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

Regulations are current to 2013-05-26 and last amended on 2013-03-21. Previous Versions

C.04.587. No person shall sell NPH Insulin 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,

    • (i) 40 International Units of insulin,

    • (ii) 80 International Units of insulin, or

    • (iii) 100 International Units of insulin.

  • SOR/82-769, s. 4.

  • C.04.588. (1) A fabricator shall not sell NPH Insulin 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 zinc-insulin crystals employed in the manufacture of NPH Insulin,

      • (i) protocols of assay of its potency in International Units per milligram,

      • (ii) a report of its moisture content in per cent determined by drying to constant weight at 100°C, 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 master lot of protamine, a report of the isophane ratio for the insulin used in the preparation of the NPH Insulin;

    • (c) for the trial mixture of NPH Insulin,

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

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

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

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

      • (v) a report on the microscopic examination of the precipitate;

    • (d) for the first finished lot of NPH Insulin from each trial mixture of NPH Insulin, a report on the amount of each component in the preparation; and

    • (e) for the first filling of the first finished lot of NPH Insulin from each trial mixture of NPH Insulin,

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

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

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

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

      • (v) a report of its identification as determined by an acceptable method.

      • (vi) [Repealed, SOR/95-203, s. 7]

  • SOR/82-769, s. 4;
  • SOR/95-203, s. 7;
  • SOR/97-12, s. 61.