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Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2022-09-11 and last amended on 2022-03-02. Previous Versions

PART GControlled Drugs (continued)

DIVISION 4Practitioners (continued)

Notice of Prohibition of Sale (continued)

Marginal note:Notice by Minister

  •  (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 licensed dealers must not sell or provide to the practitioner named in the notice a controlled drug other than a preparation or a preparation;

    • (b) pharmacists practising in the notified pharmacies must not fill a prescription or order from the practitioner named in the notice for a controlled drug other than a preparation or a preparation; 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 practitioner named in the notice has

    • (a) made a request to the Minister in accordance with section G.04.004.1 to send the notice;

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

    • (c) been convicted of a designated substance offence or of a contravention of this Part.

  • Marginal note:Recipients

    (3) The notice must be sent to

    • (a) all licensed dealers;

    • (b) all pharmacies within the province in which the practitioner named in the notice is registeredand entitled to practice and is practising;

    • (c) the provincial professional licensing authority of the province in which the 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 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; and

  • 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 practitioner named in the notice

    • (a) has contravened a provision of the Act or this Part;

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

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

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

    • (f) is unable to account for the quantity of controlled drug for which the practitioner was responsible under this Part.

  • 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 practitioner to whom the notice relates is registered and entitled to practise;

    • (b) given that practitioner an opportunity to be heard

    • (c) considered

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

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

Marginal note:Notice of retraction

 The Minister must provide the licensed dealers, pharmacies and provincial professional licensing authorities who were sent a notice under subsection G.04.004.2(1) with a notice of retraction of that notice if

  • (a) in the circumstance described in paragraph G.04.004.2(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 a circumstance described in any of paragraphs G.04.004.2(2)(b) and (c) and (4)(a) to (f), 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 practitioner is registered and entitled to practise, in which the authority consents to the retraction of the notice.

 [Repealed, SOR/2003-135, s. 6]

DIVISION 5Hospitals

Marginal note:Record — controlled drugs

  •  (1) A person who is in charge of a hospital shall keep or cause to be kept a record of the following information:

    • (a) the name and quantity of any controlled drug received for the hospital by a hospital employee or a practitioner in the hospital;

    • (b) the name and address of the person from whom any controlled drug was received and the date on which it was received;

    • (c) the name and quantity of any controlled drug used in the making or assembling of a product or compound containing that controlled drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;

    • (c.1) the name and quantity of any controlled drug produced and the date on which it was placed in stock;

    • (d) the name of the patient for whom a controlled drug was dispensed;

    • (e) the name of the practitioner ordering or prescribing a controlled drug; and

    • (f) the date on which a controlled drug was ordered or prescribed and the form and quantity thereof.

  • Marginal note:Record keeping

    (2) Subject to subsections (3) and (4), the record of information referred to in subsection (1) shall be kept

    • (a) in a manner that permits an audit to be made;

    • (b) in a book, register or similar record maintained exclusively for controlled drugs; and

    • (c) for a period of at least two years.

  • Marginal note:Exception — preparation

    (3) The information referred to in paragraphs (1)(d) to (f) may, with respect to a preparation, be kept in a form other than that specified in paragraph (2)(b).

  • Marginal note:Exception — Part II or III of schedule

    (4) The information referred to in subsection (1) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b).

  • SOR/78-427, s. 8
  • SOR/85-550, s. 11
  • SOR/88-482, s. 6
  • SOR/97-228, s. 18
  • SOR/2004-238, s. 27
  • SOR/2019-171, s. 18(F)

Marginal note:Providing information and assisting inspector

 A person who is in charge of a hospital shall

  • (a) furnish such information respecting the use of controlled drugs therein, in such form and at such times as the Minister may require;

  • (b) produce to an inspector any books, records or documents required by these Regulations to be kept;

  • (c) permit an inspector to make copies thereof or take extracts from such books, records and documents; and

  • (d) permit an inspector to check all stocks of controlled drugs in the hospital.

Marginal note:Selling, providing or administering controlled drug

  •  (1) No person in charge of a hospital shall permit a controlled drug to be sold, provided or administered except in accordance with this section.

  • Marginal note:Prescription or written order

    (2) On receipt of a prescription or a written order signed and dated by a practitioner, the person in charge of a hospital may permit a controlled drug to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided to the person or to the person in charge of the animal.

  • Marginal note:Emergency — other hospital

    (3) Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be provided, for emergency purposes, to a hospital employee or a practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order.

  • Marginal note:Emergency — pharmacist

    (4) Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist.

  • Marginal note:Research purposes

    (5) The person in charge of a hospital may permit a controlled drug to be provided to a person employed in a research laboratory in that hospital for the purpose of research.

  • Marginal note:Signature

    (6) No person in charge of a hospital shall permit a controlled drug to be sold or provided under subsection (3) or (4) unless the signature of the pharmacist in the other hospital or of the practitioner authorized by the person in charge of the other hospital to sign an order is known to the person who sells or provides the controlled drug or has been verified.

 
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