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

C.04.077 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.

C.04.078 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.

C.04.079 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.

C.04.080 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.

C.04.081 No person shall sell fluid B.C.G. vaccine that is not packaged in containers sealed by fusion.

C.04.082 No inner label shall be required for fluid B.C.G. vaccine in single-dose containers.

C.04.083 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.

C.04.084 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.

C.04.085 The provisions of subparagraph C.04.019(b)(iv) do not apply to freeze-dried B.C.G. vaccine.

Products Analogous to Bacterial Vaccines

C.04.090 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.

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.

Virus and Rickettsial Vaccines

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 Minister 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.

Smallpox Vaccine

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.

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.

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.

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.

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