Food and Drug Regulations

C.01.062 (1) Subject to subsections (2) to (5), no manufacturer shall sell a drug in dosage form where the amount of any medicinal ingredient therein, determined using an acceptable method, is

• (a) less than 90.0 per cent of the amount of the medicinal ingredient shown on the label; or

• (b) more than 110.0 per cent of the amount of the medicinal ingredient shown on the label.

(2) Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a volatile substance of botanical origin or its synthetic equivalent, the amount of that ingredient, determined using an acceptable method, shall be

• (a) not less than 85.0 per cent of the amount of the medicinal ingredient shown on the label; and

• (b) not more than 120.0 per cent of the amount of the medicinal ingredient shown on the label.

(3) Subject to subsection (5), where a drug in capsule form contains a medicinal ingredient that is a vitamin in a fish-liver oil, no variation from the amount of the medicinal ingredient as shown on the label, determined using an acceptable method, is permitted other than that which is in accordance with the variation for that fish-liver oil as stated in any publication whose name is referred to in Schedule B to the Act.

(4) Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a vitamin, no variation from the amount of the medicinal ingredient shown on the label, determined using an acceptable method, is permitted other than the variation set out in column III or IV of an item of the table to this section opposite the vitamin set out in column I of that item for the amount of vitamin set out in column II of that item.

(5) Subsections (1) to (4) do not apply in respect of

• (a) a drug for which a notice of compliance has been issued pursuant to section C.08.004;

• (b) [Repealed, SOR/98-423, s. 8]

• (c) a drug for which a standard is contained in any publication whose name is referred to in Schedule B to the Act;

• (d) a drug described in Schedule C or D to the Act or Division 6 of Part C of these Regulations; or

• (e) a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and in respect of which

  • (i) the conditions of pharmaceutical production and quality control are suitable for controlling the identity, quality, purity, stability, safety, strength and potency of the drug,

  • (ii) all labels, package inserts, product brochures and file cards to be used in connection with the drug make proper claims in respect of the drug,

  • (iii) the drug can, without undue foreseeable risk to humans, be used for the purposes and under the conditions of use recommended by the manufacturer, and

  • (iv) the drug is effective for the purposes and under the conditions of use recommended by the manufacturer.