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Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating

Author(s):  Martin Matt

Issue:  Jul/Aug 2018 - Volume 22, Number 4
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Abstract:  Compounding pharmacists must separately and collectively evaluate multiple aspects of a compounded sterile preparation when determining their beyond-use date. Considerations include the microbiological risk level, storage temperature, chemical stability, batch size, and whether or not a sterility test will be performed. The United States Pharmacopeia Chapter <797> provides guidance on the maximum beyond-use date allowed solely based on the microbiological risk level associated with the compounding of a sterile preparation. Compounders should select the shortest beyond-use date between the risk-level based beyond-use date and the chemical stability of the compound. When compounding pharmacists intend to provide a compounded sterile preparation with a beyond-use date that exceeds the risk-level based recommendations in United States Pharmacopeia Chapter <797>, they must ensure that their formulations are sterility tested in compliance with United States Pharmacopeia Chapter <71>. United States Pharmacopeia Chapter <71> compliance includes conducting method suitability that is applicable to the strength and batch size that they plan to prepare. Chemical stability must be a separate consideration for each formulation.

Related Keywords: Matt Martin, PharmD, compounded sterile preparations, beyond-use date, microbial contamination, storage temperature, chemical stability, sterility testing, United States Pharmacopeia Chapter <797>, USP, United States Pharmacopeia Chapter <71> Sterility Tests, US Food and Drug Administration Form 483, microbiological risk, batch size

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

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