Guidance Document: Inspection Guide for Licensed Dealers of Controlled Substances (CS-GD-016)

Effective Date: 2019/12/09

Table of Contents

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 provide assistance to staff within Health Canada to ensure 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 the relevant programme area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

It is 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 adequately assess the safety and security of controlled substances and precursors. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

1. Introduction

1.1 Purpose

This guidance document outlines the responsibilities, and provides guidance on the legislative and regulatory requirements for licensed dealers conducting activities with controlled substances under the:

for any controlled substances as listed in Schedules I to V of the Controlled Drugs and Substances Act (CDSA).

Guidance documents like this one are meant to help industry understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the regulations are administered in a fair, consistent and effective way across Canada.

1.2 Background

The Office of Controlled Substances (OCS) within Health Canada administers legislation and activities of controlled substances listed in the schedules to the Controlled Drugs and Substances Act (CDSA). The 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.

The OCS establishes open communication with regulated parties and fosters collaboration amongst other federal departments (such as the Canada Border Services Agency) and law enforcement, for the purposes of protecting public health and safety by minimizing the diversion of controlled substances to the illegal market.

The OCS has a regulatory framework that allows Canada to fulfill its international obligations with respect to the monitoring and control of controlled substances and other chemicals used in the production of illegal drugs.

Please refer to the Controlled Substances section for information on the licence and the physical security directive.

1.3 Scope

Under the NCR, FDR and BOTSR, a licence is required for any person to produce, assemble, sell, provide, transport, send, deliver, import and export controlled substances. The relevant regulations also specify requirements for record-keeping, security and reporting.

This document is intended to support licensed dealers who conduct activities with controlled substances by providing guidance for relevant regulations.

To better understand how risk ratings are assigned during inspections of licensed dealers of controlled substances, see the Risk classification guide for Licensed Dealers of Controlled Substances’ Inspection Observations (CS-GD-017).

2. Regulations

For each section below, the reference to the relevant regulations is provided followed by the requirement’s explanation in plain language. Please note that a requirement may apply to more than one regulation and in those instances, the interpretation is only stated once.

The following table shows the three types of icons used in this document, and the way they are intended to be used.

Important: Key or cautionary information to know.

Information: Supplementary information like citations and legal references.

Tip: Suggestions that can help people comply with the regulations.

Information: Health Canada inspectors are designated by the Minister of Health and authorized to conduct inspections of regulated parties to monitor and verify compliance with the CDSA and its associated regulations. Anyone in Canada who conducts an activity or possesses a product, article, device, or thing that is subject to the laws administered and enforced by Health Canada becomes a regulated party and may be subjected to an inspection by Health Canada.

Subsection 31 (1) of the CDSA lists the detailed powers of an inspector to inspect a place that conducts an activity with, or possesses, a controlled substance.

2.1 Advertising and Labelling

Labelling

Type of Controlled Substance Section or Subsection

Narcotic

NCR 70(c)
NCR 70 It is prohibited to
(c) publish any written advertisement respecting a narcotic unless that advertisement displays the symbol “N” in a clear and conspicuous colour and size in the upper left quarter of its first page.

Identification
24 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to narcotics, including labels, orders, shipping documents, invoices and advertising.

Controlled Drugs

FDR Part G, G.06.004(b)
G.06.004 lt is prohibited to
(b) publish any written advertisement respecting a controlled drug unless that advertisement displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page: Controlled drugs

Identification
FDR Part G, G.02.050
G.02.050 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to controlled drugs, including labels, orders, shipping documents, invoices and advertising

Restricted Drugs

FDR Part J, J.01 .063
J.01.063 (1) A licensed dealer that sells or provides a restricted drug must ensure that its package is labelled so that its inner and outer labels show
(a) the proper name or, if there is no proper name, the name of the drug;
(b) the net contents of the package;
(c) the unit strength of the drug and the number of units per package, if applicable;
(d) the lot number of the drug;
(e) the expression "Restricted Drug"; and
(f) the name and municipal address of the manufacturer or assembler of the drug.

Identification
J.01.058 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to restricted drugs, including labels, orders, shipping documents, invoices and advertising.

Benzodiazepines and Other Targeted Substances

BOTSR 78(b)
78 It is prohibited to
(b) publish any written advertisement respecting a targeted substance unless the advertisement
(i) is published in literature distributed to, or in a trade publication for, licensed dealers, pharmacists, practitioners or hospitals, and
(ii) displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page: Targeted substances

Identification

BOTSR 31
A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to targeted substances, including labels, orders, shipping documents, invoices and advertising.

Requirement

A person who advertises in accordance with the relevant regulations, meaning other than for the general public, must clearly show that it is for a controlled substance. Depending on the controlled substance, a symbol must be clearly displayed in the upper left quadrant of the front page of the advertisement:

Controlled drugs
Controlled drugs
Targeted substances
Targeted substances
N
Narcotics

A licensed dealer must include its name, as set out in its dealer’s licence, on all documents and records relating to controlled substances, such as advertising, product labels, orders, shipping documents and invoices.

For restricted drugs, every package must be labelled so that the inner and outer labels show the following:

  1. the proper name or, if there is no proper name, the common name of the drug;
  2. the net contents of the package;
  3. the unit strength of the drug and the number of units per package when it is in unit form;
  4. the lot number of the drug;
  5. the words “Restricted Drug”; and
  6. the name and address of the producer, maker or assembler of the drug.

Advertising to the Public

Advertising to the Public
Type of Controlled Substance Section or Subsection

Narcotic

NCR 70
70 It is prohibited to
(a) advertise a narcotic to the general public;

Controlled Drug

FDR Part G, G. 06.004
G.06.004 lt is prohibited to
(a) advertise a controlled drug to the general public;

Benzodiazepines and Other Targeted Substances

BOTSR 78(a)
78 It is prohibited to
(a) advertise a targeted substance to the general public;

Requirement

No person is permitted to advertise controlled substances to the general public. This includes advertising on a website, social media, flyers, etc. Health Canada’s logo or a photo of the dealer’s licence issued by Health Canada is also not permitted to be posted on an advertisement, website, social media, etc. A licensed dealer may mention on their website that they hold a valid licence but the licence itself cannot be displayed electronically. However, controlled substances may be advertised in published literature or trade publications intended for licensed dealers, pharmacists, practitioners or hospitals.

Important: A licensed dealer is not permitted to offer for sale a controlled substance on its website that is visible to the general public.

2.2 Destruction

Destruction
Type of Controlled Substance Section or Subsection

Narcotics

Destruction at site
NCR 27.5
NCR 27.5 A licensed dealer that intends to destroy a narcotic at the site specified in their licence must ensure that the following conditions are met:
(a) the licensed dealer obtains the prior approval of the Minister;
(b) the destruction is carried out in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i):
(i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, and
(ii) a person who works for or provides services to the licensed dealer and holds a senior position;
(c) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the narcotic was completely destroyed, to which each signatory must add their name in printed letters.

Destruction elsewhere than at site
NCR 27.6
NCR 27.6 A licensed dealer that intends to destroy a narcotic elsewhere than at the site specified in their licence must ensure that the following conditions are met:
(a) the licensed dealer obtains the prior approval of the Minister;
(b) the licensed dealer takes any measures that are necessary to ensure the security of the narcotic while it is being transported in order to prevent its diversion to an illicit market or use;
(c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business;
(d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the narcotic was completely destroyed and containing
(i) the municipal address of the place of destruction,
(ii) the name and quantity of the narcotic and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it,
(iii) the method of destruction,
(iv) the date of destruction, and
(v) the names in printed letters and signatures of that person and the other person who was present at the destruction.

Records keeping
28.4 A licensed dealer must record the following information concerning any narcotic that they destroy at the site specified in their licence:
(a) the municipal address of the place of destruction;
(b) the name, form and quantity of the narcotic and, if applicable, the brand name and quantity of the product containing the narcotic or the name and quantity of the compound containing the narcotic;
(c) the method of destruction; and
(d) the date of destruction.

Controlled Drugs

Destruction at site
G.02.067 A licensed dealer that intends to destroy a controlled drug at the site specified in their licence must ensure that the following conditions are met:
(a) the licensed dealer obtains the prior approval of the Minister;
(b) the destruction occurs in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i):
(i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, and
(ii) a person who works for or provides services to the licensed dealer and holds a senior position;
(c) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the controlled drug was completely destroyed, to which each signatory must add their name in printed letters.

Destruction elsewhere than at site
G.02.068 A licensed dealer that intends to destroy a controlled drug elsewhere than at the site specified in their licence must ensure that the following conditions are met:
(a) the licensed dealer obtains the prior approval of the Minister;
(b) the licensed dealer takes any measures that are necessary to ensure the security of the controlled drug while it is being transported in order to prevent its diversion to an illicit market or use;
(c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business;
(d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the controlled drug was completely destroyed and containing
(i) the municipal address of the place of destruction,
(ii) the name and quantity of the controlled drug and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it,
(iii) the method of destruction,
(iv) the date of destruction, and
(v) the names in printed letters and signatures of that person and the other person who was present at the destruction.

Records keeping
G.02.075 A licensed dealer must record the following information concerning any controlled drug that they destroy at the site specified in their licence:
(a) the municipal address of the place of destruction;
(b) the name, form and quantity of the controlled drug and, if applicable, the brand name and quantity of the product containing the drug or the name and quantity of the compound containing the drug;
(c) the method of destruction; and
(d) the date of destruction.

Restricted Drugs

Destruction at site
FDR Part J, J.01.071
J.01.071 A licensed dealer that intends to destroy a restricted drug at the site specified in their licence must ensure that the following conditions are met:
(a) the licensed dealer obtains the prior approval of the Minister;
(b) the destruction occurs in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i):
(i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, and
(ii) a person who works for or provides services to the licensed dealer and holds a senior position;
(c) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the restricted drug was completely destroyed, to which each signatory must add their name in printed letters.

Destruction elsewhere than at site
FDR Part J, J.01.072
J.01.072 A licensed dealer that intends to destroy a restricted drug elsewhere than at the site specified in their licence must ensure that the following conditions are met:
(a) the licensed dealer obtains the prior approval of the Minister;
(b) the licensed dealer takes any measures that are necessary to ensure the security of the restricted drug while it is being transported in order to prevent its diversion to an illicit market or use;
(c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business;
(d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the restricted drug was completely destroyed and containing
(i) the municipal address of the place of destruction,
(ii) the name and quantity of the restricted drug and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it,
(iii) the method of destruction,
(iv) the date of destruction, and
(vi) the names in printed letters and signatures of that person and the other person who was present at the destruction.

Records keeping
J.01.078 A licensed dealer must record the following information concerning any restricted drug that they destroy at the site specified in their licence:
(a) the municipal address of the place of destruction;
(b) the name, form and quantity of the restricted drug and, if applicable, the brand name and quantity of the product containing the drug or the name and quantity of the compound containing the drug;
(c) the method of destruction; and
(d) the date of destruction.

Benzodiazepines and Other Targeted Substances

Destruction at site
BOTSR 36
(36) A licensed dealer that intends to destroy a targeted substance at the site specified in their licence must ensure that the following conditions are met:

(a) the licensed dealer obtains the prior approval of the Minister;
(b) the destruction is carried out in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i):
(i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, and
(ii) a person who works for or provides services to the licensed dealer and holds a senior position.
(c) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the targeted substance was completely destroyed, to which each signatory must add their name in printed letters.

Destruction elsewhere than at site
BOTSR 37
37 A licensed dealer that intends to destroy a targeted substance elsewhere than at the site specified in their licence must ensure that the following conditions are met:

(a) the licensed dealer obtains the prior approval of the Minister to carry out the destruction;
(b) the licensed dealer takes any measures that are necessary to ensure the security of the targeted substance while it is being transported in order to prevent its diversion to an illicit market or use;
(c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business;
(d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the targeted substance was completely destroyed and containing
(i) the municipal address of the place of destruction,
(ii) the specified name and quantity of the targeted substance and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it,
(iii) the method of destruction,
(iv) the date of destruction, and
(v) the names in printed letters and signatures of that person and the other person who was present at the destruction.

Records keeping
44 A licensed dealer must record the following information concerning any targeted substance that they destroy at the site specified in their licence:
(a) the municipal address of the place of destruction;
(b) the specified name, the form and the quantity of the targeted substance and, if applicable, the brand name and quantity of the product containing the targeted substance or the name and quantity of the compound containing the targeted substance;
(c) the method of destruction; and
(d) the date of destruction.

The requirements for the destruction of controlled substances are detailed in the guidance document Destruction of Narcotics, Controlled and Restricted Drugs and Targeted Substances by Licensed Dealers (CS-GD-020).

Approval prior to destruction

Requirement

Before the destruction of any controlled substances, including laboratory standards and returns, a licensed dealer must obtain approval from the Minister by contacting the Regional CSP office. The QPIC or A/QPIC of the Licensed Dealer compiles all drug products containing controlled substances for destruction. Please refer to the contact list in the guidance document Destruction of Narcotics, Controlled and Restricted Drugs and Targeted Substances by Licensed Dealers (CS-GD-020). Licensed Dealers must provide requested information, including the inventory of all controlled substances to be destroyed and the associated destruction process to the regional CSP office.

Important: The destruction method used must alter or denature a controlled substance to such an extent that its consumption is rendered impossible or improbable.

Information: Destructions must be conducted in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation in the place of destruction.

Destruction at site

Requirement

When the destruction is performed at the site of the licensed dealer, the licensed dealer’s full destruction process needs to be witnessed by qualified witnesses so that it can be verified that controlled substances were in fact destroyed and not diverted.

At least two qualified witnesses who work for the licensed dealer must be present to witness the destruction. At least one of the witnesses must be the SPIC, the QPIC or an A/QPIC. The second witness is a person who works for or provides services to the licensed dealer and holds a senior position such as:

Information: Police Officers may witness destructions.

Only the two witnesses and any other person required for completing the destruction, such as the operator of the equipment, may be present during the destruction.

As soon as the destruction is completed, the witnesses must sign and date a witness document containing the following:

In addition, the licensed dealer must record the following information concerning any controlled substances that they destroy at the site specified in their licence:

The above records must be maintained for a minimum of two (2) years.

Destruction elsewhere than at site

Requirement

If the destruction is performed elsewhere than at the site of the licensed dealer, the destruction must be conducted by a licensed dealer specializing in the destruction of controlled substances. Appropriate measures must be taken to ensure the security of the controlled substances during transit to an off-site location.

If the destruction is performed elsewhere than at the site of the licensed dealer, the witnesses for the destruction must be a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business.

In addition, the person who carried out the destruction must immediately provide the licensed dealer with a dated declaration attesting that the controlled substance was completely and containing the following information:

The above records must be maintained for a minimum of two (2) years.

Important:  As this transaction involves two licensed dealers, they both have to meet the requirements in this guidance document.

A written order is mandatory, meaning the QPIC has to submit a manifest of the exact inventory they are sending for destruction. This written order is signed by the QPIC who verifies and attests the content of the shipment; therefore, they are accountable for the physical inventory transferred/sold.

The chain of signatures is mandatory, except for targeted substances.

At the licensed dealer specializing in destruction, the reception is done by the QPIC or an A/QPIC as they are the only persons authorized to open the cage or vault (according to the type of products) and store the controlled substances in the appropriate location for inventory.

The QPIC or an A/QPIC verifies the accuracy of all goods received against the transfer authorization inventory within 24 hours and enters it in the inventory system.

Destruction of post-consumer returns

The regulatory requirements for the destruction of post-consumer returns are slightly different than the requirements for controlled substances. Licensed dealers specializing in the destruction of controlled substances and who destroy post-consumer returns must refer to the requirements, such as the record keeping responsibilities for licensed dealers who destroy post-consumer returns, outlined in the guidance document Handling and destruction of post-consumer returns containing controlled substances.

Important: 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. However, some security requirements applicable to controlled substances remain.

Important: Licensed dealers specializing in the destruction of controlled substances are not required to apply to Health Canada for an authorization to destroy post-consumer returns; however, 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.

Information: For information on post-consumer returns, refer to Guidance document: Handling and destruction of post-consumer returns containing controlled substances.

2.3 Security

Security Measures

Security Measures
Type of Controlled Substance Section or Subsection

Narcotics

NCR 27
27 A licensed dealer must take any measures that are necessary to ensure the security of any narcotic in their possession and any licence or permit in their possession.

Controlled Drugs

FDR Part G, G.02.062
G.02.062 A licensed dealer must take any measures that are necessary to ensure the security of any controlled drug in their possession and any licence or permit in their possession.

Restricted Drugs

J.01.065 A licensed dealer must take any measures that are necessary to ensure the security of any licence or permit in their possession.

J.01.066 The following persons must take any measures that are necessary to ensure the security of any restricted drugs in their possession:
(a) a licensed dealer;

Benzodiazepines and Other Targeted Substances

35 A licensed dealer must take any measures that are necessary to ensure the security of any targeted substance in their possession and any licence or permit in their possession.

Storage
Place
71 Subject to section 59, every person who is authorized under these Regulations to deal in a targeted substance and who stores the targeted substance must do so in the place used for the purpose of conducting their business or professional practice and in the area in that place where only authorized employees have access, except if the targeted substance is for their own use or the use of another person for whom, or an animal for which, they are responsible.

Requirement

Licensed dealers must take precautions to ensure the safety and security of any controlled substance at their site and, during transportation, to provide protection against loss or theft.

The current requirement is to comply with the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis.

As per circular letter Technical Staff in Charge of Narcotic, Controlled and/or Restricted Drugs (CL 119) dated May 3, 1982, the designated personnel must ensure that alarms and sensors are functioning properly and trigger an alarm response with the monitoring center. All sensors and alarms for vaults or cages should be tested on a regular basis to ensure that the security system is operational.  Records regarding the results of sensors and alarm system testing must be retained for 2 years.  

The physical security measures identified on the licensee's application and approved by the OCS must be maintained. Controlled substances must be stored in a secure and approved location. The licensed dealer must calculate the illicit value of the substances in the approved storage area. The maximum illicit value for the approved cage or vault must include all controlled substance within the cage or vault, such as waste and samples, and must not exceed what is allowed by the security level. The licensed dealer should have a mechanism in place to ensure that the illicit value limit within an approved storage area is not exceeded at any given time.

The access at the licensed site where controlled substances are kept must be restricted to persons whose presence is required by their work responsibilities or to authorized employees.  The opening and closing of the approved storage must be restricted to the QPIC and A/QPIC. Other drugs or articles, such as financial files, equipment, or records must not be kept with controlled substances in the approved vault and cage. Controlled substances owned by different licensed dealers must be stored in separate approved storage areas.

Important: All transactions have to be done under the supervision of the QPIC/AQPIC. If there is no QPIC/AQPIC to supervise operations on the site, it is imperative that all controlled substances are stored in a locked vault or cage. Only QPICs and A/QPICs should have the keys and combinations to unlock cages and vaults.

Packaging

Type of Controlled Substance Section or Subsection

Narcotics

Packaging - sale and provision
NCR 26 (1)
(1)A licensed dealer that sells or provides a narcotic, other than a preparation described in section 36, must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

Exception
(3) Subsection (1) does not apply to a test kit that contains a narcotic and that has a registration number.

Controlled Drugs

Packaging - sale and provision
G.02.060 (1) A licensed dealer that sells or provides a controlled drug must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

Exception
(3) Subsection (1) does not apply to a test kit that contains a controlled drug and that has a registration number.

Restricted Drugs

Packaging - sale and provision
J.01.062 (1) A licensed dealer that sells or provides a restricted drug must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

Exception
(3) Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number.

Benzodiazepines and Other Targeted Substances

Packaging - sale and provision
34 (1) A licensed dealer that sells or provides a targeted substance must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

Exception
(3) Subsection (1) does not apply to a test kit that contains a targeted substance and that has a registration number.

Requirement

Every licensed dealer must securely pack a controlled substance in its immediate container and seal it in such a manner that it cannot be opened without breaking the seal.

Changes to security measures

Changes to security measures
Type of Controlled Substance Section or Subsection

Narcotics

NCR 13(1)(a)
(1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(a) a change affecting the security measures in place at the site specified in the dealer’s licence;

Controlled Drugs

FDR Part G, G.02.018(1)(a)
G.02.018(1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written request to the Minister:
(a) a change affecting the security measures at the site specified in the dealer’s licence;

Restricted Drugs

FDR Part J, J.01.026 (1)(a)
J.01.026 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(a) a change affecting the security measures in place at the site specified in the dealer’s licence;

 Benzodiazepines and Other Targeted Substances

BOTSR 20 (1)
(1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(a) a change affecting the security measures in place at the site specified in the dealer’s licence;

Requirement

A licensed dealer shall obtain the Minister’s approval before making an amendment related to the security at the site referred to in the dealer’s licence.

Important: All proposed changes to the physical security of the storage area for controlled substances, such as the addition of sensors, the addition of a ventilation opening to the vault or the replacement of broken equipment, must be submitted to the Office of Controlled Substances for review, even if the change does not entail a change to the security level.

For the addition of a vault, safe or cage, the new installation cannot be used for the secure storage of controlled substances until the new security level is reflected on the licence.

Information: Please refer to the Controlled Substances website for the application forms to submit an amendment.

Tip: Should there be changes to the state of the site and security measures, such as after a natural catastrophe or damaged/broken security equipment, the OCS should be informed by sending an email to: hc.cds-sdc.sc@canada.ca.

Reporting of Loss or Theft

Reporting of Loss or Theft
Type of Controlled Substance Section or Subsection

Narcotics

Protective measures
NCR 27 A licensed dealer must take any measures that are necessary to ensure the security of any narcotic in their possession and any licence or permit in their possession.

Theft or loss - licences and permits
NCR 27.1 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

Theft or unexplainable loss – narcotics
NCR 27.2 A licensed dealer that becomes aware of a theft of a narcotic or of a loss of a narcotic that cannot be explained on the basis of normally accepted business activities must
(a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and
(b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

Explainable loss of narcotic
NCR 28.3 A licensed dealer that becomes aware of a loss of a narcotic that can be explained on the basis of normally accepted business activities must record the following information:
(a) the name of the lost narcotic and, if applicable, the brand name of the product or the name of the compound containing it;
(b) the form and quantity of the narcotic and, if applicable, the form of the product or compound containing it, the strength per unit of the narcotic in the product or compound, the number of units per package and the number of packages;
(c) the date on which the dealer became aware of the loss; and
(d) the explanation for the loss.

Controlled Drugs

Protective measures
FDR G.02.062 A licensed dealer must take any measures that are necessary to ensure the security of any controlled drug in their possession and any licence or permit in their possession.

Theft or loss - licence and permit
FDR G.02.063 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

Theft or unexplainable loss - controlled drug
FDR G.02.064 A licensed dealer that becomes aware of a theft of a controlled drug or of a loss of a controlled drug that cannot be explained on the basis of normally accepted business activities must
(a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and
(b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

Explainable loss of controlled drug
FDR G.02.074 A licensed dealer that becomes aware of a loss of a controlled drug that can be explained on the basis of normally accepted business activities must record the following information:
(a) the name of the lost controlled drug and, if applicable, the brand name of the product or the name of the compound containing it;
(b) the form and quantity of the controlled drug and, if applicable, the form of the product or compound containing it, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages;
(c) the date on which the dealer became aware of the loss; and
(d) the explanation for the loss.

Restricted Drugs

Protective measures - licences and permits
FDR J.01.065 A licensed dealer must take any measures that are necessary to ensure the security of any licence or permit in their possession.

Protective measures - restricted drugs
FDR J.01.066 The following persons must take any measures that are necessary to ensure the security of any restricted drugs in their possession:
(a) a licensed dealer;

Theft or loss - licences and permits
FDR J.01 .067 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

Theft or loss - restricted drugs
FDR J.01.068 (1) Subject to subsection (2), any person referred to in section J.01.066 who becomes aware of a theft or loss of a restricted drug must
(a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and
(b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

Explainable loss - licensed dealer
(2) Subsection (1) does not apply to a licensed dealer that becomes aware of a loss of a restricted drug that can be explained on the basis of normally accepted business activities.

Explainable loss of restricted drug
FDR J.01.077 A licensed dealer that becomes aware of a loss of a restricted drug that can be explained on the basis of normally accepted business activities must record the following information:
(a) the name of the lost restricted drug and, if applicable, the brand name of the product or the name of the compound containing it;
(b) the form and quantity of the restricted drug and, if applicable, the form of the product or compound containing it, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages;
(c) the date on which the dealer became aware of the loss; and
(d) the explanation for the loss.

Benzodiazepines and Other Targeted Substances

Protective measures
BOTSR 35 A licensed dealer must take any measures that are necessary to ensure the security of any targeted substance in their possession and any licence or permit in their possession.

Theft or loss - licences and permits
BOTSR 35. 1 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

Theft or unexplainable loss - targeted substances
BOTSR 35.2 A licensed dealer that becomes aware of a theft of a targeted substance or of a loss of a targeted substance that cannot be explained on the basis of normally accepted business activities must
(a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and
(b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

Explainable loss of targeted substance
BOTSR 43 A licensed dealer that becomes aware of a loss of a targeted substance that can be explained on the basis of normally accepted business activities must record the following information:
(a) the name of the lost targeted substance and, if applicable, the brand name of the product or the name of the compound containing it;
(b) the form and quantity of the targeted substance and, if applicable, the form of the product or compound containing it, the strength per unit of the targeted substance in the product or compound, the number of units per package and the number of packages;
(c) the date on which the dealer became aware of the loss; and
(d) the explanation for the loss.

Loss or theft of a licence or permit

Requirement

For the loss or theft of a licence or permit issued by the OCS, the licensed dealer must provide a written report to the Minister within 72 hours after becoming aware of it.

Loss or theft of a controlled substance

Requirement

The licensed dealer should have a process in place for comparing the theoretical inventory against the stock inventory to identify any loss or theft in a timely manner.  

A licensed dealer should also establish limits to determine what is to be considered a loss or an unusual disappearance of controlled substances.  The reasonable limits, or explainable loss, should be based on the nature of their business. For example, a manufacturer may lose a quantity of controlled substances during the manufacturing process; however, any limit for a loss would not be relevant to distributors. The rationale of the established limits of loss has to be demonstrated.

Important:  For finished products, when it is possible to count the unit, the limit should be practically 0.

Even if an explainable loss of controlled substances doesn't have to be reported to the OCS, the following information must be recorded:

If a licensed dealer experiences a theft of a controlled substance or a loss of a controlled substance that cannot be explained on the basis of normally accepted business activities, the licensed dealer must provide a notice to:

  1. a member of a police force within 24 hours after becoming aware of the theft or loss and
  2. the OCS, in writing, within 72 hours after becoming aware of the theft or loss

When submitting the loss or theft report, all information available at the time of submission should be provided.

An internal investigation should be initiated without delay after a loss, a suspected loss, or a theft is discovered. The licensed dealer should take sufficient measures to remediate the security issue, if applicable.

Important:  The licensed dealer must report the loss or theft to the OCS within 72 hours of discovery. If the investigation is not complete at the time of submission, any additional information should be provided to the OCS as an amendment to the original form when available.

For more information, please refer to the Reporting Loss or Theft of Controlled substances and Precursors(CS-GD-005) guidance document.

Suspicious Transactions

Suspicious Transactions
Type of Controlled Substance Section or Subsection

Narcotics

Suspicious transaction
NCR 27.3 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a narcotic to an illicit market or use:
(a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;
(b) the name and municipal address of the other party to the transaction;
(c) details of the transaction, including its date and time, its type, the name and quantity of the narcotic and, in the case of a product or compound, the quantity of every narcotic that it contains;
(d) in the case of a product that contains the narcotic, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any; and
(e) a detailed description of the reasons for those suspicions.

Good faith
NCR (2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

Non-disclosure
NCR (3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Partial protection against self-incrimination
NCR 27.4 A report made under any of sections 27.1 to 27.3, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Controlled Drugs

Suspicious transaction
FDR G.02.065 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a controlled drug to an illicit market or use:
(a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;
(b) the name and municipal address of the other party to the transaction;
(c) details of the transaction, including its date and time, its type, the name and quantity of the controlled drug and, in the case of a product or compound, the quantity of every controlled drug that it contains;
(d) in the case of a product that contains the controlled drug, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2; and
(e) a detailed description of the reasons for those suspicions.

Good faith
(2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

Non-disclosure
(3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Partial protection against self-incrimination
FDR G.02.066  A report made under any of sections G.02.063 to G.02.065, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Restricted Drugs

Suspicious transaction
FDR J.01.069 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a restricted drug to an illicit market or use:
(a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;
(b) the name and municipal address of the other party to the transaction;
(c) details of the transaction, including its date and time, its type, the name and quantity of the restricted drug and, in the case of a product or compound, the quantity of every restricted drug that it contains;
(d) in the case of a product that contains the restricted drug, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2, if any; and
(e) a detailed description of the reasons for those suspicions.

Good faith
(2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

Non-disclosure
(3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Partial protection against self-incrimination
FDR J.01.070 A report made under any of sections J.01.067 to J.01.069, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Benzodiazepines and Other Targeted Substances

Suspicious transaction
BOTSR 35.3 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a targeted substance to an illicit market or use:
(a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;
(b) the name and municipal address of the other party to the transaction;
(c) details of the transaction, including its date and time, its type, the specified name and quantity of the targeted substance and, in the case of a product or compound, the quantity of every targeted substance that it contains;
(d) in the case of a product that contains the targeted substance, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any; and
(e) a detailed description of the reasons for those suspicions.

Good faith
(2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

Non-disclosure
(3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Partial protection against self-incrimination
BOTSR 35.4 A report made under any of sections 35.1 to 35.3, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Requirement

A licensed dealer must have a system in place with a written procedure to detect suspicious transactions. It is important that licensed dealers take reasonable measures to identify their customers, understand the normal and expected transactions conducted by those customers and, thereby, identify those transactions conducted by their customers that appear suspicious in nature.

Tip: Please refer to the guidance document Recording and Reporting of Suspicious Transactions for Controlled Substances and Precursors for requirements on the reporting of suspicious transactions (CS-GD-025).

In the course of their activities, if a licensed dealer has reasonable grounds to suspect that a transaction may be related to the diversion of a controlled substance to an illicit market, they must inform the OCS within 72 hours after becoming aware of the transaction.  The following information must be provided:

Licensed dealers must not disclose that they have made a suspicious transaction record under this section or disclose the contents of the record, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

Important: No civil proceedings lie against a licensed dealer for having provided the report in good faith.

Transportation of controlled substances

Transportation of controlled substances
Type of Controlled Substance Section or Subsection

Narcotics

Transport
NCR 26.1 (1) A licensed dealer must, in taking delivery of a narcotic that they have imported or in making delivery of a narcotic,
(a) take any measures that are necessary to ensure the security of the narcotic while it is being transported;
(b) subject to subsection (2), use a method of transportation that permits an accurate record to be kept of all handling of the narcotic as well as of the signatures of every person handling the narcotic until it is delivered to the consignee;
(c) in the case of an imported narcotic, transport it directly to the site specified in their licence after it is released under the Customs Act; and
(d) in the case of a narcotic that is to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.

Exception
(2) A licensed dealer may have a verbal prescription narcotic transported by a common carrier.

Controlled Drugs

Transport
FDR G.02.061 (1) A licensed dealer must, in taking delivery of a controlled drug that they have imported or in making delivery of a controlled drug,
(a) take any measures that are necessary to ensure the security of the drug while it is being transported;
(b) subject to subsection (2), use a method of transportation that permits an accurate record to be kept of all handling of the drug as well as the signatures of every person handling it until it is delivered to the consignee;
(c) in the case of an imported drug, transport it directly to the site specified in their licence after it is released under the Customs Act; and
(d) in the case of a drug to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.

Exception
(2) A licensed dealer may have a preparation transported by a common carrier.

Restricted Drugs

Transport
FDR J.01.064 A licensed dealer must, in taking delivery of a restricted drug that they have imported or in making delivery of a restricted drug,
(a) take any measures that are necessary to ensure the security of the drug while it is being transported;
(b) use a method of transportation that permits an accurate record to be kept of all handling of the drug as well as of the signatures of every person handling it until it is delivered to the consignee;
(c) in the case of an imported drug, transport it directly to the site specified in their licence after it is released under the Customs Act; and
(d) in the case of a drug to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.

Benzodiazepines and Other Targeted Substances

Transport
BOTSR 34.1 A licensed dealer must, in taking delivery of a targeted substance that they have imported or in making delivery of a targeted substance,
(a) take any measures that are necessary to ensure the security of the targeted substance while it is being transported; 
(b) in the case of an imported targeted substance, transport it directly to the site specified in their licence after it is released under the Customs Act; and
(c) in the case of a targeted substance that is to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.

Requirement

A licensed dealer who sends a controlled substance is responsible for the security of that controlled substance until such time that the final recipient has signed an acknowledgment.

Tip: The requirement for a chain of signatures does not apply to targeted substances.

The licensed dealer must take precautions to ensure the safety and security of any controlled substance during transportation to provide protection against loss or theft. For example, a licensed dealer should assess the worst case scenario to determine the impact and the risk of diversion to illicit markets. The licensed dealer who sends a controlled substance must choose a transport company that is able to ensure the safety of controlled substances. Methods of transportation used by the licensed dealer must ensure that accurate records are kept of the substance while in transit and of the signatures of any persons having charge of the substance, such as a chain of signatures, until it is delivered to its final recipient.

A common carrier can only transport a verbal prescription narcotic or a preparation of controlled drugs.

In order to minimize the risk of diversion, no identification of the controlled substance, such as name, potency and quantities, should be displayed on the boxes, label or shipper.

Important:  The licensed dealer is responsible to retain comprehensive records, such as the chain of signatures, for a minimum of 2 years in an auditable format.

2.4 Dealer’s Licence

Possession of controlled substances

Possession of controlled substances
Type of Controlled Substance Section or Subsection

Narcotics

Authorized persons
NCR 3(1)(a)(i)
3 (1) A person is authorized to possess a narcotic if the person has obtained the narcotic in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, or from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that narcotic, and the person
(a) requires the narcotic for their business or profession and is
(i) a licensed dealer,

General
8 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a narcotic if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

Controlled Drugs

Authorized persons
G.01.005(1)(a)(i)
G.01.005 (1) A person is authorized to possess a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 and 17 of Part I of the schedule to this Part if the person has obtained the controlled drug in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, or from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that controlled drug, and the person
(a) requires the controlled drug for their business or profession and is
(i) a licensed dealer,

General
G.02.001 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Restricted Drugs

Authorized persons
FDR, Part J, J.01.004(1)(a) 
J.01.004 (1) The following persons are authorized to possess a restricted drug listed in Part I of the schedule to this Part or referred to in paragraph (b) of the definition restricted drug in section J.01.001:
(a) a licensed dealer;

General
J.01.009 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Benzodiazepines and Other Targeted Substances

Authorized persons
3 (1) A person is authorized to possess a targeted substance set out in Part 2 of Schedule 1 if the person has obtained the targeted substance in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, or from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that targeted substance, and the person
(a) requires the targeted substance for their business or profession and is
(i) a licensed dealer,

General
12 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a targeted substance if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

Alteration prohibited
74 A person must not make any mark on or alter or deface in any manner any licence, permit or registration number issued under these Regulations.

Requirement

A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only controlled substances specified on their licence. A licensed dealer may only possess a controlled substance if required for their business and obtained under the relevant regulations.

A person must not make any mark on or alter or deface in any manner any licence, permit or registration number issued under the relevant regulations.

Terms and conditions may be added to the licence of a licensed dealer, as needed. A licensed dealer must comply with any conditions set out on its license.

Important: The licence cannot be displayed in the lobby of the licensed dealer.

2.5 Personnel

Designated Personnel

Designated Personnel
Type of Controlled Substance Section or Subsection

Narcotics

Qualified person in charge present
NCR 8 (2) A licensed dealer may conduct an activity in relation to a narcotic at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Senior person in charge
NCR 9.1 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to narcotics that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

Qualified person in charge
NCR 9.2 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to narcotics that are specified in the licence application and for ensuring that those activities comply with these Regulations. The applicant may designate themself if the applicant is an individual.

Alternate qualified person in charge
(2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

Qualifications
(3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:
(a) they work at the site specified in the dealer’s licence;
(b) they
(i) are entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,
(ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
(iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold
(A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;
(c) they have sufficient knowledge of and experience with the use and handling of the narcotics specified in the dealer’s licence to properly carry out their duties; and
(d) they have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

Exception
(4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if
(a) no other individual working at the site meets those requirements;
(b) those requirements are not necessary for the activities specified in the licence; and
(c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

Controlled Drugs

Qualified person in charge present
FDR Part G, G.02.001 (2)
(2) A licensed dealer may conduct an activity in relation to a controlled drug at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Senior person in charge
FDR Part G, G.02.003
G.02.003 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to controlled drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

Qualified person in charge
FDR Part G, G.02.004
G.02.004 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to controlled drugs that are specified in the licence application and for ensuring that those activities comply with this Part. The applicant may designate themself if the applicant is an individual.

Alternate qualified person in charge
(2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

Qualifications
(3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:
(a) they work at the site specified in the dealer’s licence;
(b) they
(i) are a person entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,
(ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
(iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold
(A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;
(c) they have sufficient knowledge of and experience with the use and handling of the controlled drugs specified in the dealer’s licence to properly carry out their duties; and
(d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

Exception
(4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if
(a) no other individual working at the site meets those requirements;
(b) those requirements are not necessary for the activities specified in the licence; and
(c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

Restricted Drugs

Qualified person in charge present
FDR, Part J, J.01.009(2)
(2) A licensed dealer may conduct an activity in relation to a restricted drug at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Senior person in charge
J.01 .011 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to restricted drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

Qualified person in charge
J.01 .012 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to restricted drugs that are specified in the licence application and for ensuring that those activities comply with this Part. The applicant may designate themself if the applicant is an individual.

Alternate qualified person in charge
(2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

Qualifications
(3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:
(a) they work at the site specified in the dealer's licence;
(b) they
(i) are a person entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,
(ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
(iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold
(A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;
(c) they have sufficient knowledge of and experience with the use and handling of the controlled drugs specified in the dealer’s licence to properly carry out their duties; and
(d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

Exception
(4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if
(a) no other individual working at the site meets those requirements;
(b) those requirements are not necessary for the activities specified in the licence; and
(c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

Benzodiazepines and Other Targeted Substances

Qualified person in charge present
BOTSR 12(2)
(2) A licensed dealer may conduct an activity in relation to a targeted substance at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Senior person in charge
BOTSR 14
An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to targeted substances that are specified in the licence application. The applicant may designate themself if the applicant is an individual

Qualified person in charge
BOTSR 15
(1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to targeted substances that are specified in the licence application and for ensuring that those activities comply with these Regulations. The applicant may designate themself if the applicant is an individual.

Alternate qualified person in charge
(2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

Qualifications
(3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:
(a) they work at the site specified in the dealer’s licence;
(b) they
(i) are entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,
(ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
(iii)  hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold
(A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
(B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;
(c) they have sufficient knowledge of and experience with the use and handling of the targeted substances specified in the dealer’s licence to properly carry out their duties; and
(d)  they have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

Exception
(4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if
(a) no other individual working at the site meets those requirements;
(b) those requirements are not necessary for the activities specified in the licence; and
(c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

Requirement

A licensed dealer must designate one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the site specified in the licence, supervise the activities with controlled substances specified in the licence and ensure that those activities meet the regulations. The qualified person in charge is responsible for the inventory and for all transactions with controlled substances at the licensed site.

Important: The licensed dealer shall not perform regulated activities outside the working hours of any Person-in-Charge, or when no Person-in-Charge was physically onsite. All controlled substances must be locked up in the absence of a person in charge.

Important: The qualified person in charge assumes full responsibility for all transactions involving controlled substances. For the purposes of these guidelines, transactions include receiving, shipping, and any time the cage, vault, safe or storage room is opened, as only the qualified person in charge and the alternate qualified person in charge are authorized to access the secure area. All internal use of the controlled substances in the company (analysis, manufacturing, packaging, etc.) must be done in accordance with a perpetual tracking system allowing for the reconciliation of the inventory.

The licensed dealer may employ an alternate qualified person in charge at the site who may perform the duties of the qualified person in charge when that person is absent.
 
To properly carry out their duties, the qualified person in charge and, if applicable, the alternate qualified person in charge must:

The licensed dealer is responsible for providing adequate resources to train the QPIC and A/RPIC(s). Training may include following a written training program and job shadowing. Written evidence, such as training records, should be available for auditing purposes.

A qualified person in charge or an alternate qualified person in charge must be available on site during the hours of operations of the licensed dealer. Physical supervision by the qualified person in charge or an alternate qualified person is required.  Mechanisms should also be in place to ensure limited access to the storage area to minimize the risk of diversion.

Changes in personnel

Changes in personnel
Type of Controlled Substance Section or Subsection

Narcotics

Application
13 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(b) the replacement of the senior person in charge;
(c) the replacement of the qualified person in charge; Or
(d) the replacement or addition of an alternate qualified person in charge.

Notice - five days
14.1 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Notice - 10 days
14.2 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(a) a person ceases to act as the senior person in charge;

Controlled Drugs

Application
FDR Part G, G.02.018(1)
G.02.018(1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written request to the Minister:
(b) the replacement of the senior person in charge;
(c) the replacement of the qualified person in charge; or
(d) the replacement or addition of an alternate qualified person in charge.

Notice - five days
FDR Part G, G.02.022
G.02.022 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Notice - ten days
FDR Part G, G.02.023
G.02.023 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(a) a person ceases to act as the senior person in charge;

Restricted Drugs

Application
FDR, Part J, J.01.026
J.01.026 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(b) the replacement of the senior person in charge;
(c) the replacement of the qualified person in charge; or
(d) the replacement or addition of an alternate qualified person in charge.

Notice - five days
FDR, Part J, J.01.030
J.01.030 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Notice - ten days
J.01.031 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(a) a person ceases to act as the senior person in charge;

Benzodiazepines and Other Targeted Substances

Application
20 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:
(b) the replacement of the senior person in charge;
(c) the replacement of the qualified person in charge; or
(d) the replacement or addition of an alternate qualified person in charge.

Notice - five days
21.1 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

Notice - 10 days
21.2 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(a) a person ceases to act as the senior person in charge;

Requirement

A licensed dealer must obtain the Minister's approval before making any of the following changes to the personnel:

Information:  Please refer to the Controlled Substances website for the application forms to submit an amendment.

A licensed dealer shall advise the OCS:

Only individuals authorized to place an order can place orders and sign for the purchase of a controlled substance on behalf of the licensed dealer.

Important: Licensed dealers do not have to notify the OCS of changes to the list of individuals authorized to place an order. That list should be maintained by licensed dealers.

Important: No regulated activities are to take place in the absence of a QPIC or A/QPIC.

2. 6 Documents

Documents
Type of Controlled Substance Section or Subsection

Narcotics

Method of recording information
NCR 28 A licensed dealer must record any information that they are required to record under these Regulations using a method that permits an audit of it to be made at any time.

Information - general
28.1 A licensed dealer must record the following information:
(a) the name, form and quantity of any narcotic that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;
(b) the name, form and quantity of any narcotic that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;
(c) in the case of a narcotic that the dealer sells or provides,
(i) the brand name of the product or the name of the compound containing the narcotic and the name of the narcotic,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any,
(iii) the form and quantity of the narcotic and, if applicable, the strength per unit of the narcotic in the product or compound, the number of units per package and the number of packages,
(iv) the name and municipal address of the person to whom it was sold or provided, and
(v) the date on which it was sold or provided;
(d) the name, form and quantity of any narcotic that the dealer manufactures or assembles and the date on which it was placed in stock and, if applicable, the strength per unit of the narcotic in the product or compound, the number of units per package and the number of packages;
(e) the name and quantity of any narcotic that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;
(f) the name, form and quantity of any narcotic in stock at the end of each month;
(g) the name, form and quantity of any narcotic that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;
(h) the name, form and quantity of any narcotic that the dealer imports, the date on which it was imported, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and
(i) the name, form and quantity of any narcotic that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

Retention period
29 A licensed dealer and a former licensed dealer must keep any document containing the information that they are required to record under these Regulations, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Location
29. 1 The documents must be kept
(a) in the case of a licensed dealer, at the site specified in their licence; and
(b) in the case of a former licensed dealer, at a location in Canada.

Quality of documents
29.2 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Controlled Drugs

Method of recording information
G.02.071 A licensed dealer must record any information that they are required to record under this Part using a method that permits an audit of it to be made at any time.

Information - general
G.02.072 A licensed dealer must record the following information:
(a) the name, form and quantity of any controlled drug that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;
(b) the name, form and quantity of any controlled drug that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;
(c) in the case of a controlled drug that the dealer sells or provides,
(i) the brand name of the product or the name of the compound containing the controlled drug and the name of the controlled drug,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any,
(iii) he form and quantity of the controlled drug and, if applicable, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages,
(iv) the name and municipal address of the person to whom it was sold or provided, and
(v) the date on which it was sold or provided;
(d) the name, form and quantity of any controlled drug that the dealer manufactures or assembles and the date on which it was placed in stock and, if applicable, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages;
(e) the name and quantity of any controlled drug that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;
(f) the name, form and quantity of any controlled drug in stock at the end of each month;
(g)  the name, form and quantity of any controlled drug that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;
(h) the name, form and quantity of any controlled drug that the dealer imports, the date on which it was imported, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and
(i) the name, form and quantity of any controlled drug that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

Retention period
G.02.077 A licensed dealer and a former licensed dealer must keep any document containing the information that they are required to record under this Part, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Location
G.02.078 The documents must be kept
(a) in the case of a licensed dealer, at the site specified in their licence; and
(b) in the case of a former licensed dealer, at a location in Canada.

Quality of documents
G.02.079 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Restricted Drugs

Method of recording information
J.01.075 A licensed dealer must record any information that they are required to record under this Part using a method that permits an audit of it to be made at any time.

Information - general
J.01.076 A licensed dealer must record the following information:
(a) the name, form and quantity of any restricted drug that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;
(b) the name, form and quantity of any restricted drug that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;
(c) in the case of a restricted drug that the dealer sells or provides,
(i) the brand name of the product or the name of the compound containing the restricted drug and the name of the restricted drug,
(ii)  the drug identification number that has been assigned to the product under section C.01.014.2, if any,
(iii) the form and quantity of the restricted drug and, if applicable, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages,
(iv) the name and municipal address of the person to whom it was sold or provided, and
(v) the date on which it was sold or provided;
(d) the name, form and quantity of any restricted drug that the dealer manufactures or assembles and the date on which it was placed in stock and, if applicable, the strength per unit of the restricted drug in the product or compound, the number of units per package and the number of packages;
(e) the name and quantity of any restricted drug that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;
(f) the name, form and quantity of any restricted drug in stock at the end of each month;
(g) the name, form and quantity of any restricted drug that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;
(h) the name, form and quantity of any restricted drug imported, the date on which it was that the dealer imports, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and
(i) the name, form and quantity of any restricted drug that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

Retention period
J.01.084 A licensed dealer, a former licensed dealer, an institution and a person referred to in section J.01.083 must keep any document containing the information that they are required to record under this Part, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Location
J.01 .085 The documents must be kept
(a) in the case of a licensed dealer, at the site specified in their licence;
(d) in the case of a former licensed dealer, at a location in Canada.

Quality of documents
J.01.086 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Benzodiazepines and Other Targeted Substances

Method of recording information
40 A licensed dealer must record any information that they are required to record under these Regulations using a method that permits an audit of it to be made at any time.

Information - general
41 A licensed dealer must record the following information:
(a) the specified name, the form and the quantity of any targeted substance that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;
(b) the specified name, the form and the quantity of any targeted substance that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;
(c) in the case of a targeted substance that the dealer sells or provides,
(i) the brand name of the product or the name of the compound containing the targeted substance and the specified name of the targeted substance,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any,
(iii) the form and quantity of the targeted substance and, if applicable, the strength per unit of the targeted substance in the product or compound, the number of units per package and the number of packages,
(iv) the name and municipal address of the person to whom it was sold or provided, and
(v) the date on which it was sold or provided;
(d) the specified name, the form and the quantity of any targeted substance that the dealer produces and the date on which it was placed in stock and, if applicable, the strength per unit of the targeted substance in the product or compound, the number of units per package and the number of packages
(e) the specified name and the quantity of any targeted substance that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;
(f) the specified name, the form and the quantity of any targeted substance in stock at the end of each month;
(g) the specified name, the form and the quantity of any targeted substance that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;
(h) the specified name, the form and the quantity of any targeted substance that the dealer imports, the date on which it was imported, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and
(i) the specified name, the form and the quantity of any targeted substance that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

Retention period
75 A person must keep any document containing all of the information that they are required to record under these Regulations, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Location
76 The documents must be kept
(a) in the case of a licensed dealer, at the site specified in their licence; and
(b) in the case of a former licensed dealer or any other person, at a location in Canada.

Quality of documents
77 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Requirement

A licensed dealer must furnish information respecting dealings with controlled substances; produce books and records for the inspector, and permit the inspector to make copies of books, and records or documents; and permit the inspector to check stock.

The QPIC or an A/QPIC must be on site for the reception of a controlled substance. Upon receipt of a controlled substance, the licensed dealer must weigh or count and verify the controlled substance received and add it to their inventory system on the day of receipt.

Important: If it is not possible to verify the inventory within the reception due to the volume of the controlled substances received, the licensed dealer must take all necessary steps to ensure the 100% verification is completed upon arrival and within 24 hours post reception (timely manner).

A licensed dealer must record the following information:

A perpetual inventory must be maintained which must list all controlled substances including returns, destruction material, retained samples, etc.

Important:  The date sold is the date the substance left the building and the date received is the date the substance entered the building.

Monthly activities reports

Requirement

A licensed dealer shall keep a record of the name, form and quantity of any controlled substance in stock at the end of each month. The monthly physical inventory must include all finished product, raw materials, samples, products to be destroyed and returns. The OCS highly recommends that the licensed dealer performs an inventory at the end of the last day of each month. The actual physical inventory count must be used and not the theoretical quantity. Seals of containers should be verified during the inventory. Any differences between theoretical and physical count must be documented and justified. Adjustments made to records should be explained and documented. Losses must be reported accordingly.

The requirements for the monthly report are defined in the circular letter The Monthly Activities Report
Requirements for All Licensed Dealers who Possess a Licence Pursuant to the Provisions of the Controlled Drugs and Substances Act and its Regulations (CL #2088) dated December 5, 2018.

All licensed dealers must submit a monthly activities report of all transactions involving specific controlled substances using the template provided by the OCS. The monthly activities report must be submitted within 15 calendar days of the period that is being reported.

Important: All information in the monthly activities report must balance.

If no activities were conducted during the reporting period, a nil report is required to be submitted with the same deadlines indicated above.

Tip: Information on monthly activities reports is reviewed by the OCS. For your reference please find below a list of reminders:

  • If no transactions regarding substances listed in the template have occurred in the reporting period, a nil report must be provided.
  • Licensed dealers should select names from the substances lists and not a synonym.
  • For clients, the physical address must be used and not the billing address.
  • All transactions within the reporting period, including imports and exports, must be reported.
For imports and exports, the transaction date should match the date reported in the declaration.

Information: Should you have questions on the monthly activities report, please contact the monitoring section at: hc.ocscontrolleddrugsreport-rapportsustancescontrolleesbsc.sc@canada.ca

Information:  A licensed dealer may also be a pharmacy. Only products sold under the licensed dealer should be reported in the monthly activities report. Products sold through the pharmacy licence should not be included.

Records maintained for 2 years in an auditable manner

Requirement

The licensed dealer must keep any document containing all of the information that they are required to record pertaining to controlled substances, including every declaration and a copy of every report, for a minimum of two years following the day on which the last record is recorded in the document at the site specified in their licence. All records must be kept at the licensed site, physically or electronically. All records demonstrating that the licensed dealer is in compliance with their legal obligations should also be maintained.

Important: In the case of a former licensed dealer, documents are to be kept at a location in Canada.

All records must be kept in a manner that permits an audit to be made at any time. For example, the controlled substances inventory records must be retained by the licensed dealer to allow inventory verification during the inspection. The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Licensed dealers, as regulated parties, are expected to:

Important: The licensed dealer is responsible to maintain all records required by the relevant regulations. The system used by the licensed dealer must ensure that all records can be accessed in a timely manner.

Information:  All records, including documents that confirm that the licensed dealer complies with the relevant regulations, are to be maintained for a minimum of 2 years.

2.7 Annual Reports

Annual Reports
Type of Controlled Substance Section or Subsection

Narcotics

Annual report
28.5 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains
(a) the name, form and total quantity of each narcotic that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each narcotic that they use to manufacture or assemble a product or compound;
(b) the name, form and quantity of each narcotic in physical inventory taken at the site specified in their licence at the end of the calendar year; and
(c) the name, form and quantity of any narcotic that has been lost or stolen in the course of conducting activities during the calendar year.

Non-renewal or revocation within first three months
(2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister
(a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and
(b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Non-renewal or revocation after third month
(3) If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Controlled Drugs

Annual report
G.02.076 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains
(a) the name, form and total quantity of each controlled drug that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each controlled drug that they use to manufacture or assemble a product or compound;
(b) the name, form and quantity of each controlled drug in physical inventory taken at the site specified in their licence at the end of the calendar year; and
(c) the name, form and quantity of any controlled drug that has been lost or stolen in the course of conducting activities during the calendar year.

Non-renewal or revocation within first three months
(2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister
(a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and
(b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Non-renewal or revocation after third month
(3) If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Restricted Drugs

Annual report
J.01.079 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains
(a) the name, form and total quantity of each restricted drug that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each restricted drug that they use to manufacture or assemble a product or compound;
(b) the name, form and quantity of each restricted drug in physical inventory taken at the site specified in their licence at the end of the calendar year; and
(c) the name, form and quantity of any restricted drug that has been lost in the course of conducting activities during the calendar year.

Non-renewal or revocation within first three months
(2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister
(a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and
(b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Non-renewal or revocation after third month
(3) If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Benzodiazepines and Other Targeted Substances

Annual report
45 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains
(a) the specified name, the form and the total quantity of each targeted substance that they receive, produce, assemble, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each targeted substance that they use to manufacture or assemble a product or compound;
(b) the specified name, the form and the quantity of each targeted substance in physical inventory taken at the site specified in their licence at the end of the calendar year; and
(c) the specified name, the form and the quantity of any targeted substance that has been lost or stolen in the course of conducting activities during the calendar year.

Non-renewal or revocation within first three months
(2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister
(a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and
(b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Non-renewal or revocation after third month
(3)  If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Annual Report

Requirement

A licensed dealer must provide to the OCS, within three months after the end of each calendar year, an annual report that contains:

A licensed dealer is required to report the amount of all controlled substances in their possession at the close of business on December 31. The original copy of the report using the template provided by the OCS must be submitted to the OCS by March 31. Data submitted by the licensed dealer on the annual report at the end of each year must be based on physical inventory (weight or count of each product).  The annual report must include the requested information, including exported amounts and returns. 

If no activities were conducted during the reporting period, a nil report is required to be submitted with the same deadlines as indicated above.

Important: If a licensed dealer's licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the OCS:

  • within three months after the end of the preceding calendar year, the annual report in respect of that year; and
  • within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the above-noted information for that period.

The quantity in the physical inventory is to be calculated as of the date of expiry or revocation.

Important: If a licensed dealer's licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the OCS:

  • within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information above for that period

The quantity in physical inventory is to be calculated as of the date of expiry or revocation.

2.8 Sales

Selling to an unauthorized person

Selling to an unauthorized person
Type of Controlled Substance Section or Subsection

Narcotics

Sale to another licensed dealer
NCR 25 A licensed dealer may sell or provide a narcotic to another licensed dealer.

Sale to pharmacist
NCR 25.1 (1) Subject to subsection (2), a licensed dealer may sell or provide a narcotic to a pharmacist.
(2) A licensed dealer must not sell or provide to a pharmacist who is named in a notice issued under subsection 48(1) the narcotics referred to in the notice
(3) Subsection (2) does not apply to a licensed dealer that has received a notice of retraction issued under section 49 in respect of a pharmacist named in a notice issued under subsection 48(1)

Sale to practitioner
NCR 25.2 (1) Subject to subsections (2) and (3), a licensed dealer may sell or provide to a practitioner a narcotic other than diacetylmorphine (heroin)
(2) A licensed dealer may sell or provide diacetylmorphine (heroin) to the following practitioners:
(a) a practitioner of medicine;
(b) a practitioner of dentistry, if practising in a hospital that provides care or treatment to persons; or
(c) a nurse practitioner
(3) A licensed dealer must not sell or provide to a practitioner who is named in a notice issued under subsection 59(1) the narcotics referred to in the notice unless the dealer has received a notice of retraction issued under section 60.

Provision to hospital employee
NCR 25.3 (1) Subject to subsection (2), a licensed dealer may provide a narcotic to a hospital employee.
(2) A licensed dealer may provide diacetylmorphine (heroin) to a hospital employee only if that hospital provides care or treatment to persons.

Sale to exempted person
NCR 25.4 A licensed dealer may sell or provide a narcotic to a person who is exempted under section 56 of the Act with respect to the possession of that narcotic.

Sale to Minister
NCR 25.5 A licensed dealer may sell or provide a narcotic to the Minister.   

Controlled Drugs

Sale to another licensed dealer
G.02.051 A licensed dealer may sell or provide a controlled drug to another licensed dealer.

Sale to pharmacist
G.02.052 (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a pharmacist.
(2) A licensed dealer must not sell or provide to a pharmacist named in a notice issued under section G.03.017.2 the controlled drugs referred to in the notice unless the dealer has received a notice of retraction issued under section G.03.017.3.

Sale to practitioner
G.02.053 (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a practitioner.
(2) A licensed dealer must not sell or provide to a practitioner who is named in a notice issued under section G.04.004.2 the controlled drugs referred to in the notice, unless the dealer has received a notice of retraction issued under section G.04.004.3.

Provision to hospital employee
G.02.054 A licensed dealer may provide a controlled drug to a hospital employee.

Sale to exempted person
G.02.055 A licensed dealer may sell or provide a controlled drug to a person who is exempted under section 56 of the Act with respect to the possession of that drug.

Sale to Minister
G.02.056 A licensed dealer may sell or provide a drug to the Minister.

Restricted Drugs

J.01.059 (1) Despite section C.08.002 and subject to subsections (3) and (4), a licensed dealer may sell a restricted drug to an institution for one of the following purposes if the institution submits to the dealer or the Minister an application to purchase the drug and the Minister issues a prior written authorization for the sale:
(a) clinical testing in the institution by qualified investigators for the purpose of determining the hazards and efficacy of the drug; or
(b) laboratory research in the institution by qualified investigators.

J.01.060 A licensed dealer may sell or provide a restricted drug to the Minister.

Benzodiazepines and Other Targeted Substances

 BOTSR 32 (1)
(1) Subject to subsection (2), a licensed dealer may sell or provide a targeted substance to
(a) another licensed dealer,
(b) a pharmacist,
(c) a practitioner,
(d) a hospital,
(e) a person to whom an exemption relating to the substance has been granted under section 56 of the Act; or
(f) the Minister.  

BOTSR 32(2)
(2) The licensed dealer must not sell or provide a targeted substance to a pharmacist or practitioner named in a notice issued under section 79, unless the dealer has received a notice of retraction issued under section 80.

Requirement

A licensed dealer may sell or provide a narcotic other than diacetylmorphine (heroin), a controlled drug or a targeted substance to:

The licensed dealer should have a process in place to verify the status of the person to whom the controlled substances are sold or provided. If a section 56 exemption is in place, the terms and conditions of that exemption must be followed. Records must be kept. If a licensed dealer is providing or selling to another licensed dealer, they should verify the customer's licence to ensure that it is valid and that the relevant substance is listed on the licence.

A licensed dealer may sell a restricted drug to an institution for one of the following purposes if the institution submits to the dealer or to the Minister an application to purchase the drug and the Minister issues a prior written authorization for the sale:

A licensed dealer may also sell or provide a restricted drug to the Minister.

Selling to an person named in a notice of restriction

Requirement

All licensed dealer must know their client. No licensed dealer shall sell to a pharmacist or a practitioner named in a notice of restriction. This does not apply if there is a notice of retraction of the notice for the pharmacist or practitioner in question. The licensed dealer should have a proper system for checking orders against the notices of restriction.

2.9 Orders

Orders
Type of Controlled Substance Section or Subsection

Narcotics

Written order
NCR 25.6 A licensed dealer may sell or provide a narcotic under any of sections 25 to 25.5 if
(a) the dealer has received a written order that specifies the name and quantity of the narcotic to be supplied and is signed and dated
(i) in the case of a narcotic to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to sign the order, and
(ii) in any other case, by the person to whom the narcotic is to be sold or provided; and
(b) the dealer has verified the signature, if it is unknown to them.

Verbal order
NCR 25.7 (1)
(1) A licensed dealer may sell or provide a verbal prescription narcotic under sections 25 to 25.5 if
(a) the dealer has received a verbal order that specifies the name and quantity of the narcotic to be supplied; and
(b) in the case of the provision of the narcotic to a hospital employee or a practitioner in a hospital, the order has been placed by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to place the order.

Receipt
(2) A licensed dealer that receives a verbal order from a pharmacist or practitioner must, within five working days after filling the order, obtain and keep a receipt that includes
(a) the signature of the pharmacist or practitioner who received the narcotic;
(b) the date on which the pharmacist or practitioner received the narcotic; and
(c) the name and quantity of the narcotic.

No further sale without receipt
(3) If the licensed dealer has not obtained the receipt within five working days, the dealer must not sell or provide a narcotic to the pharmacist or practitioner in accordance with a further verbal order received from them until after obtaining the receipt. 

Records
Verbal prescription narcotic
28.2 A licensed dealer that receives a verbal order for a verbal prescription narcotic and sells or provides it to a pharmacist, a practitioner or a hospital employee must immediately record
(a) the name of the person who placed the order;
(b) the date on which the order was received; and
(c) the name of the person recording the order.

Controlled Drugs

Written order
FDR Part G, G.02.057
G.02.057 A licensed dealer may sell or provide a controlled drug under any of sections G.02.051 to G.02.055 if
(a) the dealer has received a written order that specifies the name and quantity of the drug to be supplied and is signed and dated
(i) in the case of a drug to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to sign the order, and
(ii) in any other case, by the person to whom the drug is to be sold or provided; and
(b) the dealer has verified the signature, if it is unknown to them.

Verbal order
G.02.058 (1) A licensed dealer may sell or provide a controlled drug listed in Part II or III of the schedule to this Part if
(a) the dealer has received a verbal order that specifies the name and quantity of the drug to be supplied; and
(b) in the case of the provision of the drug to a hospital employee or a practitioner in a hospital, the order has been placed by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to place the order.

Receipt
(2) A licensed dealer that has received a verbal order from a pharmacist or practitioner must, within five working days after filling the order, obtain and keep a receipt that includes
(a) the signature of the pharmacist or practitioner who received the controlled drug;
(b) the date on which the pharmacist or practitioner received the controlled drug; and
(c) the name and quantity of the controlled drug.

No further sale without receipt
(3) If the licensed dealer has not obtained the receipt within five working days, the dealer must not sell or provide a controlled drug to the pharmacist or practitioner in accordance with a further verbal order received from them until after obtaining the receipt.

Documents - Verbal order
G.02.073 A licensed dealer that receives a verbal order for a controlled drug listed in Part II or III of the schedule to this Part and sells or provides it to a pharmacist, practitioner or hospital employee must immediately record,
(a) the name of the person who placed the order;
(b) the date on which the order was received; and
(c) the name of the person recording the order.

Restricted Drugs

Not applicable

Benzodiazepines and Other Targeted Substances

Verification of Identity
Order
70 Every person who fills an order or prescription for a targeted substance must verify the identity of the person who gave the order or issued the prescription if
(a) the signature on the order or prescription is unknown to the person; or
(b) the order or prescription is verbal and the person placing it is not known to the person.

Order required
33 (1) A licensed dealer may sell or provide a targeted substance in accordance with section 32 if the dealer has received from one of the following persons a written or verbal order indicating the specified name and the quantity of the substance and, in the case of a written order, the conditions specified in subsection (2) are met:
(a) in the case of a licensed dealer, a person who is authorized to place an order for the substance on their behalf;
(b) in the case of a hospital, the pharmacist in charge of the hospital’s pharmacy or a practitioner authorized by the person in charge of the hospital to sign the order; or
(c) in any other case, the person to whom the substance is to be sold or provided.

Conditions
(2) The following conditions apply to a written order:
(a) it must be signed and dated by one of the persons referred to in subsection (1) and
(b) the licensed dealer must verify the signature if it is unknown to them.

Documents - Verbal order
42 A licensed dealer that receives a verbal order for a targeted substance must immediately record the following information:
(a) the name of the person who placed the order;
(b) the date on which the order was received; and
(c) the name of the person recording the order.

Written order

Requirement

A licensed dealer may only sell or provide, including for destruction, a narcotic or a controlled drug pursuant to an order that specifies the name and quantity of the narcotic or controlled drug to be supplied. These orders may be received as:

The written order must be signed and dated by:

A licensed dealer who has received a written order may sell or provide the narcotic or the controlled drug if the order is signed and dated by the required person and the signature of the person has been verified if it is unknown to them. A mechanism should be in place to verify the signature and ensure that the person is authorized to place an order. 

For targeted substances, a licensed dealer must verify the identity of the person who sent the written order or issued the prescription before filling an order if the signature on the order or prescription is unknown to the person.

A licensed dealer may sell or provide a targeted substance if:

The licensed dealer must verify the signature on the written order if it is unknown to them.

Important: Please refer to the document Policy Statement on the Electronic Ordering of Controlled Substances for additional information on electronic ordering.

Information: The implementation of a password protection is recommended for PDF orders sent by email as an additional security measure. A 2-stage authentication process of orders that are sent through secured fax is also recommended, for example by verification of the client’s address and signature, and a call back to confirm the legitimacy of the order.

Please note that a licensed dealer is not required to obtain a written order from their clients upon filling the orders received through fax. This is also applicable to PDF orders as long as the scanned copies of written orders are signed. The licensed dealer must keep all records of faxed and PDF orders on site for a minimum of 2 years in an auditable format.

The licensed dealer must ship the controlled substances to the person or entity at the address indicated on the order. The quantity sold or provided must not exceed the quantity on the order.

Verbal Orders

Requirement

A licensed dealer may sell or provide a verbal prescription narcotic or controlled drug, if:

A licensed dealer that receives a verbal order from a pharmacist or practitioner must, within five working days after filling the order, obtain and keep a receipt that includes:

If the licensed dealer has not obtained the receipt within five working days, they must not sell or provide a narcotic or a controlled drug to that pharmacist or practitioner until after obtaining a receipt. 

A licensed dealer that receives a verbal order for a verbal prescription narcotic or controlled drug and sells or provides it to a pharmacist, a practitioner or a hospital employee must immediately record

For targeted substances, a licensed dealer must verify the identity of the person who gave the verbal order or issued the prescription before filling an order if the order or prescription is verbal and the person placing it is not known to the licensed dealer.

A licensed dealer may sell or provide a targeted substance if the licensed dealer has received a verbal order indicating the specified name and the quantity of the substance:

Multiple Deliveries

Multiple Deliveries
Type of Controlled Substance Section or Subsection

Narcotics

Not applicable

Controlled Drugs

Anticipated multiple sales
G.02.059 (1) A licensed dealer may sell or provide a controlled drug more than once in respect of one order if the order indicates
(a) the number of sales or provisions, not exceeding four;
(b) the specific quantity for each sale or provision; and
(c) the intervals between each sale or provision.

Multiple sales - insufficient stock
(2) A licensed dealer may sell or provide a controlled drug more than once in respect of one order if, at the time of receipt of the order, the dealer temporarily does not have in stock the quantity of the drug ordered, in which case the dealer may sell or provide against the order the quantity of the drug that the dealer has available and deliver the balance later.

Restricted Drugs

Not applicable

Benzodiazepines and Other Targeted Substances

Anticipated multiple sales
33.1 (1) A licensed dealer may sell or provide a targeted substance more than once in respect of one order if the order indicates
(a) the number of sales or provisions, not exceeding four;
(b) the specific quantity for each sale or provision; and
(c) the intervals between each sale and provision.

Multiple sales - insufficient stock
(2) A licensed dealer may sell or provide a targeted substance more than once in respect of one order if, at the time of receipt of the order, the dealer temporarily does not have in stock the quantity of the substance ordered, in which case the dealer may sell or provide against the order the quantity of the substance that the dealer has available and deliver the balance later.

Requirement

Multiple deliveries for one order are permitted only if the order states the quantity of targeted substance or controlled drug to be sold or provided in specified portions, in separate deliveries, not exceeding 4 deliveries, and at specified intervals. If the licensed dealer has insufficient stock of a targeted substance or a controlled drug at the time an order is received, the licensed dealer may supply the quantity of the substance that they have in stock and may deliver the balance afterwards in a single supplementary delivery.  

Important: Multiple deliveries are prohibited for narcotics and restricted drugs.

2.10 Importation and Exportation

Issuance of the permit

Issuance of the permit
Type of Controlled Substance Section or Subsection

Narcotics

General
NCR 8(1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a narcotic if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

Permit - import and export
NCR 8(3) A licensed dealer must obtain a permit in order to import or export a narcotic.

Possession for export
NCR 8(4) A licensed dealer may possess a narcotic for the purpose of exporting it if they have obtained it in accordance with these Regulations.

Import Permits
Application

18 (1) A licensed dealer must submit to the Minister, before each importation of a narcotic, an application for an import permit that contains the following information:
(a) their name, municipal address and dealer's licence number;
(b) with respect to the narcotic to be imported,
(i) its name, as specified in the dealer's licence,
(ii) it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the narcotic is contained in a product to be imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages;
(d) the name and municipal address of the exporter in the country of export from whom the narcotic is being obtained;
(e) the name of the customs office where the importation is anticipated; and
(f) each proposed mode of transportation and any proposed country of transit or transhipment.

Return of permit
18.3 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Export Permits
Application

NCR 21 (1)
(1) A licensed dealer must submit to the Minister, before each exportation of a narcotic, an application for an export permit that contains the following information and document:

(a) their name, municipal address and dealer’s licence number;
(b) with respect to the narcotic to be exported,
(i) its name, as specified in the dealer’s license
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of raw material, its purity and its anhydrous content;
(c) in the case of the exportation of a product that contains the narcotic,
(i) the brand of the product
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages;
(d) the name and municipal address of the importer in the country of final destination;
(e) the name of the customs office where the exportation is anticipated
(f) each proposed mode of transportation to be used and any proposed country of transit or transhipment; and
(g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

Return of permit
21.3 If an export permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Controlled Drugs

General
G.02.001 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Permit - import and export
FDR Part G, G.02.001(3) 
G.02.001(3) A licensed dealer must obtain a permit to import or export a controlled drug.

Possession for export
FDR Part G, G.02.001(4) 
G.02.001(4) A licensed dealer may possess a controlled drug for the purpose of exporting it if they have obtained it in accordance with this Part.

Import Permits
Application

FDR Part G, G.02.030 
(1) A licensed dealer must submit to the Minister, before each importation of a controlled drug, an application for an import permit that contains the following information:
(a) their name, municipal address and dealer’s licence number;
(b) with respect to the controlled drug to be imported,
(i) its name, as specified in the dealer’s license
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of raw material, its purity and its anhydrous content;
(c) if the controlled drug is contained in a product to be imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages;
(d) the name and municipal address, in the country of export, of the exporter from whom the controlled drug is being obtained;
(e) the name of the customs office where the importation is anticipated; and
(f) each proposed mode of transportation and any proposed country of transit or transhipment.

Return of permit
FDR Part G, G.02.033
G.02.033 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Export permits
Application

FDR Part G, G.02.040
G.02.040 (1) A licensed dealer must submit to the Minister, before each exportation of a controlled drug, an application for an export permit that contains the following information and document:
(a) their name, municipal address and dealer's licence number;
(b) with respect to the controlled drug to be exported,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the controlled drug is contained in a product to be exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages;
(d) the name and municipal address of the importer in the country of final destination;
(e) the name of the customs office where the exportation is anticipated;
(f) each proposed mode of transportation and any proposed country of transit or transhipment; and
(g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

Return of permit
FDR Part G, G.02.043 
G.02.043 If an export permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Restricted Drugs

General
J.01.009 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Permit - import and export
FDR, Part J, J.01.009(3)
(3) A licensed dealer must obtain a permit to import or export a restricted drug.

Possession for export
FDR, Part J, J.01.009(4)
(4) A licensed dealer may possess a restricted drug for the purpose of exporting it if they have obtained it in accordance with this Part.

Import Permits
Application

J.01.038 (1) A licensed dealer must submit to the Minister, before each importation of a restricted drug, an application for an import permit that contains the following information:
(a) their name, municipal address and dealer's licence number;
(b) with respect to the restricted drug to be imported,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the restricted drug is contained in a product to be imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages;
(d) the name and municipal address, in the country of export, of the exporter from whom the restricted drug is being obtained;
(e) the name of the customs office where the importation is anticipated; and
(f) each proposed mode of transportation and any proposed country of transit or transhipment.

Return of permit
J.01.041 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Export Permits
Application

J.01.048 (1) A licensed dealer must submit to the Minister, before each exportation of a restricted drug, an application for an export permit that contains the following information and document:
(a) their name, municipal address and dealer's licence number;
(b) with respect to the restricted drug to be exported,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the restricted drug is contained in a product to be exported,
(ii the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.0 1.014.2, if any, and
(iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages;
(d) the name and municipal address of the importer in the country of final destination;
(e) the name of the customs office where the exportation is anticipated;
(f) each proposed mode of transportation and any proposed country of transit or transhipment; and
(g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

Return of permit
J.01.051 If an export permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Benzodiazepines and Other Targeted Substances

Authorized Activities
BOTSR 12 (3)
(3) A licensed dealer must obtain a permit in order to import or export a targeted substance.
(4) A licensed dealer may possess a targeted substance for the purpose of exporting it if they have obtained it in accordance with these Regulations.

Import permits
Application

25 (1) A licensed dealer must submit to the Minister, before each importation of a targeted substance, an application for an import permit that contains the following information:
(a) their name, municipal address and dealer's licence number;
(b) with respect to the targeted substance to be imported,
(i) its specified name, as set out in the dealer's licence,
(ii) if it is a salt, the name of the salt,
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the targeted substance is contained in a product to be imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the targeted substance in the product, the number of units per package and the number of packages;
(d) the name and municipal address, in the country of export, of the exporter from whom the targeted substance is being obtained;
(e) the name of the customs office where the importation is anticipated; and
(f) each proposed mode of transportation and any proposed country of transit or transhipment.

Return of permit
25.3 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Export permits
Application

BOTSR 28 (1)
(1) A licensed dealer must submit to the Minister, before each exportation of a targeted substance, an application for an export permit that contains the following information and document:
(a) their name, municipal address and dealer’s licence number;
(b) with respect to the targeted substance to be exported,
(i) its specified name, as set out in the dealer’s licence,
(ii) if it is a salt, the name of the salt
(iii) its quantity, and
(iv) in the case of a raw material, its purity and its anhydrous content;
(c) if the targeted substance is contained in a product to be exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.0142 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the targeted substance in the product, the number of units per package and the number of packages; and
(d) the name and municipal address of the importer in the country of final destination;
(e) the name of the customs office where the exportation is anticipated;
(f) each proposed mode of transportation to be used and any proposed country of transit or transhipment; and
(g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

Return of permit
28.3 If an export permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.

Requirement

No person, except a licensed dealer, shall import or export a controlled substance or a restricted drug and they must have a permit for importation or exportation.

A licensed dealer must submit to the OCS, before each importation of a controlled substance, an application for an import permit that contains the following information:

A licensed dealer must submit to the Minister, before each exportation of a controlled substance, an application for an export permit of a controlled substance that contains the following information:

Permits are only valid for the exact preparation, such as the substance, package size, and concentration, and up to the maximum quantity indicated on the permit. The permit is only valid for one shipment. The importation or exportation must take place within the validity period of the permit. In addition, all information on the permit must be accurate. For example, the name and the address of where the controlled substances were shipped must be the same as the address as found on the import or export permit.

Important: If errors, such as with the name and address, quantity or name of the substances,  are found on the permit issued by the OCS, the incorrect permit must be returned and a new permit will be issued.

Important: If an import or an export permit expires, the licensed dealer must return the original permit to the OCS within 15 days after its expiry to the:

Permits Section
Office of Controlled Substances
Health Canada
AL 0300B
Ottawa ON K1A 0K9

The holder of an export permit shall ensure that an official copy of the permit is attached to the shipment and that an official copy of the permit is surrendered to a customs officer at the port of exit at the time of export.

The holder of an import permit shall ensure that an official copy of the permit is surrendered to a customs officer at the port of entry at the time of import.

Information: Please contact the OCS to make any general enquiries or comments on import and export permits. Note that at any time, regulations supersede guidance documents.

Permits Section
Office of Controlled Substances
Health Canada
AL 0300B
Ottawa ON K1A 0K9
 Email: hc.permitspermis.sc@canada.ca

Packaging

Packaging
Type of Controlled Substance Section or Subsection

Narcotics

Packaging - transport and export
NCR 26 (2) A licensed dealer that transports or exports a narcotic must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal.

Controlled Drugs

Packaging - transport and export
G.02.060 (2) A licensed dealer that transports or exports a controlled drug must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal.

Restricted Drugs

Packaging - transport and export
J.01.062 (2) A licensed dealer that transports or exports a restricted drug must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal.

Benzodiazepines and Other Targeted Substances

Packaging - transport and export
34(2) A licensed dealer that transports or exports a targeted substance must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal

Requirement

A licensed dealer shall securely pack in a package sealed in such a manner that it cannot be opened without breaking the seal any controlled substance intended for export out of Canada.

Declaration of imports and exports

Declaration of imports and exports
Type of Controlled Substance Section or Subsection

Narcotics

Import Permits
Declaration

18.6 The holder of an import permit must provide the Minister, within 15 days after the day of release of the narcotic specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the import permit that applies to the narcotic;
(b) with respect to the narcotic,
(i) its name, as set out in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the narcotic is contained in a product that they have imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the narcotics was released and the date of the release

Export permits
Declaration

21.6 The holder of an export permit must provide the Minister, within 15 days after the day of export of the narcotic specified in the permit, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the export permit that applies to the narcotic;
(b) with respect to the narcotic,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the narcotic is contained in a product that they have exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the narcotic was exported and the date of export.

Controlled Drugs

Import permits
Declaration

FDR Part G, G.02.036
G.02.036 The holder of an import permit must provide the Minister, within 15 days after the day of release of the controlled drug specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:
(a) their name and the numbers of their dealer’s licence and the import permit that applies to the controlled drug;
(b) with respect to the controlled drug,
(i) its name, as set out in the dealer's licence,
(ii) it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the controlled drug is contained in a product that they have imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the controlled drug was released and the date of the release.

Export Permits
Declaration

FDR Part G, G.02.046 
G.02.046 The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled drug specified in the permit, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the export permit that applies to the controlled drug;
(b) with respect to the controlled drug,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the controlled drug is contained in a product that they have exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.O1.014.2, if any, and
(iii) the strength per unit of the controlled drug in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the controlled drug was exported and the date of export.

Restricted Drugs

Import Permits
Declaration

J.01.044 The holder of an import permit must provide the Minister, within 15 days after the day of release of the restricted drug specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the import permit that applies to the restricted drug;
(b) with respect to the restricted drug,
(i) its name, as set out in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the restricted drug is contained in a product that they have imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the restricted drug was released and the date of the release.

Export Permits
Declaration

J.01.054 The holder of an export permit must provide the Minister, within 15 days after the day of export of the restricted drug specified in the permit, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the export permit that applies to the restricted drug;
(b) with respect to the restricted drug,
(i) its name, as specified in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the restricted drug is contained in a product that they have exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and
(iii) the strength per unit of the restricted drug in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the restricted drug was exported and the date of export.

Benzodiazepines and Other Targeted Substances

Import Permits
Declaration

25.6 The holder of an import permit must provide the Minister, within 15 days after the day of release of the targeted substance specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the import permit that applies to the targeted substance;
(b) with respect to the targeted substance,
(i) its specified name, as set out in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the targeted substance is contained in a product that they have imported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the targeted substance in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the targeted substance was released and the date of the release.

Export Permits
Declaration

28.6 The holder of an export permit must provide the Minister, within 15 days after the day of export of the targeted substance specified in the permit, with a declaration that contains the following information:
(a) their name and the numbers of their dealer's licence and the export permit that applies to the targeted substance;
(b) with respect to the targeted substance,
(i) its specified name, as set out in the dealer's licence,
(ii) if it is a salt, the name of the salt, and
(iii) its quantity;
(c) if the targeted substance is contained in a product that they have exported,
(i) the brand name of the product,
(ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
(iii) the strength per unit of the targeted substance in the product, the number of units per package and the number of packages; and
(d) the name of the customs office from which the targeted substance was exported and the date of export.

Requirement

Notice of Import Requirement

The holder of an import permit must provide the Minister, within 15 days after the day of release of a controlled substance specified in the permit, with a declaration that contains:

The declaration must include a statement signed by the QPIC or A/QPIC for the licensed site to which the shipment will be transported after being released under the Customs Act, stating that all the information set out in the declaration is correct and complete to the best of their knowledge.

Notice of Export Requirement

The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled substance specified in the permit, with a declaration that contains:

The declaration must include a statement signed by QPIC or A/QPIC for the licensed site from which the shipment will be transported to the port of exit, stating that all the information set out in the declaration is correct and complete to the best of their knowledge.

Important: The name of the substance imported or exported should match the one of the permit.  No synonyms should be used.

Tip: It is suggested that the holder of an import or export permit should send the declaration as soon as possible to prevent discrepancies in the monthly activities report.

Important: Information on the declaration must represent the controlled substances imported or exported. The quantity must not exceed the quantity on the permit.

Tip: The name of the substance imported or exported should be included in the same field as the quantity of substances imported or exported.

2. 11 Test Kits

Test Kits
Type of Controlled Substance Section or Subsection

Narcotics

NCR 4
4 A person may sell, possess or otherwise deal in a test kit if the following conditions are met:
(a) a registration number has been issued for the test kit under section 6 and has not been cancelled under section 7;
(b) the test kit bears, on its external surface,
(i) the manufacturer's name,
(ii) the trade name or trademark, and
(iii) the registration number; and
(c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Controlled Drugs

FDR Part G, G.01.006
G.01.006 A person may sell, possess or otherwise deal in a test kit if the following conditions are met:
(a) a registration number has been issued for the test kit under section G.01.008 and has not been cancelled under section G.01.009;
(b) the test kit bears, on its external surface,
(i) the name of the manufacturer,
(ii) the trade name or trademark, and
(iii) the registration number; and
(c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Restricted Drugs

FDR Part J, J.01 .005
J.01.005 A person may sell, possess or otherwise deal in a test kit if the following conditions are met:
(a) a registration number has been issued for the test kit under section J.01.007 and has not been cancelled under section J.01.008;
(b) the test kit bears, on its external surface,
(i) the name of the manufacturer,
(ii) the trade name or trademark, and
(iii) the registration number; and
(c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Benzodiazepines and Other Targeted Substances

BOTSR 4
4 A person may sell, possess or otherwise deal in a test kit if the following conditions are met:
(a) a registration number has been issued for the test kit under section 6 or subsection 10(2) and has not been cancelled under subsection 9(1)
(b) the test kit is labelled with
(i) the registration number, and
(ii) in the case of a test kit that is not subject to the labelling requirements of the Medical Devices Regulations,
(A) the name and address of the manufacturer or assembler or, if the test kit is manufactured or assembled in accordance with a custom order, the name and address of the person for whom the test kit was manufactured or assembled, and
(B) its brand name; and
(c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Requirement

Any person may sell, possess or otherwise deal in a test kit that contains a controlled substance if:

  1. a registration number has been issued for the test kit pursuant to the regulations;
  2. the test kit bears, on its external surface,
    1. the name of the manufacturer,
    2. for targeted substances, the name and address of the manufacturer or assembler or, if the test kit is manufactured or assembled in accordance with a custom order, the name and address of the person for whom the test kit was manufactured or assembled,
    3. the trade name or trade mark, and
    4. the registration number issued.
  3. the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and
  4. the registration number has not been cancelled.

2.12 Activities

Activities
Type of Controlled Substance Section or Subsection

Narcotics

NCR 8(1)
8 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a narcotic if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

Opium poppy - production
(5) A licensed dealer may cultivate, propagate or harvest opium poppy only for scientific purposes.

Notice – ten days
14.2 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph 10(1)(f) that has been submitted to the Minister.

Notice of cessation of activities
14.3 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Controlled Drugs

FDR Part G, G.02.001 (1)
G.02.001 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Notice - ten days
FDR Part G, G.02.023
G.02.023 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph G.02.006(1)(f) has been submitted to the Minister.

Notice of cessation of activities
FDR Part G, G.02.024 (1)
G.02.024 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Restricted Drugs

J.01.009 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

Notice - ten days
J.01.031 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph J.01.014(1)(f) that has been submitted to the Minister.

Notice of cessation of activities
J.01.032 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Benzodiazepines and Other Targeted Substances

BOTSR 12(1)
(1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a targeted substance if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

Notice – ten days
21.2 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:
(b) he licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph 17(1)(f) that has been submitted to the Minister.

Notice of cessation of activities
21.3 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Requirement

A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled substance if they comply with the relevant regulations.

A licensed dealer must notify the OCS in writing within 10 days if:

A licensed dealer that intends to cease conducting activities at their site - whether on or before the expiry of their licence - must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Appendices

Appendix A – Glossary

Acronyms

A/QPIC
Alternate Qualified Person in Charge
BOTSR
Benzodiazepines and Other Targeted Substances Regulations
CDSA
Controlled Drugs and Substances Act
FDR
Food and Drug Regulations
NCR
Narcotic Control Regulations
OCS
Office of Controlled Substances
QPIC
Qualified Person in Charge
SPIC
Senior Person in Charge

Terms

Important: If there is any conflict with a definition in the Controlled Drugs and Substances Act and the Narcotic Control Regulations and/or Food and Drug Regulationsand/or Benzodiazepines and Other Targeted Substances Regulations, the definition in the Act/Regulations prevails.

Controlled Drug
a controlled substance included in the Schedule related to section G of the Food and Drug Regulations, or a product or compound that contains the substance;
Controlled Substance
a substance included in Schedule I, II, III, IV or V of the CDSA Diversion the transfer of substances listed in the schedules of the CDSA from the licit to illicit market
Diversion
the transfer of substances listed in the schedules of the CDSA from the licit to illicit market
Inspector
Any person designated as an inspector under section 30 of the CDSA
Licensed Dealer
the holder of a licence
Narcotic
any substance set out in the schedule of the Narcotic Control Regulations or anything that contains the substance
Observation
A deviation or deficiency (i.e., non-compliance) to the requirements of the regulations noted by an inspector during the inspection that is documented in writing in the inspection report.
Restricted Drug
a controlled substance included in the Schedule related to section J of the Food and Drug Regulations, or a product or compound that contains the substance;
Targeted substance
a controlled substance included in Schedule 1 of the Benzodiazepines and Other Targeted Substances Regulations, or a product or compound that contains the substance;

Appendix B – References

Laws and regulations

Controlled Drugs and Substances Act (CDSA)
Narcotic Control Regulations (NCR)
Food and Drug Regulations (FDR-G or FDR-J)
Benzodiazepines and Other Targeted Substance Regulations (BOTSR)

Related Documents

Compliance and Enforcement Policy for Controlled Substances and Precursors (CS-POL-001)
Destruction of narcotics, controlled and restricted drugs and targeted substances by licensed dealers – Guidance document (CS-GD-020) (CS-GD-020)
Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis
Inspection Strategy for Licensed Dealers of Controlled Substances and Class A Precursors (CS-POL-002)
Policy Statement on the Electronic Ordering of Controlled Substances
Recording and Reporting of Suspicious Transactions for Controlled Substances and Precursors (CS-GD-025)
Reporting Loss or Theft of Controlled Substances and Precursors (CS-GD-005)
Risk classification guide for Licensed Dealers of Controlled Substances’ Inspection Observations (CS-GD-017)

Websites

A Guide to Health Canada Inspections
Compliance and enforcement policy framework
Controlled substances – Licences
Reporting Loss or Theft of Controlled Substances and Precursors

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