FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
Sikaliascompounding.grSikalias Greek Formulary
Home / Quality system / Stability-study applicability and BUD extension · SOP-020

SOP-020 / 2.1

Stability-study applicability and BUD extension

Acceptance of published or commissioned studies for an exact monograph.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.1Record editorial review date: 2026-10-14

Download bilingual PDFJSON

Procedure

  1. Identify the full study, authors, version, DOI/URL and corrections. An abstract or promotional claim is insufficient for complete method appraisal.
  2. Compare active/salt, concentration, starting product, all excipients/preservatives, process, container/closure and temperature. Record every difference and its relevance.
  3. Determine whether the assay separates API from degradation products and whether recovery suits the matrix. Assess physical attributes and dose delivery, not only percentage API.
  4. For an aqueous extension beyond default limits, require suitable <51> preservative effectiveness for the exact formula and container/closure materials or valid bracketing. Assess opening/withdrawal conditions. Passing microbiology at time zero is insufficient.
  5. Set the maximum supported period only within the applicable framework. The public USP implementation allows up to 180 days with a suitable study; a specific USP–NF monograph is assessed in its full current text. No general Greek legal applicability is asserted.
  6. The reviewer approves F-013 and transfers period, temperature and restrictions to F-006 and the label. Changing a critical feature prevents automatic reuse of the decision.

Additional detail

For a compounded vehicle without API, assess appropriate matrix attributes such as appearance, pH, composition, microbiology and preservation; an assay of a nonexistent active is not required. Published and unpublished data undergo the same suitability appraisal.

Stop criterion

Unresolved critical mismatch or inadequate study: no extension beyond an applicable default.

Related forms

F-013, F-006

Sources and references

  1. 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
  2. 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
  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 certification2026-10-14
  4. 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
  5. 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