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

Storage

Marginal note:Place

71 Subject to section 59, every person who is authorized under these Regulations to deal in a targeted substance and who stores the targeted substance must do so in the place used for the purpose of conducting their business or professional practice and in the area in that place where only authorized employees have access, except if the targeted substance is for their own use or the use of another person for whom, or an animal for which, they are responsible.

Security

Marginal note:Protective measures

• 72 (1) The following persons must take any measures that are necessary to ensure the security of any targeted substance in their possession:

  • (a) a pharmacist;

  • (b) a practitioner;

  • (c) the person in charge of a hospital;

  • (d) a person to whom an exemption has been granted under section 56 of the Act; and

  • (e) a person who, in accordance with a permit for transit or transhipment, is responsible for the targeted substance while it is in transit or in transhipment in Canada.

• Marginal note:Theft or loss

  (2) A person referred to in subsection (1) who becomes aware of a theft or loss of a targeted substance must provide a written report to the Minister within 10 days after becoming aware of the occurrence.

Destruction

Marginal note:Restriction

• 73 (1) Subject to subsection (2) and sections 36 and 37, a person must not destroy a targeted substance unless they have received it in accordance with these Regulations for their own use or the use of another person for whom, or an animal for which, they are responsible.

• Marginal note:Conditions

  (2) A pharmacist, a practitioner or the person in charge of a hospital may destroy a targeted substance if

  • (a) subject to subsection (3), the destruction is witnessed by a pharmacist or practitioner;

  • (b) the targeted substance is destroyed using a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction;

  • (c) they record the following information:

    • (i) the municipal address of the place of destruction,

    • (ii) the specified name of the targeted substance to be destroyed and, if applicable, the brand name of the product containing it or the name of the compound containing it,

    • (iii) the form and quantity of the targeted substance to be destroyed or the product or compound containing it and, if applicable, its strength per unit, the number of units per package and the number of packages,

    • (iv) the method of destruction, and

    • (v) the date of the destruction; and

  • (d) immediately following the destruction, the person who carried out the destruction and the pharmacist or practitioner who witnessed it sign and date a joint declaration attesting that the targeted substance was completely destroyed, to which each signatory must add their name in printed letters.

• Marginal note:Exception — open ampule

  (3) A targeted substance that constitutes the remainder of an open ampule, the partial contents of which have been administered to a patient, may be destroyed by a hospital employee who is a licensed health professional without a witness.

Documents

Marginal note:Alteration prohibited

74 A person must not make any mark on or alter or deface in any manner any licence, permit or registration number issued under these Regulations.

Marginal note:Retention period

75 A person must keep any document containing all of the information that they are required to record under these Regulations, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Marginal note:Location

76 The documents must be kept

• (a) in the case of a licensed dealer, at the site specified in their licence; and

• (b) in the case of a former licensed dealer or any other person, at a location in Canada.

Marginal note:Quality of documents

77 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Advertising

Marginal note:Restrictions

78 It is prohibited to

• (a) advertise a targeted substance to the general public; or

• (b) publish any written advertisement respecting a targeted substance unless the advertisement

  • (i) is published in literature distributed to, or in a trade publication for, licensed dealers, pharmacists, practitioners or hospitals, and

  • (ii) displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page:

    

Minister

Marginal note:Notice of prohibition of sale

• 79 (1) In the circumstances described in subsection (2), the Minister must send a notice to the persons and authorities specified in subsection (3) advising them that

  • (a) pharmacists practising in the notified pharmacies and all licensed dealers must not sell or provide any targeted substance to the pharmacist or the practitioner named in the notice;

  • (b) pharmacists practising in the notified pharmacies must not fill an order or prescription for any targeted substance provided by the practitioner named in the notice; or

  • (c) the prohibitions in both paragraphs (a) and (b) apply with respect to the practitioner named in the notice.

• Marginal note:Circumstances requiring a notice

  (2) The notice must be sent if the pharmacist or practitioner named in the notice has

  • (a) made a request to the Minister in accordance with subsection 57(1) or section 62 to send the notice;

  • (b) contravened a rule of conduct established by the provincial professional licensing authority in the province in which the pharmacist or practitioner is practising and the authority has requested the Minister in writing to send the notice; or

  • (c) been convicted of a designated substance offence or of a contravention of these Regulations.

• Marginal note:Recipients

  (3) The notice must be sent to

  • (a) all licensed dealers;

  • (b) all pharmacies within the province in which the pharmacist or practitioner named in the notice is registered and entitled to practise and is practising;

  • (c) the provincial professional licensing authority of the province in which the pharmacist or practitioner named in the notice is registered and entitled to practise;

  • (d) all pharmacies in an adjacent province in which a prescription or order from the pharmacist or practitioner named in the notice may be filled; and

  • (e) any provincial professional licensing authority in another province that has requested the Minister in writing to send the notice.

• Marginal note:Other circumstances

  (4) The Minister may send the notice described in subsection (1) to the persons and authorities specified in subsection (3) if the Minister has taken the measures specified in subsection (5) and has reasonable grounds to believe that the pharmacist or practitioner named in the notice

  • (a) has contravened a provision of the Act or these Regulations;

  • (b) has, on more than one occasion, self-administered a targeted substance under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted professional practice;

  • (c) has, on more than one occasion, prescribed, administered or provided a targeted substance to a person who is a spouse, common-law partner, parent or child of the pharmacist or practitioner, including a child adopted in fact, contrary to accepted professional practice; or

  • (d) is unable to account for a quantity of targeted substance for which the pharmacist or practitioner was responsible under these Regulations.

• Marginal note:Measures before sending notice

  (5) The measures that must be taken before sending the notice are that the Minister has

  • (a) consulted with the provincial professional licensing authority of the province in which the pharmacist or practitioner to whom the notice relates is registered and entitled to practise;

  • (b) given that pharmacist or practitioner an opportunity to be heard; and

  • (c) considered

    • (i) the compliance history of the pharmacist or practitioner in respect of the Act and its regulations, and

    • (ii) whether the actions of the pharmacist or practitioner pose a risk to public health or safety, including the risk of the targeted substance being diverted to an illicit market or use.

Marginal note:Prohibition of sale — notice of retraction

80 The Minister must provide the persons and authorities who were sent a notice under subsection 79(1) with a notice of retraction of that notice if

• (a) in the circumstance described in paragraph 79(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was sent by the Minister; or

• (b) in the circumstance described in any of paragraphs 79(2)(b) and (c) and (4)(a) to (d), the pharmacist or the practitioner named in the notice has

  • (i) requested in writing that a retraction of the notice be sent, and

  • (ii) provided a letter from the provincial professional licensing authority of the province in which the pharmacist or practitioner is registered and entitled to practise in which the authority consents to the retraction of the notice.

Marginal note:Communication of information by Minister to licensing authority

• 81 (1) The Minister must provide in writing any factual information about a pharmacist, practitioner or nurse that has been obtained under the Act or these Regulations to the provincial professional licensing authority that is responsible for the registration and authorization of the person to practise their profession

  • (a) in the province in which the person is or was registered and entitled to practise if

    • (i) the authority submits a written request that sets out the name and address of the person, a description of the information being requested and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or

    • (ii) the Minister has reasonable grounds to believe that the person has

      • (A) contravened a rule of conduct established by the authority,

      • (B) been convicted of a designated substance offence, or

      • (C) contravened these Regulations; or

  • (b) in a province in which the person is not registered and entitled to practise, if the authority submits to the Minister

    • (i) a written request that sets out the person’s name and address and a description of the information being requested, and

    • (ii) a document that shows that

      • (A) the person has applied to that authority to practise in that province, or

      • (B) the authority has reasonable grounds to believe that the person is practising in that province without being authorized to do so.

• Marginal note:Definition of nurse

  (2) For the purpose of subsection (1), nurse does not include a nurse practitioner.