February 7, 2017
On Thursday, Feb. 2, representatives from ACAAI and AAAAI participated in a United States Pharmacopeia (USP) roundtable on the proposed changes to USP 797 guidelines on compounding of allergen extracts in allergists offices and clinics. Members of the USP Roundtable Steering Committee, Drs. James Sublett, Tom Casale, Mike Nelson, and Steve Kagen attended and were joined by Drs. David Bernstein, Linda Cox, Gary Gross, Stephen Imbeau, Aidan Long, Kathleen May, and Andrew Murphy along with our legal advisors. Representatives from the AAOA, AAN, AAFA, the FDA, State Federation of Medical Boards, the Allergen Extract Manufacturers Association and other stakeholders were also in attendance. The roundtable was a day long discussion with the USP staff and USP 797 Expert Panel on the potential impact of the proposed changes.
The stated objectives for the revision of USP 797 are to assure sterility and stability. Several advances by our specialty have been made since the last Chapter 797 update. Our purpose was to educate the USP staff, 797 Expert Panel Chair and Vice-Chair and other roundtable members of those accomplishments.
Following a presentation on Allergen Immunotherapy Vial Preparation, overviews of data and research and recent publications on sterility and the lack of infection risk from immunotherapy were presented. Comments related to the most recent Practice Parameter on Immunotherapy, which has been updated since the last USP 797 update, were included. There was also discussion on the importance of continued patient access to immunotherapy and its risk/benefits. One important factor that differentiates our compounding extracts is the use of phenol and glycerin in our vials. This will be considered in any decision on Beyond Use Dates.
The panel recognized the continuing efforts by our professional societies to assure improved safety including the College’s Allergenic Extract Quiz, Annual Media Fill Test and the recently updated Allergen Immunotherapy Extract Preparation Physician Instruction Guide.
Overall, the roundtable allowed us to fill many knowledge gaps for USP related to allergen immunotherapy. Continued dialogue will occur, and, after the revised draft of the Expert Panel is published, there will be another opportunity for public comments.
Stephen Tilles, MD, FACAAI
Thomas Fleisher, MD, FAAAAI