Discussions with USP
Leaders of the Advocacy Council and the College had a call with USP officials on Wednesday morning. We had requested it because we'd been told USP still had many misconceptions on preparation and use of allergenic extracts.
We were able to clarify mixing and storage procedures. At the end of our presentation, no one from USP had any questions. USP let us know that a second draft proposal would likely be released; it's likely the comment period will extend into 2017.
We were told that USP's next meeting would be in September to discuss comments received. They also will be hosting expert round table discussions, although participation is by invitation only, and will include various science and policy experts. We plan to request an invitation.
AMA on our side
On another front, a resolution presented by Stephen Imbeau, MD, FACAAI, Advocacy Council vice chair, regarding compounding was passed at the annual AMA meeting this week. It proclaimed AMA's support for retention of the current USP 797 allergy exception. It also proposed the formation of a Specialty Coalition (allergy, dermatology otolaryngology, oncology, ophthalmology, and neurology) to jointly engage with USP, the FDA and Congress on the issue of physician office-based compounding and the proposed changes to USP 797. The resolution supports the position that regulation of compounding in physician's offices be regulated by the State Medical Boards and not State Pharmacy Boards.
"The AMA supports the current 2008 USP Ch. 797 sterile compounding rules as they apply to allergen extracts, including specifically requirements related to the beyond use dates of compounded allergen extract stock."
While Dr. Imbeau was integral in guiding the resolution through the AMA House of Delegates, this was a team effort, including our AMA representatives, Alnoor Malick, MD and John Seyerle, MD, as well as the delegates from the American Academy of Allergy, Asthma & Immunology's George Green, MD and the American Academy of Otolaryngology's Wes VanderArk, MD.