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Demystifying pharmacy regulations

Tuesday, 11 October 2016

Demystifying pharmacy regulations USP 797 USP 800 Bridgeport Hospital Pharmacy Renovation
Satisfying the recently updated U.S. Pharmacopeial Compounding Compendium Convention regulations – more frequently known as USP 797 – can be a daunting task for healthcare facilities. At the New England Healthcare Engineers’ Society Annual Fall Conference, one of our architects noted that out of the dozens health facility representatives present at the USP 797/800 lecture, only a handful were confident that their pharmacies met upcoming USP 800 standards. After witnessing all of the apprehension, we decided to shed 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 join USP 797 and features new protocols and requirements aimed at compounding hazardous drugs. More stringent than any other regulation, it comes with an official compliance deadline of July 1, 2018.

How can my pharmacy meet the requirements with minimal disruption?
The experts at Shepley Bulfinch point out that 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,” says Katie Westrick, the project manager who has worked on numerous Yale New Haven Health System (YNHH) hospital projects. She notes that, while some changes may be operational, the updates most hospitals need to prepare for are mechanical infrastructure upgrades, which can be quite costly and challenging to implement depending on the department location.

Based on our experience retrofitting and constructing new pharmacies to meet USP 797 and USP 800 in the state of Connecticut, we noted a few broad guidelines that would be useful for all facilities working towards upgrading their pharmacies.

What should my facility consider first?
Building a new pharmacy to meet USP 800 may be easier than retrofitting an existing one in place. Too often, the floorplan is restricted and adding new space – a requirement intended to improve staff workflow and safety – isn’t feasible without making significant architectural modifications. Other changes include HVAC infrastructure upgrades, including air control and monitoring, and interior finish improvements. In Shepley Bulfinch’s experience, something as minor as a humidifier addition required 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 meeting your unique 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? Does the pharmacy have to stay open throughout construction? Understanding how your project will be undertaken will yield a more accurate budget and project duration estimate to help you prepare. With YNHH, Shepley Bulfinch worked with the construction manager to establish an approach that aligned with the operational, budgetary, and schedule-based needs of our client by addressing the challenges early.

While upgrading your pharmacy to meet USP 800 regulations can evolve into a large undertaking, an early start and a comprehensive plan will alleviate many disruptions. In the meantime, a good way to get ahead is to understand what needs to be done at your specific facility to determine your best course of action.


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