Food and Drug Regulations

C.04.019 The provisions of section C.01.004 do not apply to a drug as defined in this Division but every package of such drug shall carry

• (a) on both the inner and the outer labels

  • (i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name in type not less than one-half the size of that of the brand name,

  • (ii) the name of the distributor referred to in paragraph C.01A.003(b),

  • (iii) the potency of the drug, where applicable,

  • (iv) the recommended dose of the drug,

  • (v) the lot number,

  • (vi) the expiration date except upon the inner label of a single-dose container, and

  • (vii) adequate direction for use; and

• (b) on the outer label

  • (i) the address of the distributor referred to in paragraph C.01A.003(b),

  • (ii) for whole blood and its components, the establishment licence number of the distributor referred to in paragraph C.01A.003(b), preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof,

  • (iii) the proper name, or the common name if there is no proper name, and the amount, of any preservative in the drug,

  • (iv) a statement that the drug shall be stored at a temperature of not less than 2°C and not more than 10°C, unless the Minister has received evidence demonstrating that such a statement is not required, and

  • (v) a statement of the net contents in terms of weight, measure, or number.