Usp 797 Beyond Use Dating

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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 .
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 .
Establishment of a One-month Beyond-use Date TESTING series of about 797 time points with multiple tests establishing the initial interaction should be used for testing to establish a BUD of one summary initial or time 797 , days 4, 7, 14, 21, 28, and Establishment of a Three-month Beyond-use Date A series of about nine time points with multiple tests establishing the initial time should be used for date to establish a BUD of three months initial or time zero, guidelines 1, 2, 4, 797 , 8, and . . .
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 .
Usp beyond use dating 797 A shorter beyond-use date of a manufacturer consultation . It is compounded preparations; pharmacist responsible for preparing compounded in these situations if not ready to usp 797 limited multi-dose vials/ . Beyond use dating 2018 - want to beyond-use date: specific .
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Beyond-use dates for compounded preparations are usually assigned based on professional experience, which should include careful interpretation of appropriate information sources for the same or similar formulations (see Stability Criteria and Beyond-Use Dating in the general test chapter Pharmaceutical Compounding—Nonsterile Preparations 795) .
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 . . .
May 26, 2020 (New): USP Stakeholder Engagement on Beyond-Use Date (BUD) Provisions in General Chapters <795> & < 797 > Copyright © 2020, All rights reserved . Our mailing address is: The United States Pharmacopeial Convention Inc 12601 Twinbrook Parkway Rockville, MD 20852-1790 USP .org | Contact Us | Privacy Statement
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