International journal of pharmaceutical compounding
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For former National Football League player Kerry Schmidt, BA,MBA, chronic pain is a part of everyday life. To repair sports-related trauma sustained during his 6-year career as a defensive back, Schmidt has undergone 24 major orthopedic surgeries over the past three decades and will undergo two or three additional procedures to repair his lower back. Now a sports reporter, a syndicated sports columnist, and a business owner, Schmidt says his pain at times has rated a 10-plus on a 10-point pain scale. ⋯ After he consulted with Jack P. McNulty, MD,FACP, a specialist in the management of chronic pain, who collaborated with George B. Muller, RPh, a compounding pharmacist, Schmidt found relief with no adverse effects from the seldom-prescribed drug levorphanol.
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This article introduces endotoxins and the application of the bacterial endotoxins (pyrogen) test to test for endotoxins in a manner compliant with the United States Pharmacopeia-National Formulary Chapter 797 Pharmaceutical Compounding-Sterile Preparations, the intent of which is to prevent harm and fatality to patients which could result from microbial contamination (nonsterility), excessive bacterial endotoxins, or compounding errors. Basic information about endotoxins is supplied in this article, along with information on testing methods. The purpose of this article is to assist compounding pharmacists to develop a documented system in which the quality of the components and the compounding procedure are well controlled and testing for endotoxins becomes a formality.