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

C.04.551. No person shall sell or dispense an insulin preparation that has not been stored by him continuously at a temperature between 35° and 50°F (2° and 10°C).

C.04.552. The zinc-insulin crystals used in an insulin preparation shall contain, as determined by an acceptable method,

• (a) not less than 21 International Units of insulin per milligram, and

• (b) on the dry basis, not less than 0.30 per cent and not more than 0.90 per cent zinc.

C.04.553. The insulin preparation, “Insulin injection” or “Insulin” shall be a clear colourless or almost colourless sterile solution free from turbidity and insoluble matter, prepared from insulin or zinc insulin crystals, shall have a pH of not less than 2.5 or more than 3.5, or not less than 7.0 or more than 7.8 and shall contain

• (a) weight by volume,

  • (i) not less than 0.1 per cent and not more than 0.25 per cent of either phenol or cresol, and

  • (ii) not less than 1.4 per cent and not more than 1.8 per cent glycerin; 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 for Insulin Injection prepared from zinc-insulin crystals, and not more than 8.5 milligrams of nitrogen for Insulin Injection other than that made from zinc-insulin crystals,

  • (ii) not less than 0.10 milligram and not more than 0.40 milligram of zinc for Insulin Injection prepared from zinc-insulin crystals, and not more than 0.40 milligram of zinc for Insulin Injection other than that made from zinc-insulin crystals, and

  • (iii) in the case of Insulin Injection other than that made from zinc-insulin crystals, not more than 1.0 milligram of ash.

C.04.554. No person shall sell Insulin Injection 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;

• (b) the vial label indicates that each cubic centimetre has a potency equal to

  • (i) 40 International Units of insulin,

  • (ii) 80 International Units of insulin, or

  • (iii) 100 International Units of insulin; and

• (c) each cubic centimetre thereof has an actual potency that is at least 95 per cent and does not exceed 105 per cent of the potency indicated on the label as determined by an acceptable method.

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

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

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

  • (c) has received from the Director 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]