FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
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SOP-002 / SOP v2.0

Request and risk assessment

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

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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.

Edition-specific detail

Assess patient risk, operator exposure and cross-contamination separately. Record active form, quantity and frequency, open operations and containment effectiveness. Absence from the NIOSH list does not remove the need to assess the SDS. Explain residual risk and the actual facility’s suitability.

Stop criterion

Unknown route/strength, inadequate containment or unresolved HOLD record: stop.

Related forms

F-001

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 defaults2026-09-12
  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 revision2026-09-12
  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 certification2026-09-12
  4. NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare SettingsDHHS (NIOSH) 2023-130Risk assessment and activity-specific control table, printed pp. 27–33Exposure routes and hierarchy of occupational controls2026-09-12