FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
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PUB-003 / 2.1

Compounding documentation with controlled records

Repeatable preparation requires identifiable instructions and a complete actual record. Documentation links decisions to evidence and batches to recipients.

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

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From instructions to actual records

Master record F-002 specifies what should happen. Batch record F-003 records what happened: lots, weights, times, equipment, tests, yield, label and signatures. Enter records when work occurs. A correction retains the original information and adds reason, date and identity. Do not pre-sign results or release decisions.

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.

Safe handover and learning

Handover links the correct patient, preparation, strength, route and dosing device. Assess understanding through demonstration and teach-back. Investigate complaints or failures using evidence rather than automatically assigning one mechanism. CAPA includes an owner, deadline and effectiveness check so the finding produces a concrete improvement.

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

  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 defaults2026-10-14
  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 revision2026-10-14
  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 — 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
  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 guidance2026-10-14
  6. 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