Joint message on release of USP Chapter 797
The long-awaited revision of Chapter 797 Standards for Sterile Compounding (797) of the United States Pharmacopeia (USP) was released today, Tuesday, Nov. 1, with an expected implementation date of Nov. 1, 2023.
We are pleased to report that thanks to the vigorous collective advocacy of the Allergy/Immunology community, the final standards for compounding of allergen extract mirror the proposed standards released in 2019. The ACAAI and AAAAI believe these standards to be reasonable and achievable.
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.
The ACAAI and AAAAI are pleased that our work has resulted in standards that allow for the continued compounding of allergen extract prescription sets for individual patients in physicians’ offices. We wish to acknowledge leadership of the ACAAI and AAAAI who championed crucial advocacy outreach on this issue since 2015.
In addition, we must recognize the leaders who, throughout the history of our specialty, have taken very seriously the responsibility to educate and encourage Allergists/Immunologists to uphold safety standards for the compounding of allergen extracts, and investment in ongoing study thereof.
This commitment generated the data that enabled the USP Expert Compounding Committee to accept that in-office compounding can be done safely, and thus work to create meaningful patient safety standards that are also achievable in the office setting. We accept the new additional requirements, reflecting our shared dedication to past, present and future patient safety.
The new Chapter 797 standards are only available via individual subscription to the USP Compounding Compendium, an electronic platform that hosts quality assurance standards for health care settings and drugs marketed in the United States. We are working with the USP on a possible discounted subscription rate for our Allergist/Immunologist members. However, because the standards for compounding allergen extracts remain the same as those posted in 2019, you can access the information you need through ACAAI and AAAAI resources at the ACAAI’s Allergen Extract Mixing Toolkit and the AAAAI’s Compounding Corner.
We look forward to ongoing engagement with the USP in policy and standards development and additional issues relevant to ensuring patient safety while protecting access to care and improving patient outcomes.
Mark Corbett, MD, FACAAI
David A. Khan, MD, FAAAAI