On November 4, the revised Chapter 797, Pharmaceutical Compounding-Sterile Preparations, of the United States Pharmacopeia (USP) was released. The revised chapter includes updates to beyond-use-dates (BUDs), better reflects advancements in science and clinical practice, and protects patient safety while maintaining patient access to allergen immunotherapy through physician in-office compounding of allergenic extracts.
Given the critical role that the management of allergic disorders plays in our specialty, the AAO-HNS, the American Academy of Otolaryngic Allergy (AAOA), and other affected organizations, have collaborated over the past six years to influence several iterations of USP Chapter 797 drafts.
In 2018, the AAO-HNS submitted its comment to the United States Pharmacopeia (USP), supporting its proposed revisions to Chapter 797 regarding physician in-office sterile compounding. The proposed revisions re-established an exception for allergen extracts mixed with aseptic technique, but without the environmental and other controls required for more dangerous compounded drugs.
Physicians have been preparing allergenic extracts in their offices for more than 100 years under general aseptic conditions, but outside of an ISO-classified environment, with no evidence of sterility problems or patient harm. In the Academy’s comment, we thanked the USP Expert Committee for its decision to protect patient safety while maintaining patient access to allergen immunotherapy through physician in-office compounding of allergenic extracts.
The revised Chapter is effective November 1, 2023. To learn more about the revisions, please visit Updates to USP Chapter 797.
