C.01.003. No person shall sell a drug that is not labelled as required by these Regulations.
- SOR/80-544, s. 1.
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,
(iii) where a standard for the drug is prescribed in Division 6 of this Part, a statement that the drug is a Canadian Standard Drug, for which the abbreviation C.S.D. may be used,
(iv) where a standard for the drug is not prescribed in Division 6 of this Part but is contained in a publication mentioned in Schedule B to the Act, the name of the publication containing the standard used or its abbreviation as provided in Schedule B or, if a manufacturer’s standard is used, a statement setting forth the fact that such a standard is used, and
(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 drug required by this Part or Part D to be sold on prescription, but in no other case shall the symbol Pr appear on the label of a drug,
(ii) the symbol “” 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 subsection 1(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,
(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,
(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,
(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) In addition to the requirements of subsection (1), when a drug is intended for human use, its outer label must contain a list of all non-medicinal ingredients, or, if the outer label is too small, the list must appear on a tag, tape or card that is attached to the package.
(1.2) The non-medicinal ingredients must be listed in alphabetical order or in descending order of predominance by their proportion in the drug, preceded by words that clearly distinguish them from the medicinal ingredients.
(1.3) In the case of flavour, fragrance or pharmaceutical ink, the expressions “flavour/saveur”, “fragrance/parfum” and “pharmaceutical ink/encre pharmaceutique”, respectively, may be included in the list to indicate that such ingredients have been added to the drug, instead of listing those ingredients or combinations of them individually.
(1.4) When the composition of the drug varies from one lot to another, the outer label must include a reference to all non-medicinal ingredient alternatives that may be present in the drug, preceded by the symbol “+/–” or “±” or the expression “or/ou” or “may contain/peut contenir”.
(1.5) Subsections (1.1) to (1.4) do not apply to
(a) a drug that is required to be sold pursuant to a prescription;
(b) a drug that is not required to be sold pursuant to a prescription but is administered only under the supervision of a practitioner;
(c) a drug that is represented as being solely for use as a disinfectant on hard non-porous surfaces; or
(d) a drug for veterinary use.
(2) In addition to the requirements of subsection (1) and, if applicable, subsections (1.1) to (1.4), the outer label of a drug must show all of 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 one medicinal ingredient, the brand name of the drug,
(ii) the potency of the drug except where, in the case of a drug with more than one medicinal ingredient, the name used pursuant to subparagraph (i) for that drug is unique for a particular potency of the drug,
(iii) the net contents of the drug if it is not in a discrete dosage form,
(iv) the route of administration of the drug if other than oral,
(v) the lot number of the drug,
(vi) the name of the manufacturer of the drug,
(vii) the expiration date of the drug, and
(viii) the identification of special characteristics of the dosage form if they are not evident from the name of the drug under subparagraphs (i) or (ii).
(4) [Repealed, SOR/92-654, s. 2]
(5) This section does not apply to
(a) a drug sold to a drug manufacturer; or
(b) a drug dispensed pursuant to a prescription, if its label carries suitable directions for use and complies with the requirements of section C.01.005.
- SOR/80-543, s. 2;
- SOR/81-334, s. 1(E);
- SOR/85-715, s. 2;
- SOR/89-229, s. 1;
- SOR/90-216, s. 1;
- SOR/90-586, s. 1;
- SOR/92-654, s. 2;
- SOR/93-202, s. 2;
- SOR/97-228, s. 1;
- SOR/97-515, s. 1;
- SOR/2000-219, s. 1;
- SOR/2001-181, s. 4;
- SOR/2010-105, s. 2;
- SOR/2011-88, s. 1.
- Date modified: