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SOP-014 / SOP v2.0

Stability and BUD justification

Assigning a use period for the exact formula, packaging and conditions.

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Procedure

  1. Compare the studied and local preparations: active, salt, strength, excipients, water, pH, process and container.
  2. Assess study quality and whether analysis distinguishes degradation. Preserved appearance alone does not demonstrate chemical stability.
  3. Assess chemical, physical and microbiological stability separately, preservative effectiveness where required, and in-use behaviour.
  4. Consider current jurisdictional requirements and material limitations. Do not automatically transfer a numerical BUD between sources or countries.
  5. In F-006 record the selected period, starting point, temperature, packaging, evidence and limitations. Calculate the actual date for each batch.
  6. Reassess after vehicle, supplier, process or container changes and temperature excursions. Do not extend expiry by relabelling without evidence.

Edition-specific detail

This edition uses the revised 2022 USP defaults for nonsterile preparations: unpreserved aqueous up to 14 days at 2–8 °C; appropriately preserved aqueous up to 35 days; nonaqueous oral liquids up to 90 days; other nonaqueous forms up to 180 days, with aw <0.60 for the last two categories. Category temperature and source compatibility are essential to the decision. A shorter supported limit or component expiry takes precedence. Do not assign a 14-day room-temperature period when refrigeration is incompatible.

Stop criterion

Insufficient evidence for critical stability: complete the assessment before release.

Related forms

F-006

Sources and references

  1. NAPRA — Model Standards for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 4–9Risk, personnel, facilities and QA; its historical BUD table is not used for current USP defaults2026-09-12
  2. NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-09-12
  3. 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
  4. 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
  5. 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