Beyond-use date: difference between revisions

Diff·revision 14 → 15·20:32, 31 Mar 2025

Difference between revision 14 and revision 15 of Beyond-use date. 6 lines changed; the page grew by 1,020 bytes.

Revision 14 — 06:13, 14 Mar 2025 RotationRosalind (talk) expand §Assignment in the absence of data 12,094 bytes +1,001	Revision 15 — 20:32, 31 Mar 2025 CategoryBot (talk) bot: sort category members 13,114 bytes +1,020
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21	{{hatnote\|Not to be confused with the manufacturer expiration date, which is established by a formal stability programme under ICH Q1A(R2).}}	21	{{hatnote\|Not to be confused with the manufacturer expiration date, which is established by a formal stability programme under ICH Q1A(R2).}}
+		22	{{accuracy\|date=February 2026\|talk=RfC: conflation of beyond-use date and expiration date}}
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23	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}}	24	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}}
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81	The 2023 chapter also permits longer dating where supported by a stability-indicating study on the preparation, or by published stability information for the same formulation in the same container and storage condition. The qualification about container and condition is not incidental: published stability data for a solution in a glass vial does not transfer to the same solution in a plastic syringe, because sorption and permeation differ.{{r\|usp795,trissel2022}}	82	The 2023 chapter also permits longer dating where supported by a stability-indicating study on the preparation, or by published stability information for the same formulation in the same container and storage condition. The qualification about container and condition is not incidental: published stability data for a solution in a glass vial does not transfer to the same solution in a plastic syringe, because sorption and permeation differ.{{r\|usp795,trissel2022}}
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+		84	Water activity is the organising principle behind the dosage-form distinctions. Preparations in which water is available support microbial growth and hydrolytic degradation; those in which it is not, or is bound, support neither to the same degree. This is the same principle that makes a lyophilised solid far more stable than its reconstituted solution, and it connects the compendial framework to the physical chemistry set out at [[Lyophilisation]].{{r\|usp795}}
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83	== Opened containers ==	86	== Opened containers ==
84	Entering a container ends the applicability of its expiration date, because the container closure system on which that date depended has been breached. Dating from that point follows the rules described at [[Multi-dose vial\|multiple-dose containers]] and summarised here.	87	Entering a container ends the applicability of its expiration date, because the container closure system on which that date depended has been breached. Dating from that point follows the rules described at [[Multi-dose vial\|multiple-dose containers]] and summarised here.
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88	; Pharmacy bulk packages : As stated on the label, conventionally a small number of hours after entry.{{r\|usp797,usp659}}	91	; Pharmacy bulk packages : As stated on the label, conventionally a small number of hours after entry.{{r\|usp797,usp659}}
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+		93	The 28-day figure derives from the antimicrobial effectiveness testing in USP <51>, whose challenge protocol runs over 28 days, together with infection-control practice. It is not a chemical stability figure and was never derived as one, a point on which this wiki has had to correct several articles.{{r\|usp51,ppbud}}
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90	== References ==	95	== References ==
91	{{reflist}}	96	{{reflist}}
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93	<ref name="usp795">United States Pharmacopeia, General Chapter <795>, "Pharmaceutical Compounding — Nonsterile Preparations", 2023 revision.</ref>	98	<ref name="usp795">United States Pharmacopeia, General Chapter <795>, "Pharmaceutical Compounding — Nonsterile Preparations", 2023 revision.</ref>
94	<ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref>	99	<ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref>
+		100	<ref name="usp51">United States Pharmacopeia, General Chapter <51>, "Antimicrobial Effectiveness Testing". USP–NF, current revision.</ref>
95	<ref name="usp1191">United States Pharmacopeia, General Chapter <1191>, "Stability Considerations in Dispensing Practice" (informational). USP–NF, current revision.</ref>	101	<ref name="usp1191">United States Pharmacopeia, General Chapter <1191>, "Stability Considerations in Dispensing Practice" (informational). USP–NF, current revision.</ref>
96	<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>	102	<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>