Beyond-use date: difference between revisions
Diff·revision 52 → 53·11:28, 19 Sep 2025
Difference between revision 52 and revision 53 of Beyond-use date. 9 lines changed; the page grew by 1,459 bytes.
| Revision 52 — 01:57, 12 Sep 2025 SharpsSukhi (talk) attribute claim in-text 19,030 bytes ±0 | Revision 53 — 11:28, 19 Sep 2025 ImportRecordIna (talk) ce, tighten prose 20,489 bytes +1,459 | ||
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| 108 | A second worked case illustrates the same rule with a percentage. Under the superseded 25% provision in the older <795>, a preparation made on 12 March from a product expiring on 12 September — 184 days remaining — would have received 25% of 184 days, or 46 days, giving 27 April, since 46 days is less than six months. Under the 2023 revision that calculation is not performed at all and the dosage-form default applies. The two approaches give different answers, which is why the revision status of a cited source matters.{{r|usp795,trissel2022}} | 108 | A second worked case illustrates the same rule with a percentage. Under the superseded 25% provision in the older <795>, a preparation made on 12 March from a product expiring on 12 September — 184 days remaining — would have received 25% of 184 days, or 46 days, giving 27 April, since 46 days is less than six months. Under the 2023 revision that calculation is not performed at all and the dosage-form default applies. The two approaches give different answers, which is why the revision status of a cited source matters.{{r|usp795,trissel2022}} |
| 109 | 109 | ||
| + | 110 | {{note|Both dates are properties of a record, not of a container. A vial whose reconstitution date was not written down has no determinable beyond-use date, and compounding practice treats that as equivalent to an expired preparation rather than as a documentation lapse to be corrected retrospectively.}} | |
| + | 111 | ||
| 110 | === Where testing is available === | 112 | === Where testing is available === |
| 111 | A beyond-use date may be extended beyond the defaults where supported by evidence, and the evidence expected is specific. For chemical stability, a [[Analytical method validation|validated]] stability-indicating assay applied to the actual preparation, in the actual container, at the actual storage temperature, over the proposed period, with the acceptance criterion stated in advance. For sterility, testing under USP <71> on a statistically defensible sample, together with endotoxin testing under USP <85> where relevant.{{r|usp797,usp795}} | 113 | A beyond-use date may be extended beyond the defaults where supported by evidence, and the evidence expected is specific. For chemical stability, a [[Analytical method validation|validated]] stability-indicating assay applied to the actual preparation, in the actual container, at the actual storage temperature, over the proposed period, with the acceptance criterion stated in advance. For sterility, testing under USP <71> on a statistically defensible sample, together with endotoxin testing under USP <85> where relevant.{{r|usp797,usp795}} |
| ⋮ | ⋮ | ||
| 123 | * the storage condition assumed; | 125 | * the storage condition assumed; |
| 124 | * 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 | ||
| + | 128 | == 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. | |
| + | 130 | ||
| + | 131 | Asked whether a date can be extended, the answers differ. An expiration date can be extended only by the manufacturer on the basis of further stability data, and in specific circumstances by a regulator, as has occurred during shortages. A beyond-use date can be extended by whoever assigned it, if they obtain evidence supporting a longer period — because it was a conservative default and not a measurement.{{r|ich_q1a,usp795}} | |
| + | 132 | ||
| + | 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}} | |
| 125 | 134 | ||
| 126 | == References == | 135 | == References == |