The meeting included four different panel discussions:
Container label and carton labeling design as they relate to
reducing the risk of medication errors.
Study design, conduct and interpretation of human factors
analysis, Failure Mode and Effects Analysis (FMEA), usability
studies, and other studies specifically focused on evaluating the
safety of container label and carton labeling designs to reduce
the risk of medication errors.
Manufacturers’ packaging used for medications as they relate
to the safe use of the medicine from a medication errors
Developing proprietary names as they relate to reducing
By the end of fiscal year (FY) 2010, the FDA will publish draft
guidance on best practices for naming, labeling and packaging
drugs and biologics to reduce medication errors. Final guidance
will be published by the end of FY 2011. In addition, by the end
of FY 2012, the FDA will publish the draft guidance on
proprietary name evaluation best practices, with final guidance
to follow as soon as feasible.