Abstract

Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations

Author(s): Okeke Claudia C, Allen Loyd V Jr

Issue: May/Jun 2010 - Pain Management

Page(s): 232-238

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  • Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations Page 1
  • Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations Page 2
  • Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations Page 3
  • Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations Page 4
  • Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations Page 5
  • Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations Page 6
  • Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations Page 7

Abstract

Pharmacies should have standard operating procedures in place for each step involved in sterile compounding. These procedures include but are not limited to: storing; beyond-use dating; and maintaining the sterility, purity, and stability of compounded preparations. This article discusses the storage, beyond-use date, and the packing and transportation of finished compounded sterile preparations. The topics are discussed in a practical manner to provide practice clarification to the current standards set forth in the United States Pharmacopeia.

Related Keywords

  • United States Pharmacopeia Chapter <797>
  • USP
  • sterile preparations
  • standards
  • storage
  • beyond-use dating
  • sterility
  • purity
  • stability
  • potency
  • standard operating procedures
  • SOP
  • quality assurance
  • quality control
  • multiple use vials
  • staff training

Related Categories

  • ENVIRONMENTAL
  • STABILITIES, COMPATIBILITIES
  • STERILE PREPARATIONS
  • QUALITY CONTROL
  • UNITED STATES PHARMACOPEIA CONVENTIONS
  • STORAGE

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