PUB-010 / v2.0
Written procedures for nonsterile compounding
This updated text links procedure, responsibility and evidence. Collection SOPs need named local approval, suitable equipment and training before use.
Scope and professional responsibility
Article 3 of Directive 2001/83/EC provides specific scope exclusions: pharmacy preparation against a prescription for an individual patient and, separately, pharmacopoeial preparation supplied directly to that pharmacy’s patients. This is not a blanket exemption for every activity called compounding and does not remove national quality or operational requirements. Industrial product development and supply require a separate regulatory assessment.
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.
Patient staff and contamination
Assess clinical risk, staff exposure and residue carryover into the next task separately. Quantity, frequency, dust/vapour generation and containment influence the decision. Use the exact material’s current SDS and an appropriate active-drug source. Absence from a hazardous-drug list does not mean absence of hazard.
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.
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.
Minimum procedural structure
ID, revision, scope, responsibilities, prerequisites, sequence, predefined criteria, deviation action, records and sources. Actual limits are specified in the relevant master record or method. Copying another facility’s procedure does not establish that the local facility can implement it.
Sources and references
- 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
- 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
- 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
- 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