Reporting of loss or theft of controlled substances and precursors

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Organization: Health Canada

Type: Guidance

Date published: 2018-03-01

Date Adopted: 2018-03-01

Effective Date: 2018-03-01

Related Topics

Guidance Document Document #: CS-GD-005

Published by authority of the Minister of Health

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented 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.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in the document, in order to allow the Department to adequately assess the safety, efficacy or quality. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

Table of Contents

Our mission is to help the people of Canada maintain and improve their health, while respecting individual choices and circumstances.

- Health Canada

Health Canada's mandate is to help Canadians maintain and improve their health, while respecting individual choices and circumstances. The Office of Controlled Substances (OCS) within the Controlled Substances Directorate (CSD), and the Office of Medical Cannabis (OMC) administers legislation and activities controlling the possession, import, export, production, distribution and sale of substances listed in the schedules to the Controlled Drugs and Substances Act (CDSA). These include narcotics, controlled drugs, restricted drugs, benzodiazepines, targeted substances, precursors, industrial hemp and marihuana for medical purposes.

In addition, the OCS and the OMC also establishes open communication with regulated parties and fosters collaboration amongst other federal departments (such as the Canada Border Services Agency), provincial agencies (such as provincial licensing authorities for medicine and pharmacy) and law enforcement, for the purposes of protecting public health and safety by minimizing the diversion of controlled substances and precursor chemicals to the illegal market.

- Office of Controlled Substances
Office of Medical Cannabis
Healthy Environments and Consumer Safety Branch
Cannabis Legalization and Regulations Branch

1. Purpose

This document provides guidance to regulated parties and section 56 exemptees under the Controlled Drugs and Substances Act (CDSA) and its Regulations in completing a Loss or Theft Report Form for controlled substances and precursors.

Regulated parties and s.56 exemptees must notify the Minister of the loss or theft of controlled substances and precursors in accordance with the relevant regulations. Such notifications can be submitted to Health Canada, Office of Controlled Substances (OCS) or the Office of Medical Cannabis (OMC) using the Loss or Theft Report Form for Controlled Substances and Precursors (CS-FRM-011) found in Appendix A.

2. Scope

This document was developed to provide guidance to regulated parties in meeting the regulatory requirements for reporting losses or thefts of controlled substances and precursors. Regulated parties include (but are not limited to) licensed or registered dealers, licensed producers, licensed holders, registered persons, practitioners, (including, for example, physicians, nurse practitioners, midwives, and podiatrists), and hospitals. This document also applies to s.56 exemptees who must report any losses or thefts as per the conditions of their exemptions.

2.1 Regulations Governing the Reporting of Losses or Thefts (see Appendix B)

Controlled Substances:

  • Narcotic Control Regulations; para. 20 (b), s. 42, para. 55 (g), para. 63 (c)
  • Part G of the Food and Drug Regulations (Controlled Drugs); para. G02.019 (b),
  • S. G.03.013, para. G.04.002A (g), s. G.05.004
  • Part J of the Food and Drug Regulations (Restricted Drugs); para. J.01.028 (b)
  • Benzodiazepines and Other Targeted Substances Regulations; s. 7, s. 61
  • Access to Cannabis for Medical Purposes; s. 29, s. 196(2)
  • Industrial Hemp Regulations; s. 34

Precursors:

  • Precursor Control Regulations; ss. 90 (2), s. 91.96

This document is not intended to replace the CDSA or its Regulations respecting the loss or theft of controlled substances and precursors. The CDSA and its Regulations shall, in all circumstances take precedence over these guidelines should there be any inconsistency.

To report the loss or theft of the following documents, excluding those covered under the Access to Cannabis for Medical Purposes Regulations (ACMPR):

  • Official documents/information such as: Licences, Registration Certificates, Authorization Certificates, Export or Import Permits, Transshipment Permits, Transit Permits:
    Please contact the OCS at 613-952-2177 or OCS_BSC@hc-sc.gc.ca

To report the loss or theft of the following documents covered under the ACMPR:

  • Official documents/information such as: Licences, Registration Certificates, Export or Import Permits:
    Please contact the OMC at CMC@hc-sc.gc.ca

3. Key Definitions for the Purpose of this Document

In this document and the accompanying Loss or Theft Report Form (CS-FRM-011) the following terms are used. Please note that the redundancy between the Guidance Document and the form is voluntary so they can also be used independently.

3.1 General

"Controlled Substance" means any substance included in Schedule I, II, III or IV of the CDSA. A controlled substance also includes:

  • Any synthetic or natural forms of a listed substance;
  • Any substance that contains a controlled substance; and,
  • Anything that has on it a controlled substance and is used/intended/designed to either (i) produce the substance, or (ii) to introduce it into a human body.

"Date of Discovery" means the date at which the regulated party discovers (i.e. becomes aware of the occurrence) or suspects that a loss or theft has occurred. Please note that this applies to a situation in which it is assumed a loss has occurred, even if there is an investigation ongoing to confirm it. If, after 10 days post-date of discovery, the occurrence no longer meets the definition of a reportable loss, an amendment to the Loss or Theft Report must be sent to Health Canada.

"Facility" means the premises or site used for the purpose of conducting regulated activities with controlled substances and/or precursors.

"Post-consumer return" means 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;

"Precursor" means any substance included in Schedule VI of the CDSA.

"Restricted Drugs" means

  1. any substance that is set out in the schedule to Part J of the FDR or anything that contains the substance; and
  2. 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.

"Unserviceable stock" means drug product containing a narcotic, controlled drug or targeted substance that is unused, expired and/or that cannot be dispensed for some reason.

3.2 Regulated Parties

"Exemptee" means an individual or class of individuals that are exempted under s. 56 of the CDSA such as but not limited to: Methadone Prescribers, Paramedics, Researchers, Principal Investigator of Human Clinical Trial, Research Laboratories, registered nurses delivering primary health care at health facility in a remote and/or isolated community, Officers of the Canada Border Services Agency (CBSA).

"Hospital" means a facility:

  1. that is licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness, or
  2. that is owned or operated by the Government of Canada or the government of a province and that provides health services.

"Licensed Dealer" means the holder of a licence to produce, make, assemble, package, import, export, sell, provide, transport, send or deliver controlled substances or precursors.

"Licensed Holder" means the holder of a licence under s.9 of the IHR to import, export, produce, sale, offer to sale, provide, transport, send or deliver industrial hemp.

"Licensed Researchers" means the holder of a licence under s. 67 of the NCR to cultivate, gather or produce opium poppy or marihuana for scientific purposes.

"Licensed Producer" means the holder of a licence issued under s. 35 of the ACMPR.

"Midwife" means a person who is registered and entitled under the laws of a province to practice midwifery and who is practicing midwifery in that province.

"Nurse" means an individual who is:

  1. a registered nurse; i.e. an individual who is registered with a provincial Nursing College and who holds a current annual practice permit with the college and can use the protected title Registered Nurse; or
  2. a registered / licensed practical nurse; i.e. an individual who is registered with a provincial college and holds a current annual practice permit with the college.

"Nurse practitioner" means a person who is registered and entitled under the laws of a province to practice as a nurse practitioner or an equivalent designation and who is practicing as a nurse practitioner or an equivalent designation in that province. For the purpose of this definition, a designation is equivalent when it designates a person who:

  1. is a registered nurse;
  2. possesses additional health care related educational preparation and experience; can autonomously diagnose, order and interpret diagnostic tests, prescribe drugs and perform other specific procedures under the laws of a province; and
  3. is authorized to practise, for example, under the following provincial laws, as amended from time to time:
    1. the Extended Practice Regulation, Man. Reg. 43/2005, made under The Registered Nurses Act of Manitoba, C.C.S.M., c. R40,
    2. Ontario Regulation 275/94, made under the Nursing Act, 1991 of Ontario, S.O. 1991, c. 32, or
    3. the Regulation respecting Ordre des infirmières et infirmiers du Québec classes of specialities related to the performance of acts contemplated in section 36.1 of the Nurses Act, R.R.Q., c. I-8, r. 8, made under the Nurses Act of Quebec, R.S.Q., c. I-8.
    4. Registered Nurses Profession Regulation, Alta. Reg 232/2005 made under the Health Professions Act of Alberta.

"Official Individual" means the regulated healthcare professional or other individual designated in accordance with the CDSA and/or its regulations that is responsible on behalf of the organization /establishment for ensuring regulated activities, e.g. possession, provision, dispensing, import, export, production, comply with the CDSA and its regulations with respect to controlled substances and precursors. Note that the official individual is responsible for the information reported on the loss or theft form.

The official individual varies with the type of facility. e.g. for a licensed dealer of controlled substances, the Qualified Person in Charge (QPIC) or their alternates is the official individual. For a pharmacy, staff pharmacists or the pharmacy manager (if they are a pharmacist) are the official individuals.

"Pharmacist" means an individual who is registered and entitled under the laws of a province:

  1. to practice pharmacy, and
  2. to operate a pharmacy or dispensary

and who is currently practicing pharmacy in that province and may also be currently operating a pharmacy or dispensary.

For the purposes of loss or theft reporting, pharmacists includes individuals, working in a practice setting outside of a licensed pharmacy, having contact with controlled substances or precursors.

"Podiatrist" means a person who is registered and entitled under the laws of a province to practice podiatry and who is practicing podiatry in that province.

"Practitioner" means an individual who is registered and entitled under the laws of a province to practice in that province the profession of medicine, dentistry or veterinary medicine, and includes any other person or class of persons prescribed as a practitioner under the CDSA and its regulations. This includes new classes of practitioners (i.e. midwives, podiatrists and nurse practitioners).

"Registered Dealer" means the holder of a registration certificate. This is specific to Class B Precursor Chemicals.

"Registered Person" and "Designated Person" means a person registered with the Minister under part 2 of the ACMPR

3.3 Types of Reportable Losses or Thefts

"Armed Robbery" means the theft of a controlled substance or precursor accomplished through threats of violence toward personnel at a facility during working hours.

"Break and Entry" means the theft of a controlled substance or precursor from the storage of a facility by forced entry after working hours.

"Grab Theft" means the theft of a controlled substance or precursor from a facility during working hours without warning. The person conducting the theft 'grabs' the product and escapes.

"Loss in Transit" occurs when product has been lost, misplaced or stolen during transport from one location to another.

"Loss Unexplained" including inventory discrepancies that cannot be explained (comment on the frequency of reconciliation counts), is:

  1. a loss unexplained at the time of reporting (i.e. within 10 days of its discovery, except under the IHR and Part J of the FDR) that continues to be investigated internally and upon completion, and additional information should be provided to the OCS or the OMC as an amendment to the original form; or
  2. a loss that remains unexplained after an internal investigation, which may be subject to an external investigation by law enforcement and for which an amendment must be sent to the OCS or the OMC upon completion of the investigation if known; or
  3. a loss that cannot be attributed to any particular cause or action (excluding unusual waste).

N.B. Any report that is submitted as a loss unexplained must be amended if an investigation into the loss is completed with an explanation regarding the findings that contradicts/complements the report already submitted.

"Pilferage" means the theft of a controlled substance or precursor chemical from a facility by an employee during working hours.

"Unusual Waste" means claims of waste of a controlled substance or precursors that can be explained but not on the basis of normally accepted business activities. (e.g. production waste, yield loss).

"Other Loss or Theft" means any other type of loss or theft that doesn't fit in the categories above (e.g. picking errors, manufacturer's shortages: i.e. sealed bottles containing fewer product than listed on label, etc.)

4. Background

Canada is signatory to the Single Convention on Narcotic Drugs, 1961, the Convention on Psychotropic Substances, 1971, the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 and is party to the resolutions set by the International Narcotics Control Board (INCB). Part of the mandate of the INCB is to prevent diversion of controlled substances and precursors to the illegal market.

The OCS within the CSD and the OMC plays an important role in ensuring that controlled substances are used for legal purposes and as such, uses multiple avenues to accomplish that task, by administration of legislation and activities governing the possession, import, export, production, and sale or provision of substances listed in the schedules to the CDSA. Prevention of diversion is also accomplished through gathering information regarding losses or thefts of controlled substances and precursors. These can be primary sources of substances for the illegal market.

Furthermore, as per INCB guidelines, Canada is also required to submit information regarding yearly losses or thefts that have occurred nationally to the United Nations, so as to create a more concrete picture regarding the diversion of controlled substances across the country.

5. What is a reportable loss?

For the purpose of this document, a reportable loss is an incident in which the possibility that the lost substance will be diverted to an illegal market is high or where no explanation exists at the time of reporting as to how the substance has gone missing. Notwithstanding discrepancies described in section 5.1 of this document (i.e. known losses) all other losses with the potential for diversion should be reported. This being said, any discrepancies (regardless of diversion risk) should be recorded in an incident report and filed on site for 2 years to be made available during inspections.

N.B. The lost substance may come from unserviceable stock, filled prescriptions awaiting pickup or delivery, transportation or inventory. This should be indicated on the loss or theft report submitted.

An example of a reportable loss would be when physical inventory counts fall short of those in the records and for licensed producers, exceed the acceptable limits set by your organization. Routine reconciliation of records will help prevent against the diversion of controlled substances and precursors.

5.1 Examples of cases that do not meet the definition of a reportable loss but must be recorded (with records kept on site):

  • A known and accidental dispensing error (as long as it is recorded in accordance with applicable regulations) is not considered a reportable loss. In this case, the pharmacist has full knowledge of where the product is and there is no risk of diversion.
  • Substances rendered unserviceable due to spillage or breaking do not qualify as reportable losses.
  • An economic loss (that is, one in which there is no risk of the substance being diverted to any illegal markets, but results in the loss of the monetary value of the substance) is not considered a reportable loss under the CDSA (e.g. Fire & flood.)
  • Claims of waste of a controlled substance or precursor that can be reasonably explained on the basis of normally accepted business activities.

N.B. Overages do not need to be reported but they should be recorded in an incidence report.

6. What is a Theft?

A theft is the removal of any quantity of controlled substances or precursors under the custody of a regulated party without its explicit legitimate consent.

7. Internal Investigation

An internal investigation should be initiated without delay after a loss, a suspected loss or theft is discovered. If the internal investigation is in progress at the time of reporting (i.e. within the time frames specified in section 10 of this document) or within the time period required for reporting past the date of discovery, this should be indicated on the form. Once the internal investigation is completed, any additional information should be provided to the OCS or the OMC as an amendment to the original form. Please indicate that this attachment is supplemental to the previously submitted loss or theft report.

An internal investigation may be useful to the establishment as it may reveal inconsistencies in certain procedures or point out blind spots.

If a substance suspected to be lost or stolen is recovered, the OCS or the OMC should be informed that the substance is no longer considered lost or stolen and the original report has been retracted. This can be done by completing a new loss or theft report form (appendix A) to amend the previous one by checking recovery in box 1.

8. Loss or Theft Reporting

8.1 Contact Information for Loss or Theft Reports

Loss or theft reports for substances covered under the CDSA Regulations excluding the ACMPR must be reported to the OCS.

Loss or theft reports for substances covered under the ACMPR must be reported to the OMC.

Contact information can be found at the end of the document.

8.2 Situations where a Loss Should be Reported

A Loss or Theft Report Form must be completed and submitted to the OCS or the OMC if a loss (as specified in section 5 of this document) or theft of a controlled substance or precursor has occurred at a regulated establishment. Some types of Losses or Thefts are listed in section 3.3 of this document.

Any unexplainable losses such as: manufacturer's shortages (i.e. sealed bottles that contain less than the listed amount of product outside the ranges specified by C.01.061 of the FDR); unexplained yield loss during manufacturing or packaging; and other unexplained loss should also be reported as per the regulations.

N.B. The official individual that discovers the loss or theft is responsible for reporting it. Picking errors and manufacturer's shortages should be reported by the entity that discovers the error (i.e. the receiver once the chain of signature is signed or the Licensed Dealers if discovered before or during transport).

8.3 Situations where Reporting is not Required

A Loss or Theft Report Form is not required for losses of a controlled substance or precursor that results from normal business activities, e.g. yield loss during manufacturing which falls with the organization's predefined acceptable limits (e.g. discrepancy in weigh scale and billing accuracy of bulk form precursor delivery at a licensed facility, visual estimates of precursor residues removed from tanker trucks at tank cleaning facility). Where an incident occurs and results in unusable/unserviceable product (e.g. through spillage, breakage in transit, breakage on site, fire or flood), the official individual need not report a loss or theft, but should create an Incident Report or its equivalent and keep it on file at site for a minimum of two years. The official individual is to develop their own method of documenting non reportable losses for their inventory records.

An Incident Report should be signed by the official individual and a witness and include at least the information outlined below:

  • the date of the incident;
  • the name of the drug or product;
  • the strength of the product;
  • the dosage form;
  • the quantity wasted or destroyed; and
  • a brief summary of the incident.

9. Loss or Theft Reporting Form for Controlled Substances and Precursors

The form is available on Health Canada's web page or writing to OCS_Reporting_Rapporter_BSC@hc-sc.gc.ca or CMC@hc-sc.gc.ca

The online fillable form can be saved and emailed to OCS_Reporting_Rapporter_BSC@hc-sc.gc.ca (for the OCS) or to CMC@hc-sc.gc.ca (for the OMC) as the preferred method of submission. Alternatively, the form may be printed out and filled in by hand (in blue or black ink) and faxed or mailed in to the OCS or the OMC (contact information can be found at the end of the document).

9.1 Instructions for completing the Loss or Theft Report Form

9.1.1 Contact Information

The administrative information listed below must be entered on the form:

  • The name of the establishment that is reporting the loss/theft exactly as it appears as per their accreditation or as designated by the Department of Indigenous Services Canada.
  • The date of discovery is when the loss or theft was discovered or suspected to have occurred. Please note that this is not the date of submission of the form or the date at which an internal investigation was completed.
  • The address where the establishment is located along with the phone number of the official individual.
  • The type of establishment should be entered, along with the licence number assigned to them by their licensing body:
    • Pharmacists must enter their licence number as assigned by the College of Pharmacists in their province, if pharmacy is chosen as the type of establishment.
    • Practitioners must enter their licence number as assigned by the College of Physicians and Surgeons in their province.
    • Nurse Practitioners must enter their licence number as assigned by the College of Registered Nurses in their province.
    • If the establishment is a hospital and the responsible person is not one of the above, the licence number field can be ignored.
    • Licensed Dealers and Licensed Researchers must enter the licence number assigned to them by the OCS.
    • Licensed Holders must enter the licence number assigned to them by the OCS.
    • Registered Dealers must enter the registration number assigned to them by the OCS.
    • Licensed Producers must enter the licence number assigned to them by the OMC.
    • Registered Persons must enter their registration number assigned to them by the OMC.
    • Exemptees under section 56 of the CDSA should enter the authorization number assigned to them by the OCS. Exemptees that carry a Class Exemption should enter their professional licence numbers.
  • The type of loss suffered by the establishment should be entered. If the loss falls under the parameters of the options listed, choose the one that fits. If the type of loss does not fit those listed, choose 'other' and describe the type of loss that occurred as best as possible.

9.1.2 Reporting to the Police

9.1.2.1 Mandatory Reporting:

It is mandatory to report losses or thefts pertaining to restricted drugs to the police immediately and those pertaining to precursors and cannabis products to the police within 24 hours of discovery.

9.1.2.2 Licensed Dealers:

Licensed Dealers must respect the conditions on their licence such as but not limited to conducting regulated activities with controlled release formulations of oxycodone products, to report loss (including unusual waste) to the police within 24 hours of discovery. The report provided to the police, a copy thereof or a summary should accompany the loss or theft report submitted to OCS within 72 hours of the date of discovery. Please refer to the Circular Letter dated January 10, 2013 that can be made available on request.

9.1.2.3 Voluntary Reporting:

Although the regulations do not require that all types of losses or thefts be reported to the police, it is advised that the official individual notify the local police force in the case of any reportable loss or theft.

If a police report has been made, please check the appropriate box on the form and provide the following information:

  • The date of the report;
  • The name of the police service;
  • The incident number assigned to the case by the police service;
  • The telephone number and e-mail address of the investigating police officer; and
  • The name of the investigating officer.

9.1.3 Loss in Transit

9.1.3.1 Transportation

The official individual responsible for the product during transit must specify the name of the company transporting the controlled substance(s) or precursor(s).

N.B. the Canadian organization doing the shipping is responsible for the product while in transit in Canada until signed for by the recipient. Therefore, any losses must be reported by the Canadian originating organization if the recipient had not yet signed for the product

9.1.3.2 Investigation Report

Any additional information obtained from the company transporting the controlled substance(s) or precursor (s) should be provided as an attachment including:

  • A summary of the investigation report issued by the transportation company.

9.1.4 List of Controlled Substance(s) or Precursor(s) Lost or Stolen

The official individual should ensure the following information is indicated regarding the controlled substances or precursors listed as lost or stolen:

  • The trade name of the substance as it appears on the bottle or in inventory reports should be listed. If the trade name is unknown, the proper or chemical name (generic name) of the substance along with the manufacturer should be listed. It is imperative that the name of the substance be filled out as comprehensively as possible (without the use of acronyms or internal short forms) because it is one of the most important pieces of information the OCS or the OMC has to track diversion.
  • The form the substance is present in should be listed. Some of the common forms are as follows:
    • Tablets
    • Capsules
    • Gels
    • Injectables (liquid)
    • Liquid (e.g. oil)
    • Powders (raw materials)
    • Patches
    • Suppositories
    • Drops
    • Vaporizers
    • Topical Creams
    • Seeds
    • Plants
    • Dry Material
  • The quantity of substance lost or stolen has to be listed. This should be an exact number and based on the dosage form of the substance lost/stolen. For example, if the substance is present in tablet form, the quantity listed would be 100, which would mean that 100 tablets have been lost or stolen. If the substance is a powder, please specify the unit lost or stolen in mg, g, or kg (as applicable).
  • The DIN or NPN of the drug, the Lot # for precursors or cannabis products, or the variety of hemp product, if applicable. This is a unique identifier for the substance and should always be listed if known.

N.B. The last recorded inventory count may be used to determine the quantity of substance lost or stolen for losses where the exact number would be hard to determine, such as for thefts, armed robberies and pilferages.

9.1.5 Discovery: The Specifics

In the report to Health Canada, the official individual may also include the following information as an attachment to the form:

  • A detailed synopsis regarding how the loss or theft occurred to the best of the official individual's knowledge regarding the situation, including any potential explanations for the loss or theft.
  • A description of the security measures that the establishment had in place prior to the loss or theft. This may include physical security (such as alarms, safes, etc.) and also other precautionary measures such as frequency of drug counts, electronic flagging, the type of record keeping conducted and others. For Licensed Dealers, a description is only required if the measures are different than what the Authorizations Division, formerly known as the Licenses and Permits Division, of OCS, has on file.
  • A description of the security measures put into place after the loss or theft. As above, this may include physical changes or changes in the way business is conducted. For Licensed Dealers, changes to physical security for the storage of controlled substances may require approval prior to implementation. Please submit any proposed security changes to Controlled_Drugs_Office@hc-sc.gc.ca indicating your file/licence #. For Licensed Producers, changes to the physical security of the site or to areas for cannabis is present may require approval prior to implementation - please submit any proposed security changes to acmpr-racfm@hc-sc.gc.ca

10. Submission of the Completed Report Form

The loss or theft should be reported to the OCS or the OMC (as a representative of the Minister) within the time limits specified by the Regulations relevant to the missing substances. When reporting the loss of multiple substances at once, please use the most stringent reporting requirement under the regulations.

Reporting Timeline
Type of Substance Lost / Stolen Loss to be reported to Police within: Loss to be reported to Minister within:
Precursors 24 hours 72 hours
Narcotics Without delay based on best practices 10 days
Oxycodone CR (for LDs) 24 hours 72 hours
Controlled Substances - Part G Without delay based on best practices 10 days
Targeted Substances - BOTSR Without delay based on best practices 10 days
Restricted Substances - Part J Immediately Immediately
Access to Cannabis for Medical Purposes 24 hours 10 days (LPs)
72 hours (RPs and DPs)
Industrial Hemp Without delay based on best practices Immediately

The Loss or Theft Form (CS-FRM-011) and its attachments can be faxed or emailed to the Compliance and Monitoring Division (CMD) of the OCS or the National Compliance and Enforcement Section of the OMC at the number or email listed on the form.

Any additional information provided post-submission must be sent as an amendment to the original report and specified as such on the form by referencing the original report's date of submission and checking the relevant type of report in box 1.

Contact Information for the Office of Controlled Substances:

Health Canada
Office of Controlled Substances
161 Goldenrod Driveway
A.L. 0300B
Ottawa ON K1A 0K9
Tel: 613-952-2177
Toll Free: 1-866-569-2560
Fax: 613-957-0110
E-mail: OCS_Reporting_Rapporter_BSC@hc-sc.gc.ca

Contact Information for the Office of Medical Cannabis:

Health Canada
Office of Medical Cannabis
A.L. 0300B
Ottawa ON K1A 0K9
Toll Free: 1-866-337-7705
Fax : 613-941-6840
E-mail: CMC@hc-sc.gc.ca

Appendix A:

Loss or Theft Report Form (CS-FRM-011) 2016

Appendix B: Applicable Regulations relating to Statutory Reporting Responsibilities

Narcotic Control Regulations (NCR)

s. 20 Every licensed dealer shall

  1. report to the Minister any loss or theft of a narcotic within 10 days of his discovery thereof.

s. 42 A pharmacist shall report to the Minister any loss or theft of a narcotic within 10 days of his discovery thereof.

s. 55 A practitioner shall

  1. report to the Minister any loss or theft of a narcotic within 10 days of the practitioner's discovery of the loss or theft.

s. 63 A person who is in charge of a hospital shall

  1. take all necessary steps to protect narcotics in the hospital against loss or theft, and report to the Minister any loss or theft of narcotics within 10 days of his discovery thereof.

Note on s. 55(g): this section covers physicians practicing outside hospitals' setting in private professional clinics.

Controlled Drugs: Part G of the Food and Drug Regulations

G.02.019 Every licensed dealer shall

  1. report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.

G.03.013 A pharmacist shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.

G.04.002A A practitioner shall

  1. report to the Minister any loss or theft of a controlled drug within 10 days of the practitioner's discovery of the loss or theft.

G.05.004 A person who is in charge of a hospital shall take all steps necessary to protect controlled drugs in the hospital against loss or theft and shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.

Precursor Control Regulations (PCR)

s. 90(2) If a licensed dealer or registered dealer experiences a theft of a precursor or an unusual waste or disappearance of a precursor that cannot be explained on the basis of normally accepted business activities, the licensed dealer or registered dealer

  1. shall provide notice of the occurrence to a member of a police force within 24 hours after becoming aware of the occurrence; and
  2. shall provide notice of the occurrence to the Minister, in writing, within 72 hours after becoming aware of the occurrence and confirm that the notice required under paragraph (a) has been provided.

s. 91.96 A pharmacist, practitioner or hospital that sells or provides only on a retail basis, or possesses for the purpose of sale or provision, preparations or mixtures containing Class A precursors, shall

  1. on discovering an unusual waste or disappearance of a Class A precursor that cannot be explained on the basis of normally accepted business practices, notify
    1. a member of a police force within 24 hours after the discovery, and
    2. the Minister, in writing, within 72 hours after making the discovery, and confirm that the notice required under subparagraph (i) has been provided.
  2. on discovering a theft of a Class A precursor set out in column 1 of the schedule, if the package in which it is contained is not intended for retail sale and contains a quantity of the precursor exceeding the maximum quantity specified for the precursor in column 2 of the schedule, notify the persons mentioned in subparagraphs (b)(i) and (ii) within the applicable time-periods;

Benzodiazepines and Other Targeted Substances Regulations (BOTSR)

s. 7(1) The following persons must take any steps that are necessary to ensure the security of a targeted substance in their possession and any licence or permit in their possession with respect to a targeted substance and must, not later than 10 days after discovery, report to the Minister any loss or theft of a targeted substance or of a licence or permit:

  1. a licensed dealer;
  2. a pharmacist;
  3. a practitioner;
  4. the person in charge of a hospital;
  5. a person to whom an exemption has been granted under section 56 of the Act; and
  6. a person who, pursuant to a permit issued under Part 7, is responsible for the targeted substance while it is in transit or in transhipment in Canada.

(2) Every person who has issued or been issued an identifying code referred to in subsections 27(6) and (7) of the Narcotic Control Regulations must

  1. take any steps that are necessary to ensure the security of the code; and
  2. report to the Minister, not later than 10 days after discovery, any loss or theft of the code, a machine that is capable of producing a code or a document that discloses the code.

s. 61(1) An agent of a practitioner of medicine referred to in subsection 59(1) must

  1. take reasonable steps to protect any targeted substance in their possession from loss or theft; and
  2. inform the practitioner without delay of any loss or theft of a targeted substance.

(2) A practitioner of medicine who is informed by their agent of loss or theft of a targeted substance must inform the Minister in accordance with section 7.

Restricted drugs: Part J of the Food and Drug Regulations

J.01.028 Every person who is in possession of a restricted drug and every institution to which the sale of a restricted drug has been authorized by the Minister shall

  1. provide such protection against loss or theft of the restricted drug as may be required by the Minister: and
  2. report forthwith to the Minister and to local law enforcement authorities any loss or theft of a restricted drug.

Access to Cannabis for Medical Purposes Regulations

For Licensed Producers:

29 If a licensed producer experiences a theft of cannabis or an unusual waste or disappearance of cannabis that cannot be explained on the basis of normally accepted business activities, the licensed producer must

  1. report the occurrence to a member of a police force within 24 hours after becoming aware of it; and
  2. provide a written report to the Minister within 10 days after becoming aware of the occurrence.
For Registered Persons:

196 (2) In the case of the loss or theft of cannabis or the registration certificate, the registered person or the individual who is responsible for them must

  1. within the 24 hours after becoming aware of the occurrence, notify a police force; and
  2. within the next 72 hours after becoming aware of the occurrence, notify the Minister, in writing, and include confirmation that the notice required under paragraph (a) has been given.
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