Guidance Document: Handling and destruction of post-consumer returns containing controlled substances (CS-GD-021)

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 compliance-conformite@hc-sc.gc.ca.

Table of Contents

• 1. Introduction
  • 1.1 Context
  • 1.2 Objectives
  • 1.3 Scope and Application
• 2. Roles and Responsibilities
  • 2.1 Pharmacists
  • 2.2 Licensed Dealers (who are licensed and specialized in destruction)
• 3. Storage
• 4. Procedures for Destruction
  • 4.1 Local Destruction of Post-Consumer Returns
    • 4.1.1 Witnessing
    • 4.1.2 Record Keeping
  • 4.2 Providing to a Licensed Dealer Authorized to Destroy
    • 4.2.1 Record Keeping
• 5. Loss or Theft of Post-Consumer Returns
• Appendices
• Appendix A - Definitions

1. 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 CDSA, most activities involving substances regulated under the CDSA, such as possession, import, export, trafficking, production, etc., are prohibited.

Controlled substances are regulated and grouped into Schedules I to V to the CDSA.

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 are permitted. Three regulations are relevant to this Guidance Document:

• Narcotic Control Regulations(NCR)
• Part G of the Food and Drug Regulations(FDR-Part G)
• Benzodiazepines and Other Targeted Substances Regulations(BOTSR)

Post-consumer returns are unused or expired substances that are, or contain, a narcotic, targeted substance, or a controlled drug, that have been returned by an individual to a pharmacy for the purpose of destruction. Post-consumer returns do not include any substances that have been returned to a hospital pharmacy from a patient ward or products returned as part of an exchange program, such as Ontario's fentanyl patch-for-patch program.

1.1 Context

This guidance document is to be read 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 handling and destruction of post-consumer returns and unserviceable stock.

It is also clarifying the requirements of the Subsection 56(1) Class Exemption for Pharmacists, Practitioners, Persons in Charge of a Hospital and Licensed Dealers for the Provision and Destruction of Unserviceable Stock and Post- consumer Returns.

1.2 Objectives

This guidance document will:

• set out procedures for pharmacists involved in the collection, provision 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 businesses involved in the provision and destruction of post-consumer returns must obtain a Controlled Drugs Licence;
• clarify that licensed dealers authorized to destroy a narcotic, controlled drug or targeted substance can accept both post-consumer returns as well as unserviceable stock; and
• set out record-keeping requirements for licensed dealers and pharmacists involved in the provision and destruction of post-consumer returns.

1.3 Scope and Application

This document applies to pharmacists and licensed dealers as referenced in the NCR, FDR-Part G, and BOTSR.

2. Roles and Responsibilities

Pharmacists and licensed dealers are responsible to take all reasonable steps that are necessary to protect post-consumer returns against loss or theft.

Pharmacists must report any loss or theft to Health Canada within 10 days of discovery. Licensed dealers authorized to destroy must report any loss or theft to Health Canada within 72 hours of discovery.

2.1 Pharmacists

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.

Effective April 1, 2018, Health Canada no longer requires that pharmacists record the name of the drug product, strength and quantity for post-consumer returns. Consequently, there is no requirement to separate post-consumer returned controlled drugs and substances from other post-consumer returned prescription or non-prescription medications. Record keeping responsibilities for pharmacists are described in section 4.0.

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

2.2 Licensed Dealers (who are licensed and specialized in destruction)

Businesses that are involved in the provision or destruction of post-consumer returns of controlled substances must be licensed by Health Canada. This requirement ensures the secure storage of post-consumer returns until they are destroyed.

Licensed dealers are not required to apply to Health Canada for an authorization to destroy post-consumer returns. Record keeping responsibilities for licensed dealers authorized to destroy are described in section 4.0.

All licensed dealers must carry out any destruction of post-consumer returns in accordance with all applicable federal, provincial and municipal legislation.

3. Storage

Post-consumer returns must be stored in a one way entry container that has a unique identifier. It is recommended that the container is also opaque, inconspicuous and tamper evident.

Containers must 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 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, such as the installation of security cameras.

Since post-consumer returns of controlled substances are commonly mixed with other prescription and non-prescription medications, their illicit market value is unknown. Consequently, post-consumer returns will not contribute to the value of inventory permitted by the licensed dealer's Security Directive level.

Licensed dealers that only handle post-consumer returns are required to have minimal secure environs in accordance with the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, including sufficient space to manage the volume of goods handled.

Licensed dealers that also handle serviceable and unserviceable stock are not required to store post-consumer returns with this inventory. In these facilities, however, post-consumer returns must be stored in a manner that prevents their diversion, such as in a restricted-access area.

4. Procedures for Destruction

Pharmacists have choices with respect to the method of destruction of post-consumer returns. They can:

• destroy the returns locally;
• use a post-consumer returns container with an integrated system to destroy products that are placed within it; or
• sell or provide post-consumer returns to a licensed dealer (see section 4.2).

Pharmacists and licensed dealers authorized to destroy should treat all post-consumer returns as controlled substances.

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

Stockpiling is strongly discouraged. Pharmacists and licensed dealers authorized to destroy should destroy post-consumer returns on a regular basis as an accumulation may increase diversion risk.

4.1 Local Destruction of Post-Consumer Returns

Pharmacists are not required 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.

Pharmacists should be aware that the destruction process may vary from substance to substance depending on the chemical or physical properties of the substance in question, however a change of state is recommended (i.e., from solid to liquid).

Pharmacists are encouraged to consult Workplace Hazardous Materials Information System (WHMIS) sheets or their respective provincial regulatory colleges for instructions on the appropriate method of destruction of controlled substances.

Once subjected to local destruction, post-consumer returns may be placed in an appropriate container and disposed of in a manner that is safe, environmentally responsible, secure and compliant with legal and professional requirements to protect confidential patient information. Already denatured products need not be sent to licensed dealers for disposal and can be placed in the regular pharmaceutical waste.

4.1.1 Witnessing

All local destructions must be witnessed by a practitioner, pharmacist, a pharmacy intern, or a pharmacy technician.

4.1.2 Record Keeping

Pharmacists carrying out local destruction of post-consumer returns must record:

• the method of destruction used;
• the date the destruction took place;
• the unique identifier of the container; and
• the number of containers destroyed.

Records for the local destruction of post-consumer returns should be kept separate from those for post-consumer returns being sent to a licensed dealer.

The generated record must be signed by the pharmacist 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 at least two years, in a manner that permits an audit to be made^{Footnote 1}.

4.2 Providing to a Licensed Dealer Authorized 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 licensed dealer.

4.2.1 Record Keeping

Record keeping for post-consumer returns must enable the pharmacist or licensed dealer to meet their loss or theft reporting responsibilities. This could be accomplished through normal business practices such as receipts and invoices exchanged by the pharmacist and licensed dealer.

If a shipment provided to a licensed dealer for the purpose of destruction contains post-consumer returns, a pharmacist must note the:

• number of containers being sold or provided;
• date on which the containers were sold or provided;
• unique identifier 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.

Note that records for post-consumer returns being sent to a licensed dealer should be kept separate from unserviceable stock being returned to a licensed dealer.

Any records related to the provision or destruction of post-consumer returns must be retained for a period of no less than two years, in a manner that permits an audit to be made.

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

• number of containers being received;
• date on which the containers were received;
• unique identifier assigned to each container; and
• name and address of the pharmacist from whom the shipment was received.

Although licensed dealers are not required to apply to Health Canada for an authorization to destroy post-consumer returns, they must keep appropriate records for at least two years from the date of destruction, in a manner that permits an audit to be made.

5. Loss or Theft of Post-Consumer Returns

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

Appendices

Appendix 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 preparation^{Footnote 2}

destruction

to alter or denature a controlled substance to such an extent that its consumption is rendered impossible or improbable;

licensed dealer

means a licensed dealer 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 Schedule^{Footnote 3}

pharmacy technician

means 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 practitioner^{Footnote 4}

post-consumer return

means unused or expired substance that is, or contains, a narcotic, targeted substance, or a controlled drug, that has been returned by an individual to a pharmacy for the purpose of destruction, but does not include any substance that has been returned to a hospital pharmacy from a patient ward;

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.