Usp 797 beyond use dating are jessica sanchez and deandre brackensick dating
If you would have asked me a couple of months ago what BUD to assign to a stock bag, I would have said 30 or 48 hour depending on conditions.
However, with news of recent surveys here in California that’s no longer my advice.
When an official monograph isn't present, a systematic approach to assigning the date can be as follows: Step 1.
Beyond use dates should be in accordance with the manufacturer's approved labeling.
It’s beyond me how the state board can interpret a stock bag differently from any other low-risk or medium-risk level CSP, but they are.
At least that’s how things are in California at the moment. Does that still count if one uses a CSTD or other port that prevents re-entry via the stopper?
Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 air quality, and any remaining contents must be discarded.
Otherwise, the pharmacist should ensure that the manufacturer's stability information is product specific, that is, the exact strength, diluent, fill volume, and container type (PVC bag, plastic syringe, elastomeric infusion device, etc.) will be used by the pharmacist when preparing the HSD.
A CSP prepared under medium-risk conditions receives a 30 hour BUD when stored at controlled room temperature.