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Beyond-use Date: Establishment and Maintenance

Author(s):  Osteen Richard

Issue:  Nov/Dec 2012 - Volume 16, Number 6
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Abstract:  With the introduction of United States Pharmacopeia Chapters <795> and <797>, the long-standing concept of drug stability (beyond-use dates and expiration dates) came to the forefront of pharmacy compounding practice. Beyond-use date extension can only be done if end-point sterility testing is done on compounded sterile preparations. It is not for everyone and can only be accomplished by using an analytical approach. This article discusses the unique skill set required by pharmacists to accomplish and maintain these processes.

Related Keywords: Richard Osteen, DPh, drug stability, beyond-use dates, compounded sterile preparations, United States Pharmacopeia Chapter <797>, USP, expiration dates, quality assurance, sterility testing, stability-indicating method, potency over time, degradation testing, practice standards

Related Categories: STABILITIES, COMPATIBILITIES, UNITED STATES PHARMACOPEIA CONVENTIONS, STORAGE

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