After weeks of partisan debate and internal Republican disagreements, President Trump signed the One Big Beautiful Bill Act (H.R. 1) into law on July 4. The sweeping reconciliation package advances many of the President’s top legislative priorities—including an extension of…
Looking for USP <797> Guidance? It’s in Your AAOA Member Benefits
10.
Looking for USP <797> Guidance? It’s in Your AAOA Member Benefits
USP General Chapter 797 Sterile Allergen Extract Compounding AAOA Online Module and Resources
USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations continues to impact allergy immunotherapy vial preparation since the updated rule went into effect on November 1, 2023. As a reminder, to support our members, AAOA has developed tools and resources to help you and your practice meet and document compliance.
All compounding personnel must meet key compliance criteria annually. We recommend you review your standard operating procedures (SOP) to help assure you are documenting training, competency, test results, vial lots, BUDs, and your internal processes. It is recommended that a minimum of two staff are trained to help assure your allergy services are not hampered by vacations or sick leave.
Featured in the following document is the AAOA Compliance Checklist. This easy-to-use checklist is intended to help you document compliance. We recommend pulling it out to make it part of your annual compliance review. Pages 1-3 are the compliance checklist. Page 4 is a sample log you can adapt to your practice or incorporate into your SOP manual. Pages 6-8 review personnel qualifications, facilities specifications, and documentation. It also offers a glossary of key sterile compounding terms.
More tools and resources:
- AAOA USP General Chapter <797> Allergen Extract Compounding Learning Module
- Special AAOA member pricing for Valiteq Media Fill & Glove Fingertip Test kits
- Valiteq Order Form
- Valiteq Kit Instructions
- Practice Resource Tool Kit
- Clinical Care Statement
- USP <797> Workshop Handout
- AAOA YouTube Video
While the USP no longer allows AAOA to reproduce the document in part or in total, you can visit the USP website to purchase a copy, should you wish.
FAQs
Q: How often do staff who prepare vials need to be trained?
A: All personnel involved in vial prep must document compliance. Below are three (3) key compliance measures.
- Annual personnel training and competency must be documented. Personnel must demonstrate proficiency in knowledge of principles and skills for sterile testing.
• AAOA USP General Chapter <797> Allergen Extract Compounding Learning Module is available for your practice to meet this requirement. https://www.aaoallergy.org/education/usp-797-sterile-allergen-extract-compounding-module/
- Successful completion of the glove fingertip and thumb sampling on both hands, no fewer than three (3) separate times.
- Successful completion of the media fill test to demonstrate sterile technique.
• AAOA members get a special discounted rate through Valiteq on both the glove fingertip sampling and media fill test kits.
- Valiteq Media Fill and Glove Fingertip Test Kit Instructions
- Order Form
- Media Fill and Glove Fingertip Testing Kit Unboxing Video
Q: Does AAOA have glove fingertip or media fill tests for USP General Chapter <797> compliance?
A: USP General Chapter <797> defines training and competency as the successful completion of the media fill test to demonstrate sterile technique and successful completion of the glove fingertip and thumb sampling on both hands, no fewer than 3 separate times. Current AAOA members can order discounted test kits for both the glove fingertip test and media fill test using the instructions and order form below.
- Valiteq Media Fill and Glove Fingertip Test Kit Instructions
- Order Form
- Media Fill and Glove Fingertip Testing Kit Unboxing Video
Q: What are the specific requirements for the allergy extract mixing area?
A: The specific requirements for the allergy extract mixing area listed in the Allergen Extract Compounding of In-Office Immunotherapy Vials, the USP 797 Compliance Tool, and explained in the video.
Compounding must occur in either (1) an ISO Class 5 Primary Engineering Control (PEC) or (2) in a dedicated Allergenic Extracts Compounding Area (AECA), either of which must not be within 1 meter from a sink and cannot be near unsealed windows, doors to the outside, or high traffic or other areas that present environmental control challenges (e.g. bathrooms, kitchens).
- Allergen Extract Compounding of In-Office Immunotherapy Vials Clinical Care Statement
- USP <797> Compliance Tool
- USP General Chapter 797 Sterile Allergen Extract Compounding AAOA Online Module and Resources video
Additional Resources
USP <797> FAQs https://go.usp.org/USP_GC_797_FAQs
The American Academy of Otolaryngic Allergy (AAOA) Practice Resources are intended as a guide to help AAOA members integrate allergy into their otolaryngology practice and to continually improve on this integration as new information, regulations, and resources become available.
While these tools are meant as resources, we highly recommend seeking input from your practice counsel and local/state medical associations and regulatory authorities, as rules vary between states. Each practice is responsible for confirming coverage, coding, and payment parameters for those payers and regulators affecting their practice. Our intention is to offer insights by sharing what others within AAOA do. These are not meant as recommendations.
