Beyond-use date: difference between revisions
Diff·revision 22 → 23·15:23, 22 Jan 2025
Difference between revision 22 and revision 23 of Beyond-use date. 4 lines changed; the page grew by 900 bytes.
| Revision 22 — 05:31, 16 Jan 2025 NurseNoteNessa (talk) rv — see talk 8,887 bytes +492 | Revision 23 — 15:23, 22 Jan 2025 TrialsTabitha (talk) rm citation to a supplier's own page 9,787 bytes +900 | ||
|---|---|---|---|
| 13 | | Stability in dispensing practice = USP <1191> | 13 | | Stability in dispensing practice = USP <1191> |
| 14 | }} | 14 | }} |
| + | 15 | {{hatnote|Not to be confused with the manufacturer expiration date, which is established by a formal stability programme under ICH Q1A(R2).}} | |
| 15 | 16 | ||
| 16 | A '''beyond-use date''' ('''BUD''') is the date, or date and time, after which a compounded preparation or an opened container is not to be used. It is assigned by the person who prepares or opens the preparation, using compendial default tables or, where available, testing specific to the preparation. It is distinct from an '''expiration date''', which is assigned by a manufacturer on the basis of a formal stability programme conducted on the finished product in its final container.{{r|usp797,usp1191}} | 17 | A '''beyond-use date''' ('''BUD''') is the date, or date and time, after which a compounded preparation or an opened container is not to be used. It is assigned by the person who prepares or opens the preparation, using compendial default tables or, where available, testing specific to the preparation. It is distinct from an '''expiration date''', which is assigned by a manufacturer on the basis of a formal stability programme conducted on the finished product in its final container.{{r|usp797,usp1191}} |
| ⋮ | ⋮ | ||
| 68 | | Water-containing topical, dermal and mucosal liquid and semisolid formulations | 30 days | | 69 | | Water-containing topical, dermal and mucosal liquid and semisolid formulations | 30 days | |
| 69 | 70 | ||
| + | 71 | Periods are those in the 2023 revision.{{r|usp795}} The revision removed a widely known earlier provision under which a preparation made from a manufactured product could be assigned a beyond-use date of not later than 25% of the time remaining until that product's expiration date, or six months, whichever was earlier. That ''25% rule'' remains in circulation in secondary sources and in older references, and is no longer the compendial position; sources quoting it should be checked against the current revision.{{r|usp795,trissel2022}} | |
| + | 72 | ||
| 70 | == References == | 73 | == References == |
| 71 | {{reflist}} | 74 | {{reflist}} |
| ⋮ | ⋮ | ||
| 74 | <ref name="usp1191">United States Pharmacopeia, General Chapter <1191>, "Stability Considerations in Dispensing Practice" (informational). USP–NF, current revision.</ref> | 77 | <ref name="usp1191">United States Pharmacopeia, General Chapter <1191>, "Stability Considerations in Dispensing Practice" (informational). USP–NF, current revision.</ref> |
| 75 | <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> | 78 | <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> |
| + | 79 | <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> | |
| 76 | <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> | 80 | <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> |
| 77 | 81 |