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  • (ii) [Repealed, SOR/2013-179, s. 3]

  • (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,

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

  • (vi) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:

    “HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.

    SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.”.