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

C.04.144. The human test dose of diphtheria toxin for Schick test, when fresh toxin containing no 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 1/1,500 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 1/100 of one test dose must not cause, and 1/50 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”.

C.04.145. The human test dose for the Schick control shall give a negative Schick reaction when injected intracutaneously into normal guinea pigs.

C.04.146. No person shall sell diphtheria toxin for Schick test unless both the inner and the outer labels carry a statement of the number of human test doses it contains together with the name of any stabilizer.

C.04.147. The expiration date of Schick test reagents for the diagnosis of susceptibility to diphtheria shall be not later than 12 months after the date of manufacture or the date of issue.

C.04.160. Liquid diphtheria toxoid shall be sterile, formalized, detoxified diphtheria toxin and shall not contain more than 0.02 per cent free formaldehyde.

C.04.161. Diphtheria toxoid alum precipitated shall be prepared from diphtheria toxoid, and shall not contain more than 15 milligrams of alum per human dose.

C.04.162. The alum used in the preparation of diphtheria toxoid alum precipitated shall contain not less than 99.5 per cent pure potassium alum, Al K(SO₄)₂,12H₂O.

C.04.163. No fabricator shall use a culture medium for the production of diphtheria toxin that contains horse protein or Witte peptone or that has not been freed as far as possible from any other allergenic ingredient.

C.04.164. Diphtheria toxin from which diphtheria toxoid is prepared shall have a toxicity, as indicated by an L+dose, of not more than 0.20 millilitre or by an M.L.D. of not more than 0.0025 millilitre.

C.04.165. A fabricator shall test each bulk container of diphtheria toxoid, before being dispensed into the final containers, for toxicity by an acceptable method, and it shall be non-toxic.

C.04.166. No person shall sell any lot of diphtheria toxoid unless such lot has been shown to meet a test for antigenicity made by an acceptable method.

C.04.167. A fabricator shall fill diphtheria toxoid aseptically into clear glass containers and where preservative is not added shall seal the containers by fusion.