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USP 800 Guidelines

Pharmacies and other healthcare facilities must keep their personnel safe from dangers posed by hazardous drugs. Potential exposure to more than 200 hazardous drugs used commonly in healthcare settings can lead to chronic and acutely negative health effects. The National Institute for Occupational Safety and Health (NIOSH) establishes criteria and classifies hazardous drugs, while the United States Pharmacopeia (USP) has developed standards for the handling of hazardous drugs, in order to minimize public health risks. One of these standards is USP 800, which provides criteria for the safe handling of hazardous drugs for the protection of patients, healthcare workers, and the environment.

Our LicenseTrak compliance software helps you keep your pharmacy operations compliant with all current USP 800 and other USP regulations. We help you meet the requirements of a USP 800 compliance checklist.

USP 800 Regulations and Guidelines

The USP 800 guidelines detail the requirements and duties of medical personnel handling hazardous drugs. The aspects covered include engineering and facility controls, deactivating procedures, spill control, decontamination and cleaning, and documentation. The standards under USP 800 are applicable to all healthcare workers who receive, prepare, transport, administer, or in any other way make contact with hazardous drugs and every setting in which these drugs are handled.

The NIOSH designates a drug as hazardous if it produces at least one of the following characteristics in humans or animals: organ toxicity at low dosage, developmental or teratogenicity toxicity, genotoxicity, reproductive toxicity, carcinogenicity, or toxicity and structure profiles of new drugs that imitate existing hazardous drugs.

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For more information about how our LicenseTrak software can keep you compliant with all applicable USP 800 standards, call us today at 480-500-6236 or complete our contact form.