record-keeping requirements for licensed dealers receiving, handling and destroying post-consumer returns.

1.3 Scope and application

This document applies to:

  • pharmacists, as referenced in the NCR, FDR-Part G, and BOTSR; and
  • licensed dealers, including those licensed to possess narcotics, controlled drugs or targeted substances for the purposes of destruction.

2.0 Roles and Responsibilities

2.1 Pharmacists working in a retail or community pharmacy

Pharmacists are responsible for securing the post-consumer returns that a pharmacy accepts until they are destroyed locally or are sent off-site for destruction purposes.

Post-consumer returns must be received by a pharmacist, pharmacy intern, or pharmacy technician, and deposited in a tamper-evident, single-use, one-way entry container with a unique identifier number.

2.2 Licensed Dealers including those Licensed to Destroy

Licensed dealers, including those who specialize in the destruction of narcotics, controlled drugs, and targeted substances, must carry out any destruction of post-consumer returns in accordance with all applicable federal, provincial and municipal legislation.

Licensed dealers are responsible for the secure storage of post-consumer returns prior to their destruction.

Licensed dealers are not required to apply to Health Canada for an authorization to destroy post-consumer returns since they may be mixed with other medications, and hence their street value is unknown. It is recommended that licensed dealers destroy post-consumer returns on a regular basis. Licensed dealers must keep appropriate records for 2-years from the date of destruction. An accumulation of post-consumer returns increases the risk of their diversion.

3.0 Record Keeping

Pharmacists, pharmacy technicians, or pharmacy interns may want to suggest to consumers returning unused or expired medications that they remove personal information from pill bottles and packages. This is the responsibility of consumers.

As a matter of policy, Health Canada has been recommending that pharmacists record the name of the drug products, strength and quantity for post-consumer returns. Effective April 1, 2018, Health Canada no longer requires this information to be recorded for post-consumer returns. Consequently, there is no requirement to separate post-consumer returned controlled substances from other post-consumer returned prescription or non-prescription medications.

If a shipment provided to a dealer licensed to destroy contains only post-consumer returns or post-consumer returns combined with unserviceable stock, a pharmacist must note the post-consumer returns by recording the:

  • number of containers collected,
  • date the containers are collected,
  • unique identifier/tracking number assigned to each container, and
  • name and address of the licensed dealer to whom the shipment was sold or provided.  

The record requesting the destruction of post-consumer returns must be signed and dated by the pharmacist.

Similarly, the licensed dealer must note the post-consumer returns by recording the:

  • number of containers being received;
  • date the containers are being received;
  • unique identifier/tracking number assigned to each container; and,
  • name and address of the pharmacist from whom the shipment was received.

These records must be retained for a period of two years, in a manner that permits an audit to be made.

4.0 Storage

It is recommended that post-consumer returns are stored in single-use, one-way entry collection containers that are opaque, inconspicuous, tamper-evident and have a unique identifier.

Ideally, collection containers should be kept in the pharmacy dispensary when in active use, and access should be limited to pharmacy staff.  Should there be limited space inside the dispensary, the collection containers may be placed outside of the dispensary as long as they are in plain sight of the pharmacy staff and secured to the floor.
Pharmacists are also encouraged to use other means to enhance security in and around the dispensary area, e.g., such as the installation of security cameras.

Licensed dealers are not required to store post-consumer returns with their inventory containing narcotics, controlled drugs, or targeted substances, however, these products should be stored in a manner that prevents their diversion, such as in a restricted-access area. Post-consumer returns will not contribute to the value permitted based on a licensed dealer’s physical security directive level.

5.0 Procedure for Destruction

Pharmacists have various choices with respect to the destruction of post-consumer returns:

Pharmacists should treat all post-consumer returns as controlled substances.

Post-consumer returns can be shipped with unserviceable stock being sent to a dealer licensed to destroy narcotics, controlled drugs, or targeted substances, but they are not to be co-mingled in order to ensure proper record-keeping.

Pharmacists should denature or send post-consumer returns for destruction on a regular basis as an accumulation may increase diversion risk. Stockpiling is not recommended.

5.1 Local Destruction of Post-Consumer Returns

Health Canada no longer requires pharmacists, practitioners, or persons in charge of the hospital to send destruction requests to Health Canada in order to proceed with local destruction.

Pharmacists performing local destruction must follow all applicable municipal, provincial and federal environmental laws and the destruction must render the controlled substances unusable. In addition, pharmacists carrying out local destruction of post-consumer returns must record the date the destruction took place, the unique identifier of the container, and the number of containers destroyed.

If post-consumer returns are to be destroyed at the same time as unserviceable stock, the pharmacist carrying out the local destruction must include the information of post-consumer returns (e.g. unique identifier of the container) in the record of unserviceable stock local destruction.

The generated record must be signed by the pharmacist, practitioner or person in charge of the hospital who carried out the destruction and the witness present. The destruction must be witnessed in duplicate by the individual destroying the substances and any other practitioner, pharmacy intern, or pharmacy technician. Both persons must sign and print their names on the generated record and indicate that they witnessed the destruction and that the substance was altered or denatured to such an extent that its consumption was rendered impossible or improbable.

This information must be recorded in a register similar to that required to be kept for orders involving narcotics, controlled drugs, and targeted substances, and must be retained for a period of two years, in a manner that permits an audit to be madeFootnote 1.

5.2  Providing to a Dealer Licensed to Destroy

Only a pharmacist, practitioner, or person in charge of a hospital can arrange for a narcotic, controlled drug, or targeted substance to be sold or provided to a dealer who is licensed to destroy them.

6.0  Loss or Theft of Post-Consumer Returns

Any loss or theft of post-consumer returns should be reported to law enforcement and Health Canada. Please refer to the Guidance Document Reporting of Loss or Theft of Controlled Substances and Precursors.

Annex A: Definitions

The following definitions are provided for reference:

controlled drug
a drug set out in the Schedule to Part G of the FDR, including a preparationFootnote 2
destruction
to alter or denature a controlled substance to such an extent that its consumption is rendered impossible or improbable;
licensed dealer
the holder of a dealer's licence issued under the NCR, the FDR – Part G or the BOTSR;
local destruction
on-site destruction;
narcotic
any substance set out in the Schedule to the NCR or anything that contains any substance set out in that ScheduleFootnote 3
pharmacy technician
a person who works in a pharmacy or dispensary and meets any applicable provincial or professional requirements in order to work as a pharmacy technician or equivalent designation.
Practitioner
a person who is registered and entitled under the laws of a province to practise in that province the profession of medicine, dentistry or veterinary medicine, and includes any other person or class of persons prescribed as a practitionerFootnote 4
post-consumer return
unused or expired drug substance or drug products containing a narcotic, controlled drug  or targeted substance that are returned by an individual consumer to a retail pharmacy for destruction purposes but do not include drug products returned to a hospital pharmacy from patient wards;
targeted substance
a controlled substance that is included in Schedule 1 to the BOTSR or a product or compound that contains a controlled substance that is included in Schedule 1 to the BOTSR;
Footnote 1

See section 31(1) of the Controlled Drugs and Substances Act.

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Footnote 2

See G.01.001(1) of Part G-FDR.

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Footnote 3

See subsection 2(1) of the NCR.

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Footnote 4

See subsection 2.(1) of the CDSA.

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