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Immunotherapy Safety and United States Pharmacopeia (USP) 797 Update


The AAAAI remains committed to advancing the practice of allergen immunotherapy and continues to fight the Chapter 797 changes proposed by the United States Pharmacopeia (USP). As communicated in June Practice Matters, AAAAI and other organizations participated in a June 3 Food and Drug Administration (FDA) listening session on compounding. Advocacy Chair Andrew W. Murphy, MD, FAAAAI, spoke with USP representatives in person at that meeting to reinforce our concerns. Executive Vice President Thomas B. Casale, MD, FAAAAI, Past President Linda Cox, MD, FAAAAI, Board member Aidan A. Long, MD, FAAAAI, and others also spoke with leaders from USP at the Eastern Allergy conference in Palm Beach, Florida on June 4.

The AAAAI recently submitted comments to the FDA in response to proposed rules about compounding in hospital and health system pharmacies. One proposed rule would allow products compounded by such a pharmacy to only be administered within one mile of the facility. We told FDA this threatens access to allergen immunotherapy for patients seen by staff physicians of healthcare systems who practice in community clinics, some of which are in economically depressed areas where pediatric patients receive allergen immunotherapy for allergic asthma. We reiterated that any proposed change to compounding rules must balance perceived safety risks with patient access to proven, safe and effective medical care. See the AAAAI's comments here.

The AAAAI received support from the American College of Physicians (ACP), which also submitted comments to the FDA in support of patient access to care and safety concerns that necessitate allergen extracts prepared via physician in-office compounding. See the ACP's letter here.

Additional postings from the FDA earlier this week will also be commented on, and outreach to members of Congress and other interested organizations continues as well. While it is difficult to estimate when the USP issue will be resolved, we are extremely confident that USP is much more aware and tuned into the concerns of the A/I community related to the proposed Chapter 797 changes.

Click here to find out more about USP.

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