PUB-013 / v1.0
Practical BUD selection and documentation
A day count needs an applicable category, temperature and specific limitations. This text covers nonsterile preparations; its limits are not transferred to sterile or allergen products without appropriate assessment.
What each source supports
An official monograph can establish formula and tests without publishing a complete stability study. A product label can support active-drug warnings without covering the compounded vehicle. Assess authority, exact edition and claim applicability. References identify their actual scope of support rather than serving as a decorative list.
Dating with explicit conditions
BUD follows evidence for the actual formula or an applicable default after checking its conditions. A default duration is not a stability experiment. Temperature, container, microbiological condition and component expiries constrain the decision. Numerical rules appear in SOP-014 and PUB-013; record batch rationale in F-006.
Changes and process transfer
The same rpm in a different mixer does not establish equivalent mixing. Scale, impeller diameter, time, geometry and temperature affect the process. Assess packaging-material or excipient-supplier changes against the attributes they could alter. Document applicability in F-013 before reusing the previous dating decision.
General maximum limits
Without a specific applicable monograph/study: unpreserved aqueous aw ≥0.60, up to 14 days at 2–8 °C; appropriately preserved aqueous, up to 35 days at controlled room temperature or permitted compatible refrigeration; nonaqueous oral liquid aw <0.60, up to 90 days; other nonaqueous forms aw <0.60, up to 180 days. Use the last two categories under conditions allowed by source and framework.
Calculation for an actual batch
The starting point is preparation date/time. Select the earliest of: start plus permitted period, component expiries and any shorter supported limit. Apply a separate in-use limit if shorter. Repackaging, stirring or adding fresh material does not create a new starting point.
When additional evidence is needed
Do not apply a number when category is undefined or required refrigeration conflicts with known physical stability. Extension needs a suitable stability-indicating study and required microbiological evidence. A national formulary instruction remains visible as a source instruction; it is not presented as equivalent to complete published experimental data.
Sources and references
- USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
- Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic regulatory checklist, accessed 2026-09-12pp. 15–16; USP <795> sections 10.1–10.5Temperature conditions and requirements for supported extension; jurisdiction-specific guidance2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12