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Quality-Control Analytical Methods: Overview of Beyond-Use Dating for Compounded Sterile Preparations

Author(s):  Trissel Lawrence A

Issue:  Nov/Dec 2008 - Arthritis and Immunological Diseases
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Abstract:  United States Pharmacopeia Chapter <797> provides guidelines and standards that deal with the preparation, compounding, and labeling of compounded sterile preparations. These standards ensure patient care and safety by defining safe practice. The Chapter gives instructions on determining beyond-use dates for the different risk categories associated with compounded preparations. Each of these categories has specific aspects of environmental, personnel, and situational deterrents that Chapter <797> requires to be taken into account. By following the standards of Chapter <797>, compounding pharmacists can alleviate danger to the patient and themselves in any situation.

Related Keywords: Lawrence A. Trissel, BS, RPh, FASHP, United States Pharmacopeia, Chapter <797>, compounded sterile preparations, beyond use dating, quality control, standards, drug storage, sterility, drug stability, microbiological contamination risk category, risk level

Related Categories: STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, STORAGE

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