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

C.04.168. No person shall sell diphtheria toxoid that contains phenol.

C.04.169. No person shall sell diphtheria toxoid unless both the inner and the outer labels carry a statement of the appropriate dose for purposes of immunization.

C.04.170. The expiration date of diphtheria toxoid shall be not later than two years after the date of manufacture or the date of issue.

C.04.180. Liquid tetanus toxoid shall be sterile, formalized, detoxified tetanus toxin, and shall not contain more than 0.02 per cent free formaldehyde.

C.04.181. Tetanus toxoid alum precipitated shall be prepared from tetanus toxoid, and shall not contain more than 15 milligrams of alum per human dose.

C.04.182. The alum used in the preparation of tetanus toxoid alum precipitated shall contain not less than 99.5 per cent pure potassium alum, Al K(SO₄)₂, 12H₂O.

C.04.183. No fabricator shall use a culture medium for the production of tetanus toxin that contains horse protein or Witte peptone or that has not been freed as far as possible from any other allergenic ingredient.

C.04.184. Tetanus toxin from which tetanus toxoid is prepared shall have a toxicity as indicated by an M.L.D. for the guinea pig of not more than 0.0001 millilitre.

C.04.185. A packager/labeller shall test each bulk container of tetanus toxoid, before being dispensed into the final containers, for toxicity by an acceptable method, and it shall be non-toxic.

C.04.186. No person shall sell any lot of tetanus toxoid unless such lot has been shown to meet a test for antigenicity made by an acceptable method.

C.04.187. No person shall sell tetanus toxoid unless both the inner and the outer labels carry a statement of the appropriate dose for purposes of immunization.

C.04.188. A fabricator shall fill tetanus toxoid aseptically into clear glass containers and where a preservative is not added shall seal the container by fusion.

C.04.189. No person shall sell tetanus toxoid that contains phenol.

C.04.190. The expiration date of tetanus toxoid shall be not later than two years after the date of manufacture or the date of issue.

C.04.210. An antitoxin or antiserum shall be the serum or fraction thereof separated from the blood of animals that have been artificially immunized against the by-products or antigenic fractions of specific cultures of micro-organisms, or against specific venoms.