INCREASED TIME COMMITMENTS AND COSTS FOR ADHERENCE TO USP 797 STANDARDS FOR MIXING ALLERGY IMMUNOTHERAPY

USP Chapter 797 standards for mixing allergy immunotherapy changed in November 2023. Major requirement changes include: certifications for compounding personnel, a dedicated compliant area for mixing, and updated immunotherapy mixing and disinfection workflow protocols. New mixing allergy immunotherapy procedures ensure allergen extract purity. Personnel must undergo testing and certification to ensure proper care of compounded sterile preparations (CSPs) every 12 months in accordance with USP Chapter 797. Testing includes: personnel hygiene and protection, cleaning and disinfection of the area, compounding, aseptic technique, maintenance of sterility, documentation, and proper workflow and utilization of the area. Additionally, certified staff must undergo new workflow changes to ensure sterility of the compounding area and product. We hypothesized the new mixing allergen extract procedures, including disinfection protocols, would take an additional 15 minutes to conduct, not inclusive of original mixing times and thus increase cost of personnel testing, cleaning materials and personal protective equipment (PPE) per clinician versus traditional methods. Compliance with USP 797 entails hand hygiene, proper PPE usage, clear documentation, accurate mixing, and disinfection of area before and after compounding. Our office implemented these changes which resulted in an additional 10 minutes of time being recorded for prep and post disinfection. USP 797 guidelines have increased the time clinical staff must spend to mix allergen extracts. The additional 10 minutes does not include: allergen extract administration, bottle mixing, nor the certification of personnel and the monthly disinfectant maintenance of the area. Additionally, results do not include maintenance material costs for continued operation.