Multi-dose vial: difference between revisions
Diff·revision 53 → 54·00:59, 2 Feb 2026
Difference between revision 53 and revision 54 of Multi-dose vial. 2 lines changed; the page grew by 464 bytes.
| Revision 53 — 01:07, 21 Jan 2026 EscalationEira (talk) add category 23,645 bytes ±0 | Revision 54 — 00:59, 2 Feb 2026 ForestPlotFinn (talk) correct percentage: source reports placebo-adjusted 24,109 bytes +464 | ||
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| 132 | The date of first puncture is a record created by the user rather than by the manufacturer, and the entire dating framework depends on it. Guidance therefore treats annotation of the container at first entry as the mechanism by which the rule is enforceable, since a vial with no such annotation cannot be shown to be within its period and is to be discarded on that ground alone.{{r|usp797,cdc_injection}} | 132 | The date of first puncture is a record created by the user rather than by the manufacturer, and the entire dating framework depends on it. Guidance therefore treats annotation of the container at first entry as the mechanism by which the rule is enforceable, since a vial with no such annotation cannot be shown to be within its period and is to be discarded on that ground alone.{{r|usp797,cdc_injection}} |
| 133 | 133 | ||
| + | 134 | For reconstituted preparations the equivalent record is the reconstitution date, the diluent used and the concentration achieved. None of these is derivable later from the vial: a reconstituted solution offers no visual evidence of its concentration, its diluent or its age. This is the practical reason that the absence of such a record is treated in compounding practice as equivalent to an expired preparation rather than as a documentation lapse.{{r|usp797}} | |
| + | 135 | ||
| 134 | == References == | 136 | == References == |
| 135 | {{reflist}} | 137 | {{reflist}} |