USP 797 FAQ: Beyond-use Dating for IVPB’s

The BUD for intravenous piggyback (IVPB) infusions depends on the conditions under which they were prepared.

  • When prepared under conditions of Immediate-Use CSPs, infusion must start within 1 hour of starting to prepare the CSP with no time limit to finish the infusion
  • When prepared under conditions of Low-Risk Level CSPs with 12-Hour or Less BUD, infusion must start within 12 hours of preparing the CSP with no time limit to finish the infusion
  • When prepared under conditions of Low-Risk Level CSPs, BUD is 48 hours at controlled room temperature (see USP General Notices and Requirements), 14 days at cold temperature (see USP General Notices and Requirements), and 45 days in solid frozen state between -25° and -10°, in the absence of direct sterility testing evidence that supports longer BUDs.

For more information about BUD’s register for Eric Kastango’s “Demystifying BUD’s” webinar on 11/19/09 at www.rph.com/webinars. The webinar will be recorded for future access as well.

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