Controlled Substances Regulations (SOR/2025-242)

Marginal note:Suspension

• 48 (1) Subject to subsection (2), the Minister must immediately suspend an export permit 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 substance from being diverted to an illicit market or use; or

  • (c) the Minister has reasonable grounds to believe that 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 provides the licensed dealer with a written 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

• 49 (1) The Minister must revoke an export permit if

  • (a) the dealer’s licence has been revoked;

  • (b) 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;

  • (c) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 48(2)(c) by the specified date; or

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

• Marginal note:Prior notice

  (2) Before revoking an export permit, the Minister must

  • (a) provide the licensed dealer with a prior written notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard; and

  • (b) consider the licensed dealer’s submissions, if applicable.

Authorizations and General Conditions Applicable to Activities

Marginal note:Authorized activities

50 A licensed dealer may conduct the following activities if it does so in accordance with their dealer’s licence and any permit issued under these Regulations:

• (a) produce a controlled substance;

• (b) sell or provide a controlled substance to

  • (i) another licensed dealer,

  • (ii) with the exception of a restricted drug, a pharmacist, other than one who is practising in a hospital,

  • (iii) a practitioner,

  • (iv) with the exception of a restricted drug, a hospital,

  • (v) a person exempted under subsection 56(1) of the Act with respect to that controlled substance, if there are terms and conditions for the sale or provision by a licensed dealer that are specified in the exemption,

  • (vi) the Minister, or

  • (vii) a government laboratory;

• (c) transport, send or deliver a controlled substance; or

• (d) import or export a controlled substance.

Marginal note:Packaging — conditions

51 A licensed dealer that packages a controlled substance may only do so in accordance with their dealer’s licence issued under these Regulations.

Marginal note:Destruction

52 A licensed dealer specialized in destruction that destroys a controlled substance may only do so in accordance with their dealer’s licence issued under these Regulations.

Marginal note:Qualified person in charge present

53 A licensed dealer may conduct an activity in relation to a controlled substance at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

Marginal note:Identification

54 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which it identifies itself in regard to their activities in relation to a controlled substance, including labels, shipping documents, invoices and advertising.

Marginal note:Information and documents

55 A licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any relevant information or document to demonstrate their compliance with the provisions of the Act and these Regulations.

Sale of Controlled Substances

Marginal note:Sale to another licensed dealer

56 A licensed dealer that sells or provides a controlled substance to another licensed dealer may only do so if it first receives from the other licensed dealer a written order that is signed and dated and that contains the following:

• (a) with respect to the other licensed dealer placing the order, their name and, if applicable, title, as well as their municipal address;

• (b) with respect to the licensed dealer selling or providing the controlled substance, their name and, if applicable, title, as well as their municipal address;

• (c) the date of the order;

• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity;

• (e) in the case of a mixture or finished product,

  • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

  • (iii) its drug identification number, if any; and

• (f) in the case of a controlled substance sold or provided for the purposes of destruction, a statement to that effect.

Marginal note:Sale to pharmacist

• 57 (1) A licensed dealer that sells or provides a controlled substance to a pharmacist may only do so if it first receives from the pharmacist a written order that is signed and dated and that contains the following information:

  • (a) with respect to the pharmacist, their name and the name and municipal address of the place where they practise;

  • (b) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;

  • (c) the date of the order;

  • (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and

  • (e) in the case of a mixture or finished product,

    • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

    • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

    • (iii) its drug identification number, if any.

• Marginal note:Exception — prohibition

  (2) A licensed dealer must not sell or provide to the pharmacist a controlled substance that is the subject of a prohibition on the pharmacist’s professional practice imposed by the provincial professional regulatory authority.

Marginal note:Sale to practitioner

• 58 (1) A licensed dealer that sells or provides a controlled substance, other than a restricted drug, to a practitioner may only do so if it first receives from the practitioner a written order that is signed and dated and that contains the following information:

  • (a) with respect to the practitioner, their name and the name and municipal address of the place where they practise;

  • (b) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;

  • (c) the date of the order;

  • (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and

  • (e) in the case of a mixture or finished product,

    • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

    • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

    • (iii) its drug identification number, if any.

• Marginal note:Restricted drugs

  (2) A licensed dealer that sells or provides a restricted drug to a practitioner may only do so if

  • (a) the licensed dealer first receives a letter of authorization in which it is named;

  • (b) the practitioner is named in the letter of authorization and the municipal address of the place where they practise is specified in that letter; and

  • (c) the licensed dealer sells or provides the restricted drug only in the quantity specified in the letter of authorization and, if applicable, in the form and strength specified in that letter.

• Marginal note:Exception — prohibition

  (3) A licensed dealer must not sell or provide to the practitioner a controlled substance that is the subject of a prohibition on the practitioner’s professional practice imposed by the provincial professional regulatory authority.

Marginal note:Sale to hospital

59 A licensed dealer that sells or provides a controlled substance to a hospital may only do so if it first receives from the hospital a written order that is signed and dated by a person permitted to place an order on the hospital’s behalf and that contains the following information:

• (a) with respect to the hospital, its name and municipal address, as well as the name and title of the person placing the order;

• (b) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address;

• (c) the date of the order;

• (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and

• (e) in the case of a mixture or finished product,

  • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

  • (iii) its drug identification number, if any.

Marginal note:Sale to exempted person

60 A licensed dealer that sells or provides a controlled substance to a person exempted under subsection 56(1) of the Act with respect to that substance may only do so in accordance with the terms and conditions for the sale or provision by the licensed dealer that are specified in the exemption and if it first receives from the exempted person a copy of that exemption.

Marginal note:Sale to Minister

61 A licensed dealer that sells or provides a controlled substance to the Minister may only do so if it first receives from the Minister a written order that is signed and dated on the Minister’s behalf and that contains the following information:

• (a) with respect to the individual signing the order, their name and, if applicable, title, as well as the municipal address of the place where the controlled substance is to be delivered, sent or transported;

• (b) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address and licence number;

• (c) the date of the order;

• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and

• (e) in the case of a mixture or finished product,

  • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

  • (iii) its drug identification number, if any.

Marginal note:Sale to government laboratory

62 A licensed dealer that sells or provides a controlled substance to a government laboratory may only do so if it first receives from the government laboratory a written order that is signed and dated and that contains the following information:

• (a) with respect to the government laboratory, its name and municipal address;

• (b) with respect to the licensed dealer, their name and, if applicable, title, as well as their municipal address and licence number;

• (c) the date of the order;

• (d) in the case of a controlled substance set out in any of Schedules 1 to 4, its name, form and quantity; and

• (e) in the case of a mixture or finished product,

  • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

  • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

  • (iii) its drug identification number, if any.

Marginal note:Anticipated multiple sales

• 63 (1) A licensed dealer that sells or provides a controlled substance, other than a restricted drug, may do so more than once in respect of one order, within six months after the order was made, if the order indicates

  • (a) the number of sales or provisions;

  • (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 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 the quantity of the substance that the dealer has available and sell or provide the balance later.

Verification of Identity

Marginal note:Orders

64 A licensed dealer that receives an order from a person for a controlled substance must verify the person’s name and, if applicable, their title as well as their signature if it is not known to the licensed dealer.

Delivery, Sending and Transportation

Marginal note:Requirements during transportation

• 65 (1) A licensed dealer that takes delivery of a controlled substance that it has imported or that delivers, sends or transports a controlled substance to another person may only do so if it

  • (a) ensures that its outermost container is inconspicuous, without any mark identifying its contents, and sealed in such a manner that the container cannot be opened without breaking the seal;

  • (b) ensures that all inner containers are sealed in such a manner that they cannot be opened without breaking the seal;

  • (c) takes all reasonable measures to ensure the security of the controlled substance while it is being delivered, sent or transported;

  • (d) uses a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it;

  • (e) in the case of an imported controlled substance, delivers, sends or transports it directly to the site specified in their licence after it is released under the Customs Act; and

  • (f) in the case of a controlled substance that is to be exported, delivers, sends or transports it directly from the site specified in their licence to the customs office where it will be exported.

• Marginal note:Exception

  (2) Subsection (1) does not apply to a test kit that has a registration number.