USP General Chapter <797> Compliant?  AAOA Has the Resources You Need

Impacting allergy immunotherapy vial preparation, USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations went into effect November 1^st. With this comes opportunities to review and refine your allergy vial prep processes and protocols. AAOA has developed tools and resources to help you 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 at a minimum two staff are trained to help assure your allergy services are not hampered by vacations or sick leave. All personnel involved in vial prep must document compliance. Below are 3 key compliance measures:

1. Annual personnel training and competency must be documented. Personnel must demonstrate proficiency in knowledge of principles and skills for sterile compounding
   • AAOA USP <797> Allergen Extract Compounding Learning Module helps you meet this requirement
2. Successful completion of the gloved fingertip and thumb sampling on both hands, no fewer than 3 separate times. 
3. Successful completion of the media fill test to demonstrate sterile technique
   • AAOA members get a special discounted rate through Valiteq on both the gloved fingertip sampling and media fill test kits (https://x9j1f2.p3cdn1.secureserver.net/wp-content/uploads/2023/10/Allerteq-Order-Form-AAOA.pdf)

Featured in the following document is the AAOA Compliance Checklist. This easy to use check list  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 standard operating procedures 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:

• Online Sterile Allergen Extract Compounding Module
• Special AAOA member pricing for Valiteq Media Fill Test kits
• Special AAOA member pricing for Valiteq Gloved Finger Test kits
• Practice Resource Tool Kit
• Clinical Care Statement
• USP 797 Workshop Handout 
• AAOA YouTube Video
• Valiteq Order Form 
• Valiteq Kit Instructions

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.