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

C.04.133. No fabricator shall sell poliovirus vaccine, live, oral, unless he has tested each lot for extraneous micro-organisms and the vaccine is free therefrom.

C.04.134. A fabricator of poliovirus vaccine, live, oral shall test, by a method acceptable to the Director, each lot of vaccine for neurovirulence and for genetic markers and it shall meet the requirements established by the Director.

C.04.135. No fabricator shall employ any person in the manufacture of poliovirus vaccine, live, oral unless such person

• (a) is free from infectious disease;

• (b) has been vaccinated successfully against poliomyelitis by poliovirus vaccine, live, oral; and

• (c) has been proved by periodic tests to be a non-carrier of poliomyelitis virus.

C.04.136. A fabricator of poliovirus vaccine, live, oral shall not permit the entry to a building in which the vaccine is manufactured of any person who

• (a) is not directly concerned with the manufacturing processes; or

• (b) has been working on the same day with experimental animals or with infectious agents.

C.04.137. Bacteriophage shall be a virus preparation with specific lytic action against micro-organisms actually or potentially pathogenic.

C.04.138. The expiration date of bacteriophage shall be not later than 12 months after the date of manufacture or the date of issue.

C.04.140. Schick test reagents for the diagnosis of susceptibility to diphtheria shall be

• (a) diphtheria toxin for Schick test;

• (b) Schick control; and

• (c) diphtheria toxin for Schick test with control.

C.04.141. Diphtheria toxin for Schick test shall be sterile diluted diphtheria toxin stabilized by an acceptable method.

C.04.142. Schick control shall be suitably diluted

• (a) diphtheria toxoid; or

• (b) sterile diphtheria toxin heated at a temperature of 95°C for five minutes.

C.04.143. The human test dose of diphtheria toxin for Schick test, when aged toxin containing a preservative is used, shall be determined by

• (a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction but mixed with 1/1,250 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction”; and

• (b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/50 of one test dose must not cause, and 1/25 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”.