USP 800

USP 800 is a chapter of the United States Pharmacopeia (USP) that provides standards for the safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. The chapter was published on February 1, 2016 and became official on December 1, 2019.

Overview

USP 800 applies to all healthcare personnel who handle hazardous drug preparations and all entities that store, prepare, transport, or administer hazardous drugs, including but not limited to: pharmacies, hospitals, healthcare clinics, and physician's offices. The chapter describes requirements including responsibilities of personnel handling hazardous drugs, facility and engineering controls, procedures for deactivating, decontaminating and cleaning, spill control, and documentation.

Requirements

USP 800 requires that all healthcare personnel who handle hazardous drug preparations must receive proper training. This includes understanding the risks involved in handling these drugs and the use of Personal Protective Equipment (PPE).

Facilities must also have proper engineering controls in place. These include both primary engineering controls (PECs) and secondary engineering controls (SECs). PECs provide a sterile environment for compounding, while SECs provide a controlled environment in which the PEC is placed.

Implementation

Implementing USP 800 can be a complex process, as it requires changes in practice and infrastructure for many healthcare facilities. It is recommended that facilities conduct an Assessment of Risk to identify areas where they may be non-compliant and develop a plan to address these areas.

See also

• United States Pharmacopeia
• Hazardous drugs
• Personal Protective Equipment

References

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