Food and Drug Regulations

C.04.573 (1) A fabricator shall not sell Insulin Zinc Suspension — Prolonged 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 — Prolonged,

  • (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 the nitrogen content in milligrams and of its zinc content in milligrams per 1,000 International Units of insulin;

• (b) for the first finished lot of Insulin Zinc Suspension — Prolonged 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 of 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 — Prolonged 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. 5]