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Records and Record-Keeping for the Hospital Compounding Pharmacist

Author(s):  McElhiney Linda F

Issue:  Mar/Apr 2007 - Diabetes
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Abstract:  The United States Pharmacopeial Convention, Inc., is recognized by federal law and by most state boards of pharmacy as the official group for setting the standards for pharmaceuticals and pharmacy practice, including compounding. The standards of United States Pharmacopeia Chapter <795> require that a pharmacy maintain records on a compounded preparation, including the formulation record, the compounding record, and a Material Safety Data Sheets file. The American Society of Health-Systems Pharmacists’ guidelines require that hospital pharmacy departments maintain at least four sets of records in the compounding area: (1) compounding formulas and procedures, (2) compounding logs of all compounded preparations, including batch records and sample batch labels, (3) equipment maintenance records, and (4) a record of ingredients purchased, including certificates of analysis and Material Safety Data Sheets. Hospital compounding records may be inspected by any of several outside organizations, including state boards

Related Keywords: hospital pharmacy, extemporaneous compounding logs, records, documentation, quality control, standard, regulation, USP, ASHP, JCAHO, SOP


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