The College coordinated representation by allergy organizations that attended the FDA’s Listening Session on compounding last week. We continue to defend the allergists’ right to provide allergy immunotherapy in their offices.
For more than a decade, the College and Advocacy Council have been closely monitoring all government discussion related to compounding and USP Chapter 797. In the mid-2000s, the Advocacy Council (then the Joint Council), worked closely with USP to develop an allergy exception in USP Chapter 797. It was published in 2008 and remained in place until 2015, when USP proposed a revision to the Chapter that eliminated the allergy exception. The elimination of the exception would have restricted allergy extract preparation in allergists’ offices.
The Advocacy Council worked tirelessly, and with the help of your grass roots efforts, a new exception in USP Chapter 797 – Section 21 – was agreed upon. A complete review of Section 21 is essential for all those preparing extract. Highlights of the section include:
- New personnel qualifications.
- New facility requirements.
- New documentation requirements.
While the final rule published June 1, 2019 has not been implemented yet, the Advocacy Council and College do not anticipate any changes to Section 21 and strongly recommend all preparers of allergenic extract implement and abide by the new rules. The College has developed the Allergen Extract Mixing Toolkit, which contains everything you need to be compliant. The Advocacy Council – we have you covered.