CSA Z264.2-99:2014 pdf download.Labelling of Drug Ampoules, Vials, and Prefilled Syringes
1.1 CSA Z264.2-99 defines minimum design requirements for the presentation of critical information on inner labels for parenteral drug products provided in ampoules, vials, or prefilled syringes, including those requiring reconstitution. These requirements are intended to facilitate the identification and safe administration of parenteral drug products for human use. This Standard complements the requirements contained in the Food and Drugs Act and Regulations; labels conforming to this Standard are also expected to conform to the Act and applicable Regulations.
1.2 This Standard does not provide requirements for packaging, outer labels, or medical inhalants, and does not provide specifications for the physical components of the container.
1.3 In this Standard,“shall" indicates a mandatory requirement; "should" indicates a recommendation or that which is advised but not mandatory; and "may" indicates an advisory or optional statement. Figures, tables, and accompanying legends are mandatory; the appendices and notes are not mandatory. The purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered to be part of the figure or table and are written as mandatory requirements.
4.2.1 Drug product information shall be placed in standard locations on the label to enhance proper identification and safe administration (see prototype labels in Appendix A). Critical information一common name(s), concentrations, and total amounts一shall be the most prominent features on the main panel of the label. Critical information shall appear in English and French in a single field on the main panel. This field shall not be disrupted by colour or graphics (see Clauses 4.4.6 and 4.5).
4.2.2 The common name(s) of the drug(s) shall be printed immediately below the brand name (if included),shall be legible, and shall be printed in a typeface having a stroke width, weight, character height, and x-height according to the requirements of Clause 4.4. If the size of the label does not permit this, the brand name shall be reduced in size or eliminated.
4.5.1 The use of colours or trade dress is acceptable on labels, providing they do not intrude upon the critical information field or distract from the legibility of critical information (see Clauses 4.2.1 and 4.4.6).
Note: While colour and graphics can be used to facilitate differentiation among the formulations of the same drug product,the best use of colour and graphics is to supplement legible label information. Black lettering on a white field is the most legible form of communication under daylight conditions.CSA Z264.2-99 pdf download.