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

Regulations are current to 2022-01-12 and last amended on 2022-01-05. Previous Versions

PART CDrugs (continued)

DIVISION 4 (continued)

Preparations from Human Sources

 Preparations from human sources shall be pooled blood plasma, or pooled blood serum, or fractions of either separated by a method satisfactory to the Minister.

 A fabricator shall obtain human serum, or human plasma, only from a person certified by a qualified medical practitioner to be healthy.

  • SOR/97-12, s. 61

 A fabricator shall not use a person to serve as a donor of blood, placenta, or cord who has a history of a disease transmissible by blood transfusion including syphilis, infectious hepatitis, or malaria.

  • SOR/97-12, s. 61

 The operation of drawing blood from a donor shall be under the supervision of a qualified medical practitioner, and shall be carried out in a suitable bleeding room under the control of the fabricator.

  • SOR/97-12, s. 61

 A fabricator shall obtain human placenta and cord used in the manufacture of preparations from human sources only from women confined in public hospitals, and the donor of such placenta and cord shall have been free from the toxaemias of pregnancy, and the placenta and cord shall not show gross evidence of any pathological condition.

  • SOR/97-12, s. 61
  •  (1) Subject to subsections (2) and (3), dried human serum, dried human plasma or dried fractions of either shall not contain more than one per cent moisture when determined by an acceptable method.

  • (2) Dried Rho(D) Immune Human globulin shall not contain more than three per cent moisture when determined by an acceptable method.

  • (3) Dried Antihemophilic Factor Human shall not contain more than two per cent moisture when determined by an acceptable method.

  • SOR/81-334, s. 3

 A fabricator shall provide directions or means for the removal of particles of such size as to be dangerous to the recipient from preparations from human sources that are issued in fluid form or that are reconstituted from the dried form.

  • SOR/97-12, s. 61

 A fabricator of preparations from human sources shall maintain complete records of all donors, which records shall include the medical certificate required by section C.04.231.

  • SOR/97-12, s. 61

 A fabricator, packager/labeller or distributor referred to in paragraph C.01A.003(b) may issue human serum or human plasma, or fractions of either of them, for prophylactic or therapeutic use in any of the following forms:

  • (a) immune human serum, which shall be serum separated from the blood of persons recovered from the disease or from persons specifically immunized against the disease for which the serum is intended as a prophylactic or therapeutic agent;

  • (b) immune human globulins, or other immune human serum fractions, which shall be prepared from immune human serum or plasma;

  • (c) normal human serum, or normal human plasma, or fractions of either of these prepared from the blood of normal individuals; and

  • (d) dried products prepared from any of these.

  • SOR/97-12, s. 46

 No person shall sell a preparation from human sources unless both the inner and the outer labels clearly indicate that the preparation is derived from human sources.

 The expiration date for preparations from human sources issued in fluid or dried form shall be not later than five years after the date of filling the immediate container.

 The date of manufacture of preparations from human sources shall be the date of bleeding the donor.

 [Repealed, SOR/81-335, s. 3]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2013-179, s. 4]

 [Repealed, SOR/2006-353, s. 1]

 [Repealed, SOR/2006-353, s. 1]

 [Repealed, SOR/2006-353, s. 1]

 [Repealed, SOR/97-12, s. 50]

 [Repealed, SOR/2006-353, s. 1]

Insulin Preparations

[
  • SOR/82-769, s. 5
]
  •  (1) Insulin means the active principle of the pancreas that affects the metabolism of carbohydrates in the animal body and that is of value in the treatment of diabetes mellitus.

  • (2) The Canadian Reference Standard for insulin shall be the International Standard therefor.

  • (3) The insulin preparations described in these Regulations shall contain insulin to which may be added only such ingredients as are prescribed in these Regulations.

  • (4) The potency of an insulin preparation shall be expressed in units per cubic centimetre and each unit per cubic centimetre shall provide one International Unit of insulin per cubic centimetre.

  • SOR/82-769, s. 4

 No person shall sell or dispense an insulin preparation that has not been stored by him continuously at a temperature between 35° and 50°F (2° and 10°C).

  • SOR/82-769, s. 4

 The zinc-insulin crystals used in an insulin preparation shall contain, as determined by an acceptable method,

  • (a) not less than 21 International Units of insulin per milligram, and

  • (b) on the dry basis, not less than 0.30 per cent and not more than 0.90 per cent zinc.

  • SOR/82-769, s. 4

Insulin Injection or Insulin

 The insulin preparation, “Insulin injection” or “Insulin” shall be a clear colourless or almost colourless sterile solution free from turbidity and insoluble matter, prepared from insulin or zinc insulin crystals, shall have a pH of not less than 2.5 or more than 3.5, or not less than 7.0 or more than 7.8 and shall contain

  • (a) weight by volume,

    • (i) not less than 0.1 per cent and not more than 0.25 per cent of either phenol or cresol, and

    • (ii) not less than 1.4 per cent and not more than 1.8 per cent glycerin; and

  • (b) as determined by an acceptable method, for each 1,000 International Units of insulin,

    • (i) not more than 7.0 milligrams of nitrogen for Insulin Injection prepared from zinc-insulin crystals, and not more than 8.5 milligrams of nitrogen for Insulin Injection other than that made from zinc-insulin crystals,

    • (ii) not less than 0.10 milligram and not more than 0.40 milligram of zinc for Insulin Injection prepared from zinc-insulin crystals, and not more than 0.40 milligram of zinc for Insulin Injection other than that made from zinc-insulin crystals, and

    • (iii) in the case of Insulin Injection other than that made from zinc-insulin crystals, not more than 1.0 milligram of ash.

  • SOR/82-769, s. 4
  • SOR/85-715, s. 7

 No person shall sell Insulin Injection unless,

  • (a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres;

  • (b) the vial label indicates that each cubic centimetre has a potency equal to

    • (i) 40 International Units of insulin,

    • (ii) 80 International Units of insulin, or

    • (iii) 100 International Units of insulin; and

  • (c) each cubic centimetre thereof has an actual potency that is at least 95 per cent and does not exceed 105 per cent of the potency indicated on the label as determined by an acceptable method.

  • SOR/82-769, s. 4
  •  (1) A fabricator shall not sell Insulin Injection unless he

    • (a) has filed with the Minister, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Minister;

    • (b) has furnished the Minister with such additional information as the Minister may require; and

    • (c) has received from the Minister 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 Injection

      • (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,

      • (iii) a report of the ash content in the case of insulin, and

      • (iv) 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 Injection prepared from each master lot of insulin or zinc-insulin crystals, a report on the amount of each component thereof; and

    • (c) for the first filling of the first finished lot of Insulin Injection from each master lot of insulin or zinc-insulin crystals,

      • (i) a report of assay of its nitrogen content in milligrams per 1,000 International Units of insulin,

      • (ii) a report of assay of its zinc content in milligrams per 1,000 International Units of insulin, and

      • (iii) a report on the determination of its pH.

      • (iv) [Repealed, SOR/95-203, s. 2]

  • SOR/82-769, s. 4
  • SOR/95-203, s. 2
  • SOR/97-12, s. 61
  • SOR/2018-69, ss. 27, 31(E), 32(F)

 The expiration date printed on the inner and outer labels of every package of Insulin Injection shall be a date not later than two years after the date of removal for distribution from the fabricator’s place of storage.

  • SOR/82-769, s. 4
  • SOR/97-12, s. 61

Insulin Zinc Suspension — Rapid

 The insulin preparation “Insulin Zinc Suspension — Rapid” shall be a sterile suspension in a buffered aqueous medium, of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain,

  • (a) weight by volume,

    • (i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2.3H2O),

    • (ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and

    • (iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and

  • (b) as determined by an acceptable method, for each 1,000 International Units of insulin,

    • (i) not more than 7.0 milligrams of nitrogen; and

    • (ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid.

  • SOR/80-545, s. 1
  • SOR/82-769, s. 4
  • SOR/85-715, s. 8

 The insulin used in the preparation of Insulin Zinc Suspension — Rapid shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of Insulin Zinc Suspension-Rapid when the precipitate is suspended uniformly.

  • SOR/82-769, s. 4
 
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