Introducing: USP Chapter <797> Series: Lessons from the Field

August 2023

By: Chris Beebe, SVP, Compliance and Regulatory Services

USP Chapter <797>: What's happening in the field?

Ready or not, November is almost here! Our consulting team at CPS has been hard at work helping many hospitals prepare for <797>’s enforcement. Lately, though, I’ve noticed something interesting. When we start working with a hospital, the most common question I hear is:

“What are other hospitals actually doing that works?”

I’ve noticed it, too. There’s a lot to absorb in the revised standards, yet I don’t see a lot addressing real-world best practices. So, my team and I started looking at things differently.

What’s missing from the <797> discourse? (And why we’re writing about it)

I realized: We keep hearing the same old advice as we await November’s enforcement deadline.

I informally polled a few of my colleagues on our consulting team about what we can do differently. We’re a close group of pharmacists, regulatory and compliance specialists, and hospital pharmacy leaders, so I value their diverse perspective and experience. Many of us have been in your shoes before, so we can feel how frustrating it must be to see the same headline again and again: “You must start preparing now!”

We know this.  But what to look at first?

We wanted to start this series to show—not tell—you how you can improve <797> and pharmacy compliance.

Here's the advice you want: From your peers

We want to give you the kind of real-world advice we’d want as compliance managers, pharmacy directors, and other stakeholders. The pitfalls, triumphs, checklists, and informed predictions. The stuff that’s working for your peers and the advice we can pass on to you. Ready to begin your first lesson?

Read on to see the 4-step trick hospitals are using to understand USP Chapter <797>’s final revision and prepare for enforcement.

Decoding USP Chapter <797>’s final revision: 4 essentials to know

There’s a lot to absorb as you ready your hospital for USP Chapter <797> compliance—especially as you digest the details from the final revision. What’s key, and where should you focus? Here’s the 4-part formula our hospital partners use to understand and adapt to the final revisions:

1. What’s easier?: Let’s start with the good news! <797>’s final revision has some updates that will make your life easier, including changes to certification requirements and longer beyond-use dates. Understanding these areas first, many of which will actually streamline your team’s activities, will make compliance prep feel more manageable.
2. What’s clearer?: The revised chapter makes many things more straightforward—from personnel garbing to CSP classifications. It eliminates ambiguity that we all have struggled with. I recommend focusing on six main areas, including: CSP classification; garbing; cleaning; material handling; physical plant improvements; and incubation.
3. What’s more challenging?:  Although the final revisions are a welcome evolution for <797>, change is never easy. Many of our partners say they’re most concerned about the revisions related to competencies. There is greater complexity, so having a partner who can help you understand, perform, and document the critical steps is important. Read more about what's challenging.
4. What’s new? Interestingly, I’m hearing a lot of feedback around new policies like nail polish requirements. This may seem like a minor addition, but it often requires a significant change for staff. Additionally, our hospital partners are prioritizing the new, more managerial standards, like naming a designated person for compounding oversight and implementing specific standard operating procedures (SOPs). It’s important to identify all these new items now and make sure they are implemented. Your staff must be aware of them as well. Read more about what's new here.

Final revisions, final countdown: What's next?

The most important thing to remember?

Your <797> compliance efforts must be part of a larger strategy empowering your pharmacy as a key service within the hospital. The culture should embrace pharmacy teams as essential to advancing patient safety and care quality goals.

If that’s not the case for you, a <797> compliance evaluation could be the first step in revealing where compliance gaps exist. Fixing these will improve the performance of your pharmacy, and ultimately patient care at your hospital. The best thing you can do to help yourself and your staff? Get the right support.

Here are some places to start:

1. Schedule an initial consult evaluation
2. Connect with me on LinkedIn
3. Email me to share your USP worries, successes, and ideas: Chris.Beebe@cps.com