USP has finalized the Chapter 797 standards for sterile compounding, including standards specifically for physician in-office compounding of allergen extracts in allergy practices, with an implementation date of November 1, 2023. The purpose of the standards is to ensure safe treatment of an allergy clinic's patients.
The Compounding Corner has been established to prepare physicians, practice managers, and clinic staff at allergy practices to achieve and maintain compliance ahead of the updated implementation date. Ensure your practice is ready by browsing our resources and working through our training module below.
Request the Full Chapter from USP It will be emailed to you. (Do check your Spam or Junk folders if it does not come to your inbox.) To see the revisions in the allergenic extracts section, click here.
The contents of this page are currently under review. We welcome your feedback at email@example.com.
Guides to Compliance
AAAAI Resources on Chapter 797
AAAAI Practice Management Resource Guide, Chapter 9: Allergen Immunotherapy Extract Preparation
The information in this chapter is consistent with the current immunotherapy practice parameter. It is currently under revision to include the new USP 797 requirements.
A Case-Based Immunotherapy Prescription Mixing Workshop Video of 2019 Annual Meeting Session
Allergen Immunotherapy Mixing Process: Mayo Clinic
Important: This video is provided as a review of procedures for sterile compounding of allergen extract. Please note that this was filmed in 2012 and the area in which it is filmed is not compliant with currently pending USP Chapter 797 requirements. It is provided for instruction on the compounding process only.