CEimpact Podcast

Regulatory Essentials for Safe and Compliant Compounding

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Compounded medications serve a critical role in meeting patient-specific needs, but compliance is essential to ensure safety and quality. This episode covers what pharmacists need to know about documentation, prescription validity, beyond-use dating, and common missteps that can put compliance at risk. Tune in to strengthen your compounding practices and stay aligned with current regulatory expectations.

HOST
Joshua Davis Kinsey, PharmD
VP, Education
CEimpact

Jessica Gustin, PharmD
CMO & PIC/COO
Gwinnett Drugs/SynerGrx

Joshua Davis Kinsey and Jessica Gustin have no relevant financial relationships to disclose.
 
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CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Identify key compliance requirements related to patient-specific prescriptions and compounded medication preparation.
2. Describe common compliance challenges in pharmacy compounding and strategies to avoid regulatory missteps.

0.05 CEU/0.5 Hr
UAN:  0107-0000-25-273-H07-P
Initial release date: August 18, 2025
Expiration date: August 18, 2026
Additional CPE details can be found here.

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Speaker 1:

Hey, ce Impact subscribers, welcome to the Game Changers Clinical Conversations podcast. I'm your host, josh Kinsey, and, as always, I'm super excited about our conversation today. Compounding plays a vital role in meeting individual patient needs, but even small missteps can lead to serious regulatory and safety concerns. In this episode, we'll break down the key compliance principles that compounding pharmacists should know to ensure compounded medications meet both legal requirements and professional standards, and it is so great to have our guest for today, jessica Gustin. Jessica, thank you so much for being here.

Speaker 2:

Thank you so much for having me, Josh. I appreciate it.

Speaker 1:

Yeah, so Jess and I go pretty far back. Jess was one of my students back in the day when I was on faculty and just been so excited to see her trajectory and her career path and have followed her and just really excited that she's agreed to come on today to talk about this subject. So, jess, I'll let you introduce yourself to the learners and tell us a little bit about your background and what you currently do little bit about your background and what you currently do.

Speaker 2:

Awesome Thanks, yeah, I know it's been so fun to catch up. So I'm a graduate of Mercer University where I got to learn alongside Dr Kinsey and all the amazing staff there. After pharmacy school I got involved in the independent community space, so I worked at an independent pharmacy and still help there now, and that's a local independent pharmacy that does compounding and it's called Gwinnett Drugs. I'm really excited because, out of my opportunities and learning all things compounding and helping to build out like a sterile compounding lab and a USP 800 hazardous non-sterile lab, you know, we sparked innovation and started a new company called CenterGRX, which is where most of my time is spent. Now it's more of like a healthcare technology company where we have pharmacists integrated into physician offices doing chronic care disease state management. It's really exciting.

Speaker 1:

That's awesome. So, yeah, again, like I mentioned, lots of innovative things that Jess and her team are doing and just really excited that she carved out some time for me today to talk about this. So what we're going to focus on today, as I mentioned, is compounding, and specifically, we're going to really focus on 503A compounding. So I want to start out with as I always like to do in the podcast is just kind of set the foundation for the listeners and just make sure we're on the same page with what we're discussing. So, Jess, if you can take a little bit of time, to kind of tell us about what specifically is 503A compounding and why that's different. You also mentioned hazardous and sterile and you know there's so many different varieties of that. So let's focus on 503A and really set the stage for what we're going to be talking about today.

Speaker 2:

Yeah. So 503A pharmacies are what you kind of think about, your traditional compounding pharmacy, like one that you can walk in. Your doctor has sent a prescription there and it's getting filled and made by the pharmacist that's on site. So 503A actually comes from the Federal Food, drug and Cosmetic Act and it really outlines the legal framework that the traditional compounding is going to have and what the requirements are for compounded medications to have an identified patient with a valid prescription, and it's prohibiting any sort of compounding of commercially available compounds and different products that are out there. So the regulation is typically completed by your state boards and the FDA will then step in if there's public health risks or something like that that may arise.

Speaker 1:

Sure, Okay. So basically just anybody who has an independent pharmacy or community pharmacy can get into the space of 503A. There's no, you know, when we're talking about sterile compounding, there's specific equipment and it's very expensive and whatnot. But what are the, I guess, the startup requirements for a 503A? They're more on the simpler side, I would suppose, right.

Speaker 2:

Well, 503a is really just kind of like the framework of what compounding you're doing, what the different components are really set by USP standards and so, while you may be a 503A like more community traditional compounding, you're still going to be regulated and need to abide by USP standards. So the USP standards are really setting the type of compounds that you can make and 795 is going to be your quote unquote most simple standard. That's there because that's your non-stair compounding. So think creams, ointments, capsules, stuff like that.

Speaker 1:

That's great. So you've perfectly transitioned us into the next one that I want to go over, and you talked about USB standards. So let's just chat briefly about those who sets those what, where you know, where do they come from, how often are they updated, and and the compliance implications for for USB standards.

Speaker 2:

Yeah, so USP is its own United States pharmacopoeia that we are utilizing. There's a couple of different chapters that we follow in 503A compounding, so specifically 795, which is your non-sterile, 797, which is your sterile compounding, and USP 800, which is your hazardous drug handling. So they're not laws, but I say, but they're enforceable standards. So they focus really more on, like how we're able to compound. So that's going to take place in part of, like your facility design, how you need to train people, how you actually need to like go inside the labs to compound the documentation quality assurance. Go inside the labs to compound the documentation quality assurance. That sort of thing I almost like to use like a bakery or like a restaurant example.

Speaker 2:

And I like to say that like 503A is kind of giving us like what items are on the menu that you could basically make from a recipe, versus like USP is kind of telling you like what kitchen can you make it in and how does your kitchen need to be cleaned and how do you need to enter your kitchen. It seems basic, but it's kind of a good way for me to be able to think about like the two differences and how they're able to help standardize the practice.

Speaker 1:

Yeah, that's great, that's a that's a great foundation level of it. Just to make sure that everyone's clear with that. Yeah, that's super helpful. Thanks for sharing that. So, one of the things that you mentioned earlier and I want to dig into it a little bit I want to kind of get into some of those key terms and then we'll talk about more of the opportunities for pharmacists and what they can be doing and that kind of thing. But let's define a few of the key terms, and you mentioned a few, so we'll just kind of start out with one that you first mentioned and that was patient-specific prescription and the fact that it needs to be an intended patient and a valid prescription. So let's talk a little bit about what that means and the extreme necessity of that.

Speaker 2:

You know, when you're compounding, yeah, so the patient-specific prescription is what is allowing us to be able to compound. So it is a prescriber order for a named patient that is required for every compound to be dispensed. So essentially, I can't compound something without having a specific prescription requirement and it's super important. Essentially it's just protecting us from saying, oh, you can just compound this for everybody, and you really can. It needs to be for a specific patient.

Speaker 1:

Got it and along those lines. So I think something that people have probably heard before is like batch compounding. Or we created a whole batch of this and then I'm going to go tell a prescriber that you know I've made a whole batch and start, you know, telling people to come get it, like that's not allowed and that's what that's saying is. It needs to be patient specific. So in that same space, another term would be anticipatory compounding or batch compounding. So if you can talk to each of those, that'd be great.

Speaker 2:

Yeah, so anticipatory compounding is really like preparing limited stock in advance and it's based on historical patient needs and are strict within the 503A limit. So it's looking at again beyond use date, which we'll get into that terminology, but it's really looking at you're not having a large quantity on hand. You're looking at what was there before, so it's only existing or historically served patients. You need to have historical need. You really don't want to have a large quantity available in anticipatory compounding. I think a lot of state boards actually advise compounding no more than 30 days of anticipated supply. You obviously can't do the office use distribution. So that's more of our 503B facilities. Those are like the bulk unscripted batches, that kind of. You know I'm going to send a bunch of orders and try to buy it for an office use. That's 503B and the 503A anticipatory batch. You know you still need to comply with all the USP requirements. So the dating is appropriate, you have documentation, you're using all the records appropriately, but you're not. You're not going to just batch a bunch for no said reason.

Speaker 2:

You're going to have to be able to show his history for it.

Speaker 1:

Exactly, and you had mentioned before, you know, like actually pulling reports and seeing use of that and making sure you know like you have to be able to back up your anticipatory compounding. So you have to be able to say, well, I made this much because of X, y, z reports or whatnot. So yeah, so you mentioned another one. So let's just I know it's another big one that you know I guess is somewhat confusing to some people but what is a BUD? What is a beyond use date?

Speaker 2:

Yeah, and I get this question like all the time because when we, when we send out our prescriptions, they have beyond use dates on them and I get calls it's like, oh, it was supposed to go till here. And you know, beyond use dating is really the date or time after a compounded medication must not be used. It's not going to be the same as, like, the expiration date. You may have expiration dates of APIs or active pharmaceutical ingredients that you're using to make that compound that go beyond the beyond use date that you're given. Beyond use dates are also based off of the USP standards, and so it's going to be dependent on the type of preparation, the risk of microbial contamination, stability if you have that information on file and then the storage conditions, so whether it's stored at a refrigerated temperature, frozen room temp and you know. If there's no stability data, you just go straight to the beyond use date that's provided in the USP chapters. So that's really where the USP chapters come into a large play.

Speaker 1:

Yeah, and that's you know. It's really important. I can see where the confusion would come from from pharmacy staff, especially if compounding is new to them, because they're used to one drug having an expiration date and that is. That is all it is. But when you're making a compounded product you're usually using multiple ingredients. You know it would have to have other different components that are making it. You know the emollient or the whatever, and and so everything has to be taken into account and so that BUD is like the new expiration date for that compounded product. Is that right?

Speaker 2:

That's right, and like there's even like roles are reversed too. An API could have an expiration date before the beyond use date, and if that's the case, then you have to adjust the beyond use date for the expiration of the API. That's the case, then you have to adjust the beyond use date for the expiration of the API. That's there. A lot of times they're looking at like water component and anything water containing has a lot of different beyond use dating, especially for 795. It's very common, yeah.

Speaker 1:

So again, as we're talking about this, super important to always review the standards and to make sure that you're staying compliant with those. You can't just willy-nilly choose an expiration date or slap something on there 30 days beyond when you made it. It's very prescriptive, in a sense, that you have to make sure that you're following all the standards to determine that BUD.

Speaker 2:

Yeah, and there's also situations, too, that I've seen in practice where there will be like a beyond use dating study, so they're using some of the stability data to be able to extend a beyond use date outside of. Usp, but you have to always make sure that you're using those exact APIs that were used within the study in order to apply that beyond use state. That can be a large concern for confusion for some compounders.

Speaker 1:

Got it. Got it Very helpful. Is there any other like main key terms that you want to go over before we kind of dig into like anything else to set the foundation? Did we cover most of those?

Speaker 2:

I think we covered most of it. One thing I did discuss that I didn't get to highlight was like a compounding record. So that's going to have like your detailed log ingredients, you know the lot number, your calculations, the processes and how that batch or product was actually verified, and it's going to be really important as we discuss what the pharmacist role is with that compounding record.

Speaker 1:

Got it, got it.

Speaker 1:

And again, as we as you probably remember me when I taught different courses document, document, document is key for everything we do in pharmacy.

Speaker 1:

And you know, just as a realtor always says, location, location, location, I always said document, document, document. And that's going along with this compounding record as well, that that's kind of like if you're going back to the food references that's through recipe, like that's what you have, that's how you made it and you know. That way you have kind of a standard to go back to and look at if there's any questions or issues. So before we get into more of those specific roles and kind of deeply dive into what kind of farms do and what should they be doing, and you know watching out for I just want wanna kind of touch on I always like to bring it back to the community Like how is if our listeners out there are in the compounding space already? Hopefully they're just getting a refresher and they're getting some updates and reminders and whatnot, and then if we have listeners out there who are wondering if this should be their space, you know what's the impact on communities and patient outcomes with compounding?

Speaker 2:

Yeah, so I think compounding provides a really unique space, one. I love it because it's a niche service, but it provides a need that's not commercially available, and that's really where I always go back to on our stance as being a 503A facility. It's like, well, I'm able to provide a medication and a treatment available to a patient that they wouldn't otherwise have access to. But I do think that, as a pharmacist too, there's a lot being said over compounding pharmacies and making sure it's safe, because you just don't want to have, you know, being able to go in and make any cream and then it harms people even more. So you know we have a really unique role here to play where we can provide unique, customized treatments and options for patients, sometimes that are going to even help them for a false perspective, which can be really, really helpful. But, you know, compliance with it's really not optional, because it's how we're protecting both us and the patients and our profession.

Speaker 1:

Yeah, I love that. That's if I were to like take one statement away from today compliance is not optional when it comes to compounding. So I love that. Okay, so now let's dig into our, I guess, main focus, I suppose you could say, and just kind of giving all of the opportunities and roles and responsibilities of the pharmacist in this space. So in general, obviously, maintaining compliance, appropriate documentation, that kind of thing. But I want to kind of jump into what that looks like. You know kind of break them down. So let's talk about the pharmacist role and ensuring compliance just in the daily workflows. Like how can we make sure, like, do you have to constantly look at SOPs? Are you constantly training your staff? You know, like, how can you make sure that workflow is following all the right steps for compliance?

Speaker 2:

Yeah, it's a loaded question, but it's so important. So I think, like pharmacists' role in compounding is the guardian of the entire process, right? So we're overseeing facilities, those processes, the personnel, making sure we're abiding by all the USP standards. So how do you do that in an entire day? Right, you're like this is a lot to oversee, so ensuring, like you said, documentation or it didn't happen no-transcript that it's reproducible every single time, that it's safe and can be verified for consistency every single time.

Speaker 2:

You know, while you're given error percentages that you're allowed to have, maybe you tighten them up a little bit so you have that little bit more of a safety factor beside it. You need to make sure your personnel are trained. You need to make sure that they're competent before they go in the lab. That means visually inspecting what they look like, making sure that they're abiding by all of the procedures appropriately and then setting them from the start. I think that's one thing to take away from this entire conversation is, if you don't set it up for success, it's likely that it's easy to break along the time, and so we always have a saying that, like you know, people are going to live up to your minimum expectation. So make your minimum expectation very, very high when you're setting these compliance standards for your labs.

Speaker 1:

Yeah, yeah, no, that's. That's great advice and you know, as you mentioned, I think the key to it is ensuring that you have that foundation built before you jump into it. If you know if compounding is something you want to consider and something you want to do, or if it's something you're already doing, take a step back. Make sure that your SOPs are in order, make sure that they maintain compliance with the USP standards, and not just that you have a book of SOPs, but that they're actually maintaining compliance.

Speaker 2:

Yeah.

Speaker 1:

And updating them as you go along. Like we don't see USP updates super often, but when we do you should review everything and make sure. And then one other thing I heard you say with the recipe is and I love this example because sometimes I love to cook and it's kind of like my, one of my creative outlets, and but I've gotten even more like lax with like oh, it says to add you know two teaspoons of this and I'm going to add three or whatever, and that's not really something you can do in compounding, because then you're not going to be able to verify its validity and its safety and you know all of that kind of stuff. So I loved your example of making sure that it's you know the exact recipe and reproducible each time to those standards.

Speaker 2:

Yeah, and I'm laughing almost because I cook just the way you do. I'm like, well, I'll just add a little bit every now and then. So maybe I need to change it. It's more like baking, because baking is more precise. Yes you're.

Speaker 1:

You're way more precise, and so baking is more precise.

Speaker 2:

Yeah, it doesn't have as many like. Oh, I can just add a little bit in here, because you know, then your whole entire cake is going to come up like yep or or yeah, or collapse or and that's kind of the way you have to think about with compounding too, because you put too much in.

Speaker 2:

Well, is it going to be too thick of a cream, is it? Is it actually going to now be way too potent and hurt my patient? Did I not put enough of it in? Did I wet it correctly? And now I can't get it to formulate the way I want to? There's a lot that can potentially go wrong, and that's where, again, setting up that recipe so it can be reproducible, you can see every single step and know that it's done correctly, is so important.

Speaker 1:

Yeah, that's great. That's great. You also mentioned educating staff, and I know that that is something that I would assume is an ongoing process because you know and identifying when there may be a misstep and then pulling them out and re-educating, retraining on something. So I'm sure that's an ongoing process. It's never a well. They've been trained, so I don't have to worry about them again, right?

Speaker 2:

No, and I, you know, compounding takes a lot of CEs. To be honest, we do. We do a lot of continuing education. I would say one thing that was very helpful with our operations is getting a system that tracks all of the training for us and shows us when you're going to be out of compliance, kind of taking it back to USP requirements or those standards are. You know, you do have certain standards that need to be met, but you need to make sure everyone is staying on top of the competencies with it that they're passing.

Speaker 2:

You're not just checking someone off just to check them off like they need to be competently showing you that they can do it. And compounding personal training is not just like a didactic. I can go sit at my desk and fill out this, you know, watch a movie and answer some quiz questions Like you have to demonstrate a lot of successful operations even before you can step foot in some of the labs. So it is entirely important that you have competently trained personnel and that's why it's also a great kind of career path option for some technicians that want to be able to practice at the top of their pharmacy technician license.

Speaker 1:

Yeah, that's great, that's a great call out. I love the fact that you know this is an opportunity for your techs to take it a step higher, to empower them to do something different. And you know, while we're talking about the pharmacist role and how, that is kind of the glue and the conduit for everything. But they can't possibly do all steps. There has to be some assistance and there has to be other people, and they're actually, you know, doing the recipes and making the products. So, yeah, okay. So then, how do you ensure we've talked a little bit about patient safety and, again, following that recipe and making sure that it's reproducible, but also that weighs into the calculating the BUD and, you know, based on standards and whatnot? What are other ways that you build in kind of safety procedures or precautions to ensure that the product that you're handing over to the patient is really what it is and, as you mentioned before, not too potent, potent enough. You know that kind of thing. So yeah.

Speaker 2:

So I think you could almost take it from like the starting point right, like making sure the prescriber is sending in appropriate prescription right With compounds order to compound it, and or you're calling to discuss with the provider or physician to be able to make those changes. It is like an effective dose for the patient, um, and then it's something you're able to compound from the get-go too, because there are certain products that you're just not able to compound even though the provider says compound it. And then what you want to do is have a solidified verification step process, like in our pharmacy. We use software and technology with taking pictures and having integrated weights, so you can see the exact amount that my technician weighed and I can verify that. We use barcode scanning methods, methods. So being able to put in some of those verification checks were really really essential and really non-negotiables for us, because it helps us know that at any point in time we're able to track that order from start to finish yeah and when it got typed in and approved by the pharmacist to fill.

Speaker 2:

all the way to verification of the final product. All of our formulations will have certain walkthroughs that the pharmacist has to complete to ensure that the product is safe and ready to be able to use, and a lot of it is looking at. You know the compounding process was accurate. It is a stable product. You know if you're making a cream it's not coming out of solution or anything or out of the cream in any sort of way, and then, when it's appropriate, right. Your last final step should always be that it's an appropriate use for your patient. And that really brings it back to the unique case of having 503A pharmacies is this is being compounded for an individualized patient need, so it is their customized prescription. It's not going to be the same for all.

Speaker 1:

Yep, it's not a mass produced thing that one size fits all Like. That's the whole purpose of compounding is. It's a niche, customized product. So yeah, okay. So then, last thing I'll mention here in the opportunity space or the space kind of the roles of the pharmacist is ensuring, and you've pretty much touched on it. But are there any other, like self-assessments or ongoing QA projects or, you know, qi or anything like that that you're implementing in your practice? Yeah, you're shaking your head, so I'm assuming there's tons yeah.

Speaker 2:

We do like, so we do mock audits all the time. We're really fortunate that at our facility we have a biochemical engineer that helps with all of our processes and procedures. And I can tell you, as a pharmacist, I'm very thankful to have somebody who understands laboratory operations to be able to help guide and build some of those standard operating procedures for us, to be able to help guide and build some of those standard operating procedures for us. But what I've learned from it is being able to do a checks balance with your team right and going through and checking it and almost acting as if you know this was your board of pharmacy walking in the store at any point in time. Would you pass their audit?

Speaker 2:

And if you couldn't have them come in on a random Wednesday and be able to pass an audit, then you have compliance issues that you're going to need to fix. Not necessarily do you mean to shut down or anything, but if you couldn't offer them the ability to come in at any time, you're going to need to change some processes in place. I have like a funny rule, but I'm like anyone should be able to visit my house anytime, because it's going to stay clean, it's presentable, it would be there. It's kind of the same way we think about the pharmacy. Any point in time you want to be able to let people walk in to be able to do that.

Speaker 2:

So mock checklists are super, super important Again finding a program or some sort of resource that allows you to be able to see where you're at or where things are out of compliance and where you can kind of fine tune them, and then making sure, like we talked about, if rules and regulations or USP guidelines are getting updated that you're putting those new changes into effect and that they're actually getting done new changes into effect and that they're actually getting done. Because what you would hate to see happen is, like you know, you've been compounding something a certain way and now it's changed, but you're in this habit and you forget to make the change and now you're suddenly out of compliance. And it's not anything that you've intended to do, it's just that you're not staying up to date on those processes.

Speaker 1:

Yep, yeah, that's all great. I love your analogy too. You know, my house is always show ready, because I have practiced by the same thing, like when you leave a room, fold the blanket up, put it back in the drawer. You know, like always do it. So that that's a great analogy in the space of you know, always be ready for that auditor or for that inspector to come in. And if you're working under that, you know practice, then you're always ready, which is great. So, yeah, okay, great.

Speaker 1:

So let's dig into just a little bit there. You know we've we've made it sound great, wonderful, but also lots of steps, right. So let's just really kind of re highlight those challenges and those areas where you need to make sure that you're staying compliant. And you know, here here are potential barriers. You know, we know that this is maybe be a harder thing to overcome or whatever. But I think one of the things we talked about, which I'm sure, even after lots of training, people are still confused on, is that anticipatory batch compounding rules like how much can I make, how much can I be ready for, as well as like calculating the BUD, Like I can imagine that's still a great barrier for a lot of staff on your team.

Speaker 2:

Yeah, I would say, like the confusion around USP standards or misunderstanding the 503A limits is one of the, like, largest challenges, right? So 2023 updates to USP added a lot more complexity. It was a lot more strict, so sometimes it's been hard for some teams to be able to adjust their SOPs or training to reflect those changes. So you want to make sure you look at the updates, you're applying the updates and you're ensuring that they're being done.

Speaker 2:

A lot of things again come out of habit.

Speaker 2:

So if you're like, oh, I'm used to this product with water and this cream and it's going to have this BUD, but now it got stricter, you're not thinking you're doing anything wrong by having a longer BUD, but you could be, you know, harming your practice in that sense.

Speaker 2:

And then making sure that that you know your staff is really understanding the difference of 503a and that it needs to be patient, specific, and that you can't anticipatory compound and who controls that you know. Making sure that you have a champion that's monitoring, that you're not putting out you know a ton and ton of batch products and that you are compounding it for that small historical requirement, um, and that that is something that I feel like are two of the larger challenges and then maybe missing some important sops, like if something did get changed and you just like bypassed it because it was never something you've seen before and now you're missing a large component. So it's super, super important Again. There's really really great tools out there, I will say, that help guide and ensure that you're abiding by those practices. It's always good to look at like Board of Pharmacy requirements, rules and regulations and then always go back to USP chapters and ensure that you've got everything covered.

Speaker 1:

Yeah, that's great. Well, before I roll into kind of a summary and a kind of a recap, one thing I felt like we'd be remiss you kind of touched on it earlier, but I feel like we'd be remiss if we didn't just at least address the fact that you know there has been some negative press lately around compounding, especially from, I guess, a couple of different angles, one of them being, you know, advertising, the making of a product that you really shouldn't be making anymore because it's no longer, you know, on back order or whatnot. And then another one being, you know well, like either claiming something incorrectly or actually producing a bad product that has negative outcomes, and you see those negative outcomes in patients. So how I'm pretty sure of what your answer is going to be to this but how can we ensure that those things are not happening, you know, and if we're overseeing a compounding pharmacy or if we want to get into that space, how can we be sure that that's not something that's tainting? You know our practice.

Speaker 2:

Yeah, the short answer is stay compliant.

Speaker 1:

Yep, I knew that's what you're going to say. That's exactly right.

Speaker 2:

So short answer is stay compliant. Long answer is you know, make sure that you understand what it takes to stay compliant. So what are the requirements of 503A patient-specific compounding? You need to be able to make sure your prescription that you've received is, you know, checked off and good to be able to compound before you even start compounding it. But also ensuring that you are abiding like checking the shortage list right and making sure you know what's on there, what you can compound, what you can't compound and when it is going to be considered patient-specific need calling the doctor, you know, talking to them about it, ensuring that your staff is aware of all of the changes and what you can be doing. But short answer is stay compliant. You know, don't try to do too much. Really, really ensure that you're abiding by the USP standards and your requirements of being able to have 503A compounds.

Speaker 1:

Yeah, that's great. So, as a further summary, I'm just breaking those down, as I assumed you would answer with stay compliant, which is exactly what I wanted you to do. So, again, reviewing those compliance cornerstone pieces, and that's reviewing the prescriptions for validity, making sure that they're patient specific, maintaining clear, appropriate documentation for all preparations every time you make it so that you can always go back and check for safety, ensuring that your staff are formally trained and ongoing training is received, making sure that the BUDs are calculated properly and relayed to patients. And then, as you mentioned, just always having those checks and balances systems, those ongoing QI QA programs that are making sure that you are audit ready, inspection ready and that you're constantly maintaining compliance. So, yeah, well, jess, as we kind of finish up here with our time, as I always like to ask the guest what do you feel like? Is the game changer here? Like, what's the key summary take-home point that you want to share with the learners?

Speaker 2:

I love this question actually. I know you told me to like think about it earlier, but I actually really love this question because I think, as a pharmacist and knowing where pharmacy is going, we have to be thinking of game changer options. And I think, as a pharmacist, and knowing where pharmacy is going, we have to be thinking of game changer options. And I think compounding pharmacy allows you to do that right niche models, whether it's providing an individualized, unique, only option for that patient solution through compounding, or even finding unique ways for pharmacists to be able to help their community. And I think compounding pharmacy is still part of the future. I think having customized medication and being able to individualize patient needs is still going to be the future and it allows us to be able to do that and it allows us to be able to provide to the community what they wouldn't standardly be able to get.

Speaker 1:

Yeah, that's great. I love it. That's yeah. So, as Jess says, she's inspiring you to be innovative, she's inspiring you to consider compounding, but find that niche and that is the game changer here is compounding can fill that void for some people. So that's great. Jess, thank you so much for your time. I really appreciate it. It was great seeing you again and great having you on as our guest today.

Speaker 2:

Thank you, I appreciate it.

Speaker 1:

If you're a CE plan subscriber, be sure to claim your CE credit for this episode of Game Changers by logging in at CEimpactcom. And, as always, have a great week and keep learning. I can't wait to dig into another game changing topic with you all next week.