Beyond-use Date: Establishment and Maintenance
Author(s): Osteen Richard
Issue: Nov/Dec 2012 - Volume 16, Number 6
View All Articles in Issue
Page(s): 471-474
Download in electronic PDF format for $75
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: 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