Food and Drug Regulations

C.04.595 (1) A fabricator shall not sell Protamine Zinc 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 insulin or zinc-insulin crystals employed in the manufacture of Protamine Zinc Insulin,

  • (i) protocols of assay of its potency 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 on 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 components used in the preparation of the trial mixture of Protamine Zinc Insulin, a report on the quantity of

  • (i) insulin in grams or in International Units,

  • (ii) zinc in grams or in milligrams, per 1,000 International Units of insulin,

  • (iii) protamine in grams or in milligrams, per 1,000 International Units of insulin, and

  • (iv) the volume of the preparation in cubic centimetres or litres;

• (c) for the trial mixture of Protamine Zinc 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 per 1,000 International Units of insulin,

  • (iii) protocols of its biological reaction showing retardation of the insulin effect, and

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

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

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

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

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

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

  • (iv) [Repealed, SOR/95-203, s. 8]