Food and Drug Regulations

C.02.019 (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.

(4.2) Subsection (1) does not apply to a packager/labeller, distributor or importer if the following conditions are met:

• (a) the drug is a radiopharmaceutical or a radionuclide generator, as defined in section C.03.001, and has a useful life of no more than 30 days; and

• (b) the packager/labeller, distributor or importer maintains evidence satisfactory to the Minister to demonstrate that

  • (i) the drug has been tested against the specifications for that drug, and

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

(4.3) Subsections (1) and (2) do not apply to a packager/labeller, distributor or importer if the following conditions are met:

• (a) the drug is

  • (i) for human use,

  • (ii) in dosage form,

  • (iii) listed in Schedule D to the Act,

  • (iv) not a vaccine, and

  • (v) composed of genetically modified autologous human nucleated cells or is delivered to cells using an adeno-associated virus vector; and

• (b) the packager/labeller, distributor or importer maintains evidence satisfactory to the Minister to demonstrate that

  • (i) the drug has been tested against the specifications for that drug, and

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

(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 (4.2), (4.3) or (5) and that is imported may be shipped directly to a person other than the importer if 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.