USP General Chapter <797> Released

After a multi-year effort, the long-awaited revision of Chapter 797 Standards for Sterile Compounding (797) of the United States Pharmacopeia (USP) has been released with an expected implementation date of November 1, 2023.

Thanks to the joint efforts of the AAOA, AAAAI, ACAAI, and AAOHNS, the final standards for compounding of allergen extract mirror the proposed standards released in 2019. The final document still allows for physician compounding in an office setting to ensure patient access to allergy therapy.

This final revision includes updates to beyond-use-dates (BUDs) and better reflects advancements in science and clinical practice. The allergen extract compounding requirements address compounding personnel training and evaluation, hygiene and garbing, and updated documentation requirements, plus either installation of an ISO Class 5, Primary Engineering Control (PEC) OR establishment of a Dedicated Allergenic Extracts Compounding Area (AECA) with specifications and requirements provided for either option.

To access the new USP General Chapter <797>, one needs to subscribe to the USP Compounding Compendium via its new online platform that hosts quality assurance standards for healthcare settings and drugs marketed in the United States. AAOA has resources available on its website outlining the changes as proposed in 2019, along with access to AAOA USP Compliance tools.

AAOA’s USP General Chapter <797> Sterile Allergen Extract Compounding Online Module

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As we learn more about the update, we will keep you posted.   

Here is a link to the USP’s Fact Sheet and FAQs:

https://aaoallergy.org/wp-content/uploads/2022/11/USP22_HQS_Compounding_Handout_6a_with_pricing___final.pdf

https://aaoallergy.org/wp-content/uploads/2022/11/USP22_USP_HQS_Compounding_Compendium_FAQ_V2_10.27.pdf