For the last decade, USP Chapter <797> has gone unchanged. Until now. Monitoring compliance with these requirements is the responsibility of state and federal regulators, including the Joint Commission and FDA.Pharmacies are expected to have adopted the new requirements when the standard becomes official and enforceable. As the official and enforceable date approaches, it’s important to understand the chapter changes and how they affect your organization.
In a recent webinar, Eric Kastango BS Pharm, MBA, FASHP, explored key areas of change that have come about since USP <797> was first introduced in 2008.
1. Three risk levels have been changed to only two categories
In 2008, USP designated three levels of risk as it related to compounded pharmaceuticals, classifying those three levels as low, medium, and high. But now the chapter focuses on where the compounded preparation is being made, making the lines completely clear and eliminating frustration when trying to achieve compliance.
2. Personnel qualifications
Personnel qualifications are the same for both Category 1 and 2. It’s important that organizations are observing personnel ensure compliance with standards and documented practices. The training should not be limited to compounders. There may be other personnel handling CSPs or accessing the compounding area, including housekeeping, certifiers, and guests. All personnel accessing compounding areas must demonstrate competency in proper behavior to maintain the environment.
Also new is that a designated person, or persons, are required to ensure that any person who enters the sterile compounding area can maintain its quality. They are responsible for ensuring that the day-to-day operations are being conducted according to the chapter requirements.
3. Facility requirements
One of the major changes of note on the facility side is that CAI/CACI systems are now called Restricted Access Barrier Systems (or RABS) and they must be placed in the cleanroom suite to get Category 2 BUDs . For compounding robots to qualify for the full dating, they must be placed in a cleanroom suite.
So, what is a cleanroom suite according to the 2019 USP <797> chapter? It will consist of at least two rooms, an anteroom and buffer room. Read here for more.
4. Air and surface sampling
The first change to this section of the chapter was a renaming from Environmental Monitoring to Microbial Air and Surface Monitoring.
- Viable air sampling must occur every six months, and surface sampling must be done monthly.
- For cleaning and disinfecting, the frequency is not dependent on the CSP category. Organizations are responsible for maintaining clean and disinfected facilities.
- Cleaning and disinfection of the sink surface, pass-through, work surfaces, and floors must be done daily and a sporicidal agent must be used at least monthly. For wall, doors, ceilings, and storage, cleaning and disinfecting must be done every month.
5. Beyond Use Dates
Defined as the date and hour after which a CSP must not be used, or administration began, BUDs must be established based on Tables 10 and 11 of the USP <797> chapter. BUDs must not exceed the shortest remaining expiration date.
- The BUDs in Category 1, the PEC placement is not in an ISO classified area. In this instance, sterility and endotoxin testing are not required, and the maximum BUDs at room temperature is 12 hours, and refrigerated is 24 hours.
- Learn more in this guide for details on BUDs in Category 2.
6. Aseptic Preparation versus Terminal Sterilization
Aseptic preparation and terminal sterilization definitions are made clearer in this latest iteration of USP 797. The definition of terminal sterilization is when the CSP is filled into its final container, and expose it to steam, heat or radiation. If you use a filter or transfer ingredients from a vial to a final container, that defines aseptic processing. If you decide to extend the dating by performing sterility testing, the testing process hasn’t changed, but special allowances have been made for batch sizes under 40.
7. Master Formulation Requirement
This is an area of major change in USP <797> if organizations are making batches for more than one patient or if any CSP is made with nonsterile ingredients. This change indicates there must be master formulation and compounding records for these cases. Documentation is required.
8. Quality Assurance and Control
Additionally, there are now expanded descriptions and requirements for quality assurance and control, including specifics on notification and recall of out-of-specification dispensed CSPs, as well as specifics about complaint handling and adverse event reporting handling.
If you missed it, Eric Kastango BS Pharm, MBA, FASHP, from the Kastango Consulting Group, goes into even more detail on these changes in Navigating the Revised USP Chapter <797> — How to Ensure Compliance and download A Guide to the Crosswalk of Changes to 2019 USP <797> to learn more.
With the revisions to USP Chapter 797, managing and documenting your pharmacy’s compliance requires extensive time and resources. Rely on a solution that documents your competencies, tasks, and bulk CSP formulations and compounding records seamlessly. Receive customizable alerts when there are items that are out of limits or overdue alongside robust analytics and reporting capabilities —allowing for a trouble-free inspection. Rely on Simplifi 797®.
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