Tag: USP 797

  • What USP <797> has to say about beyond-use dating of stock bags

    Nothing. It says nothing, which leaves things open to interpretation. That’s bad.

    Beyond use dating (BUD) in USP <797> is pretty straightforward, but there’s really no language in there describing stock bags.

    Here are some things to think about. When performing routine compounding, USP <797> states that in the absence of sterility testing, the assigned BUD must not exceed the following:

    USP 797 BUD for temp and risk
    (more…)