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

C.02.010. (1) The testing referred to in section C.02.009 shall be performed on a sample taken

• (a) after receipt of each lot or batch of raw material on the premises of the fabricator; or

• (b) subject to subsection (2), before receipt of each lot or batch of raw material on the premises of the fabricator, if

  • (i) the fabricator

    • (A) has evidence satisfactory to the Director to demonstrate that raw materials sold to him by the vendor of that lot or batch of raw material are consistently manufactured in accordance with and consistently comply with the specifications for those raw materials, and

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

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

(2) After a lot or batch of raw material is received on the premises of the fabricator, the lot or batch of raw material shall be tested for identity.

C.02.011. (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall have written procedures prepared by qualified personnel in respect of the drug to ensure that the drug meets the specifications for that drug.

(2) Every person required to have written procedures referred to in subsection (1) shall ensure that each lot or batch of the drug is fabricated, packaged/labelled and tested in compliance with those procedures.

C.02.012. (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler of a drug shall maintain

• (a) a system of control that permits complete and rapid recall of any lot or batch of the drug that is on the market; and

• (b) a program of self-inspection.

(2) Every fabricator and packager/labeller and, subject to subsections (3) and (4), every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall maintain a system designed to ensure that any lot or batch of the drug fabricated and packaged/labelled on premises other than their own is fabricated and packaged/labelled in accordance with the requirements of this Division.

(3) The distributor referred to in paragraph C.01A.003(b) of a drug that is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities is not required to comply with the requirements of subsection (2) in respect of that drug.

(4) If a drug is fabricated or packaged/labelled in an MRA country at a recognized building, the distributor referred to in paragraph C.01A.003(b) or importer of the drug is not required to comply with the requirements of subsection (2) in respect of that activity for that drug if

• (a) the address of the building is set out in that person’s establishment licence; and

• (b) that person retains a copy of the batch certificate for each lot or batch of the drug received by that person.