Labelling of Drug Ampoules, Vials and Prefilled Syringes

1.1 This Standard defines minimum design requirements for the presentation of critical information on inner labels for p arenteral 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.