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

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46 [Repealed, SOR/2019-170, s. 2]

47 [Repealed, SOR/2019-170, s. 2]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.

Marginal note:Prescription required

• 51 (1) In addition to the activities authorized under section 55, a pharmacist may, subject to section 52, sell, provide, send, deliver or transport a targeted substance to or for an individual or for the benefit of an animal if

  • (a) the pharmacist sells or provides the substance in a container labelled in accordance with subsection (2);

  • (b) the transaction is made pursuant to a prescription

    • (i) dated and signed by a practitioner,

    • (ii) provided verbally to the pharmacist by a practitioner, or

    • (iii) transferred to the pharmacist under subsection 54(1) in accordance with subsection 54(2);

  • (c) the pharmacist has not transferred the prescription to another pharmacist; and

  • (d) when the prescription has been provided verbally, the transaction is recorded by the pharmacist in accordance with subsection (3).

• Marginal note:Labelling required

  (2) A pharmacist who sells or provides a targeted substance to an individual must do so in a container that is labelled with the following information:

  • (a) the name and address of the pharmacy or pharmacist;

  • (b) the date of issuance of the prescription and the number given to it by the pharmacist;

  • (c) the name of the individual for whose benefit the targeted substance is sold or provided or, if it is sold or provided for the benefit of an animal, the name of the individual having caring of the animal or the name of the animal;

  • (d) the name of the practitioner who issued the prescription;

  • (e) the specified name or brand name of the targeted substance;

  • (f) the quantity and, if applicable, the strength per unit of the targeted substance; and

  • (g) the directions for use specified by the practitioner.

• Marginal note:Record of verbal prescription

  (3) A pharmacist who receives a verbal prescription for a targeted substance must, before filling it,

  • (a) record the following information:

    • (i) the name and address of the individual for whose benefit the prescription is provided or, if it is provided for the benefit of an animal, the name and address of the individual having caring of the animal and, if applicable, the name of the animal,

    • (ii) the date that the verbal prescription was provided,

    • (iii) the specified name or brand name of the targeted substance, as specified in the prescription,

    • (iv) the quantity and, if applicable, the strength per unit of the targeted substance,

    • (v) the name of the recording pharmacist and the name of the practitioner who issued the prescription,

    • (vi) the directions for use specified by the practitioner, and

    • (vii) if the prescription is to be refilled, the number of times it may be refilled and, if specified, the interval between refills; and

  • (b) keep a hard copy or create a written record of the prescription.

Marginal note:Refills

52 A pharmacist may only refill a prescription for a targeted substance if

• (a) the practitioner who prescribed it expressly directs that the prescription may be refilled and specifies the number of refills;

• (b) the pharmacist makes a record of each refill in accordance with section 53;

• (c) less than one year has elapsed since the day on which the prescription was issued by the practitioner;

• (d) at least one refill remains on the prescription; and

• (e) in the case where an interval between refills has been specified by the practitioner, it has expired.

Marginal note:Records

53 A pharmacist who fills or refills a prescription for a targeted substance must record the following information:

• (a) the date the prescription was filled or refilled;

• (b) the quantity of the targeted substance provided at the original filling and at each refill;

• (c) the pharmacist’s name or initials; and

• (d) the number assigned to the prescription.

Marginal note:Transfer of prescription

• 54 (1) A pharmacist may transfer a prescription for a targeted substance to another pharmacist, except a prescription that has already been transferred.

• Marginal note:Additional information

  (2) Before a pharmacist sells or provides a targeted substance to an individual under a prescription transferred under subsection (1), the pharmacist must

  • (a) in the case of a verbal transfer, record the information required by subsection 51(3);

  • (b) in the case of a written transfer, have obtained from the transferring pharmacist a copy of

    • (i) the prescription written by the practitioner, or

    • (ii) the record made in accordance with subsection 51(3) of the practitioner’s verbal prescription; and

  • (c) in all cases, record

    • (i) the name and address of the transferring pharmacist,

    • (ii) the number of authorized refills remaining and, if applicable, the specified interval between refills, and

    • (iii) the date of the last refill.

• Marginal note:Records — transferring pharmacist

  (3) A pharmacist who transfers a prescription under subsection (1) must record the date of the transfer, the name of the pharmacist to whom the prescription was transferred, the name and address of the pharmacy where that pharmacist practises and, if applicable, the number of refills that are being transferred.

Marginal note:Activities without a prescription

• 55 (1) A pharmacist may sell, provide, send, deliver or transport a targeted substance without a prescription to any of the following persons on receipt of an order from that person that specifies the name and quantity of the targeted substance:

  • (a) if the order is written, a licensed dealer who

    • (i) sold or provided the targeted substance, or

    • (ii) is licensed to destroy targeted substances, other than those that the licensed dealer produced, made, assembled, sold or provided;

  • (b) subject to subsection (2),

    • (i) a practitioner,

    • (ii) another pharmacist, if the other pharmacist states that the targeted substance is required because of a delay or shortfall in an order for the targeted substance placed with a licensed dealer, or

    • (iii) a hospital, if the order is placed by a pharmacist practising in the hospital or by a practitioner who is authorized to order the targeted substance on behalf of the hospital;

  • (c) the Minister, if the order is a written order signed on the Minister’s behalf; or

  • (d) a person to whom an exemption with respect to the targeted substance has been granted under section 56 of the Act, if the order is a written order and is accompanied by a copy of the exemption.

• Marginal note:Verbal orders

  (2) In the circumstances set out in subparagraphs (1)(b)(i) to (iii), if the order is verbal, the pharmacist must record the following information:

  • (a) the name and address of the pharmacist or practitioner placing the order;

  • (b) if the order was placed on behalf of an establishment, the name and address of the establishment;

  • (c) the date of the order;

  • (d) the specified name or the brand name of the targeted substance ordered, as specified in the order;

  • (e) the quantity and, if applicable, the strength per unit of the targeted substance; and

  • (f) the name of the recording pharmacist.

• Marginal note:Records

  (3) A pharmacist who sells, provides, sends, delivers or transports a targeted substance without a prescription must keep a record of the following information:

  • (a) the brand name of the targeted substance 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;

  • (c) the name and address of the person referred to in subsection (1) to whom the targeted substance was sold, provided, sent, delivered or transported; and

  • (d) the date of the transaction.

• Marginal note:Copies

  (4) The pharmacist must keep the written order or, if the order is verbal, must create a hard copy of the order.

General Obligations of Pharmacists

Marginal note:Change of location

56 A pharmacist who closes premises in which a targeted substance has been stored must, not later than 10 days after the closure, inform the Minister of the date of closure, the location to which the targeted substance was moved and the quantity of the targeted substance that was moved.

Marginal note:Renunciation of privileges

• 57 (1) A pharmacist who does not wish to receive or have possession of targeted substances may make a written request to the Minister to send to licensed dealers and pharmacies a notice, issued under section 79, that states that targeted substances must not be supplied to that pharmacist.

• Marginal note:Prohibited actions

  (2) A pharmacist must not, unless their pharmacy has received a retraction issued under section 80,

  • (a) sell or provide a targeted substance to a pharmacist or practitioner named in a notice issued under section 79; or

  • (b) fill a prescription or order for a targeted substance from a practitioner named in a notice issued under section 79.

Practitioners

Marginal note:To patients only

58 A practitioner may, with respect to a targeted substance, prescribe it for or administer it to an individual or animal, or sell, provide, send, deliver or transport it to or for an individual or for the benefit of an animal, only if

• (a) the individual or animal is a patient that the practitioner is treating in their professional capacity; and

• (b) the targeted substance is required to treat the individual’s or animal’s medical condition.

Marginal note:Emergency supply

• 59 (1) A practitioner of medicine may store an emergency supply of targeted substances at a remote location where emergency medical treatment is not readily available or in an emergency medical service vehicle, if the practitioner has an agent or mandatary at that location or in the vehicle who will control and administer the targeted substances on behalf of, and under the direction of, the practitioner.

• Marginal note:Emergency use

  (2) When aid is being provided to an individual in an emergency, the agent or mandatary of the practitioner of medicine may administer a targeted substance from the emergency supply to the individual if

  • (a) the practitioner of medicine has, by telephone or other means, directed the agent or mandatary to administer the targeted substance; or

  • (b) the agent or mandatary follows written directives provided by the practitioner with respect to the administration of the targeted substance.