PUB-013 / 2.1
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
Absent a specific applicable monograph/study, under the selected USP <795> framework: unpreserved aqueous aw ≥0.60 up to 14 days at 2–8 °C; preserved aqueous up to 35 days at controlled room temperature or compatible refrigeration; nonaqueous oral liquid aw <0.60 up to 90 days; other nonaqueous forms aw <0.60 up to 180 days, at controlled room temperature or compatible refrigeration. These are category ceilings, not experimental proof for the exact formula or Greek law.
Calculation for an actual batch
The clock starts at compounding initiation date/time. Select the shortest supported period/date with its conditions. Do not exceed commercial-component expiry. A compounded component’s BUD generally constrains the final preparation; a specific modifier/vehicle exception needs final-quality justification. A shorter in-use limit also constrains use. Repackaging, stirring or fresh-material addition does not restart BUD.
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.
Aqueous extension and preservation testing
Extension beyond 14/35 days under USP requires a stability-indicating study for APIs, exact formula and container/closure materials, plus suitable <51> antimicrobial effectiveness. Preservation studies cover formula/container or valid bracketing, not every batch. Enumeration, absence of specified organisms and antimicrobial effectiveness are different tests.
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 law2026-10-14
- 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 guidance2026-10-14
- 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 certification2026-10-14
- USP — General Chapter <795> FAQsUpdated 1 November 2023; retrieved 14 October 2026Questions 52–66, especially 52, 54–56, 58–59, 61–64Publisher interpretation: optional formula-specific aw testing, initiation-date BUD, stock-component exceptions, exact-formula stability studies and antimicrobial-effectiveness testing. Not Greek law.2026-10-14
- USP — Compounding Standards <795> and <797>, USP scientific presentation2025 USP scientific presentation; NCPA-hosted public copySlides 12–15 (nonsterile BUD table and extension)Primary USP educational presentation confirming nonsterile category ceilings and storage columns; not a substitute for the full current chapter.2026-10-14