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

Regulations are current to 2022-06-01 and last amended on 2022-03-02. Previous Versions

PART CDrugs (continued)

DIVISION 2Good Manufacturing Practices (continued)

Finished Product Testing (continued)

  •  (1) A packager/labeller of a drug, a distributor referred to in paragraph C.01A.003(b) and an importer of a drug other than an active ingredient shall perform the finished product testing on a sample of the drug that is taken either

    • (a) after receipt of each lot or batch of the drug on their premises in Canada; or

    • (b) before receipt of each lot or batch of the drug on their premises in Canada if the following conditions are met:

      • (i) the packager/labeller, distributor or importer

        • (A) has evidence satisfactory to the Minister to demonstrate that drugs sold to them by the vendor of that lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for those drugs, and

        • (B) undertakes periodic complete confirmatory testing, with a frequency satisfactory to the Minister, and

      • (ii) the drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

  • (2) If the packager/labeller, distributor or importer receives a lot or batch of a drug on their premises in Canada the useful life of which is more than 30 days, the lot or batch shall be tested for identity and the packager/labeller shall confirm the identity after the lot or batch is packaged/labelled.

  • (3) Subsections (1) and (2) do not apply to a distributor if the drug is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes that activity.

  • (4) Subsections (1) and (2) do not apply to a distributor or importer if the drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and they retain a copy of the batch certificate for each lot or batch of the drug that they receive.

  • (4.1) Subsections (1) and (2) do not apply to a distributor or importer of a COVID-19 drug if it is the subject of a written request made under section C.04.015.

  • (5) Subsections (1) and (2) do not apply to a distributor or importer of a drug that is not a prescription drug and that is part of a class of drugs that is set out in column 1 of the List of Non-prescription Drugs Not Subject to Certain Testing Requirements if all of the following conditions are met:

    • (a) the drug contains, as its only active ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6;

    • (b) the drug is

      • (i) fabricated in Canada or in a recognized country or region,

      • (ii) packaged/labelled in Canada or in a recognized country or region, and

      • (iii) tested in a recognized country or region;

    • (c) the distributor or the importer retains a copy of the batch certificate for each lot or batch of the drug that is distributed or imported, as the case may be.

  • (6) A drug that is referred to in subsection (5) may be shipped directly to a person other than an importer if all of the following conditions are met:

    • (a) before importing the drug, the importer receives a document that demonstrates that the drug complies with the specifications for that drug;

    • (b) the importer and the distributor have measures in place to ensure that all the requirements of these Regulations in respect of the importation of the drug are met.

Records

  •  (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall maintain all of the following records on their premises in Canada for each drug that they fabricate, package/label, distribute or import:

    • (a) except in the case of an importer of an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act, master production documents for the drug;

    • (b) evidence that each lot or batch of the drug has been fabricated, packaged/labelled, tested and stored in accordance with the procedures described in the master production documents;

    • (c) evidence that the conditions under which the drug was fabricated, packaged/labelled, tested and stored are in compliance with the requirements of this Division;

    • (d) evidence that establishes the period during which the drug in the container in which it is sold or made available for further use in fabrication will meet the specifications for that drug; and

    • (e) evidence that the finished product testing referred to in section C.02.018 was carried out and the results of that testing.

  • (2) Every distributor referred to in paragraph C.01A.003(b) and importer shall make available to the Minister, on request, the results of testing performed on raw materials and packaging/labelling materials for each lot or batch of a drug that it distributes or imports.

  • (3) Every fabricator shall maintain on their premises written specifications for all raw materials and adequate evidence of the testing of those raw materials referred to in section C.02.009 and of the test results.

  • (4) Every person who packages a drug shall maintain on their premises written specifications for all packaging materials and adequate evidence of the examination or testing of those materials referred to in section C.02.016 and of any test results.

  • (5) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada detailed plans and specifications of each building in Canada where they fabricate, package/label or test drugs and a description of the design and construction of those buildings.

  • (6) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada personnel records in respect of each person who is employed to supervise the fabrication, packaging/labelling and testing of drugs, including the person’s title, responsibilities, qualifications, experience and training.

  • SOR/82-524, s. 3
  • SOR/89-174, ss. 3(F), 8(F)
  • SOR/97-12, ss. 17, 52, 60
  • SOR/2013-74, s. 11
  • SOR/2017-259, s. 15
  • SOR/2018-69, s. 27
  •  (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
  •  (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

 Every distributor of an active ingredient referred to in paragraph C.01A.003(a) and every fabricator, packager/labeller, wholesaler and importer of an active ingredient shall add all of the following information to the documentation that accompanies the active ingredient, immediately after any like information that has been added by another person:

  • (a) their establishment licence number, or if there is none, their name, address, telephone number, fax number and email address;

  • (b) an indication whether they have fabricated, packaged/labelled, wholesaled, distributed or imported the active ingredient and the date on which that activity was carried out;

  • (c) the expiration date; and

  • (d) the lot number.

  • SOR/2013-74, s. 12

Samples

  •  (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for one year after the expiration date of the drug unless their establishment licence specifies otherwise.

  • (2) Subject to subsection (4), the fabricator of a drug in dosage form shall retain a sample of each lot or batch of raw materials used in the fabrication for two years after the materials were last used in the fabrication unless their establishment licence specifies some other period.

  • (3) Subject to subsection (4), the fabricator of an active ingredient shall retain a sample of each lot or batch of it for the following period unless their establishment licence 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.

  • (4) If a fabricator is required to maintain samples 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. 4(F)
  • SOR/92-654, s. 8
  • SOR/97-12, s. 20
  • SOR/2013-74, s. 13
  • SOR/2021-46, s. 8

 The samples referred to in section C.02.025 shall be in an amount that is sufficient to determine whether the drug or raw material complies with the specifications for that drug or raw material.

  • SOR/82-524, s. 3

Stability

  •  (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug.

  • (2) Every fabricator and importer of an active ingredient shall establish the period during which each drug in the package in which it is sold will comply with the specifications for that drug.

  • SOR/82-524, s. 3
  • SOR/97-12, s. 58
  • SOR/2013-74, s. 14
  •  (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug in dosage form shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.

  • (2) Every fabricator and importer of an active ingredient shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.

  • SOR/82-524, s. 3
  • SOR/97-12, s. 58
  • SOR/2013-74, s. 14

Sterile Products

 In addition to the other requirements of this Division, a drug that is intended to be sterile shall be fabricated and packaged/labelled

  • (a) in separate and enclosed areas;

  • (b) under the supervision of personnel trained in microbiology; and

  • (c) by a method scientifically proven to ensure sterility.

  • SOR/82-524, s. 3
  • SOR/97-12, s. 21
 
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