Beyond-use date: difference between revisions
Diff·revision 22 → 23·08:59, 29 Aug 2025
Difference between revision 22 and revision 23 of Beyond-use date. 12 lines changed; the page grew by 876 bytes.
| Revision 22 — 15:42, 9 Aug 2025 GramsNotUnitsGil (talk) fix a dangling clause 18,154 bytes +989 | Revision 23 — 08:59, 29 Aug 2025 UnitAuditUwe (talk) clarify that the figure is per dose, not per vial 19,030 bytes +876 | ||
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| 115 | For material distributed outside regulated channels, third-party purity testing of a reconstituted solution after storage is occasionally reported and is a genuine improvement on assertion. Without a matched baseline result on the same lot before storage, however, it cannot distinguish degradation during storage from a purity deficit present at manufacture — the same limitation described at [[Temperature excursion]].{{r|ppbud}} | 115 | For material distributed outside regulated channels, third-party purity testing of a reconstituted solution after storage is occasionally reported and is a genuine improvement on assertion. Without a matched baseline result on the same lot before storage, however, it cannot distinguish degradation during storage from a purity deficit present at manufacture — the same limitation described at [[Temperature excursion]].{{r|ppbud}} |
| 116 | 116 | ||
| + | 117 | == Labelling and records == | |
| + | 118 | A beyond-use date exists only as a record, which makes labelling part of the standard rather than an administrative addition. USP <797> requires that a compounded sterile preparation be labelled with, among other items, the assigned beyond-use date and the storage condition to which it applies, because the date is conditional on that condition and is meaningless without it.{{r|usp797}} | |
| + | 119 | ||
| + | 120 | Three items make a beyond-use date interpretable, and the omission of any one makes it uninterpretable: | |
| + | 121 | ||
| + | 122 | * the date, with the convention stated or evident; | |
| + | 123 | * the storage condition assumed; | |
| + | 124 | * what the preparation is, at what concentration, in enough detail to identify the applicable default. | |
| + | 125 | ||
| 117 | == References == | 126 | == References == |
| 118 | {{reflist}} | 127 | {{reflist}} |
| ⋮ | ⋮ | ||
| 129 | * American Society of Health-System Pharmacists. "ASHP Guidelines on Compounding Sterile Preparations." ''American Journal of Health-System Pharmacy'' 71(2):145–166 (2014). | 138 | * American Society of Health-System Pharmacists. "ASHP Guidelines on Compounding Sterile Preparations." ''American Journal of Health-System Pharmacy'' 71(2):145–166 (2014). |
| 130 | * United States Pharmacopeia, General Chapter <825>, "Radiopharmaceuticals — Preparation, Compounding, Dispensing, and Repackaging" — a parallel dating framework for a different product class. | 139 | * United States Pharmacopeia, General Chapter <825>, "Radiopharmaceuticals — Preparation, Compounding, Dispensing, and Repackaging" — a parallel dating framework for a different product class. |
| + | 140 | ||
| + | 141 | == External links == | |
| + | 142 | * [https://www.usp.org/ USP compounding compendium (index)] — Chapters <795>, <797> and <825>; text is paywalled, revision status is public. | |
| 131 | 143 | ||
| 132 | == See also == | 144 | == See also == |