With the release this month of USP <800> Hazardous Drugs—Handling in Healthcare Settings, most pharmacy directors are likely curious as to what the chapter’s impact will be from multiple standpoints. Among these are concerns related to the use and certification of primary engineering controls (PECs). In addition, there is some confusion about the effects USP <800> will have in light of established USP <797> Pharmaceutical Compounding—Sterile Preparations recommendations and requirements. These are certainly relevant and important considerations for hospital pharmacy operations.
The Scope of USP <800>
Whereas USP <797> focused on the environmental conditions for hazardous and non-hazardous sterile compounding, the new USP <800> chapter takes a broader view of handling and processing hazardous drugs (HDs). Specifically, it addresses the storing and handling of HDs prior to, during, and post-compounding for both sterile and non-sterile HD products. Among the more specific changes outlined in the new chapter is the need for designated storage areas that meet the 12 air changes per hour (ACPH) requirement (see SIDEBAR 1).
For those pharmacies that are not yet fully compliant with USP <797>, there are certain initiatives that should be prioritized in order to be in line with the new USP <800> requirements. Pharmacies moving into USP <797> compliance need to ensure the spaces or rooms utilized for HD compounding are designed and engineered to meet ISO class 7 environment requirements. This requires storage rooms with 12 ACPH and anterooms and sterile compounding areas with 30 ACPH, all running a HEPA-filtered air supply, and with 0.01 and 0.03 inches of water column negative pressure, respectively. It is important to note that negative pressure cleanrooms and positive pressure cleanrooms can share a single anteroom, provided they are carefully engineered to meet all air pressures and air change requirements for ISO-7 class environments.
Primary Engineering Control Certification
As USP <800> comes to be integrated into hospital pharmacies, the companies and individuals charged with inspecting and certifying primary engineering controls (PECs) will adapt their processes to account for the new USP guidance. To begin with, the inspection process will be extended beyond the sterile compounding area to include testing and performance verification of HD storage environments.
The certifiers likely will employ the same techniques and air flow measurement instrumentation used to certify sterile compounding environments, so the chapter is not expected to have an appreciable impact on individual certifier qualifications. However, certifiers will have more areas to review and the process will take a little longer. Among the storage requirements that certainly should be checked is the separation and segregation of stored HDs from non-HDs, which is an additional USP <800> mandate.
Managing PECs Within the USP <800> Framework
It is important to keep in mind that the rules regarding containment primary engineering controls (C-PECs) or biological safety cabinets (BSCs) have not deviated from those listed in USP <797> for sterile compounding. However, USP <800> does provide additional, specific language addressing the environmental performance requirements for the placement of C-PECs for non-sterile compounding. The net result is the previous latitude allowed for low-volume HD compounding in a BSC within a non-compliant environment is being eliminated. However, in the new allowance, a containment segregated compounding area (C-SCA)—a separate, negative pressure room with at least 12 ACPH—can house a BSC or compounding aseptic containment isolator (CACI) provided the beyond-use date of the CSP produced does not exceed 12 hours.
The driving emphasis of USP <800> addresses the total process of handling and storing HDs, and seeks to create a safer environment for pharmacy technicians (and by extension, all staff and patients) while ensuring the quality of the drugs being handled. Under the new chapter, the use of BSCs with integrated glove box transfer compartments do remain viable, as these devices are known to enable overall aseptic technique. However, the glove box feature is not required when the unit is placed within a fully compliant ISO-7 class environment as this feature is rendered redundant and the gloves can be cumbersome. Lastly, there is not expected to be an appreciable change to environmental monitoring practices based on USP <800>. Most noticeably, the practice will extend to include HD storage accommodations. For more information on facility requirements in light of both USP <797> and <800>, see SIDEBAR 2.
As with the previous USP General Chapters that focus on sterile and non-sterile compounding, the first step is to actually read the document. If questions arise during reading, make notes to discuss with your certifier. I have found certifiers to be wonderful resources for providing suggestions regarding improved placement of C-PECs and BSCs to provide maximum performance within an ISO space. While certifiers are not likely to provide cleanroom design and engineering services, it is important to maintain an open dialogue on all issues related to safe medication compounding.
Karl M. Kilgore, president of Denver-based CPI Group, has more than 40 years’ experience as a health care architect and nationwide design consultant. He is a licensed architect with LEED-AP, EDAC and NCARB registrations and current licenses in Arizona, California, Colorado, North Dakota, South Dakota, Wyoming, and Texas.
As of February 1, 2016, USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings is available via the USP website. The USP Compounding Compendium is available at: www.usp.org/store/products-services/usp-compounding-compendium
Hazardous Drug Storage
Under the Facilities section of USP <800>, section 5.2 addresses proper storage conditions for HDs as thus:
Antineoplastic HDs requiring manipulation other than counting or repackaging of final dosage forms and any HD API must be stored separately from non-HDs in a manner that prevents contamination and personnel exposure. These HDs must be stored in an externally ventilated, negative-pressure room with at least 12 air changes per hour (ACPH). Non-antineoplastic, reproductive risk only, and final dosage forms of antineoplastic HDs may be stored with other inventory if permitted by entity policy. Sterile and nonsterile HDs may be stored together, but HDs used for nonsterile compounding should not be stored in areas designated for sterile compounding to minimize traffic into the sterile compounding area.
Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH [eg, storage room, buffer room, or containment segregated compounding area (C-SCA)]. If a refrigerator is placed in a negative pressure buffer room, an exhaust located adjacent to the refrigerator’s compressor and behind the refrigerator should be considered.
Facility Requirements: USP <797> and <800>
Facility requirements that differ between USP <797> Pharmaceutical
Compounding—Sterile Preparations and USP <800> Hazardous Drugs—Handling in Healthcare Settings will be harmonized through an upcoming revision of <797>, which will include the following:
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