November 1, 2023

USP <797> is now enforceable. Here are the new things you need to know.

By: Chris Beebe

It’s time! Revised <797> is official and enforceable. And while it’s been a long time coming, our work is only just beginning.

There’s a lot to take in, which is why we’re here to help. Over the past few months, we've revisited the chapter together, focusing on changes in four categories (let’s call them “buckets”):

1. What's clearer?
2. What’s more challenging?
3. What’s easier?
4. What’s new?

Today marks a new era for USP <797>. So, it’s only appropriate we continue our series by discussing what’s in the NEW bucket that you need to know.

The New USP <797> Requirements You Need to Know 

USP has added items to <797> that haven’t been addressed before. Four areas stand out to me:

1. Designated person identification
   Revised 797 requires you to identify a person to fill this role. However, the role hasn't really existed before, so finding this person could be tricky for a lot of facilities. My advice? Start by understanding the responsibilities so you can build your ideal job description.
   
   So, what are these responsibilities? Basically, this person should coordinate everything. They don’t necessarily have to be an ‘expert’ in sterile compounding, or microbiology, or infection prevention, but they do need to know how to plan and implement operations. Think: Training programs; SOPs; certification; microbiological and environmental monitoring and response; and the general QA. Additionally, the chapter says you should seek a ‘qualified’ individual, but it doesn’t define what that means. Whoever you choose at your facility for this role really needs to understand and accept the responsibilities that are described.
   
   The most effective way you can find this person? With our help. CPS has developed an approach and document, which can be put in your USP records. If we can offer support, let's connect.
   
2. Training personnel (and documenting it well)
   USP has now addressed training for non-compounding managers and supervisors. Previously, it was just compounders who needed to complete the required competencies every six months. Now, those who supervise compounding--but don't compound themselves--also have to do the same training. Only instead of every six months, it needs to be completed every year.
   
   Like the designated person requirement, it may be hard to work these requirements into an official job description. We’ve seen sites with a running list documenting compounder and non-compounder training: This should work if it’s kept up. The list can also be adapted to document training for those who only clean or stock. For example: If you have pharmacy clerks who only go into the IV room to replenish supplies, they’d fall into the "basic training" category.
   
   I see many pharmacies just have people going into the dirty side of the anteroom to bring stuff in but never cross the line of demarcation; you can specify in SOPs if you still want them to do the basic competency. It’s the same for EVS; garbing and hand hygiene which will be observed. The actual training on cleaning is a separate issue. Oh, and none of these folks would have to do GFTs because they don’t compound.
   
   And finally, 797 states that those who make immediate use preps need to have evidence of training on file. This is not necessarily an observed competency and can be didactic in nature. And it has to happen at least once, then per your SOPs.
   

3. Staff preparation for compounding areas

   We all know the basics on this, right? No jackets, scarves, makeup, etc. But there are two new items: eyeglasses and fingernail polish.

   Glasses now must be cleaned as part of the process, which makes sense. It’s one of those things that was just never addressed. I’ve seen it done outside before entering the anteroom or on the dirty side; your choice.

   Current 797 is silent on fingernail polish; it just talks about false nails and extenders, so our staff who wear polish were able to keep doing so unless you prohibited it locally. This changes under the new requirements. Additionally, we can now cover jewelry that cannot be removed (like rings that are stuck on fingers).

   And finally: For hand hygiene...it's time to put away those scrub brushes for good because of skin sloughing. Most of us have moved away from this practice, but here's your reminder it's now mandatory.

4. SOPs 
   And finally in the "new" bucket, standard operating procedures. The new chapter defines many more that are needed. These items could be outlined or referred to in policies, but here's a rule of thumb: Anyone should be able to follow the steps to perform the activity.
   
   This is really the test; if the SOPs are clear, any staff member can do it.
   
   Another addition is that these SOPs must be reviewed annually by all staff they affect, and documentation of acknowledgement is required. Same with any changes to the SOPs. This documentation may prove challenging, so consider the best way to get this done at your facility.
   

It may be a new day for USP <797>, but our work together is only beginning. With so many new requirements and uncertainties, I recommend you find a trusted partner to help you through this next phase of compliance preparation. 

I know we at the CPS team would welcome the opportunity to help.

Read Part 2 -- The Next Chapter: More New <797> Requirements to Know