Food and Drug Regulations — C.04.009
C.04.009 (1) The principal display panel of both the inner and outer labels of a drug in dosage form must show (a) the drug’s brand name, if any; (b) the drug’s proper name, if any, which, if there is a brand name, must immediately precede or follow the brand name in type not less than one-half the size of that of the brand name; (c) if there is no proper name, the drug’s common name, which, if there is a brand name, must immediately precede or follow the brand name in type not less than one-half the size of that of the brand name; (d) the net quantity of the drug in the immediate container for the purpose of the inner label and the net quantity of the drug in the outer package for the purpose of the outer label; (e) if the drug is sterile, an indication to that effect; (f) if any of the drug’s medicinal ingredients are sourced or derived from human biological source material, an indication to that effect; and (g) if any of the drug’s medicinal ingredients are sourced or derived from animal biological source material, the animal species from which each of those ingredients is sourced or derived. (2) The inner and outer labels of a drug in dosage form must show on any panel (a) the name of the holder of the drug identification number assigned for the drug; (b) the potency of the drug, if applicable; (c) the recommended dose of the drug; (d) the lot number of the drug; (e) the expiration date of the drug; (f) adequate directions for use of the drug; and (g) any other information that is necessary to prevent injury to human health. (3) Paragraph (2)(f) does not apply if adequate directions for use of the drug must be displayed on the label in accordance with section C.01.004.02 or C.01.004.03. (4) Despite paragraph (2)(g), if another provision of these Regulations requires that information referred to in that paragraph be shown on a particular panel of a label, the information must be shown on that panel. (5) The outer label of a drug in dosage form must show on any panel (a) the address of the holder of the drug identification number assigned for the drug; (b) a quantitative list of any preservatives contained in the drug, by their proper names, or if a preservative has no proper name, by its common name; (c) the approved storage conditions for the drug; (d) any other information that is necessary for the proper storage and handling of the drug, accompanied, as the case may be, by any designated space for the addition of supplementary information in this regard by the person who stores or handles the drug; and (e) 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. ” (6) The inner label requirements of these Regulations do not apply in respect of a drug in dosage form whose immediate container is too small to accommodate an inner label that meets those requirements if (a) the inner label shows (i) the drug’s brand name, if any, (ii) the drug’s proper name, if any, (iii) the drug’s common name, if there is no proper name, (iv) the drug identification number assigned for that drug, preceded by the expression “Drug Identification Number” or “Drogue : identification numérique”, or both, or the abbreviation “DIN”, (v) the name of the holder of the drug identification number assigned for the drug, (vi) the net quantity of the drug in the container, (vii) the drug’s potency, if applicable, unless the drug contains more than one medicinal ingredient and the drug’s brand name is unique for a particular potency of the drug, (viii) the drug’s lot number, (ix) t