Advocacy in Action: Revised physician compounding requirements improved

February 2019 – Vol. 38, No. 1

The AAO-HNS recently submitted comments to the United States Pharmacopeia (USP) supporting its proposed revisions to Chapter 797 regarding in-office sterile compounding by physicians. The revised chapter, which is markedly different from the first USP draft released in 2016, re-establishes an exception for allergen extracts mixed with aseptic technique, but without the environmental and other controls required for more dangerous compounded drugs.

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 been working collaboratively over the past three years to influence this latest iteration of the USP Chapter 797 draft.

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 comments, 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 final version of the chapter is expected to be posted on June 1, 2019, and will take effect in December 2019.

To view the AAO-HNS letter to USP, visit www.entnet.org/advocacy or contact healthpolicy@entnet.org.