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

Regulations are current to 2017-11-20 and last amended on 2017-11-13. Previous Versions

  •  (1) A person is authorized to have a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 or 17 of Part I of the schedule to this Part in his or her possession where the person has obtained the controlled drug under these Regulations, in the course of activities performed in connection with the enforcement or administration of an Act or regulation, or from a person who is exempt under section 56 of the Controlled Drugs and Substances Act from the application of subsection 5(1) of that Act with respect to that controlled drug, and the person

    • (a) requires the controlled drug for his business or profession and is

      • (i) a licensed dealer,

      • (ii) a pharmacist, or

      • (iii) a practitioner who is registered and entitled to practise in the province in which he has such possession;

    • (b) is a practitioner who is registered and entitled to practise in a province other than the province in which he has such possession and such possession is for emergency medical purposes only;

    • (c) is a hospital employee or a practitioner in a hospital;

    • (d) has obtained the controlled drug for his own use from a practitioner or pursuant to a prescription that is not issued or obtained in contravention of these Regulations;

    • (e) is a practitioner of medicine who received the controlled drug under subsection G.06.001(3) or (4) and whose possession is for a purpose referred to in subsection G.06.001(5);

    • (f) is an agent of a practitioner of medicine who received the controlled drug under subsection G.06.001(3) and whose possession is for the purpose of complying with subsection G.06.001(4);

    • (g) is employed as an inspector, a member of the Royal Canadian Mounted Police, a police constable, peace officer or member of the technical or scientific staff of any department of the Government of Canada or of a province or university and such possession is for the purposes of and in connection with such employment;

    • (h) is a person other than a person referred to in paragraph (e) or (f), is exempted under section 56 of the Controlled Drugs and Substances Act with respect to possession of that controlled drug and whose possession is for a purpose set out in the exemption; or

    • (i) is a person referred to in paragraph G.06.001(5)(b).

  • (2) A person is authorized to have a controlled drug referred to in subsection (1) in his possession where the person is acting as the agent for any person referred to in paragraph (1)(a) to (e), (h) or (i).

  • (3) A person is authorized to have a controlled drug referred to in subsection (1) in his possession where

    • (a) the person is acting as the agent for a person he has reasonable grounds to believe is a person referred to in paragraph (1)(g); and

    • (b) the possession of the controlled drug is for the purpose of assisting that person in the enforcement or administration of an Act or a regulation.

  • SOR/97-515, s. 3;
  • SOR/99-125, s. 1;
  • SOR/2003-34, s. 1;
  • SOR/2003-413, s. 1.

 Section C.01.004 does not apply to a test kit that contains a controlled drug where a registration number has been issued for the test kit pursuant to section G.06.002.3 and has not been cancelled pursuant to section G.06.002.4.

  • SOR/80-543, s. 11.

 In the case of a controlled drug that is dispensed by a pharmacist pursuant to a prescription, section C.01.004 does not apply but the label of the package in which the controlled drug is contained shall carry the following:

  • (a) the name and 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.

  • SOR/80-543, s. 11;
  • SOR/2004-238, s. 2(F).

 The Controlled Drugs and Substances Act and this Part do not apply in respect of a controlled drug that is contained in an agricultural implant and set out in Part III of the schedule to this Part, but nothing in this section exempts such a drug from the requirements of Part C.

  • SOR/92-386, s. 2;
  • SOR/97-228, s. 8.

 [Repealed, SOR/80-543, s. 12]

 Except as otherwise provided in this Part, no person shall sell a controlled drug or preparation that does not comply with all provisions of Parts C and D applicable to it.

 No person shall

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

  • (b) issue or publish any other written advertisement respecting a controlled drug unless that advertisement carries the symbol Symbol for caution, consisting of a diamond shape outline in which an uppercase letter C is centred. in a clear and conspicuous colour and size in the upper left quarter of the first page of the advertisement.

 [Repealed, SOR/80-543, s. 12]

Prescribed Manner of Notice of Application for an Order of Restoration

  •  (1) For the purpose of subsection 24(1) of the Controlled Drugs and Substances Act, notice of application for an order of restoration shall be given in writing to the Attorney General by registered mail.

  • (2) The notice referred to in subsection (1) shall be mailed not less than 15 clear days prior to the date the application for an order of restoration is to be made to the magistrate and shall specify

    • (a) the magistrate to whom the application is to be made;

    • (b) the time and place where the application is to be heard;

    • (c) the controlled drug or other thing in respect of which the application is to be made; and

    • (d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the controlled drug or other thing referred to in paragraph (c).

  • SOR/97-228, s. 9.

DIVISION 2Licences and Licensed Dealers

 Subject to this Part, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a controlled drug.

  • SOR/2004-238, s. 3.

 To be eligible for a dealer’s licence, a person must be

  • (a) an individual who ordinarily resides in Canada;

  • (b) a corporation that has its head office in Canada or operates a branch office in Canada; or

  • (c) the holder of a position that includes responsibility for controlled drugs on behalf of a department of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.

  • SOR/2004-238, s. 3.
  •  (1) A licensed dealer

    • (a) shall designate one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to controlled drugs specified in the licence and for ensuring, on behalf of the licensed dealer, that those activities comply with these Regulations; and

    • (b) may designate an alternate qualified person in charge who must work at the premises specified the licence and have authority to replace the qualified person in charge when that person is absent.

  • (2) The qualified person in charge and, if applicable, the alternate qualified person in charge

    • (a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties;

    • (b) shall either

      • (i) be a pharmacist or a practitioner of medicine, dentistry or veterinary medicine, registered with a provincial professional licensing authority, or

      • (ii) possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and

    • (c) shall not have been convicted, as an adult, within the preceding 10 years, of

      • (i) a designated drug offence,

      • (ii) a designated criminal offence, or

      • (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).

  • SOR/2004-238, s. 3;
  • SOR/2010-222, ss. 1(E), 34;
  • SOR/2012-230, s. 7;
  • SOR/2014-260, s. 14(F).
 
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