Expert: What Pharmacies Should Be Prioritizing to Stay Compliant With Updated USP Chapters <797>, <795>, <800>

Pharmacy Times® interviewed Annie Lambert, PharmD, BCSCP, clinical program manager of clinical surveillance and compliance at Wolters Kluwer Health, who has been working closely with hospitals to ensure they are ready for the revisions to USP guidelines for <797>, <795>, and <800> when they go into effect. Further, Annie explains what to expect from the new guidelines and what pharmacies should be prioritizing to stay compliant, based on her current role at Wolters Kluwer and past experience working directly in a health system.

Pharmacy Times®: What are the new USP guidelines on compounding compliance that went into effect on November 1?

Annie Lambert: So the USP <795> and <797> chapters were published—they aren't fully yet in effect—but they were published on November 1, 2022. And why I say they're not yet an effect is because there's actually a 1-year implementation period before they become official. So that'll be November 1, 2023. With that official date also comes the enforcement date, and that also means that USP <800>, the hazardous drug compounding and safe handling standards will also become official.

I think this is really important because the current standards that we are following are from 2008 and 2014, respectively. And so these standards really are bringing our compounding industry into sort of the contemporary time and reflect a lot of changes in the industry over the last now dozen or so years.

Pharmacy Times®: How will hospitals be affected by these new USP guidelines, and how have hospital leaders been preparing?

Annie Lambert: Yeah, lots of things to unpack. Every section of the chapters have been changed with both chapters <795> and <797>, even from the published drafts that we have been working on over the last year. But I think they can really be summarized by saying what were once best practices are now being held as standards and are being published as such in the chapters. And what does that really mean? I mean, it's a many pages of documents. But, to summarize it, I think it really means that that hospital pharmacies, and really any pharmacies, are going to have to do more frequent activities to maintain their compliance. And that includes areas like training and competency assessment, cleaning standards, environmental monitoring, and then, of course, a major change in the framework for beyond use dates.

They're also, I mean, all of these are really more operational impacts, if you will, compared to USP <800> when that was released, 5 plus years ago now, those were much heavier on the facility and equipment impacts, and also much more expensive in terms of how to how to make those changes. But these are really more labor and supply impacts, which, given the current state of financials in hospital systems, and with staffing shortages, that may make implementation still a struggle.

Pharmacy Times®: What should pharmacies be prioritizing to stay compliant?

Annie Lambert: Yeah, at this point, there is, like I said, a lot to unpack. The chapters have only been out for 10 days now, and so it's a little bit overwhelming. So hopefully, there's a couple of things to help clarify or organize your process.

So, number one, read the chapters. That is definitely where you need to start to really understand what is stated in there. And then there are also, for both <795> and <797>, there's a very thorough FAQ document that goes with each that really answers a lot of the frequently asked questions, obviously. But it helps explain the rationale behind a lot of the changes as well.

After you've read the chapters, I think the next thing you can do is really be looking at your workflows, particularly around personnel competency assessment and environmental monitoring. And this is—as I have talked with colleagues over the last year or so—an area where they realize the most impact in terms of financial resources, both for labor and supplies. So I think by starting there, you can really get a good sense of what you need to do and how you're going to begin to operationalize that. That might even mean reaching out to vendors to support you in different ways or making adjustments with staffing models. So that's definitely a good next step.

Then your policies—you will probably already have a lot of policies that are in place, but those will likely all need to be updated or tweaked a bit to meet those new standards. And as you are doing all of this work, training is definitely a big piece of it too. So I would encourage you to think not just about the core competencies and the new training and competency standards, but also all of these other changes—how you're going to educate your direct pharmacy staff and the support staff that are involved—any change that you make should have an action plan or communication plan attached to it.

Then last but not least, I think your documentation templates are really important. You're already documenting your cleaning and your competencies, but those may need to be updated too. And if you're using a software system to help with that, then that hopefully will make your change management process a bit easier. And I would even reach out to those vendors to find out what they're doing to bring those templates up to speed with the new standards, because that will definitely save you some time.

Pharmacy Times®: Will hospital pharmacists primarily be the individuals responsible for making changes in accordance with this update, and if not, who else will be involved?

Annie Lambert: Yeah, well hospital pharmacist for sure. And every time pharmacists are mentioned, I have to just give a big shout out to our pharmacy technicians. They're actually the ones that do most of this hands-on work day to day, as well as lead many of these initiatives. So let's give them some credit where it's due.

Then it's also beyond hospitals. So really anywhere compounding happens, so that could be infusion centers, oncology clinics, physician practices, home infusion, certainly. And then, of course, our independent compounding pharmacies that maybe in a more retail setting, they're affected too. And so we really believe that patients deserve the best care everywhere, where all of those practice settings are. And these are safety standards meant to bring the best care to those patients in those different settings.

Pharmacy Times®: How long can it take health systems to fully implement an update such as this compounding compliance update?

Annie Lambert: Many folks have already been working at it. So kudos to them. If you haven't been working at it yet, now's your sign—the official publication date and enforcement date—to get moving.

I think really, the answer is that depends on the size of your facility and the size of your staff. That's really going to affect the scope of how many changes you need to make or how many people you need to educate. With, as I mentioned, the more frequent testing, cleaning, sampling—all of those things, that's really going to be magnified by the number of sites and staff that you have. Now, that being said, get going if you haven't gotten started already.

Pharmacy Times®: Any closing thoughts?

Annie Lambert: This is really a long overdue update to the chapters. We are grateful that they're here. We're grateful to the compounding expert committee, not just this cycle, but the last several years’ worth of effort that have gone into all this. So thank you to that group.

We're just grateful to have a clear chapter to work from and then an implementation date to work toward. We've been in limbo for so long. So we're grateful for that.

And I would say yes, there's a lot of work to do, but get going. And these are, as we mentioned, best practices that have now become standard. So this is the time to start work on those things.

Then there's just also a lot going on. So with staffing shortages, with financial challenges—don't let that slow your effort, just let it help you stage things—reach out to your vendors and to your expert partners to help you make those changes. We're in this together, I will say that, as a compounding community, we're very collaborative. And if you have questions, there's lots of people in resources to get answers from. So keep doing the good work and get going.