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Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2024-11-26 and last amended on 2023-11-24. Previous Versions

PART GControlled Drugs (continued)

DIVISION 2Licensed Dealers (continued)

Sale of Controlled Drugs (continued)

Marginal note:Anticipated multiple sales

  •  (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.

  • Marginal note: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.

Packaging and Transportation

Marginal note:Packaging — sale and provision

  •  (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.

  • Marginal note:Packaging — transport and export

    (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.

  • Marginal note:Exception

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

Marginal note:Transport

  •  (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.

  • Marginal note:Exception

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

Thefts, Losses and Suspicious Transactions

Marginal note:Protective measures

 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.

Marginal note:Theft or loss — licence and permit

 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.

Marginal note:Theft or unexplainable loss — controlled drug

 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.

Marginal note:Suspicious transaction

  •  (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.

  • Marginal note:Good faith

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

  • Marginal note: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.

Marginal note:Partial protection against self-incrimination

 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.

Destruction of Controlled Drugs

Marginal note:Destruction at site

 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.

Marginal note:Destruction elsewhere than at site

 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.

Marginal note:Application for prior approval

  •  (1) A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister’s prior approval to destroy a controlled drug:

    • (a) their name, municipal address and dealer’s licence number;

    • (b) the proposed date of destruction;

    • (c) the municipal address of the place of destruction;

    • (d) a brief description of the method of destruction;

    • (e) if the destruction is to be carried out at the site specified in the dealer’s licence, the names of the persons proposed for the purpose of paragraph G.02.067(b) and information establishing that they meet the conditions of that paragraph;

    • (f) the name of the controlled drug and, if applicable, the brand name of the product containing it or the name of the compound containing it; and

    • (g) the form and quantity of the controlled drug or the product or compound containing it 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.

  • Marginal note:Signature and attestation

    (2) The application must

    • (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and

    • (b) include an attestation by that person that

      • (i) the proposed method of destruction complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction, and

      • (ii) all of the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

  • Marginal note:Additional information and documents

    (3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

Marginal note:Approval

 On completion of the review of the approval application, the Minister must approve the destruction of the controlled drug unless

  • (a) in the case of a destruction that is to be carried out at the site specified in the dealer’s licence, the persons proposed for the purpose of paragraph G.02.067(b) do not meet the conditions of that paragraph;

  • (b) the Minister has reasonable grounds to believe that the controlled drug would not be destroyed;

  • (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the approval application;

  • (d) the controlled drug or a portion of it is required for the purposes of a criminal or administrative investigation or a preliminary inquiry, trial or other proceeding under any Act or its regulations; or

  • (e) the Minister has reasonable grounds to believe that the approval would likely create a risk to public health or safety, including the risk of the controlled drug being diverted to an illicit market or use.

 

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