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

General

C.06.001 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

C.06.002 [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.

Conjugated Estrogens for Injection

C.06.003 [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.

Conjugated Estrogens Tablets

C.06.004 [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.

C.06.100 and C.06.101 [Repealed, SOR/80-544, s. 12]

Digitoxin

C.06.120 [S]. Digitoxin shall be the drug digitoxin described in the Pharmacopeia of the United States of America.

Digitoxin Tablets

C.06.121 [S]. Digitoxin tablets shall be the drug digitoxin tablets described in the Pharmacopeia of the United States of America.

Digoxin

C.06.130 [S]. Digoxin shall be the drug digoxin described in the Pharmacopeia of the United States of America.

Digoxin Elixir

C.06.131 [S]. Digoxin Elixir shall be the drug digoxin elixir described in the Pharmacopeia of the United States of America.

Digoxin Injection

C.06.132 [S]. Digoxin injection shall be the drug digoxin injection described in the Pharmacopeia of the United States of America.

Digoxin Tablets

C.06.133 [S]. Digoxin tablets shall be the drug digoxin tablets described in the Pharmacopeia of the United States of America.

C.06.140 to C.06.142 [Repealed, SOR/80-544, s. 12]

C.06.150 to C.06.153 [Repealed, SOR/80-544, s. 12]

C.06.154 to C.06.156 [Repealed, SOR/80-544, s. 12]

C.06.157 to C.06.160 [Repealed, SOR/80-544, s. 12]

Esterified Estrogens

C.06.161 [S]. Esterified estrogens shall be the drug esterified estrogens described in the Pharmacopeia of the United States of America.

Esterified Estrogens Tablets

C.06.162 [S]. Esterified estrogens tablets shall be the drug esterified estrogens tablets described in the Pharmacopeia of the United States of America.

Gelatin

C.06.170 Gelatin shall be the drug gelatin described in the Pharmacopeia of the United States or the British Pharmacopeia.

C.06.180 to C.06.183 [Repealed, SOR/80-544, s. 12]

C.06.230 to C.06.233 [Repealed, SOR/80-544, s. 12]

C.06.240 to C.06.242 [Repealed, SOR/80-544, s. 12]

Thyroid

C.06.250 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.

C.06.251 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.

C.06.252 [Repealed, SOR/80-544, s. 12]

C.06.260 to C.06.264 [Repealed, SOR/80-544, s. 12]

C.06.270 to C.06.280 [Repealed, SOR/80-544, s. 12]

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

Interpretation

C.07.001 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)

Application

C.07.002 This Division applies to the sale of drugs for the purposes of implementing the General Council Decision.

Application for Authorization

C.07.003 An application by a manufacturer for authorization to sell a drug under this Division shall be submitted to the Minister and shall contain the following information and documents:

• (a) a statement that the manufacturer intends to file an application with the Commissioner of Patents under section 21.04 of the Patent Act;

• (b) in respect of a new drug, the submission number and date of filing of the new drug submission or abbreviated new drug submission filed under section C.08.002 or C.08.002.1, respectively, and of any supplement filed under section C.08.003 in respect of the drug;

• (c) in respect of a drug that is not a new drug,

  • (i) the application number and date of filing of the application that has been filed under section C.01.014.1 in respect of the drug, or

  • (ii) the drug identification number, if one has been assigned in respect of the drug pursuant to section C.01.014.2;

• (d) for a drug in a solid dosage form, the manner in which the drug is marked in accordance with paragraph C.07.008(a) and evidence that such manner does not alter the safety and efficacy of the drug;

• (e) for a drug in a dosage form that is not solid, the manner in which the immediate container is marked in accordance with paragraph C.07.008(a); and

• (f) a sample of the label for the drug that includes the information required by paragraph C.07.008(c).

Authorization

C.07.004 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer’s drug meets the requirements of the Act and these Regulations if

• (a) the manufacturer has submitted to the Minister an application in accordance with section C.07.003 and a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act;

• (b) in respect of a new drug, an examination of the new drug submission or abbreviated new drug submission or supplement to either submission by the Minister demonstrates that the submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1;

• (c) in respect of a drug that is not a new drug, a drug identification number has been assigned pursuant to section C.01.014.2; and

• (d) the Minister is satisfied that the manufacturer and the drug comply with the Act and these Regulations.

C.07.005 Despite sections C.01.014, C.08.002 and C.08.003, a manufacturer may sell a drug under this Division if

• (a) the Minister has notified the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the drug meets the requirements of the Act and these Regulations; and

• (b) the manufacturer has received authorization under section 21.04 of the Patent Act.

C.07.006 Sections C.01.005 and C.01.014.1 to C.01.014.4 do not apply to new drugs sold under this Division.

Notice to Commissioner of Patents

C.07.007 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the Patent Act in the event that the Minister is of the opinion that the manufacturer’s drug authorized to be sold under this Division has ceased to meet the requirements of the Act and these Regulations.

Marking and Labelling

C.07.008 No person shall sell a drug under this Division unless

• (a) the drug itself permanently bears the mark “XCL”, in the case of a drug in a solid dosage form, or the immediate container permanently bears the mark “XCL”, in the case of a drug in a dosage form that is not solid;

• (b) the colour of the drug itself is significantly different from the colour of the version of the drug sold in Canada, in the case of a drug in a solid dosage form; and

• (c) the label of the drug permanently bears the mark “XCL”, followed by the export tracking number assigned by the Minister under section C.07.009 and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” or “POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA.”

C.07.009 The Minister shall assign an export tracking number to each drug in respect of which the Minister has notified the Commissioner of Patents under section C.07.004.

Records

C.07.010 The manufacturer shall, with respect to a drug authorized to be sold under this Division,

• (a) establish and maintain records, in a manner that enables an audit to be made, respecting the information referred to in subsection C.08.007(1), and retain those records for at least seven years from the day on which they were established; and

• (b) provide to the Minister the summaries referred to in section C.08.008.

Notice to Minister

C.07.011 The manufacturer shall notify the Minister in writing not less than 15 days before commencing the manufacture of the first lot of a drug authorized to be sold under this Division and not less than 15 days before the exportation of each subsequent lot of the drug.

DIVISION 8

New Drugs

C.08.001 For the purposes of the Act and this Division, new drug means a drug, other than a veterinary health product,

• (a) that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;

• (b) that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or

• (c) with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration or duration of action, and that has not been sold for that use or condition of use in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug.