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

C.01.031.1 [Repealed, SOR/87-484, s. 3]

• C.01.031.2 (1) Sections C.01.029 to C.01.031 do not apply to a drug that is

  • (a) a prescription drug or a drug that is required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations;

  • (b) intended for parenteral use only;

  • (c) in effervescent or powder form;

  • (d) in suppository form;

  • (e) intended for topical use, unless it is a liquid preparation containing more than five per cent alkyl salicylates;

  • (f) packaged in a non-reclosable package containing not more than two adult standard dosage units per package; or

  • (g) in toothpaste form.

• (2) Sections C.01.029 to C.01.031 do not apply to a drug that is repackaged by a pharmacist or practitioner at the time of sale.

• (3) Section C.01.031 does not apply to a drug that is

  • (a) sold only in containers that have roll-on or spray applicators or permanently installed wick applicators;

  • (b) sold for exclusive use in animals other than household pets; or

  • (c) intended solely for use in dentists’ offices, or packaged for hospital use only.

C.01.032 No person shall sell a corticosteroid drug for ophthalmic use unless

• (a) the outer label or the package insert carries, as part of the directions for use, the following statements:

  “Contraindications

  Viral diseases of the cornea and conjunctiva;

  Tuberculosis of the eye;

  Fungal diseases of the eye;

  Acute purulent untreated infections of the eye, which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid.

  Side Effects

  Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur.”;

  and

• (b) the inner label carries the statements required by paragraph (a) or instructions to see the outer label or package insert for information about contraindications and side effects.

C.01.033 Section C.01.032 does not apply to a corticosteroid drug that is sold by a pharmacist under a prescription.

C.01.034 No person shall disseminate to a practitioner promotional literature about corticosteroid drugs for ophthalmic use unless the statements required by paragraph C.01.032(a) are included in that literature.

C.01.035 Sections C.01.032 and C.01.034 do not apply to a drug sold solely for veterinary use.

Miscellaneous

• C.01.036 (1) No manufacturer or importer shall sell

  • (a) a drug that contains phenacetin in combination with any salt or derivative of salicylic acid;

  • (b) a drug for human use that contains

    • (i) oxyphenisatin,

    • (ii) oxyphenisatin acetate, or

    • (iii) phenisatin; or

  • (c) a drug for human use that contains mercury or a salt or derivative thereof, unless the drug is

    • (i) a drug described in Schedule C or D to the Act, or

    • (ii) one of the following drugs, namely,

      • (A) an ophthalmic drug or other drug to be used in the area of the eye,

      • (B) a drug for nasal administration,

      • (C) a drug for otic administration, or

      • (D) a drug for parenteral administration that is packaged in a multi-dose container,

    in which the mercury or the salt or derivative thereof is present as a preservative and the manufacturer or importer has submitted evidence to the Minister demonstrating that the only satisfactory way to maintain the sterility or stability of the drug is to use that preservative.

• (2) For the purpose of clause (1)(c)(ii)(A), area of the eye means the area bounded by the supraorbital and infraorbital ridges and includes the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge.

C.01.036.1 No person shall sell, or advertise for sale, nitrous oxide to the general public.

• C.01.037 (1) No person shall sell to the general public a drug that is recommended solely for children if the package in which the drug is sold contains

  • (a) more than 1.92 g of salicylamide or salicylic acid or the equivalent quantity of a salt of salicylic acid;

  • (b) more than 1.92 g of acetylsalicylic acid or the equivalent quantity of a salt or derivative thereof;

  • (c) more than 3.2 g of acetaminophen in 160 mg dosage units; or

  • (d) more than 1.92 g of acetaminophen in 80 mg dosage units.

• (2) Subsection (1) does not apply to a drug dispensed pursuant to a prescription.

C.01.038 A drug for human use is adulterated if it contains

• (a) Strychnine or any of its salts;

• (b) extracts or tinctures of

  • (i) Strychnos nux vomica,

  • (ii) Strychnos Ignatii, or

  • (iii) a Strychnos species containing strychnine, other than those species mentioned in subparagraphs (i) and (ii);

• (c) Methapyrilene or any of its salts;

• (d) Echimidine or any of its salts; or

• (e) any of the following plant species or extracts or tinctures thereof:

  • (i) Symphytum asperum,

  • (ii) Symphytum x uplandicum, or

  • (iii) any other plant species containing echimidine.

C.01.039 In vitro diagnostic products that are or contain drugs other than drugs listed in Schedule E to the Act, and drugs listed in Schedule D to the Act that are labelled for veterinary use only, are exempt from the application of this Part.

C.01.040 No manufacturer or importer shall sell a drug for human use that contains as an ingredient

• (a) chloroform; or

• (b) arsenic or any of its salts or derivatives, other than arsenic trioxide.

C.01.040.1 No manufacturer shall use methyl salicylate as a medicinal ingredient in a drug for internal use in humans.

Colouring Agents

• C.01.040.2 (1) No manufacturer shall use a colouring agent in a drug other than a colouring agent listed in subsections (3) and (4).

• (2) No person shall import for sale a drug that contains a colouring agent other than a colouring agent listed in subsections (3) and (4).

• (2.1) The following definitions apply in subsections (3) to (4.1):

  C.I. (indication of the number)

  C.I. (indication of the number) means the designation used to identify a colouring agent in the Colour Index published by The Society of Dyers and Colourists, as amended from time to time; (C.I. (indication du numéro))

  D & C (indication of the colour and the number)

  D & C (indication of the colour and the number) means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in drugs and cosmetics; (D&C (indication de la couleur et du numéro))

  FD & C (indication of the colour and the number)

  FD & C (indication of the colour and the number) means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in food, drugs and cosmetics. (FD&C (indication de la couleur et du numéro))

• (3) The following colouring agents are permitted in drugs for internal and external use, namely,

  • (a) ACID FUCHSIN D (D & C Red No. 33; C.I. No. 17200),

    • ALIZARIN CYANINE GREEN F (D & C Green No. 5; C.I. No. 61570),
    • ALLURA RED AC (FD & C Red No. 40; C.I. No. 16035),
    • AMARANTH (Delisted FD & C Red No. 2; C.I. No. 16185),
    • ANTHOCYANIN DERIVED FROM JUICE EXPRESSED FROM FRESH EDIBLE FRUITS OR VEGETABLES,
    • ß-APO-8¹-CAROTENAL (C.I. No. 40820),
    • BRILLIANT BLUE FCF SODIUM SALT (FD & C Blue No. 1; C.I. No. 42090),
    • BRILLIANT BLUE FCF AMMONIUM SALT (D & C Blue No. 4; C.I. No. 42090),
    • CANTHAXANTHIN (C.I. No. 40850),
    • CARAMEL,
    • CARBON BLACK (C.I. No. 77266),
    • CARMINE (C.I. No. 75470),
    • CARMOISINE (Delisted Ext. D & C Red No. 10; C.I. No. 14720),
    • ß-CAROTENE (C.I. No. 40800),
    • CHLOROPHYLL (C.I. No. 75810),
    • EOSIN YS ACID FORM (D & C Red No. 21; C.I. No. 45380:2),
    • EOSIN YS SODIUM SALT (D & C Red No. 22; C.I. No. 45380),
    • ERYTHROSINE (FD & C Red No. 3; C.I. No. 45430),
    • FAST GREEN FCF (FD & C Green No. 3; C.I. No. 42053),
    • FLAMING RED (D & C Red No. 36; C.I. No. 12085),
    • HELINDONE PINK CN (D & C Red No. 30; C.I. No. 73360),
    • INDIGO (D & C Blue No. 6; C.I. No. 73000),
    • INDIGOTINE (FD & C Blue No. 2; C.I. No. 73015),
    • IRON OXIDES (C.I. Nos. 77489, 77491, 77492, 77499),
    • LITHOL RUBIN B SODIUM SALT (D & C Red No. 6; C.I. No. 15850),
    • LITHOL RUBIN B CALCIUM SALT (D & C Red No. 7; C.I. No. 15850:1),
    • PHLOXINE B ACID FORM (D & C Red No. 27; C.I. No. 45410:1),
    • PHLOXINE B SODIUM SALT (D & C Red No. 28; C.I. No. 45410),
    • PONCEAU 4R (C.I. No. 16255),
    • PONCEAU SX (FD & C Red No. 4; C.I. No. 14700),
    • QUINOLINE YELLOW WS (D & C Yellow No. 10; C.I. No. 47005),
    • RIBOFLAVIN,
    • SUNSET YELLOW FCF (FD & C Yellow No. 6; C.I. No. 15985),
    • TARTRAZINE (FD & C Yellow No. 5; C.I. No. 19140),
    • TITANIUM DIOXIDE (C.I. No. 77891);

  • (b) preparations made by extending any of the colouring agents listed in paragraph (a) on a substratum of

    • (i) alumina,

    • (ii) blanc fixe,

    • (iii) gloss white,

    • (iv) clay,

    • (v) zinc oxide,

    • (vi) talc,

    • (vii) rosin,

    • (viii) aluminum benzoate,

    • (ix) calcium carbonate, or

    • (x) any combination of the substances listed in subparagraphs (i) to (ix); and

  • (c) preparations made by extending any sodium, potassium, aluminum, barium, calcium, strontium or zirconium salt of any of the colouring agents listed in paragraph (a) on a substratum of

    • (i) alumina,

    • (ii) blanc fixe,

    • (iii) gloss white,

    • (iv) clay,

    • (v) zinc oxide,

    • (vi) talc,

    • (vii) rosin,

    • (viii) aluminum benzoate,

    • (ix) calcium carbonate, or

    • (x) any combination of the substances listed in subparagraphs (i) to (ix).

• (4) The following colouring agents are permitted in drugs for external use, namely,

  • (a) ACID VIOLET 43 (Ext. D & C Violet No. 2; C.I. No. 60730),

    • ALIZUROL PURPLE SS (D&C Violet No. 2; C.I. No. 60725),
    • ANNATTO (C.I. No. 75120),
    • BISMUTH OXYCHLORIDE (C.I. No. 77163),
    • CHROMIUM HYDROXIDE GREEN (PIGMENT GREEN 18 (C.I. No. 77289)),
    • DEEP MAROON (D&C Red No. 34; C.I. No. 15880:1),
    • DIBROMOFLUORESCEIN (SOLVENT RED 72 (C.I. No. 45370:1); ORANGE No. 5 (D & C Orange No. 5)),
    • FERRIC FERROCYANIDE (C.I. No. 77510),
    • GUANINE (C.I. No. 75170),
    • MANGANESE VIOLET (C.I. No. 77742),
    • MICA (C.I. No. 77019),
    • ORANGE II (D&C Orange No. 4; C.I. No. 15510),
    • PYRANINE CONCENTRATED (D&C Green No. 8; C.I. No. 59040),
    • QUINIZARIN GREEN SS (D&C Green No. 6; C.I. No. 61565),
    • TONEY RED (D&C Red No. 17; C.I. No. 26100),
    • URANINE ACID FORM (D&C Yellow No. 7; C.I. No. 45350:1),
    • URANINE SODIUM SALT (D&C Yellow No. 8; C.I. No. 45350);
    • ZINC OXIDE (C.I. No. 77947);

  • (b) preparations made by extending any of the colouring agents listed in paragraph (a) on a substratum of

    • (i) alumina,

    • (ii) blanc fixe,

    • (iii) gloss white,

    • (iv) clay,

    • (v) zinc oxide,

    • (vi) talc,

    • (vii) rosin,

    • (viii) aluminum benzoate,

    • (ix) calcium carbonate, or

    • (x) any combination of the substances listed in subparagraphs (i) to (ix); and

  • (c) preparations made by extending any sodium, potassium, aluminum, barium, calcium, strontium or zirconium salt of any of the colouring agents listed in paragraph (a) on a substratum of

    • (i) alumina,

    • (ii) blanc fixe,

    • (iii) gloss white,

    • (iv) clay,

    • (v) zinc oxide,

    • (vi) talc,

    • (vii) rosin,

    • (viii) aluminum benzoate,

    • (ix) calcium carbonate, or

    • (x) any combination of the substances listed in subparagraphs (i) to (ix).

• (4.1) Despite subsection (1), no manufacturer shall use a preparation made by extending any of the following substances on a substratum of mica in a drug unless the requirements in subsection (4.3) are met:

  • (a) titanium dioxide (C.I. No. 77891);

  • (b) iron oxides (C.I. Nos. 77489, 77491, 77492, 77499); or

  • (c) a mixed oxide made from substances referred to in both paragraphs (a) and (b).

• (4.2) Despite subsection (2), no person shall import for sale a drug that contains a preparation made by extending any of the substances referred to in paragraphs (4.1)(a) to (c) on a substratum of mica unless the requirements in subsection (4.3) are met.

• (4.3) The requirements referred to in subsections (4.1) and (4.2) are the following:

  • (a) the drug shall be in a solid dosage form intended for oral administration or in a liquid dosage form intended for oral administration or it shall be a drug intended for external use;

  • (b) in the case where the drug is in a solid dosage form intended for oral administration, the drug shall not contain more than 3% of the preparation;

  • (c) in the case where the preparation was made using iron oxides, the preparation shall not contain more than 55% iron oxides.

• (5) Subsections (1), (2), (4.1) and (4.2) do not apply in respect of a drug that is represented as being solely for use in the disinfection, for disease prevention, of

  • (a) medical devices;

  • (b) health care facilities; or

  • (c) premises in which food is manufactured, prepared or kept.