Beyond-use date: difference between revisions
Diff·revision 24 → 25·22:47, 11 Oct 2025
Difference between revision 24 and revision 25 of Beyond-use date. 5 lines changed; the page grew by 676 bytes.
| Revision 24 — 00:54, 19 Sep 2025 StubSorterBot (talk) bot: normalise unit spacing 20,489 bytes +1,459 | Revision 25 — 22:47, 11 Oct 2025 ForestPlotFinn (talk) alphabetise the see-also list 21,165 bytes +676 | ||
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| 126 | * what the preparation is, at what concentration, in enough detail to identify the applicable default. | 126 | * what the preparation is, at what concentration, in enough detail to identify the applicable default. |
| 127 | 127 | ||
| + | 128 | For an opened manufactured container the equivalent record is the date of first entry, annotated on the container. Guidance treats an unannotated multiple-dose container as undatable and therefore to be discarded, on the ground that no evidence exists that it is within its period.{{r|usp797,cdc_injection_bud}} | |
| + | 129 | ||
| 128 | == Terminology and the conflation problem == | 130 | == Terminology and the conflation problem == |
| 129 | The two kinds of date are conflated pervasively, and the conflation is not merely pedantic to correct, because the two respond differently to the questions readers ask. | 131 | The two kinds of date are conflated pervasively, and the conflation is not merely pedantic to correct, because the two respond differently to the questions readers ask. |
| ⋮ | ⋮ | ||
| 133 | Asked what happens on the day after, the answers differ. Passing an expiration date means the manufacturer's assurance of conformance to specification has ended; the product is very often still within specification, and stability studies extending past labelled shelf life routinely show that. Passing a beyond-use date on a preserved multiple-dose container means a microbiological risk bound has been exceeded, which is a different kind of statement and not one about assay values.{{r|usp1191,usp51}} | 135 | Asked what happens on the day after, the answers differ. Passing an expiration date means the manufacturer's assurance of conformance to specification has ended; the product is very often still within specification, and stability studies extending past labelled shelf life routinely show that. Passing a beyond-use date on a preserved multiple-dose container means a microbiological risk bound has been exceeded, which is a different kind of statement and not one about assay values.{{r|usp1191,usp51}} |
| 134 | 136 | ||
| + | 137 | Asked whether refrigeration helps, the answers differ, as set out in §Definition and contrast with the expiration date. | |
| + | 138 | ||
| 135 | == References == | 139 | == References == |
| 136 | {{reflist}} | 140 | {{reflist}} |
| ⋮ | ⋮ | ||
| 142 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003), read with ''Q1E: Evaluation for Stability Data'' (2003).</ref> | 146 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003), read with ''Q1E: Evaluation for Stability Data'' (2003).</ref> |
| 143 | <ref name="trissel2022">Trissel LA. ''Handbook on Injectable Drugs''. 21st edition, American Society of Health-System Pharmacists (2022). The standard compilation of published stability and compatibility data.</ref> | 147 | <ref name="trissel2022">Trissel LA. ''Handbook on Injectable Drugs''. 21st edition, American Society of Health-System Pharmacists (2022). The standard compilation of published stability and compatibility data.</ref> |
| + | 148 | <ref name="cdc_injection_bud">Centers for Disease Control and Prevention. ''Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care'', with associated injection-safety guidance on dating opened vials.</ref> | |
| 144 | <ref name="ppbud">PeptidePedia community dating-practice tally and the 2026 request for comment on dating terminology (self-reported practice; weak evidence — see [[Project:Sourcing_guidelines]]).</ref> | 149 | <ref name="ppbud">PeptidePedia community dating-practice tally and the 2026 request for comment on dating terminology (self-reported practice; weak evidence — see [[Project:Sourcing_guidelines]]).</ref> |
| 145 | 150 |