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

Regulations are current to 2016-01-25 and last amended on 2015-06-13. Previous Versions

 The Minister must provide the licensed dealers, pharmacies and provincial professional licensing authorities who were issued 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 issued 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 issued, and

    • (ii) provided a letter from the provincial professional licensing authority of the province in which the practitioner is registered or entitled to practise, in which the authority consents to the retraction of the notice.

  • SOR/88-482, s. 5(F);
  • SOR/2003-135, s. 6;
  • SOR/2010-222, s. 21.

 [Repealed, SOR/2003-135, s. 6]

DIVISION 5Hospitals

  •  (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.

  • (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.

  • (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).

  • (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).

  • SOR/78-427, s. 8;
  • SOR/85-550, s. 11;
  • SOR/88-482, s. 6;
  • SOR/97-228, s. 18;
  • SOR/2004-238, s. 27.

 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.

  •  (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.

  • (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.

  • (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.

  • (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.

  • (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.

  • (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.

  • SOR/85-550, s. 12;
  • SOR/88-482, s. 7;
  • SOR/2004-238, s. 28;
  • SOR/2010-222, s. 22(F).

 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.

  • SOR/78-427, s. 9.

Division 6

Authority and Penalty

  •  (1)  and (2) [Repealed, SOR/99-125, s. 5]

  • (3) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a controlled drug in their possession, provide or deliver the drug to

    • (a) a practitioner of medicine; or

    • (b) an agent of a practitioner of medicine, where the agent has been exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession of that controlled drug.

  • (4) If an agent of a practitioner of medicine receives a controlled drug under subsection (3), they shall immediately provide or deliver it

    • (a) to the practitioner of whom he is the agent; or

    • (b) to the Minister or his agent.

  • (5) A practitioner of medicine who receives a controlled drug under subsection (3) or (4) shall immediately provide or deliver it

    • (a) for the purpose of identification or analysis thereof, to a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession of that controlled drug for that purpose; or

    • (b) to the Minister or his agent.

  • SOR/99-125, s. 5;
  • SOR/2004-238, s. 29.

 Every person who is exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession or administration, as the case may be, of a controlled drug shall

  • (a) keep and retain for a period of two years from the date of the making of the record, a record of

    • (i) the kind, date and quantity of any controlled drug purchased or received by him,

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

    • (iii) particulars of the use to which the controlled drug was put; and

  • (b) furnish such information respecting such controlled drugs as the Minister may require, and shall permit access to the records required to be kept by this Part.

  • SOR/85-550, s. 13;
  • SOR/88-482, s. 8(F);
  • SOR/99-125, s. 6.

Test Kits Containing Controlled Drugs

 Any person may sell, possess or otherwise deal in a test kit that contains a controlled drug if

  • (a) a registration number has been issued for the test kit pursuant to section G.06.002.3;

  • (b) the test kit bears, on its external surface,

    • (i) the name of the producer, maker or assembler,

    • (ii) the trade name or trade mark, and

    • (iii) the registration number issued therefor pursuant to section G.06.002.3;

  • (c) the test kit is sold, possessed or otherwise dealt in for the purpose of medical, laboratory, industrial, educational or research use; and

  • (d) the registration number has not been cancelled pursuant to section G.06.002.4.

  • SOR/2004-238, s. 30.
 
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