Food and Drug Regulations

C.04.656 (1) Notwithstanding section C.04.554, a person who holds an establishment licence may sell Insulin Injection made from zinc-insulin crystals contained in vials of approximately 20 cubic centimetre capacity each of which vials

• (a) contains an excess volume sufficient to permit withdrawal of 20 cubic centimetres, and

• (b) provides 500 International Units of insulin per cubic centimetre,

if

• (c) notwithstanding section C.04.651, both the inner and outer labels are printed in black ink on white stock and overprinted in narrow brown and white diagonal stripes, of which there shall be at least five but not more than 20 to each inch;

• (d) both the inner and the outer labels carry the statement “Warning — High Potency — Not for Ordinary Use”; and

• (e) each package contains a descriptive circular that conforms to the requirements of section C.04.655 and, in addition, includes,

  • (i) at the beginning of the circular the statement:

    “Warning — This insulin preparation contains 500 International Units of insulin in each cubic centimetre. Extreme caution must be observed in the measurement of doses because inadvertent overdose may result in irreversible shock. Serious consequences may result if it is used other than under constant medical supervision. Unless specifically prescribed it should never be used by patients to replace use of any other insulin preparations.”,

  • (ii) a statement that Insulin made from Zinc-Insulin crystals 500 International Units per cubic centimetre should not be administered intravenously, and

  • (iii) a statement giving information for the safe and effective use by physicians of the drug in insulin shock therapy and in the treatment of diabetic patients with high insulin resistance (daily requirement more than 200 International Units of insulin).

(2) [Repealed, SOR/95-203, s. 10]