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My name is Karla Palmer and with me are two industry experts, Travis, Leeah at QuVa, pharma and Kimberly Kiefer, who is at Empower, and both of them can give you a little bit of introduction of what their background is with respect to compounding, outsourcing, etc. In this dynamic and evolving market. My name is Karla Palmer. I’m an attorney in Washington DC for a food and drug law boutique. And I have about 27 years of experience practicing law. And since the 2013 timeframe, a substantial part of my practice has been devoted to representing company pharmacies and outsourcing facilities. And so I hope that I can guide these two panelists and an interesting discussion of the challenges that they are facing today and how to how to include business decisions in their planning. Vis a vis the regulatory challenges that they face. So Kimberly, why don’t you go ahead and provide us a little introduction concerning your background and experience for compounding.
Kim Kieffer 1:06
Thank you, Karla. So I’m Kim Kieffer and I am the Regulatory Affairs Director at Empower Pharmacy in Texas currently, but I come from a fairly long background in the compounding industry. Prior to my work, now, I worked for many of the raw material suppliers, the supply, compounding pharmacies, the technical consultants, so I have been working with pharmacies all over the country for many, many years. And I have seen development since we received the DQSA and how it’s really changed the quality standards or it has the ability to up quality standards and push the industry a little bit more. And so since I’ve been at empower, I’ve gotten a much bigger education and how GMP works and what the realities of this 503B industry are. It’s very interesting and exciting to me.
Travis Leeah 1:55
Hello, everyone. My name is Travis Leah. I am a pharmacist practicing pharmacist with the QuVa pharma over clinical services and pharmacist in charge. And been in the compounding industry since about 1999 was in the hospital pharmacist, but before that have run operations and compounding pharmacies have been president, CEO, owner and vice president and also direct revenue about every different version in the industry. I’ve learned a lot. I’ve gone through USP 797, and all the changes to 503B. And so it’s been a great ride. I have no regrets and have enjoyed it. So I’m looking forward to this panel.
Karla Palmer 2:42
Thank you for that introduction. And so what we’d like to do today is I want to ask some questions of each of you. And then if you all could respond based on your experience and expertise in compounding and working in outsourcing facilities, that would be great. Okay, so our first question that we would like to consider today is why especially in the compounding space, does it seem that compliance decisions involving compounding must be fully integrated into the business activities of the company?
Travis Leeah 3:12
Yeah, especially with 503B’s facilities, there’s been so many compliance changes, especially back, everybody remembers the horrible NECC tragedy. And that was just a complete tragedy from a compounding standpoint. And many other issues were compounded drugs were not produced in a way where you have good quality standards, we’ve got a lot of regulations that we have to meet both on the federal and the state level. First of all, it takes money, everybody wonders about the money, right. So it takes a lot of money, a lot of work within your group, and your regulatory group to make sure you include the compliance decisions amongst your business plan and plan off of what you can do from a compliance standpoint. You could have a great sales team come along and say, Hey, we can sell the heck out of this, we could sell the heck out of you know, name is Banco myosin, or whatever, we could sell a bunch of it. The problem is, there’s a lot of things you have to look at from a compliance standpoint to make sure that you can sell that when you it can be part of your business plan. You have to integrate commercial copies, you have to integrate your development work development work isn’t cheap in the 503b facility, you have to have it you have to have your the V word, the validation work, that that all wraps into your compliance and we’re the ones that are responsible for the patient safety. And that’s what comes first. If you don’t wrap that into your business activities, your I can tell I can tell you from a budgeting standpoint is is not going to happen. There’s a lot of expense behind the scenes. Everybody sees the finished syringe or IV bag when they say us great. And you know, I only cost you $10 to make that, No, it didn’t. There’s a lot of costs behind the scenes, especially that goes from into compliance. So a whole nother animal with 503B, and GMP practices, I kind of look at it from there different business models. You have the pharmacy business model, you have a pharma business model, you have a 503B business model. And they’re all they’re separate. They’re black and white. Now, I think a lot of people overlook that you have to change your business model to be successful.
Karla Palmer 5:47
Let me ask a follow up question there. I mean, I’ve known you since at the time of inception, and promulgation of Section 503.b after NECC. Back in 2013. And you were good. The transition from a 503B from a 503A compounding pharmacy, because there weren’t a 503B’s to a 503B, looking back on this time period over the last long, nine years. What was the greatest regulatory challenge for you?
Travis Leeah 6:19
I was in the 797 world for so long. It was getting myself out of the 797 pharmacy practice and getting myself into the pharma business that to me, that was a real struggle, because you lose pharmacists that probably admit that they’re control freaks, and we like to control things. But when you have a pharma model pharmacist has a different role to play in 787. a pharmacist is part time quality, part time engineering, part time plumber, part time, glue, man, you know, you name it, you there’s a lot of different hats you wear in the 797 business. Well, in a GMP business, the pharmacist is the clinical master. And you’ve got engineers, you’ve got microbiologists, you’ve got quality teams, you’ve got all these other what I call SMEs, subject matter experts that you lean on to make sure that you cover all your GMP, you don’t have to do it all yourself. And when when I first started with 503B, we were still trying to do it all as pharmacists, and you’ve got to bring in those subject matter experts to get it done. Right. That was a big change for me and in it. And Kim can probably agree to this, it takes a lot of fortitude. There’s a lot of frustration from a GMP standpoint. Because once you have everything ready to go and you think you’re ready to rock and roll, oops, there’s a little impurity that was found in your API or something like that, which brings everything to a screeching halt. And guess what, you start all over, you have to do your investigations and everything. So it’s just to me that change for me was the toughest, it was really hard. It was a lot of sleepless nights, a lot of upset stomach, some nausea, saying, Okay, how are we going to do this, the cleaning procedures to eat, you have to prove everything from a GMP standpoint, you can’t just buy the best cleaner on the market and start cleaning up the cleanroom. You have to prove that, okay, what does this cleaner actually kill the wood surfaces of the kill on? Are you going to use it? Right? Are your technicians going to use it? Right? You can validate and cleaner off at a large company. And that’s great documentation. But the first thing from GMP standpoint is Oh, can you repeat this in your facility? Oh, we didn’t think about that. So yeah, you have to go back and make sure that your processes your procedures can be effective 100% from what the validation were that your cleaning company, neither your, your vendor, there’s a lot of work it’s all about and it goes back to it’s all about scientific evidence, you know, you have the evidence in hand.
Karla Palmer 9:14
And Kimberly, do you have a take on this as well? I mean, you know, let’s discuss from your perspective, why in this space, this outsourcing facility space, so to speak, you know, does it seem that compliance and important points decision must be fully integrated into the business activities of the company?
Kim Kieffer 9:30
I think Travis’s hit on most of them. I mean, it’s really understanding what your markets are requiring and if that makes sense for you, because it all does come down to money and the cost to produce one product in a GMP environment appropriately is so vastly different than I think Travis hit the nail on the head when he said, Oh, I have this bag here and it cost me $10 to make it or it cost me 42 cents to make it or some crazy number, but when you really consider what your return on investment is for that one Final unit or 500, or whatever you make in your first batch, it’s really tremendous. So you have to understand what that looks like, from a business perspective, like, Can we really make money on this? And I think a big thing that I noticed, though, that we struggle with is you have a tremendous outpouring from the medical community, we want all of these things. But is it really feasible to do GMP on all of these things? Does it make sense, that’s a hard thing to balance because there is this desire as compounding pharmacy to build these needs. But in a lot of cases, it’s not, it doesn’t make sense, from a financial standpoint, they have to really understand that and be able to weigh that from a business perspective and still have some sort of compassion, the FDA has given a lot of, they’ve given guidance in their GMP documents for 503B, specifically, that help you to do these smaller batches to fill some of those needs. But I think even when you break those down fully, you see that the financial commitment is so much greater. So there’s that that balancing is, is tremendously difficult, also, like Travis was mentioning was the validation side of it. And if there is a problem, and you have to stop, and that’s another thing that I think is tremendously difficult, because, again, we have this financial situation that you have to push through, but then we have to stop and investigate. And those, those are tricky. So they’re very, very tricky. And also, from us just the standpoint of the compliance side, really understanding what is allowed to do, I mean, we have statutory language, it tells us and we have these guidance documents, which tells us so we have to really understand what those mean. And then what you can do, because if you start on a road of well, maybe I can do it, maybe I can’t do it, or I don’t understand if I can really do it, or I don’t understand if I can do it. And I have seen other 503B’s get trapped into this, we didn’t really understand initially going in what was expected. And then so then the guidances, and the rules kind of change for us over the years. And then all of a sudden, like, Oh, we really couldn’t do this. And so then there’s been investment into a particular product that actually isn’t going to have any real teeth going forward, because we don’t have a lot of support it. So that’s a tricky one too. And I think that’s kind of if you’re outside of the hospital space where there’s lots of need for outsourcing. But if you’re there’s all these other sort of markets that rely on because of this, or this or that the other thing, if those things are in a gray area, it’s hard to plan for the future, knowing all of that up front can save you a ton of money. And it’s just really understanding that and that that is tricky. I think in general.
Thanks a lot. It sounds both complicated and risky to be perfectly frank. And I believe like our industry right now. Our industry needs crystal ball to be able to protect the future. And these are the how FDA is going to react to outsourcing because it gives us and taketh away so to speak with with the implementation of its books and from lists and changes to that list and shifting guidance on these issues as well. In a little bit more detail. And I’ll start with you, Kimberly, how do you go about integrating compliance procedures into business activities? And why is this important to you in your organization?
I Think I preemptively answered this a little bit. But I think the best way is to truly understand what the guidances are telling you and they are shifting, really understand what what the law allows for you to do and put your bets on that. Whatever is the most black and white for the long term. Because it is such a tremendous process in terms of investment. But it it is because if you’re looking at longevity, what is the best case for it. And right now we we have so much gray and we have a lot of guidance. And thank God we have some guidances at least we have something to work with right now. But that is ever shifting. And it’s tricky. And I’m hoping that it will continue develop to develop more because this idea of having GMP in the pharmacy space is great. I mean, it’s just so good for the patients. GMP is massive and cumbersome, but it’s also really, really good. And it can can even when it’s effective, it is amazing for the final product and just everyone going to sleep at night. So I am hoping that more of that will will help or will get more not concessions but more things that are black and white so that we know how to move forward. But I think the most important reason that you would want to be fully aware of what the compliance is offering you is just your return on investment. Because you don’t want to crash and burn at the end and you don’t want the misery and it is actually easier to comply and move forward in that respect then to like try to work in the gray than those sometimes we have to work in the gray. The easiest path is the compliance time.
Karla Palmer 15:01
So so but isn’t cgmp even as defined by FDA and its guidance documents for outsourcing facilities? Isn’t it still, in necessary I get it, it’s completely necessary. But isn’t it onerous from a financial standpoint, that it makes the compounding of certain needed products simply prohibited, especially those that are on a shortage list, which is what FDA wants to say. And in especially some products that may be requested by a hospital system or a clinic or certain facility, but not in a, in an amount of, or a lot size? or what have you that will cause this to be a profitable, and I don’t even mean being profitable, just a somewhat profitable venture for the outsourcing facility.
Kim Kieffer 15:53
I think that there’s a way I think there’s a way to work with em some of the concessions that they’ve given us, I don’t think it always works. But I think it can work. In some instances, the shortage thing is really in contention. Because you have such a short tail time. If you want to feel shortages, you’re allowed to go ahead and do that. But it’s gonna take you quite a bit of time to like, do all the validations necessary to get the product out the door, and by then you may have a shortage that’s no longer there. And so this has been the big argument. And FDA is giving you 60 days to sell your product, and then you’re done once that shortage is resolved. So I think there’s been a lot of requests of the agency to like, increase that tail time to make it a little bit more feasible. And I think they, they started to do that a little bit with some of the COVID medications that are needed. And I think people are hoping that that will open up doors for the future. Because I don’t think I think in tremendous, there’s been a tremendous interest to fill these faculty shortages. But almost everyone has comments that, you know, we don’t have a crystal ball. If we do this, are we going to be out of business in a little while I think there are substances, and I know, Travis would agree that you can bet are going to be on shortage, and you can you can make a really solid crystal ball bet on those. And those might be a good place to start. So there is opportunity in there. But for the small one off, I think sometimes it can work, depending on how small it is and how much time you can just, you know, can you invest at clean room staff to go in to make 60 units? So something that you can only charge $50 a unit for? I mean, that’s a internal discussion, I think it just depends on the, you know, the size of your operation and how you’ve got scheduling happening. I think sometimes it can work. But again, it really just depends on the operation. And it may not be profitable, not especially.
Travis Leeah 18:01
Yes. echoing what Kim was saying. Yeah, I’ve seen it a lot in other 503b facilities where they were trying to go 60 miles an hour and be compliant, you know, you know, putting in compliance procedures at same time. When I was with unique, we couldn’t do that we shut down, we shut completely down. I don’t know how you can do that. On the Run. There’s too much. There’s just too much change. So yeah, I integrated compliance procedures in the business activities, putting your business plan for the front. I said the other day on on another talk. You got to get the right budget, that’s going to be the hard thing is is budgeting how much you’re going to need. Because we we spent a lot of time on our budget and we we exceeded it quite a bit. And so it’s it’s one of those, yeah, you got to get everything done at the at the front end, I wouldn’t, I wouldn’t put a product out until you have everything in place. Because once you do start producing and product goes out the door, it’s it’s going to a lot of changes. They may seem small, like a small little process change or equality change in the or procedure within, you know, within your process, but they get really, really big, especially when you’re running at full speed or even half speed. So I think you’ve got to you got to integrate all that in to the front end. And from a compliance standpoint, when you’re talking you’ve got DEA requirements, you got FDA, here, you also have your states if you want to sell into the states, they all have requirements, all of them do. You better get a team together to make sure that they they watch what’s going on in each state. What’s going on the federal level on a continuous standpoint, you put in your budget to hire that team because you’re gonna need that team it’s it’s gonna be pharmacists quality folks that are watching what’s happening and making sure that you’re going to dot every I cross every T and and then you don’t get caught red handed with with changes in, let’s say Ohio or Indiana has to change. That can be an issue and a lot of times, compounding pharmacies and 503B outsourcing facilities have have been caught not following certain procedures and in certain states to and and at the same time. All the states, they they’re continuing to change their requirements and what they need. They’re changing their licenses, license changes, you know. So you, you you’ve got to, you’ve got to plan to have that team put in place for sure.
Karla Palmer 21:06
So the bottom line is you need a very, you know, a high functioning quality and regulatory team. Is that is that with you today? Yes. And you need to be very friendly with your various state boards that may regulate you because all of them play an active role in compounding slash outsourcing facility. regulation. So and so you want to pay attention to what your state what all the various states in which you’re shipping products are doing. Because those states initial in a state can really wreak havoc because of reciprocity of those decisions in one state and the effect that they can have on licensing in other states as well. So those are all very good. And, and thank you for discussing the difficulties and integrating your business, you know your compliance procedures into the business activities of your companies. It is extremely important and something that it’s very weary on these issues.
Transcribed by https://otter.ai
Karla Palmer 1:25
What role do FDA communications play in your regulatory business activities? So in particular, consider FDA guidance documents for outsourcing facilities inspection communication, such as 483s, warning letters issued to outsourcing facilities, etc. How do you integrate those communications for FDA in whatever form and there are many of them, and they’re varied? How does this play into your business operations.
Kim Kieffer 2:05
So just to start with a guidance documents, so those are incredibly important and need to be constantly monitored, we see draft guidances, we see final guidances. And though they are not binding, they are with the agency’s thinking. So it’s really important to know what they say, and to be evaluating your business against them as we see them come out. I think they’re, in some ways, very, very helpful. And then there are other guidance documents outside of what is just offered specifically to 503B. I mean, there’s all sorts of guidance documents for pharmaceutical manufacturing industry. And those are actually really great reference documents. And I think we and I, myself, referenced them often. And those are available in tremendously helpful because I mean, it’s giving you information that’s consistent with GMP. And it’s, you know, and what has already been the ethos. And so they’re comfortable with that. And those are things that you’re also subject to, and then in terms of 483, and warning letters, those are just a part of the reality of living in our new environment. And as an outsourcing facility, you’re registered. So your primary regular regulator is FDA, and they use these observational 483 is an inspection report to help us grow. But they’re also to point out places where either we need to look at compliance or improve operations, etc. And I think that where we see the biggest issues with those are with state boards, not necessarily understanding that those aren’t, those aren’t enforcement actions, but they are observations. And so I think from the state board, you know, it’s so concerning to them. And the other side of it, you’re going to have your clients are going to also be reading these 483s and the agency has made it very visible on their website, you know, if you want to read it 483 for Merck and Pfizer, that’s a little bit harder to find. But if you want to find them for compounding pharmacies, it’s like with flashing lights, so you can easily find those with the Google with like a two second Google search. So those are there. And so you have to be understanding how you’re going to plan how you respond to your clients, because they come in, they evaluate you and they have questions about that. So that that also has to be like, how do we make sure that they’re comfortable and understand like, this is what it says, but this is actually what we’re doing and how we responded and in whatever you want to get into. So those things, I think it’s just a matter of like, making sure you respond to them, right and doing the improvements that they offer them. Because in some cases, I think in a lot of cases, you know, they give you some very good observations that can help you improve, we’re all learning here, and everybody gets these, everybody in the industry gets them. And the GMP environment is really there to make you improve and help you continuously improve improve. So if we just I think if we think about 483s and warning letters, obviously in this respect that it’s just part of the development process, then obviously, it helps us improve compliance. And wow, there’s nothing like an infection to get things approved and things push through. That you’ve been working on baby to finish, and maybe you couldn’t get a signature on them and help you push through that implementation,
Karla Palmer 5:05
You know, on the 483s I have an observations race there. And by FDA, I definitely have been before different state boards that have taken a 483 and complained about an outsourcing facility concerning an allegation in the 483. And I have on numerous occasions taken the approach that these are not binding decisions on behalf of the agent by the agency on behalf of the compounder or outsourcing facility. Instead, they are FDA observations only. And so therefore, they don’t have a binding legal effect on anybody. And I have been told, and this is something that I found very interesting. And actually, I, I get the point, but I wish states wouldn’t make the point until the outsourcing facility has time to address the observation, I get the comeback from one state word wrap that when the FDA observes mold, and then indicate that observation on a 483, that’s a problem. And and so when you put it in that context, unfortunately, because it really did ruin my argument that these are not final decisions of the agency, their observations only, etc, etc, etc. The state’s response was nobody wants to be in a situation where FDA is observing mold in your compounded formulations. And I thought that was really telling because it just brought it all back to an NECC type retort by the state. And indeed, I have not spent a lot of time going forward raising the fact that these are not legally binding findings on behalf of the agency that are set forth in the 483s, it did put me back on my heels a bit with the state’s response in that manner.
Kim Kieffer 6:44
I was thinking that though FDA has the Center for Excellence, and there’s the regulatory framework, and if everybody has not run immediately to take that a lot of it is review, but it’s very good. And they talk a lot about inspections and 483s and warning letters and untitled letters that they make this distinction that these are not enforcement activities, but they are observations of things that could potentially precipitate enforcement activities. And so yes, we want the state boards to understand what they are, but they are in fact, observations of things that are potentially out of compliance. So I think not the to give the state boards a path that it is concerning to them. So it’s part of just managing that their expectations.
Karla Palmer 7:23
Yeah. And I’ve lost the argument to the contrary. So Travis anything to add?
Travis Leeah 7:29
Yeah, very, very good information. For sure. The thing I keep coming back to within your company, and this goes to the leadership to the top of your leadership of your company is one of the goals one of the priorities of every company 503B, this should be in business, I highly recommend that you put quality is one of your priorities, if not number one, because this all pertains to quality and patient safety. I have been in a lot of inspections. And one thing I can say there’s a lot of them that I did not like there’s a lot of them that I was okay with some were absolutely destructive. But I can also say that every FDA inspection has made us a better company. We learn a lot from inspections and 483s. Do we like them? No, we don’t. But FDA has been very good from a communication standpoint. And the dialogue has been phenomenal for 503B standpoint. So I’ve learned a lot from dialoguing with the FDA. Do I agree with everything they decide on? No, of course not. But I can’t say we’ve learned we always learn from 483 inspections. And this has got to be a priority for every 503B company. bar none because if you don’t have this done, then the money, the profits later on are not going to happen. Because it’s if you don’t have control your processes, you don’t have the quality built in the quality priority. I see a lot of 503B’s that put sales and profits above quality. It doesn’t work. They’re not around forever. It’s going to catch up to this part of the business. You have to be ready for the FDA to come in any day. You don’t want to do training on FDA inspections, you should run a facility that no matter what day it is, if the FDA walks in, it’s okay, you’re ready. You want to be FDA ready. And that’s extremely important. And you definitely don’t want to go down the road of warning letters and enforcement actions with the FDA because they’ll give you FDA is fair and they’ll give you chances to correct things but you know, if you don’t invest in correcting NPL take the 483 serious they’re not going to waste time on going down the road of enforcement actions.
Karla Palmer 10:00
My take on this industry is that it’s highly regulated. It’s one of the most other than DEA, it’s really one of the most This is the I actually think there’s FDA is and outsourcing facilities regulated by FDA, even more highly regulated than those entities that handle controlled substances, and most outsourcing facilities do both. So it’s highly regulated, or you’re under the microscope with highly active federal agencies as well DEA and FDA. And it’s just not an industry that’s for the faint of heart, so to speak, you have to be ready at all times for a government investigator to knock at your door and permit themselves to enter. Because they have that right. And you have to be able to stand up your compliance team and show these agencies that you are on it, so to speak, as far as your regulatory compliance is, if you DEA and FDA, to be perfectly frank, and let’s go to the next question. So not being somebody that works at an outsourcing facility myself concerning complaints of readiness and everything that we’ve already discussed up to this point and how significant compliance plays in your day to day operations. How much time do you actually spend on these issues? Is it monthly, daily, weekly? What do you focus on when considering compliance readiness? And how much of your day does it take?
Travis Leeah 11:21
You put in a lot of processes and procedures, departments, investigative teams, quality teams in your dream team? So this is something that daily for sure, daily, I can’t see how you can do it weekly or monthly. It’s got to be daily. Like I said, if you’re compliant, ready, then you’re ready for the FDA to come in any day. If it’s weekly, what if you’re going to work on your compliance on Friday, and they come in on Tuesday, it’s gonna be daily. Without doubt,
Kim Kieffer 11:51
it’s daily. And I think also, it’s not even a we’re going to consciously spend time today it’s like an every procedure, you have compliance activities for added into it. Everything, everything you do, fixing a label, updating a label, sending the cleanroom is sending facilities into the cleanroom. I mean, everything that you’re that you have to do, there’s a compliance component. And everyone really needs to be on board and trained in that area. To understand why that’s important, are required
Travis Leeah 12:21
It’s got to be built in your quality.
Karla Palmer 12:23
Was that expected or unexpected for either of you when you first undertook your roles at an outsourcing facility? I mean, Travis, I know that you were at a 503A before then that rolled up into an outsourcing facility. So it may have been a little bit different. 795 and 797 have completely different structure to be perfectly frank at announcer at a company, but Kim especially you, I mean, have you been surprised by the amount of compliance readiness and engaging in compliance issues that you’ve needed to be involved with since being in power?
Kim Kieffer 12:55
Oh, absolutely. Because I had been on the raw material side looking and unders trying to understand the regulations and you know, helping people not go to jail, but as much as possible, but not really in the thick of it practicing. So there wasn’t really it was a huge change. And come the 503A, you know, the the compounding side, it is so much different. That part I’m not super surprised with but the B is really it’s all on, you know, GMP is big and the compliance around it is massive. And then you throw it in the state boards all having to have their own special version of things. It’s everywhere. And it’s just, it’s just part of the process of GMP to have those procedures, the like as the backbone of everything. And but I like it, I think it’s really interesting. It makes everybody a lot more honest. And there’s not this Well, my friend did it. So it’s fine. Oh, if I had $1 for every time Oh, pharmacy down there is using just the on your face. So it’s got to be funny, you know, like I have such a rich person. For all the years I heard these things, and to the manufacturing side or the commercial drug industry side requires a lot more science to be at the heart of things. I mean, we all want to think we’re doing science when we’re compounding and we are to a certain extent but there’s so many unknowns that we’re not held responsible for. And then in GMP you are held responsible for it and it’s actually enlightening and really interesting and you probably like I said earlier sleep better when things are in balance and you’re continually moving and learning.
Vivian Juter Frankel 14:27
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Karla Palmer 14:48
Doesn’t it bother you though? Let me just throw this question. I see it a lot of time in my practice. I mean the issue of selective enforcement so to speak and you know, FDA is not a police officer. They’re not catching people speaking speeding, etc. But there is a degree of that in the industry and doesn’t that bother you? I mean, you know, you stop doing what you’re supposed to you comply, you engage in compliance activities on a daily basis. It is part of your company’s fabric so to speak. But there are entities that seemed to, quote, not comply, and all the while don’t seem to have a regulatory issue with the agency isn’t that difficult to grapple with?
Kim Kieffer 15:28
So it depends on what part of it
Travis Leeah 15:32
for me, I’ve seen so much, I get to think I’ve been in the industry for so long, I’ve seen so many different things. And yeah, I’ve seen that the selective enforcement, we just tried to concentrate on making ourselves better for the most part. And I think, in the end, quality always wins. So we can just work on ourselves and make ourselves better on a continuous basis. And that’s, that’s something else I didn’t mention is a lot of these GMPs that you follow that he think are waste of money, you’ll learn a lot more about your products than you ever realized from 797 standpoint, and that learning is invaluable. And going forward. So we use mainly just concerned we worry internally about ourselves being the best we can be.
Kim Kieffer 16:19
I really think that that’s probably the best way to look at it. And I don’t think in terms of the quality aspects of the GMP that there’s that you can be concerned about selective enforcement at all. I think there’s parts of the guidance and shaky things in terms of like planning your business model where a selective enforcement becomes an issue for people. But in terms of the quality aspects, and just the production of your products, there’s no part of that that you can really even be concerned with, you have to do the quality.
Karla Palmer 16:49
So getting into the nuts and bolts of what you guys actually compound, what role do the actual substances that you may use in compounding play in your business activities. So let’s consider shortage medications, combinations, new therapies, meeting, requests, and needs, etc.
Travis Leeah 17:09
From our end, all of these have been within our decision making, of course, you know, the shortage medications are a big one, we have abilities to do sterile, the sterile and API processing. So we do both the shortage medications for sure the bulk substances is a big one. And we have also had some really interesting therapeutic needs and develop products for interesting therapeutic needs. And the interesting thing about 503B, that it’s such a cool business, because everything we make comes from our client, you know, our client asked us Hey, Travis, can you make this fentanyl? ropivacaine? Or, Travis, can you make this? Or can you make that everything we make is what the hospitals ask us for? I think from a business model standpoint, we don’t have to go that creative route and figure out what do our clients want? We basically go to them and say, Hey, what do you need today? what’s what’s your headache? What can you not get? I mean, what can a 503B facility do for you? And they’ll tell you, and they’ll give you a list. And sometimes it’s really long, and sometimes it’s short. But that’s what’s neat about the industry is we just make things that our clients need areas.
Kim Kieffer 18:31
Yeah, I would say that we also see that exact same situation, there’s no need to try to be creative people will come out of the woodwork. With things, I think where it becomes difficult. And we talked about this, I think earlier on is when you have clients that come to you and say I want this thing that is not eligible. It’s not on one of the category list, right? It’s not on category one, but even on category three, nobody’s ever heard of it before. I mean, maybe we’ve heard of it, but never like in a compounding setting, and they need it to be an X dosage form. Or however, then there’s the process of nominating you can nominate that substance. And then it goes into this sort of black hole of Unknowing where you may see it again, you may not see it again. Or it might be years before you see it. Again, I think we’re seeing some movement now from the industry or the agency in terms of re evaluating or this positioning these nominations that they’ve received, because they’ve received I think, lots and lots and lots, hundreds of them by now, over the years. And we’re starting to see some movement in terms of them actually looking at them again. And then they’ve also reached out to some other organizations to help with that process. But you can’t know. So if your physician says I need this for x, you can’t necessarily do that for them. I think that’s tricky and difficult and there’s always this desire to do it, but you can’t and so that becomes an area where it I think it falls a little bit short because it would be better, always better for that to be made under a GMP environment. That’s tracked
Karla Palmer 19:59
How about Covid So, you know, we’re all living in this odd environment right now, the pandemic has wreaked havoc on drug supply throughout the world, including in the United States. And have you at your facility been able to, you know, FDA has its guidance documents on using compounders, and outsourcing facilities to alleviate drug shortages for patients and hospitals throughout the United States. So how has that played into your business and strategic decision making in the last six months or so if at all.
Travis Leeah 20:30
Huge, huge. One thing we want to do strive is the industry as a company is to make sure you will, we’re taking care of patients, we’re improving their health, we’re treating their ailments. Fortunately, our company had a lot of products that were used in supportive care of COVID. And we basically doubled, tripled our production of those products so we can meet those needs. So it’s been huge. And we remind everyone what we’re doing here, and it’s for these patients, and they can make a difference.
Kim Kieffer 21:08
We actually have not responded very much to the COVID we don’t really have the way our current operation is set up and a capacity to do a lot of hospital products.
Karla Palmer 21:17
Got it?
Kim Kieffer 21:18
You’ve done a few here and there.
Karla Palmer 21:20
So Travis, and Kimberly thank you so much. And I’d also like to thank PharmaSalon for hosting such a unique and interesting sessions for our industry to continue to learn and educate ourselves and others etc. And so I’ll leave it at that.
