USP 800: Compliance and Opportunity for Pharmacies

USP 800 impacts not only the day-to-day operations of our nation’s pharmacies, but the physical space in which they do their life-saving work. While the newest standard is comprehensive, Patricia C. Kienle, RPh, MPA, FASHP, told Ready for 800 it comes down to a simple goal. “It’s all about personal protective equipment, engineering controls and work practices we need to change to protect the healthcare worker,” she said.

As your team defines the best way to comply with USP 800, we would like to share what we’ve learned designing other pharmacies faced with this same task. While complying with new regulations can seem arduous, in our experience, USP 800 is providing pharmacies with an opportunity to make desirable upgrades.

Key Factors in the Renovate vs Build Decision

Pharmacies will need to decide how to meet USP 800 standards. Is it better to renovate or build new? Here are three key factors to consider as you make your decision:

Square Footage

The USP 800 dictates non-hazardous drugs and hazardous drugs (HDs) must not be unpacked, stored or compounded in the same room (ASHE). In addition, the HD compounding room must be separated from work areas by an anteroom. This means pharmacies will need to find or build additional space.

Think about your current space. Do you have enough soft space in your current location to accommodate separate rooms for HD and non-HD unboxing, storage, and prep? If not, can you physically expand or are you landlocked? Or, if you have a smaller facility, is it more economical to outsource HD compounding altogether?

The Condition/Capacity of Existing Systems

The USP 800 requires rooms where HDs will be stored and compounded to have a neutral or negative air pressure. It is best practice to design HD unpacking areas to be negative as well.

USP 800’s strict requirements make it risky to assume your existing systems are compliant (ASHE). We recommend having your HVAC and electrical systems inspected to identify deficiencies and associated upgrade costs (ASHE).

Keeping the Pharmacy Open

Keeping the pharmacy open during construction is another key factor, especially as COVID-19 continues to be a concern. You should ask whether or not a temporary pharmacy trailer is feasible or if you can continue operating during a phased renovation. A licensed healthcare architect can help you answer those questions.

Design Recommendations

As you get into the nitty gritty of what your pharmacy project is going to look like, we have some recommendations for saving space, saving money, and integrating efficiency upgrades into your new design.

Space Efficiencies

To save space, we recommend combining multiple functions into a single room. For example, HD buffer and non-HD buffer rooms can share an anteroom (ASHE). Or you could also elect to unpack HDs in the dedicated storage room.

Depending on your levels of HD compounding, a whole room may not be necessary. For some low- and medium-risk preparations, compounding could occur in a containment segregated compounding area (C-SCA). This arrangement doesn’t require an adjacent anteroom (HCD Mag).

If you have the space to move staff around, existing offices can be converted into a negatively pressurized HD space, without the need to build.

Value Opportunities

If your pharmacy needs HD spaces as described by USP 800, some modifications are cheaper than others. For instance, you can keep existing wooden doors if you coat them with epoxy paint. If you can keep walls right where they are, cover them with non-porous materials. These simpler upgrades are compliant, safe and easier to clean. (ASHE)

You might also reconsider the source of your budget. Integrating the pharmacy into your facilities master plan might help you reallocate existing funds. Or follow in the steps of one REES client who supplemented their pharmacy budget with CARES Act funds.

Efficiency Upgrades

This is the perfect time to also to improve day-to-day operations. Consider communication upgrades like phones, intercoms and call systems. Design for better flow and collaboration with large windows between workspaces and minimizing travel paths. Or make the changes easier on staff by integrating a building monitoring system or creating a staff break room.

It’s also a great idea to think long-term. Choose durable, easy-to-clean materials and furniture. Plan for the unexpected with amenities like a second exhaust hood to serve as backup for the primary hood.

Your Next Step

USP 800 is all about protecting healthcare workers and patients who come into contact with hazardous drugs. However, it’s also an opportunity to incorporate needed upgrades. If you’d like to discuss how to implement USP 800 in your facility, or how to use this opportunity to add efficiency measures to your building, contact REES for a free initial consultation.