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

Regulations are current to 2016-04-03 and last amended on 2016-02-09. Previous Versions

 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]

 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.

 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
1Insulin 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.
2Insulin 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.
3Insulin 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.
4Globin 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.
5NPH 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.
6Protamine 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
7Sulphated 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.

 The packager/labeller of an insulin preparation shall print on the outer label of every package thereof instructions to store the preparation in a refrigerator at 35° to 50°F (2° to 10°C) and to avoid exposing it to freezing.

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

 The packager/labeller of an insulin preparation that consists of a precipitate suspended in a buffered aqueous medium shall print on the inner label of every package thereof the statement “Shake Carefully”.

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

 The packager/labeller of an insulin preparation may, in lieu of printing adequate directions for its use on both the inner and outer labels thereof as required by subparagraph C.04.019(a)(vii), print the descriptions for use in a descriptive circular prepared in accordance with section C.04.655, but in such case he shall

  • (a) enclose a copy of the circular in the package containing the preparation; and

  • (b) state on the outer label of the package that such a circular is enclosed therein.

  • SOR/82-769, ss. 7, 9;
  • SOR/97-12, s. 65.

 The descriptive circular referred to in section C.04.654 shall include, at least, the following information:

  • (a) a statement that

    • (i) the treatment of diabetes mellitus requires medical supervision and review,

    • (ii) insulin preparations should be used only as determined by a physician for each patient in the light of blood-sugar and urinary-sugar findings, and

    • (iii) the physician’s instructions concerning diet, dosage, rest and exercise should be followed carefully;

  • (b) an outline of the procedure to be followed in withdrawing the insulin preparation from the vial, including techniques for sterilization of the syringe and needle, vial-stopper and site of injection;

  • (c) a statement explaining that injections should be subcutaneous, and not intravenous or intramuscular, and a caution against successive injections in any one site;

  • (d) a statement that doses are specified in terms of Units of potency per cubic centimetre and that the volume of each dose will depend upon the potency in terms of units per cubic centimetre stated on the label of the insulin preparation and that, for these reasons, it is important that the patient understand the markings on syringes;

  • (e) a brief explanation of hypoglycemia together with emergency measures suitable for use by patients and those caring for patients in the event of hypoglycemic reactions;

  • (f) a statement indicating the possibility of undesirable reactions associated with illness or infection, with the omission or loss of a meal, and with a shortage of the insulin preparation;

  • (g) a statement warning against using any other type of insulin preparation than that prescribed by the physician;

  • (h) a statement that the use of a package should not be commenced after the expiration date printed on the package;

  • (i) a statement that the contents should be used as continuously as practicable and that any vial from which a part of the contents has been withdrawn should be discarded in the event of its being in disuse for several weeks’ time;

  • (j) a statement stressing the importance of visiting a physician regularly and of carefully following his instructions;

  • (k) in the case of insulin preparations consisting of a clear, colourless or almost colourless solution, free from turbidity and from insoluble matter, a statement that if the contents of the vial become cloudy or turbid, use of that vial should be discontinued;

  • (l) in the case of insulin preparations consisting of a precipitate suspended in a buffered aqueous medium, a statement explaining that it is necessary to shake the vial carefully before withdrawing a dose, noting that if the contents have become lumpy or granular in appearance or have formed a deposit of particles on the wall of the container, the use of that vial should be discontinued;

  • (m) instructions that the insulin preparation should be stored in a refrigerator at 35° to 50°F (2° to 10°C) and should not be exposed to freezing; and

  • (n) in the case of Sulphated Insulin, a statement explaining that this insulin preparation is not for ordinary use, but is a chemically modified insulin which may be more effective than the usual insulin preparations in certain insulin-resistant or insulin-allergic diabetic patients.

  • SOR/82-769, ss. 7, 10.
 
Date modified: