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

Regulations are current to 2013-04-29 and last amended on 2013-03-21. Previous Versions

  • C.02.021. (1) Subject to subsection (2), all records and evidence on the fabrication, packaging/labelling, testing and storage of a drug that are required to be maintained under this Division shall be retained for a period of at least one year after the expiration date on the label of the drug, unless otherwise specified in the person’s establishment licence.

  • (2) All records and evidence on the testing of raw materials and packaging/labelling materials that are required to be maintained under this Division shall be retained for a period of at least five years after the materials were last used in the fabrication or packaging/labelling of a drug, unless otherwise specified in the person’s establishment licence.

  • SOR/82-524, s. 3;
  • SOR/89-174, s. 8(F);
  • SOR/92-654, s. 6;
  • SOR/97-12, s. 18.

C.02.022. Every distributor referred to in section C.01A.003, wholesaler and importer of a drug shall retain records of the sale of each lot or batch of the drug, which enable them to recall the lot or batch from the market, for a period of at least one year after the expiration date of that lot or batch, unless otherwise specified in their establishment licence.

  • SOR/82-524, s. 3;
  • SOR/92-654, s. 7;
  • SOR/97-12, s. 18.

  • C.02.023. (1) On receipt of a complaint or any information respecting the quality of a drug or its deficiencies or hazards, every fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) or importer of the drug, as the case may be, shall

    • (a) in the case of a complaint or information described in subsection C.02.015(2), make a record of the complaint or information, its investigation and, if applicable, any corrective action taken; and

    • (b) in the case of a complaint or information described in subsection C.02.015(2.1), make a record of the complaint or information, the name and business address of the person in charge of the quality control department to whom it was forwarded and the date on which it was forwarded.

  • (2) The fabricator, packager/labeller, wholesaler, distributor referred to in paragraph C.01A.003(b) or importer of the drug, as the case may be, shall retain the record for a period of at least one year after the expiration date of the lot or batch of that drug, unless their establishment licence specifies otherwise.

  • SOR/82-524, s. 3;
  • SOR/92-654, s. 7;
  • SOR/97-12, s. 18;
  • SOR/2010-95, s. 7.
Previous Version

  • C.02.024. (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler shall

    • (a) maintain records of the results of the self-inspection program required by section C.02.012 and of any action taken in connection with that program; and

    • (b) retain those records for a period of at least three years.

  • (2) Every person who fabricates or packages/labels a drug shall

    • (a) maintain records on the operation of the sanitation program required to be implemented under section C.02.007; and

    • (b) retain those records for a period of at least three years.

  • SOR/82-524, s. 3;
  • SOR/97-12, ss. 19, 53.