OIT-007 · Allergen label and safe handover

OIT-007 · 1.0 · 10.09.2026

Scope

Preventing allergen, concentration and dose mix-ups.

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. Prominently identify the allergen and species. Pistachio and peanut have separate identities and are not interchangeable.

2. State the exact measured/justified concentration basis. Do not label a quantity derived only from food mass as mg protein/mL.

3. Link administration instructions only to the confirmed clinical order. The label does not create an escalation schedule.

4. Add lot, actual BUD, storage, justified shaking, withdrawal device and allergen warning. Independently check similar containers of different strengths.

5. Verify the recipient and their understanding of how to contact the clinical team and follow their own emergency plan.

6. Record container count, lot, recipient and handover conditions in a protected record. Do not enter patient details on a public website or Facebook group.

Stop criterion

Related records

• F-010 · Allergen traceability and handover

Sources

• EAACI — Guidelines on the management of IgE-mediated food allergy
• NAPRA — Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018; clarification 2022)
• FDA — PALFORZIA: product information and package insert

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: __________