Abstract

Performing a United States Pharmacopeia Chapter <800> Compliant Assessment of Risk

Author(s): Cabaleiro Joe

Issue: Jan/Feb 2020 - Volume 24, Number 1

Page(s): 21-27

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Abstract

United States Pharmacopeia Chapter <800>, which became effective on December 1, 2019, addresses handling of hazardous drugs in facilities that make compounded preparations. The Chapter includes minimum facility, engineering controls, personal protective equipment, and other requirements under which all hazardous drugs must be handled. For certain hazardous drugs, an assessment of risk may be performed to determine alternative containment strategies or work practices. This article addresses the legal enforceability of Unites States Pharmacopeia Chapter <800>, how to determine whether a drug is eligible for an assessment of risk, and details important considerations when performing assessments of risk.

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