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Follow on Google News | New Free White Paper Helps Pharmacy Directors Meet USP 797 RegulationsA new, free white paper to help directors of compounding pharmacy with the problems meeting new USP 797 regulations is now available from Microtest Laboratories at http://www.usp797.com/whitepaper.
By: Tiziani Whitmyre, Inc. In the last several years, the U.S. government has issued a series of regulations, contained in General Chapter (USP 797), mandating tighter control of sterile preparations in compounding pharmacies. All covered pharmacies were warned to be prepared to demonstrate and document their compliance with all relevant USP 797 provisions as of January 1, 2008, and failure to comply may have catastrophic consequences. Reaching full compliance poses a serious dilemma for pharmacy directors and USP 797 is a complex document with ever-changing implications. As a result, many facilities are struggling with the implementation of sterility best-practices programs as well as to provide adequately controlled compounding environments, in terms of personal, air, and surface contamination. Many also face the challenge of furnishing the documented procedure sets, environmental monitoring, end-product testing, and process validation necessary to provide critical controls on the sterile products they prepare. The new, free white paper, “The Compliance Dilemma: Problems and Solutions in Meeting USP 797 Regulations for Compounding Pharmacies,” The paper is authored by Douglas M. Jaciow, director of compliance services for Microtest Laboratories, a 30-year clinical laboratory veteran, an A.S.M., and an A.S.C.P. board-certified microbiologist/ Download the free white paper at: http://www.usp797.com/ Microtest (www.usp797.com) # # # Microtest (www.usp797.com) Website: www.microtestlabs.com End
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