Destruction of narcotics, controlled and restricted drugs and targeted substances by licensed dealers – Guidance document

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Organization: Health Canada

Effective date: 2019/09/06

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

1.0 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 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:

1.1 Context

This guidance document replaces Circular Letter No. 402 (Circular Letter to Narcotic and Controlled Drug Licensed Dealers) dated December 15, 1983 and is being issued to clarify the recommended procedures for the application, witnessing, transportation and acceptable methods of destruction of:

Collectively, the above terms will be referenced as ‘controlled substances’ throughout the document.

This document does not apply to post-consumer returns as defined in Guidance Document: Provision and destruction of post-consumer returns containing controlled substances.

1.2 Objectives

This guidance will:

1.3 Scope and application

This document applies to:

2.0 Roles and Responsibilities of Licensed Dealers

2.1 Environmental Legislation & Health Hazards

Despite having received an authorization from the regional Controlled Substances Program (CSP), it is still the responsibility of the Licensed Dealer to ensure that the destruction is not in contravention of any environmental legislation and will not present any health hazard.

2.2 Records

Licensed Dealers are to maintain, on the premises described in the licence, accurate records (refer to Section 3.4) of all inventories pertaining to controlled substances and provide the Regional Office with complete application forms (see Section 3.2) for destruction. Records should be made available to inspectors during an inspection and provide traceability of the inventory.

2.3 Security – Storage and Transportation

The Qualified Person in Charge (QPIC) or Alternate QPIC (A/QPIC) is responsible for ensuring that adequate measures are in effect for the secure storage of unused, unserviceable or expired controlled substances. Products that are awaiting destruction must be stored in the approved security environ, such as safe, vault etc., as indicated on the Licensed Dealer’s Controlled Drugs and Substances (CDS) Licence. The Licensed Dealer should have an appropriate measure/system in place to ensure that the value of the controlled substances, stored in their secure environ, does not exceed the maximum street value permitted under their license. The Licensed Dealer must also maintain security over the products if they need to be transported off-site until the destruction has been completed and the products are no longer recoverable.

3.0 Destruction Overview

Destruction of controlled substances cannot take place until they have been authorized by the CSP. An application must be submitted to the regional CSP office once the destruction is scheduled (refer to Section 3.2). All information presented in the application, including the method of destruction, date, time, name of witnesses and list of products to be destroyed, must be correct and unaltered from the time the authorization was provided until the time of the actual destruction.

Licensed Dealers must determine the total street value of the controlled substances for destruction as described in Appendix B – Table 1 of the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis. It is the Licensed Dealer’s responsibility to ensure all the requirements when applying for each of the following destructions are met.

3.1 Unwitnessed and Witnessed Destructions

3.1.1 Unwitnessed Destruction

If the total street value of the destruction is less than $750,000, the Licensed Dealer may destroy the controlled substances without the presence of a CSP inspector after receiving authorization from the CSP. 

3.1.2 Witnessed Destruction

If the total street value of the destruction is more than $750,000, the Licensed Dealer must contact the CSP to schedule a witnessed destruction with the presence of a CSP inspector at least 30 calendar days in advance of the planned destruction date.

Depending on the total street value of the destruction, the use of an escort to ensure the security during transportation should be evaluated and discussed with the Regional CSP office.

The Licensed Dealer is required to implement occupational health and safety measures that are necessary to reasonably ensure the safety of inspectors and other personnel during the witnessing of destruction.  The regional Inspector may contact the Licensed Dealer to confirm that safety measures are in place prior scheduling a destruction date.

The regional Inspector from the CSP will conduct product reconciliation at the Licensed Dealer’s site, witness transportation of the products (if applicable) and witness the destruction of the products. Licensed Dealers need to ensure that there is adequate time for the Inspector to conduct their duties prior to destruction.

In situations where significant deficiencies are identified during reconciliation, the destruction may be halted and the Licensed Dealer may be required to submit a corrective action plan prior to the destruction taking place.

3.1.3 Unannounced Compliance Verification

All destruction applications with a street value of less than $750,000 may be subject to compliance verification inspections to verify that the information listed in the application is accurate and that the requirements of the destruction process are met.

In situations where significant deficiencies are identified during compliance verification, the destruction may be halted and the Licensed Dealer may be required to submit a corrective action plan prior to receiving subsequent authorizations for destruction.

3.2 Application Requirements

Licensed Dealers must contact the Regional CSP office and follow the regional processes to submit an application for destruction. Licensed Dealers must provide requested information pertaining to controlled substances inventory included in a destruction shipment and the associated destruction process to the regional CSP office. This information provides auditable and traceable records on products destroyed for subsequent inspections.

Licensed Dealers are required to submit a destruction application to the respective regional CSP at least ten business days prior to the proposed date of destruction if the total street value of the destruction is below $750,000. For destructions with a street value of $750,000 and above, Licensed Dealers are required to contact the respective regional CSP at least 30 calendar days in advance to schedule a Witnessed Destruction of the controlled substances. See Annex B for Regional CSP contact information to obtain further information on application and service standards.

All applications must contain, at minimum, the following:

The following information, at minimum, must also be submitted in a table format:

In order to determine the quantity of a controlled substance in its base form, the following formula can be utilized to calculate the conversion factor, which is used when a product contains controlled substances in a salt derivative form.

Conversion factor = [molecular weight of base] / [molecular weight of salt]

The International Narcotics Control Board (INCB) also provides a list of common derivatives in the Yellow List and Green List.

The street value of the substances to be destroyed is to be calculated as described by the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis. It is the responsibility of the Licensed Dealer to contact the regional CSP office to confirm the street value of a controlled substance not present on the list.

It is important to ensure that applications are correct and complete to the best of the QPIC or A/QPICs knowledge. Any application that requires amendments and/or further clarifications may take longer to be processed for approval by the CSP. If the application is inadequate, it will be sent back to the applicant and will not be processed until the inadequacies are addressed.  This may include, but not limited to, missing required fields, incorrect conversion factor use, or missing signatures.

3.2.1 Multiple Destruction Applications

Licensed Dealers are allowed to submit a maximum of two unwitnessed destruction applications with the same proposed date of destruction. Licensed Dealers that are specialized in waste destruction may submit more than two destruction applications with the same proposed date of destruction. The following requirements have to be met for the applications to be accepted:

Licensed Dealers cannot combine multiple destructions into one.

3.2.2 Changes to Authorized Destruction Application

The CSP must be notified via email a minimum of one business day prior to the date of destruction if there are any planned changes to the original authorized destruction application (see Annex B for Regional CSP contact information). 

Should a destruction not occur on the authorized date due to unforeseen circumstances (e.g. incinerator malfunction, witnesses unavailable), the CSP must be notified via email within 24 hours. 

A Licensed Dealer must provide an amended application for any changes to an authorized destruction, specifying all the changes made to the initial application, which can include, but are not limited to, changes in witness and the date/time of destruction as well as an explanation for the changes. Any change to the list of controlled substances being destroyed requires a new application to be submitted to the Regional CSP office for review and previous authorization is annulled.

3.3 Personnel Involved

The QPIC or A/QPIC of the Licensed Dealer compiles all drug products containing controlled substances for destruction. The QPIC or A/QPIC signs the application and submits it to the CSP, requesting authorization for destruction of the listed products.

3.3.1  Licensed Dealer Witnesses

At least two people are required to be present to witness the destruction. One of the witnesses must be the QPIC or an A/QPIC when the QPIC is unable to attend the destruction. There must also be one of the following people acting as a second witness during the destruction:

No other person shall be present at the destruction unless they are required for one or more of the following reasons:

The Licensed Dealer may have more than two witnesses present if it is necessary for security or operational reasons and their presence does not reduce drug security.

Witnesses cannot leave the destruction site until all controlled substances are destroyed.

3.4 Record Keeping Requirements

Within 24 hours of completing the destruction, the witnesses present must sign and date a witness document containing the following:

A copy of all documents relevant to the destruction must be forwarded to the regional CSP within 15 business days of the destruction date. The original records must be retained on the Licensed Dealer’s premises for at least two years in an auditable format.

4.0 Method of Destruction

The method of destruction must alter or denature the narcotics, controlled and restricted drugs and/or targeted substances to such an extent that consumption has been rendered impossible or improbable. Licensed Dealers should be aware that the method of destruction may vary from substance to substance depending on its chemical or physical properties. It is the responsibility of the Licensed Dealer to ensure that all controlled substances are properly destroyed by the proposed method of destruction.

Incineration is the preferred method of destruction for all unserviceable narcotics, controlled and restricted drugs and targeted substances; however, other methods of destruction may be considered for instances listed under section 4.2.

Licensed Dealers must carry out destructions in compliance with all applicable federal, provincial, and municipal environmental legislation or bylaws.

4.1 Incineration

The incinerator must:

4.2 Denaturation

Chemical destruction (denaturation) can be used in instances where:

Licensed Dealers are encouraged to consult product monographs for instructions on the appropriate method of destruction of controlled substances.

4.2.1 Acceptable Methods of Denaturation

The Licensed Dealer is responsible to ensure that the proposed method of denaturation will render consumption of the products impossible or improbable. The following are examples of denaturing methods:

A description of the method of destruction, that includes but is not limited to, the quantity of denaturing agent to be used, the period of time the mixture will be stirred/settled and what will be done with the resulting chemical waste components (i.e. incinerated as pharmaceutical waste) should be included in the application.

5.0 Loss or Theft

Licensed Dealers that are specialized in waste destruction are responsible to maintain accurate records of all controlled substances received from others Licensed Dealers for destruction by performing a 100% inventory reconciliation upon reception.

Any loss or theft must be reported to Health Canada. Please refer to the Guidance Document: Reporting of loss or theft of controlled substances, precursors and cannabis.

Annex A: Definitions

The following definitions are provided for reference:

controlled drug
means a drug set out in the Schedule to Part G of the FDR and includes a preparationFootnote 1;
destruction
means to alter or denature a controlled substance to such an extent that its consumption is rendered impossible or improbable;
inspector
means any person properly designated as an inspector under section 30 of the CDSA;
licensed dealer
means the holder of a dealer’s licence issued under the NCR, the FDR – Parts G and J, the BOTSR or the Precursor Control Regulations (PCR);
narcotic
means any substance set out in the Schedule to the NCR or anything that contains any substance set out in that ScheduleFootnote 2;
post-consumer return
means unused or expired drug substance or drug products containing a narcotic, targeted substance or controlled drug  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;
practitioner
means 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 3;
restricted drug
means a substance set out in the Schedule to Part J of the FDR or anything that contains the substance; and cocaine (benzoylmethylecgonine) or any of its salts, or anything that contains such a substance, except a drug in dosage form, as defined in subsection C.01.005(3), that has a drug identification number assigned to it under Division 1 of Part C or that is authorized for sale under Division 5 of Part C, and except cocaine (benzoylmethylecgonine) or any of its salts, or anything that contains such a substance, that is to be or that has been compounded by a pharmacist in accordance with or in anticipation of a prescription;
targeted substance
means 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;
unserviceable stock
means drug product containing a narcotic, targeted substance or controlled drug that is unused, expired and/or that cannot be dispensed.

Annex B: Contact Information

Office of Controlled Substances
National Compliance Section
161 Goldenrod Driveway
AL 0300B
Ottawa ON K1A 0K9
Email: hc.compliance-conformite.sc@canada.ca

Controlled Substances Program, Eastern Region
Email: hc.controlled.substances-substances.controlees.sc@canada.ca
Province/Territory: Quebec, Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland and Labrador

Controlled Substances Program, Central Region
Email: hc.destructions.on.sc@canada.ca
Province/Territory: Ontario and Nunavut

Controlled Substances Program, Western Region
Email: hc.cspwestern.sc@canada.ca
Province/Territory: British Columbia, Alberta, Saskatchewan, Manitoba, Yukon and Northwest Territories

Footnotes

Footnote 1

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

Return to footnote 1 referrer

Footnote 2

See Interpretation section of the NCR.

Return to footnote 2 referrer

Footnote 3

See Section 2.(1) of the CDSA.

Return to footnote 3 referrer

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