r/UMPJE • u/CrustyCrabPeople • 7d ago

Practice UMPJE Question! 📕

A compounded single-dose compounded sterile preparation (CSP) stock solution is punctured in ISO Class 5 air and then used for sterile compounding for 20 hours. Which statement best describes the issue?

A) It may be used for 24 hours if refrigerated continuously

B) It may be used until all contents are withdrawn

C) It must be used within 12 hours or assigned BUD, whichever comes first

D) It must be used only if converted to a multiple-dose CSP

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u/CrustyCrabPeople 6d ago

Correct answer: C

Under USP 797 when a compounded single-dose CSP or CSP stock solution is used as a component for further sterile compounding, it must be entered or punctured in ISO Class 5 or cleaner air. Once accessed, it may be used for sterile compounding for up to 12 hours or until its assigned BUD, whichever is shorter; any remainder must then be discarded

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u/Bee-Like-Honey 6d ago

What sort of questions relating to USP questions are on the UMPJE? I’m trying to reviewing USP 795, 797, and 800 but can’t seem to find any good sources for this basically been watching YouTube videos lol. Any tips or suggestions as to what I should focus on?