After years of collecting and analyzing information across the industry, the United States Pharmacopeia (USP) published its final version of the revisions to General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, originally issued in 2008. The USP update to <797> incorporate advances in science and clinical practice and aim to clarify topics that were not consistently understood. The updates also represent response to stakeholders and 1400+ comments from the public from September 2021 to March 2022. The new standards and requirements take effect November 1, 2023. Is your facility ready for these significant changes?
As the compounding market is projected to grow 6.5% over the next 5 years, the USP seeks to reduce the risks of sterile compounding which comprises about a third of all compounded prescriptions in the US. The the latest USP <797> revision presents the following major challenges sterile compounding facilities:
- Revamping personnel training and evaluations to a role-based model
- Understanding the new compounded sterile preparation (CSP) category definitions and incorporating into practices by updating beyond-use dates (BUDs) for each
- Upgrading facility practices for microbiological air and surface monitoring
- Incorporating changes to standard operating procedures for cleanroom cleaning tasks, solutions, and frequencies
- Redefining the designated person(s) role and quality program
- Complying with new documentation requirements.
Given that the revisions were developed over 3 years before becoming a part of the official revision, many sterile compounding facilities have invested significantly to ensure their cleanrooms already meet updated standards. Examples include cleanroom design and upgrades that addresses all essential processes, procedures, and personnel:
- All materials, equipment, fixtures, and furniture as well as structural surfaces (ceilings, walls, floors) that are a part of or enter critical areas must be non-permeable, non-shedding, cleanable, disinfectant-resistant, and remain free of cracking and crevices that prevent effective cleaning and disinfection. Examples of structural updates include epoxy paint, cleanroom-grade (smooth and seamless) ceiling tiles, and seamlessly coved vinyl
- The Primary Engineering Control (or hood) must be an ISO Class 5 environment or better. The positive pressure buffer area must be an ISO Class 7 environment or better, and positive pressure ante rooms must be an ISO Class 8 environment or better.
One of the most challenging areas of the revisions is the comprehensive training and evaluation program updates. Here is how to begin.
The revisions to USP <797> stipulates notable changes in all staff training and evaluations, and in some cases, even facility visitors. The changes are designed to provide more assurances that everyone involved in sterile compounding the knowledge and skills to safely and effectively perform their job duties, maintain the critical environment’s quality, and, ultimately, heighten patient safety.
Long (1+ hour) focusing on cleaning processes to address USP <797> revisions.
Effective November 2023, USP <797> requires personnel must demonstrate highly specific knowledge and skills in four areas:
- Sterile compounding practices and principles
- Garbing and hand hygiene
- Aseptic techniques and manipulation
- Maintenance of sterile compounding environment
Sterile compounding facilities must upgrade and increase frequency of their formal and hands-on training in these areas as well as how competency is validated. For example, compounding personnel performing Category 2 compounding will require a competency evaluation every six months instead of annually with additional personnel sampling metrics. Failure of any portion of the evaluation requires repeating the entire competency. These changes should increase patient safety, but do come at a cost. It will at least double the needs for gloved-fingertip media and aseptic validation media needs, as well as personnel costs for the training time and training/evaluation resources.
In addition to increased training and evaluation, the new guidelines modify supporting roles, including restocking and cleaning personnel, in-process or final verification personnel, immediate-use compounders, and a variety of others who may enter your facility, such as inspectors, certifiers, surveyors, or maintenance personnel. Your SOP must adapt to include new definitions for these support roles and their requirements for scope and frequency of training and evaluation for hand hygiene, garbing, and other relevant procedures.
- Revise or create your Sterile Compounding Training Program. To get the buy-in and team participation, review updates with staff including what has changed and why while developing updates to the training.Tip: Consider defining and designating an “Assigned Trainer” role to assist with competency evaluations. Develop role-based compliance training for your staff including non-pharmacy personnel to include:
- Role definitions
- Required training and evaluations by role
- Frequency of training and evaluations
- Corrective actions.
- Update SOPs, obtain addtional cleanroom supplies to support the revised training, evaluations, and procedures. Once you have adequate stock of TSA plates and media fill units, set a target date for cutover to the new standards giving enough time to begin the new training program.
- Implement revised USP <797> training.
After defining the role-based training and evaluations and before going live with the new SOPs, begin training all staff on the new program. Document the competencies the staff has achieved, ensuring all criteria for incubation, passing thresholds, and skills have been validated.
Once all revised USP <797> standards have been met you can begin implementing new BUDs. Click on image at right to enlarge.
The revised <797> chapter compounded sterile preparation (CSP) categorization from microbial contamination risk levels 3 specifically defined categories that delineate requirements that must be met to BUDs up to a maximum of 180 days.
Compounding pharmacists combined intuition and scientific method to develop an ever-widening array of medical cures and treatments. Allantoin produced by fly larva was discovered to rejuvenate damaged skin. Quinine alkaloids that treat malaria were derived from the bark of the South American Cinchona tree. The list of medicines from compounding pharmacists experimenting and exploring are nearly a limitless list.
Contact us with your USP <797> compliance questions and to get guaranteed best pricing on many of the cleanroom supplies required to prepare for these training and evaluation changes.