Hello all,

We usually try to find good stability indicating studies (like stability indicating HPLC studies) to extend our compounded preparations (still within USP 797 BUD limit). For some reason we are unable to find anything other that stability studies according to measured PH and co2 levels...does anyone know if this is considered sufficient? if so, why? wouldn't this be only potency indicating, but stability indicating? I appreciate your help!

Thanks!

Hi all,

There was some discussion in our pharmacy regarding BUD vs spike time. Let's say we have vancomycin 750 mg IVPB that was compounded with a BUD of 8/13 @0600. If a nurse were to hang it at 8/13 @0559 is that still okay knowing it is an hour infusion? Or

How do your facilities and USP interpret that? If the above scenario holds true, how does one interpret longer infusions (>4h)...nobody goes back and thinks "well it's past the BUD, but what time was it spiked?"

Any feedback is appreciated! Thanks.

Is anyone putting a BUD on inhalers? If so, how do you operationalize this process? Practically speaking, an inhaler used in a hospital setting is going to be finished long before the BUD, however, a recent JC consultant asked a nurse at our facility what the BUD was on the inhaler. The consultant said when inhalers are removed from the packaging and foil wrap, they need to have BUD expiration sticker. The inhalers have different BUD, for example albuterol is 12 months and Symbicort is 3 months. Any help is appreciated.