In pursuit of USP <800> compliance, a strong focus on facility design is paying dividends across facilities of all sizes. Many of the key facility requirements in USP <800> have been achieved by 90% or more of US hospitals and health systems, from venting CPECs externally to incorporating constant pressure monitoring in the cleanroom. Other requirements are approaching the 90% compliance mark, including appropriately segregated HD storage with dedicated refrigerators. These steps are not only requirements under USP <800>—they are also best practices. As such, every effort should be made to implement the facility requirements immediately; waiting for the chapter to become official will simply be too late.
When USP <800> was first introduced, the unpacking site for HDs was often an afterthought. That is no longer the case as the number of facilities unpacking in positive pressure has dropped by half, while those utilizing a negative-pressure area for HD unpacking has doubled.
The commitment to separating and segregating HDs from non-HDs in storage continues to grow. This practice is expected to pass the 90% mark once USP <800> becomes official.
Even through the challenges of the pandemic, an increasing number of facilities have purchased dedicated refrigerators for Group 1 drug storage. Per USP <800>, these refrigerators are to be located in a negative-pressure area with at least 12 ACPH, typically either a storage room, a C-SCA, or the buffer room itself.
The number of facilities that have designated their HD compounding areas as authorized access only and utilize a continually monitored pressure indicator in the HD cleanroom has passed the 90% mark.
Rare is the facility that continues to permit delivery of liquid or antineoplastic HDs to the units via pneumatic tubes.