USA – FDA issues clarification on insulin pen distribution

The FDA clarified the intent of November 2019 revisions to labeling for insulin pens that state that health care professionals should dispense the pens to a single patient in the original sealed carton.

There is an increased risk for dispensing errors and patients using the wrong product if individual insulin pens are stored or dispensed outside of their carton, according to the FDA notice. Insulin pens dispensed individually outside of their cartons may have contributed to medication errors, including wrong-drug and wrong-dose errors resulting in hyperglycemia or hypoglycemia, missed doses, complaints of possible tampering, and dispensing without the instructions for use…