CAN/CSA-Z264.2-99 (R2014)
1. Scope
1.1
This Standard 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.
SDO:
CSA
Language:
English
ICS Codes:
11.040.01;
11.040.20
Status:
Withdrawn
Publish date:
1999-01-30
Standard Number:
CAN/CSA-Z264.2-99 (R2014)