Usp 797 Beyond Use Dating 2022

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PDF Beyond Use Dating for Sterile Compounding
PDF USP Compounding Standards and Beyond-Use Dates (BUDs)
USP General Chapter 797
PDF 2020-2022 Sterile Compounding eLearning Curriculum 32 . . .
STORAGE AND BEYOND-USE DATING - uspbpep .com
Beyond-Use Dating for Sterile Compounding : June 2021 . . .
General Chapter <797> Pharmaceutical Compounding—Sterile . . .
PDF Q&A
PDF General Chapters <797> Pharmaceutical . . . - USP-NF | USP-NF
2019 Homestudy CE: Navigating the 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 .
May 26, 2020 - Update on stakeholder engagement activities related to beyond - use -date (BUD) provisions in General Chapters <795> & < 797 > March 12, 2020 - Appeals Panel issues decisions on the Appeals to USP <795>, < 797 >, and <825> (see FAQs on USP Compounding Appeals) September 23, 2019 - Revised General Chapter < 797 > is postponed until further notice . Click here for more information . June 1, 2019 - Publication Date of Revised < 797 > in USP -NF
www .criticalpoint .info › Resources › S-001 20200909 Sterile Compounding eCurriculum crosswalk .pdf
Determining Beyond-Use Dating (1 hour) 0761-9999-20-134-H07-P . 0761-9999-20-134-H07-T • Describe situations that are not considered compounding . • Differentiate expiration from beyond-use dates . • Explain the immediate- use provision in USP 797 (2019) . • Discuss the conditions that influence the beyond-use date (BUD) assignment .
ftp .uspbpep .com › v29240 › usp29nf24s0_c797s66 .html
When assigning a beyond-use date, pharmacists should consult and apply drug-specific and general stability documentation and literature where available, and they should consider the nature of drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy (see Expiration Date and Beyond-Use Date under Labeling in the General Notices and Requirements) . Stability information must be carefully interpreted in . . .
Beyond-Use Dating for Sterile Compounding . Beyond-use dating can be a key component to waste reduction efforts in the pharmacy, yet it must be applied carefully and strategically to ensure patient safety . Determining the beyond-use date (BUD) for compounded sterile preparations (CSPs) can seem complex—given the many factors that need to be . . .
In accordance with the 2020-2025 Rules and Procedures of the Council of Experts, this is to provide notice that the Compounding Expert Committee intends to revise General Chapter < 797 > Pharmaceutical Compounding—Sterile Preparations . The revisions proposed are based on numerous stakeholder engagement activities and intended to improve clarity .
dates . That is bad practice . Second, USP < 797 > offers beyond-use dating based on the storage of a preparation, and those time limits must include the time taken to mix the compound all the way up to when the infusion begins or the injection is given . There is some confusion about whether or not the beyond-use date includes the time of infusion . It doesn't .
Posting Date24-Apr-2020 . Official Date01-May-2020 . Expert CommitteeCompounding . Reason for Revision Compliance - Appeals Panel Decision In accordance with the Rules and Procedures of the 2015-2020 Council of Experts, USP is updating the status of Pharmaceutical Compounding - Sterile Preparations < 797 > based on the Appeals Panel decision .
There are 2 steps to completing this Homestudy CE . Step 1: Watch the entire recorded video titled " Navigating the Beyond-Use Dating Landscape ." Step 2: Click on "Take the Test" to complete the post-test and evaluation . Please Note: A handout is provided - print out and follow along with the video recording . Objectives .
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Usp 797 Beyond Use Dating 2022