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

 Every licensed dealer shall notify the Minister forthwith of any change

  • (a[Repealed, SOR/2010-222, s. 33]

  • (b) in the premises in which a restricted drug is produced, made, assembled or stored; and

  • (c) in the process and conditions of producing, making, assembly or storage of a restricted drug.

  • SOR/2004-238, s. 38;
  • SOR/2010-222, s. 33.

 Every person who is in possession of a restricted drug and every institution to which the sale of a restricted drug has been authorized by the Minister shall

  • (a) provide such protection against loss or theft of the restricted drug as may be required by the Minister; and

  • (b) report forthwith to the Minister and to local law enforcement authorities any loss or theft of a restricted drug.

 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

 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.

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

 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.

  • SOR/2004-238, s. 39.

 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.

  •  (1) and (2) [Repealed, SOR/99-125, s. 8]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 of a practitioner, where the agent 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 of a practitioner has received a restricted drug under subsection (3), the agent 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 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.

  • SOR/99-125, s. 8;
  • SOR/2004-238, s. 40.