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

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

C.04.115. Smallpox vaccine, when tested by acceptable methods,

  • (a) shall be free from extraneous micro-organisms, in the case of vaccine prepared for use by jet gun; and

  • (b) shall contain not more than 500 viable non-pathogenic bacteria per millilitre, in the case of vaccine prepared for use by the multiple pressure technique or by scarification.

C.04.116. Smallpox vaccine must demonstrate evidence of disease prevention that is at least equivalent to that of a vaccine that

  • (a) is known to prevent human to human transmission of smallpox; and

  • (b) meets the potency of equal to or greater than 108 pockforming units per millilitre, as determined using chick embryo chorioallantoic membranes.

  • SOR/2006-2, s. 2.

C.04.117. No person shall sell smallpox vaccine unless

  • (a) in the case of fluid vaccine, it has been stored at a temperature below -10°C;

  • (b) in the case of dried vaccine, it has been stored at a temperature below 10°C; and

  • (c) the outer label carries a statement that it shall be stored at a temperature of not more than 5°C.

  • SOR/97-12, s. 44.

C.04.118. Notwithstanding the provisions of section C.04.003, the date of issue of smallpox vaccine shall be not later than

  • (a) in the case of fluid vaccine, nine months after the date of manufacture; and

  • (b) in the case of dried vaccine, 24 months after the date of manufacture.

C.04.119. The expiration date of smallpox vaccine shall not exceed the following, unless supported by evidence of stability satisfactory to the Minister:

  • (a) in the case of fluid vaccine, 3 months after the date of issue; or

  • (b) in the case of dried vaccine, 12 months after the date of issue.

  • SOR/2006-2, s. 3.

C.04.120. No inner label shall be required for smallpox vaccine in single-dose containers or when dispensed in capillary tubes.

C.04.121. No person shall sell smallpox vaccine to which an antibiotic has been added.

Poliomyelitis Vaccine

C.04.122. Poliomyelitis vaccine shall be an aqueous suspension of killed poliomyelitis viruses, Types I, II, and III.

C.04.123. Poliomyelitis vaccine shall be prepared in acceptable tissue culture medium from strains of poliomyelitis virus proven capable of producing vaccine of acceptable potency.

C.04.124. Poliomyelitis vaccine in its final form shall contain not more than 0.35 milligram per millilitre of total nitrogen, nor more than one part per million of animal serum.