01Formula and ingredient review
- ✓Exact API and excipient identities, concentrations, dosage form, batch size and route
- ✓Current supplier SDS, hazard classifications, sensitization and reproductive-risk information
- ✓Powder, vapour, aerosol, splash, skin and eye exposure routes
- ✓Commercial availability, therapeutic rationale and whether the activity remains compounding
Process and frequency
- ✓Steps likely to generate dust, droplets, heat, pressure or difficult-to-clean residues
- ✓Quantities handled, frequency, duration and number of personnel potentially exposed
- ✓Risk created by crushing, milling, transferring, levigating, mixing or cleaning
- ✓Cumulative exposure across all preparations made in the same area
Controls and decision
- ✓Engineering controls, ventilation or containment and evidence they are suitable
- ✓PPE, work practices, spill response, waste streams and deactivation or cleaning method
- ✓Facility and equipment requirements plus cross-contamination controls
- ✓Assigned Level A, B or C with a written, formula-specific justification
Approval and reassessment
- ✓Residual risk after controls and any conditions or restrictions on preparation
- ✓Approval by authorized pharmacy personnel before implementation
- ✓Review trigger for ingredient, supplier, process, equipment, facility or evidence changes
- ✓Scheduled reassessment and linkage to training, incidents and corrective actions