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Food and Drug Regulations

Version of section C.04.588 from 2018-04-04 to 2019-07-01:

  •  (1) A fabricator shall not sell NPH Insulin 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 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
  • SOR/2018-69, ss. 27, 31(E), 32(F)
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