Food and Drug Regulations — C.01.004
C.01.004 (1) The inner and outer labels of a drug shall show (a) on the principal display panel (i) the proper name, if any, of the drug which, if there is a brand name for the drug, shall immediately precede or follow the brand name in type not less than one-half the size of that of the brand name, (ii) if there is no proper name, the common name of the drug, and (iii) [Repealed, SOR/2024-238, s. 3] (iv) [Repealed, SOR/2024-238, s. 3] (v) in both official languages, the notation “sterile” “ stérile ” if the drug is required to be sterile by these Regulations; (b) on the upper left quarter of the principal display panel (i) the symbol “Pr” in the case of a prescription drug, but the symbol “Pr” shall not appear on the label of any other drug, (ii) the symbol “ Symbol consisting of a diamond shape outline in which an uppercase letter C is centred. ” in a clear manner and a conspicuous colour and size, in the case of a controlled drug, other than a controlled drug contained in an agricultural implant and set out in Part III of the schedule to Part G, (iii) the symbol “N” in a colour contrasting with the rest of the label or in type not less than half the size of any letters used thereon, in the case of a narcotic as defined in the Narcotic Control Regulations, and (iv) in the case of a targeted substance as defined in section 1 of the Benzodiazepines and Other Targeted Substances Regulations , the following symbol in a colour contrasting with the rest of the label and in type not less than half the size of any other letter used on the main panel, namely, Symbol consisting of a square outline divided in half from top left corner to bottom right corner. The top right half has an uppercase letter C inside and lower left half has an uppercase letter T inside. (c) on any panel (i) the name and address of the manufacturer of the drug, (ii) the lot number of the drug, (iii) adequate directions for use of the drug, except in the case of a drug to which section C.01.004.02 applies, (iv) a quantitative list of the medicinal ingredients of the drug by their proper names or, if they have no proper names, by their common names, except in the case of a drug to which section C.01.004.02 applies, (v) the expiration date of the drug, 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. ”. (1.1) to (1.5) [Repealed, SOR/2014-158, s. 3] (2) In addition to the requirements of subsection (1), the outer label of a drug shall display the following information: (a) the net amount of the drug in the container in terms of weight, measure or number; (b) in the case of a drug intended for parenteral use, a quantitative list of any preservatives present therein by their proper names or, if they have no proper names, by their common names; and (c) in the case of a drug for human use that contains mercury or a salt or derivative thereof as a preservative, a quantitative list of all mercurial preservatives present therein by their proper names or, if they have no proper names, by their common names. (3) Where the container of a drug is too small to accommodate an inner label that conforms to the requirements of these Regulations, the inner label requirements of these Regulations do not apply to the drug in that container if (a) there is an outer label that complies with the labelling requirements of these Regulations; and (b) the inner label shows (i) the proper name of the drug, the common name of the drug if there is no proper name or, in the case of a drug with more than