Examples of C-PECs include biosafety cabinets (BSCs), compounding aseptic isolators (CAIs), and compounding aseptic containment isolators (CACIs). Unlike laminar airflow workbenches (LAFWs) that simply facilitate product protection, containment primary engineering controls (C-PECs) are ventilated devices designed and operated to minimize worker and environmental exposure to hazardous drugs by controlling emissions of airborne contaminants. The buffer room in which the PEC is placed is considered the secondary engineering control (SEC). FIRST LET’S REVIEW SOME USP 800 TERMINOLOGYĬreating and controlling the environment for pharmaceutical compounding is typically performed through the use of primary engineering controls (PECs) - usually laminar airflow workbenches, biological safety cabinets, and compounding aseptic isolators. This in turn will determine the number of receiving/unpacking rooms, storage rooms, buffer rooms, and anterooms that it needs. The facility requirements for USP 800 are particularly confusing because a pharmacy may have separate workflows (and spaces) for compounding nonsterile hazardous drugs, sterile hazardous drugs, and sterile non-hazardous drugs depending on the drugs that it handles and type of compounding it performs. USP 800 refers to the room where sterile compounding or mixing occurs as a buffer room or clean room and these rooms also require an anteroom for activities such as handwashing, gowning, and various staging activities. Additionally, the compounding of sterile and nonsterile hazardous drugs needs to occur in separate rooms. Also, the compounding of hazardous drugs must be performed in a room with negative pressure and external ventilation which is separate from where non-hazardous drugs are compounded. Moreover, hazardous drugs must be stored separately from all non-hazardous drugs in an externally-ventilated room with negative pressure. Hazardous drugs must be unpacked in a dedicated room with either neutral/normal or negative air pressure to prevent the spread of hazardous drugs from packaging material. OVERVIEWĪ key requirement of USP 800 is the separation of hazardous and non-hazardous drug spaces - for drug receiving/unpacking, storage, and compounding. Facilities previously designed to comply with both USP 795 and USP 797 will also need to comply with USP 800. Although both USP 797 and 795 focused on preventing harm to patients, they lacked standards that specifically protected the personnel who are exposed daily to hazardous drugs and the environment in which they are being handled. USP 800 expands upon the previously published chapters USP 797 (Pharmaceutical Compounding Sterile Preparations) and USP 795 (Pharmaceutical Compounding Nonsterile Preparations) by differentiating between the handling procedures and facilities for hazardous and non-hazardous drugs, both sterile and nonsterile. Effective December 1, 2019, most pharmacies need to comply with USP 800. Hazardous drugs include those used for cancer chemotherapy, antiviral drugs, hormones, and some bioengineered drugs. Chapter 800, titled “Hazardous Drugs - Handling in Healthcare Settings,” applies to all healthcare personnel who handle hazardous drug preparations and all entities that store, prepare, transport, or administer hazardous drugs, such as pharmacies, hospitals, clinics, and physician offices. As a result, the United States Pharmacopeia (USP) - a nonprofit compendium of drug information - published the nation’s first standards on the handling of hazardous drugs from receipt to disposal. Research studies over the past several decades have indicated the possible harmful effects on healthcare workers from low-level work-related exposure to any of more than 200 medications that are considered hazardous drugs.
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