FOR PHARMACISTS · SCIENTIFIC COLLECTION 10.0310 monographs · 36 SOPs · 22 forms
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OIT-001 / 2.1

Allergist interface and order verification

Laboratory support for individual allergen preparations. This is neither a treatment protocol nor manufacturing authorisation.

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

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Procedure

  1. Identify the responsible specialist and agreed clinical plan. Patient selection, initiation and dose escalation belong to the specialist clinical team.
  2. 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.
  3. 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.
  4. Confirm a clinical plan for reactions, illness, missed doses and restarting. The pharmacy must not improvise dose changes.
  5. Check whether local facilities, permissions and controls are adequate. Following this template does not certify clinical efficacy or lawful supply.
  6. For pistachio, document the specific basis of the clinical plan. Peanut recommendations do not automatically extend to tree nuts.

Additional detail

The allergist agreement identifies the exact protocol and product, allowed strength range and management of deviations/missed doses. EMA industrial-allergen guidance and FDA PALFORZIA information do not authorise local compounding. Do not add initiation or escalation schedules to a laboratory SOP.

EMA 2025 Type I allergy quality principles may inform technical assessment. Type IV/patch-testing exceptions are not transferred to OIT, and this guideline creates no clinical dosing programme.

Stop criterion

Ambiguous order, no clinical lead or unsupported strength basis: do not compound.

Related forms

F-001, F-002, 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