PUB-006 / 2.1
Stability rationale in pharmacy compounding
Dating is justified for a particular formula, package and conditions. Separate source instructions, experimental data and the default selected for the batch.
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.
Tests that answer the question
Appearance identifies some failures but does not establish strength, absence of degradants or microbiological suitability. Select method and criterion for the actual dosage form and use. A suspension needs redispersibility and device-delivered-dose assessment; at low strength, uniform mass does not imply uniform API. A critical specification failure requires quarantine and investigation.
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.
Starting point and type of dating constraint
The record separates initiation, completion and handover. BUD runs from initiation. Commercial expiry, in-use limit and a compounded component’s BUD are different constraints and are recorded separately. A specific modifier/vehicle exception needs final-quality justification.
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