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Ongoing compliance with USP 797

Accreditation Connection, September 12, 2005

The move to compliance with USP 797 is an ongoing process for many hospitals.

"The standard can create problems not only from an organizational standpoint, but also from a financial one," says Ken Baker, executive director of the Pharmacy Compounding Accreditation Board, an accreditation standards group. Hospitals need to assess their pharmacy conditions and then live up USP 797's provisions, he says.

"And to make things more difficult, 797 says such and such needs to happen but doesn't say how to do it," he adds.

"The thing to remember is to work toward the standard with the goal of protecting the patient at all times."

With that in mind, safety officers will need to examine the preparation facility requirements of USP 797 to determine how they affect any EC renovations to the pharmacy's cleanroom, as well as gowning and equipment changes. Hospitals may need to include a laminar-airflow workbench (LAFW)/biological safety cabinet certified to ISO Class 5 for airborne particles. These ISO criteria refer to the International Organizations for Standardization's rules for particle counts.

These items must be located within an ISO Class 8 environment. An approved alternative is the barrier isolator certified to ISO Class 5 that may be used outside an ISO Class 8 environment.

Adapted from the September issue of Briefings on Hospital Safety.

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