USP Chapter <800> Terminology

By | June 22, 2016

USP <800> Hazardous Drugs – Handling In Healthcare Settings introduces not only new rules around hazardous drug compounding, but some new terminology/vocabulary as well. Most of the terminology doesn’t address unique items, but rather how items are described when handling hazardous drugs (HDs).

USP Chapter <800> refers to “containment” primary and secondary engineering controls (C-PECs and C-SECs). Think of C-PECs and C-SECs as the USP Chapter <800> equivalent of PECs and SECs found in USP Chapter <797>.

C-PECs are commonly referred to as “hoods” and C-SECs are synonymous with “buffer area” or “buffer room”. Simply put, C-SECs are the rooms where C-PECs must be placed to perform sterile HD compounding.

USP Chapter <800> introduces the concept of a containment segregated compounding are (C-SCA), which is an area where limitations are placed on compounding, such as what type of HD compounding may take place as well as maximum BUDs allowed.

As USP Chapter <800> covers nonsterile HD compounding as well as sterile compounding, most of you may not be familiar with the concept of a Containment Ventilated Enclosure (CVE).

When discussing USP Chapter <800> it’s important that we’re all on the same page. Sometimes new terminology can create confusion, so I recommend you educate yourself sooner rather than later.

Summary
C-PEC (Containment Primary Engineering Control) – A ventilated device designed and operated to minimize worker and environmental exposure to HDs by controlling emissions of airborne contaminants

C-SEC (Containment Secondary Engineering Control) – The C-SEC is the room in which the C-PEC is placed. It incorporates specific design and operational parameters required to contain the potential hazard within the compounding room, e.g., restricted access, barriers, special construction technique, ventilation, and room pressurization are components of the secondary control strategy

C-SCA (Containment Segregated Compounding Area) – A type of C-SEC with nominal airflow and room pressurization requirements related to HD compounding. HD compounding in the C-SA is limited for use with a BSC when preparing low- or medium-risk level CSPs with 12-hour or less BUDs, preparing CSPs in a CACI that meets <797> requirements, or preparing non-sterile HDs in a C-PEC.

CVE (Containment Ventilated Enclosure) – A full of partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants (through HEPA filtration) and prevent their release into the work environment.

Containment Supplemental Engineering Control – Containment Supplemental Engineering Control basically refers to  closed system drug-transfer devices (CSTDs*) and provide adjunct controls to offer an additional level of protection during compounding or administration.

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*A closed system drug-transfer device (CSTD) is a device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. There’s still quite a bit of controversy around the definition of these devices.

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