PHARMACY DESIGN
COMPLIANCE WITH U.S. PHARMACOPEIA (USP) 797
A. ISSUES:
1. JCAHO has announced its intent to begin surveying healthcare facilities for
compliance with the provision of USP Chapter 797 <797> on compounded
sterile preparations entitled "Pharmaceutical Compounding, Sterile
Preparations". USP <797> is considered to be an official minimum standard
for pharmacy sterile compounding and it is therefore enforceable by the Food
and Drug Administration (FDA), state boards of pharmacy and other
regulatory agencies. As such USP <797> is an enforceable requirement that
mandates procedures and processes for sterile drug compounding (mixing)
of pharmaceuticals in a clean room environment. USP <797> specifies
International Organization for Standardization (ISO) for acceptable clean
room airborne particulate concentrations and assessment procedures.
2. NIOSH has jurisdiction over the standards for drugs requiring separate
preparation areas for personnel safety.
B. BACKGROUND:
USP is an independent organization that establishes standards for drugs and drug
preparations. JCAHO has adopted USP <797> for its inspection of sterile
compounding area in healthcare facilities. This will have a significant impact on the
design of pharmacy clean rooms and perhaps other spaces as well. According to
JCAHO, timelines, the USP <797> standards for environmental design for drug
preparation clean rooms must be fully implemented and certified by January 1,
2008. VA's Pharmacy Benefits Management SHG (PBM SHG) at VACO has formed
a USP 797 Work Group to assist VHA facilities plan for implementation of the USP
<797> provisions and to meet JCAHO requirements.
Most VA pharmacies that prepare sterile compounding of pharmaceuticals also
prepare hazardous drugs. The hazardous drugs should also be produced as sterile.
Therefore, it is important to address requirements for these two separate areas in a
pharmacy.
The purpose of this design alert; however is to discuss various options to deal with
issues related to physical infrastructure such as mechanical and architectural items
related to both sterile compounding and hazardous drugs.
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