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United States Pharmacopeia (USP) 797

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Dalatec has seen many new requirements from hospitals and pharmacies that need cleanroom consumables, wipers, swabs, mops and disinfectants for their required sterile environments. The United States  Pharmaccpeida (USP) has developed standards for compounding in sterile environments. These standards help compounding practitioners adhere to widely acknowledged, scientifically sound procedures and practices, and facilitate the delivery of consistent and good-quality prepared medicines to patients. State Boards of Pharmacy may adopt these USP standards into their regulations. The objective of USP <797> is to describe conditions and practices to prevent harm, including death, to patients that could result from: Microbial contamination,Excessive bacterial endotoxins,Variability in the intended strength of ingredients,Chemical and physical contaminants,Incorrect type or quality of ingredients in Compounded Sterile Preparations (CSPs). USP <797> provides practice and quality standards for all persons who prepare CSP drugs and nutrients and all places they are prepared. They require that the preparation of CSPs occur in...

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