USP 800 Cleanroom

What is USP 800?
General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.
What is the purpose of this chapter?
The purpose of the chapter is to describe practice and quality standards for handling hazardous drugs in healthcare settings and help promote patient safety, worker safety, and environmental protection. The chapter defines processes intended to minimize the exposure to hazardous drugs in healthcare settings. The chapter was developed by the USP Compounding Expert Committee with the assistance of the USP Compounding with Hazardous Drugs Expert Panel and government liaisons from the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) including NIOSH. The chapter was published for the first time for public comment in March 2014. Based on the public comments received, the chapter was revised and proposed for another round of public comments in December 2014. The chapter was revised again and published in the USP-NF in February 2016.
To Whom does it apply too?
Chapter <800> was written to protect all workers, patients and the general public who may be accessing facilities where hazardous drugs (HDs) are prepared. This includes but is not limited to pharmacists, technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians. If any workers come in contact with HDs, they must receive HD training, and be assessed for an understanding of the training. All personnel who handle HDs are responsible for understanding the fundamental practices and precautions and for continually evaluating these procedures and the quality of final HDs to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and patient-care environment.


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