USP Chapter 797 update

Representatives of the College and AAAAI attended a very brief conference call with the United States Pharmacopeia (USP) on Feb. 26 regarding their timeline for Chapter <797> – listed below. USP has reviewed all comments received on their previously proposed revisions to Chapter <797> and plans to release a new proposal for comment.

2018

  • July 27: Proposed rule – new Chapter <797> – open for public comments
  • Nov. 30: Comment period ends

2019

  • June 1: Intended publication of revised Chapter <797>
  • Dec. 1: FINAL rule becomes official

We will continue to work with USP and will notify members when your grassroot efforts are needed. It will be important for all members to support the College and AAAAI’s position – that allergenic extract mixing should not be subject to the same stringent requirements that apply to pharmaceutical compounding – once the new proposal is released. We’ll keep you updated as this issue progresses.

Advocacy Issue: 
Mixing Allergen Extracts
Extracts