Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

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

Regulations are current to 2022-01-12 and last amended on 2022-01-05. Previous Versions

PART GControlled Drugs (continued)

DIVISION 2Licensed Dealers (continued)

Documents (continued)

Marginal note:Verbal order

 A licensed dealer that receives a verbal order for a controlled drug listed in Part II or III of the schedule to this Part and sells or provides it to a pharmacist, practitioner or hospital employee must immediately record

  • (a) the name of the person who placed the order;

  • (b) the date on which the order was received; and

  • (c) the name of the person recording the order.

Marginal note:Explainable loss of controlled drug

 A licensed dealer that becomes aware of a loss of a controlled drug that can be explained on the basis of normally accepted business activities must record the following information:

  • (a) the name of the lost controlled drug and, if applicable, the brand name of the product or the name of the compound containing it;

  • (b) the form and quantity of the controlled drug and, if applicable, the form of the product or compound containing it, the strength per unit of the controlled drug in the product or compound, the number of units per package and the number of packages;

  • (c) the date on which the dealer became aware of the loss; and

  • (d) the explanation for the loss.

Marginal note:Destruction

 A licensed dealer must record the following information concerning any controlled drug that they destroy at the site specified in their licence:

  • (a) the municipal address of the place of destruction;

  • (b) the name, form and quantity of the controlled drug and, if applicable, the brand name and quantity of the product containing the drug or the name and quantity of the compound containing the drug;

  • (c) the method of destruction; and

  • (d) the date of destruction.

Marginal note:Annual report

  •  (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains

    • (a) the name, form and total quantity of each controlled drug that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each controlled drug that they use to manufacture or assemble a product or compound;

    • (b) the name, form and quantity of each controlled drug in physical inventory taken at the site specified in their licence at the end of the calendar year; and

    • (c) the name, form and quantity of any controlled drug that has been lost or stolen in the course of conducting activities during the calendar year.

  • Marginal note:Non-renewal or revocation within first three months

    (2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister

    • (a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and

    • (b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

  • Marginal note:Non-renewal or revocation after third month

    (3) If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

Marginal note:Retention period

 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

 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

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

DIVISION 3Pharmacists

[
  • SOR/2019-171, s. 2(F)
]

Record of Controlled Drugs Received

[
  • SOR/2019-171, s. 2
]

Marginal note:General information

  •  (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).

  • SOR/78-427, s. 5
  • SOR/85-550, s. 4
  • SOR/86-91, s. 2(F)
  • SOR/90-261, s. 3(F)
  • SOR/97-228, s. 12
  • SOR/2004-238, s. 13
  • SOR/2010-222, s. 14(E)

Sale of Controlled Drugs

[
  • SOR/2019-171, s. 3
]

Marginal note:No sale without prescription

 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.

  • SOR/2004-238, s. 14

Marginal note:Prohibition — pharmacist or practitioner named in notice

 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

 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.

  • SOR/2003-135, s. 4

Marginal note:Sale to practitioner – order

  •  (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

 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.

  • SOR/2004-238, s. 17

Marginal note:Provision to hospital

 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

 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.

 
Date modified: