USP General Chapter <797> Sterile Allergen Extract
Compounding Online Module
About the Module
The new USP General Chapter <797> Guidelines go into effect November 1, 2023. For more on the AAOA resources to help you and your practice meet compliance click here .
As background, the United States Pharmacopeia (USP) is a nonprofit, nongovernmental standard-setting organization.
USP General Chapter <797> Sterile Compounding Timeline
2003: The initial compounding guidelines and USP <797> requirements came out.
2008: USP issued revisions in June of 2008 with reduced requirements including removing the need for a vent hood for compounding and short-storage period.
2013: In November of 2013, Congress passed legislation regulating the compounding of sterile medications as a reaction to 64 deaths. The two enacted requirements were the need to write a prescription for all sterile compounded medications and for all physicians to comply with USP General Chapter <797> sterile compounding rules.
2019: USP released an update to General Chapter <797> on June 1, 2019 with an anticipated date effect date of December 1, 2019.
Due to overwhelming feedback from key stakeholders, the 2019 document has undergone several reviews and iterations. AAOA worked closely with the otolaryngology and allergy societies to help impact how the guideline addresses allergy immunotherapy vial preparation.
2023: November 1 the updated USP General Chapter <797> Sterile Compounding is effective.
To assist AAOA members with compliance we have developed several resources. Key is our online adaptive-learning module on sterile vial prep. Unlike other compliance tools, this module is designed to teach throughout the testing process to help assure the learner comprehends all the core components of sterile vial preparation.
The AAOA USP General Chapter <797> Sterile Compounding module is an online learning tool created to help compounding personnel meet the sterile vial prep qualifications set by USP General Chapter <797>. Personnel must demonstrate proficiency in knowledge of principles and skills for sterile compounding every 12 months. Annual personnel training and competency must be documented.
This module is a tool to help you check that compliance box.
View other compliance requirements here.
Register Today
- AAOA Member $125
- Non-Member $300
Only the individual registered for this module will receive access to it and a certificate for completing it.
Module access will be activated within a week of the registration for the module being processed.
Registration fees are non-transferable and non-refundable.
For questions, please email [email protected] or call 202-955-501 during regular business hours.