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

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

G.06.002. 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

G.06.002.1. 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.

G.06.002.2. The manufacturer of a test kit that contains a controlled drug may apply for a registration number therefor by submitting to the Director 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.

G.06.002.3. 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).