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

Regulations are current to 2014-11-11 and last amended on 2014-11-07. Previous Versions

 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.