Food and Drug Regulations

C.04.555 (1) A fabricator shall not sell Insulin Injection 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 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  • (iv) [Repealed, SOR/95-203, s. 2]