ALG-004 / v1.0
Milk allergy and preparation evidence
A new profile separating milk clinical recommendations from quality of an individual laboratory preparation.
Development dossier · No validated formula, clinical dosing schedule or established finished-preparation BUD.
Clinical-evidence scope
EAACI suggests oral immunotherapy for selected children/adolescents with milk allergy, generally after four years of age, under a specialist team. This is not a self-administration instruction or technical compounding monograph. The specialist determines patient, material and regimen.
Different materials
Liquid milk, milk powder, protein fractions and differently heat-treated products are not identical materials. Absence of lactose does not establish absence of milk proteins. The clinical order must identify exact material and strength basis.
Required technical assessment
Require identity, lot, transport conditions, analytical concentration in the matrix, uniformity, microbiology and packaging. A food’s dating does not automatically transfer to a differently diluted compounded product. This source profile assigns neither recipe nor BUD.
Sources and references
- 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
- 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
- NIH NIDDK — Definition & Facts for Lactose IntoleranceReviewed February 2018; accessed 2026-09-12What is lactose intolerance?Lactose is milk sugar; lactose intolerance differs from immune-mediated milk allergy2026-09-12