Abstract

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

Author(s): Martin Matt

Issue: Jul/Aug 2018 - Volume 22, Number 4

Page(s): 303-312

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  • Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating Page 6
  • Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating Page 7
  • Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating Page 8
  • Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating Page 9
  • Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating Page 10

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

  • 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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