Labelling of Drug Ampoules, Vials and Prefilled Syringes
This is the first edition of CSA Standard 2264.2, Labelling of Drug Ampoules, Vials, and Prefilled Syringes. This Standard has been developed based on the Guidelines for Drug Packaging and Labelling for Manufacturers developed by the Canadian Society of Hospital Pharmacists (CSHP). This Standard is written in SI (metric) units.
Patient safety with respect to drug administration is a major concern for everyone involved in the delivery of health care. Accurate selection of the correct drug product is necessary for safe drug administration. Label design can enhance the legibility of a label and increase product recognition, hereby supporting the goal of safe drug administration.
This Standard was developed by the Subcommittee on Labelling and Packaging of Drug Ampoules and Vials under the jurisdiction of the Technical Committee on Drug-Related Standards and the Strategic Steering Committee on Health Care Technology, and was formally approved by the Technical Committee. it will be submitted to the Standards Council of Canada for approval as a National Standard of Canada.
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.
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.
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.