C.04.002. This Division does not apply to a drug in oral dosage form that contains micro-organisms if the drug is recommended solely for restoring, normalizing or stabilizing the intestinal flora.
- SOR/97-12, s. 33.
C.04.003. The date of issue of a drug shall be the date on which the finished product is removed from cold storage but in any case shall be, not later than
(a) six months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 10°C;
(b) 12 months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 5°C; or
(c) two years after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 0°C.
C.04.004. to C.04.006. [Repealed, SOR/97-12, s. 34]
C.04.007. [Repealed, SOR/97-12, s. 67]
C.04.008. to C.04.012 [Repealed, SOR/97-12, s. 36]
C.04.013. Every fabricator and packager/labeller shall safely segregate all work with spore-bearing, pathogenic micro-organisms and other infectious agents known to require special precautions in manipulation and shall take such care of equipment and arrangements for supervision that the possibility of contamination of other drugs is avoided.
- SOR/97-12, s. 63.
C.04.014. No person shall conduct laboratory procedures of a diagnostic nature in their premises unless those procedures are entirely segregated from the fabrication, packaging/labelling and testing of drugs.
- SOR/97-12, s. 37.
C.04.015. On written request from the Director, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot of the drug before it is sold, and no person shall sell any lot of that drug if the protocol or sample fails to meet the requirements of these Regulations.
- SOR/97-12, s. 37.
C.04.016. All animals from which drugs are prepared and preserved shall be
(a) under the direct supervision of competent medical or veterinary personnel;
(b) kept in quarantine by the fabricator for at least seven days before use; and
(c) healthy and free from infectious disease.
- SOR/97-12, s. 38.
C.04.017. A fabricator shall keep necropsy records of all animals that die or are killed after having been used in the production of a drug.
- SOR/97-12, s. 61.
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