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

Regulations are current to 2017-04-12 and last amended on 2017-03-14. Previous Versions

 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”.

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

 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.

 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.

Diphtheria Toxoid

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

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

 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.

 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.

  • SOR/97-12, s. 61.

 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.

 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.

  • SOR/97-12, s. 61.

 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.

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

  • SOR/97-12, s. 61.

 No person shall sell diphtheria toxoid that contains phenol.

 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.

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

Tetanus Toxoid

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

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

 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.

 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.

  • SOR/97-12, s. 61.

 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.

 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.

  • SOR/97-12, s. 65.

 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.

 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.

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

  • SOR/97-12, s. 61.

 No person shall sell tetanus toxoid that contains phenol.

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

Antitoxins, Antisera

 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.

 The potency of an antitoxin or antiserum shall be determined by an acceptable method and where applicable the unit of potency shall be the International Unit.

 Liquid diphtheria antitoxin shall have a potency of not less than 500 International Units per millilitre.

 Liquid tetanus antitoxin shall have a potency of not less than 400 International Units per millilitre.

 A liquid antitoxin or antiserum shall contain not more than 20 per cent solids.

 A dried antitoxin shall be prepared from a liquid antitoxin and, when reconstituted to the original volume of the liquid antitoxin, shall have a potency not less than that prescribed for such liquid antitoxin.

 A dried antitoxin or antiserum shall not contain more than one per cent moisture when determined by an acceptable method.

 Each lot of antitoxin or antiserum shall be tested by an acceptable method for pyrogenicity and it shall be pyrogen-free, and, after filling into the final containers, for identity and it shall be true to name.

 No person shall sell an antitoxin or antiserum unless both the inner and the outer labels carry a statement of the species of animal used, when other than the horse, and the net contents in millilitres or the number of units in the container.

 In respect of antitoxins, the expiration date shall be

  • (a) for liquid antitoxins with standards of potency, not later than five years after the date of manufacture;

  • (b) for dried antitoxins with standards of potency, not later than five years after the date of manufacture;

  • (c) for liquid antioxins with no standards of potency, not later than 12 months after the date of manufacture; and

  • (d) for dried antitoxins with no standards of potency, not later than five years after the date of manufacture.

 In respect of antisera, the expiration date shall be

  • (a) for liquid antisera with standards of potency, not later than three years after the date of manufacture;

  • (b) for dried antisera with standards of potency, not later than five years after the date of manufacture;

  • (c) for liquid antisera with no standards of potency, not later than 12 months after the date of manufacture; and

  • (d) for dried antisera with no standards of potency, not later than five years after the date of manufacture.

Preparations from Human Sources

 Preparations from human sources shall be pooled blood plasma, or pooled blood serum, or fractions of either separated by a method satisfactory to the Minister.

 A fabricator shall obtain human serum, or human plasma, only from a person certified by a qualified medical practitioner to be healthy.

  • SOR/97-12, s. 61.

 A fabricator shall not use a person to serve as a donor of blood, placenta, or cord who has a history of a disease transmissible by blood transfusion including syphilis, infectious hepatitis, or malaria.

  • SOR/97-12, s. 61.

 The operation of drawing blood from a donor shall be under the supervision of a qualified medical practitioner, and shall be carried out in a suitable bleeding room under the control of the fabricator.

  • SOR/97-12, s. 61.
 
Date modified: