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What You Need to Know about Proposed Changes to USP 797


As previously reported to AAAAI members, the practice of allergen immunotherapy as we know it is at risk. The United States Pharmacopeia (USP) has proposed changes to be required of all sterile compounding, including allergen extract preparation.

These changes include more complicated mixing procedures, significantly shortened timeframes for how long extracts can be used, and add burden to your storage and documentation processes. You can read more about the changes in the draft update of USP Chapter 797 available here, which was open for public comment until January 31. Thank you to everyone who submitted comments to USP during this public comment period and to all who shared the AAAAI’s change.org petition to save patient access to allergen immunotherapy. The response from AAAAI members and their patients was extraordinary.

In addition, the AAAAI collaborated with the American College of Allergy, Asthma & Immunology and its Advocacy Council; the American Rhinologic Society; the American Association of Otolaryngic Allergy; the American Academy of Otolaryngology-Head and Neck Surgery; and the Allergy and Asthma Network to develop comments to send to USP.

You can read our letter here.

The AAAAI will continue to keep you updated on the situation as we learn more.

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