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

Regulations are current to 2022-09-11 and last amended on 2022-07-21. Previous Versions

PART GControlled Drugs (continued)

DIVISION 3Pharmacists (continued)

[
  • SOR/2019-171, s. 2(F)
]

General Obligations of Pharmacist (continued)

[
  • SOR/2019-171, s. 8
]

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.

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.03.017.2(1) with a notice of retraction of that notice if

  • (a) in the circumstance described in paragraph G.03.017.2(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.03.017.2(2)(b) and (c) and (4)(a) to (f), the pharmacist 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 is entitled to practise, in which the authority consents to the retraction of the notice.

 [Repealed, SOR/2003-135, s. 5]

DIVISION 4Practitioners

Administration of Designated Drugs and Other Controlled Drugs

Marginal note:Restriction

  •  (1) Subject to subsections (2) and (3) and to an exemption granted under section 56 of the Act with respect to the administration of the controlled drug specified in the exemption, a practitioner must not administer a controlled drug to any person or animal.

  • Marginal note:Conditions

    (2) A practitioner may administer a controlled drug, other than a designated drug, to a person or to an animal, if

    • (a) that person or animal is under their professional treatment; and

    • (b) the controlled drug is required for the condition for which that person or animal is receiving treatment.

  • Marginal note:Purposes

    (3) A practitioner of medicine, dentistry or veterinary medicine or a nurse practitioner may administer a designated drug to a person or animal who is under their professional treatment if the designated drug is for the treatment of any of the following conditions:

    • (a) in the case of persons,

      • (i) narcolepsy,

      • (ii) hyperkinetic disorders in children,

      • (iii) epilepsy,

      • (iv) parkinsonism, or

      • (v) hypotensive states associated with anesthesia; or

    • (b) in the case of animals, depression of cardiac and respiratory centres.

  • Marginal note:Definitions

    (4) The following definitions apply in this section.

    administer

    administer includes to prescribe, sell or provide a drug. (administrer)

    designated drug

    designated drug means any of the following controlled drugs:

    • (a) amphetamine and its salts;

    • (b) benzphetamine and its salts;

    • (c) methamphetamine and its salts;

    • (d) phenmetrazine and its salts; or

    • (e) phendimetrazine and its salts. (drogue désignée)

Records

Marginal note:Record of controlled drugs sold or provided

  •  (1) A practitioner who sells or provides a controlled drug to a person for self-administration or for administration to an animal shall, whether or not the practitioner charges for the drug, keep a record showing the name and quantity of the controlled drug sold or provided, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided if the quantity of the controlled drug exceeds

    • (a) three times the maximum daily dosage recommended by the manufacturer or assembler of the controlled drug; or

    • (b) three times the generally recognized maximum daily therapeutic dosage for that controlled drug if the manufacturer or assembler has not recommended a maximum daily dosage.

  • Marginal note:Accessibility of record

    (2) A practitioner who is required by this section to keep a record shall keep the record in a place, form and manner that will permit an inspector readily to examine and obtain information from it.

General Obligations of Practitioner

[
  • SOR/2019-171, s. 15
]

Marginal note:Requirements

 A practitioner shall

  • (a) furnish to the Minister on request such information respecting

    • (i) the use by the practitioner of controlled drugs received — including the administering, selling or providing of the drugs to a person — , and

    • (ii) the prescriptions for controlled drugs issued by the practitioner,

    as the Minister may require;

  • (b) produce to an inspector on request any records that these Regulations require the practitioner to keep;

  • (c) permit an inspector to make copies of such records or to take extracts therefrom;

  • (d) permit an inspector to check all stocks of controlled drugs on the practitioner’s premises;

  • (e) retain in his possession for at least two years any record that these Regulations require him to keep;

  • (f) take adequate steps to protect controlled drugs in his possession from loss or theft; and

  • (g) report to the Minister any loss or theft of a controlled drug within 10 days of the practitioner’s discovery of the loss or theft.

  • SOR/2004-238, s. 25

 [Repealed, SOR/2010-222, s. 18]

Communication of Information by Minister to Licensing Authority

Marginal note:Contraventions by practitioner

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

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

    • (i) the authority submits to the Minister a written request that sets out the practitioner’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 practitioner 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 practitioner is not registered and entitled to practise, if the authority submits to the Minister

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

    • (ii) a document that shows that

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

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

 
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