Allergen immunotherapy: How to stay current with USP 797 and practice guidelines.

Abstract

Background: The United States Pharmacopeia (USP) Chapter 797 provides critical standards for compounding sterile preparations to ensure patient safety and medication efficacy. The latest revision, effective November 1, 2023, introduces updates particularly relevant to the compounding of allergenic extracts, which emphasizes stringent compliance measures. Objective: This article aims to review the key updates to USP Chapter 797, outline the compliance requirements for personnel and facilities, and offer strategies for staying current with these practice guidelines, leveraging resources from professional organizations such as American College of Allergy, Asthma, and Immunology and American Academy of Allergy, Asthma, and Immunology. Methods: An extensive review of the updated USP Chapter 797 guidelines was conducted, along with supplementary research from professional resources and literature to provide a comprehensive overview of the new standards and best practices for compliance. Results: The updated USP Chapter 797 mandates comprehensive training and competency testing for compounding personnel, facility maintenance and documentation standards, and robust quality assurance protocols to minimize contamination and ensure the efficacy of compounded allergenic extracts. Key requirements include enhanced personnel hygiene and garbing requirements, facility maintenance protocols, and detailed documentation practices. Conclusion: Staying current with USP Chapter 797 and practice guidelines is crucial for allergists and immunotherapy practitioners to ensure high standards of patient care and safety. By understanding the key updates, complying with personnel and facility requirements, leveraging professional resources, and adopting standardized practices, health-care providers can effectively navigate the evolving regulatory landscape. Continuous education and adherence to quality assurance protocols will further support compliance and enhance patient outcomes in allergen immunotherapy.