FDA clarifies revisions to labeling regulations on insulin pens

NCPA October 16, 2020

On Oct. 13, the FDA released information to clarify the intent of the earlier revisions to labeling requirements for insulin pens, which stated that health care professionals should dispense pens to a single patient in the original sealed carton. While the FDA still advocates for the adoption of this standard as well as encouraging manufacturers to produce pens in smaller carton sizes to better control administration of the pens, the agency publicly recognizes situations where a practitioner would dispense pens to patients outside of the original carton. In these situations, the agency encourages those health care professionals to weigh the risks associated and take appropriate safety measures to mitigate risks. However, the FDA is not pursuing further action as this time but will continue to monitor the situation and may take additional steps in the future. The NCPA Long-Term Care Division has been actively advocating for more flexibility for dispensing pens for LTC patients since the FDA released these revisions in November./p>