Are you prepared for the USP <797> revisions for sterile compounding?
October 31, 2023 Todd McEvoy, PhD
Beginning November 1, 2023, recent revisions to USP <797> Pharmaceutical Compounding – Sterile Preparations will be enforceable. If you have not taken steps to prepare for these regulatory changes, it’s not too late.
Changes have been made to the regulatory guidance for compounded sterile preparations (CSPs) to provide clarity in scope and requirements for compliance. In addition to the many changes that have been implemented with this latest revision, the categories for CSPs have been redefined and are based on preparation environment and their associated beyond use date.
The 2008 version categories of Low Risk, Low Risk with 12-h BUD, Medium Risk, and High Risk are now defined as Category 1, Category 2, and Category 3, and are based on the environmental conditions of where product is being compounded, gowning, environmental monitoring program, cleaning program, and beyond use dating.
Changes to Testing Requirements
This revision to the categories now allows new testing requirements to be developed as a function of each category. A few of these key changes, which require the collection and analysis of samples, are outlined below.
| Test | 2008 version | 2022 version |
Personnel Qualifications | Gloved fingertip sampling | Low/med risk CSPs – Annually
High risk CSPs – Semi-annually | Categories 1 and 2 – at least every 6 months
Category 3 – at least every 3 months |
Personnel Qualifications | Media Fill | Low/med risk CSPs – Annually
High risk CSPs – Semi-annually | Categories 1 and 2 – at least every 6 months
Category 3 – at least every 3 months |
Microbial | Viable air | At least every 6 months | Categories 1 and 2 – at least every 6 months
Category 3 – at least monthly |
Microbial | Surface sampling | On a periodic basis | Categories 1 and 2 – at least monthly
Category 3 – at least weekly |
Microbial | Identifications | Required regardless of microbial count to at least genus level | Required to attempt identification to genus level when action levels are exceeded |
NOTE: adapted from Open Forum Session, Revisions to USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, USP November 8, 2022.
How You Can Take Action
Whether you haven’t started, are just beginning to plan, or are already making the transition to the new standard’s testing requirements, here are some actions you can still take:
Establish a Plan
- Evaluate which changes impact your facility the most and prioritize their adoption. Build a plan that addresses the changes and focuses on where you have compliance gaps. Ensure you have a well written training program, a program for ongoing qualifications of trained staff, and established procedures for collection and analysis of air and surface samples.
- For those who compound hazardous drugs, begin preparations for hazardous drug residue testing under QUP <800>
Evaluate your Resources
- Determine whether it is best operationally and financially to perform any necessary testing internally, externally, or a combination of the two.
- Ensure you have the time and people available
- Ensure you have properly trained staff, as well as the ability to train new staff as needed
Have a Partner
- Identify an experienced primary laboratory to subcontract your sampling and testing. Fast track their qualification and get alignment on the deliverables.
- Identify a backup lab in the situation you want to handle everything internally. Sometimes, not all goes to plan, and you need a qualified vendor to help with capacity constraints.
How Can We Help
Azzur Labs, an Azzur Group Company, offers contract laboratory services with locations nationwide that can be a resource for you to ensure regulatory compliance. Azzur Labs provides surface testing for hazardous drugs, environmental monitoring, gowning validation, personnel training and monitoring, and drug testing for potency, sterility, and endotoxin.
Azzur Training Center (ATC) is a resource we provide to organizations performing aseptic activities. ATC offers aseptic gowning training, aseptic behavior and process training, and qualification programs tailored specifically to client procedures. We take the risk out of contaminating an operational facility while qualifying personnel to meet client-specific requirements.
If you need guidance or assistance on how to move forward with the revisions to USP <797>, contact a team member here to get started.
