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

Regulations are current to 2017-07-03 and last amended on 2017-06-20. Previous Versions

Canadian Standard Drugs

  • Conjugated Estrogens
  • Conjugated Estrogens for Injection
  • Conjugated Estrogens Tablets
  • Digitoxin
  • Digitoxin Tablets
  • Digoxin
  • Digoxin Elixir
  • Digoxin Injection
  • Digoxin Tablets
  • Esterified Estrogens
  • Esterified Estrogens Tablets
  • Gelatin
  • Thyroid
  • SOR/80-544, s. 11.

General

 In this Division,

  • (a) solubility and specific gravity shall be determined at 25°C;

  • (b) tests for identity, quantitative tests for arsenic, lead, copper, zinc, fluorine, and sulphur dioxide, and limit tests shall be made by the official methods; and

  • (c) determination of physical and chemical constants shall be carried out by acceptable methods.

Conjugated Estrogens

 [S]. Conjugated estrogens shall be the drug conjugated estrogens described in The Pharmacopeia of the United States of America, XVIII (1970), except that

  • (a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

  • (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

  • SOR/82-429, s. 5.

Conjugated Estrogens for Injection

 [S]. Conjugated estrogens for injection shall be the drug conjugated estrogens for injection described in The Pharmacopeia of the United States of America, XVIII (1970), except that

  • (a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

  • (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

  • SOR/82-429, s. 6.

Conjugated Estrogens Tablets

 [S]. Conjugated estrogens tablets shall be the drug conjugated estrogens tablets described in The Pharmacopeia of the United States of America, XVIII (1970), except that

  • (a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and

  • (b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.

  • SOR/82-429, s. 7.

 [Repealed, SOR/80-544, s. 12]

Digitoxin

 [S]. Digitoxin shall be the drug digitoxin described in the Pharmacopeia of the United States of America.

Digitoxin Tablets

 [S]. Digitoxin tablets shall be the drug digitoxin tablets described in the Pharmacopeia of the United States of America.

Digoxin

 [S]. Digoxin shall be the drug digoxin described in the Pharmacopeia of the United States of America.

Digoxin Elixir

 [S]. Digoxin Elixir shall be the drug digoxin elixir described in the Pharmacopeia of the United States of America.

Digoxin Injection

 [S]. Digoxin injection shall be the drug digoxin injection described in the Pharmacopeia of the United States of America.

Digoxin Tablets

 [S]. Digoxin tablets shall be the drug digoxin tablets described in the Pharmacopeia of the United States of America.

 [Repealed, SOR/80-544, s. 12]

 [Repealed, SOR/80-544, s. 12]

 [Repealed, SOR/80-544, s. 12]

 [Repealed, SOR/80-544, s. 12]

Esterified Estrogens

 [S]. Esterified estrogens shall be the drug esterified estrogens described in the Pharmacopeia of the United States of America.

Esterified Estrogens Tablets

 [S]. Esterified estrogens tablets shall be the drug esterified estrogens tablets described in the Pharmacopeia of the United States of America.

Gelatin

 Gelatin shall be the drug gelatin described in the Pharmacopeia of the United States or the British Pharmacopeia.

 [Repealed, SOR/80-544, s. 12]

 [Repealed, SOR/80-544, s. 12]

 [Repealed, SOR/80-544, s. 12]

Thyroid

 Thyroid shall be the cleaned, dried, powdered thyroid glands of domestic animals used for food, and shall contain not less than 0.17 per cent, and not more than 0.23 per cent iodine and no added iodine in either inorganic or organic form, and

  • (a) its characters are

    Description, —

    • (i) General, — thyroid occurs as a cream-coloured, amorphous powder; the odour and taste are faint and meat-like, and

    • (ii) Microscopical, — when suitably mounted and examined under the microscope, thyroid shows the following: numerous smooth to striated hyaline fragments of colloids, of angular to irregular shape, that are colourless to pale yellow in water mounts, brown in Mallory’s stain and pink in solution of eosin, some of these fragments containing granules, minute vacuoles, crystalloidal bodies and cells; numerous irregular fragments of follicular epithelium staining brown with Mallory’s stain, the individual cells more or less polygonal to rounded-angular or irregularly cuboidal, often with prominent nuclei staining dark blue, their cytoplasm purplish with Delafield’s solution of haematoxylin; slender glistening segments of capillaries of closely undulate outline; numerous slender segments of neuraxons; numerous aggregates of particles of intercellular substance and slender, mostly straight connective tissue fibres staining blue to greenish blue with a mixture of Mallory’s stain and solution of phosphotungstic acid, the bundles of fibres often appearing reddish in Mallory’s stain; few glistening fragments of blood vessels with serrated or crenated ends as viewed in water mounts; and

  • (b) the tests for its purity are

    • (i) Inorganic iodine, — add to one gram of thyroid 10 millilitres of a saturated solution of zinc sulphate in water, shake, allow to stand five minutes, and filter through a fritted glass filter; add to five millilitres of the filtrate 0.5 millilitre of mucilage of starch and four drops each of a 10 per cent w/v solution of sodium nitrite in water and dilute sulphuric acid, shaking after each addition: no blue colour is produced, and

    • (ii) Moisture, — thyroid loses not more than six per cent moisture.

 Thyroid shall be

  • (a) assayed by official method DO-26, Thyroid, October 15, 1981; and

  • (b) stored in a cool place and in a tightly-closed container.

  • SOR/82-429, s. 8.

 [Repealed, SOR/80-544, s. 12]

 [Repealed, SOR/80-544, s. 12]

 [Repealed, SOR/80-544, s. 12]

DIVISION 7Sale of Drugs for the Purposes of Implementing the General Council Decision

Interpretation

 The definitions in this section apply in this Division.

Commissioner of Patents

Commissioner of Patents means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. (commissaire aux brevets)

General Council Decision

General Council Decision has the meaning assigned by subsection 30(6) of the Act. (décision du Conseil général)

  • SOR/2005-141, s. 1.
 
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