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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

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

Issue:  May/Jun 2010 - Pain Management
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Page(s):  232-238

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

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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: Claudia C. Okeke, PhD, RPh, Loyd V. Allen, Jr., PhD, RPh, 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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