USP 800: Storage and Unpacking of Hazardous Drugs
Upgrading a USP <797> Cleanroom for USP <800> Compliance?
USP 800 Storage of Hazardous Drugs
Some USP 795 and 797 facilities store both hazardous and non-hazardous products in a shared positive pressure environment. USP 800 dictates a clear separation for the storage of non-hazardous and hazardous drugs. Only sterile HDs may be stored within a sterile compounding area. HDs cannot be stored on the floor.
Facilities unpacking hazardous drugs within a negative or neutral pressure room do not require infrastructure changes to meet USP 800 unpacking area requirements. Facilities unpacking hazardous drugs (HDs) within positive pressure ante rooms or facility spaces will require reconsideration.
USP 800 Air Change Rates Per Hour (ACH)
HD storage requires negative or neutral pressure, external ventilation and a minimum of 12 ACH (air changes per hour). The air change rate of an HD storage room or isolator should not be confused with the air change rate of primary engineering control.
Final Unit Dose Storage and Labeling
An exception is made for HDs stored alongside non-HDs when the HD is within its final unit dose or unit-of-dose packaging and appropriately labeled.
Drug Inventory and Unpacking
Drug inventory, receiving, or unpacking rooms for USP 800 require negative or neutral pressure storage. Storage containment should be considered so that any spills, falls, or breaks remain locally isolated. Separate storage for sterile and nonsterile drugs is not mandated, but nonsterile HDs cannot be stored in a sterile compounding area.
Storage and Compounding Exemptions
USP 800 does not allow storage, unpackaging, or manipulation of HDs in positive pressure areas, nor does it allow the USP 797 exemption for low volumes of HD compounding in a non-negative pressure room.
Which Facilities Will Be Most Affected By USP 800 Storage Needs?
Facilities that previously stored or unpacked HDs in a positive pressure environments require a reevaluation of current storage conditions. Storage conditions and square footage are paramount. Converting or constructing separate spaces that meet hazardous drug storage requirements is common. Increasing storage density is a less intrusive option if feasible.
“Stick-built” cleanrooms that process sterile and non-sterile hazardous drugs face the most adverse USP 800 compliance changes. Continued operation while undergoing on-site construction is challenging. Construction is likely to impede daily compounding activities without moving off-site, constructing a temporary facility, or outsourcing operations. Square footage and inadequate air systems inherit the majority of costly renovations. Speaking with a cleanroom engineer about how a modular system alleviates these construction barriers is beneficial for most facilities.