New Free White Paper Helps Pharmacy Directors Meet USP 797 Regulations

AGAWAM, MASS. – June 25, 2007 – A 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.

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,” can help. The white paper discusses the areas in which compounding pharmacies face increasing compliance burdens, including risk levels, personnel training, environmental control, and procedural controls. It also outlines the host of solutions offered by a turnkey consulting/training/testing supplier.

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/mycologist.

Download the free white paper at: http://www.usp797.com/whitepaper.

Microtest (www.usp797.com) is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology. Founded in 1984, the company’s expertise and flexible processes enhance product safety and security, speed time to market, and minimize supply chain disruption. Mictrotest’s unique single-source capability to provide testing and manufacturing solutions allows the company to support a full pharmaceutical or medical device product release. Our facilities in Agawam, Massachusetts, include state-of-the-art aseptic manufacturing areas; analytical chemistry, microbiological, and virological laboratories; Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus depyrogenation capabilities; purified water systems; and voice/data systems.

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