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

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G.04.004.4 and G.04.004.5 [Repealed, SOR/2003-135, s. 6]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

Marginal note:Providing information and assisting inspector

G.05.002 A person who is in charge of a hospital shall

• (a) furnish such information respecting the use of controlled drugs therein, in such form and at such times as the Minister may require;

• (b) produce to an inspector any books, records or documents required by these Regulations to be kept;

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

• (d) permit an inspector to check all stocks of controlled drugs in the hospital.

Marginal note:Selling, providing or administering controlled drug

• G.05.003 (1) No person in charge of a hospital shall permit a controlled drug to be sold, provided or administered except in accordance with this section.

• Marginal note:Prescription or written order

  (2) On receipt of a prescription or a written order signed and dated by a practitioner, the person in charge of a hospital may permit a controlled drug to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided to the person or to the person in charge of the animal.

• Marginal note:Emergency — other hospital

  (3) Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be provided, for emergency purposes, to a hospital employee or a practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order.

• Marginal note:Emergency — pharmacist

  (4) Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist.

• Marginal note:Research purposes

  (5) The person in charge of a hospital may permit a controlled drug to be provided to a person employed in a research laboratory in that hospital for the purpose of research.

• Marginal note:Signature

  (6) No person in charge of a hospital shall permit a controlled drug to be sold or provided under subsection (3) or (4) unless the signature of the pharmacist in the other hospital or of the practitioner authorized by the person in charge of the other hospital to sign an order is known to the person who sells or provides the controlled drug or has been verified.

Marginal note:Loss or theft

G.05.004 A person who is in charge of a hospital shall take all steps necessary to protect controlled drugs in the hospital against loss or theft and shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.

DIVISION 6General

Marginal note:Labelling — drug dispensed in accordance with prescription

G.06.001 In the case of a controlled drug that is dispensed by a pharmacist in accordance with a prescription, section C.01.004 does not apply but the label of the package in which the controlled drug is contained must include the following:

• (a) the name and municipal address of the pharmacy or pharmacist;

• (b) the date and number of the prescription;

• (c) the name of the person for whom the controlled drug is dispensed;

• (d) the name of the practitioner;

• (e) directions for use; and

• (f) any other information that the prescription requires be shown on the label.

Marginal note:Labelling — test kit

G.06.002 Section C.01.004 does not apply to a test kit that contains a controlled drug and that has a registration number.

G.06.002.1 [Repealed, SOR/2019-171, s. 20]

G.06.002.2 [Repealed, SOR/2019-171, s. 20]

G.06.002.3 [Repealed, SOR/2019-171, s. 20]

G.06.002.4 [Repealed, SOR/2019-171, s. 20]

Marginal note:Identification or analysis of controlled drug

• G.06.003 (1) Despite anything in this Part, a person may, for the purpose of identification or analysis of a controlled drug, provide or deliver the drug to

  • (a) a practitioner of medicine; or

  • (b) an agent or mandatary of a practitioner of medicine, if the agent or mandatary is exempted under section 56 of the Act with respect to the possession of that drug for that purpose.

• Marginal note:Agent or mandatary of practitioner of medicine

  (2) An agent or mandatary of a practitioner of medicine who receives the controlled drug must immediately provide or deliver it to

  • (a) the practitioner; or

  • (b) the Minister.

• Marginal note:Practitioner of medicine

  (3) A practitioner of medicine who receives the controlled drug must immediately provide or deliver it

  • (a) for the purpose of its identification or analysis, to a person exempted under section 56 of the Act with respect to the possession of that drug for that purpose; or

  • (b) to the Minister.

Marginal note:Advertising

G.06.004 It is prohibited to

• (a) advertise a controlled drug to the general public; or

• (b) publish any written advertisement respecting a controlled drug unless that advertisement displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page:

  

  • SOR/2019-171, s. 20

Marginal note:Record keeping — specific cases

G.06.005 Every person who is exempted under section 56 of the Act with respect to the possession or administration of a controlled drug and every practitioner of medicine who has received a controlled drug under subsection G.06.003(1) or (2) and every agent or mandatary of a practitioner of medicine who has received a controlled drug under subsection G.06.003(1) must

• (a) keep a record of the following information for a two-year period beginning on the day on which the record is made:

  • (i) the name and quantity of any controlled drug purchased or received by them and the date on which it was purchased or received,

  • (ii) the name and address of the person from whom the controlled drug was purchased or received, and

  • (iii) details of the use of the controlled drug;

• (b) provide any information respecting those controlled drugs that the Minister may require; and

• (c) permit access to the records required to be kept by this Part.