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

C.04.186 No person shall sell any lot of tetanus toxoid unless such lot has been shown to meet a test for antigenicity made by an acceptable method.

C.04.187 No person shall sell tetanus toxoid unless both the inner and the outer labels carry a statement of the appropriate dose for purposes of immunization.

C.04.188 A fabricator shall fill tetanus toxoid aseptically into clear glass containers and where a preservative is not added shall seal the container by fusion.

C.04.189 No person shall sell tetanus toxoid that contains phenol.

C.04.190 The expiration date of tetanus toxoid shall be not later than two years after the date of manufacture or the date of issue.

Antitoxins, Antisera

C.04.210 An antitoxin or antiserum shall be the serum or fraction thereof separated from the blood of animals that have been artificially immunized against the by-products or antigenic fractions of specific cultures of micro-organisms, or against specific venoms.

C.04.211 The potency of an antitoxin or antiserum shall be determined by an acceptable method and where applicable the unit of potency shall be the International Unit.

C.04.212 Liquid diphtheria antitoxin shall have a potency of not less than 500 International Units per millilitre.

C.04.213 Liquid tetanus antitoxin shall have a potency of not less than 400 International Units per millilitre.

C.04.214 A liquid antitoxin or antiserum shall contain not more than 20 per cent solids.

C.04.215 A dried antitoxin shall be prepared from a liquid antitoxin and, when reconstituted to the original volume of the liquid antitoxin, shall have a potency not less than that prescribed for such liquid antitoxin.

C.04.216 A dried antitoxin or antiserum shall not contain more than one per cent moisture when determined by an acceptable method.

C.04.217 Each lot of antitoxin or antiserum shall be tested by an acceptable method for pyrogenicity and it shall be pyrogen-free, and, after filling into the final containers, for identity and it shall be true to name.

C.04.218 No person shall sell an antitoxin or antiserum unless both the inner and the outer labels carry a statement of the species of animal used, when other than the horse, and the net contents in millilitres or the number of units in the container.

C.04.219 In respect of antitoxins, the expiration date shall be

• (a) for liquid antitoxins with standards of potency, not later than five years after the date of manufacture;

• (b) for dried antitoxins with standards of potency, not later than five years after the date of manufacture;

• (c) for liquid antioxins with no standards of potency, not later than 12 months after the date of manufacture; and

• (d) for dried antitoxins with no standards of potency, not later than five years after the date of manufacture.

C.04.220 In respect of antisera, the expiration date shall be

• (a) for liquid antisera with standards of potency, not later than three years after the date of manufacture;

• (b) for dried antisera with standards of potency, not later than five years after the date of manufacture;

• (c) for liquid antisera with no standards of potency, not later than 12 months after the date of manufacture; and

• (d) for dried antisera with no standards of potency, not later than five years after the date of manufacture.

Preparations from Human Sources

C.04.230 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.

C.04.231 A fabricator shall obtain human serum, or human plasma, only from a person certified by a qualified medical practitioner to be healthy.

C.04.232 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.

C.04.233 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.

C.04.234 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.

• C.04.235 (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 Rh_o(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.

C.04.236 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.

C.04.237 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.

C.04.238 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.

C.04.239 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.

C.04.240 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.

C.04.241 The date of manufacture of preparations from human sources shall be the date of bleeding the donor.

C.04.300 and C.04.301 [Repealed, SOR/81-335, s. 3]

C.04.400 [Repealed, SOR/2013-179, s. 4]

C.04.401 [Repealed, SOR/2013-179, s. 4]

C.04.402 [Repealed, SOR/2013-179, s. 4]

C.04.403 [Repealed, SOR/2013-179, s. 4]

C.04.404 [Repealed, SOR/2013-179, s. 4]

C.04.405 [Repealed, SOR/2013-179, s. 4]

C.04.406 [Repealed, SOR/2013-179, s. 4]

C.04.407 [Repealed, SOR/2013-179, s. 4]

C.04.408 [Repealed, SOR/2013-179, s. 4]

C.04.409 [Repealed, SOR/2013-179, s. 4]

C.04.410 [Repealed, SOR/2013-179, s. 4]

C.04.411 [Repealed, SOR/2013-179, s. 4]

C.04.412 [Repealed, SOR/2013-179, s. 4]

C.04.413 [Repealed, SOR/2013-179, s. 4]

C.04.414 [Repealed, SOR/2013-179, s. 4]

C.04.415 [Repealed, SOR/2013-179, s. 4]

C.04.416 [Repealed, SOR/2013-179, s. 4]

C.04.417 [Repealed, SOR/2013-179, s. 4]

C.04.418 [Repealed, SOR/2013-179, s. 4]

C.04.419 [Repealed, SOR/2013-179, s. 4]

C.04.420 [Repealed, SOR/2013-179, s. 4]

C.04.421 [Repealed, SOR/2013-179, s. 4]

C.04.422 [Repealed, SOR/2013-179, s. 4]

C.04.423 [Repealed, SOR/2013-179, s. 4]

C.04.424 [Repealed, SOR/2006-353, s. 1]

C.04.425 [Repealed, SOR/2006-353, s. 1]

C.04.426 [Repealed, SOR/2006-353, s. 1]

C.04.427 [Repealed, SOR/97-12, s. 50]

C.04.428 [Repealed, SOR/2006-353, s. 1]

Insulin Preparations

• C.04.550 (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.

C.04.551 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).

C.04.552 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.

Insulin Injection or Insulin

C.04.553 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.

C.04.554 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.

• C.04.555 (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]