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Analytical Testing of Extemporaneously Compounded Preparations

Author(s):  Kupiec Thomas C

Issue:  Mar/Apr 2000 - Compounding for Diabetes Patients
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Abstract:  An important way to ensure efficacy and safety in compounding is to establish a quality-control program that involves the submission of compounded preparations for analytical and microbiological testing. In this article, the author addresses the following questions: Why does my pharmacy need a quality-control program? What types of tests should compounding pharmacists have performed on their preparations? What type of preparations should be tested? When or how often should samples be tested? Where should I submit samples for testing? Is it cost effective to submit compounded preparations for testing? He concludes that compounding pharmacists should ensure that preparations are free of microbiological contamination and that the concentration is as stated on the label. Submitting samples for testing is a positive, proactive approach that would be favorably looked upon by the US Food and Drug Administration.

Related Keywords: quality assurance, quality control, compounding, potency tests, microbial tests, sterility, pyrogenicity, endotoxins, preservative effectiveness, stability, laboratory, turnaround time, patient safety, sample analysis

Related Categories: LEGAL, SUPPORT, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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