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

Regulations are current to 2014-07-22 and last amended on 2014-05-16. Previous Versions

 A fabricator of B.C.G. vaccine shall keep, at a temperature not exceeding 5.0°C, and for not less than six months,

  • (a) the culture on glycerine-water potato medium from which the Sauton I and Sauton II subcultures were made, and

  • (b) not less than six vials of the final product

from each lot thereof.

  • SOR/97-12, s. 61.

 Every fabricator and packager/labeller of B.C.G. vaccine shall keep, in form satisfactory to the Minister, continuous clinical records of the use of B.C.G. vaccine in humans.

  • SOR/97-12, s. 63.

 A fabricator of B.C.G. vaccine shall examine pathologically all test animals used and shall immediately report to the Minister any evidence of active, progressive tuberculosis in any such animals.

  • SOR/97-12, s. 61.

 The expiration date for B.C.G. vaccine shall be not more than

  • (a) 10 days after harvesting in the case of fluid vaccine;

  • (b) 12 months after harvesting in the case of freeze dried vaccine stored at a temperature of 4°C or above; or

  • (c) 20 months after harvesting in the case of freeze dried vaccine stored at a temperature below 4°C.

 No person shall sell fluid B.C.G. vaccine that is not packaged in containers sealed by fusion.

 No inner label shall be required for fluid B.C.G. vaccine in single-dose containers.

 The label of fluid B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of

  • (a) the weight of bacteria per millilitre; and

  • (b) the route of administration of the vaccine.

 The label of freeze-dried B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of

  • (a) the amount of bacteria per vial or per dose; and

  • (b) the route of administration of the vaccine.

 The provisions of subparagraph C.04.019(b)(iv) do not apply to freeze-dried B.C.G. vaccine.

Products Analogous to Bacterial Vaccines

 A product analogous to a bacterial vaccine shall be

  • (a) a bacterial antigen, other than a bacterial vaccine, such as a lysate, or

  • (b) an extract prepared from a bacterial culture,

and shall conform to the requirements of these Regulations for bacterial vaccines except those of paragraphs (a) and (b) of C.04.054.