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USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings NIOSH defines criteria and identifies hazardous drugs (HD) USP develops the standards for handling these HDs to minimize the risk to public health. The goals of the USP standards are to help increase awareness, provide uniform guidance to reduce the Ready for <800> SM is an online educational resource from B. Braun Medical Inc., supported by expert insight, experiences, and recommendations, with focus on awareness and education of the new hazardous drug safety standard, USP <800>. development of standard operating procedures, USP and/or state law compliance, and provides onsite training to compounding personnel. She is a member of multiple pharmacy-related organizations and is currently the vice-chair of the APhA Compounding Special Interest Group GENERAL OVERVIEW OF USP GENERAL CHAPTER <800> The USP published General Chapter <800> with a public health motivation to provide a legally enforceable standard to limit occupational exposure to HDs to protect patients, health care personnel, and the environment from the effects of handling HDs. 8 General Chapter <800> addresses handling HDs throughout the entire continuum of receipt, transfer Introduction of USP <800> Proposed USP <800> builds upon Chapters <795> and <797>, with a strong focus on the requirements for receiving, storing, compounding, dispensing, administering, and disposing of HDs. 7 Its purpose is to describe standards to promote patient safety, worker safety, and environmental protection. 3,8 The The United States Pharmacopeia (USP) is a nonprofit organization that sets purity and safety standards for medications and foods. Recent updates to hazardous drug (HD) handling guidelines were published in 2014 then updated in 2016, by USP USP <800> By Patricia Kienle, RPh, MPA, FASHP, and Kate Douglass MS, RN, CRNI Perform an Assessment of Risk to Comply with USP <800> 1. Download the NIOSH 2016 list2 2. Identify all of the HDs handled within the entity including each dosage form used. This review must encompass formulary items as well as any non-formulary items utilized. USP Chapter 800 Hazardous Drugs -Handling in Healthcare Settings Kentucky Statute KRS 217.015(31) - "Official compendium" means the official United States Pharmacopoeia, official homeopathic pharmacopoeia of the United States, official national formulary, or any supplement to any of them. Progression to USP 800 1990 ASHP TAB 2004 NIOSH USP <800> Requirement: Create a Hazardous Drugs List • Each entity must maintain a list of hazardous drugs that the entity handles • Drugs included on the entity's list of hazardous drugs must be handled according to the requirements in USP Chapter <800> • Before trying to apply USP <800> standards you need to identify your hazardous drugs! pdfs/233a_2015-12857.pdf. Drugs Considered Hazardous I. General Approach to Handling Hazardous Drugs Early concerns about occupational exposure to antineoplastic drugs first appeared in the 1970s. Although the antineoplastic drugs remain the principal focus of the Alert, other drugs may also be considered hazardous because they are potent About the Author: Seth DePasquale is a compounding pharmacist and Co-owner of BET Pharm, LLC. In 2017 he started writing on compounding pharmacy compliance through his website pharmacyinspection.com and subsequently also started producing a podcast with his co-host Bryan Prince. About the Author: Seth DePasquale is a compounding pharmacist and Co-owner of BET Pharm, LLC. In 2017 he start

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