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OIT-007 / SOP v2.0

Allergen label and safe handover

Preventing allergen, concentration and dose mix-ups.

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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.

Edition-specific 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.

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, 2008Sections 2, 4.1.1, 4.2.4, 4.3, 4.4.3–4.4.5; pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-09-12
  2. Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Abstract and published guideline recommendations; DOI 10.1111/all.16345Specialist clinical recommendations; not stability evidence for local syrups or suspensions2026-09-12
  3. FDA — PALFORZIA prescribing informationUS prescribing information, July 2024 revision, accessed 2026-09-12Sections 1, 2.3, 4, 5 and 16Specific authorised product only; no equivalence with pharmacy-made peanut preparations2026-09-12
  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 revision2026-09-12