OIT-001 · Allergist interface and order verification
Laboratory support for individual allergen preparations. This is neither a treatment protocol nor manufacturing authorisation.
Template for local scientific review and approval. This is not an approved SOP of a specific laboratory.
OIT-001 · 1.0 · 10.09.2026
Scope
Laboratory support for individual allergen preparations. This is neither a treatment protocol nor manufacturing authorisation.
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
Identify the responsible specialist and agreed clinical plan. Patient selection, initiation and dose escalation belong to the specialist clinical team.
Verify the exact allergen, raw-material form, route and dose basis. Clarify in writing whether the order refers to food mass, total protein or another defined quantity.
Agree the required final concentration, dosing device and permitted variability using suitable scientific evidence. Do not arbitrarily convert grams of nut to milligrams of protein.
Confirm a clinical plan for reactions, illness, missed doses and restarting. The pharmacy must not improvise dose changes.
Check whether local facilities, permissions and controls are adequate. Following this template does not certify clinical efficacy or lawful supply.
For pistachio, document the specific basis of the clinical plan. Peanut recommendations do not automatically extend to tree nuts.
Stop criterion
Ambiguous order, no clinical lead or unsupported strength basis: do not compound.
Related records
- F-001 · Local adoption and risk assessment
- F-002 · Master formulation record
- F-010 · Allergen traceability and handover
Sources
- EAACI — Guidelines on the management of IgE-mediated food allergy
- Santos et al. — EAACI management guideline, DOI 10.1111/all.16345
- NAPRA — Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018; clarification 2022)
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: __________