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

Regulations are current to 2024-02-06 and last amended on 2023-11-24. Previous Versions

PART GControlled Drugs (continued)

DIVISION 2Licensed Dealers (continued)

Export Permits (continued)

Marginal note:Declaration

 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.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 exported and the date of export.

Marginal note:Suspension

  •  (1) The Minister must suspend an export permit without prior notice if

    • (a) the dealer’s licence is suspended;

    • (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use; or

    • (c) the exportation would contravene the laws of the country of final destination or any country of transit or transhipment.

  • Marginal note:Notice

    (2) The suspension takes effect as soon as the Minister sends the licensed dealer a notice that

    • (a) sets out the reasons for the suspension;

    • (b) gives the dealer an opportunity to be heard; and

    • (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

  • Marginal note:Reinstatement of permit

    (3) The Minister must reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Marginal note:Revocation

  •  (1) Subject to subsection (2), the Minister must revoke an export permit if

    • (a) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;

    • (b) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph G.02.047(2)(c) by the specified date;

    • (c) the licensed dealer has contravened a term or condition of the permit;

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

    • (e) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled drug to an illicit market or use; or

    • (f) the dealer’s licence has been revoked.

  • Marginal note:Exceptions

    (2) The Minister must not revoke an export permit for a ground set out in paragraph (1)(d) or G.02.028(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a controlled drug from being diverted to an illicit market or use:

    • (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and

    • (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

  • Marginal note:Notice

    (3) Before revoking an export permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

Marginal note:Return of permit

 If an export permit is revoked, the licensed dealer must return the original of the permit to the Minister within 15 days after the effective date of the revocation.

Identification

Marginal note:Name

 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

Sale of Controlled Drugs

Marginal note:Sale to another licensed dealer

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

Marginal note:Sale to pharmacist

  •  (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a pharmacist.

  • Marginal note:Exception — pharmacist named in notice

    (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.

Marginal note:Sale to practitioner

  •  (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a practitioner.

  • Marginal note:Exception — practitioner named in notice

    (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.

Marginal note:Provision to hospital employee

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

Marginal note:Sale to exempted person

 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.

Marginal note:Sale to Minister

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

Marginal note:Written order

 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.

Marginal note:Verbal order

  •  (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.

  • Marginal note: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.

  • Marginal note: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.

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.

 

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