New Revised USP 797 Allergy Compounding

Published: August 7, 2018

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On July 27 USP released a new proposed revision to the 797 sterile compounding guidelines. In particular, there are substantial changes being implemented to allergy immunotherapy treatment set compounding. In order to be in compliance with the revised USP 797, facilities engaging in the compounding of allergy treatment sets will need to essentially meet all of the testing, qualification, cleaning, and documentation requirements of the full USP 797 required of all other sterile compounding activities. Some specific examples include:

1) A dedicated allergenic extracts compounding area
2) Smooth, impervious, non-shedding preparation surfaces
3) Cleaning of ceilings, walls, floors, and fixtures
4) Temperature and humidity controls within the compounding space
5) SOPs describing all aspects of the compounding process
6) Annual written exams for compounding personnel
7) Fingertip and thumb sampling
8) Successful completion of media-fill testing
9) Personnel training records, competency assessments, and qualification records
10) Refrigerator temperature logs
11) Investigations and corrective actions

As a result of these stringent requirements, it will become very difficult for allergy practices to put in place the necessary facilities, personnel, and processes to remain in compliance. Edge Pharma helps health systems, hospitals, and clinics continue to offer these valuable services while maintaining compliance with compounding regulations. In addition to just compliance, however, the benefits of outsourcing treatment set compounding results in substantial improvements to clinic efficiency, reduced logistics and inventory of extracts, and more accurate dosages because of the high standards placed on FDA regulated Outsourcing facilities. As the only FDA registered 503B Outsourcing facility offering allergy treatment set compounding, Edge is in a unique position to help hospitals and allergy practices make this transition with easy ordering and full time dedicated sales staff including experienced allergy pharmacists that help with every detail.