Beyond-use date: difference between revisions
Diff·revision 15 → 16·03:43, 13 Dec 2024
Difference between revision 15 and revision 16 of Beyond-use date. 6 lines changed; the page grew by 991 bytes.
| Revision 15 — 20:08, 4 Dec 2024 Hedgerow_Hal (talk) expand §Nonsterile preparations under USP <795> 6,327 bytes +197 | Revision 16 — 03:43, 13 Dec 2024 StubSorterBot (talk) bot: sort category members 7,318 bytes +991 | ||
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| 18 | Beyond-use dates in sterile compounding are limited principally by microbiological risk rather than by chemical degradation. The default periods in USP <797> are graduated by how the preparation was made, by whether sterility testing was performed and passed, and by storage temperature — not by the chemistry of the active substance. Chemical stability is a separate constraint, and where it is shorter it governs.{{r|usp797}} | 18 | Beyond-use dates in sterile compounding are limited principally by microbiological risk rather than by chemical degradation. The default periods in USP <797> are graduated by how the preparation was made, by whether sterility testing was performed and passed, and by storage temperature — not by the chemistry of the active substance. Chemical stability is a separate constraint, and where it is shorter it governs.{{r|usp797}} |
| 19 | 19 | ||
| + | 20 | The distinction between the two kinds of date is imperfectly maintained in secondary sources and in ordinary usage, where both are called an expiry. On this wiki the conflation has been the subject of a request for comment, and the resulting convention is that ''expiration date'' is reserved for manufacturer dating supported by a stability programme, and ''beyond-use date'' for everything else.{{r|ppbud}} | |
| + | 21 | ||
| 20 | == Definition and contrast with the expiration date == | 22 | == Definition and contrast with the expiration date == |
| 21 | An expiration date is the output of a defined regulatory process. Under ICH Q1A(R2), a manufacturer conducts long-term studies at the intended storage condition, intermediate studies where required, and accelerated studies at elevated temperature and humidity, on at least three primary batches in the container closure system intended for marketing. The results are evaluated — under ICH Q1E — to establish a retest period or shelf life, and the date is stated on the label. It applies to the unopened product stored as labelled.{{r|ich_q1a}} | 23 | An expiration date is the output of a defined regulatory process. Under ICH Q1A(R2), a manufacturer conducts long-term studies at the intended storage condition, intermediate studies where required, and accelerated studies at elevated temperature and humidity, on at least three primary batches in the container closure system intended for marketing. The results are evaluated — under ICH Q1E — to establish a retest period or shelf life, and the date is stated on the label. It applies to the unopened product stored as labelled.{{r|ich_q1a}} |
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| 35 | Two consequences of the table are worth drawing out. Because the two dates are limited by different things, they respond differently to storage: refrigeration extends a microbiologically limited beyond-use date substantially and generally extends an expiration date not at all, since the expiration date already assumes the labelled condition. And because a beyond-use date is assigned rather than measured, it can be assigned correctly to a preparation that has in fact already degraded, if the degradation route was one the default table does not contemplate.{{r|usp797,usp1191}} | 37 | Two consequences of the table are worth drawing out. Because the two dates are limited by different things, they respond differently to storage: refrigeration extends a microbiologically limited beyond-use date substantially and generally extends an expiration date not at all, since the expiration date already assumes the labelled condition. And because a beyond-use date is assigned rather than measured, it can be assigned correctly to a preparation that has in fact already degraded, if the degradation route was one the default table does not contemplate.{{r|usp797,usp1191}} |
| 36 | 38 | ||
| + | 39 | Where both dates apply, the earlier governs. A preparation compounded on a date that would yield a 45-day beyond-use date, from a component whose own expiration date falls in 20 days, has a usable life of 20 days.{{r|usp795}} | |
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| 37 | == Sterile preparations under USP <797> == | 41 | == Sterile preparations under USP <797> == |
| 38 | USP <797> classifies compounded sterile preparations into categories by the conditions under which they are made, and assigns default beyond-use dates by category, by whether sterility testing was performed, and by storage temperature. | 42 | USP <797> classifies compounded sterile preparations into categories by the conditions under which they are made, and assigns default beyond-use dates by category, by whether sterility testing was performed, and by storage temperature. |
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| 52 | {{reflist}} | 56 | {{reflist}} |
| 53 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision, including the beyond-use date tables for Category 1, 2 and 3 preparations.</ref> | 57 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision, including the beyond-use date tables for Category 1, 2 and 3 preparations.</ref> |
| + | 58 | <ref name="usp795">United States Pharmacopeia, General Chapter <795>, "Pharmaceutical Compounding — Nonsterile Preparations", 2023 revision.</ref> | |
| 54 | <ref name="usp1191">United States Pharmacopeia, General Chapter <1191>, "Stability Considerations in Dispensing Practice" (informational). USP–NF, current revision.</ref> | 59 | <ref name="usp1191">United States Pharmacopeia, General Chapter <1191>, "Stability Considerations in Dispensing Practice" (informational). USP–NF, current revision.</ref> |
| 55 | <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> | 60 | <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> |
| + | 61 | <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> | |
| 56 | 62 | ||
| 57 | {{DEFAULTSORT:Beyond-use date}} | 63 | {{DEFAULTSORT:Beyond-use date}} |