Food and Drug Regulations

Version of section C.04.567 from 2006-03-22 to 2018-04-03:

  •  (1) A fabricator shall not sell Insulin Zinc Suspension-Medium 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 Zinc Suspension-Medium,

      • (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-Medium 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 in milligrams per cubic centimetre or per 1,000 International Units of insulin,

      • (iii) a report of assay of its zinc content in milligrams per cubic centimetre or 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 on the determination of the proportion of the nitrogen in the crystalline component of the suspended precipitate,

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

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

      • (viii) 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 — Medium 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. 4]

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