Benzodiazepines and Other Targeted Substances Regulations (SOR/2000-217)

Marginal note:Application for prior approval

• 38 (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 targeted substance:

  • (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 36(b) and information establishing that they meet the conditions of that paragraph;

  • (f) the specified name of the targeted substance 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 targeted substance or the product or compound containing it 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.

• 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

39 On completion of the review of the approval application, the Minister must approve the destruction of the targeted substance 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 36(b) do not meet the conditions of that paragraph;

• (b) the Minister has reasonable grounds to believe that the targeted substance 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 targeted substance 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 targeted substance being diverted to an illicit market or use.

Documents

Marginal note: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.

Marginal note: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.

Marginal note: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.

Marginal note:Explainable loss of targeted substance

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.

Marginal note:Destruction

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.

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

46 [Repealed, SOR/2019-170, s. 2]

47 [Repealed, SOR/2019-170, s. 2]

Pharmacists

Permitted Activities

Marginal note:Application

48 Sections 49 to 56 do not apply to a pharmacist when they are practising in a hospital.

Marginal note:Authorization

49 A pharmacist may, in accordance with sections 50 to 57, compound a targeted substance in accordance with a prescription.

Marginal note:Record of receipt from licensed dealer

50 If a pharmacist receives a targeted substance from a licensed dealer, a pharmacist in another pharmacy or a hospital, the pharmacist must keep a record of the following information:

• (a) the brand name of the targeted substance received or, if the targeted substance does not have a brand name, the specified name;

• (b) the quantity and strength per unit of the targeted substance received, the number of units per package and the number of packages;

• (c) the name and address of the licensed dealer, pharmacist or hospital that supplied it; and

• (d) the date on which it was received.