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

Regulations are current to 2020-07-28 and last amended on 2019-12-09. Previous Versions

Individuals (continued)

Marginal note:Export

 An individual may, at the time of their departure from Canada, export a targeted substance that is in their possession at the time of departure if

  • (a) the substance has been obtained under a prescription and is labelled with the information set out in paragraphs 51(2)(a) to (g);

  • (b) the individual is exporting the substance

    • (i) for their own use,

    • (ii) for the use of a person for whom the individual is responsible and who is travelling with them, or

    • (iii) for the use of an animal for which the individual is responsible and that is travelling with them;

  • (c) the substance is required to meet the medical needs of the individual or animal for whose benefit it is prescribed; and

  • (d) the quantity exported does not exceed the lesser of

    • (i) a single course of treatment, and

    • (ii) a 90-day supply, based on the usual daily dose.

  • SOR/2019-170, s. 15

Verification of Identity

Marginal note:Order

 Every person who fills an order or prescription for a targeted substance must verify the identity of the person who gave the order or issued the prescription if

  • (a) the signature on the order or prescription is unknown to the person; or

  • (b) the order or prescription is verbal and the person placing it is not known to the person.

  • SOR/2010-223, s. 32
  • SOR/2019-170, s. 16

Storage

Marginal note:Place

 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.

  • SOR/2010-223, ss. 33, 42(E)
  • SOR/2019-170, s. 16

Security

Marginal note:Protective measures

  •  (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.

  • SOR/2010-223, ss. 34, 43(F)
  • SOR/2019-170, s. 16

Destruction

Marginal note:Restriction

  •  (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.

  • SOR/2010-223, s. 35(E)
  • SOR/2019-170, s. 16

Documents

Marginal note:Alteration prohibited

 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.

  • SOR/2010-223, s. 36
  • SOR/2019-170, s. 16

Marginal note:Retention period

 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.

  • SOR/2019-170, s. 16

Marginal note:Location

 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.

  • SOR/2019-170, s. 16

Marginal note:Quality of documents

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

  • SOR/2010-223, ss. 37(E), 42(E)
  • SOR/2018-69, s. 78(E)
  • SOR/2019-170, s. 16

Advertising

Marginal note:Restrictions

 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:

      The symbol consists of a square outline divided in half from top left corner to bottom right corner. An uppercase letter C appears in the centre of the top right half and an uppercase letter T appears in the centre of the lower left half.
  • SOR/2010-223, ss. 38(E), 43(F)
  • SOR/2019-170, s. 16

Minister

Marginal note:Notice of prohibition of sale

  •  (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.

  • SOR/2010-223, ss. 39, 43(F)
  • SOR/2014-260, s. 38
  • SOR/2019-170, s. 16
 
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