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Originally posted on April 05, 2018

Updated August 2, 2021 

While the COVID-19 pandemic has contributed to medication shortages, the FDA acknowledges that drug shortages can occur almost any time, due to factors such as manufacturing delays, quality issues, or discontinuations. In fact, the FDA now offers a Drug Shortages Mobile App to receive notifications within selected therapeutic categories.

As a result of pandemic-related shortages, some hospitals and health systems have opted to establish a combination of in-house and outsourced unit-dose drug repackaging to ensure supply availability and to keep costs in check. Regardless of which approach a facility chooses, cross-contamination remains a vitally important consideration for every hospital's unit-dose repackaging strategy.

For many hospitals, in-house repackaging often seems like the most cost-effective way to package drugs into unit-dose. Unfortunately, with limited resources, hospital pharmacies don’t always have the time needed to focus on packaging. To offset staff time spent on packaging, many pharmacies purchase whatever is available in commercial unit-dose. Unfortunately, many of those unit-dose purchases have a significant cost premium versus bulk bottles.

The National Institute for Occupational Safety and Health (NIOSH) developed USP General Chapter <800> to better protect all workers, patients and general public who may potentially come in contact with hazardous drugs. Many hospitals are keeping this top of mind as they try to understand how these requirements impact their pharmacy operations. If your hospital pharmacy currently repackages hazardous drugs in-house, you may need to implement new steps and process changes to be compliant with USP <800> (official December 2019).