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

Marginal note:Retention period

G.02.077 A licensed dealer and a former licensed dealer must keep any document containing the information that they are required to record under this Part, 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.

Marginal note:Location

G.02.078 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, at a location in Canada.

Marginal note:Quality of documents

G.02.079 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

DIVISION 3Pharmacists

Record of Controlled Drugs Received

Marginal note:General information

• G.03.001 (1) A pharmacist, on receipt of a controlled drug from a licensed dealer or from another pharmacist, shall keep a record of the name and quantity of the controlled drug received by them, the name and address of the person who sold or provided it and the date it was received.

• Marginal note:Record

  (2) The record of information referred to in subsection (1) shall be kept

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

  • (b) subject to subsection (3), in a book, register or similar record maintained exclusively for controlled drugs.

• Marginal note:Exception

  (3) The record of 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).

Sale of Controlled Drugs

Marginal note:No sale without prescription

G.03.002 No pharmacist shall, except as otherwise provided in this Part, sell or provide a controlled drug to any person unless the pharmacist has first been provided with a prescription for it, and

• (a) if the prescription is in writing, it has been signed and dated by the practitioner issuing the same and the signature of the practitioner where not known to the pharmacist, has been verified by him; or

• (b) if the prescription is given verbally, the pharmacist has taken reasonable precaution to satisfy himself that the person giving the prescription is a practitioner.

Marginal note:Prohibition — pharmacist or practitioner named in notice

G.03.002.1 Subject to section G.03.002.2 and notwithstanding sections G.03.002, G.03.003 and G.03.005, no pharmacist shall

• (a) sell or provide a controlled drug, other than a preparation, to a pharmacist named in a notice given by the Minister under section G.03.017.2;

• (b) sell or provide a preparation to a pharmacist named in a notice given by the Minister under section G.03.017.2;

• (c) dispense, sell or provide a controlled drug, other than a preparation, to, or pursuant to a prescription or order given by, a practitioner named in a notice given by the Minister under section G.04.004.2; or

• (d) dispense, sell or provide a preparation to a practitioner or pursuant to a prescription or order given by a practitioner named in a notice given by the Minister under section G.04.004.2.

Marginal note:Exception — notice of retraction

G.03.002.2 Section G.03.002.1 does not apply to a pharmacist to whom the Minister has issued a notice of retraction of the notice

• (a) under section G.03.017.3, in respect of a pharmacist named in a notice issued by the Minister under section G.03.017.2; or

• (b) under section G.04.004.3, in respect of a practitioner named in a notice issued by the Minister under section G.04.004.2.

Marginal note:Sale to practitioner – order

• G.03.003 (1) A pharmacist may sell or provide a controlled drug to a practitioner for use in their practice

  • (a) upon a written order, signed and dated by that practitioner, that has been verified if the signature of the practitioner is unknown to the pharmacist; or

  • (b) upon a verbal order specifying the name and quantity of the drug if the pharmacist has taken reasonable precautions to satisfy themself that the person making the order is a practitioner.

• (2) [Repealed, SOR/2019-171, s. 5]

Marginal note:Prescription file

G.03.004 A pharmacist shall, in respect of controlled drugs sold or provided to a practitioner under section G.03.003, keep in a special prescription file a record showing the date, the name and address of the practitioner, and the quantity and kind of controlled drug sold or provided.

Marginal note:Provision to hospital

G.03.005 A pharmacist may provide a controlled drug to a hospital employee or to a practitioner in a hospital on receipt of a written order signed and dated by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to sign the order, if the signature of that pharmacist or practitioner is known to the pharmacist or, if unknown, has been verified by the pharmacist.

Marginal note:Refilling prescription

G.03.006 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.

Records

Marginal note:Written order or prescription

G.03.007 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.

Marginal note:Verbal order or prescription

G.03.008 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

G.03.009 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

G.03.010 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

Marginal note:Providing information and assisting inspector

G.03.011 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

G.03.012 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.

Marginal note:Loss or theft — report

G.03.013 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

Marginal note:Written order

G.03.014 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.

Marginal note:Record

G.03.015 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.

Marginal note:Notice to Minister

G.03.016 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

G.03.017 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.