Food and Drug Regulations

C.04.588 (1) A fabricator shall not sell NPH 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 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  • (vi) [Repealed, SOR/95-203, s. 7]