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BRIEF RESEARCH REPORT article

Front. Allergy

Sec. Allergen Immunotherapy

Economics of Compliance for Mixing Allergy Immunotherapy

Provisionally accepted
Katarina  TrapanottoKatarina Trapanotto1,2*Mary  F. Lee-WongMary F. Lee-Wong3,4Robert  A. PromisloffRobert A. Promisloff5Anthony  SzemaAnthony Szema6
  • 1Stony Brook University, Stony Brook, United States
  • 2Stony Brook Medicine, Stony Brook, United States
  • 3Maimonides Medical Center, New York, United States
  • 4Icahn School of Medicine at Mount Sinai Department of Medicine, New York, United States
  • 5Drexel University College of Medicine, Philadelphia, United States
  • 6Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, United States

The final, formatted version of the article will be published soon.

United States Pharmacopeia (USP) Chapter 797 standards for the preparation of allergy immunotherapy vials changed in November 2023. These guidelines impacted facility and personnel qualifications, workflow, and laboratory documentation. We hypothesized adhering to regulations may be financially difficult for allergy practices. To comply, offices must either use mail order prescription facilities or allocate financial resources to purchase a Primary Engineering Control (PEC) Hood or build-out an Allergenic Extract Compounding Area (AECA). We performed a comparative analysis to determine financial feasibility of these three scenarios with the support of a Public Service Enterprise Group (PSEG) grant. Of these three options prescription sets were most costly, followed by PEC Hood and AECA. For both PEC Hood and AECA, costs were recouped by the third week of operation. In conclusion, for long term operation, the AECA would be most feasible for small private practice outpatient clinics regarding overall cost and estimated revenue.

Keywords: allergenic extracting compounding area (AECA), United States Pharmacopeia (USP), Immunotherapy, Cost analyses, primary engineering control (PEC) hood, compounding, Allergenic extract

Received: 20 Oct 2025; Accepted: 02 Dec 2025.

Copyright: © 2025 Trapanotto, Lee-Wong, Promisloff and Szema. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Katarina Trapanotto

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