Drug Topics: Good morning, Kevin, thank you so much for joining me today. Before we dive into this discussion about compounding, I want to turn things over to you and let you introduce yourself to our audience.
Kevin Hope, RPh: Sure, absolutely. Thank you, Lauren. My name is Kevin Hope, I’m a pharmacist by trade, but I’m the senior director of pharmacy education for Pharmcon.
Drug Topics: Thank you so much for being here. So, let’s just dive right in. Is continuing education required for compounders?
Hope: It is. It really depends upon the state and we’ve seen a lot of interest in this compounding topic recently in the continuing education world because things continue to evolve and things continue to change. Every state is different. I think that’s kind of the understanding that people always understand in the pharmacy world, especially with continuing education and things that vary like that. But there are some commonalities and for example, the USP <795> was just recently updated, and one of the things that they implemented was training requirements around compounding. A lot of states were already doing this anyway, but this is now officially all across the country. If you’re compounding you have to have training. Now they don’t necessarily specify that that training has to be accredited continuing education, but certainly for pharmacists and pharmacy technicians, that’s always a nice added bonus. If it is you can knock out 2 birds with 1 stone, so to speak.
So, in respect across the board, yes, if you’re compounding, you do have to have training. Whether that training has to be continuing education really depends upon the state. Some states are very heavy with compounding requirements and others are very light or nonexistent.
Drug Topics: I feel like that seems to be the rule of thumb with almost anything in pharmacy, whether you’re talking about scope of practice or ability to vaccinate. It’s literally just check your state because there is no kind of federal oversight.
Hope: That’s correct. You know, with this particular topic, USP <795>, this does add some sort of across the board requirement for training, but not necessarily continuing education.
Drug Topics: Some might argue that the rules are constantly changing for compounding. Would you say that that’s accurate?
Hope: It seems like that and I think that goes back to a lot of those state requirements where interpretations change based on a particular state and that kind of thing. If we go back and look at [USP] <795> itself, the year 2000 was the first year that that was released, and then it was updated about 4 years later. Since then, it’s about every 10 years. It was updated in 2014, and then again in 2023. So, we really don’t see a lot of updates on this, although it does seem that way.
Drug Topics: Why is it then that so many pharmacists seem to be caught off guard by the revisions that went into effect on November 1 of this year?
Hope: That’s a great question and it’s one that we in the continuing education world really struggled to understand. I think it really comes down to how frequently people are compounding. This was an activity that people do just kind of here and there, working in a retail pharmacy, for example, they may not have been as tuned in to what was going on if you’re full time business is compounding. What we found is that a lot of the folks who were compounding pharmacists and compounding pharmacies that do that full time, they were very tuned in to what’s going on here. They were very involved in the conversations all along and it wasn’t a surprise. The folks that we found caught off guard were the folks that just kind of do this here and there. It’s kind of a side thing for them and they’re seeing things on social media and they’re like, “Oh, wait, what just happened?”
Drug Topics: That makes a lot of sense when you put it that way.
Hope: It is a really big need right now in the continuing education space. I really can’t emphasize that enough. If you’re doing any compounding, whether that’s your full business or whether you’re just doing it once in a while, there’s new information out there that you need to be aware of.
Drug Topics: Can you talk a little bit about what’s changed in training requirements in the new version of USP <795>?
Hope: Yes, and I did mention early on that this requires training, not necessarily continuing education training, but some sort of training. In addition to that, every facility has to designate a specific individual in their standard operating procedures who is responsible for the operations of the compounding that’s happening in their facility. In addition to that, there are some musts in the training requirements, in that they have to have the initial training, they have to have competency demonstration. This would be things like cleaning. The regulations are we’re cleaning or that we’re putting on gloves, are we able to do that properly? Having someone check off to see that this is physically being done and that it’s being done appropriately.
Then that refresher training has to occur every 12 months and as with everything in pharmacy, you have to document. If you’re audited on this, just saying, “Oh, we do this annually” is not going to be good enough. It’s having these things signed off, that the training actually occurred.
Drug Topics: Can you dive a little bit deeper into that documentation piece and talk a little bit about what that’s going to look like for pharmacists? What kind of lift it’s going to be for them?
Hope: Yes, absolutely. Documentation is just that. It’s looking at what the requirement is, whether there’s a competency demonstration. So, looking at, gowning and garbing, for example, and having what are in our standard operating procedures, what the requirements are, and having that this occurred and that 1 of the coworkers or somebody on site observed that being done correctly. It’s just kind of signing off on that and just having that on hand and keeping all the documents on hand.
There’s a lot of software out there that the pharmacies are using in terms of keeping track when this stuff is done. That’s really [good] about reminding you and there’s some nice templates out there as well.
Drug Topics: How are compounding pharmacies working to handle the additional training requirements that has come with these USP changes?
Hope: That’s a great question. It really does vary by facility. I can tell you that some of the folks, especially those who do this day in and day out, they’ve been on top of this for a while now and really have developed really nice in-house training programs that they’re using. Other folks are reaching out to continuing education providers, so other providers like freeCE and there are others out there as well that have been working really hard to develop ongoing training that will help meet this need.
Drug Topics: Regarding the designated space that’s required within facilities to make a compounded product, can you talk a little bit about what’s changed?
Hope: I sure can. There’s been quite a bit that’s changed with regard to the facility. Number 1, hand washing measures have been added. That seems like kind of a no brainer, but it’s the first time that it’s really been in the standards as a requirement in non-sterile compounding. It has been a big part of sterile compounding for a long time. Also, things like removing jewelry, earbuds, anything that could interfere with the integrity of the compound. Gloves are now required. Again, kind of 1 of those things that, seems intuitive, but it’s now required. Now that has to be in the standard operating procedures. Other gowning, like gowns, shoe coverings, facemask, all those are things that are going to depend upon the compound that you’re making. That really just has to be spelled out into your own facility standard operating procedures.
If there’s a hazardous drug, for example, that we’re compounding, then the garbing requirements are going to look a little bit different than if we’re just compounding a relatively benign cream, for example.
Drug Topics: It’s so interesting to me that handwashing measures were not written in stone until this update. Like you said, it seems so intuitive. Who wouldn’t wash their hands before doing this? One
of the biggest critiques that’s been made of the changes is the need for the potentially costly changes within the facility itself. What types of issues are people concerned about with this?
Hope: I think that really is probably the biggest valid concern, especially for those who are just doing compounds here and there. If you think about yourself in a retail setting and 99% of what you do is kind of the standard prescription and then occasionally, you get a magic mouthwash or something that requires some compounding, now you really are going to have to start thinking about [if] this is a compounding process. What does this need to look like in my facility? Number 1, no other activities can be happening at the same space. I think back to the days when I was working in retail pharmacy and we got a compound and it just kind of went over to the counter to the side and did it with all the other stuff that was going on. That’s no longer the case. Those days are gone. You really have to think about what’s happening in that space around us. There are things like the space that we’re in can’t contain carpet. If you’re at a pharmacy where you know the floor is all carpeted, now you’re going to have to look at not only a separate space, but you’re going to have to look at redoing the floor, potentially, if you’re in the pharmacy that has all carpet. That area has to have a sink with both hot and cold water.
All of this is to say that I think if you’re in a facility that’s just doing a compound here and there, and you’re looking at something like this, if you’re a pharmacy owner or have vested interest in the business, you’re probably really going to have to make a decision. Is it really worth investing in these other things to do the occasional compound?
Drug Topics: That leads right into my next question. Do you think that these changes are going to push some pharmacies out of the compounding space entirely?
Hope: I think that it will. That’s just a supposition on my part, but if you really think about the dollars behind it and the additional requirements, it’s really going to come down to does it make financial sense. Now, obviously, if you’re a compounding pharmacy and that’s your business day in and day out, you’re going to do what you need to do. Most of those folks probably already have facilities that meet the requirements that we talked about. On the other hand, if you’re a retail pharmacy just kind of occasionally doing these things on the fly here and there, it may be a different story. I’ve heard some pharmacies talk about this already. “Well, we just stopped doing compounds, we send those somewhere else now.”
Drug Topics: For those listening in our audience who maybe aren’t super familiar, could you just talk a little bit about the difference between sterile and non-sterile compounding?
Hope: In a very general sense, you can think of sterile compounding as something that you would see in a hospital setting, with your IVs and the injectable products and those types of things. But it can also be in a traditional compounding pharmacy in the form of eyedrops, that’s another example of things that have to be sterile. You think about anything where the potential for contamination is very, very high.
Now, when we talk about non-sterile compounding, we’re usually talking [about] things like making capsules or making creams and ointments, those types of things, where we’re going to be using it in an area or we’re going to be applying it to an area or using an area that’s not sterile anyway. For example, if you’re ingesting a tablet. Those are the types of things that really [are] the differentiator between what we call sterile and what we call non-sterile.
Drug Topics: We all know the cleaning schedules are a big part of sterile compounding, but we haven’t really seen that level of attention apply to non-sterile compounding. How has that changed?
Hope: It has changed and these are spelled out in the USP <795>. If you are compounding that’s an area where you want to get some continuing education or dig into this a little bit further to see what those are. It’s things like work surfaces, you have to clean those at the beginning and ending of each shift or anytime there’s a spill, or between different compounding different products, if you’re working on one compound and then start on another, that’s a time that has to be cleaned.
The floors have to be cleaned daily. That’s a new one for non-sterile compounding to think about. We’re accustomed to those types of things in sterile compounding, but now in non-sterile compounding, we have to clean the floors daily. Things like the ceilings and walls that we look at in sterile compounding and a cleanroom, not required necessarily for non-sterile compounding, but only if they’re visibly soiled. There’s a lot of things that go into this, the storage shelving is another example. There is now a requirement that they be cleaned every 3 months or if there’s a spill. Again, we’re talking about more things to keep track of. If you’re compounding, doing non-sterile compounding, they’re going to want to see documentation that those storage shelves have been cleaned on a 3 month basis.
Drug Topics: What do you see as the largest barriers for today’s compounders?
Hope: I think the biggest barriers are going to be in the equipment costs, certainly in the changes potentially to the facility. If we’re looking at changing flooring, those kinds of things. Training is a big piece. I think that’s being introduced here. If I’m doing an occasional compound, how am I documenting that my employees are being trained on that compound and keeping track of everything? The big thing, the documentation that all of these things are actually happening, I think it’s a time consuming piece. That is really going to require attention from a lot of folks who have been historically just doing these things on the fly, so to speak.
Drug Topics: There have also been conversations about the procurement of ingredients for compounding, is that correct? What do those conversations look like?
Hope: Yeah, absolutely. Where do these ingredients come from? How do we ensure that they’re pure? Keep in mind that many of these provisions echo that of the Drug Supply Chain Security Act. This is another big topic that’s going on right now. We could have an entirely different conversation on that in itself. But the fact being that the same things apply to compounding procurement of drugs as they do to traditional procurement of drugs. There are some new things but there are some commonalities here and that’s that we have written standards and procedures in terms of how we secure these drugs.
We have certificates of analysis that our staff has been trained to read and know what to do with. Then of course procurement from an FDA registered facility. That’s just to name a few things. Nothing lives in a vacuum, so the compounding world really [needs] to pay attention to this Drug Supply Chain Security Act. That’s another opportunity for continuing education to really stay abreast on that.
Drug Topics: It sounds like there’s also been additional language that’s been added around the final inspection of compounded products. Could you talk a little bit about that?
Hope: This is something that everybody probably does anyway. You’re talking about in the container to make sure that there are no cracks, leaks, etc. If you’re compounding things, that’s something that you probably are inherently doing and don’t even necessarily think about. But now it’s part of this chapter. Now we have another place where we have to document that this was done. We did do this final inspection, so to speak.
Drug Topics: Can you talk a little bit about the changes in rules for establishing beyond use dating?
Hope: I can and the biggest thing that I can say here is that you need to go back and look at the chapter when it comes to this, because there are lots of caveats. I hate to hesitate here to even throw out some numbers because there’s differentiation between if it’s an aqueous compound, if it’s preserved, if it’s not preserved. To eliminate confusion, I would refer people back to an educational program or to the chapter itself. We’re looking at these things that you need to know. The big thing that you need to know is that if you are compounding, there have been changes to those beyond use dating rules that are applied to those products. You need to check that out to make sure that you’re now compliant with the news chapter.
Drug Topics: Is there anything else that you wanted to touch on? Maybe some final thoughts to leave the audience with today?
Hope: Yes, sure. You know, I think the biggest message for today is that continuing education is extremely important. Whether that’s being actually for credit, where you can hit your license, or just the training exercises that you can do in non-sterile compounding. All of those things are vitally important. Just to recap some of the big things that we talked about, facilities are going to have to have that designated person that’s responsible and accountable for the compounding activities that are happening in the pharmacy. Training personnel have to be trained and that’s not only the initial training, but every 12 months thereafter. Then looking at those gowning and garbing requirements that are happening in the pharmacy, those now still in compliance with the new chapter and building the facility requirements for non-sterile compounding. Is the environment that we’re compounding in still compliant? Looking at the cleaning and sanitizing schedules. Are we documenting those things? Are we doing those things? Those are very, very important things to be thinking about and to be evaluating. The spill and disposal processes, we didn’t even talk much about that. What do we do if there’s a spill? How do we clean that up? Then the facilities process for evaluating beyond use dating, looking at what the beyond use date is and when it’s appropriate to use that product after preparation. Lots of things to think about, lots of changes in this particular space.
We just encourage people to refer to freeCE, we have some excellent continuing education programs that look at this topic. I would encourage people to go actually read the chapter for themselves, because a lot has changed and it is a space that a lot of people kind of seem to be caught off guard about.