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

C.04.091. The expiration date of a product analogous to a bacterial vaccine shall be not later than 18 months after the date of manufacture or the date of issue, but for dried tuberculin and tuberculin containing at least 50 per cent glycerin the expiration date shall be not later than five years after the date of manufacture or the date of issue, and for all other tuberculins not more than 12 months after the date of manufacture or the date of issue.

C.04.100. A virus vaccine, rickettsial vaccine, shall be a suspension of, or prepared from, living or killed viruses or rickettsiae.

C.04.101. No person shall sell a virus or a rickettsial vaccine unless the fabricator has submitted to the Minister details of the source of the strains of viruses or rickettsiae used, the method of their propagation, the method of fabrication of the vaccine, the methods employed for determining sterility, safety, identity and potency and any other tests required by these Regulations.

C.04.102. Upon written request from the Director every fabricator and packager/labeller shall submit with respect to each lot of virus or rickettsial vaccine, when ready for sale, detailed protocols of sterility, safety, identity, potency, and of any other tests required by these Regulations.

C.04.110. Smallpox vaccine

• (a) shall be a virus vaccine;

• (b) shall be the living virus of vaccinia or its derivatives obtained from

  • (i) the vesicles produced in the skin of healthy calves by inoculation of vaccinia virus,

  • (ii) specifically infected membranes of chick embryos, or

  • (iii) suitable tissue culture infected with vaccinia virus or its derivatives; and

• (c) shall be in fluid or dried form.

C.04.111. Every fabricator and packager/labeller shall fabricate and package/label smallpox vaccine only in an independent unit that is isolated from all other laboratory activities, and in or about which no extraneous materials are permitted or stored.

C.04.112. A fabricator shall exclude the personnel who care for the vaccine animals from horse stables and paddocks and from contact with horses while smallpox vaccine is being propagated.

C.04.113. Every fabricator and packager/labeller shall dispense smallpox vaccine only in sterile glass containers that are sealed under aseptic conditions.

C.04.114. Every fabricator and packager/labeller shall test smallpox vaccine to establish that it is free from

• (a) spore-forming anaerobic micro-organisms;

• (b) coagulase positive staphylococci;

• (c) haemolytic streptococci; and

• (d) any other contaminating pathogenic micro-organisms.