FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
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OIT-001 / SOP v2.0

Allergist interface and order verification

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

Download individual SOP · PDF

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.

Edition-specific 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.

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, 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