[10/13/2020] The U.S. Food and Drug Administration is clarifying the intent of the November 2019 revisions to labeling for insulin pens, which state that health care professionals should dispense the pens to a single patient in the original sealed carton.

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

In November 2019, FDA approved revisions to the labeling for insulin pens to emphasize the agency’s recommendation for dispensing insulin pens to a single patient in their original sealed carton.

Insulin pens are approved to be dispensed in their original sealed cartons. Although FDA approved the first