Submitted by Ellen Price on
USP has finalized the Chapter 797 standards for sterile compounding, including standards specifically for physician in-office compounding of allergen extracts in allergy practices, with an implementation date of November 1, 2023. The purpose of the standards is to ensure safe treatment of an allergy clinic's patients.
The Compounding Corner has been established to prepare physicians, practice managers, and clinic staff at allergy practices to achieve and maintain compliance ahead of the updated implementation date. Ensure your practice is ready by browsing our resources and working through our training module below. View the final language from the allergenic extracts section here.
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AAAAI Training Module
|Activity Title||Credit||Cost||Start and Expiration Dates|
|USP Chapter 797: Allergen Extract Compounding||$0.00||10/31/2022 - 8:00am to 06/30/2023 - 11:59pm|
Guides to Compliance
AAAAI Resources on Chapter 797
Podcast Episode 91: What USP 797 Means for Allergists
Podcast Episode: Episode 9: Hot Topics: USP Chapter 797 Standards for Allergen Immunotherapy
Video Recording: Mixing Allergy Serums, Safe Administration, and Compliance with USP 797 Guidelines
Summary of Facility Requirements
Summary of Personnel Requirements
Allergen Immunotherapy Practice Parameter
AAAAI Practice Management Resource Guide, Chapter 9: Allergen Immunotherapy Extract Preparation
The information in this chapter is consistent with the current immunotherapy practice parameter. It is currently under revision to include the new USP 797 requirements.
A Case-Based Immunotherapy Prescription Mixing Workshop Video of 2019 Annual Meeting Session
Allergen Immunotherapy Mixing Process: Mayo Clinic
Important: This video is provided as a review of procedures for sterile compounding of allergen extract. Please note that this was filmed in 2012 and the area in which it is filmed is not compliant with currently pending USP Chapter 797 requirements. It is provided for instruction on the compounding process only.
Frequently Asked Questions
Have a question that wasn't answered in the training module? Check our list of FAQs below.
Q: What in the new standards applies to allergen extract mixing?
A: From the USP chapter 797 posted for 2021 update:
Allergenic extracts: Licensed allergenic extracts are mixed and diluted to prepare prescription sets for administration to patients. A prescription set is a vial or set of vials of premixed licensed allergenic extracts for subcutaneous immunotherapy that have been diluted with an appropriate diluent for an individual patient. Because of certain characteristics of allergenic extracts and allergy practice, preparation of allergenic extract prescription sets is not subject to the requirements in this chapter that are applicable to other sterile CSPs. The standards for compounding allergenic extracts, which are described in 21.
Compounding Allergenic Extracts, are applicable only when:
- The compounding process involves transfer via sterile needles and syringes of conventionally manufactured sterile allergen products and appropriate conventionally manufactured sterile added substances; and
- Manipulations are limited to penetrating stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile vials
Q: Is a sink necessary in the same room as the dedicated Allergen Extract Compounding Area (AECA) in order to perform the hand washing procedure?
A: If a sink is present it must be at least one meter from the dedicated AECA. There is no requirement that there be a sink in the AECA.
Q: Can a ceiling fan circulate in the room while compounding occurs, or must the room be climate controlled?
A: A ceiling fan may not be circulating in the room while compounding occurs, nor may the dedicated Allergen Extract Compounding Area be adjacent to other environmental control challenges.
Q: Does a physician always need to be on site during allergen extract mixing?
A: Yes, according to the current Allergen Immunotherapy Practice Parameter.
Q: Where can I access the required written test?
A: A sample written test will be available here in the Compounding Corner in June, 2023.
Q: I have carpeting in my compounding area. Do I need to replace my flooring?
Yes. Under the existing rules, no area in which compounding is being performed should have carpeting.
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