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OIT-007 / 2.1

Allergen label and safe handover

Preventing allergen, concentration and dose mix-ups.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.1Record editorial review date: 2026-10-14

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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.

Additional detail

Place full botanical identity, supported concentration and route on every container and link them to the clinical order. FDA PALFORZIA instructions concern mixing with semisolid food and prompt consumption, not a stored liquid. Do not present a pharmacy suspension as equivalent to that product.

Lot ID, concentration basis and allergen identity must remain readable on small containers. Handover sequence does not replace independent product/dose verification.

Stop criterion

Product/order mismatch or dose-basis confusion: stop handover and contact the specialist.

Related forms

F-010

Sources and references

  1. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007; adopted 20 November 2008; effective 20 May 2009; remains current effective quality version on EMASections 2, 4.1.1, 4.2.4.4, 4.4.3–4.4.5; document pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-10-14
  2. Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Recommendations 8, 9, 12 and 13; desensitisation versus remission/continued treatmentSpecialist clinical recommendations; not stability evidence for local syrups or suspensions2026-10-14
  3. FDA — PALFORZIA prescribing informationUS prescribing information, Revised 07/2024; rechecked 2026-10-14Sections 2.3, 4, 5, 11 and 16; current FDA-linked labelSpecific authorised product only; no equivalence with pharmacy-made peanut preparations2026-10-14
  4. 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 revision2026-10-14
  5. EMA — Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populationsEMA/161669/2025; adopted 10 June 2025; effective 1 January 2026Sections 2, 4 and 4.1 (Type I allergy quality aspects); pp. 4–6; section 8.4 for food-allergy endpointsIndustrial allergen development and quality guidance; complements 2008 guideline. Section 4.2 Type IV patch-test exceptions are not transferred to food OIT.2026-10-14