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

J.01.029 Where a licensed dealer delivers a restricted drug, he shall

• (a) take such steps as are necessary to ensure the safekeeping of the drug during transit; and

• (b) use such methods of transportation as will ensure that an accurate record is kept of the drug while in transit and of the signatures of any persons having charge of the drug until it is delivered to the consignee.

Packaging and Labelling

J.01.030 Every restricted drug that is sold to an institution shall be securely packed by the licensed dealer who sells the drug in such a manner that the package cannot be opened without breaking the seal.

J.01.031 The provisions of section C.01.004 do not apply to a restricted drug.

J.01.032 Every package that contains a restricted drug shall be labelled so that the inner and outer labels thereon show

• (a) the proper name or, if there is no proper name, the common name of the drug;

• (b) the net contents of the package;

• (c) the unit strength of the drug where it is in unit form;

• (d) the lot number of the drug;

• (e) the words “Restricted Drug”; and

• (f) the name and address of the producer, maker or assembler of the drug.

J.01.032.1 Section J.01.032 does not apply to a test kit that contains a restricted drug where a registration number has been issued for the test kit pursuant to section J.01.033.3 and has not been cancelled pursuant to section J.01.033.4.

• J.01.033 (1) and (2) [Repealed, SOR/99-125, s. 8]

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

  • (a) a practitioner; or

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

• (4) if an agent or mandatary of a practitioner has received a restricted drug under subsection (3), the agent or mandatary shall immediately provide or deliver it

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

  • (b) to the Minister.

• (5) A practitioner who has received a restricted 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 restricted drug for that purpose; or

  • (b) to the Minister.

• (6) Sections J.01.021 and J.01.022 apply with such modifications as the circumstances may require to every person who has received a restricted drug pursuant to this section other than a person to whom a restricted drug has been administered pursuant to an exemption granted under section 56 of the Controlled Drugs and Substances Act with respect to the administration of that drug.

Test Kits Containing Restricted Drugs

J.01.033.1 Any person may sell, possess or otherwise deal in a test kit that contains a restricted drug if

• (a) a registration number has been issued for the test kit pursuant to section J.01.033.3;

• (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 J.01.033.3;

• (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 J.01.033.4.

J.01.033.2 The manufacturer of a test kit that contains a restricted 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 restricted 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.

J.01.033.3 Where, on application under section J.01.033.2, 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 restricted 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 restricted 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”.

J.01.033.4 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.

Prescribed Manner of Notice of Application for an Order of Restoration

• J.01.035 (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 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 restricted 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 restricted drug or other thing referred to in paragraph (c).

J.01.036 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.

Temporary Accelerated Scheduling

• J.01.037 (1) The Minister may, by order, add to column 1 to Part III of the schedule to this Part any item or portion of an item listed in Schedule V to the Act for a period referred to in column 2 that is the same as that listed in Schedule V for that item.

• (2) The Minister may, by order, delete any item or portion of an item from column 1 to Part III of the schedule to this Part.

• (3) An item or portion of an item listed in Part III of the schedule to this Part is deemed to be deleted on the day on which it is no longer listed in Schedule V to the Act.