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

Regulations are current to 2022-11-16 and last amended on 2022-03-02. Previous Versions

PART GControlled Drugs (continued)

DIVISION 3Pharmacists (continued)

[
  • SOR/2019-171, s. 2(F)
]

Sale of Controlled Drugs (continued)

[
  • SOR/2019-171, s. 3
]

Marginal note:Refilling prescription

 A pharmacist shall not refill a prescription for a controlled drug unless

  • (a) the practitioner, at the time that he issued the prescription, directed in writing, in the case of a controlled drug listed in Part I of the schedule to this Part, or directed in writing or orally, in the case of a controlled drug listed in Part II or III of the schedule to this Part, that the prescription be refilled, the number of times that it may be refilled and the dates for or the intervals between refills; and

  • (b) the pharmacist keeps a record of each refilling of a prescription.

  • SOR/78-427, s. 6
  • SOR/97-228, s. 13

Records

Marginal note:Written order or prescription

 If, in accordance with a written order or prescription, a pharmacist dispenses a controlled drug listed in Part I of the schedule to this Part, other than a preparation, the pharmacist must immediately enter in a book, register or similar record maintained for such purposes

  • (a) their name or initials;

  • (b) the name, initials and municipal address of the practitioner who issued the order or prescription;

  • (c) the name and municipal address of the person named in the order or prescription;

  • (d) the name, form and quantity of the controlled drug dispensed;

  • (e) the date on which the controlled drug was dispensed; and

  • (f) the number assigned to the order or prescription.

  • SOR/78-427, s. 7
  • SOR/81-359, s. 1(F)
  • SOR/97-228, s. 14
  • SOR/2004-238
  • s. 19
  • SOR/2019-171, s. 7

Marginal note:Verbal order or prescription

 A pharmacist must, before dispensing a controlled drug in accordance with a verbal order or prescription, make a written record of it that sets out

  • (a) their name or initials;

  • (b) the name, initials and municipal address of the practitioner who issued the order or prescription;

  • (c) the name and municipal address of the person named in the order or prescription;

  • (d) the name, form and quantity of the controlled drug;

  • (e) the directions for use given with the order or prescription;

  • (f) the date on which the controlled drug was dispensed; and

  • (g) the number assigned to the order or prescription.

Marginal note:File by date and number

 A pharmacist must maintain a special prescription file in which are filed, in sequence as to date and number, all written orders and prescriptions for controlled drugs that they have dispensed and the written record of all controlled drugs that they have dispensed in accordance with a verbal order or prescription.

Marginal note:Retention period

 A pharmacist shall retain in his possession for a period of at least two years, any records which he is required to keep by this Part.

General Obligations of Pharmacist

[
  • SOR/2019-171, s. 8
]

Marginal note:Providing information and assisting inspector

 A pharmacist shall

  • (a) furnish such information respecting the dealings of the pharmacist in any controlled drug in such form and at such times as the Minister may require;

  • (b) make available and produce to an inspector upon request his special prescription file together with any books, records or documents which he is required to keep;

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

  • (d) permit an inspector to check all stocks of controlled drugs on his premises.

Marginal note:Loss or theft — protective measures

 A pharmacist shall take all reasonable steps that are necessary to protect controlled drugs on his premises or under his control against loss or theft.

  • SOR/85-550, s. 8

Marginal note:Loss or theft — report

 A pharmacist shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.

Return, Sale and Transfer

[
  • SOR/2019-171, s. 9
]

Marginal note:Written order

 A pharmacist may, upon receiving a written order for a controlled drug signed and dated by

  • (a) the licensed dealer who sold or provided that drug to them, return that drug to that licensed dealer;

  • (b) another pharmacist, sell or provide any quantity of that drug to that other pharmacist that is specified in the order as being required for emergency purposes;

  • (c) the Minister, sell or provide to the Minister any quantity of that drug, specified in the order, that is required by the Minister in connection with his or her duties; and

  • (d) a person exempted under section 56 of the Act with respect to that controlled drug, sell or provide to that person any quantity of that drug that is specified in the order.

  • SOR/81-359, s. 2
  • SOR/85-550, s. 9
  • SOR/99-125, s. 3
  • SOR/2004-238, s. 21
  • SOR/2014-260, s. 8(E)
  • SOR/2018-69, s. 65
  • SOR/2019-171, s. 10

Marginal note:Record

 A pharmacist shall immediately after receiving, selling or providing a controlled drug under paragraph G.03.014(b) or (c) or subsection G.05.003(4) enter the details of the transaction in a book, register or other record maintained for the purpose of recording such transactions.

  • SOR/85-550, s. 10
  • SOR/2004-238, s. 22

Marginal note:Notice to Minister

 A pharmacist shall forthwith after removing, transporting or transferring a controlled drug from his place of business to any other place of business operated by him notify the Minister, setting out the details.

Communication of Information by Minister to Licensing Authority

Marginal note:Contraventions by pharmacist

 The Minister must provide in writing any factual information about a pharmacist that has been obtained under the Act or this Part to the provincial professional licensing authority that is responsible for the authorization of the person to practise their profession

  • (a) in the province in which the pharmacist is or was entitled to practise if

    • (i) the authority submits to the Minister a written request that sets out the pharmacist’s name and address, 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 pharmacist has

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

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

      • (C) contravened this Part; or

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

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

    • (ii) a document that shows that

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

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

Notice of Prohibition of Sale

Marginal note:Request by pharmacist

 A pharmacist may make a written request to the Minister to send to the persons and authorities specified in subsection G.03.017.2(3) a notice, issued under section G.03.017.2, advising them that recipients of the notice must not sell or provide a controlled drug other than a preparation, a preparation, or both, to that pharmacist.

  • SOR/2003-135, s. 5

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 pharmacists practising in the notified pharmacies and licensed dealers must not sell or provide to the pharmacist named in the notice a controlled drug other than a preparation or a preparation.

  • Marginal note:Circumstances requiring a notice

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

    • (a) made a request to the Minister in accordance with section G.03.017.1 to send the notice;

    • (b) contravened a rule of conduct established by the provincial professional licensing authority of the province in which the pharmacist 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 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 pharmacist named in the notice is entitled to practice and is practising;

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

    • (d) all pharmacies in an adjacent province in which an order from the pharmacist 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 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, contrary to accepted pharmaceutical practice;

    • (c) has, on more than one occasion, self-administered a preparation, contrary to accepted pharmaceutical practice;

    • (d) has, on more than one occasion, 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 pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice;

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

    • (f) is unable to account for the quantity of controlled drug for which the pharmacist 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 pharmacist to whom the notice relates is entitled to practise;

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

    • (c) considered

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

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

 
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