FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
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PUB-011 / v2.0

Compounding records and traceability

This updated text accompanies F-001 through F-018. Sources and signatures must allow retrospective review of actual product, materials and handover.

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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.

Data and traceability

Using technical experience does not require publishing identifiable patient information. Public documents describe questions and technical findings without personal details. Full order/material/batch/recipient linkage remains in the pharmacy’s protected system. Research use of data requires appropriate separate governance.

Linkage chain

Order → master-record version → actual lots and weights → tests → label → recipient. Verify unique IDs and quantity reconciliation during recall. If affected containers cannot all be identified, the deviation cannot be considered closed.

Sources and references

  1. 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
  2. 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
  3. 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
  4. European Parliament and Council — Directive 2001/83/ECConsolidated text displayed as current on 2026-09-12Articles 2, 3(1)–(2), 6; consolidated 1 January 2025Specific EU scope exclusions; national pharmacy conditions still require verification2026-09-12