Satisfying the recently updated U.S. Pharmacopeial Convention (USP) 797 and 800 regulations can be a daunting task for healthcare facilities. In fact, at a recent New England Healthcare Engineers’ Society Conference, only five health facility reps were confident that their pharmacies met current and upcoming standards. To help ease the apparent apprehension, we are shedding some light on the situation.
What are USP 797 and USP 800?
Federally enforced, USP 797 is a nationally recognized standard for pharmacies created by the U.S. Pharmacopeial Convention, a scientific, non-profit organization overseen by the FDA. These guidelines mandate spacing, procedures, infrastructure, air control, material, and equipment in all hospital pharmacies to ensure protocol-safe drug preparation. USP 800 is the upcoming set of standards that will work in tandem with USP 797, to specifically address handling of hazardous drugs, and has an official compliance deadline of December 1, 2019. This date is set to align with the next revision of USP 797.
The question many facilities are faced with is the cost at which this compliance will come, especially one that requires significant investment without being profitable. In most cases, the capital investment is not correlated to an increased demand. It is simply required to meet regulations—spending capital without a return.