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Allergy Extract Compounding Requirements Updates


AAAAI Keeps Compounding Concerns Before the AMA House of Delegates
The AAAAI submitted a resolution to the recent American Medical Association (AMA) House of Delegates Interim Meeting calling attention to the Food and Drug Administration’s (FDA) recent draft guidance, “Insanitary Conditions in Compounding Facilities.” This draft guidance inexplicably included physician in-office compounding in its definition of compounding facilities, which was inconsistent with any previous FDA action. The resolution called for the FDA to withdraw the draft guidance until the United States Pharmacopeia (USP) completes its revision of USP Chapter 797, which provides standards for sterile compounding.
 
The AAAAI worked with a number of other specialties to build support for the effort, and significant discussion and testimony were shared in Reference Committee. Ultimately, a final resolution was approved that called for FDA to remove physician in-office compounding, and also ambulatory surgery centers, from their definition of compounding facilities, without specific reference to the draft guidance regarding insanitary conditions. We are very pleased with this outcome and send our deepest thanks to the AAAAI’s AMA voting delegate, Steven G. Tolber, MD, FAAAAI, and alternate delegate and previous longtime delegate, George R. Green, MD, FAAAAI.
 
We also recognize and thank the American College of Allergy, Asthma & Immunology delegate Alnoor A. Malick, MD, FAAAAI, American Academy of Otolaryngic Allergy delegate Wesley D. Vander Ark, MD, and also Kira A. Geraci-Ciardullo, MD, and Stephen A. Imbeau, MD. Finally, we celebrate the outstanding leadership of AMA House of Delegates Chair, Susan R. Bailey, MD, FAAAAI.

Click here to find out more about the FDA and USP.

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