Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

C.04.602. The expiration date printed on the inner and outer labels of every package of Sulphated Insulin shall be a date not later than two years after the date of filling of the immediate container.

  • SOR/80-545, s. 4;
  • SOR/82-769, s. 4.

Labelling of Insulin Preparations

[SOR/82-769, s. 8]

C.04.650. The packager/labeller of Insulin Injection may label that insulin preparation “Insulin made from Zinc-Insulin crystals” only when it has been prepared from zinc-insulin crystals.

  • SOR/82-769, s. 7;
  • SOR/97-12, s. 65.

C.04.651. The packager/labeller of an insulin preparation shall print the information required by these Regulations to appear on both the inner and outer labels of every package of that insulin preparation as set out in the Table to this section.

TABLE

ItemColumn IColumn IIColumn III
Insulin PreparationPotency of PreparationSpecial Printing Requirements for Label
1.Insulin Injection, not labelled as set out in item 2.(a) 40 units per cc.(a) black ink on yellow stock.
(b) 80 units per cc.(b) black ink on green stock.
(c) 100 units per cc.(c) black ink on white stock.
2.Insulin Injection, labelled “Insulin made from Zinc-Insulin crystals.”(a) 40 units per cc.(a) red ink on grey stock.
(b) 80 units per cc.(b) green ink on grey stock.
(c) 100 units per cc.(c) black ink on white stock.
3.Insulin Zinc Suspension — Rapid, Insulin Zinc Suspension — Medium and Insulin Zinc Suspension — Prolonged.(a) 40 units per cc.(a) red ink on lavender stock plus a distinguishing mark or design.
(b) 80 units per cc.(b) green ink on lavender stock plus a distinguishing mark or design.
(c) 100 units per cc.(c) black ink on white stock.
4.Globin Insulin with Zinc.(a) 40 units per cc.(a) red ink on brown stock except that the expression “40 units per cubic centimetre” may be printed in white letters on a red background.
(b) 80 units per cc.(b) green ink on brown stock except that the expression “80 units per cubic centimetre” may be printed in white letters on a green background.
5.NPH Insulin.(a) 40 units per cc.(a) red ink on blue stocks.
(b) 80 units per cc.(b) green ink on blue stock.
(c) 100 units per cc.(c) black ink on white stock.
6.Protamine Zinc Insulin.(a) 40 units per cc.(a) red ink on white stock.
(b) 80 units per cc.(b) green ink on white stock.
(c) 100 units per cc.(c) black ink on white stock
7.Sulphated Insulin.100 units per cc.black ink on white stock plus the statement “Warning... Not for Ordinary Use... See Package Leaflet”.
  • SOR/82-769, s. 7;
  • SOR/97-12, s. 65.