Implementation of the new USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations is still postponed. In March, the Appeals Panel convened to deliberate and evaluate the appeals. After deliberation, the both General Chapters <797> and <795> (non-sterile preparation) were remanded to the Compounding Expert Committee with recommendations for further engagement on the issues raised concerning beyond-use date provisions.
What does this mean? It means the current 2008 revision of General Chapter <797> remains in effect. The Appeals Panel did not determine that the chapters require revision, but noted that the issues raised in the appeal warrant additional dialogue and consideration. The Compounding Expert Committee will determine the appropriateness of future revisions, if any.
Given the above, we do not expect any changes to the allergy component of the pending update. We will continue to monitor USP and its Compounding Expert Committee efforts to keep you informed.
In the meantime, the AAOA has worked to develop resources and tools to help you meet the compliance criteria outlined in the pending chapter.
Last Fall, we released our USP General Chapter <797> Sterile Allergen Extract Compounding Online Module to help you and your practice meet the compounding personnel criteria. USP <797> requires personnel to demonstrate proficiency in knowledge of principles and skills for sterile compounding every 12 months and to document training and competency. Partnering with Area9 and its adaptive learning platform, the AAOA’s online module is a great tool to help assure you can meet and document the proficiency defined in USP <797>. Because it is based on adaptive learning, module participants will succeed through the learning process. So it is a great tool to help learn about sterile compounding as well as document proficiency.
AAOA has also partnered with Valiteq to offer kits as a special AAOA member rate to meet the media fill and gloved fingertip testing requirements. Each kit, currently defined as Allerteq A1CDI, consists of the media fill test, the gloved fingertip test kit with 6 contact plates, 2-week incubation process, 1-week growth promotion, and a written report at 4 weeks. AAOA members will get a 15% discount on the kits. The kits list for $200 and AAOA members will pay $170 plus shipping. View what’s in the kit.
While the implementation dates for the new USP General Chapter <797> are still undefined, AAOA’s resources are available for you and your staff as you position your practice to meet the new guidance.