797 Guidelines Beyond Use Dating

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PDF Beyond Use Dating for Sterile Compounding
Usp 797 Beyond Use Dating - Guidelines for the . . .
PDF USP Compounding Standards and Beyond-Use Dates (BUDs)
PDF (797) Pharmaceutical Compounding—Ste Rile Preparations
Usp 797 Beyond Use Dating - Guidelines for the . . .
Usp 797 Beyond Use Dating - Guidelines for the . . .
PDF General Chapters <797> Pharmaceutical Compounding . . .
Questions about Multi-dose vials | Injection Safety | CDC
PDF USP Chapters <797> and <800> New and Revised Compounding . . .
Compounding Sterile Preparations - ASHP
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Beyond Use Date (BUD) is very different from expiration date . USP Chapter 797 defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding . Expiration date is a manufacturer defined term based on very specific testing used for commercially available products . A CSP cannot be labeled with the term "expiration date" or any variance thereof .
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What are Beyond-Use Dates? Beyond-use dates (BUDs) are the date or time after which a compounded sterile preparation (CSP) or compounded nonsterile preparation (CNSP) may not be stored or transported and are calculated from the date or time of compounding . Why are Beyond-Use Dates Necessary? BUDs help decrease the risks that may be posed to patients .
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Beyond-Use Date (BUD) (see . General Notices and Requirements . and . Pharmaceutical Compounding — Nonsterile Preparations 〈795〉)—For the purpose of this chapter, the date or time after which a CSP shall not be stored or transported . The date is determined from the date or time the preparation is compounded . Biological Safety Cabinet (BSC)
Beyond use date BUD is the date after which a compounded preparation shall not be used, and it is set based on the date on which the preparation was compounded . To support chart of products that are both sterile and chemically stable, beyond use dating of sterile compounded admixtures must include a thorough evaluation of appropriate resources .
The beyond-use date BUD of a pdf is not the same as the expiration date 2019 . The BUD for a GUIDELINES identifies the time by which the preparation - this web page once mixed - must be used before it is at risk for chemical pdf, contamination, and permeability of the packaging .
administration) . Beyond-use exposure and storage dates or times (see Labeling ¢7² and Pharmaceutical Compounding— Nonsterile Preparations ¢795²) for sterile products that have been either opened or prepared for administration are not specified in all package inserts for all sterile products .
In addition, the United States Pharmacopeia (USP) General Chapter 797 recommends the following for multi-dose vials of sterile pharmaceuticals: If a multi-dose has been opened or accessed (e .g ., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial .
The revisions to Chapter < 797 > are the first changes to the chapter since 2008 . While there are no significant changes to engineering control requirements, pharmacy executives should be aware of new personnel competencies, environmental monitoring and beyond-use dates .
ASHP provides several guidelines for safe compounding practices28,31,32 and a discussion guide on USP chapter 797 17 and has recognized USP chapter 797 as a relevant practice standard in the ASHP Guidelines : Minimum Standard for Pharmacies in Hospitals . 33 Other professional organizations also provide guidance on specific aspects of compounding .
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797 Guidelines Beyond Use Dating