Demystifying pharmacy regulations

by Carole Wedge

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.

How can my pharmacy meet the requirements with minimal disruption?

The key to successfully updating your facility is getting a head start on evaluating the scope of work. Every hospital will be met with its own unique situation, and while some changes may be cosmetic or operational, the ones most hospitals need to prepare for are engineered and complex.

Based on our experience retrofitting and constructing new pharmacies to meet USP 797 and USP 800, Shepley Bulfinch has been able to help clients create a set standard to be applied to all pharmacies across a larger healthcare system—noting a few broad guidelines that are useful for all facilities working towards pharmacy upgrades.

  • What should my facility consider first? Building a new pharmacy to meet USP 800 is easier than retro-fitting an existing one. Too often, the floorplan is restricted and adding new space—a requirement intended to limit foreign contamination agents—isn’t feasible without making significant structural modifications. Other changes include HVAC upgrades, air control, and infrastructure adjustments. Something a minor as a humidifier addition can require significant structural alternations to accommodate space along existing duct work. One of the best ways to be prepared for these upgrades is to work closely with architecture and engineering companies that have experience with USP compliance. Their breadth of experience can optimize the planning process by making it unique to specific institutional needs.
  • How should my facility plan operations? Another significant portion of your planning should cover phasing and timeline. Will it be possible to shut the facility down? Or, does the pharmacy have to stay open throughout construction? Understanding how your project will be carried out will yield an accurate budget and project duration to help you prepare and address challenges early in the process.

In short, while upgrading your pharmacy to meet USP 800 regulations can mature into a large undertaking, an early start and a comprehensive plan will alleviate many disruptions. Getting ahead is all about getting a baseline understanding of what needs to be done in order to determine the most optimal place of action for your facility.

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