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

Regulations are current to 2019-06-20 and last amended on 2015-06-13. Previous Versions

 Every licensed dealer and every person who has been a licensed dealer shall keep the record referred to in section J.01.023 on the premises described in the licence that was issued to him or in such other place as may be approved by the Minister for a period of at least two years and shall keep such record in a form that will facilitate an audit thereof being made at any time.

  •  (1) The Minister may, in respect of an applicant for a dealer’s licence or a licensed dealer, require an inspection, at any reasonable time, of

    • (a) the premises used or intended to be used in producing, making, assembling or storing a restricted drug; and

    • (b) the process and conditions of the producing, making, assembling or storing.

  • (2) [Repealed, SOR/2010-222, s. 32]

  • SOR/2004-238, s. 36
  • SOR/2010-222, s. 32

 Every person who sells or provides a restricted drug shall

  • (a) supply such information in such form as the Minister may require respecting the dealings of any person in the restricted drug;

  • (b) produce to an inspector any books, records or documents required to be kept under this Part;

  • (c) permit an inspector to make copies of or to take extracts from any books, records and documents; and

  • (d) permit an inspector to check all stocks of restricted drugs located on the premises described in his licence.

  • SOR/2004-238, s. 37

 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  • (a) [Repealed, SOR/2010-222, s. 33]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 licensed dealer who possesses a restricted drug, every qualified investigator who possesses a restricted drug for the purpose of and in connection with research in an institution, every person exempted under section 56 of the Act with respect to a restricted drug and every institution to which the sale of a restricted drug has been authorized by the Minister must

  • (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.

  • SOR/2015-210, s. 3
  • SOR/2018-85, s. 2

 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 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.

  • SOR/99-125, s. 8
  • SOR/2004-238, s. 40
  • SOR/2018-69, ss. 67, 69
 
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