Podcasts about 503b

⭐Apply to Join RPM and attend the live sessions: https://www.coachcarson.com/rpm-pod-503b -------------------------- Topics Covered: 00:00 I asked my brother how he'd sue me 00:21 A new Coach's Corner format (and how to send feedback) 00:56 Why I've avoided talking about liability 02:01 23 years, and the lawsuit I've never seen 03:26 Risk #1: Loans with a date attached 04:34 What a balloon note actually is 05:09 The 2008 story: a $1M property sold for $600K 06:39 The fine print that lets a bank call your loan early 08:30 Risk #2: Remodels beyond your experience level 10:47 Start simple (and my own over-budget projects) 11:33 Risk #3: Bad locations that look great on a spreadsheet 13:00 So does liability actually matter? 14:13 Liability September inside RPM 14:48 Session 1: How my brother would build a case against me 18:00 Session 2: An attorney who owns rentals and teaches the law 18:50 Session 3: What liability insurance really covers 19:18 How to join us before September 10th 20:40 Send me your liability story

In this episode of the Gladden Longevity Podcast, Dr. Gladden hosts Joshua Fritzler, President of Olympia Pharmaceuticals, and Nicole Snow to discuss the intricacies of compounding pharmacies, focusing on the differences between 503A and 503B pharmacies, the role of compounding in personalized medicine, and the current landscape of peptides and FDA oversight. The conversation highlights the importance of safety, regulation, and quality assurance in compounded medications, providing listeners with a comprehensive understanding of how these pharmacies operate and their significance in modern healthcare.   For Audience Join the other 20,000+ high-performers getting weekly insights on biological reversal, exponential strategies, and Life Energy optimization→ https://start.gladdenlongevity.com/subscribe If you're ready to measure your 60+ biological ages and build a personalized reversal plan, apply for a discovery call here → https://start.gladdenlongevity.com/apply-now   Use code 'Podcast10' to get 10% OFF on any of our supplements at https://gladdenlongevityshop.com/!    Takeaways ·       Compounding pharmacies create personalized medications not commercially available. ·       503A pharmacies serve individual patients with specific prescriptions. ·       503B pharmacies produce larger batches for clinics and have stricter regulations. ·       Compounded medications can be tailored to avoid allergens or intolerances. ·       FDA does not approve compounded medications, but regulates the pharmacies. ·       Safety profiles of compounded medications are generally high when produced correctly. ·       Patients can request specific formulations that are not available commercially. ·       Compounding pharmacies must comply with state and federal regulations. ·       Quality assurance is critical in compounding, including testing for potency. ·       Understanding the differences between compounding pharmacies is essential for patients.   Chapters 00:00 Introduction to Compounding Pharmacies 02:55 Understanding 503A and 503B Pharmacies 05:56 The Role of Compounding in Personalized Medicine 08:52 Safety and Regulation of Compounded Medications 11:54 Differences Between 503A and 503B Pharmacies 14:52 Navigating Prescription and State Regulations 17:50 The Current Landscape of Peptides and FDA Oversight 24:03 Quality Assurance in Compounding Pharmacies 27:55 Conclusion and Future Directions 55:52 A Call for a Manhattan Project in Chronic Disease Research To learn more about Joshua: Email: olympia@moburst.com Website: http://olympiapharmacy.com LinkedIn: https://www.linkedin.com/in/joshuafritzler/   Reach out to us at:    Website: https://gladdenlongevity.com/     Facebook: https://www.facebook.com/Gladdenlongevity/    Instagram: https://www.instagram.com/gladdenlongevity/?hl=en     LinkedIn: https://www.linkedin.com/company/gladdenlongevity    YouTube: https://www.youtube.com/channel/UC5_q8nexY4K5ilgFnKm7naw    

#AD This episode is sponsored by Daré Bioscience. DARE to PLAY™ Sildenafil Cream is a compounded drug. It is not FDA-approved. This product has not been reviewed by FDA for safety or efficacy. It is manufactured in a 503B outsourcing facility under pharmaceutical Good Manufacturing Practices (GMP). Shan sits down with four women to talk about the low libido nobody prepares you for: the 26-year-old who kept saying "I'm supposed to be in my prime" and quietly decided she was broken, the married woman delighting in her season of stillness, and Shan's own reframe that low libido is only a dysfunction if it comes with an F word (frustrating). Then Sabrina Martucci Johnson, founder and CEO of Daré Bioscience,  explains what actually happens in the body when desire and arousal stop cooperating, and why women were told for almost 30 years it was all in their heads.   Follow Sabrina Martucci Johnson LinkedIn: https://www.linkedin.com/in/sabrina-martucci-johnson/  TikTok: https://www.tiktok.com/@sabrinadareceo    Follow Daré Bioscience LinkedIn: https://www.linkedin.com/company/dare-bioscience  Instagram: https://www.instagram.com/darebioscience/  —- Learn more about DARE to PLAY™ https://daretoplaybio.com/   Unlock deeper pleasure with a roadmap designed for you — all it takes is 5 minutes. Go to https://beduc.at/bg2631-boody to learn more!  Follow Indigo MateoInstagram: https://www.instagram.com/indigomateoMusic: http://www.indigomateo.com/ Follow Jamille McClendonInstagram: https://www.instagram.com/thahealingfactor  Follow Saraijah BarnesInstagram: https://www.instagram.com/Rai.destinei Follow Brittany Johnsonhttp://instagram.com/brittbekountry   Want more LOVERS? Follow Shan on Instagram → http://instagram.com/shanboodram Get a free Love Letter from Shan → http://loversbyshan.com/newsletter Join the LOVERS Community → https://www.loversbyshan.com/community Explore free quizzes + worksheets → http://loversbyshan.com/quizzes Learn more about your ad choices. Visit megaphone.fm/adchoices

We have been getting the same question in our DMs for months now. Peptides are everywhere. Everyone is talking about them. But what actually has evidence behind it, what is hype, and where do hormones fit into all of this? So we went and found someone who has been living this conversation for 35 years, not just talking about it.Dr. Jennifer Berman is a urologist, New York Times bestselling author, and one of the leading voices in female sexual and menopausal health. She pioneered the field at UCLA, runs the Berman Women's Wellness Center in Beverly Hills, and has been her own first patient through every transition she now treats. She is the kind of doctor who was doing things a decade before they became mainstream and has the clinical receipts to back all of it up.In this episode we get into why peptides are the missing piece of the menopause puzzle, what hormones are really doing to your skin from the inside out, and how treatments that were written off as fringe became the new gold standard for longevity.What's Discussed:(01:42) Why peptide production declines with age and what that actually means for how women look and feel in perimenopause.(04:04) The regulatory reality around peptides right now and why medical grade from a 503B pharmacy is the only route worth taking.(06:07) The specific peptides with the strongest evidence for skin, muscle, fat loss, recovery, and cognitive function.(13:12) Why your mid to late 30s is already perimenopausal by definition and why that changes when you start.(15:02) C-Link, C-Max, and PE22-28 for mood, neuroplasticity, and cognitive protection and why Dr. Berman stacks them together.(39:17) The exact point where topical skincare stops being enough and what hormone imbalance is doing to skin that no cream can fix.(53:08) Why cycling your peptides matters, what receptor attenuation actually is, and why the protocol on your feed is not a clinical protocol.By the end of this episode you will know which peptides have actual evidence behind them, where topical skincare stops working without hormonal support, and what an inside-out longevity protocol looks like from a doctor who has lived every transition she treats.Resources Mentioned:Age-Associated Changes in Oxidative Stress and NAD+ Study: journals.plos.org/plosone/article/FASEB study on how methylene blue delays cellular senescence cells: faseb.onlinelibrary.wiley.com/doi/Find more from Young Goose:Use code PODCAST10 to get 10% OFF your first purchase, and if you're a returning customer use the code PODCAST5 to get 5% OFF at younggoose.comInstagram: @young_goose_skincareFind more from Dr. Jennifer Berman: Website: bermansexualhealth.com/Instagram: @jenbermanmd

Deb 00:00:01Imagine your body has a repair manual, instructions written in your cells that tell tissues how to heal, blood vessels, how to grow, and inflammation when to stop. But what if those instructions got lost somewhere along the way? Well, today I’m talking about peptides, tiny protein fragments that act like biological text messages. Two of them, BPC 157 and TB 500.They’re showing remarkable promise for gut repair, joint recovery, and tissue regeneration. But here’s what nobody’s telling you. Women respond differently to these healing signals, especially during hormonal transitions. And today, we’re uncovering the science behind these regenerative peptides, who actually needs them, and why your doctor might not know about them. Can you guys put our ad right in here and then I’ll go to the standard intro?Welcome back to Let’s Talk Wellness Now, the show where we uncover the root causes of chronic illness, explore cutting edge regenerative medicine, and empower you with the tools to heal. I’m Dr. Deb, your medical detective. And today we’re diving into regenerative peptides BPC157 and TB 500. If you or someone you love is struggling with slow recovery from injury, chronic joint pain, gut inflammation that just won’t quit, or you just feel like your body doesn’t bounce back the way it used to, this episode is for you. Grab a cup of coffee or tea or whatever helps you unwind, settle in, and let’s start you on your journey to deeper healing. We’ll do another sponsor break here. Deb 00:01:52So let’s start with the question I hear constantly in my practice. Dr. Deb, I’m doing everything right. I’m eating clean, I’m exercising, I’m taking my supplements, but I’m still not healing. What am I missing? Well, that answer might surprise you. Sometimes it’s not about what you’re putting in your body. It’s about whether your cells are actually receiving the repair signals they need. That’s where peptides come in. Think of peptides as The body’s original communication system. These short chains of amino acids are like biological post-it notes carrying instructions from one cell to another. They tell your human system when to calm down, your blood vessels when to grow and your tissues when to repair. Now here’s where it gets interesting for women specifically. We know that estrogen plays a massive role in collagen production, vascular health, inflammatory response. When estrogen starts declining, whether that’s perimenopause, postpartum, or even from chronic stress, our natural repair mechanisms slow down dramatically. You might notice it as my joints are aching more, I’m a little more fluid filled, you know, they hurt when I bend them, my injuries take twice as long to heal.Gut issues that suddenly appear out of nowhere and no matter what you do, they don’t seem to repair. Skin has lost its elasticity or just this general sense that your body isn’t keeping up anymore. This is where BPC 157 and TB 500 entered the picture. So BPC 157, short for body protection compound 157, is a naturally occurring peptide sequence found in your gastric juices. And according to a 2024 systemic review published in emerging use of BPC 157 in orthopedic sports medicine, this peptide promotes something called angiogenesis. That’s the formation of new blood vessels and they deliver oxygen and nutrients to damaged tissues. Now TB 500 is a synthetic fragment of thymus and beta-4. Deb 00:04:17A protein your body makes naturally during wound healing and research published in therapeutic peptides in orthopedics in 2025 shows that it works like a cellular first responder rushing to injury sites and coordinating tissue repair through a process called actin regulation. But here’s what makes these peptides different from just taking another supplement. They don’t force your body to do anything.They simply remind yourselves how to heal the way they used to. And for women navigating hormonal changes, autoimmune flares, chronic inflammatory conditions, that distinction matters enormously. all right, let’s get into some of these mechanisms because understanding how something works helps you make informed decisions about whether or not it’s right for you. So,Let’s look at the science. Do these peptides actually work? And if so, how do they work? Let’s start with BPC 157. This works through multiple pathways simultaneously. First, it activates growth factor receptors that stimulate fibroblasts. Those are the cells responsible for making collagen and rebuilding connective tissue. And according to research published in Frontiers and Pharmacology in 2023, titled Regeneration or Risk, BPC 157 also modulates nitric oxide signaling, which enhances vascular repair and reduces oxidative stress at the cellular level. So this is really important because many of us are nitric oxide deficient, especially as we get older, especially since the pandemic, we’re seeing a lot of people being more deficient in nitric oxide and you’re taking nitric oxide, many of you, to help with this process. But if we’re having other issues that don’t allow that nitric oxide to get where it needs to go, that could render it completely useless. So in plain English, when we’re talking about how BPC 157 helps the blood vessels work better and protects your mitochondria, big word for your energy factories and your cells from that inflammatory damage. Deb 00:06:38Now there’s studies in musculoskeletal and gastroenterology models that show BPC157 decreases inflammatory cytokines like TNF-alpha and IL-6. And these are chemical messengers that keep inflammation turned on. So by dialing them down, BPC157 creates an environment where healing can actually happen. Now, where do we know about this?TNFL and IL-6, well, we know it from viruses, we know it from Lyme disease, we know it from mold toxicity. These cytokines are turned up, they’re creating a massive inflammatory response in the body, and you’re struggling to get these things down because of that or potentially other reasons. So here’s where it gets really interesting with women in perimenopause or menopause. When estrogen declines, collagen synthesis slows down. And that’s why we see increased joint pain, slower wound healing, and our changes in the skin’s elasticity during this transition. We see the little wrinkles, the fine lines, we see the subcutaneous fat going away a little bit more. This is partially why this is occurring. And so from research shown in the Journal of Orthopedic Research in 2023 by Leibowitz and colleagues, that they suggest that BPC157 affects on the endothelial layers. So the cells lining the blood vessels and these may mimic some of the estrogen’s protective vascular effects without actually affecting your hormone levels. This is really huge because we know that as women lose estrogen, they have a higher risk for vascular events, heart attack, stroke, things like that. And if people have already had a heart attack or a stroke, We typically recommend that they don’t use estrogen because that could potentiate the risk for another heart attack or a stroke. But that means that you don’t gain the benefits of estrogen either. So if we think about this, we could potentially use BPC 157 to give us some of the benefits that we lost from having estrogen and potentially not being able to use estrogen. And that would be huge for us. Deb 00:08:57And not to mention the reduction of inflammation and the joint pain and the wound healing and the energy and the gut feelings. I mean, there’s just so many benefits to BPC 157 that we could talk about them all day long. But we’ve got to move on. So let’s talk about TB 500. Now this peptide works very differently. Its primary job is promoting cell migration, essentially telling repair cells to go to this spot and what to do when they get there. So it sends a signal, puts a little post-it stamp there and says, Hey, when you get there, fix A, B, C, and D. And there was a study in 2024 in cell biology international that demonstrated that TB 500 increases epithelial closure and improves tendon elasticity in models of repetitive strain injury. So let’s think about that a little bit. What does that really mean?That means faster recovery from exercise induced muscle damage, better healing of overuse injuries like tennis elbow or plantar fasciitis, improved scar tissue remodeling after surgery or a C-section, enhanced recovery from chronic inflammatory conditions affecting soft tissues. And I’ve talked about this several times. I have used these compounds post-surgical personally.And I remember going back to see my surgeon at the two to three week mark for follow-up. And she was amazed at how well everything was healing. And when I asked her if she wanted to know what I was doing, her response was no, but keep doing whatever you’re doing because it’s working. And after three weeks of a major pelvic repair surgery that I had, four hours in surgery, lots of sutures, not comfortable. I was actually walking a mile and didn’t have pain and I was recovering really well and felt amazing. And that is just not typically heard of in surgical procedures like mine. It’s usually a minimum of a six to eight week recovery before you’re starting to do that again. And I give all of the credit to these two peptides. Deb 00:11:17In my clinical practice, I see this play out constantly. Women who train hard, whether that’s CrossFit, running, yoga, or just trying to keep up with active kids, often hit a wall where their recovery can’t keep up pace with their activity level. And TB 500 helps to bridge that gap by optimizing the body’s natural repair timeline. But here’s what I want to emphasize with you. These peptides aren’t magic bullets.They work best when we combine them with proper nutrition and anti-inflammatory diet, adequate sleep, stress management, and we address the underlying root cause like the gut dysfunction or those hormonal imbalances. And they work much better when the hormones are balanced versus when they’re not. They’re amplifiers of your body’s existing healing capacity, not replacements for foundational health practices.So let’s have some real talk here. Let’s talk about evidence and what you need to know about that. Let’s take a drink, sorry. Now let’s address the elephant in the room. Regulatory status and safety. Neither BPC 157 or TB 500 are FDA approved for human medical use. They fall into a category called research compounds. And that means they’re legal to possess and use but they’re not approved as pharmaceutical drugs. And hopefully they will be back on our list of things to use relatively soon with the changes that Bobby Kennedy has made to peptides recently. So why does this matter? Because quality becomes a concern. Quality control is absolutely critical. You need to know where these compounds are manufactured, their source, their testing. their clarity, everything about them. There was a 2025 review in therapeutic peptides in orthopedics that concluded both peptides demonstrate strong regenerative signaling with minimal systemic side effects in preclinical studies. But, and this is really important, most of the robust data we have comes from animal models and cell culture models, not large scale human clinical trials. Deb 00:13:41Now that doesn’t mean that they don’t work. It just means that we are still in the early stages of understanding optimal dosing, treatment duration, and long-term effects in humans. So why do we have all of this great peptide information and we don’t quite have the ability to use them yet, or it’s extremely restricted?That comes under the guise of the FDA. came through the past administration with Biden where he removed a bunch of these peptides from the market. Both BPC and TB 500 were on the list of safe peptides to use before Biden made his changes. And it looks like they may be coming back relatively quickly for us here. So what we do have is growing clinical feedback from practitioners like myself. Who use these peptides in practice under careful supervision and under pilot studies on musculoskeletal recovery published in our organizations that we work with. So all of our information is documented and it is done under an observational study. There are other studies published in orthopedic and biomedical research from 2025.that actually found VPC-157 reduced pain scores by 35 % and improved functional mobility within eight weeks. This is really phenomenal because many people over the age of 40 are reaching for the Tylenol bottle, the Advil bottle, the Aleve bottle, which does a number on your kidneys and your gut and your liver. And it is really problematic to be using these things on a regular basis.And if we can use a compound that’s safe, that preserves the kidneys, the liver and the gut, why don’t we do that is the question that I have. Now, we see a lot of the same information in our clinic that we see in these studies. And it is the following things that we see. Significant reduction in joint pain and stiffness. I have a person that was looking at doing a knee replacement and we did 10 weeks of these two compounds. Deb 00:16:00And her knee pain reduced so much that she decided she didn’t feel like she needed that knee replacement right away, which is good because she is only 60 years old. And the length of that knee replacement wouldn’t be as long as it would if she could wait five or 10 years. The doctor didn’t say she needed to do it right away. She wasn’t that critical, but it was the pain that was driving her to the replacement. And so if we could preserve that and give her a reduction in pain, all the better to do that. We get faster recovery from surgical procedures, improved gut symptoms, especially in cases of leaky gut or inflammatory bowel conditions, better skin quality and wound healing, enhanced overall sense of resilience and recovery capacity. But here’s what you absolutely must know before considering peptide therapy. First, source matters. Because these aren’t FDA regulated pharmaceuticals, quality varies widely and you need to work with a physician who sources from compounding pharmacies 503A or 503B that provide certificates of analysis, third party testing and proper sterility verification. Secondly, context matters. Peptides work best as part of a comprehensive functional medicine approach. So if you’re still eating inflammatory foods, drinking alcohol, not managing your stress or your sleep, you have unaddressed gut dysfunction, and these peptides alone won’t fix those problems. Thirdly, realistic expectations matter. These aren’t overnight miracle cures. Most patients see gradual improvements over four to 12 weeks. Some respond dramatically, others see modest benefits. Individual variation is real. And fourth, medical supervision matters. Dosing, injection technique,monitoring for side effects and knowing when peptides are or are not appropriate. All of this requires clinical expertise. Now let me bust a few myths here because I hear this constantly. Myth number one, peptides are just for bodybuilders and athletes. That is false. While athletes use them for performance recovery, the therapeutic applications for chronic pain, gut healing and age related tissue decline are profound. Deb 00:18:26For everyday people. Myth number two, peptides will mess with my hormones. False. BPC-157 and TB-500 don’t interact with your endocrine system the way hormones do. They work through growth factors and cell signaling pathways. They are very different. Myth number three, if they’re not FDA approved, they must be dangerous. Not accurate.Many effective therapies exist in regulatory gray zones. What matters is quality sourcing, proper medical oversight, and informed consent. So the bottom line here is that these peptides show real promise backed by mechanistic science and growing clinical expertise, but they require responsible use, quality products, and realistic expectations. Now let’s talk about practical integration.Who should consider peptides? Well, so who actually benefits from the peptides? Let’s start there. Let me walk you through the three main categories I see. Number one is gut restoration. If you’re dealing with chronic gut inflammation, whether that’s IBS, inflammatory bowel disease, leaky gut, persistent digestive issues that haven’t responded to dietary changes alone, BPC 157 can be transformative.I had a patient recently, I’ll call her Sarah. She’s been struggling with severe gut pain and food sensitivities for three years. She tried elimination diets, probiotics, gut healing supplements, everything. And within six weeks of adding BPC 157 to her protocol, alongside the targeted nutritional therapy, her pain dropped by 70 % and she could tolerate foods that she hadn’t tolerated in years. Why does this happen? because BPC 157 directly supports mucosal integrity, the protective lining of your intestinal tract, and it reduces inflammatory cytokines and promotes healing of damaged tissue. Number two, muscle and joint recovery. This is where I see TB 500 shine. Women who are active, whether you’re a runner, a yogi, a cross-bitter, or someone who just wants to keep moving without pain. Deb 00:20:48They often hit a point where recovery becomes a very limiting factor. And maybe you’re dealing with chronic tendonitis, a nagging shoulder injury, a bad back that just will not quit, or just general achiness. It all makes you feel older and keeps you from being active the way you want to. TB 500 combined with therapies like red light therapy, PEMF, or targeted physical therapy, can dramatically accelerate soft tissue healing. I’ve seen recovery timelines cut in half for patients dealing with overuse injuries. Number three, menopausal transition support. This is where the intersection of peptides in women’s health gets really exciting. During perimenopause and menopause, declining estrogen affects collagen production, vascular health, and joint integrity, along with inflammatory processes and responses.Many women notice they just don’t heal as quickly and their joints hurt much more. Besides noticing their skin changes and their injuries linger longer. Low dose peptide protocols, often combining BPC157 for vascular and gut support with TB500 for soft tissue repair, can complement bioidentical hormone therapy or stand alone for women who can’t or don’t want to use hormones.Now I’m not saying that peptides replace your hormone optimization, but they can be powerful adjuncts that support tissue resilience during a time when your body’s natural repair mechanisms are shifting. Now, who should not use peptides? If you have any active cancer or a history of certain cancers, peptides that promote cell growth and angiogenesis might not be appropriate. If you’re pregnant or breastfeeding, we don’t have safety data.If you have severe kidney or liver disease, clearance and metabolism could be affected. You want to work with a practitioner who really understands this and be under medical supervision for these kinds of conditions. This really matters. A qualified functional medicine practitioner can assess your individual situation, run appropriate labs and determine whether peptides fit into your overall healing strategy. Remember, peptides are tools. They’re not magic. Deb 00:23:11They work best when you’re also addressing nutrition, sleep, stress, movement, and underlying root causes. They amplify your body’s healing capacity. They don’t replace the fundamentals. This is really important to understand. So thank you for joining me today on Let’s Talk Wellness Now. If this episode resonated with you, share it with another woman who’s ready to reclaim her body’s natural healing capacity. Remember, Wellness isn’t just about feeling good. It’s about thriving in every area of your life. Your body was designed to heal. You’re not a small version of a male. You are a woman with different biochemistry. And sometimes it just needs the right signals and the right support to remember how. If you’re ready to explore personalized regenerative medicine or peptide therapy as part of a comprehensive functional medicine approach,You can visit us at serenityhealthcarecenter.com. You can also follow us on Instagram, and you can look at my book, Seen at Last, and join the Seen at Last free community on Facebook, where we will provide all of this information and more for you. Until next time, I’m Dr. Deb, reminding you to take care of your body, mind, and spirit. Be well, and I’ll see you in the next episode.The post Episode 269 – Peptide Therapy for Women: How BPC-157 & TB-500 Heal Gut, Joints & Inflammation first appeared on Let's Talk Wellness Now.

In this presentation, Cade Archibald discusses the rapid growth of peptides and the increasing confusion surrounding their sourcing, regulation, and quality. He explains the distinction between regulated compounding pharmacies (such as 503A and 503B) and the rise of “research use only” (RUO) peptides, which are often marketed online without clear oversight or verification. Cade highlights concerns around inconsistent labeling, uncertain origins, and potential quality issues in the unregulated market, while emphasizing the importance of working with licensed professionals and verified pharmacies. He also outlines recent FDA categorization changes, ongoing reviews of certain peptides, and the broader regulatory environment shaping access and availability. Overall, the talk encourages listeners to be discerning, prioritize transparency and professional guidance, and understand the evolving landscape before making decisions.RESOURCES:Book Comprehensive Labs: https://agelessfuture.com/longevity-labs/FREE copy of The Peptide Blueprint: https://agelessfuture.com/blueprintSign up for future Health Accelerator Challenges calls LIVE! https://us02web.zoom.us/webinar/register/WN_YZsiUMOzSyqcE8IinC5YEQ#/registrationBooks: https://www.amazon.com/Books-Regan-Archibald/s?rh=n%3A283155%2Cp_27%3ARegan%2BArchibaldArticles: https://medium.com/search?q=Regan+ArchibaldLIKE/FOLLOW/SUBSCRIBE:YouTube -https://www.youtube.com/@ReganArchibald / https://www.youtube.com/@Ageless.FutureLinkedIn: https://www.linkedin.com/in/regan-archibald-ab70b813Instagram: https://www.instagram.com/ageless.future/Facebook: https://www.facebook.com/AgelessFutureHealth/DISCLAIMER: This video is for educational purposes only and does not provide medical advice, diagnosis, or treatment.  Many of the molecules discussed in this video are research compounds and are not approved by the U.S. Food and Drug Administration (FDA) for any specific medical use, indication, or condition. They are mentioned only in the context of existing scientific literature and ongoing research and are not being recommended, prescribed, sold, or offered through this video.  This content does not endorse or recommend any specific tests, products, procedures, or treatment protocols.References to our clinic are for general educational context only; investigational or non‑approved products are not available for direct ordering or prescribing based solely on viewing this content.  Do not start, stop, or change any medication, peptide, or supplement based on this video. All medical decisions must be made with a licensed prescribing clinician after a proper evaluation. No provider–patient relationship is created by viewing this content or contacting our clinic.  Regan Archibald is a Licensed Acupuncturist and longevity coach. He is not a medical doctor. Cade Archibald is COO and Co-Founder of Ageless Future, also not a medical doctor. All medical decisions, lab ordering, and prescribing in our clinic are performed only by our licensed medical team (MD, APRN, PA).  Viewers should follow the guidance of their own licensed clinicians and local health authorities regarding diagnosis and treatment decisions.

May 1, 2026: Your daily rundown of health and wellness news, in under 5 minutes. Today's top stories: Parsley Health goes in-network nationwide covering up to 150M Americans, moving functional and longevity care into reimbursement at scale FDA proposes excluding semaglutide and tirzepatide from bulk compounding lists, limiting 503B pharmacies' ability to produce lower-cost GLP-1 alternatives Garmin reports $1.75B Q1 revenue up 14% with fitness segment hitting $547M up 42%, now accounting for 31% of total revenue as largest division More from Fitt: Fitt Insider breaks down the convergence of fitness, wellness, and healthcare — and what it means for business, culture, and capital. Subscribe to our newsletter → insider.fitt.co/subscribe Work with our recruiting firm → https://talent.fitt.co/ Follow us on Instagram → https://www.instagram.com/fittinsider/ Follow us on LinkedIn → linkedin.com/company/fittinsider Reach out → insider@fitt.co

In this episode of Derms and Conditions, host James Q. Del Rosso, DO is joined by Stefan Weiss, MD for a focused discussion on compounding in dermatology, an area that often operates with less visibility but carries important clinical implications. The conversation centers on the regulatory and practical differences between 503A and 503B compounding pharmacies, with particular attention to 503A facilities, where customized medications are prepared based on individual prescriptions. They outline key concerns with this model, including variability in formulation, lack of standardized testing, and limited oversight compared with FDA-approved therapies. Unlike commercially developed medications, compounded products are not required to undergo stability testing, penetration studies, or clinical trials, raising questions about consistency, efficacy, and safety. A recurring theme is the challenge of knowing exactly what patients receive. Without controls on formulation integrity or bioavailability, clinicians may encounter variability not only between pharmacies, but even between batches from the same source, highlighting how this uncertainty can complicate treatment decisions. The episode also contrasts compounded therapies with FDA-approved options, using topical clascoterone as an example of a rigorously tested, standardized formulation. While both speakers acknowledge that compounding has a role, particularly in addressing unmet or niche patient needs, they note that its use today has expanded beyond its original intent. Tune in to the episode to hear how clinicians can approach compounded therapies with greater scrutiny, balance their use against standardized treatments, and make more informed decisions in everyday dermatology practice.

Major disruption hits the GLP-1 landscape as another large 503B compounding pharmacy halts production of semaglutide and tirzepatide. In this episode, we unpack what's driving the FDA's increased enforcement and why these shutdowns could signal a broader shift in the compounded medication market.Joined by Sabina Hemmi from glpwinner.com, we break down the key differences between 503A and 503B pharmacies, what these changes mean for supply and patient access, and why delays in prescriptions may be on the horizon. We also dive into the growing legal battles between pharma companies and telehealth providers and what that could mean for the future of affordable GLP-1 options.If you're using or considering compounded GLP-1s, this episode covers what you need to know right now and what could be coming next.

In this highly educational episode of Beauty Bytes, I sit down with Dr. Jason Pencek, a chiropractor and nurse practitioner who is highly trained in IV therapies and peptide protocols. We are tackling the "Wild West" of the current wellness space. With everyone from Pilates instructors to airline stewardesses suddenly selling peptides on social media, we break down exactly why you cannot afford to crowdsource your medical advice. We take a deep dive into the massive safety risks of buying "research grade" peptides online to save a few bucks, explaining how dangerous endotoxins and poor manufacturing can land you in the hospital. Jason outlines exactly what you need to look for in a legitimate 503A or 503B compounding pharmacy, including FDA registration and GMP certification. We also explore the nuances of hormone optimization. Jason explains why he prefers using Growth Hormone Secretagogues (like Tesamorelin and CJC-1295) to wake up your body's dormant cells, rather than shutting down your natural production with straight human growth hormone. Plus, we cover the most effective ways to administer NAD+ without sitting through a four-hour IV drip, and why checking your methylation and homocysteine levels first is an absolute must.

Pharmacy buyers play a critical role in keeping hospitals running—and their partnership with a GPO can make all the difference. In this episode of Verified Rx, Jackie Stokes sits down with Theresa Brown and Michelle Crump, two powerhouse pharmacy buyers and members of Vizient's Pharmacy Technician Committee, to talk about the tools, programs, and peer networks that help them thrive in their roles. From leveraging pharmacy analytics to navigating shortages, maximizing NovaPlus value, and strengthening buyer-to-buyer collaboration, this episode is packed with insights to help pharmacy teams work smarter, save money, and support better patient care.   Guest speakers:  Theresa Brown National Pharmacy Purchasing Specialist Prospect Medical Holdings   Michelle Crump, ASBA, CPhT National Certified Pharmacy Technician Buyer Pharmacy Host: Jackie Stokes Program Services Manager Center for Pharmacy Practice Excellence (CPPE) Vizient   Show Notes: [00:48] — Guest Introductions Theresa National pharmacy purchasing specialist Background: inventory control, home infusion startup, pharmacy technician educator [01:14] — Michelle Nationally certified pharmacy technician since 2016 Pharmacy buyer at a small independent county critical access hospital Transitioned from accounting into pharmacy purchasing   [01:26] — The Role of Vizient in Supporting Pharmacy Buyers Theresa: Biggest benefit: relationship with pharmacy executive & sourcing team Uses Pharmacy Analytics (formerly VSAP) to evaluate spend and inventory control across 63 facilities   [02:16] — How Pharmacy Analytics Supports Buyers Theresa: Data mining on spend increases/decreases Tracks product returns Identifies sharing opportunities to prevent waste [02:59] — Michelle's Experience Analytics helps mitigate waste Collaboration with other buyers has been essential — especially for someone new to the buyer role Learns navigation of Vizient systems and how to work with the local GPO Peer support helps demystify a “diverse and complex” buyer role   [04:02] — Value of the Vizient Pharmacy Technician Committee Provides national peer networking Helps buyers learn from subject matter experts Even highly experienced buyers (35+ years) learn from every call   [04:41] — Vizient Programs: NovaPlus, NES, Forum Calls, Hot Info Bimonthly Forum Calls Provide regulatory updates Help expand buyer knowledge in real time Hot Info Weekly Updates Keeps users informed on inventory, shortages, spend impacts [05:31] — Michelle on Program Impact Calls and shared expertise were critical when she was new NovaPlus program especially valuable in critical access settings   [06:32] — Deep Dive: How the NovaPlus Program Works Michelle explains: NovaPlus (Y-label) aligns with manufacturer-labeled products (M-label) Quarterly rebates provide significant savings Critical access hospitals benefit via 340B optimizer software that extracts outpatient utilization to qualify for discounted M-label purchasing Can result in “significant savings” depending on contract structure   [08:38] — What If NovaPlus Pricing Isn't the Best Price? Michelle: Buyer's responsibility to identify price discrepancies Communicates with Vizient representative to reassess contracting needs Often resolved through rebates or future price adjustments [09:30] — Theresa: Price challenges taken seriously Many result in price reductions visible in Hot Info the next week Demonstrates importance of strong GPO relationships   [10:07] — Understanding NES: NovaPlus Enhanced Supply Theresa: Her hospitals are exploring NES participation Requires 90% compliance (higher than standard 80%) Benefits include prioritized product access during shortages Critical when national backorders exceed 200+ items Ensures better patient care continuity   [11:34] — Supply Assurance & Mitigation Strategies Michelle: During the North Carolina hurricane, Vizient's mitigation strategy was “imperative” Vizient engaged Baxter directly to resolve critical fluid shortages Small hospitals especially reliant on support in crisis situations [12:36] — Theresa: Shortage team provides substitution guidance and clinical appropriateness information Vizient recommendations support discussions with local clinical teams Crucial during COVID start date — her first day in national role   [13:23] — Continuing Education (CE) Programs Theresa: Vizient CE programs help maintain technician licensure Webinars are interactive, engaging, and more informative than generic CE resources   [14:07] — Networking and Pharmacy Aggregation Groups (PAGs) Theresa: PAGs offer cost savings and peer collaboration Ability to share information and bring value back to her own network [14:44] — Michelle's Example of System-to-System Collaboration Shared compounded syringes (from a 503B facility) with another hospital to prevent waste Highlights real-world benefits of PAG networking   [15:52] — Addressing National Challenges Together Theresa: PAG roundtables help uncover shared struggles (e.g., DSCSA serialization issues) Members provide actionable advice on what's working in their systems Reinforces “we're all in the same boat”   [16:50] — Supporting and Elevating Pharmacy Technicians Jackie's goal: Support technicians and recognize the value they bring Committee exists to uplift and empower pharmacy buyers/techs [17:05] — Michelle: Worked with leadership to create a tiered technician level system Helps techs gain skills, feel valued, and earn raises Improves career satisfaction and retention   [17:46] — Closing Reflections Theresa: Being part of Vizient is “an honor and a privilege” Values shared knowledge and strong relationships [18:00] — Michelle: Gratitude for collaboration and guidance over the years Vizient connections were vital for adapting to the buyer role   VerifiedRx Listener Feedback Survey: We would love to hear from you - Please click here   Subscribe Today! 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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.

Kurt Lunkwitz, Chief Operating Officer at ProRx Pharma which is the leading health and wellness 503B outsourcing facility joins Enterprise Fit Radio. Listen to … Read more The post How 503B Compounders Power Personalized Wellness appeared first on Top Entrepreneurs Podcast | Enterprise Podcast Network.

Send us a textSchedule an Rx AssessmentSubscribe to Master The MarginWhat does it really take to start and sustain a successful compounding pharmacy in 2026? In this episode, Scotty Sykes, CPA, CFP®, and Austin Murray sit down with Amy Summers, PharmD, BCSCP and of Restore Health Consulting, to discuss how pharmacy owners can move from idea to implementation when entering the compounding space.We cover:Designing a purpose-built facility for USP standards and your product mixThe mindset shift from dispensing to creating and how to balance quality with patient careMarket analysis, relationships, and niche focus in building a sustainable businessKey trends driving growth, consolidation, and private investment in the compounding industryMore About Our Guest:Amy Summers, PharmD, BCSCP is an independent consultant, specializing in business, operations, quality assurance, and regulatory compliance matters for the pharmaceutical compounding industry. She earned her PharmD degree from the University of California San Francisco and was among the first pharmacists in the nation to earn a Board Certified Sterile Compounding Pharmacist (BCSCP) credential. Dr. Summers has spent her entire career as a pharmacist in various settings centered around non-sterile and sterile compounding. She has formerly served as Director of Operations and Pharmacist in Charge at organizations engaged in compounding and also as Managing Director of a FDA-registered 503B outsourcing facility. With extensive experience in USP standards, accreditation, cGMP, and regulatory compliance, Dr. Summers has also served as an expert witness for matters related to compounding.Stay connected with Amy and Restore Health Consulting: Amy Summers LinkedInRestore Health Consulting WebsiteRestore Health Consulting LinkedInStay connected with us on social media:Facebook: https://www.facebook.com/sykesandcoTwitter: https://twitter.com/OllinSykesLinkedIn: https://www.linkedin.com/company/sykes-&-company-p-a-?trk=tyahScotty Sykes – CPA, CFP® LinkedIn: https://www.linkedin.com/in/scottysykes/More on this topic:Podcast: The Trusted Pharmacist: Advocacy and Building a Resilient PharmacyPodcast: From Counter to Capitol

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

“When you bring care back to patients and providers, everyone heals faster.” —Shaun NoorianIn this episode of the Real Health Podcast, Dr. Ron Hunninghake is joined by Shaun Noorian, CEO and founder of Empower Pharmacy, for a conversation about how innovation and integrity are transforming the future of medicine.Shaun shares how a personal health journey led him to reimagine what pharmacy could be — one built around compassion, access, and individualized care. He and Dr. Ron explore how integrative medicine and personalized compounding can support patient well-being and advance the field of preventive pharmacology.Part of the Cancer Care Reimagined Speaker Series, leading up to Riordan Clinic's 25th International Conference on Human Functioning: Cancer Care Reimagined, held in early November.Highlights include:→ How Shaun Noorian's own healing journey inspired Empower Pharmacy→ Why individualized compounding plays a vital role in patient care→ The evolving role of pharmacy in integrative and functional medicine→ How collaboration between providers and pharmacists improves patient care→ What the future of personalized and preventive medicine looks likeAbout Shaun NoorianShaun Noorian is the CEO and founder of Empower Pharmacy, the largest compounding pharmacy and 503B outsourcing facility in the United States. With a background in engineering and a mission to make high-quality, affordable, and personalized medications accessible to all, Shaun has built Empower into a national leader serving millions of patients.Empower Pharmacy operates with a simple but powerful belief: behind every order is a person in need. This philosophy drives their commitment to compassion, innovation, and excellence in every aspect of care.SponsorThis series is made possible by Empower Pharmacy, Platinum Sponsor of the Cancer Care Reimagined Conference. Empower is a national leader in compounding and 503B outsourcing, serving providers and patients in all 50 states with safe, affordable, personalized medications. Guided by the belief that behind every order is a person in need, they bring compassion and innovation to everything they do. Learn more at empowerpharmacy.com.Episode Links & ResourcesWatch this episode on YouTubeGain Access to the Cancer Care Reimagined ConferenceLearn more about Empower PharmacyExplore the Riordan ClinicListen to more episodes of the Real Health PodcastEpisode Chapters00:00 Welcome + Speaker Series intro01:24 Meet Shaun Noorian, founder of Empower Pharmacy02:28 From patient to pharmacist to pioneer05:05 The power of personalized medicine07:40 Integrative therapies in oncology and chronic illness10:50 Vitamin C and nutrient therapy in cancer care13:40 Why individualized treatment improves outcomes16:25 The role of compounding in preventive pharmacology19:10 Partnering with providers for better patient results21:00 How Empower Pharmacy supports integrative medicine23:30 Looking ahead: innovation, prevention, and collaborationTopics we explore in this episode include:compounding pharmacy, integrative medicine, functional medicine, individualized care, preventive pharmacology, IV nutrition therapy, vitamin C research, cancer care innovation, metabolic health, patient empowerment, provider partnerships, and the evolution of personalized medicineDisclaimerThe information contained on the Real Health Podcast and the resources mentioned are for educational purposes only. They are not intended as and shall not be understood or construed as medical or health advice. The information contained on this podcast is not a substitute for medical or health advice from a professional who is aware of the facts and circumstances of your individual situation. Information provided by hosts and guests on the Real Health Podcast or the use of any products or services mentioned does not create a practitioner-patient relationship between you and any persons affiliated with this podcast.

“When you understand the why behind illness, that's when healing truly begins.” —Dr. Michelle NiesleyIn this episode of the Real Health Podcast, Dr. Ron Hunninghake is joined by Dr. Michelle Niesley—Chief Executive Officer of Riordan Clinic, clinical research, and naturopathic doctor specializing in integrative oncology—to explore how science, compassion, and curiosity come together in modern medicine.Dr. Niesley shares her path from research to leadership, the Clinic's 50-year legacy of innovation, and the importance of bridging conventional and integrative care. From terrain-based medicine to whole-brain thinking, this conversation highlights the next chapter of healing at Riordan Clinic.

“True healing happens when medicine honors both evidence and intuition — when we use science to guide us, and humanity to connect us.” —Dr. Lise AlschulerIn this episode of the Real Health Podcast, Dr. Ron Hunninghake sits down with Dr. Lise Alschuler, a leading naturopathic oncologist, educator, and author who has spent more than three decades advancing integrative approaches to cancer care. Together, they explore how the next generation of oncology is being redefined through the union of measurable science and the wisdom of the human body.Dr. Alschuler shares how her philosophy of medicine has evolved — from recognizing the innate healing intelligence within each person to embracing technology and data as powerful, but incomplete, tools. She discusses the importance of terrain-based care, personalized nutrition, and the role of natural agents like medicinal mushrooms in complementing conventional therapies. She invites us to preserve compassion, connection, and curiosity as medicine grows more data-driven and digitally advanced.

“There's no wrong medicine — only the wrong time to apply it. The best care happens when every discipline works together for the good of the patient.” —Dr. Paul AndersonIn this episode of the Real Health Podcast, Dr. Ron Hunninghake sits down with Dr. Paul S. Anderson, a leading educator and clinician in integrative and naturopathic medicine. They explore the evolution of integrative oncology — from its early roots in orthomolecular medicine to today's terrain-based, science-driven approaches that unite conventional and natural therapies.Dr. Anderson shares insights from decades of clinical experience and research, including his work in a US-NIH-funded human trial studying IV and integrative therapies for cancer patients. He discusses how medicine is shifting toward a model that treats the whole person — addressing biochemistry, immunity, environment, and lifestyle — to improve outcomes and quality of life.

"Cancer is not a single-cause disease. It's a web of factors — metabolic, mitochondrial, emotional — and each patient needs a personalized path to healing." —Dr. Pradeep NairIn this episode of the Real Health Podcast, Dr. Ron Hunninghake speaks with Dr. Manickam Mahalingam, founder of the Mirakle Integrative Health Center in Coimbatore, India, and Dr. Pradeep MK Nair, Chief Medical Officer and Head of Research at Mirakle. They share how their center has pioneered an integrative model of cancer care that blends vitamin C therapy, metabolic medicine, low-dose chemotherapy, antiparasitic protocols, and advanced technologies like oncothermia. Their patient-centered approach has offered hope and healing for people with advanced cancers from around the world.This conversation is part of the Cancer Care Reimagined Speaker Series, leading up to Riordan Clinic's Cancer Care Reimagined Conference and 50th Anniversary Gala this November.Highlights include:→ How Mirakle Integrative Health Center was founded and why it's making a global impact→ Why cancer requires personalized, terrain-based approaches rather than one-size-fits-all care→ The role of vitamin C, mitochondrial health, and metabolic therapies in treatment→ How hope, confidence, and environment influence outcomes as much as technologyMeet the GuestsManickam Mahalingam, PhD, is the founder of the Mirakle Integrative Health Center in Coimbatore, India, and the innovator of the Mirakle liposomal vitamin C drink. His vision is to shift the course of cancer treatment through integrative, patient-centered approaches.Pradeep MK Nair, MD, is the Chief Medical Officer and Head of Research at Mirakle. There, he develops personalized, multidisciplinary protocols that combine modern oncology, naturopathy, Siddha, and other systems of medicine. His work focuses on metabolic and mitochondrial health, precision medicine, and patient empowerment.SponsorThis series is made possible by Empower, the Platinum Sponsor of Cancer Care Reimagined and Riordan Clinic's 50th Anniversary Gala. As a national leader in compounding pharmacy and 503B outsourcing, Empower serves providers and patients across all 50 states with safe, affordable, and personalized medications. Guided by the belief that behind every order is a person in need, they bring compassion and innovation to everything they do. Learn more at empowerpharmacy.com.Episode Links & ResourcesWatch this episode on YouTubeLearn more about Mirakle Integrative Health CenterRegister for the Cancer Care Reimagined ConferenceLearn more about the GalaLearn more about Empower PharmacyExplore the Riordan ClinicListen to more episodes of the Real Health PodcastEpisode Chapters00:00 Welcome + introduction to the speaker series01:44 Introducing Dr. Manickam Mahalingam and Dr. Pradeep Nair03:21 Founding of Mirakle Integrative Health Center05:01 Why integrative oncology must address multiple terrains06:22 Integrating low-dose chemotherapy with metabolic therapy08:30 Patient outcomes and individualized protocols11:42 Antiparasitic and antifungal approaches in cancer care16:44 Advanced technologies: oncothermia and HIFU18:56 Building hope and positivity into the patient experience20:50 Lifestyle training and family-centered care25:52 Expanding access and global word-of-mouth growth27:00 Looking ahead: spreading integrative models worldwideTopics we explore in this episode include:cancer care reimagined, integrative oncology, Manickam Mahalingam, Pradeep Nair, Mirakle Integrative Health Center, vitamin C therapy, liposomal vitamin C, metabolic medicine, mitochondrial dysfunction, oncothermia, HIFU, ozone therapy, antiparasitic therapy, cancer remission, terrain-based medicine, India cancer care, holistic oncologyDisclaimerThe information contained on the Real Health Podcast and the resources mentioned are for educational purposes only. They are not intended as and shall not be understood or construed as medical or health advice. The information contained on this podcast is not a substitute for medical or health advice from a professional who is aware of the facts and circumstances of your individual situation. Information provided by hosts and guests on the Real Health Podcast or the use of any products or services mentioned does not create a practitioner-patient relationship between you and any persons affiliated with this podcast.

“Toxins are everywhere — in our food, water, and air. They damage our mitochondria, disrupt metabolism, and open the door to disease.” —Dr. Richard ChengIn this episode of the Real Health Podcast, Ron Hunninghake, MD, sits down with Richard Cheng, MD, PhD, ABAARM — physician, researcher, and editor of Orthomolecular Medicine News Service — to explore how environmental toxins and mitochondrial dysfunction are driving today's rise in chronic illness and cancer.Dr. Cheng shares how decades of research have revealed the link between toxins, aging, and cancer and why supporting mitochondrial health and reducing environmental exposure may be one of the most effective preventive strategies in modern medicine.

"The disease is the oxidation. Oxidative stress isn't what leads to disease — it is the disease." —Dr. Thomas LevyIn this episode of the Real Health Podcast, Ron Hunninghake, MD, sits down with Thomas Levy, MD, JD, cardiologist, attorney, and internationally known author, to explore his provocative thesis: that all disease stems from a single root cause — excess oxidation inside the cell. Drawing from decades of clinical experience and research, Dr. Levy explains how toxins, infections, and heavy metals deplete antioxidants like vitamin C and drive inflammation, and why restoring redox balance is key to healing.

"If we can reset the memory of the stem cell back to zero, we can help the body create healthy cells instead of cancer cells." —Dr. Ilyes BaghliIn this episode of the Real Health Podcast, Ron Hunninghake, MD, speaks with Ilyes Baghli, MD, President of the International Society for Orthomolecular Medicine, about his groundbreaking hybrid orthomolecular protocol. From Algeria to Japan, Dr. Baghli has championed integrative and nutritional approaches that target mitochondria, stem cells, and even parasitic pathways to reimagine how cancer can be treated.

“I had a daughter who faced cancer three times. After she died, there was nothing to do but to get on with it, and we've been at it ever since.” —Robin DalyIn this episode of the Real Health Podcast, Dr. Ron Hunninghake speaks with Robin Daly, founder and Executive Chair of Yes to Life, the UK's integrative cancer charity. Born from Robin's personal journey through his daughter's illness, Yes to Life has grown into a pioneering organization offering education, resources, and community support for cancer patients navigating integrative options.This conversation is part of the Cancer Care Reimagined Speaker Series, leading up to Riordan Clinic's Cancer Care Reimagined Conference and 50th Anniversary Gala this November.Highlights include:→ How Robin transformed personal tragedy into a patient-focused movement→ The unique challenges and opportunities of integrative oncology in the UK→ Why community, connection, and group support are as vital as medical care→ How new ideas—including metabolic and fungal theories of cancer—are expanding the future of treatmentMeet Robin DalyRobin Daly is the founder and Executive Chair of Yes to Life, a UK-based charity dedicated to empowering people with cancer to take an active role in their treatment through integrative approaches. Since 2004, Yes to Life has provided education, financial assistance, and community programs, becoming a leading voice for patient advocacy and integrative oncology in the UK and beyond.This series is made possible by Empower, the Platinum Sponsor of Cancer Care Reimagined and Riordan Clinic's 50th Anniversary Gala. As a national leader in compounding pharmacy and 503B outsourcing, Empower serves providers and patients across all 50 states with safe, affordable, and personalized medications. Guided by the belief that behind every order is a person in need, they bring compassion and innovation to everything they do. Learn more at empowerpharmacy.com.Episode Links & ResourcesExplore Yes to Life, the UK's integrative cancer charityWatch the episode on YouTubeRegister for the Cancer Care Reimagined ConferenceLearn more about Riordan Clinic's 50th Anniversary GalaSchedule your Check Your Health lab testing (Sept 15–26)Learn more about Empower PharmacyExplore the Riordan ClinicListen to more episodes of the Real Health PodcastEpisode Chapters00:00 Welcome + introduction to the speaker series01:44 Introducing Robin Daly and Yes to Life02:59 The personal story behind Yes to Life04:49 Closing the gaps in patient support08:18 Helpline, mentoring, and group programs13:54 Integrative cancer care in the UK vs US17:00 Public awareness of lifestyle and cancer risk20:15 Exploring the fungal link to cancer and Mark Lintern's work27:34 The importance of thinking outside the box30:44 Finding purpose in loss and building a legacyTopics we explore in this episode include:cancer care reimagined, integrative oncology, Yes to Life charity, Robin Daly, cancer patient advocacy, lifestyle and cancer risk, group cancer support, functional medicine cancer treatment, holistic oncology, metabolic theory of cancer, fungal link to cancer, terrain-based medicine, UK healthcare and cancer, cancer prevention strategies, patient empowerment in oncologyDisclaimerThe information contained on the Real Health Podcast and the resources mentioned are for educational purposes only. They are not intended as and shall not be understood or construed as medical or health advice. The information contained on this podcast is not a substitute for medical or health advice from a professional who is aware of the facts and circumstances of your individual situation. Information provided by hosts and guests on the Real Health Podcast or the use of any products or services mentioned does not create a practitioner-patient relationship between you and any persons affiliated with this podcast.

“I could do everything right and still die, or do everything wrong and still live. Ultimately, my life was in God's hands.” —Ivelisse PageWhat does it look like to face a stage IV cancer diagnosis, lean into faith, and turn survival into service for thousands of others?In this conversation, Dr. Ron Hunninghake is joined by Ivelisse Page, Executive Director and Co-Founder of Believe Big, to share her extraordinary journey of healing and hope. From mistletoe therapy and integrative care to the spiritual and emotional terrains of health, Ivelisse reveals how her diagnosis became the catalyst for a movement to reimagine cancer care.Highlights include:→ How Ivelisse's personal cancer story led to the creation of Believe Big→ Why integrative therapies like mistletoe can improve survival and quality of life→ The critical role of mindset, faith, and emotional healing in recovery→ A vision for the Believe Big Institute of Health and the future of integrative oncologyMeet Ivelisse PageIvelisse Page is the Executive Director and Co-Founder of Believe Big, a nonprofit dedicated to helping patients face, fight, and overcome cancer. A stage IV colon cancer survivor, Ivelisse has become a leading voice in patient advocacy, integrative oncology education, and mistletoe research. Through her work with Johns Hopkins University and the Believe Big community, she is helping thousands navigate cancer with strength, faith, and innovative care.This series is made possible by Empower, the Platinum Sponsor of Cancer Care Reimagined and Riordan Clinic's 50th Anniversary Gala. As a national leader in compounding pharmacy and 503B outsourcing, Empower serves providers and patients across all 50 states with safe, affordable, and personalized medications. Guided by the belief that behind every order is a person in need, they bring compassion and innovation to everything they do. Learn more at empowerpharmacy.com.Discover Believe Big's mission and resourcesLearn about the mistletoe clinical trials with Johns HopkinsEpisode Links & ResourcesRegister for the Cancer Care Reimagined ConferenceLearn more about Riordan Clinic's 50th Anniversary GalaSchedule your Check Your Health lab testing (Sept 15–26)Learn more about Empower PharmacyExplore the Riordan ClinicListen to more episodes of the Real Health PodcastConnect with the Real Health Podcast and Riordan Clinic✉️ Join our newsletter

"I personally do not perceive cancer as an enemy…when we wage war on it, we wage war on ourselves." —Dr. Nasha WintersWhat if cancer isn't the enemy but a profound messenger about the state of our inner and outer terrain? In this conversation, Dr. Ron Hunninghake is joined by Dr. Nasha Winters—a naturopathic oncologist, author, and Kansas native—to explore a radical shift in understanding, treating, and living with cancer.Highlights include:→ Why seeing cancer as a wound or messenger changes the path of healing→ The tangible and intangible factors that drive long-term remission→ How metabolic oncology and integrative care open new possibilities for treatmentDr. Nasha Winters shares her own survival story, her pioneering work in metabolic oncology, and how she's training clinicians, advocates, and patients worldwide to approach cancer differently.Meet Nasha Winters, ND, FABNONasha Winters, ND, FABNO, is a naturopathic oncologist, global educator, and author of “The Metabolic Approach to Cancer” and “Mistletoe and the Emerging Future of Integrative Oncology.” She is the CEO of Dr. Nasha, Inc. and Co-Founder of Terrain Holding Company, leading efforts to advance metabolic oncology research, practitioner training, and innovative cancer care models. Dr. Winters also hosts the “Metabolic Matters Podcast” and continues to shape the future of integrative oncology through education, research, and patient advocacy.This series is made possible by Empower, the Platinum Sponsor of Cancer Care Reimagined and Riordan Clinic's 50th Anniversary Gala. As a national leader in compounding pharmacy and 503B outsourcing, Empower serves providers and patients across all 50 states with safe, affordable, and personalized medications. Guided by the belief that behind every order is a person in need, they bring compassion and innovation to everything they do. Learn more at https://empowerpharmacy.com.Episode Links & ResourcesRegister for the Cancer Care Reimagined ConferenceLearn more about Riordan Clinic's 50th Anniversary GalaSchedule your Check Your Health lab testing (Sept 15–26)Learn more about Empower PharmacyExplore the Riordan ClinicListen to more episodes of the Real Health PodcastEpisode Chapters00:00 Welcome + introduction to the speaker series01:44 Introducing Dr. Nasha Winters03:05 Rethinking cancer as a messenger, not an enemy06:27 Tangible vs intangible factors in remission10:24 Nasha's early connection to Riordan Clinic16:29 Fasting, ascites, and her survival story19:56 The rise of metabolic oncology22:15 Exploring fungal and microbial drivers of cancer24:00 Trauma, PTSD, and cancer triggers27:49 Training clinicians, advocates, and allied health professionals31:57 The importance of community and connectivity in healing34:21 Shame, childhood trauma, and cancer risk37:47 Bridging art and science in medicine39:45 Looking ahead to the conference and galaConnect with the Real Health Podcast and Riordan ClinicJoin our newsletter

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.

Trump announces an Iran-Israel ceasefire, which sees him nominated for a Nobel Peace Prize, this year's NATO Summit begins at The Hague, Canada signs a security and defense pact with the EU, Germany's cabinet approves a record €503B budget, the U.S. Supreme Court allows third-country deportations to resume, Australia considers including YouTube in its under-16s social media ban, over 20% of Europeans are found to be exposed to harmful noise levels, the U.S. Senate parliamentarian blocks some provisions of the GOP's megabill, and Kirsty Coventry becomes the first female and African International Olympic Committee president. Sources: www.verity.news

Nick Capman talks with Jesse Gillikan, President of cGMP Validation, about the challenges compounding pharmacies face with GMP compliance in 2025. After helping over 100 pharmacies navigate FDA regulations since the 2013 Drug Quality and Security Act, Jesse shares candid insights about this industry transformation.The conversation reveals how compounders have moved from resistance to acceptance of GMP requirements, though major hurdles persist. For 503B facilities, the primary challenge isn't knowledge but cost, particularly testing expenses that might be manageable for pharmaceutical giants making millions of units but become prohibitive for compounders producing just thousands.Jesse highlights practical space constraints, with many facilities not designed for GMP manufacturing. He recommends dedicating one-third of facility space to clean operations and another third to compliant warehousing, which targets many smaller operations that struggle to achieve.Jesse also sheds light on validation has shifted from qualifying individual technicians to validating entire processes, requiring completely new approaches to media fills and documentation. Despite these challenges, Jesse notes the industry's impressive information sharing and collaborative spirit.When discussing FDA inspections, Jesse emphasizes the importance of thorough deviation management — a common citation area. He also addresses the FDA shortage list volatility, sharing how clients invested in automated filling lines for GLP-1 products only to have those drugs removed from the list, creating significant business disruption.Jesse maintains that while compliance is non-negotiable, the FDA genuinely wants compounders to succeed. His practical advice focuses on risk-based prioritization, industry collaboration, and maintaining open communication with regulators._____The FDA Group connects compounding pharmacies with specialized consultants who understand the unique challenges of 503B compliance. Our experts provide practical solutions that balance regulatory requirements with business viability – from GMP implementation and environmental monitoring to documentation systems and FDA inspection support. Visit https://www.thefdagroup.com/ for more information.

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.

In this episode, I'm joined by Shaun Noorian—engineer, entrepreneur, and CEO of Empower Pharmacy, the largest compounding pharmacy in the world. With compounded GLP-1s making headlines and lawsuits from Big Pharma intensifying, Shaun joins me to pull back the curtain on the regulatory, financial, and ethical storm brewing behind the scenes.Are compounded GLP-1s legal? Safe? Who controls drug pricing in the U.S., and why are Americans paying 10x more than Europeans for the same medication? And most importantly—what does all this mean for access, affordability, and patient care?This episode is a wake-up call. If you care about transparency in medicine, patient rights, or access to life-saving medications, don't miss this one.We cover:Why compounded GLP-1s are under attack—and what the FDA's recent moves really meansHow Big Pharma sets drug prices—and why Americans pay up to 10x more than other countriesThe legal battle over semaglutide, regulatory capture, and the influence of pharmaceutical lobbyingHow compounding pharmacies offer personalized care and expand access to life-saving medicationsWhat's next for patients, clinicians, and the future of affordable medicine in the U.S.Who is Shaun Noorian?Shaun Noorian is the founder and CEO of Empower Pharmacy, the largest compounding pharmacy and 503B outsourcing facility in the United States. A fierce advocate for patient access and affordable care, Shaun has become a leading voice on the role of compounding in medicine and the urgent need for reform in pharmaceutical pricing and regulation.Forever Strong Summit 2025: Can't make it to Houston on April 27th? Grab a Virtual “LIVE Access” Ticket and stream every keynote, panel, and breakthrough moment from the Forever Strong Summit 2025—live from your laptop, wherever you are. You'll get front-row access to leaders like Dr. Don Layman, Rich Diviney, and Evy Poumpouras—plus priority access to all the recordings so you can revisit the insights anytime.Get your ticket now! https://drgabriellelyon.com/forever-strong-summit-2025/ This episode is brought to you by:Puori – Code DRLYON for 20% off sitewide! → puori.com/DRLYONOur Place - Code DRLYON for 10% off – https://fromourplace.comBON CHARGE – Code DRLYON for 15% off! → boncharge.com/DRLYONMUDWTR - Code DRLYON for up to 43% off – http://mudwtr.com/DRLYONFind Shaun Noorian at:LinkedIn - https://www.linkedin.com/in/shaun-noorian X(Twitter) - http://x.com/shaunnoorianEmpower Pharmacy - https://www.empowerpharmacy.com/Find me at:Instagram: @drgabriellelyonTikTok: @drgabriellelyonFacebook: facebook.com/doctorgabriellelyonYouTube:youtube.com/@DrGabrielleLyonX (Twitter): x.com/drgabriellelyonApply to become a...

Send us a textCheck out the full episode on our Master The Margin SubStackLooking to take your pharmacy to the next level? Schedule an Rx AssessmentThinking of expanding into functional medicine, telemedicine, or cash-based care models? We've got all of that and more in this episode!  In this episode of the Bottom Line Pharmacy Podcast, we're giving you the most impactful takeaways from our recent appearance at the inaugural AtriumX show in Orlando Florida!   Scotty Sykes, CPA, CFP dives into: The rise of telemedicine Latest developments in 503B compounding The growing relevance of functional medicine and cash-based models And of course, the accounting and tax implications of these innovative areas  Tune in to this episode packed with actionable insights to help you adapt and thrive in a rapidly changing landscape. Stay up to date on new episodes by liking and subscribing! Click here for the transcriptStay connected with us:  FacebookTwitter (X)LinkedIn Instagram Scotty Sykes – CPA, CFP LinkedIn Scotty Sykes – CPA, CFP Twitter More resources about this topic:  Podcast – Infrastructure, Strategic Marketing, and Relationships Podcast – Driving Independent Pharmacy Profitability in 2025 Podcast – Functional Medicine and Weight Loss Programs  

**Today, I'm breaking down everything you NEED to know about 503B pharmacies and FDA 483 reports—and trust me, this is critical info for protecting your business and your patients.** **Show Notes:** 1. **Understanding 503B and 503A Pharmacies** [0:00] 2. **FDA Inspections and 483 Letters** [4:16] 3. **Vetting 503B Pharmacies** [11:17] 4. **Risks and Recommendations** [13:14] 5. **Conclusion and Resources** [13:28] **Links mentioned in this episode:** ProRx  FDA Letter - it's atrocious...  (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-696742-12202024)   Medivant  FDA Letter 2022 - awful and very similar to ProRx (https://www.fda.gov/media/163521/download?fbclid=IwY2xjawIIochleHRuA2FlbQIxMAABHdvrPVsxdboN8lfH4PBOdnLrAgeVDUkPnlIGO1-FMlxLsglqYbPuUIn77w_aem_lf6-woZuSn-XuHsSAwU18w)  FDA Letter 2024 483 - they obviously haven't learned to improve (https://www.fda.gov/media/184179/download)  Websites Mentioned: https://diversifyrx.com/503b-playbook-for-pharmacy-owners/ https://diversifyrx.com/weekly-awesomeness-newsletter/ https://www.drlisafaast.com/ ----- #### **Becoming a Badass Pharmacy Owner Podcast is a Proud to be Apart of the Pharmacy Podcast Network**

Decoding GLP-1: A Guide for Friends and Family of Those On The Pen By Dave Knapp

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Sana announces beta cell transplantation without the need for immunosuppresion drugs, Modular Medical teams up with Nudge BG for a brand new completely closed-loop system, the FDA moves forward to crack down on compounded Ozempic and Mounjaro, Dexcom and Abbott bury the legal hatchett for a while, and more.  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 Big news from Sana Biotechnology. Their first in human study of islet cells without any immunosuppression appears to be a success. This is very early and hasn't yet been peer reviewed and published.. but after four weeks, there were no safety issues and the transplanted beta cells were producing insulin. Sana's CEO says  “As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune competent individual. Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases.”   I've reached out to Sana to get more on this.. love to talk to them soon.   https://www.bakersfield.com/ap/news/sana-biotechnology-announces-positive-clinical-results-from-type-1-diabetes-study-of-islet-cell/article_d0390fd6-99cb-53bd-b04d-9337121e01bf.html XX FDA says no for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).  Studies showed a meaningful reduction in A1C but a meaningful increase in DKA. The FDA first rejected this in 2019 and was resubmitted last summer. But The advisory committee voted 11 to 3 against the approval of sotagliflozin stating that the benefits of sotagliflozin do not outweight the risks in adults with T1D and CKD. Sotagliflozin is currently approved under the brand name Inpefa to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with 1) heart failure; or 2) type 2 diabetes mellitus, CKD, and other cardiovascular risk factors.  According to Lexicon, Inpefa will continue to be manufactured and made available to patients. https://www.renalandurologynews.com/news/fda-denies-approval-of-zynquista-for-type-1-diabetes-and-ckd/ XX Two companies we've been following are teaming up.. Modular Medical has an FDA clear patch pump and Nudge BG has an adaptive full closed loop. They've announced a new partnership agreement. From the release: Modular Medical's easy-to-use and cost-effective MODD1 insulin pump technology. Our combined system is intended to nudge blood glucose by making small changes to insulin delivery based on estimated glucose inputs from a continuous glucose monitor." Familiar name to some of you, Lane Desborough is the founder of Nudge BG. He says this will be a fully automated system, no mealtime bolusing needed.   https://www.accesswire.com/957703/modular-medical-announces-licensing-and-partnership-agreement-with-nudge-bg XX Beta Bionics filed for an initial public offering on Monday. The company did not disclose the number of shares it will offer or the price range. Beta Bionics plans for shares to be listed on the Nasdaq under the ticker symbol “BBNX.” The Irvine, California-based company makes an insulin pump called the iLet Bionic Pancreas, which was cleared by the Food and Drug Administration in 2023. Beta Bionics plans to use the proceeds to grow its sales and manufacturing infrastructure and develop new features for its device.   https://www.medtechdive.com/news/beta-bionics-insulin-pump-files-ipo/736805/     XX Tandem Diabetes Care, Inc. signed a multi-year collaboration agreement with the University of Virginia Center for Diabetes Technology (UVA) to advance research and development efforts on fully automated closed-loop insulin delivery systems.   There's a long history here – UVA is where the Control IQ algorithm was developed.  This agreement seems to keep the team together for another decade. https://www.businesswire.com/news/home/20250107162995/en/Tandem-Diabetes-Care-Enters-Multi-Year-Research-Collaboration-with-UVA-Center-for-Diabetes-Technology-for-Development-of-Advanced-Insulin-Delivery-Systems XX New study says insulin is still the best treatment for gestational diabetes, compared to oral glucose-lowering medications. Metformin and gluburide are being closely looked at since they're easier to administer, less costly, and have better acceptance among patients. But this study says insulin was a bit better – slight more babies were born larger for the metformin group, and more moms had hypoglycemia. https://www.medpagetoday.com/obgyn/pregnancy/113651 XX In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza. Novo Nordisk last month filed a Citizen Petition with the FDA asking the federal agency to exclude its type 2 diabetes injection Victoza (liraglutide) from a proposed list of drugs eligible for compounding. https://www.biospace.com/fda/novo-launches-citizen-petition-to-block-compounded-victoza XX Bit of an update on compounded terzepatide and semaglutide. The FDA is allowing a grace period of 60 days before starting to enforce the end of allowing compounds of Mounjaro. Meanwhile, semaglutide remains on the FDA's shortage list for several dose strengths, though all doses have been reported as “available” since late October 2024. Compounding pharmacies, especially larger 503B “outsourcing facilities,” maintain they provide an essential public service by offering lower-cost versions of medications that can cost over $1,000 per month. Many insurers still refuse to cover brand-name GLP-1 products for weight loss. Yet  the FDA has reported hundreds of adverse event reports allegedly linked to compounded versions of these drugs, which do not undergo the same rigorous manufacturing inspections and clinical testing as approved brands.   https://www.drugdiscoverytrends.com/compounders-and-drugmakers-clash-over-compounded-weight-loss-drugs-with-fda-in-the-middle/ XX Interesting story here.. this study says a fecal transplant can help people with type 1 and severe gastroenteropathy. The researchers say diabetic gastroenteropathy commonly affects individuals with type 1 diabetes, causing debilitating symptoms like nausea, vomiting, bloating, and diarrhea; however, treatment options remain limited. Researchers conducted a novel clinical trial to test the benefits of FMT in adult patients with type 1 diabetes and severe symptoms of gastroenteropathy, who were randomly assigned to receive either FMT or placebo capsules as the first intervention. After four weeks, Compared with placebo, FMT led to significant changes in the diversity of the gut microbiome. https://www.medscape.com/viewarticle/fmt-shows-early-success-type-1-diabetes-bowel-issues-2025a10000bg XX A couple of weeks ago, listeners told me that the Dexcom geofencing issue we reported on seems to be resolved. Dexcom is now confirming this. Previously, if you had an issue with Dexcom G7 outside of your home country, you couldn't reinstall or use the app without customer support. As of last month, the geofencing issue has now been resolved with the latest Dexcom G7 2.6 app update. Can I travel with my Dexcom G7? | Dexcom XX Abbott and Dexcom settled all patent lawsuits related to continuous glucose monitors (CGMs). The two competitors, who lead the U.S. market for CGMs, agreed on Dec. 20 to resolve all outstanding patent disputes and not sue each other over patents for 10 years.   Dexcom and Abbott previously reached a settlement in 2014 related to their diabetes devices, which included a cross-licensing deal and an agreement not to sue each other until 2021. After that agreement expired, the companies filed a volley of patent lawsuits. https://www.medtechdive.com/news/abbott-dexcom-settle-cgm-patent-lawsuits/736300/  

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!

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 ★

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

SHR # 3024:: FDA/DEA Power Grab Over Peptides - Anthony Roberts - 503A and 503B of the FDA act called into question bulk drugs nominated for compounding as possibly having safety risks back in 2020. While many new peptides have been added to the list, technically none of the original list were truly “legal” for compounding pharmacies to be selling. But they continued to make and sell many of these peptides. The FDA is now exerting their power in this ruling and claiming everything these pharmacies sold and are selling is illegal. Anyone who has paid attention saw this coming. - CARL RECOMMENDS: superhumanradio.net/carl-recommends - - View and download all shows at https://superhumanradio.net - Visit us on Instagram: @superhumanradio - Support SHR - https://superhumanradio.net/make-a-donation

Amar Festic is in charge of Business Development and sales for Loccioni USA, an innovation company focused on high end robotics for hospital pharmacies. He is one of the nation's experts in robotics applied to IV compounding and has spent 10+ years implementing complex robotics projects and integrated platforms, working with some of the leading institutions in the United States (Mayo Clinic, Cleveland Clinic, Johns Hopkins, Ohio State, Froedtert Health and others) as well as Europe and Asia. Areas of interested and work cover oncology as well as non- hazardous compounding, both in hospitals and 503B settings.

Learn how the University of Maryland Medical Center reversed its reliance on 503B vendors through an IV robotics insourcing program for compounded sterile products (CSPs). The result is a strategic services operation delivering advanced CSP services across its organization, resulting in improved safety, increased efficiencies, and significant cost savings Learn more about your ad choices. Visit megaphone.fm/adchoices

Learn how the University of Maryland Medical Center reversed its reliance on 503B vendors through an IV robotics insourcing program for compounded sterile products (CSPs). The result is a strategic services operation delivering advanced CSP services across its organization, resulting in improved safety, increased efficiencies, and significant cost savings Learn more about your ad choices. Visit megaphone.fm/adchoices

On this episode of Leadership Lessons in Health-System Pharmacy you will hear from Kenneth Jozefczyk, MS, RPh, FASHP, Director of Centralized Pharmacy Services for the 15-hospital BayCare Health System in the Tampa Bay region of Florida. Join us as we discuss extemporaneously compounded pharmaceuticals and a 503B facility experience in a pharmacy enterprise. Prior to joining BayCare, Ken was Director of Pharmacy at both Memorial Health University Medical Center in Savannah, Georgia and at West Virginia University Hospitals, and Assistant Director at the Medical University of South Carolina. He received his B.S. in Pharmacy from Wayne State University and is a proud graduate of the MS/Residency program at The Ohio State University and The Ohio State University Hospitals. He has been recognized with multiple honors including the Jack L. Beal Postbaccalaureate Award, the GSHP Pharmacist of the Year and most notably the 2012 Clifton J. Latiolais Award.