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

Regulations are current to 2019-11-19 and last amended on 2019-06-17. Previous Versions

PART GControlled Drugs (continued)

DIVISION 6 (continued)

Test Kits Containing Controlled Drugs (continued)

 The manufacturer of a test kit that contains a controlled drug may apply for a registration number therefor by submitting to the Minister an application containing

  • (a) particulars of the design and construction of the test kit;

  • (b) a detailed description of the controlled drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;

  • (c) a statement of the proposed use of the test kit; and

  • (d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be issued.

  • SOR/2018-69, s. 70

 Where, on application under section G.06.002.2, the Minister is satisfied that the test kit to which the application applies will only be used for medical, laboratory, industrial, educational or research use and that it

  • (a) contains a controlled drug and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential, or

  • (b) contains such small quantities or concentrations of any controlled drug as to have no significant drug abuse potential,

the Minister may issue a registration number for the test kit, which shall be a number preceded by the letters “TK”.

  • SOR/81-21, ss. 1, 2
  • SOR/86-91, s. 3(F)

 The Minister may cancel the registration number for a test kit if the test kit is removed from the market by the manufacturer or if, in the Minister’s opinion,

  • (a) it is necessary to cancel the registration number in the interest of public health; or

  • (b) the test kit is used or is likely to be used for any purpose other than medical, laboratory, industrial, educational or research use.

 Any person who violates any provision of this Part is guilty of an offence and is liable on summary conviction to a fine not exceeding $500 or to a term of imprisonment not exceeding six months, or to both such fine and imprisonment.



  •  (1) In this section,


    member means any person who is registered, certified or otherwise licensed by a nursing statutory body for the practice of nursing; (membre)

    nursing statutory body

    nursing statutory body means any provincial professional licensing authority that, pursuant to the laws of that province, registers, certifies or otherwise licenses a person for the practice of nursing. (organisme de nursing)

  • (2) The Minister may provide to a nursing statutory body any information obtained under the Controlled Drugs and Substances Act, the Food and Drugs Act or these Regulations that involves any member of that body.

  • (3) Subsection (2) does not apply to a nurse practitioner.

  • SOR/82-120, s. 1
  • SOR/97-228, s. 19
  • SOR/2012-230, s. 13

 Where, pursuant to the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Controlled Drugs and Substances Act, the member or person is, in respect of that conduct, exempt from the application of this Part.

  • SOR/97-228, s. 20
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