Food and Drug Regulations
C.04.561 (1) A fabricator shall not sell Insulin Zinc Suspension — Rapid 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 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 — Rapid,
(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 — Rapid 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 per 1,000 International Units of insulin,
(iii) a report of assay of its zinc content 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 assay of the zinc content of the supernatant liquid after removal of the suspended precipitate,
(vi) a report on the determination of its pH, and
(vii) 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 — Rapid 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(iv) [Repealed, SOR/95-203, s. 3]
- SOR/82-769, s. 4
- SOR/95-203, s. 3
- SOR/97-12, s. 61
- Date modified: