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

Marginal note:Notice of retraction

G.03.017.3 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.

G.03.017.4 and G.03.017.5 [Repealed, SOR/2003-135, s. 5]

DIVISION 4Practitioners

Administration of Designated Drugs and Other Controlled Drugs

Marginal note:Restriction

• G.04.001 (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

• G.04.002 (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

Marginal note:Requirements

G.04.002A 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.

G.04.003 [Repealed, SOR/2010-222, s. 18]

Communication of Information by Minister to Licensing Authority

Marginal note:Contraventions by practitioner

G.04.004 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.

Notice of Prohibition of Sale

Marginal note:Request by practitioner

G.04.004.1 A practitioner may make a written request to the Minister to send to licensed dealers and pharmacies a notice, issued under section G.04.004.2, advising them of one or more of the following requirements:

• (a) recipients of the notice must not sell or provide a controlled drug, other than a preparation, to that practitioner;

• (b) recipients of the notice must not sell or provide a preparation to that practitioner;

• (c) pharmacists practising in the notified pharmacies must not fill a prescription or order for a controlled drug, other than a preparation, from that practitioner; and

• (d) pharmacists practising in the notified pharmacies must not fill a prescription or order for a preparation from that practitioner.

Marginal note:Notice by Minister

• G.04.004.2 (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

G.04.004.3 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.

G.04.004.4 and G.04.004.5 [Repealed, SOR/2003-135, s. 6]

DIVISION 5Hospitals

Marginal note:Record — controlled drugs

• G.05.001 (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).