Evaluating Pharmacy Environmental Compliance with USP <797>

Revised January 4, 2008 by Mark Schweder, CIH, MSPH.

USP <797> and JCAHO

The March 2006 issue of the JCAHO publication 'Perspectives' states that "JCAHO will not survey for compliance with USP <797>". This is a significant shift from 2004, when JCAHO indicated that USP <797> would be a survey requirement.

Instead of formally reviewing compliance with <797>, JCAHO now requires organizations to "evaluate the literature for new technologies and successful practices relevant to improving their medication system" (Medication Management Standard MM.8.10). Clearly, USP <797> is a consensus document that should be evaluated for guidance when planning pharmacy improvements.

Even though JCAHO is not reviewing point by point compliance with <797>, at least 15 states boards of pharmacy have adopted the guideline as a regulation for all or part of the standard (see sidebar). Additionally, the standard is required by the FDA under the Food Safety and Cosmetics Act, although the FDA has not formally detailed their intent to mandate enforcement. Finally, from a risk management perspective, USP <797> is considered an official standard practice and will likely be used as such by lawyers in the event legal action is taken against your facility.

Risk Tech USP <797> Services

* Development of a monitoring plan specific for your pharmacy(s)
* Semi-annual certification that each ISO classified area is within established guidelines (ISO 5, 7, or 8)
* Semi-annual air and surface monitoring and analysis for bacteria and fungi
* Pressure differential verification
* Trending of environmental compliance data over time
* Measurement of pharmacy air exchanges (if necessary)
* Gap analysis and renovation plan review

Additional Information - State Compliance

The most recent revisions (December 2007) complicate compliance issues further, because some pharmacies have recently undergone extensive renovations that may soon be obsolete. The current standard is more specific in regards to environmental compliance. Specific revisions and recommendations to the standard include but are not limited to:
* 30 air exchanges per hour in the clean room (15 of these air changes can come from the safety cabinet)
* HEPA filtered air supplied to clean room environment
* Recommendation for low mounted returns in clean room
* Clean room differential positive pressure of at least +0.02" w.g, with a mounted sensor
* Separate hazardous drug preparation area under negative pressure, with monitored differential pressure of at least 0.01" w.g.
* Implementation of an environmental sampling plan
* Recommendation for environmental surface sampling for hazardous drugs
* Recommendation that storage of hazardous drugs in a separate location, with at least 12 air changes per hour in storage area
* ISO 7 area surrounding the safety cabinet (formerly ISO 8)
* Routine environmental monitoring for airborne fungi and bacteria for medium risk compounding areas (every 6 months)
* Routine glove tip monitoring for bacteria
* Medium risk compounding areas do not require a completely separate anteroom. In this case, there must be a clear line of demarcation between the antearea and clean zone, with air flow from clean to dirty and a recommended minimum velocity of 40 feet/min
* Facilities without a dedicated clean room, can generally use a Compounding Aseptic Isolator (CAI), provided the CAI maintains an ISO 5 environment during material transfer with the door open

Over View

Most recently, Risk Tech successfully completed project management services and oversight of reconstruction of 42 hospitals, medical office buildings, or hospital support buildings in the aftermath of Hurricanes Katrina, Rita, and Wilma.

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