Podcasts about 503a

In this episode, our guest is Kate Campbell, PharmD, who serves as the Director of Pharmacy at Olympia Pharmacy. She is a proud alumna of the University of Florida, graduating Cum Laude with a bachelor's degree in biology and a doctorate in pharmacy. Dr. Campbell's previous work experiences in retail and hospital pharmacy have led to a passion for whole-person care and preventive medicine, prompting her shift towards compounding. In her pursuit, she has become a certified hormone replacement therapy specialist with a focus on bioidentical hormone replacement therapy for females.In her personal time, Kate loves connecting with her family and friends. She especially enjoys getting out on the water, playing pickleball and trying new restaurants.1. Opening & BackgroundKate, welcome to the show! Can you start by sharing your journey into pharmacy and what ultimately drew you toward compounding and personalized medicine?You've worked in both retail and hospital settings before moving into compounding—what gaps did you notice in traditional pharmacy that compounding helps to fill?How did your education at the University of Florida shape your path and perspective on whole-person care?2. Understanding Compounding & Regulatory LandscapeFor listeners who may not be familiar, can you explain the difference between 503A and 503B compounding pharmacies?What are some of the key compliance and quality distinctions between these two types of operations?Olympia Pharmacy operates under a 503B designation—what advantages does that provide in terms of scalability, safety, and product consistency?How do you see the role of compounding evolving as more patients seek individualized therapies?3. Hormone Replacement & Preventive MedicineYou're a certified hormone replacement therapy specialist, focusing on bioidentical hormones for women. What drew you to that niche?What are some of the biggest misconceptions about bioidentical hormone therapy?How do you personalize treatment for women across different stages of life—perimenopause, menopause, and beyond?What are the key questions women should ask their providers when considering hormone replacement therapy?4. Longevity & Wellness TrendsLongevity is becoming a buzzword in healthcare. From your vantage point, what longevity-focused products or therapies are worth the hype—and which are not?What innovations are you most excited about in the patient wellness space for the upcoming year?How is Olympia Pharmacy staying ahead of emerging trends—whether it's peptides, nootropics, or nutraceuticals?5. GLP-1s and Post-Therapy CareGLP-1 medications like semaglutide and tirzepatide have transformed weight management—but we're seeing challenges after patients discontinue them.What strategies or compounded therapies are helping patients maintain results post-GLP-1 use?How can pharmacists play a role in supporting metabolic health and sustainability beyond the initial weight-loss phase?6. Leadership, Lifestyle & Personal BalanceAs a director and pharmacist, how do you balance the science of pharmacy with the art of patient care?You've mentioned enjoying pickleball, the water, and exploring new restaurants—how do you recharge outside of work?What advice would you give to other pharmacists looking to explore nontraditional or entrepreneurial paths in pharmacy?7. ClosingWhat's next for you and Olympia Pharmacy?How can listeners connect with you or learn more about the services Olympia offers? ★ Support this podcast on Patreon ★

Retatrutide is years away from FDA approval and yet the fight over access, price, control of this medication is already well underway. That's what this podcast is going to be about today. There's well over a hundred thousand people by my estimates who are already on some form of this medication today. And that should tell you enough about how disruptive this molecule is and will be. It is a game changer among game changer. We've been talking about it for three years here at On The Pen, well before any of your favorite gym bros were talking about Retatrutide. We were talking about Reta, who tried Retatrutide here at On The Pen. And that's because we identified this triple agonist as a game changer among game changers. So This is going to be a very Retatrutide heavy episode, and so I hope you'll join us and stick with us if this is a topic you enjoy, because I think this is really going to effectively lay the groundwork for what accessibility to this medication will look like. So let's get into it. Welcome to the On The Pen Podcast with your host, Dave Knapp. Welcome to the On The Pen, the weekly dose podcast. This is our weekly roundup in incretin memetic news. And frankly, there's no news that is bigger than Reta-Trutide news. Just find me any news that is bigger than the data that we got on Reta-Trutide. Now, we already did a video about the Triumph Phase II clinical trials that we got in osteoarthritis of the knee. You can go back and check out that video if you'd like more data. So we're not gonna super... rehash the data. We'll go over at a high level what the data showed us. We're not going to go over how the medicine works, because by now we all know that it's the triple agonist, right? If terzapatide was a dual agonist, GLP-GIP, Retatrutide is the triple agonist that adds to it a glucagon component, which is absolutely just shredding, shredding liver fat. It is absolutely revving up people's metabolism and showing a tremendous amount of weight loss. So let's get into what the weight loss looked like in this first trial, because there are longer obesity trials where, where the primary outcome is the weight loss this was again a specific trial in measuring pain reduction in folks with osteoarthritis of the knee but check out these numbers these are placebo adjusted meaning it's taking the two percent out that people lost on placebo but looking at these numbers Folks on one milligram over forty eight weeks lost seventeen percent. They bumped up to four milligrams. Those folks lost twenty two percent. So right there at the lowest dose, you're already reaching the efficacy of today's drugs that are on the market, like triseptide and semaglutide in their various forms. If you bumped up to eight milligrams, you saw twenty four percent placebo adjusted weight loss and at twelve milligrams, twenty six point four percent weight loss. Adding back in that two percent of the placebo that those on placebo loss, that's twenty eight point four percent weight loss in these forty eight weeks at the highest dose. When you adjust for some of the more real world outcomes, you kind of ding the numbers a little bit based upon people who quit the drug, et cetera. Those numbers look more like a twenty percent weight loss and twenty three point seven percent weight loss at the highest dose. But even then, you're still seeing a drug that is better than the current drugs that are on the market. around forty eight percent of patients on Retatrutide lost greater than twenty five percent. And then if you were at that twelve twelve milligram dose, that highest dose patients lost fifty nine percent of patients lost more than twenty five percent of their body weight. There was a subset that lost thirty percent of their body weight and some even over thirty five percent of their body weight on Retatrutide. So the lower doses compete with today's best drugs and the upper doses are entering into bariatric surgery level weight loss. And that's putting the whole obesity system on notice and probably a lot of surgeons nervous because typical body weight loss was something like the street sleeve gastrectomy. For example, it's about eighteen to twenty five percent body weight. The Roux-en-Y gastric bypass twenty five to thirty five percent weight loss or the duodenal switch thirty to forty percent weight loss. So the upper doses of Ritutrutide overlap with sleeve and bypass outcomes without any surgery. It's incredible. It is a game changer among game changer. It is the new benchmark in obesity medicine. And there's actually more data, like I said, landing in later twenty twenty six. The longer duration will historically, if history is a marker, equal more weight loss than we even see here at this forty eight weeks. We have an interview that will be airing later this week on our channel and on our podcast with our friend Mimi from Australia who just wrapped up her clinical trial on Retatrutide. They ended it like ten weeks early on her, which was a huge bummer to her. So we're going to hear from her because she had to end abruptly. We're going to hear her story, an incredible story. She's one of those folks that got up that thirty five percent body weight loss in the time that she was on Retatrutide. So, this is just showing you that these drugs are not simply an alternative to bariatric surgery. We are approaching a point in time where these are on par with bariatric surgery, and as people are on this Reta-Trutide trial, you see that these numbers aren't plateauing either. So we will see stronger weight loss numbers the longer that these folks are on this trial. And I think you'll see some of those numbers in that population of folks on the higher doses eclipse maybe even some of what we see with some of these bariatric surgeries. the real story that i think is taking shape here is not in how powerful Retatrutide is because we've literally been expecting or anticipating this kind of data for more than three years at on the pin we've been talking about this and i think that's sort of reflected in the fact that you didn't see this massive spike in eli lilly stock wall street was expecting this as well Um, so it was on par, I think with expectations, but the expectations are astronomical compared to previous options that were available to patients and all the innovation in the world. All of these drugs, we talked at last week about WV, E double Oh seven, the James Bond of weight loss that targets fat, not only targets fat loss, but it also targets the promotion of building of, of lean muscle mass. We're talking about an insane future in obesity medicine. But none of it means anything if people can't access it. And that's really where we are today in terms of ensuring that there's going to be an option for everyone. And that's sort of what I want to get into today, because Lilly wants Retatrutide to be classified as a biologic, so not a traditional small molecule drug like you've seen every other incretin and nutrient-stimulated hormone-treating obesity on the market to date. They're trying to get this classified as a biologic. Now, we talked about this before on the podcast. That matters in three major ways. It affects the exclusivity length of time that a pharmaceutical company has on a drug. That goes from, I believe, five years of market exclusivity to twelve. It affects compounding rules because biologics cannot be compounded. And then that gives the pharmaceutical companies a tremendous amount of pricing power in the marketplace, because essentially there's no competition and there's no competition for a long time. But this whole argument about getting this classified as a biologic is not about safety. It's about protection and we're going to get into it. So let's explain this here. This is why Retatrutide really is not a biologic arguably. So biologics are large proteins. There are hundreds of or even thousands of amino acids grown in living cells that are sensitive to tiny manufacturing changes. Retatrutide is a short chain peptide. It's chemically synthesized and it is below the traditional biological size thresholds when it comes to how those things are defined. We'll just leave it at that. So even though it acts like a biologic in the body, it's made like a drug. It's made like a small molecule drug. And if it's treated as a drug, they get, like I said, five years of market exclusivity. Now, really a lot of confusion around what this means, but essentially the first five years of the life of a drug, the patent can be challenged for a number of reasons. We've seen patent challenges right now are going on in the courts for both semaglutide and terzepatide. But these companies are guaranteed that five years of market exclusivity, no matter how those patent lawsuits shake out. That five years jumps to twelve years with the biologic. So ultimately, there's no biosimilars that are allowed during that twelve year window. Again, with terzapatidin and semaglutide, it's five years. They could lose their market exclusivity within five years of the release of the patent. twelve years with a biologic. So if they lose their patent challenges on Trezabitide, they still have some time left with market exclusivity for the drug. They likely will not lose those, but that jumps to twelve years. And I think the most important thing to understand about the reclassification of Reta-Trutide to a biologic would mean that, 503A and 503B pharmacies are effectively locked out of compounding this medication, 503Bs would have some latitude arguably, but they would face extreme barriers. Routine compounding becomes legally and technically restricted because biological status doesn't slow compounding down. It actually shuts the door or almost completely shuts the door. Biologics not only would allow Lilly to have longer market exclusivity, no compounding, but it would allow them to command a higher price in the marketplace because A, they get this designation and there's an assumption when they bring this to market that they're harder to manufacture, that they're harder to copy, that there are fewer negotiating alternatives for payers. They can command a higher price with the insurance companies, and the price pressure stays muted for much longer because, again, you don't have those pressures of compounding. You don't have the pressures externally from lawsuits that could end your market exclusivity in that first five years of the drug's existence. So there's just a lot of price pressure upwards on a biologic compared to a normal small molecule drug. And when there's no credible alternative or backup option, which to Retatrutide, there wouldn't be, it'd be the first drug that has bariatric surgery level results. The prices won't come down. They'll command a massive price and the prices won't come down. So let's talk about where this currently stands because ultimately the Eli Lilly went to the FDA. We've been covering this for well over a year, maybe close to two years now, a year and a half at least. Lily went to the FDA, they said, we want this classified as a biologic, here are the reasons why. The FDA initially said, no, we're not gonna do that. So Lily challenged that decision in court. So the point that we're at today is the court told the FDA to reconsider and better explain itself So the first no given to the FDA to Lilly didn't stick. The courts looked at it and they said, you need a better, you need to reconsider your decision and you need to explain your decision better to Lilly. So ultimately we're sitting now at the point where the court has made its decision that the FDA has to go back and now we await basically what the FDA has to say on this. But if this thing is classified as a biologic, that would be a massive massive loss for patients. Now, again, we're, we're focusing on the accessibility of this drug into the future. And, and I think that this is an important conversation to have. One of the interesting points that I have to bring into the conversation is the fact that I got to sit in on a, on a closed session question and answer with the media. I didn't get to answer or, excuse me, excuse me, ask a question at this time, but shortly after the most favored nations announcement, with eli lilly and the trump administration in the oval office that day there was a press briefing that i was invited to dave ricks was asked by max bayer reporter of endpoints who we've interviewed here on this very podcast and he was asked was Retatrutide included in the most favored nations discussions meaning will we get a cash pay version of Retatrutide uh that is you know circumventing the pbms uh will we get these cheaper prices will will it be be two hundred fifty dollars also and there was a hard no there was a hard no like no that was not included that was not part of these discussions even though what we heard from the trump administration was that those these companies that were jumping on to the most favored nations agreement were also agreeing to offer future drugs at most favored nations pricing now was lily saying that no they're not going to offer it at the it wasn't part of the negotiations in terms of the price points that they had discussed for triseptide maybe or did it mean altogether there won't be a cash pay option of this medication i don't know um that we would love to get clarity on But I highly doubt we're going to get any more information than necessary at this point in time. So, Reta-Trutide is being positioned to be a drug that, and well so, should be offered at a premium. This is a drug that is far exceeding the current drugs that are on the market. I think that we're gonna see even the indications of Reta-Trutide far beyond simple obesity, but it is going to be their crown jewel for the next decade, more than likely. Reta-Trutide is going to be a massive drug, and so they're attempting to build a moat around it. And these are things that we need to be aware of as a community so that we can hold our positions and conversations about these and basically, you know, be able to articulate to people in positions of power like this is an important thing to us. This is an important thing in the advocacy of obesity and sort of the next frontier of the fight of accessibility, which marches on. each and every day because of course the current drugs, while as great as they are and as much as access is expanding, there are still people with sicker or rather more advanced versions of metabolic disease that are gonna need these newer treatments and price is going to be a huge factor. So let's talk about the gray market right now because I think it's also nearly impossible to talk about this topic without including a discussion about the gray market because there are, as I mentioned at the outset, hundreds of thousands of people on this medication already. So research grade Retatrutide exists. It's in the gray markets of the Internet. It's where people are going and they're buying, you know, basically versions of these these peptides that are made in factories overseas. They're being imported into the United States, oftentimes illicitly in shipments that are marked as something else. The FDA has tried to crack down. There's no doctor involved in this. It's a very, that's why it's called the gray market, right? So it's not a prescription medicine, but the demand for this is massive. And all you have to do is really scroll your TikTok for about fifteen minutes. You're going to come across a insane amount of content on the topic of Retatrutide. An insane amount of, and oftentimes, you know, what I find most disturbing is oftentimes it looks like very young people. very young people taking Retatrutide. Crazy, it's crazy. But the demand is massive and there's a whole gray market for it proliferating over on TikTok and in the far reaches of the internet. And I would estimate that tens, if not hundreds of thousands of people are already or have already used it. And I think it's a testament to a to to the effectiveness of this drug. It's also a testament to the fact that there needs to be more guardrails, I think, around this stuff than there currently is, because gray markets appear and they thrive when legal access lags the reality of the demand for the medication. And you saw this earlier this week as we launched a petition to fight back against the Safe Drug Act of twenty twenty five, a drug, a drug act that is in theory designed to put guardrails around compounding. But in practice, I think is creating a new battlefield for Eli Lilly and Novo Nordisk to shut down compounding on the current classes of medications, which is why We as a community need to be loud about our opposition to it. If they were really concerned about the safety of compounds, they would do two very simple things. They would require reporting around the active pharmaceutical ingredient of a compound. Patients ought to be able to know where the actual source of their medication is coming from. And they should know that those places are FDA approved and inspected. And the second thing is they should require adverse event reporting. Those are required of 503Bs. They should be required of 503As as well. 503As are making a tremendous amount of money. They're making thousands and thousands of these scripts. So when there are adverse events, they should be required to report those to the FDA. Simple. None of that is in this bill. None of it. None of it. Instead, it seeks to put caps on the amount of compounds that can be made by a compound pharmacy without them having to report to the FDA. And then it seeks to codify the definition of essential copy. Again, all of these things that will become law and then argued in court and then a battlefield for Lilly to potentially win a legal battle and thwart compounding. It's creating a new battlefield for them. They're losing in the courts. They're losing with the current language that exists in the Food, Drug, and Cosmetic Act. So we create new language. We create new law. Just vague enough to pull some threads and hopefully win something in court. That's how I see it. You may see it differently. If you do, curious to hear from you. But if you want to fight back against this legislation, you can go to otplinks.com and fight back against that. piece of legislation, because I think that we need as a community to have our voices heard on this, especially those who have gotten healthier by way of compounded medications. So the rumor on the gray market, to get back and close the thought loop here, There's been no specific FDA cutoff announced, but what the rumors going around are that that the compounded versions of GLP ones, especially obesity medicine in the gray market, are all going to turn off like a sieve on January first. Now, I seem to feel like this is probably more of a marketing tactic by these companies to sell a whole bunch of peptides at the end of the year. I think that's probably creating some panic and probably panic buying on people's parts. And so these companies are benefiting greatly. Again, that's why there should be guardrails around this. There's no guardrails around this at all. I mean, at the end of the day, they can say whatever they want to say, so long as they cloak everything in research grade. And these rumors proliferate around and people spend thousands, tens of thousands of dollars. I've heard of people having twenty years worth of Retatrutide in their freezer. Why? For what purpose do you need that? So just a massive amount of money made in this gray market. And that's not to knock people who use it. I say this all the time, but I think it's worth qualifying the statement. It's not knocking people who use it. I get it. But at the same time, we're talking about an industry that is, there's no altruism here. They're in it for money just as much as Eli Lilly is, except they have actually done nothing in the way of advancing medicine. They've just taken intellectual property, copied it, and sold it to you with a label that says, don't put this in your body. So you know where I stand on the gray market. I've heard from many people who've been injured by gray market stuff. It's just what it is. It's a gray market. You're taking your health into your own hands. Please, whatever you're doing out there, as risky as it may be, please involve your doctor and let your doctor know what you're doing so you can be monitored for the things your doctor believes you should be monitored for if you're using this. But this all underscores, again, the need for accessibility to these medications, the need for us to be aware of the fact that a moat is already being built around the most advanced metabolic drug in the pipeline. And we just need to be aware so that when it comes time to fight, we're all ready and informed. And that's what this podcast is serving to do. Before we jump into the next topic, I do want to thank our sponsor, our headline sponsor of this podcast. is a company called Shed. Now, if you are looking for access to care for obesity, then look no further than our partners at Shed who believed in this podcast enough to help us do it full time. You can go to Trished.com and use code OTP25 to save twenty five percent at Trished.com, where you're going to get connected to a doctor who will when medically necessary prescribe medication to treat your obesity. You also get access to coaching. You'll get access to all sorts of medication, whether it's the branded or the compounded versions, depending on your specific situation. All of it is available at Trished.com. They use one of my favorite compound pharmacies in the game, Strive Pharmacy, which I've gotten the chance to dig into on my own. I really love what they do there. They're a It functionally operates a lot more like a 503B. Uh, and I think that they're doing great work over at a strive pharmacy. They partner with shed. So I just love this, this, and when we were looking for somebody to offer a compounded versions, I wanted to make sure that I trusted the pharmacy. People always ask me, Dave, who, who should I go to? I'm like the pharmacy matters more than anything because you want to trust the source of your medication. So try shed.com use code OTP25. Listen, you're going to want to learn about taking any new medication before you take it. Learn about the potential side effects. Learn about the trade offs. There's no free lunch, but all of the information that you're going to need, you can find it. Try shed.com and be familiarizing yourself with all of your options there. So thank you to Shed for being a wonderful partner here at On The Pen. Now let's talk about some data that dropped. We're talking about accessibility and all of the sort of advancements in the world mean very little if people can't access it. That's why I think this data that dropped this past week from our friends over at Rowe is incredible. Absolutely game changing data. So check out this data. Real world telehealth data looking at sixty eight weeks. This is looking at patients who were enrolled in their row body program and on a GLP one specifically some maglutide mean weight loss in this study looked at again patients in over sixty eight weeks. The mean weight loss was sixteen point six percent on average. Thirty three percent of patients lost more than twenty percent and the safety in this study and looking at this data match the clinical trials. So what we're seeing here is that care for obesity can be delivered through a telehealth platform at scale and match clinical trial results. So that scalability decides how many people get access. There are not enough doctors out there to serve the over hundred million people in the United States living with overweight or obesity. so when you hear these blowhard doctors online calling all telehealth platforms except their own a pill mill or as i like to say pin mill the data is actually showing something quite different in that this type of obesity care can be delivered at scale through telehealth platforms it can meet people where they're at and allow people to get care without the shame, without the stigma, without their doctor just pointing to the door and saying, if you want a GLP-I, get out of my office. I ain't going to get it here. How ridiculous. But these people can go to platforms like Rho or Shed or any number of telehealth platforms that are out there and not only get access to medicine, but get access to care. So of course, not all telehealth companies are created equal. Of course, not all compound pharmacies are created equal. You want to do your homework and all of that. But this is data that shows that This kind of care can be delivered at scale via a virtual platform and show similar results to a clinical trial. I think, and this is peer reviewed data, and I think that this is just absolutely great news because when we talk about the problem, we need scalable solutions. The old brick and mortar ain't going to work when you don't have enough doctors to serve enough patients. If we want to get life-changing treatments like ritatratide or terzapatide, semaglutide, whatever, into the hands of the people who need it the most, we need companies to innovate scalable tech platforms that can meet patients where they are, that can leverage current technologies to find people the care that they need. And in this case, it's access to a doctor. It's access to a platform. It's access to prescription medication when appropriately prescribed. And it can be done, and it is being done. So I think this is great news, and will play a huge part in the future. As we talk about Retatrutide, even though it's a year and a half away, maybe a little bit longer, it's already exposing – the issues around accessibility and pricing. Hopefully there will be compounded versions available if they're medically necessitated, if there are shortages. We hope that the battleground for that is not already set and won by Lilly before this drug even comes to market. But there are strategies being done to keep people boxed out But I can tell you that whatever happens with Retatrutide, the future of obesity medicine is in virtual care. And platforms are rising to the occasion. Retatrutide hasn't reached patients yet, but it's already forcing the system to show us, you know, are you ready? Are you ready to deliver bariatric surgery level results at scale to the people who need them? So I am so thankful that you joined me here on this podcast today. Again, we love to talk about we're at a Retatrutide. If you're interested, we've been going live every Monday, Wednesday and Friday at eleven a.m. Central Time here on our YouTube channel, on our tick tock, on our X platform. We're doing that because there's enough news to bring you just about every single day. And we've been doing it for the last couple of weeks. If you've enjoyed it, let me know in the comments of the video on YouTube. Send me an email at David on the pen dot com. Uh, so every single Monday, Wednesday, Friday, and then we do a weekly rundown of the obesity medicine news every Tuesday. That's what this is. The weekly dose podcast. You can catch this on all of the platforms that you listen to your podcasts on, and please make sure to leave us a five star rating and review before you log out of your podcast app. That helps so much. I don't think you guys understand how much that helps, uh, the work that we do here to just train the podcast algorithms that this one is worth listening to. I hope you enjoyed today's podcast. If you did, drop it a thumbs up, five-star review, subscribe on YouTube, do all the things. Thank you for being here, and thank you for being the best part of what we do. We will catch you on the next one. Thank you, my friends. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Drug shortages are a critical issue in the US, leaving patients and healthcare providers struggling. Compounding pharmacies, however, can curb drug shortages and help lessen this growing threat to the public's health.  In a  new pharmaphorum podcast, web editor Nicole Raleigh speaks with Shawn Hodges, CEO of Revelation Pharma, a nationwide network of 503A and 503B compounding pharmacies, spanning across various locations. Hodges discusses the true state of drug shortages in the US at the moment, the essential role compounding played during COVID-19, and opportunities for policy reform. You can listen to episode 223 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.

Send us a textSchedule an Rx AssessmentSubscribe to Master The MarginCompounding Pharmacies are under a lot of fire but through advocacy, the future is bright!So, what does it really take to protect, grow, and advocate for compounding pharmacies in today's changing landscape?In this episode, Scotty Sykes, CPA, CFP®, and Austin Murray sit down with Scott Brunner, CEO of the Alliance for Pharmacy Compounding (APC), to unpack the realities of advocacy, access, and opportunity in the compounding space.We cover:- How GLP-1 shortages spotlighted the critical role of compounding pharmacies- The advocacy battles shaping patient access and prescriber freedom- Why cash-pay compounding is helping hybrids survive PBM reimbursement cuts- The rise of telehealth and private equity in personalized medicine- And more!More About Our Guest:Scott Brunner, CAE, is CEO of the Alliance for Pharmacy Compounding. APC is the industry trade association and the voice for pharmacy compounding, representing compounding pharmacists and technicians in both 503A and 503B settings, as well as prescribers, educators, researchers, and suppliers. APC works to preserve patient access to compounded drugs and the essential role of compounded medications in the American healthcare system.Brunner was formerly the senior vice president communications and external relations for the National Community Pharmacists Association and CEO of the Georgia Pharmacy Association. In his 30+year career in association management, he has also led statewide trade associations in Mississippi and Virginia.As you'll hear in his drawl, he is an Alabama native. He earned his BBA at the University of Montevallo and MPS from Auburn University Montgomery. He earned the prestigious Certified Association Executive designation in 1997.Stay connected with Scott and Alliance for Pharmacy Compounding: Scott Brunner LinkedIn APC WebsiteAPC LinkedInAPC FacebookAPC InstagramStay connected with us on social media:FacebookTwitterLinkedInScotty Sykes – CPA, CFP® LinkedInMore on this topic:Podcast: The Trusted Pharmacist: Advocacy and Building a Resilient PharmacyPodcast: From Counter to Capitol

There's been a lot of noise lately around semaglutide, tirzepatide, and other GLP-1 medications—especially as the FDA cracks down on certain compounded versions. But what's really going on? And what should patients and providers know? In this solo episode, I unpack the truth behind the headlines. We'll clarify what GLP-1 medications actually are (hint: they're not insulin), why they're in such high demand, and how compounding pharmacies legally stepped in during national shortages. I'll also break down the difference between 503A and 503B pharmacies and share how to spot quality in compounded meds. Whether you're a patient, provider, or pharmacy pro, this episode clears the fog around GLP-1s and gives you real tools to stay informed.

We talked to ASU Athletic Director Graham Rossini and then we provide our thoughts on it immediately after. It was awesome.

In this episode of RCA Radio, host Brandon Miller is joined by RCA experts Anita Michael and Arie Anahory for a deep dive into the evolving world of compounding pharmacies. Together, they explore the critical role compounders play in personalized medicine, their differences from traditional pharmaceutical manufacturers, and the increasing regulatory scrutiny they face—especially 503B outsourcing facilities.The discussion covers:The origins and types of compounding pharmacies (503A vs. 503B)Regulatory challenges post-New England Compounding Center crisisKey compliance hurdles including aseptic processing and FDA inspectionsPractical advice for both new and established compounders to stay compliantWhether you're entering the compounding space or navigating the latest compliance expectations, this episode offers timely insights and actionable guidance.

**Dr. Lisa Faast shares an important update on the current status of Semaglutide Compounding as of April 23** **Show Notes:** 1. **Semaglutide Compounding Update for 503A Pharmacies** [0:00] 2. **Tirzepatide Compounding and Legal Considerations** [3:38] 3. **Practical Advice for Pharmacies** [6:36] 4. **Final Thoughts and Contact Information** [7:39] **Links mentioned in this episode:** [FDA's decision on Semaglutide] (https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize) [OFA-Outsourcing Facilities Association] (https://www.503bs.org/) Websites Mentioned: https://www.olympiapharmacy.com/ https://www.drlisafaast.com/ ----- #### **Becoming a Badass Pharmacy Owner Podcast is a Proud to be Apart of the Pharmacy Podcast Network**

Send us a textThe 503A and 503B legal landscape is ever changing and staying on top of these changes can be tedious.  But don't worry! Sykes is here with the trustee colleagues at Brown & Fortunato.  On this episode of the Bottom Line Pharmacy Podcast, Scotty Sykes, CPA, CFP® and Bonnie Bond CPA, sit down with Brad Howard, Esq. And Michael Alexander, Esq. From Brown & Fortunato share recent changes to the 503A and 503B regulatory landscape including:The Evolving relationship between 503B and 503A pharmaciesImpact of FDA regulations and state-level inconsistenciesPossible changes coming in 2025More about our guest:Brad Howard:Bradley W. Howard is a health care attorney with extensive experience representing pharmacies, durable medical equipment providers, hospitals, and many other health care providers with compliance, enforcement, and litigation matters throughout the country. Brad enjoys working with pharmacies and other health care providers on regulatory and contractual compliance matters, payer and PBM audits and appeals, governmental demands and requests, responses to subpoenas and demand letters, and business disputes including litigation. Brad routinely handles health care investigations by the Department of Justice, HHS OIG, various boards of pharmacy, State Attorneys General, the Department of Defense, and other regulators.Michael Alexander:Michael represents health care clients in a variety of business and regulatory matters, including regulatory compliance, licensing, due diligence review in the acquisition of health care providers, government investigations, and commercial disputes. Michael's clients are primarily pharmacies, hospitals, and physician groups, but he also assists many other health care providers. Michael has successfully assisted his clients in resolving government investigations on both the state and federal level involving general compliance issues as well as matters related to fraud, waste, and abuse. He has also represented clients in payor disputes, and worked in conjunction with his clients, co-counsel, and other parties to coordinate the simultaneous acquisition and re-licensure of multiple health care providers.Learn more about the Brown & Fortunato Team: Brad Howard LinkedInMichael Alexander LinkedInBrown & Fortunato WebsiteBrown & Fortunato FacebookBrown & Fortunato LinkedInConnect with us on social media:FacebookTwitterLinkedInScotty Sykes – CPA, CFP LinkedIn Scotty Sykes – CPA, CFP TwitterBonnie Bond – CPA LinkedInBonnie Bond – CPA Twitter More resources on this topic: Podcast – Developing a Weight Loss Program with GLP1s in Your PharmacyPodcast – Driving Independent Ph

November is National Men's Health Awareness Month in the United States. Registered Pharmacist Greg McKettrick is on the show today to talk about important men's health topics. Our conversation covers the Post Prostatectomy Penile Rehabilitation Protocol Greg developed, post-op urinary incontinence, erectile dysfunction, regaining sexual intimacy, mental health, medical devices, and more.    Patients, pharmacists, student pharmacists, urologists, and other healthcare professionals need to hear our conversation. If you know at least one person who could use the information in this episode, please share it with them.   Greg is a Men's Health Specialist and a compounding pharmacist. If men's health or compounding interests you as a pharmacist or a pharmacy student, reach out to Greg McKettrick, RPh. Connect on LinkedIn, Email Greg@revelationpharma.com, or call 704-883-2895.    Thank you for listening to episode 303 of The Pharmacist's Voice ® Podcast.   To read the FULL show notes (including all links), visit https://www.thepharmacistsvoice.com/podcast.  Select episode 303.   Subscribe for all future episodes.  This podcast is on all major podcast players and YouTube.  Links to popular podcast players are below. ⬇️   Apple Podcasts   https://apple.co/42yqXOG  Spotify  https://spoti.fi/3qAk3uY  Amazon/Audible  https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt   Bio - Greg McKettrick (October 2024)   With over three decades of experience in the compounding industry, Greg McKettrick serves as a Clinical Liaison - Men's Health Specialist at Revelation Pharma, a national network of 503A and 503B compounding pharmacies dedicated to providing industry-leading pharmaceutical compounding services. Previously a compounding pharmacist at Stanley Specialty Pharmacy, Greg is a powerful voice in the world of men's health and men's sexual; wellness, drawing on his years of experience to elevate Revelation Pharma's industry presence.    In addition to his role at Revelation Pharma, Greg is a Chief Medical Advisor for the BHRT Training Academy, having designed the organization's Men's Health Module, and is on the Scientific Advisory Board for Berkeley Life Nitric Oxide. Greg is also a frequent speaker for Zerocancer groups and presentations.    A true thought leader in the industry, Greg developed his Post Prostatectomy Penile Rehabilitation Protocol, which is used by Urology clinics around the country. He has also been featured in numerous articles and as a guest on many webinars and podcasts.    Links from this episode Revelation Pharma Website https://revelationpharma.com/ Penile Rehab Protocol Website Penilerehabprotocol.com ConsultRX Website https://revconsultrx.com/    Learn more about the protocol on YouTube https://youtu.be/__ibcRJup48?si=3ogFWKw_Fy29BYuB  YouTube Video (Men's Sexual Health Overview with Pharmacist Greg McKettrick) Greg on LinkedIn https://www.linkedin.com/in/greg-mckettrick-a21404163/  Greg's email Greg@revelationpharma.com Greg's phone number 704-883-2895 Zero Prostate Cancer https://zerocancer.org/    Kim's websites and social media links: ✅ Business website https://www.thepharmacistsvoice.com ✅ The Pharmacist's Voice ® Podcast https://www.thepharmacistsvoice.com/podcast ✅ The Perrysburg Podcast (service project/hobby podcast) www.perrysburgpodcast.com  ✅ Pronounce Drug Names Like a Pro © Online Course https://www.kimnewlove.com  ✅ Self-paced, online podcast-planning Course https://www.kimnewlove.com  ✅ FREE eBook and audiobook about podcasting https://www.kimnewlove.com/podcasting  ✅ LinkedIn https://www.linkedin.com/in/kimnewlove ✅ Facebook https://www.facebook.com/kim.newlove.96 ✅ Twitter https://twitter.com/KimNewloveVO ✅ Instagram https://www.instagram.com/kimnewlovevo/ ✅ YouTube https://www.youtube.com/channel/UCA3UyhNBi9CCqIMP8t1wRZQ ✅ ACX (Audiobook Narrator Profile) https://www.acx.com/narrator?p=A10FSORRTANJ4Z ✅ Start a podcast with the same coach who helped me get started (Dave Jackson from The School of Podcasting)! **Affiliate Link - NEW 9-8-23**      Thank you for listening to episode 303 of The Pharmacist's Voice ® Podcast.  If you know someone who would like this episode, please share it with them!

If you are a provider and would like more education or information on the peptides we discussed in this podcast, here is a link to nucleus Pro: https://nucleus.nubioage.com/checkout/nucleus-pro?via=cassie If you are a provider and would like to sell any of the supplements we discussed in this podcast, here is a link to nuBioAge supplements: https://affiliates.nubioage.com/register?ref=4NJv2kFPNW&p=136448 About My Guest: Hayden Collier, PharmD is the director of clinical services at nuBioAge. He is committed to advancing healthcare through innovative, patient-centered approaches. With a passion for weightlifting, he draws parallels between the discipline of fitness and the importance of prevention in modern medicine. Hayden's expertise extends beyond the pharmacy, blending sports science with cutting-edge medical strategies to redefine how we approach health and longevity. A dedicated husband, father, and sportsman, he brings the same focus and energy to both personal and professional life, always striving to inspire others to take charge of their well-being. Social Handles: ⁠⁠⁠⁠⁠⁠⁠Facebook ⁠⁠ ⁠⁠Instagram⁠⁠ ⁠⁠NuBioAge Instagram⁠⁠ ⁠⁠Linkedin⁠⁠ Summary: Join Dr. Cassie Smith and compounding pharmacy expert Hayden Collier, PharmD, as they dive into the world of peptide therapies, mitochondrial health, and what makes a quality compounding pharmacy. Timestamps: 00:00 - Introduction to Back to the Basics and Overview of Peptide Therapy 05:00 - Guest Introduction: Hayden Collier and the Role of Compounding Pharmacies 10:15 - Explanation of 503A vs. 503B Pharmacies and Regulation Differences 16:00 - Discussion on Mitochondrial Health and Benefits of Methylene Blue 21:00 - Addressing Risks of Buying Peptides Online Without Medical Supervision 27:30 - Overview of NAD Peptides and Their Role in Energy Production 34:00 - Importance of Gut Health and Introduction to Peptides for the Gut 41:00 - Thymosin Alpha and Beta: Uses in Autoimmune and Injury Recovery 47:00 - Hormone Health and Peptides for Sexual Health and Anti-Aging 54:00 - Closing Thoughts on Peptide Therapy's Role in Holistic Health Connect with Modern Endocrine: Check out the⁠⁠⁠ ⁠website⁠⁠⁠⁠ Follow Cassie on⁠⁠⁠ ⁠Instagram⁠⁠⁠⁠ Follow Cassie on⁠⁠⁠ ⁠Facebook⁠⁠⁠⁠ Follow Cassie on⁠⁠⁠ ⁠YouTube⁠⁠⁠⁠ Follow Cassie on⁠⁠⁠ ⁠TikTok⁠⁠⁠⁠ Sign up for Modern Endocrine's⁠⁠⁠ ⁠newsletter⁠⁠⁠⁠ ⁠⁠⁠⁠Disclaimer ⁠⁠⁠

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Hurricane aid for people with diabetes, Medtronic safety warning, stem cell updates for type 1, new study about teens and young adults with type 1, and Ryan Reed returns to racing. Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Hurricane Insulin efforts XX Medtronic has notified customers that battery issues with its Minimed 600 and 700 series insulin pumps could cause the devices to stop delivering insulin significantly sooner than expected. A “low battery pump” alert, intended to signal up to 10 hours of remaining battery life, may be displayed on the device even if much less time is left. Medtronic told customers they could contact the company to determine the need for a replacement pump. Medtronic said it received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis in the U.S., from January 2023 to September 2024, potentially related to the issue. Pump models including the Minimed 630G, 670G, 770G and 780G systems are affected by the notice. https://www.medtechdive.com/news/Medtronic-Minimed-insulin-pumps-recall-battery-life/729019/ XX A woman has undergone a stem-cell therapy made from her own cells, to treat her type 1 diabetes. Researchers in China discovered the woman did not need to use insulin 75 days after the procedure, and that the stem-cell derived islet cells she was injected with had been engrafted inside her abdomen. the case is the first of its kind, and two more people have been enrolled in the clinical trial in China since, researchers involved in the study told Medical News Today. Other stem-cell based therapies for type 1 and type 2 diabetes are also currently in development and in trials. For this case study, researchers based in Tianjin First Central Hospital, Nankai University, Tianjin, China took fat cells from a 25 year-old woman with type 1 diabetes, and chemically induced them to behave as pluripotent stem cells, a type of cell that can develop into other types of cell. They then used these to create islet cells, which typically exist in the pancreas and create insulin, a hormone that regulates levels of glucose (sugar) in the bloodstream. The patient in this case study had previously had two liver transplants and a failed pancreas transplant due to complications that had arisen due to her diabetes. The induced islet cells made from the patient's own cells were then injected between the skin and abdominal muscles. Researchers discovered that these successfully engrafted in the patient, including growing their own vasculature. Before the procedure she produced enough insulin to reach her target glycemic range 43.18% of the time, and 4 months later this increased to 96.2% of the time. She was also shown to have lower glycated hemoglobin, which indicated long-term systemic glucose levels at a non-diabetic level.   https://www.medicalnewstoday.com/articles/stem-cell-therapy-reverses-type-1-diabetes-in-groundbreaking-case-study XX The state of Texas is accusing major pharmacy benefit managers and drug companies of colluding to raise the cost of insulin.   Texas alleged drug manufacturers Eli Lilly, Novo Nordisk and Sanofi raise the price of insulin and then pay an undisclosed amount back to PBMs Optum Rx, Express Scripts and CVS Caremark through a quid pro quo agreement. PBMs then give preferred status on its standard formularies to drugs with the highest list prices, the state said. Insulin costs $2 to produce and could be purchased for $20 in the 1990s but now costs up to $700, the Office of the Attorney General of Texas wrote in a news release. The filing goes so far as to describe a LinkedIn group these executives would use to discuss insulin pricing tactics. The Federal Trade Commission (FTC) recently sued Optum Rx, Express Scripts and Caremark for rising insulin prices and anticompetitive practices. The PBMs reject the FTC's findings. Drug manufacturers were not included in the lawsuit. Texas' lawsuit also noted the consolidation in the PBM market, arguing it gives PBMs a “disproportionate amount of market power.” Nearly 40 PBM entities have now been consumed by UnitedHealth Group, Cigna and CVS Caremark. https://www.fiercehealthcare.com/payers/texas-sues-pbms-manufacturers-over-insulin-conspiracy XX Canadian teens and young adults living with diabetes face double the risk of hospitalizations and emergency room visits compared with younger children with the condition, say doctors suggesting changes to how care is organized for affected families. In the October issue of the journal The Lancet Diabetes and Endocrinology, Dr. Meranda Nakhla, a pediatric endocrinologist at the Montreal Children's Hospital, and her team used Quebec health administrative data to estimate the risk of gaps in regular diabetes care for complications in children under 10, and adults up to age 23.   "With adolescents and young adults, [the complication]  tends to be more related to an insulin omission and maybe just feeling burnt out from having diabetes and just not wanting to deal with it," Nakhla said. "They may stop taking insulin and a day later end up in the emergency room with diabetic ketoacidosis." Part of the challenge, Nakhla said, is for parents to take a step back from managing all aspects of their child's diabetes to a more supportive role that allows the child to have more autonomy. What's new about the Quebec findings is they highlight how gaps in diabetes care visits start at a younger age than previously looked at, said Dr. Rayzel Shulman, a pediatric endocrinologist at Toronto's Hospital for Sick Children. Since the brains of adolescents and young adults aren't fully developed, planning ahead, thinking about the consequences of their actions and controlling impulses differs from their parents. As part of an ongoing study, Shulman's team uses text messages to send adolescents and young adults appointment reminders as well as monthly diabetes messages. They recently added an artificial intelligence chat bot programmed with answers from trusted sources. https://www.cbc.ca/news/health/diabetes-pediatric-1.7345526 XX A trade organization representing compounding pharmacies that make unbranded versions of the weight loss drugs Mounjaro and Zepbound has filed a lawsuit against the Food and Drug Administration (FDA) for declaring an end to the shortage, effectively halting the sale of “copycat” versions of these drugs.   On Oct. 2, the FDA announced that the nearly two-year-long shortage of tirzepatide, the active ingredient in Mounjaro and Zepbound, had ended. This was after the agency said it had confirmed the manufacturer, Eli Lily, had a manufacturing capacity that “can meet the present and projected national demand.”     With the shortage over, the ability of compounding pharmacies to sell unbranded, replicated versions of these drugs came to a near halt. There are two types of compounding pharmacies: 503A and 503B. The Outsourcing Facilities Association (OFA) represents 503B compounding pharmacies, which can create prescription-specific compounded drugs as well as bulk orders.   The OFA and the compounding pharmacy North American Custom Laboratories filed their lawsuit against the FDA on Monday, alleging the agency was “abruptly depriving patients of much needed treatment and artificially raising drug prices.”   “Ignoring evidence that the shortage persists, FDA removed Tirzepatide from the shortage list without notice, without soliciting input from affected parties and the public, and without meaningful rationale,” said their complaint.   The evidence that the plaintiffs cited for the shortage persisting was that the FDA noted in its announcement that “patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”   Eli Lilly made a similar statement after the shortage was declared over, saying, “Patients' experiences looking for a particular dose of medicine in their local pharmacies may vary. The supply chain is complex, especially for refrigerated medicines, and there may be many reasons why a particular pharmacy does not have a particular dose of the medicine in stock. ” https://thehill.com/policy/healthcare/4922234-trade-group-sues-fda-over-ending-mounjaro-zepbound-shortage/ XX New project in Europe to provide data to enable more people with diabetes who use insulin to work as commercial pilots and air traffic controllers. The European Union Aviation Safety Agency project focuses mainly on pilots and air traffic controllers, but the data being collected will apply to cabin crew and passengers with diabetes as well   currently only three countries in Europe — the United Kingdom, Ireland, and Austria — allow them to obtain a license that enables them to fly commercially, under a strict protocol that was first launched by the UK Civil Aviation Authority in 2012. The Irish Aviation Authority joined in 2015, and Austro Control followed in 2016.     https://www.medscape.com/viewarticle/eu-program-aims-ensure-safety-pilots-who-use-insulin-2024a1000ia6 XX Edgepark commercial XX The two-time Xfinity Series winner was competing at Talladega in McAnally-Hilgeman Racing's No. 91 truck for his first start of the season. The last time Reed drove in a NASCAR event came last fall at Las Vegas Motor Speedway in the Xfinity Series, and his most recent Truck start came in the spring of 2021 at Darlington Raceway.   “I couldn't stop making mistakes early on,” Reed said. “The truck was so fast. I think more than anything I'm really proud of myself for being able to get out there and make aggressive pushes and be able to kind of rise to the occasion.”   See also Grant Enfinger Wins Talladega, Advances to Championship 4 Despite the speed, Reed's truck burst into flames shortly after crossing the finish line. Reed said he stared at the door of teammate Christian Eckes while he crossed the line in the middle of a multi-truck pileup.     “Gosh, we could go anywhere we wanted today,” Reed told Frontstretch. “I made a lot of mistakes, but we put ourselves in position at the end. I hate that Bill [McAnally] has torn up race trucks.”   Friday marked Reed's sixth start in the past six years in Truck and Xfinity equipment, something Reed said might have added some doubt.   “When you're sitting on the couch every weekend, you think you can do it,” he reflected. “I remember I used to race every single weekend, I know how to get around these plate tracks, but you don't know, right?   “It's really gratifying to come off the couch and remind myself, like ‘hey I can still do this,' at least at superspeedways. I think I can do it at other tracks too.”     The day ended in a combination of a career-best Truck Series finish and a ball of fire for Ryan Reed in his return to NASCAR Craftsman Truck Series competition on Friday (Oct. 4).   https://frontstretch.com/2024/10/04/ryan-reed-scores-career-best-finish-in-truck-series-return/ XX Join us again soon!

In this episode of the Dr. Gabrielle Lyon Show, we dive deep into the world of compounding pharmacies and the transformative power of anabolic steroids with special guest Sean Norian, founder of Empower Pharmacy, one of the largest compounding pharmacies in the U.S.Join us as Sean shares his personal journey from engineering to pharmacy, sparked by a life-changing back injury that led him to discover the benefits of testosterone therapy. We explore the critical role compounding pharmacies play in providing customized medications that can dramatically improve health outcomes, particularly for those dealing with hormonal imbalances, muscle wasting, and more.In this episode, you'll learn:The critical role of compounding pharmacies in personalized medicineDebunking myths and addressing the stigma around anabolic steroidsThe safety and regulatory landscape for compounded medicationsThe future of healthcare through the lens of compounding pharmaciesIf you're interested in cutting-edge science, personalized healthcare, or simply want to learn more about how medications can be tailored to meet your unique needs, this episode is a must!Who is Shaun Noorian?Shaun Noorian, CEO and Founder of Empower Pharmacy, is on a mission to help people live healthier and happier lives. With a profound commitment to quality and innovation, he has overseen Empower Pharmacy's growth into one of the nation's largest and most advanced 503A compounding pharmacies and 503B outsourcing facilities, serving the functional medicine markets. Empower's dedication to excellence allows them to produce a wide range of high-quality medications tailored to the specific needs of patients and healthcare businesses across 50 states. Today, Shaun and his team are expanding their presence in the pharmaceutical market, maintaining their core belief that healthcare accessibility is achieved through affordable medications without compromising quality. Apply to become a patient - https://drgabriellelyon.com/new-patient-inquiry/ Join my weekly newsletter - https://institute-for-muscle-centric-medicine.ck.page/2ed23e2860 Get my book - https://drgabriellelyon.com/forever-strong/This episode is brought to you by :Quicksilver - Code DRLYON 15% OFF First Order - quicksilverscientific.com/drlyonThesis - 10% OFF First Box - https://takethesis.com/drlyonLMNT - Code DRLYON for FREE SAMPLE PACK - http://drinklmnt.com/DRLYONInside Tracker - Code DRLYON for 10% OFF - https://insidetracker.com/drlyonFatty15 - Code DRLYON for 15% OFF - https://fatty15.com/DRLYONFind Shaun Noorian at:Shaun LinkedIn: https://www.linkedin.com/in/shaun-noorianShaun X (Twitter): x.com/shaunnoorian?s=11&t=NDSTyVuCaZkwAQ5FhTvR4wEmpower Website: https://www.empowerpharmacy.com/Find me...

In this episode, Our guest, Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA is a pharmacist-attorney in Frier Levitt's Life Sciences Department. Her practice focuses on healthcare law; Food, Drug Cosmetic law; pharmacy law and regulatory issues; PBM issues; as well as pharmaceutical and medical device intellectual property including trademark, copyright, trade secret and all aspects of patent law (due diligence, prosecution, opinion work, litigation, and transactional matters). Dr. Rumore has over 15 years of law firm experience in the area of Food, Drug & Cosmetic Law and pharmaceutical intellectual property, counseling on early market opportunities for pharmaceutical clients particularly in the area of ANDA and 510K applications and all facets of Paragraph IV litigation.Dr. Rumore has also worked in Drug Regulatory Affairs in the pharmaceutical industry and hospital pharmacy, both at the Director level. She taught Pharmacy Law and Drug Regulatory Affairs at Arnold & Marie Schwartz College of Pharmacy and Touro College of Pharmacy for close to 20 years and currently teaches Food, Drug & Cosmetic Law at Maurice A. Deane School of Law at Hofstra University.She is a frequent lecturer and has over 200 publications and presentations. Additionally, Dr. Rumore is a Fellow and former Trustee of the American Pharmacists Association, a former Board member of the American Society for Pharmacy Law and the Accreditation Council for Pharmacy Education and is a three-time recipient of the Larry Simonsmeier Legal Writing Award.This in-depth discussion on the current regulatory landscape for compounding pharmacies will look at:Current Regulatory Environment for 503A and 503B CompoundingState Laws and State Board of Pharmacy 2023/2024Important Regulatory Considerations in the 503B to 503A Compounding Model for Community Pharmacies506e Shortages and BeyondUSP 797/795 Six Months LaterGuest - Martha Rumore Senior Counsel mrumore@frierlevitt.com 646.970.3226Host - Hillary Blackburn, PharmD, MBAwww.hillaryblackburn.com  https://www.linkedin.com/in/hillary-blackburn-67a92421/ @talktoyourpharmacist for Instagram and Facebook@HillBlackburn Twitter ★ Support this podcast on Patreon ★

My guest today, Tenille Davis, is a leading voice in the realm of pharmacy compounding. She serves as the Chief Advocacy Officer for the Alliance for Pharmacy Compounding and sits on the Arizona State Board of Pharmacy. With a robust background from Civic Center Pharmacy to advocacy, Tenille brings a wealth of experience to today's discussion on the intricate landscape of compounding pharmacies. In this episode, we delve into the following topics and more: - What is Pharmacy Compounding? - Comparing Clinical, Commercial, and Compound Pharmacies - The Essentials of 503A and 503B Regulations - Bulk Drug Substance Categories under 503A - Advocacy Efforts in Pharmacy Compounding - Technological Advances in Compounding As always, thanks for tuning in! *****Learn More about Tenille and the Alliance for Pharmacy Compounding: https://a4pc.org/ *****Click here to subscribe to my channel: https://www.youtube.com/channel/UCM2Jjqb7MqtZ7VDIuRjguLA/?sub_confirmation=1     *****Connect with me on Instagram: https://www.instagram.com/doctorjones_doctorjones/     *****Connect on Facebook: https://www.facebook.com/GregJonesNMD

In this episode of The Bottom Line Pharmacy Podcast, we explore the world of 503B and 503A pharmacies! We sit down with Dae Y. Lee, PharmD, Esq., CPBS and Partner at Frier Levitt to discuss the latest regulations, compliance requirements, and best practices for both 503B outsourcing facilities and 503A compounding pharmacies, trends in PBM audits, marketing semiglutides, and more!Do you know where your pharmacy stands financially? Schedule an Rx Assessment with our team to learn moreMore about Dae Y. Lee and Frier Levitt:Dae Y. Lee, Pharm.D., Esq., CPBS is a pharmacist attorney in Frier Levitt's Life Sciences Department. Dae's practice focuses on pharmacy operations, Plan Sponsor operations and compliance, and Pharmacy Benefit Managers (PBMs) regulations. Dae co-chairs Plan Sponsor Practice Group with Frier Levitt co-founding partner, Jonathan E. Levitt, Esq. He advises clients in a wide range of matters including insurance and PBM audits and termination, wrongful recoupment, wrongful network exclusion, and governmental investigations. For Plan Sponsors, Dae provides full panoply of legal services ranging from PBM contract negotiations to contract disputes to enforce Plan Sponsor Agreement terms and conditions. In addition, Dae prosecutes reimbursement disputes on behalf of healthcare providers and facilities against health insurance companies.  Dae has extensive experience litigating high profile commercial and personal injury cases.Did you like this episode? We share insights for Independent Pharmacy Owners every other Thursday. Stay up to date on new episodes by liking and subscribing! Click here to learn more about our podcast team and previous episodes.Click here for the transcript   Learn more about Dae and Frier Levitt: FacebookInstagramLinkedInWebsiteYouTubeTwitter (X)Stay connected with us:  Facebook TwitterLinkedIn  InstagramSpotifyApple PodcastsCPA's: Scotty Sykes – CPA, CFP LinkedInScotty Sykes – CPA, CFP TwitterBonnie Bond – CPA LinkedInBonnie Bond – CPA Twitter More resources about this topic:  Podcast - Driving Independent Pharmacy Profitability in 2024

Join our resident Business Ninja, Kelsey and Evan Gilbert, CEO of Carie Boyd Pharmaceuticals as they discuss the benefits of compound medication in modern medicine. Carie Boyd Pharmaceuticals is a top-notch FDA registered 503A outsourcing facility that provides high-quality medications to healthcare practitioners, hospitals, clinics, and other provider networks. With their 503B compounding pharmacy, they can customize medications to meet their partners' and patients' unique needs. With a commitment to superior quality, service, and innovation, Carie Boyd Pharmaceuticals is a trusted partner in the healthcare industry. Learn more at https://www.carieboyd.com.-----Do you want to be interviewed for your business? Schedule time with us, and we'll create a podcast like this for your business:  https://www.WriteForMe.io/-----https://www.facebook.com/writeforme.iohttps://www.instagram.com/writeforme.io/https://twitter.com/writeformeiohttps://www.linkedin.com/company/writ...https://www.pinterest.com/andysteuer/Want to be interviewed on our Business Ninjas podcast? Schedule time with us now, and we'll make it happen right away! Check out WriteForMe, more than just a Content Agency! See the Faces Behind The Voices on our YouTube Channel!

Ross Caputo, PhD,  President and Chief Executive Officer of Eagle Analytical Services, joins co-hosts Mike De Lisio and Sebastian Denison, RPh, FAARM (candidate), to discuss what insanitary conditions actually means in 503A pharmacies, and why its of great importance for independent pharmacies and patients today.

In this episode, we're talking with Certified Integrative Nutrition Health Coach Lori Harrison about IV Nutritional Therapy and how you can use IV/IM Nutrition to grow your practice or clinic. Traditionally used in emergency department environments to replenish dehydrated patients, IV/IM Nutrition is now known to help patients with a wide range of other health conditions such as nutrient deficiencies, low energy, immune system support, headaches and migraines, menstrual support, and even libido issues. Guest Speaker BioLori Harrison is a Certified Integrative Nutrition Health Coach with 20+ years of experience in the health and wellness industry, focusing on IV/IM nutrition and weight loss therapies.Connect on LinkedInAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support patients across the United States and commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of wellbeing.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

In this episode, we're talking with Dr. Casey Green about the controversial vitamin, vitamin C, also known as ascorbic acid. We will take a deep dive into how vitamin C works in our bodies, why it is important, common myths surrounding ascorbic acid, and low/high dosing of vitamin C. Guest Speaker BioCasey Greene, PharmD, IFMCP is a clinical pharmacist specializing in Nutrition Support and IV Therapy. Dr. Green currently holds the title of QAQC and brings forth a wealth of knowledge to the compounding industry. Connect on LinkedInAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support patients across the United States and commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of wellbeing.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

Over the past few months, I have been getting requests to talk about air and surface sampling for environmental monitoring programs. And with the release of USP 797 revisions there still isn't much guidance on choosing locations and your cant you can't sample every surface in your cleanroom; you have to choose strategic spaces. So, I thought I would go back to Abby Roth, and let her tell us the best ways to narrow down locations and develop a comprehensive sampling EM program.   Support the show (https://www.buymeacoffee.com/pharmasalon)

In this episode, we're talking with Dr. Sierra Richard, a women's health pharmacist dedicated to helping empower women to take control of their health and wellness by equipping them with the knowledge and power to ask questions.Learn about her role in women's care from behind the pharmacy counter of a hospital, and what's she's doing in her spare time to increase awareness for the pharmacists role in patient care.Guest Speaker BioSierra Richard, PharmD is a Pediatric and Women's Health Clinical Pharmacist in Columbia, Missouri, United States.Her YouTube channel offers lively information about  the day-to-day life of a pediatric and women's health clinical pharmacist, tips on how to become a pharmacist, and more!Connect on LinkedInFollow on YouTube, Instagram, and Facebook: @happypharmlifeAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support patients across  the United States and commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

Pharmacists are an integral part of the healthcare team and can provide proactive care for patients. Medications may produce unwanted side effects or have a negative impact on nutritional wellness. Pharmacists can help to overcome this by providing information about how to prevent or manage these side effects through dietary supplements. In this podcast, we're talking with John Preckshot, R.Ph., CCN, FAARM, Director of Wellness Works Nutrition, about how pharmacists can help patients be proactive about their health and the vital role nutritional supplements can play in ensuring patient health during medication treatment.Guest Speaker BioJohn Preckshot, R.Ph., CCN, FAARM is the former owner and founder of Preckshot Professional Pharmacy in Peoria, Illinois, which was widely recognized as the "non-pharmacy" pharmacy in Central Illinois. In his 35+ years of pharmacy, he has been bestowed the M. George Webber Pharmacist of the Year and the Dupont Pharmaceutical Innovative Practitioner award. He earned his fellowship in anti-aging and regenerative medicine (FAARM) in 2014 and today continues a career as Director of Wellness Works Nutrition.About Wellness WorksWellness Works & Nutrition helps independent pharmacists develop a profitable nutritional revenue stream in their pharmacies by providing a customized, personal supplement line for sale in the marketplace.About Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,500 prescribers, 90,000+ patients, and annually provide 110,000+ prescriptions to 49 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

Thank you for tuning into part 3 our 3-part series on moving from a 503A to a 503B. In this episode Kim Kieffer talks about the process, investigations, quality, documentation staffing, regulations and the investment. Support the show (https://www.buymeacoffee.com/pharmasalon)

Thank you for tuning into part 2 our 3-part series on moving from a 503A to a 503B. In this episode Kim Kieffer reviews qualifying vendors and equipment, environmental monitoring, validation and formulation and release cycles. Support the show (https://www.buymeacoffee.com/pharmasalon)

This is a another 3-part episode.  Throughout the years there has been a lot of talk about moving from a 503A to a 503B compounding pharmacy.  I know there are a lot of pros and cons, as there are to changing any business model. In this series we are going to hear Kim Kieffer talk about Empowers move to a 503B and what are the considerations when contemplating such a move. For your convenience I have broken this hour long talk into 3 episodes.  The first one talks about the key differences between a 503A and a 503B, why become a 503B outsourcing facility, how to do it, the principle of a cGMP environment and Quality systems that need to be implemented. Support the show (https://www.buymeacoffee.com/pharmasalon)

Your skin is your body's largest organ, so it's essential to take good care of it. Each November, we celebrate Healthy Skin Month, and in this episode, we're talking with a doctor of pharmacy who combined a passion for medicine with a life-long love of nature and natural healing.Listen as Dr. Allyson Brennan shares her path from the pharmacy to the store shelves.Guest Speaker BioEmogene & Co. was founded by Dr. Allyson Brennan, a clinical pharmacist with 13 years of experience in Neurology. She learned as a youngster to go to nature to calm the mind and heal the body, and after becoming a mother to her daughter, Parker Emogene, she found herself studying pure, clean ingredients for skin care.Connect with Dr. Brennan on LinkedInAboute Emogene & Co.Using natural ingredients, Emogene & Co. provides clean, effective, and affordable skincare products. Formulated for all skin types, the company strives to improve skin function and promote healthier skin from the inside out.www.emogeneandco.comFollow on Facebook and InstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 80,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

In this episode, we're continuing our conversation about BHRT. We have with us two pharmacy owners who have been talking to the public about BHRT the FDA and how what is going on will affect patients as well as 503A pharmacist.Support the show (https://www.buymeacoffee.com/pharmasalon)

The pet population can pose challenges when attempting to administer commercially available oral medications. Irregular tablet sizes and unflavored or unpalatable medications can make administration to pets difficult.Many people are unaware that compounded drugs provide tailored and flavored medication options as reasonable alternatives for appropriately delivering medication to animals.In this episode, we'll talk with veterinary pharmacist Natalie Young, PharmD, about her passion, research, and work to expand awareness and opportunities in the industry of veterinary pharmacy.Guest Speaker BioWhile in graduate school, Dr. Natalie Young realized that if you go to a traditional ‘big box' pharmacy, the pharmacist behind the counter probably does not know how to care for your animal. Through no fault of their own, they haven't been educated in veterinary pharmacy. From that point on, she knew she had found her calling. Since earning her Doctorate from the UNC-Chapel Hill Eshelman School of Pharmacy and falling head-first into veterinary pharmacy, she has blazed many new trails through the fields of pharmacy and veterinary medicine.LinkedIn @natalie-young-rvpWebsite  www.nataliewyoung.comAdditional ResourcesThe Veterinary Pharmacy PodcastRealo Veterinary PharmacySociety of Veterinary Hospital PharmacistsAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 80,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

My guest today is Robert MacArthur Pharmacy Director at the Rockefeller University Hospital. Robert has been involved in the drug industry for about 33 years and has a wealth of experience from working in pharma as well as pharmacies and academia. I was excited to speak with him about this topic because I like to explore subjects from different angles. We spoke with Alex Pytlarz from Infuserve America,  a 503A, about their experience in investigational drugs and I really wanted to get their perspective from someone from a research institution and what it is they look for when looking to work with a 503As.Support the show (https://www.buymeacoffee.com/pharmasalon)

Pharmacists can do more than help you understand medications. When you reach out to a pharmacist for consultation, they not only look at what medications you're on, but also how they interact with each other; if there are any risks associated with the drugs; and even your medical history, laboratory results, and current state of hormone health.In this episode, we're talking with pharmacist Sharzad Green, creator of FabuVag Feminine Moisturizer, to discuss her work to help women and men to understand their hormone health and improve sexual and intimate wellness.Guest Speaker BioSharzad Green, Pharm.D. is a pharmacist at Community Clinical Pharmacy who specializes in Natural or Bio - identical Hormone Replacement Therapy (B - HRT). Sharzad has been passionate about working with the patients for over 20 years. Dr. Green received her B.S. and Pharm.D. from the University of Arizona College of Pharmacy. She has vast experience in community pharmacy, nursing home and long term care pharmacy and compound ing. Thousands of men and women have benefited from private consultations with Dr. Green, where she reviews and assesses a patient's hormonal status and works with their practitioners offering B - HRT, as well as non - hormonal approaches, and other strategies for improving their quality of life.LinkedIn @drsgreenrxFacebook @DrSGreenRXInstagram @drsgreenrxAdditional ResourcesIntroduction to Hormone Replacement Therapy with Sharzad Green (video)Request Consultation with Sharzad Green, Pharm. D.FabuVag® Feminine MoisturizerAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 80,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

USP 800: Budgeting for the Build  We all know that the adoption of USP 800 has been banging around for what seems like ages. I have been talking to people like Bryan about it for over a year. Bryan and I specifically have been discussing the budgeting issues and misconceptions there are regarding upgrading to USP 800, so I was particularly excited to do this podcast. I think it's a really important issue and I believe that 503A really need to start moving towards USP 800 compliance but need a realistic idea of the process and what that is going to cost them.  In addition to our conversation about t the budgeting issues I think one of my biggest takeaways was the need to work as a  unified team and have an experienced team leader. Support the show (https://www.buymeacoffee.com/pharmasalon) See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

In my role I am always hearing about the importance of the industry to achieve the highest standards of quality. This obviously effects interactions with state boards and the FDA as well as patients and the publics perception of the industry.  Through out the years we have had many sessions on achieving quality through process and procedure. Today we are going to talk about quality assurance means quality built in, this is a lead-up to a longer discussion that we are going to have in our October event. I wanted to have this session because I think it is important to get the ball rolling on this topic and gain understanding of what this means to 503AsSupport the show (https://www.buymeacoffee.com/pharmasalon)

USP 800: Budgeting for the Build  We all know that the adoption of USP 800 has been banging around for what seems like ages. I have been talking to people like Bryan about it for over a year. Bryan and I specifically have been discussing the budgeting issues and misconceptions there are regarding upgrading to USP 800, so I was particularly excited to do this podcast. I think it's a really important issue and I believe that 503A really need to start moving towards USP 800 compliance but need a realistic idea of the process and what that is going to cost them.  In addition to our conversation about t the budgeting issues I think one of my biggest takeaways was the need to work as a  unified team and have an experienced team leader. Support the show (https://www.buymeacoffee.com/pharmasalon) See omnystudio.com/listener for privacy information.

We all know that the adoption of USP 800 has been banging around for what seems like ages. I have been talking to people like Bryan about it for over a year. Bryan and I specifically have been discussing the budgeting issues and misconceptions there are regarding upgrading to USP 800, so I was particularly excited to do this podcast. I think it's a really important issue and I believe that 503A really need to start moving towards USP 800 compliance but need a realistic idea of the process and what that is going to cost them.  In addition to our conversation about t the budgeting issues I think one of my biggest takeaways was the need to work as a  unified team and have an experienced team leader.Support the show (https://www.buymeacoffee.com/pharmasalon)

As many of us have, I've been discussing USP 800. For what feels like years now, which is saying something because I've not been in the compounding space for that long. There's so many issues involved. The one I hear most often probably because it's the most expensive is how does a pharmacist who doesn't know anything about construction, carpentry, plumbing, electrical or HVAC begin to even create a lab that is compliant. Then there's the point that USP 800 includes OSHA and NIOSH, and they are under the banner of the Department of Labor. Because at its core, USP 800 is about a labor problem. And if you don't spend any money, whether you're a hospital or community pharmacy, or even a doctor's office, and you're dealing with these drugs and not making improvements, you run the risk of an employee picking up the phone to OSHA and saying, I'm being wronged here. And that's when the fines start to fly. And then there's a piece I just learned about the involvement of CMS, the organization that controls Medicare and Medicaid, this is huge for hospital pharmacies, because non compliance is a real risk to that very important revenue stream and it could be cut off. If you're thinking that sounds like a lot of information, how are they going to touch on all that in 20 minutes? We're not. This is a long episode. So get a cup of coffee, some comfortable headphones, and let's begin.Support the show (https://www.buymeacoffee.com/pharmasalon)

Today, you are going to hear from a pharmacist who is advancing the practice of healthcare through her work in a distinct service group called Medication Therapy Management or MTM. Listen as Dr. Karmen Stephens talks about her work to improve the health of patients and the efficiency of the healthcare systems through a person-centric model of pharmaceutical care that encourages communication and collaboration across the continuum of care.Guest Speaker BioDr. Karmen Stephens is the Vice President of Clinical at Consana.  Her primary responsibilities include strategic program development and implementation, including oversight of Consana clinical operations and service innovation. Karmen wears many other hats too, so it isn't uncommon to find her writing proposals, participating in sales calls, or consulting with technology partners.Connect with Dr. Stephens on LinkedInFollow CONSANA on LinkedInAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 80,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

Pharmacists pledge public health. Dr. Carlos Irula joins us on the podcast to talk about his experience in utilizing the pharmacy profession to advance public health and wellness throughout his community and state.Listen and be inspired by his work to be a voice for the poor and expand access to patients in need of medications!Guest Speaker BioCarlos Irula, PharmD is a community pharmacist and advocates for issues affecting his local community and pharmacy profession. Currently, he leads a pharmacy team dedicated to providing free medications to patients beneath the federal poverty level.Connect with Dr. Irula on LinkedInVolunteer or make a donation through the Society of St. Vincent de Paul GeorgiaAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 80,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

A few weeks ago, I was speaking with a friend who works in private equity, she told me about a firm that was moving into the 503A compounding pharmacy space, I was intrigued by what it was they were looking to do and how they were going to do it. Given the massive amount of expenses and regulation that are facing the community. I was wondering how these people see themselves partnering with 503As, and whether it was a partnership or an acquisition.Support the show (https://www.buymeacoffee.com/pharmasalon)

This episode is with Carlos Aquino fromPharmaDiversion. I've been privy to many of Carlos his stories over the years. They're always entertaining and really shine a light on the missteps that happen in both 503A and 503B compounding pharmacies. I asked Carlos if he would like to talk about some of those issues that he sees while doing DEA mock inspections, the topic he chose to kick off with his waste management of controlled substances. I was intrigued by this because it seems like an innocuous topic. Now I know what you're thinking, no, it's not. And you're right. That said, an organization can acknowledge the seriousness of something and not live up to those standards. And that is what Carlos is seeing.Support the show (https://www.buymeacoffee.com/pharmasalon)

In this podcast, we're talking with Azizi Ray, who was a student of Mercer University College of Pharmacy in Atlanta, Georgia at the time of the interview.Listen and learn as she shares her experience in preparing for a thesis defense as a dual Pharm.D./Ph.D. Behavioral Pharmacology candidate.She will answer questions about the opportunities and challenges of pursuing a dual degree program, offer insight for successfully identifying allies to lend support, and provide practical advice for students or those interested in pursuing the same path in the future!Guest Speaker BioDr. Azizi Ray found a welcoming environment at Mercer University's College of Pharmacy, where in 2021 she earned a Pharm.D./Ph.D. degree. She plans to continue her studies at the University of Arkansas, researching how computational models of neural activity can inform treatments for drug abuse, specifically stimulant abuse in communities of color.Mercer University College of Pharmacy (video)Azizi Ray Outstanding Graduate 2021Connect with Dr. Ray on LinkedInAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 80,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

My guest today is from Infuserve  America, a 503A that has a division that focuses on investigational drugs, otherwise known as clinical trials. I was first introduced to this idea by some associates at a pharmaceutical company, they told me how they struggled to find 503A's to work with due to a variety of reasons. Some are because of misconceptions on the regulatory issues. Some are due to perceived GMP standards that they think a 503 a couldn't possibly attain. So I was really looking forward to this conversation. They've been working in this space for years and was able to shed light on how they got into this area, and what it's been like working on clinical trials with a variety of organizations.Support the show (https://www.buymeacoffee.com/pharmasalon)

Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States.[1]An estimated 26 million adults in the U.S. have diagnosed diabetes, 9.4 million adults have undiagnosed diabetes, and 91.8 million adults have prediabetes. [2]42.4% of adults are clinically obese. [3]Thankfully, with the recent developments of wearable technologies, it is now possible to prevent and treat common health conditions such as heart disease. In this podcast episode, Dr. Ram Cheruvu shares how these devices can be instrumental in detecting abnormal heart rhythms, monitoring glucose, and personalizing care. Listen as he shares his top three products to monitor and improve wellness!Guest Speaker BioDr. Ram Cheruvu, Pharm.D. is a pharmacist by education and a healer at heart. He has dedicated his life to helping others realize their full potential through functional medicine, guiding them towards clarity of purpose via high-performance coaching sessions. Dr. Ram founded Texas Functional Medicine, where he uses cutting-edge diagnostic tools to uncover the root cause of health concerns and employs a combination of interventions to eliminate triggers and restore proper function and balance.The Unlimited Potential ShowEvery week, Dr. Ram and Chris Morrell discuss their personal journeys to make self-development relatable and digestible. Each episode contains powerful habits and strategies to help listeners discover their unlimited potential.Podcast on iTunes, Spotify and AndroidInstagram @unlimitedpotentialshowFacebook @ramcheruvusterLinkedIn @doctorramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Innovation Compounding Pharmacy Innovation Compounding is a nationwide PCAB-accredited sterile and nonsterile compounding pharmacyDisclaimer: This post contains affiliate links. If you make a purchase, I may receive a commission at no extra cost to you.Support the show

Welcome to another episode in our series on partnering for growth. In this installment I continue my conversation with Greg McKetrick from Stanley Pharmacy about looking outside your organization for growth opportunities. After a discussion about expanding your reach and your community Greg and I got to talking about a company that has become particularly lucrative for Stanley Pharmacy.  They started out as a vendor and the relationship grew into a mutually beneficial partnership going beyond a typical buy/sell affiliation.Support the show (https://www.buymeacoffee.com/pharmasalon)

I wanted to explore how compounding pharmacies can grow their business. I know, particularly with 503A's that compounding pharmacies are looking for new ways to increase revenue and I became intrigued with the idea of finding new markets that a pharmacy may not have initially intended when they opened for business. One of the things that I want to explore during this series is the idea of looking outward to grow. By that I mean, exploring partners and opportunities that may not be part of your core business.  The first person I spoke with about this is Greg McKetrick from Stanley Pharmacy. Through this series he took me on a journey of how he successfully embraced business relationships to create new partners  ranging from doctors to suppliers. Relationships and a level of trust has opened up not just new opportunities in traditional pharmacy/client/customer relationships but entire new revenue streams that were never even dreamed of when Stanley Pharmacy was founded Support the show (https://www.buymeacoffee.com/pharmasalon)

CBD, or cannabidiol, is a compound derived from the cannabis plant. CBD has been used for centuries to treat various illnesses and ailments because of its anti-inflammatory properties.Today, patients ask about CBD to help with everything from pain relief, anxiety, and depression, to sleep disturbances, menstrual symptoms, acne, and more!We believe that doctors are in the best position to prescribe CBD for their patients because they know what's going on with their patients better than anyone else.In this episode, we're talking with Erika Fallon, Pharm D, RPh, to answer questions, clear up confusion, and raise red flags of caution for all who want to know, "Does CBD really do anything?" and "Could CBD provide some benefit to my current treatment plan?"Guest Speaker BioDr. Erika Fallon is a supervising pharmacist at Fallon Wellness Pharmacy. She graduated from Albany College of Pharmacy in 2008, and has been practicing since then with training in functional medicine and first line therapy.Erika has extensive experience compounding medications, including hormones, veterinary, pediatric, and general compounds.Over the years, she has noticed trends where people are getting outside their comfort zone to consider other options they wouldn't have considered before. This observation led her to become an expert in CBD and fuels her belief that combining the best of conventional medicine with complementary approaches will result in better patient outcomes. Connect with Erika on LinkedInFollow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

In this episode of DISRxUPT, we explore the important role that 503B outsourcing facilities play in today's drug supply chain. We are joined by Jeff Hval, chief operating officer and chief pharmacist with STAQ Pharma, a 503B outsourcing facility based in Colorado. Jeff explains the history behind the creation of 503B outsourcing facilities, key differences from 503A pharmacies and drug manufacturers, the role of the FDA in oversight of 503B facilities, and the importance of current good manufacturing practices (cGMP) in this space. He also highlights the key role that pharmacists play in this growing sector. Listen in as we explore this unique and important facet of the drug supply chain!

Women are facing the brunt of the coronavirus pandemic. Nowhere is this more evident than in the workplace.In this episode, we'll be talking with Lyssa Martelly, PharmD, wife, mother, and clinical pharmacist, about how she maintains a balance as the demands at work and home become more demanding.Guest Speaker BioLyssa Martelly, PharmD started her pharmacy career as a pharmacy technician before graduating from Massachusetts College of Pharmacy and Health Sciences in 2012 to become a pharmacist.She is a wife, mother, and member of the Pharmacist Moms™ Group who has a passion for helping others navigate the complex world of medications to achieve successful outcomes.Connect with Lyssa on LinkedInPharmacist Moms™ GroupThe Pharmacist Moms™ Group has over 35K women who practice in all areas of pharmacy and advocate for diversity and inclusion in the pharmacy profession.Pharmacist Moms Group (PhMG) Facebook PageWebsite www.pharmacistmomsgroup.comRegister to become a member Sign Up OnlineAll social media @pharmacistmomsFollow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding Website Support the show

The World Health Organisation has defined pharmacovigilance as "The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problem."In this episode, we're discussing adverse drug event prevention and the study of pharmacovigilance with pharmacist and researcher Dr. Sara Rogers, PharmD, BCPS. Listen along as we review:The current state of drug safety in the U.S. The study of pharmacovigilancePrevention of adverse drug eventsThe American Society of Pharmacovigilance (ASP)PharmacogenomicsAnd more...Guest Speaker BioSara Rogers, PharmD, BCPS, is a Board Certified Pharmacotherapy Specialist (BCPT), researcher and nonprofit director. As a proponent of personalized medicine and preventing harm from medication use, she co-founded the American Society of Pharmacovigilance in 2018. Since there is a strong genetic component in the way that patients respond to medications, she has taken an active role in addressing barriers to widespread implementation of pharmacogenomics. Dr. Rogers is a member of the Clinical Pharmacogenetics Implementation Consortium, Chairman of the Pharmacogenomics Access and Reimbursement Coalition, and an organizational member of the NIH National Human Genomics Research Institute (NHGRI) Inter-Society Coordinating Committee. She hopes these efforts will lead to improved health outcomes for patients across the US, regardless of socioeconomic status.Additional Resources & LinksThe American Society of PharmacovigilanceFollow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

In this episode, we're going to talk with AllerScripts, Director of Allergy, Robert Erskine, to touch on Sublingual Immunotherapy, also called SLIT.Learn how it can be an effective form of treatment when looking to reduce patients' sensitivity to allergens.Robert Erskine received a Bachelors of Science in Microbiology from Texas A&M University and completed three years of postgraduate study at Harvard Medical School, Division of Medical Sciences Immunology program. During his career, he has gained extensive experience in the use of allergenic extracts for allergy skin testing and immunotherapy, and he has been invited to lecture at numerous allergy fellowship training programs in the US and Canada.Robert also has ten years of laboratory research experience with appointments at the University of Texas Southwestern Medical Center, Harvard University, and Biogen.Follow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to most states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

In this episode, we're going to talk with AllerScripts, Director of Allergy, Robert Erskine, to touch on Subcutaneous Immunotherapy, also called SCIT.Learn how it can be an effective form of treatment when looking to reduce patients' sensitivity to allergens.Robert Erskine received a Bachelors of Science in Microbiology from Texas A&M University and completed three years of postgraduate study at Harvard Medical School, Division of Medical Sciences Immunology program. During his career, he has gained extensive experience in the use of allergenic extracts for allergy skin testing and immunotherapy, and he has been invited to lecture at numerous allergy fellowship training programs in the US and Canada.Robert also has ten years of laboratory research experience with appointments at the University of Texas Southwestern Medical Center, Harvard University, and Biogen.Follow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to most states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

Immunotherapy refers to treatment and management plans that train the immune system to act differently than it normally would—for example, treating your immune system not to react to allergens. There are multiple types of immunotherapy used for allergies, and in this podcast episode, we're going to speak with AllerScripts, Director of Allergy, Robert Erskine.Robert Erskine received a Bachelors of Science in Microbiology from Texas A&M University and completed three years of postgraduate study at Harvard Medical School, Division of Medical Sciences Immunology program. During his career, he has gained extensive experience in the use of allergenic extracts for allergy skin testing and immunotherapy, and he has been invited to lecture at numerous allergy fellowship training programs in the US and Canada.Robert also has ten years of laboratory research experience with appointments at the University of Texas Southwestern Medical Center, Harvard University, and Biogen.Follow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to most states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

Pharmacy compounding is the art and science of preparing customized medications for patients. From capsules to injectables and even topical creams, compounded medications can improve patients' quality of life by offering them a personalized approach to reaching their desired goals for health.Many diet plans fail because they do not provide real and measurable results for weight loss. In this episode, we speak with nutritionist and medical weight loss coach, Jamie Young, about how she uses compounded medications to help her weight loss patients achieve real results.Links & ResourcesReal Results®Follow on Facebook @realresultsforlifeFollow on Instagram @real.results.for.lifeFree Gift: Real Results Guide to Surviving the Holidays!Peloton App: Try it free for 30 daysFollow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

With the pharmacy profession consistently changing and evolving, it becomes apparent that pharmacists' leadership is instrumental in advancing patient health and healthcare systems. On a global scale, pharmacists are in the driver's seat when it comes to advocating for the right to safe and effective medication on behalf of their patients. In this episode, we're talking with Scott Brunner, CEO of the Alliance for Pharmacy Compounding, about his love for compounding pharmacy and his work to advance the profession through legislative, regulatory, and public health policy efforts.Links & ResourcesAlliance for Pharmacy Compounding (APC)Follow on Facebook @4pcrxFollow on Instagram @4pcrxJoin APC today! Annual MembershipsFollow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

Holiday weight gain is a well-studied phenomenon. Researchers have found that people gain about a pound from November to January.It may not seem like much, but small weight gains have a way of adding up over the years. Without a plan, it can be difficult to resist sugary treats or consuming too many carbohydrates. In this episode, we'll be talking with nutritionist and medical weight loss coach, Jamie Young, to bring you a Holiday Nutrition Survival Guide for keeping nutrition and weight gain under control throughout this winter season.Links & ResourcesReal Results®Follow on Facebook @realresultsforlifeFollow on Instagram @real.results.for.lifeFree Gift: Real Results Guide to Surviving the Holidays!Peloton App: Try it free for 30 daysFollow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

Join me for my conversation with Wedgewood Pharmacy's Dan Rowan, Vice President of Sales and Marketing, and  Jodi Donohue, Director of Marketing, to see how Wedgewood Pharmacy has proven that you can achieve high levels of empathy and meaningful customer communication no matter the size of your company. Wedgewood started as a local community pharmacy and has grown to one of the largest compounding pharmacies in the United States, all while maintaining the personalized touch they had from the beginning. To Wedgwood, empathy is about more than just being nice, it is about truly listening, utilizing design thinking, and seeing things from your customer's perspective, allowing everyone to truly live the company's mission and purpose. Key Takeaways:No matter how big you get, you need to keep checking in with your customers on a regular basis and keep the feedback loops open. Make the time within your own company to just listen. You can achieve empathy and customer communication at scale and be wildly successful while doing so! "If you really listen to your customers, and your internal and external stakeholders, you can drive an incredible organization." —  Dan Rowan About Wedgewood Pharmacy: Wedgewood Pharmacy is the largest 503A animal-health compounding pharmacy in the U.S. and has also served the human-health market since its founding in 1980. Compounded medications are preparations customized to the unique needs of a patient. They are created and prepared by specially trained pharmacists and pharmacy technicians in state-regulated facilities when mass-manufactured drugs are not, according to the prescriber, available or are not appropriate for a patient.  In its 40 years, Wedgewood Pharmacy has grown from a local community pharmacy to become one of the largest compounding pharmacies in the United States; it is the leading pharmacy in animal health. Wedgewood Pharmacy serves more than 50,000 prescribers and hundreds of thousands of patients throughout the U.S. every year. George (late) and Lucy Malmberg, both pharmacists, purchased Wedgewood Pharmacy in 1981; the pharmacy was founded in 1980. In June 2016, New Harbor Capital, became the majority shareholder of the company. In July 2018, the company acquired Diamondback Drugs, Scottsdale, Arizona. In 2020, the company began production at Wedgewood Connect, an FDA-registered 503B Outsourcing Facility, in San Jose, California. Wedgewood Pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB®) for compliance with PCAB and other nationally recognized compounding standards. PCAB was formed by eight of the nation's leading pharmacy associations and is a service of Accreditation Commission for Health Care. As a third-party accreditation organization, PCAB has developed the highest national standards against which providers are measured to demonstrate their ability to effectively and efficiently deliver quality compounded medications to consumers. Wedgewood Pharmacy employs more than 650 people in its state-of-the-art compounding pharmacies in Swedesboro, New Jersey and Scottsdale, Arizona, in its Wedgewood Connect 503B Outsourcing Facility in San Jose, California, and its Wildlife Pharmaceuticals/ZooPharm facilities in Colorado and Wyoming  Connect with Wedgewood, Dan Rowan, and Jodi Donohue:  Website: WedgewoodPharmacy.comFacebook: facebook.com/WedgewoodPetRxTwitter: twitter.com/wedgewoodpetrxDan Rowan on LinkedIn: linkedin.com/in/danrowanJodi Donohue on LinkedIn: linkedin.com/in/jodi-donohue-41a4252  Don't forget to download your free guide! Discover The 5 Business Benefits of Empathy: http://red-slice.com/business-benefits-empathy  Connect with Maria: Get the podcast and book: TheEmpathyEdge.comLearn more about Maria's brand strategy work and books: Red-Slice.comHire Maria to speak at your next event: Red-Slice.com/Speaker-Maria-RossLinkedIn: Maria RossInstagram: @redslicemariaTwitter: @redsliceFacebook: Red Slice

Join me for my conversation with Wedgewood Pharmacy's Dan Rowan, Vice President of Sales and Marketing, and  Jodi Donohue, Director of Marketing, to see how Wedgewood Pharmacy has proven that you can achieve high levels of empathy and meaningful customer communication no matter the size of your company. Wedgewood started as a local community pharmacy and has grown to one of the largest compounding pharmacies in the United States, all while maintaining the personalized touch they had from the beginning. To Wedgwood, empathy is about more than just being nice, it is about truly listening, utilizing design thinking, and seeing things from your customer's perspective, allowing everyone to truly live the company's mission and purpose. Key Takeaways:No matter how big you get, you need to keep checking in with your customers on a regular basis and keep the feedback loops open. Make the time within your own company to just listen. You can achieve empathy and customer communication at scale and be wildly successful while doing so! "If you really listen to your customers, and your internal and external stakeholders, you can drive an incredible organization." —  Dan Rowan About Wedgewood Pharmacy: Wedgewood Pharmacy is the largest 503A animal-health compounding pharmacy in the U.S. and has also served the human-health market since its founding in 1980. Compounded medications are preparations customized to the unique needs of a patient. They are created and prepared by specially trained pharmacists and pharmacy technicians in state-regulated facilities when mass-manufactured drugs are not, according to the prescriber, available or are not appropriate for a patient.  In its 40 years, Wedgewood Pharmacy has grown from a local community pharmacy to become one of the largest compounding pharmacies in the United States; it is the leading pharmacy in animal health. Wedgewood Pharmacy serves more than 50,000 prescribers and hundreds of thousands of patients throughout the U.S. every year. George (late) and Lucy Malmberg, both pharmacists, purchased Wedgewood Pharmacy in 1981; the pharmacy was founded in 1980. In June 2016, New Harbor Capital, became the majority shareholder of the company. In July 2018, the company acquired Diamondback Drugs, Scottsdale, Arizona. In 2020, the company began production at Wedgewood Connect, an FDA-registered 503B Outsourcing Facility, in San Jose, California. Wedgewood Pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB®) for compliance with PCAB and other nationally recognized compounding standards. PCAB was formed by eight of the nation's leading pharmacy associations and is a service of Accreditation Commission for Health Care. As a third-party accreditation organization, PCAB has developed the highest national standards against which providers are measured to demonstrate their ability to effectively and efficiently deliver quality compounded medications to consumers. Wedgewood Pharmacy employs more than 650 people in its state-of-the-art compounding pharmacies in Swedesboro, New Jersey and Scottsdale, Arizona, in its Wedgewood Connect 503B Outsourcing Facility in San Jose, California, and its Wildlife Pharmaceuticals/ZooPharm facilities in Colorado and Wyoming  Connect with Wedgewood, Dan Rowan, and Jodi Donohue:  Website: WedgewoodPharmacy.comFacebook: facebook.com/WedgewoodPetRxTwitter: twitter.com/wedgewoodpetrxDan Rowan on LinkedIn: linkedin.com/in/danrowanJodi Donohue on LinkedIn: linkedin.com/in/jodi-donohue-41a4252  Don't forget to download your free guide! Discover The 5 Business Benefits of Empathy: http://red-slice.com/business-benefits-empathy  Connect with Maria: Get the podcast and book: TheEmpathyEdge.comLearn more about Maria's brand strategy work and books: Red-Slice.comHire Maria to speak at your next event: Red-Slice.com/Speaker-Maria-RossLinkedIn: Maria RossInstagram: @redslicemariaTwitter: @redsliceFacebook: Red Slice

In this podcast, Pharmacist Tara Thompson co-host a special Movember edition of the Mix It Up Pharmacy Podcast with sexual health counselor and healthcare practitioner Dr. Heather Quaile, founder of The Sexual Health Optimization and Wellness (SHOW) Center.Across the globe, the Movember campaign seeks to change the face of men's health by encouraging education and conversation around men's health issues, such as prostate cancer, testicular cancer, and men's suicide.Because many men do not recognize major health differences until complications occur in the bedroom, we interviewed Shawn Hodges, PharmD, about men's sexual health and how a drop in libido or performance may signify larger health problems that need to be addressed.Follow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

In celebration of National Pharmacy Week, we want to acknowledge the invaluable contributions that pharmacists, pharmacy assistants, and all staff in pharmacy departments make to patient care.In a previous episode, we spoke with Pharmacist Casey Greene about his work and leadership in implementing quality-based programs in pharmacy.In this episode, we will talk about another aspect of pharmacy—effective communication and leading a pharmacy team.Follow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

In celebration of National Pharmacy Week, we want to acknowledge the invaluable contributions that pharmacists, pharmacy assistants, and all staff in pharmacy departments make to patient care.Today, we want to recognize future leaders in pharmacy by talking with student Savannah Cunningham who was about her experience in pharmacy school and the advice she has for students looking to make the most of their education and future career in pharmacy.Follow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

In celebration of National Pharmacy Week, we want to acknowledge the invaluable contributions that pharmacists, pharmacy assistants, and all staff in pharmacy departments make to patient care.Today, pharmacists are caring for more individuals of diverse age, gender, race, ethnicity, socioeconomic status, religion, sexual orientation, and health beliefs than in previous decades. In this episode, we'll talk about the importance of developing cultural competence as a pharmacist.Follow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

In celebration of National Pharmacy Week, we want to acknowledge the invaluable contributions that pharmacists, pharmacy assistants, and all staff in pharmacy departments make to patient care.A quality-based program is vital in every compounding pharmacy to ensure that each preparation is compounded properly and is stable for its expected duration of use. In this episode, we're going to talk with a pharmacist who demonstrates excellence in quality improvement about his leadership role inside and outside of the pharmacy.  Follow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

In celebration of National Pharmacy Week, we want to acknowledge the invaluable contributions that pharmacists, pharmacy assistants, and all staff in pharmacy departments make to patient care.In a previous episode, we spoke with a pharmacy student about the experience of attending a college of pharmacy. Today, we'll talk about making the transition from student to pharmacist, and how to enter your career in pharmacy confidently.Follow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

In celebration of National Pharmacy Week, we want to acknowledge the invaluable contributions that pharmacists, pharmacy assistants, and all staff in pharmacy departments make to patient care.Today, we're speaking with Shawn Hodges, President & CEO of Innovation Compounding pharmacy, about the pharmacy profession's importance, pharmacy leadership, and pharmacists' crucial role in health care.Follow us on Social MediaLinkedInFacebookInstagramAbout Innovation CompoundingInnovation Compounding is licensed as a 503A, compounding pharmacy, accredited by The Pharmacy Compounding Accreditation Board (PCAB®).Today, we support over 7,000 prescribers, 70,000+ patients, and annually provide 100,000+ prescriptions to 46 states across the U.S. We commit to individualized pharmaceutical care by being relentless in our drive for personalized medicine, compassionate toward our patients and doctors, and being a #WellnessAdvocate for our patients' lives and state of well being.Learn more about the work we do and how we can help to build your practice by visiting us online:Innovation Compounding WebsiteSupport the show

CATECISMO DE LA IGLESIA CATÓLICA: 172-173-174-175-176-177-178-179-180-181-182-183-184 III Una sola fe 172 Desde siglos, a través de muchas lenguas, culturas, pueblos y naciones, la Iglesia no cesa de confesar su única fe, recibida de un solo Señor, transmitida por un solo bautismo, enraizada en la convicción de que todos los hombres no tienen más que un solo Dios y Padre (cf. Ef 4,4-6). San Ireneo de Lyon, testigo de esta fe, declara: 173 "La Iglesia, diseminada por el mundo entero hasta los confines de la tierra, recibió de los Apóstoles y de sus discípulos la fe [...] guarda diligentemente la predicación [...] y la fe recibida, habitando como en una única casa; y su fe es igual en todas partes, como si tuviera una sola alma y un solo corazón, y cuanto predica, enseña y transmite, lo hace al unísono, como si tuviera una sola boca" (Adversus haereses, 1, 10,1-2). 174 "Porque, aunque las lenguas difieren a través del mundo, el contenido de la Tradición es uno e idéntico. Y ni las Iglesias establecidas en Germania tienen otro fe u otra Tradición, ni las que están entre los iberos, ni las que están entre los celtas, ni las de Oriente, de Egipto, de Libia, ni las que están establecidas en el centro el mundo..." (Ibíd.). "El mensaje de la Iglesia es, pues, verídico y sólido, ya que en ella aparece un solo camino de salvación a través del mundo entero" (Ibíd. 5,20,1). 175 "Esta fe que hemos recibido de la Iglesia, la guardamos con cuidado, porque sin cesar, bajo la acción del Espíritu de Dios, como un contenido de gran valor encerrado en un vaso excelente, rejuvenece y hace rejuvenecer el vaso mismo que la contiene" (Ibíd., 3,24,1). Resumen 176 La fe es una adhesión personal del hombre entero a Dios que se revela. Comprende una adhesión de la inteligencia y de la voluntad a la Revelación que Dios ha hecho de sí mismo mediante sus obras y sus palabras. 177 "Creer" entraña, pues, una doble referencia: a la persona y a la verdad; a la verdad por confianza en la persona que la atestigua. 178 No debemos creer en ningún otro que no sea Dios, Padre, Hijo, y Espíritu Santo. 179 La fe es un don sobrenatural de Dios. Para creer, el hombre necesita los auxilios interiores del Espíritu Santo. 180 "Creer" es un acto humano, consciente y libre, que corresponde a la dignidad de la persona humana. 181 "Creer" es un acto eclesial. La fe de la Iglesia precede, engendra, conduce y alimenta nuestra fe. La Iglesia es la Madre de todos los creyentes. "Nadie puede tener a Dios por Padre si no tiene a la Iglesia por Madre" (San Cipriano de Cartago, De Ecclesiae catholicae unitate, 6: PL 4,503A). 182 "Creemos todas aquellas cosas que se contienen en la Palabra de Dios escrita o transmitida y son propuestas por la Iglesia [...] para ser creídas como divinamente reveladas" (Pablo VI, Credo del Pueblo de Dios, 20). 183 La fe es necesaria para la salvación. El Señor mismo lo afirma: "El que crea y sea bautizado, se salvará; el que no crea, se condenará" (Mc 16,16). 184 "La fe [...] es un gusto anticipado del conocimiento que nos hará bienaventurados en la vida futura" (S. Tomás de A., Compendium theologiae, 1,2).

Having issues controlling temperature in your cleanroom? Here's what NOT to do and what you should do... Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!   SUBSCRIBE: You Tube   Stitcher   Anchor FM   iHeart   Spotify   Radio Public   Pocket Casts   over cast   Cast box   Podcast App   Breaker   Google Podcasts   iTunes   Podbean

Having issues controlling temperature in your cleanroom? Here's what NOT to do and what you should do... Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!   SUBSCRIBE: You Tube   Stitcher   Anchor FM   iHeart   Spotify   Radio Public   Pocket Casts   over cast   Cast box   Podcast App   Breaker   Google Podcasts   iTunes   Podbean

How much are we a product of our nation's history? Learn about the struggles between Chief Joseph of the Nez Perce and US General Oliver Otis Howard in the years following the Civil War. We'll also hear about the growing number of older, "houseless" Americans living full time in RVs and camper vans: For some, it's the ultimate freedom; for others, it's all they have left. For more information on Travel with Rick Steves - including episode descriptions, program archives and related details - visit www.ricksteves.com.

A.J. Day, PharmD, PCCA Vice President of Clinical Services, joins Mike and Sebastian to discuss various details of federal oversight on 503A compounding as well as an important FDA ruling on several bulk substances related to compounding for human use, which goes into effect on March 21, 2019. 

In our 15th episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also discuss differences between owning a 503A and 503B and what he learned making this transition. This is the second part of possibly a three part series that we recorded last year. Stay tuned! Sign up to receive the entire episode: [mc4wp_form id="14886"] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We're just getting warmed up; there's SO many more topics to cover! Stay tuned for what's to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! --- Support this podcast: https://anchor.fm/pharmacy-inspection/support

In our sixth episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also discuss differences between owning a 503A and 503B and what he learned making this transition. This podcast is a little longer than our previous; our whole conversation with Bill was well over 90 minutes; I'll make this entire conversation available to my subscribers shortly because there is a TON of valuable information! Sign up to receive the entire episode: [mc4wp_form id="14886"] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We're just getting warmed up; there's SO many more topics to cover! Stay tuned for what's to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! --- Support this podcast: https://anchor.fm/pharmacy-inspection/support

In our 15th episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also discuss differences between owning a 503A and 503B and what he learned making this transition. This is the second part of possibly a three part series that we recorded last year. Stay tuned! Sign up to receive the entire episode: [mc4wp_form id="14886"] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We're just getting warmed up; there's SO many more topics to cover! Stay tuned for what's to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!      

In our 15th episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also discuss differences between owning a 503A and 503B and what he learned making this transition. This is the second part of possibly a three part series that we recorded last year. Stay tuned! Sign up to receive the entire episode: [mc4wp_form id="14886"] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We're just getting warmed up; there's SO many more topics to cover! Stay tuned for what's to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!      

In our sixth episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also discuss differences between owning a 503A and 503B and what he learned making this transition. This podcast is a little longer than our previous; our whole conversation with Bill was well over 90 minutes; I'll make this entire conversation available to my subscribers shortly because there is a TON of valuable information! Sign up to receive the entire episode: [mc4wp_form id="14886"] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We're just getting warmed up; there's SO many more topics to cover! Stay tuned for what's to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!     

In our sixth episode Pharmacist and rockstar entrepreneur, Bill Fixler talks about his experience in co-owning 3 pharmacies; all of which compound. Most recently, Bill has been working on opening a 503B pharmacy, Asteria Health in Birmingham, Alabama. We also discuss differences between owning a 503A and 503B and what he learned making this transition. This podcast is a little longer than our previous; our whole conversation with Bill was well over 90 minutes; I'll make this entire conversation available to my subscribers shortly because there is a TON of valuable information! Sign up to receive the entire episode: [mc4wp_form id="14886"] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We're just getting warmed up; there's SO many more topics to cover! Stay tuned for what's to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!     

First time pharmacy buyers must be careful when buying a pharmacy. An ill-advised pharmacy purchaser may find himself purchasing a headache, and a prepared pharmacy purchaser may find herself getting a better deal than originally anticipated. The first 2 major questions to answer before beginning the process is to determine the type of pharmacy to purchase and the way you intend to purchase it. 503A v 503B Is there adequate space Compounding within state v out of state Patients in state v out of state Large volume compounding v small volume compounding Sterile v non sterile Licenses DEA Pharmacy State Board One board? Multiple boards FDA NABP/NCPDP number (National Association of Boards of Pharmacy (NABP) to obtain a NABP/NCPDP number so that you may bill third-party payers.) NPI number (The National Plan and Provider Enumeration System (NPPES) to apply for a NPI number for the pharmacy and, if applicable, for the pharmacists who will be providing patient care.) Recommended Agreements Agreements with various insurance providers Lease on facility Building/store lease In-store vending machines, such as copiers or photo-processing kiosks Collection service contracts, such as water, utility or phone Business or franchise contracts with third parties, such as UPS or the United States Post Office Building and/or parking lot maintenance contracts Drop-ship vendors for front-end products Direct accounts with suppliers of gifts, cards and so on Pharmacy automation equipment Pharmacy services, such as compounding Regulations Have SOPs in place Training required for SOPs Laws of Interest HIPAA FCA Anti-Kickback Advertising and coupons Fraud Audit the pharmacy All prescriptions have valid prescriptions Billing concerns Some recommended clauses Indemnification Stock purchase v asset purchase License use/continuation of contracts Ownership of issues like name etc State v area of focus Non Compete/ Non Disparagement Likely involves some amount of employment by previous owner Deal Exhaustion is a real thing!! Darshan Kulkarni, Pharm.D, MS, Esq. The Kulkarni Law Firm 2929 Arch Street, Suite 1700 Philadelphia, PA 19104 Office Number: 215-948-8183 Twitter: @FDALawyers See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

First time pharmacy buyers must be careful when buying a pharmacy. An ill-advised pharmacy purchaser may find himself purchasing a headache, and a prepared pharmacy purchaser may find herself getting a better deal than originally anticipated. The first 2 major questions to answer before beginning the process is to determine the type of pharmacy to purchase and the way you intend to purchase it. 503A v 503B Is there adequate space Compounding within state v out of state Patients in state v out of state Large volume compounding v small volume compounding Sterile v non sterile Licenses DEA Pharmacy State Board One board? Multiple boards FDA NABP/NCPDP number (National Association of Boards of Pharmacy (NABP) to obtain a NABP/NCPDP number so that you may bill third-party payers.) NPI number (The National Plan and Provider Enumeration System (NPPES) to apply for a NPI number for the pharmacy and, if applicable, for the pharmacists who will be providing patient care.) Recommended Agreements Agreements with various insurance providers Lease on facility Building/store lease In-store vending machines, such as copiers or photo-processing kiosks Collection service contracts, such as water, utility or phone Business or franchise contracts with third parties, such as UPS or the United States Post Office Building and/or parking lot maintenance contracts Drop-ship vendors for front-end products Direct accounts with suppliers of gifts, cards and so on Pharmacy automation equipment Pharmacy services, such as compounding Regulations Have SOPs in place Training required for SOPs Laws of Interest HIPAA FCA Anti-Kickback Advertising and coupons Fraud Audit the pharmacy All prescriptions have valid prescriptions Billing concerns Some recommended clauses Indemnification Stock purchase v asset purchase License use/continuation of contracts Ownership of issues like name etc State v area of focus Non Compete/ Non Disparagement Likely involves some amount of employment by previous owner Deal Exhaustion is a real thing!! Darshan Kulkarni, Pharm.D, MS, Esq. The Kulkarni Law Firm 2929 Arch Street, Suite 1700 Philadelphia, PA 19104 Office Number: 215-948-8183 Twitter: @FDALawyers See omnystudio.com/listener for privacy information.

First time pharmacy buyers must be careful when buying a pharmacy. An ill-advised pharmacy purchaser may find himself purchasing a headache, and a prepared pharmacy purchaser may find herself getting a better deal than originally anticipated. The first 2 major questions to answer before beginning the process is to determine the type of pharmacy to purchase and the way you intend to purchase it. 503A v 503B Is there adequate space Compounding within state v out of state Patients in state v out of state Large volume compounding v small volume compounding Sterile v non sterile Licenses DEA Pharmacy State Board One board? Multiple boards FDA NABP/NCPDP number (National Association of Boards of Pharmacy (NABP) to obtain a NABP/NCPDP number so that you

The latest Gavel & Pestle Podcast focuses on - 3 Tips for Buying a Pharmacy Pharmacy Buyers must be careful when buying a pharmacy. An ill-advised pharmacy purchaser may find himself purchasing a headache, and a prepared pharmacy purchaser may find herself getting a better deal than originally anticipated. The first 2 major questions to answer before beginning the process is to determine the type of pharmacy to purchase and the way you intend to purchase it. 503A v 503B Is there adequate space Compounding within state v out of state Patients in state v out of state Large volume compounding v small volume compounding Sterile v non sterile   Licenses DEA Pharmacy State Board One board? Multiple boards FDA NABP/NCPDP number (National Association of Boards of Pharmacy (NABP) to obtain a NABP/NCPDP number so that you may bill third-party payers.) NPI number (The National Plan and Provider Enumeration System (NPPES) to apply for a NPI number for the pharmacy and, if applicable, for the pharmacists who will be providing patient care.)   Recommended Agreements Agreements with various insurance providers Lease on facility Building/store lease In-store vending machines, such as copiers or photo-processing kiosks Collection service contracts, such as water, utility or phone Business or franchise contracts with third parties, such as UPS or the United States Post Office Building and/or parking lot maintenance contracts Drop-ship vendors for front-end products Direct accounts with suppliers of gifts, cards and so on Pharmacy automation equipment Pharmacy services, such as compounding   Regulations Have SOPs in place Training required for SOPs   Laws of Interest HIPAA FCA Anti-Kickback Advertising and coupons Fraud Audit the pharmacy All prescriptions have valid prescriptions Billing concerns   Some recommended clauses Indemnification Stock purchase v asset purchase License use/continuation of contracts Ownership of issues like name etc State v area of focus Non Compete/ Non Disparagement Likely involves some amount of employment by previous owner   Deal Exhaustion is a real thing!! Darshan Kulkarni, Pharm.D, MS, Esq. The Kulkarni Law Firm 2929 Arch Street, Suite 1700  Philadelphia, PA 19104 Office Number: 215-948-8183 Twitter: @FDALawyers See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

The latest Gavel & Pestle Podcast focuses on - 3 Tips for Buying a Pharmacy Pharmacy Buyers must be careful when buying a pharmacy. An ill-advised pharmacy purchaser may find himself purchasing a headache, and a prepared pharmacy purchaser may find herself getting a better deal than originally anticipated. The first 2 major questions to answer before beginning the process is to determine the type of pharmacy to purchase and the way you intend to purchase it. 503A v 503B Is there adequate space Compounding within state v out of state Patients in state v out of state Large volume compounding v small volume compounding Sterile v non sterile   Licenses DEA Pharmacy State Board One board? Multiple boards FDA NABP/NCPDP number (National Association of Boards of Pharmacy (NABP) to obtain a NABP/NCPDP number so that you may bill third-party payers.) NPI number (The National Plan and Provider Enumeration System (NPPES) to apply for a NPI number for the pharmacy and, if applicable, for the pharmacists who will be providing patient care.)   Recommended Agreements Agreements with various insurance providers Lease on facility Building/store lease In-store vending machines, such as copiers or photo-processing kiosks Collection service contracts, such as water, utility or phone Business or franchise contracts with third parties, such as UPS or the United States Post Office Building and/or parking lot maintenance contracts Drop-ship vendors for front-end products Direct accounts with suppliers of gifts, cards and so on Pharmacy automation equipment Pharmacy services, such as compounding   Regulations Have SOPs in place Training required for SOPs   Laws of Interest HIPAA FCA Anti-Kickback Advertising and coupons Fraud Audit the pharmacy All prescriptions have valid prescriptions Billing concerns   Some recommended clauses Indemnification Stock purchase v asset purchase License use/continuation of contracts Ownership of issues like name etc State v area of focus Non Compete/ Non Disparagement Likely involves some amount of employment by previous owner   Deal Exhaustion is a real thing!! Darshan Kulkarni, Pharm.D, MS, Esq. The Kulkarni Law Firm 2929 Arch Street, Suite 1700  Philadelphia, PA 19104 Office Number: 215-948-8183 Twitter: @FDALawyers See omnystudio.com/listener for privacy information.

The latest Gavel & Pestle Podcast focuses on - 3 Tips for Buying a Pharmacy Pharmacy Buyers must be careful when buying a pharmacy. An ill-advised pharmacy purchaser may find himself purchasing a headache, and a prepared pharmacy purchaser may find herself getting a better deal than originally anticipated. The first 2 major questions to answer before beginning the process is to determine the type of pharmacy to purchase and the way you intend to purchase it. 503A v 503B Is there adequate space Compounding within state v out of state Pa

Part 1 - Noah Andre Trudeau, author of 'Southern Storm: Sherman's March to the Sea.'

Part 1 - Noah Andre Trudeau, author of 'Southern Storm: Sherman's March to the Sea.'

Part 1 - Noah Andre Trudeau, author of 'Southern Storm: Sherman's March to the Sea.'

Part 1 - Noah Andre Trudeau, author of 'Southern Storm: Sherman's March to the Sea.'