SOP-023 / SOP v1.0
Clinical excipient and dose review
Assessing order suitability for the actual patient.
Procedure
- Verify patient, age, weight where needed, route, prescribed dose and frequency. Clarify ambiguous instructions with the prescriber.
- Record known allergies/adverse reactions and the responsible ingredient. Distinguish allergy from intolerance, irritation or preference.
- Calculate excipient exposure from the maximum daily preparation amount. Consult current official warnings for age/route and concomitant products.
- Check units: concentration, dose and volume are different quantities. For C mg/mL and D mg, volume = D/C mL, only for the confirmed chemical and dose basis.
- If an excipient must change, reassess the complete new formula, uniformity, preservation and BUD. Do not retain old evidence as applicable without comparison.
- Document the decision, source and date. Free from a specified ingredient does not mean free from allergy risk.
Stop criterion
Dose, route or critical-excipient mismatch: no supply before clarification.
Related forms
Sources and references
- 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
- 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