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

Regulations are current to 2014-09-29 and last amended on 2014-08-21. Previous Versions

 The expiration date printed on the inner and outer labels of every package of Insulin Injection shall be a date not later than two years after the date of removal for distribution from the fabricator’s place of storage.

  • SOR/82-769, s. 4;
  • SOR/97-12, s. 61.

Insulin Zinc Suspension — Rapid

 The insulin preparation “Insulin Zinc Suspension — Rapid” shall be a sterile suspension in a buffered aqueous medium, of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain,

  • (a) weight by volume,

    • (i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2.3H2O),

    • (ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and

    • (iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and

  • (b) as determined by an acceptable method, for each 1,000 International Units of insulin,

    • (i) not more than 7.0 milligrams of nitrogen; and

    • (ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid.

  • SOR/80-545, s. 1;
  • SOR/82-769, s. 4;
  • SOR/85-715, s. 8.

 The insulin used in the preparation of Insulin Zinc Suspension — Rapid shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of Insulin Zinc Suspension-Rapid when the precipitate is suspended uniformly.

  • SOR/82-769, s. 4.

 The clear supernatant liquid obtained from Insulin Zinc Suspension — Rapid shall contain not more than 1.0 International Unit of Insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method.

  • SOR/82-769, s. 4.

 No person shall sell Insulin Zinc Suspension — Rapid unless

  • (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and

  • (b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly,

    • (i) 40 International Units of insulin,

    • (ii) 80 International Units of insulin, or

    • (iii) 100 International Units of insulin.

  • SOR/82-769, s. 4.