Improve Sterility Assurance And Data Integrity In A 503B Compounding Pharmacy

By Sheila Dell, Automated Systems of Tacoma

Over the last 20 years, there have been more than 1,500 adverse events, including at least 116 deaths, from errors or potential errors made at compounding pharmacies in the United States. As concerning as these numbers are, they are likely just a portion of the total, as only about 30 percent of states require sterile compounding pharmacies to report these events.¹ Many consider the 2012 fungal meningitis outbreak a tipping point for quality oversight at compounding pharmacies, when over 100 patients died and nearly 800 were sickened by tainted steroid injections from the New England Compounding Center (NECC).²

The NECC tragedy not only brought nationwide attention to sterility assurance in compounding pharmacies, but it also initiated a greater focus by the FDA on ensuring drugs made in these facilities meet appropriate quality standards. In addition, sterility issues have caught the attention of hospitals and clinics that outsource to 503B compounding pharmacies, as they need to ensure they are working with partners who can maintain the safety and health of their patients.

One of the most effective ways to prevent contamination is by adopting automated technologies and robotics to reduce errors, drive productivity, and increase efficiency. Given the challenges 503B compounding pharmacies face in ensuring quality oversight, implementing these solutions could overcome issues with sterility, ultimately gaining the trust of the regulators as well as the hospitals and clinics they serve.