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

• C.04.555 (1) A fabricator shall not sell Insulin Injection unless he

  • (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister;

  • (b) has furnished the Minister with such additional information as the Minister may require; and

  • (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

• (2) A submission filed pursuant to subsection (1) shall include at least,

  • (a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Injection

    • (i) protocols of assay of its potency expressed in International Units per cubic centimetre, in the case of insulin, and in International Units per milligram, in the case of zinc-insulin crystals,

    • (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals,

    • (iii) a report of the ash content in the case of insulin, and

    • (iv) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;

  • (b) for the first finished lot of Insulin Injection prepared from each master lot of insulin or zinc-insulin crystals, a report on the amount of each component thereof; and

  • (c) for the first filling of the first finished lot of Insulin Injection from each master lot of insulin or zinc-insulin crystals,

    • (i) a report of assay of its nitrogen content in milligrams per 1,000 International Units of insulin,

    • (ii) a report of assay of its zinc content in milligrams per 1,000 International Units of insulin, and

    • (iii) a report on the determination of its pH.

    • (iv) [Repealed, SOR/95-203, s. 2]

C.04.556 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.

Insulin Zinc Suspension — Rapid

C.04.557 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.

C.04.558 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.

C.04.559 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.

C.04.560 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.

• C.04.561 (1) A fabricator shall not sell Insulin Zinc Suspension — Rapid unless he

  • (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister;

  • (b) has furnished the Minister such additional information as the Minister may require; and

  • (c) has received from the Minister a notice that the information contained in the submission is in accordance with the requirements of this section.

• (2) A submission filed pursuant to subsection (1) shall include at least,

  • (a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension — Rapid,

    • (i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals,

    • (ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and

    • (iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;

  • (b) for the first finished lot of Insulin Zinc Suspension — Rapid prepared from each master lot of insulin or zinc-insulin crystals

    • (i) a report on the amount of each component used in the preparation,

    • (ii) a report of assay of its nitrogen content per 1,000 International Units of insulin,

    • (iii) a report of assay of its zinc content per 1,000 International Units of insulin,

    • (iv) a report of the insulin content in International Units per cubic centimetre of the supernatant liquid after removal of the suspended precipitate,

    • (v) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate,

    • (vi) a report on the determination of its pH, and

    • (vii) a report on the microscopic appearance of the suspended precipitate; and

  • (c) for the first filling of the first finished lot of Insulin Zinc Suspension — Rapid from each master lot of insulin or zinc-insulin crystals,

    • (i) a report on the determination of its pH,

    • (ii) a report on the microscopic examination of the precipitate, and

    • (iii) a report on its identification, as determined by an acceptable method.

    • (iv) [Repealed, SOR/95-203, s. 3]