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

Regulations are current to 2014-09-01 and last amended on 2014-08-21. Previous Versions

 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.