SOP-002 · Request and risk assessment

SOP-002 · 1.0 · 10.09.2026

Scope

Before accepting a new preparation or material change. This does not validate sterile compounding.

Roles and prerequisites

Responsible pharmacist: approves implementation and release. Trained operator: performs and records work. Reviewer: verifies critical items. Specialist clinician/analytical partner: as specified.

Before implementation complete local document IDs, named roles, suitable equipment, specific specifications and acceptance criteria. Check the applicable framework in your country.

Procedure

1. Confirm the prescription or permitted request, route, strength, population and clinical purpose. Resolve ambiguities with the prescriber.

2. Consider suitable authorised products and the reason for individualisation. Record the technical and professional rationale.

3. Assess potency, toxicity, sensitisation, dust, volatility, microbial risk and patient vulnerability.

4. Match risk to available facilities, containment, staff and analytical capability. Experience does not replace suitable facilities.

5. Record prerequisites, outsourced testing and the release authority. Sterile, cytotoxic or particularly hazardous work requires a separate specialist assessment.

6. Accept, request further information or refer to a suitable facility. Communicate limitations before compounding.

Stop criterion

Related records

• F-001 · Local adoption and risk assessment

Sources

• NAPRA — Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018; clarification 2022)
• NAPRA — Guidance Document for Non-sterile Preparations

These sources inform the original editorial synthesis. Their publishers do not adopt or endorse this SOP.

Local approval

Local version: __________ Effective date: __________
Author: __________ Reviewer: __________ Pharmacist approval: __________
Signatures / dates: __________ Next review: __________