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

Regulations are current to 2014-09-29 and last amended on 2014-08-21. Previous Versions

  •  (1) All records and evidence of the fabrication, packaging/labelling, finished product testing referred to in section C.02.018 and storage of a drug in dosage form that are required to be maintained under this Division shall be retained for one year after the expiration date of the drug unless the person’s establishment licence specifies some other period.

  • (2) Subject to subsection (4), all records and evidence of the fabrication, packaging/labelling, finished product testing referred to in section C.02.018 and storage of an active ingredient that are required to be maintained under this Division shall be retained in respect of each lot or batch of the active ingredient for the following period unless the person holds an establishment licence that specifies some other period:

    • (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or

    • (b) in any other case, one year after the expiration date of the lot or batch.

  • (3) Subject to subsection (4), all records and evidence of the raw material testing referred to in section C.02.009 and of the testing of packaging/labelling materials that are required to be maintained under this Division shall be retained for five years after the raw materials and packaging/labelling materials were last used in the fabrication or packaging/labelling of a drug unless the person’s establishment licence specifies some other period.

  • (4) If a fabricator is required to maintain records and evidence in respect of the same active ingredient under subsections (2) and (3), they shall maintain them for the longest period that is applicable.

  • SOR/82-524, s. 3;
  • SOR/89-174, s. 8(F);
  • SOR/92-654, s. 6;
  • SOR/97-12, s. 18;
  • SOR/2013-74, s. 11.
  •  (1) Every wholesaler, distributor referred to in section C.01A.003 and importer of a drug in dosage form shall retain records of sale of each lot or batch of the drug, which enable them to recall the lot or batch from the market, for one year after the expiration date of that lot or batch unless their establishment licence specifies some other period.

  • (2) Every distributor of an active ingredient referred to in paragraph C.01A.003(a) and every wholesaler and importer of an active ingredient shall retain records of sale of each lot or batch of the active ingredient, which enable them to recall the lot or batch from the market, for the following period unless the person holds an establishment licence that specifies some other period:

    • (a) in the case of an active ingredient that has a retest date, three years after the lot or batch has been completely distributed; or

    • (b) in any other case, one year after the expiration date of the lot or batch.

  • SOR/82-524, s. 3;
  • SOR/92-654, s. 7;
  • SOR/97-12, s. 18;
  • SOR/2013-74, s. 11.
  •  (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 section C.01A.003 and importer of the drug shall make a record of the complaint or information that contains the following:

    • (a) the results of any investigation carried out under subsection C.02.015(2) and, if applicable, the corrective action taken; or

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

  • (2) Records referred to in subsection (1) shall be retained for the following period unless the person holds an establishment licence that specifies some other period:

    • (a) in the case of a drug in dosage form, one year after the expiration date of the lot or batch of the drug; and

    • (b) in the case of an active ingredient,

      • (i) if the active ingredient has a retest date, three years after the lot or batch has been completely distributed, or

      • (ii) in any other case, one year after the expiration date of the lot or batch of the active ingredient.

  • SOR/82-524, s. 3;
  • SOR/92-654, s. 7;
  • SOR/97-12, s. 18;
  • SOR/2010-95, s. 7;
  • SOR/2013-74, s. 11.