US Pharmacopeia (USP<800>, USP<797>)

The United States Pharmacopeia (USP) is a non-profit organization that publishes an annual collection of drug information.

US Pharmacopeia (USP<800>)

The USP’s mission is to “improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.”

USP<800> was published on February 1, 2016 in the First Supplement to USP 39–NF 34. The Expert Committee approved a delayed official implementation date of December 1, 2019 to allow entities additional time to implement the standard.

The chapter describes practice and quality standards for handling hazardous drugs to promote patient safety, worker safety and environmental protection. Handling hazardous drugs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration and disposal of sterile and non-sterile products and preparations.

    US Pharmacopeia (USP<797>)

    Understanding the risks inherent in sterile compounding and incorporating established standards are essential for patient safety. Compounded drugs made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death.

    USP develops standards for preparing compounded sterile drugs to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing.

    USP General Chapter <797> describes a number of requirements, including responsibilities of compounding personnel, training, facilities, environmental monitoring, and storage and testing of finished preparations.

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