<![CDATA[Compounding Interest]]>561311ff-6a0a-5fbe-ad22-8aff63623a27Tue, 29 Sep 2026 09:00:30 +0000Captivate.fmAmy Summershttps://artwork.captivate.fm/6fa5a89b-465c-454b-bd03-966cf3b7d6b7/Restore-Health-Consulting-Cover-Art-Option-1.jpgCompounding InterestAmy SummersAmy SummersWelcome to Compounding Interest: The Business of Personalized Medicine, the podcast exploring what it takes to build, scale, and safeguard high-performing operations in the rapidly evolving world of personalized medicine. Hosted by Amy Summers, PharmD, BCSCP, FAPC - a nationally recognized authority in pharmacy compounding and 503B outsourcing operations - and backed by the expert team at Restore Health Consulting, this show features insightful conversations with healthcare innovators, compliance executives, and life science operators who are rethinking what it means to deliver specialized care in a highly scrutinized landscape. Each episode examines the rigorous regulatory frameworks, quality systems design, and strategic leadership approaches that help organizations elevate their operations far beyond basic compliance. Through real-world insights and field-tested strategies, guests share how they navigate complex guidelines, optimize 503A and 503B facilities, and transform strict quality controls into an organizational strength. Drawing from a deep portfolio of enterprise-level operational transformations and proven industry playbooks, the show explores how an unwavering dedication to clinical and operational excellence can become a powerful differentiator when organizations intentionally design businesses built to scale. https://compounding-interest.captivate.fmfalseserialnopodcastCan a 160-Year-Old Pharmacy Shape the Future of Personalized Medicine? with Rosemary MihalkoCan a 160-Year-Old Pharmacy Shape the Future of Personalized Medicine? with Rosemary MihalkoWhat happens when one of Pittsburgh’s oldest pharmacies combines more than 160 years of history with modern personalized medicine? In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Rosemary Mihalko, owner of Hieber’s Pharmacy. Rosemary shares how she has preserved the pharmacy’s historic roots while transforming it into a modern compounding operation offering sterile, non-sterile, hazardous, and non-hazardous preparations.

Rosemary Mihalko is the owner of Hieber’s Pharmacy, Pittsburgh’s oldest pharmacy. She has owned the business for more than seven years and is both its first female owner and its first owner with a Doctor of Pharmacy degree. From bringing back the traditional pharmacy soda fountain to creating customized medications for people and pets, Rosemary explains why the future of independent pharmacy can sometimes look surprisingly similar to its past.

Expect to Learn

  • How Rosemary took stewardship of a pharmacy with more than 160 years of history and balanced preserving its legacy with modernizing the business.
  • Why Hieber’s brought back the traditional pharmacy soda fountain and the surprising connection between pharmacists, chemistry, and the origins of popular soft drinks.
  • How personalized compounding can adapt dosage forms, flavors, strengths, and delivery methods around the needs of individual patients and even pets.
  • What goes into operating sterile and non-sterile compounding labs, including the infrastructure, procedures, transparency, and patient education involved.
  • How Rosemary hopes Hieber’s can remain more than a place to pick up medication by becoming a lasting community gathering place for Pittsburgh.

Timestamps

[00:00] - Episode Teaser

[01:32] - Meet Rosemary Mihalko and Hieber’s Pharmacy

[04:25] - Bringing a Historic Pharmacy Back Home

[06:37] - Making the Old New Again

[08:34] - Why Pharmacists and Soda Fountains Belong Together

[13:55] - Jonas Salk, Polio and Hieber’s Oral History

[16:57] - Meet Gummy and the Modern Pharmacy Soda Fountain

[23:32] - Inside Hieber’s Compounding Capabilities

[24:39] - Personalizing Medicine Around the Patient

[28:36] - LDN, Ménière’s Disease and Specialized Preparations

[32:45] - Sterile Eye Drops, Safety and the Future of Hieber’s

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"Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

]]>What happens when one of Pittsburgh’s oldest pharmacies combines more than 160 years of history with modern personalized medicine? In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Rosemary Mihalko, owner of Hieber’s Pharmacy. Rosemary shares how she has preserved the pharmacy’s historic roots while transforming it into a modern compounding operation offering sterile, non-sterile, hazardous, and non-hazardous preparations.

Rosemary Mihalko is the owner of Hieber’s Pharmacy, Pittsburgh’s oldest pharmacy. She has owned the business for more than seven years and is both its first female owner and its first owner with a Doctor of Pharmacy degree. From bringing back the traditional pharmacy soda fountain to creating customized medications for people and pets, Rosemary explains why the future of independent pharmacy can sometimes look surprisingly similar to its past.

Expect to Learn

  • How Rosemary took stewardship of a pharmacy with more than 160 years of history and balanced preserving its legacy with modernizing the business.
  • Why Hieber’s brought back the traditional pharmacy soda fountain and the surprising connection between pharmacists, chemistry, and the origins of popular soft drinks.
  • How personalized compounding can adapt dosage forms, flavors, strengths, and delivery methods around the needs of individual patients and even pets.
  • What goes into operating sterile and non-sterile compounding labs, including the infrastructure, procedures, transparency, and patient education involved.
  • How Rosemary hopes Hieber’s can remain more than a place to pick up medication by becoming a lasting community gathering place for Pittsburgh.

Timestamps

[00:00] - Episode Teaser

[01:32] - Meet Rosemary Mihalko and Hieber’s Pharmacy

[04:25] - Bringing a Historic Pharmacy Back Home

[06:37] - Making the Old New Again

[08:34] - Why Pharmacists and Soda Fountains Belong Together

[13:55] - Jonas Salk, Polio and Hieber’s Oral History

[16:57] - Meet Gummy and the Modern Pharmacy Soda Fountain

[23:32] - Inside Hieber’s Compounding Capabilities

[24:39] - Personalizing Medicine Around the Patient

[28:36] - LDN, Ménière’s Disease and Specialized Preparations

[32:45] - Sterile Eye Drops, Safety and the Future of Hieber’s

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"Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

]]>0dfca571-984a-47ed-8822-820824749db1Tue, 29 Sep 2026 14:00:00 +050037:41falsefull77Can Modern Pharmacy Keep Up with Telehealth and Personalized Medicine? with Christian StellaCan Modern Pharmacy Keep Up with Telehealth and Personalized Medicine? with Christian StellaIn this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with fourth-generation pharmacist Christian Stella to explore how compounding has evolved from the neighborhood pharmacies of the early 1900s into a technology-enabled industry serving telehealth companies and patients at scale. Christian draws parallels between the pharmaceutical industrialization his great-grandfather experienced and today's convergence of telehealth, personalized medicine, GLP-1 therapies, changing regulations, and new fulfillment models.

Christian Stella is a PharmD, fourth-generation pharmacist, and CEO of Precision Medicine. Pharmacy has been part of Christian's life from the beginning. He grew up around his family's pharmacies, progressing from stocking shelves and making neighborhood deliveries to attending pharmacy school and eventually building a compounding operation of his own. Today, his focus includes scalable pharmacy infrastructure, technology integrations, quality and compliance, personalized formulations, innovative dosage forms, and long-term partnerships with telehealth companies.

Expect to Learn

  • How compounding pharmacy is evolving alongside telehealth, personalized medicine, and changing patient expectations.
  • What telehealth companies need from pharmacy partners to deliver medications efficiently at scale.
  • Why quality and compliance must remain central as a compounding pharmacy grows.
  • How long-term risk shaped Precision Medicine’s decision to step away from GLP-1 compounding.
  • Why saying no to certain revenue opportunities can create room for innovation and sustainable growth.

Timestamps

[00:00] - Episode Teaser

[01:10] - Four Generations of Pharmacy

[02:33] - Why Compounding Pharmacy Is Changing Again

[05:38] - Growing Up in the Family Pharmacy

[07:39] - Building the “Garage Band” of Compounding Pharmacy

[10:31] - Building Pharmacy Infrastructure for Telehealth

[17:42] - Scaling Without Sacrificing Quality or Compliance

[19:21] - Evaluating Telehealth Partners Like Investments

[21:40] - Walking Away From the GLP-1 Opportunity

[26:30] - Diversification and Dosage-Form Innovation

[38:21] - Quality, Necessary Endings, and Preparing for California

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"Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

]]>In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with fourth-generation pharmacist Christian Stella to explore how compounding has evolved from the neighborhood pharmacies of the early 1900s into a technology-enabled industry serving telehealth companies and patients at scale. Christian draws parallels between the pharmaceutical industrialization his great-grandfather experienced and today's convergence of telehealth, personalized medicine, GLP-1 therapies, changing regulations, and new fulfillment models.

Christian Stella is a PharmD, fourth-generation pharmacist, and CEO of Precision Medicine. Pharmacy has been part of Christian's life from the beginning. He grew up around his family's pharmacies, progressing from stocking shelves and making neighborhood deliveries to attending pharmacy school and eventually building a compounding operation of his own. Today, his focus includes scalable pharmacy infrastructure, technology integrations, quality and compliance, personalized formulations, innovative dosage forms, and long-term partnerships with telehealth companies.

Expect to Learn

  • How compounding pharmacy is evolving alongside telehealth, personalized medicine, and changing patient expectations.
  • What telehealth companies need from pharmacy partners to deliver medications efficiently at scale.
  • Why quality and compliance must remain central as a compounding pharmacy grows.
  • How long-term risk shaped Precision Medicine’s decision to step away from GLP-1 compounding.
  • Why saying no to certain revenue opportunities can create room for innovation and sustainable growth.

Timestamps

[00:00] - Episode Teaser

[01:10] - Four Generations of Pharmacy

[02:33] - Why Compounding Pharmacy Is Changing Again

[05:38] - Growing Up in the Family Pharmacy

[07:39] - Building the “Garage Band” of Compounding Pharmacy

[10:31] - Building Pharmacy Infrastructure for Telehealth

[17:42] - Scaling Without Sacrificing Quality or Compliance

[19:21] - Evaluating Telehealth Partners Like Investments

[21:40] - Walking Away From the GLP-1 Opportunity

[26:30] - Diversification and Dosage-Form Innovation

[38:21] - Quality, Necessary Endings, and Preparing for California

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"Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

]]>d7c8f7cf-f896-4d27-8618-afec04a20364Tue, 22 Sep 2026 14:00:00 +050047:11falsefull66How a Pharmacy Technician Became a Director of Compounding with Ashley BartonHow a Pharmacy Technician Became a Director of Compounding with Ashley BartonWhat does a career in compounding pharmacy look like when you start as a technician and refuse to see that title as a ceiling? In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Ashley Barton to explore the evolving role of pharmacy technicians in compounding. Ashley shares how she progressed from working as a technician during college to directing compounding operations across multiple locations, and the lessons that helped her move into leadership.

Ashley Barton is the Director of Compounding Operations for Peoples Pharmacy in Austin, Texas. She began her pharmacy career as a technician while attending the University of Texas and ultimately recognized that the opportunities available to her in pharmacy extended far beyond the compounding lab. The conversation goes beyond career advancement to tackle some of the biggest operational challenges facing compounding pharmacies today: technician recruitment and retention, building productive teams, improving non-sterile compounding throughput without sacrificing quality, and using smarter workflows and technology to scale. From sharing firsthand patient experiences to speaking with legislators, she makes the case that technicians have an important voice in shaping the future of pharmacy.

Key Takeaways

  • How technicians can build a leadership career in compounding pharmacy by identifying problems, proposing solutions, and actively pursuing new responsibilities.
  • Why technician recruitment and retention have become challenging and how externships, colleges, and healthcare training programs can create a stronger talent pipeline.
  • How to improve non-sterile compounding productivity without compromising quality, including batching, lab layout, dosage-form sequencing, and better planning.
  • Where automation could transform compounding pharmacy, from prescriber portals and AI-assisted prescription entry to automated capsule machines and 3D-printed dosage forms.
  • Why technicians should have a voice in pharmacy advocacy and how their firsthand experiences with patients, reimbursement, and access can help inform policy.

Timestamps

[00:00] - Episode Teaser

[01:25] - From Pharmacy Technician to Compounding Leader

[03:54] - Problem-Solving as a Path to Leadership

[07:04] - Breaking Through the Technician Career Ceiling

[10:37] - Solving Technician Recruitment and Retention Challenges

[13:26] - What Makes a Great Non-Sterile Compounder?

[15:20] - Balancing Productivity, Profitability, and Quality

[17:23] - Improving Compounding Throughput and Workflow

[22:49] - Quality Safeguards When Increasing Production

[25:14] - Scaling Compounding Through Automation and AI

[27:15] - Advocacy, Patient Access, and the Technician's Voice

[31:34] - Closing Thoughts

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"Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

]]>What does a career in compounding pharmacy look like when you start as a technician and refuse to see that title as a ceiling? In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Ashley Barton to explore the evolving role of pharmacy technicians in compounding. Ashley shares how she progressed from working as a technician during college to directing compounding operations across multiple locations, and the lessons that helped her move into leadership.

Ashley Barton is the Director of Compounding Operations for Peoples Pharmacy in Austin, Texas. She began her pharmacy career as a technician while attending the University of Texas and ultimately recognized that the opportunities available to her in pharmacy extended far beyond the compounding lab. The conversation goes beyond career advancement to tackle some of the biggest operational challenges facing compounding pharmacies today: technician recruitment and retention, building productive teams, improving non-sterile compounding throughput without sacrificing quality, and using smarter workflows and technology to scale. From sharing firsthand patient experiences to speaking with legislators, she makes the case that technicians have an important voice in shaping the future of pharmacy.

Key Takeaways

  • How technicians can build a leadership career in compounding pharmacy by identifying problems, proposing solutions, and actively pursuing new responsibilities.
  • Why technician recruitment and retention have become challenging and how externships, colleges, and healthcare training programs can create a stronger talent pipeline.
  • How to improve non-sterile compounding productivity without compromising quality, including batching, lab layout, dosage-form sequencing, and better planning.
  • Where automation could transform compounding pharmacy, from prescriber portals and AI-assisted prescription entry to automated capsule machines and 3D-printed dosage forms.
  • Why technicians should have a voice in pharmacy advocacy and how their firsthand experiences with patients, reimbursement, and access can help inform policy.

Timestamps

[00:00] - Episode Teaser

[01:25] - From Pharmacy Technician to Compounding Leader

[03:54] - Problem-Solving as a Path to Leadership

[07:04] - Breaking Through the Technician Career Ceiling

[10:37] - Solving Technician Recruitment and Retention Challenges

[13:26] - What Makes a Great Non-Sterile Compounder?

[15:20] - Balancing Productivity, Profitability, and Quality

[17:23] - Improving Compounding Throughput and Workflow

[22:49] - Quality Safeguards When Increasing Production

[25:14] - Scaling Compounding Through Automation and AI

[27:15] - Advocacy, Patient Access, and the Technician's Voice

[31:34] - Closing Thoughts

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"Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

]]>baccfa6b-c828-49d9-8cf0-48927669cd8dTue, 08 Sep 2026 14:00:00 +050033:00falsefull55Personalized Medicine Cannot Scale Without Automation for Pharmacies with Adam P. CrandallPersonalized Medicine Cannot Scale Without Automation for Pharmacies with Adam P. CrandallAs personalized medicine continues to expand; from GLP-1 therapies and peptides to hormone replacement therapy, the demand placed on compounding pharmacies has never been greater. While personalized care has traditionally relied on manual sterile compounding, increasing regulatory expectations, workforce shortages, and production demands are driving a major shift toward automation. In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Adam P. Crandall to discuss how automation is transforming sterile compounding, why both 503A and 503B facilities are beginning to adopt automated filling technologies, and what pharmacy owners should consider when evaluating automation solutions.

Adam P. Crandall is the Chief Revenue Officer at Addtronics, where he leads sales, marketing, and business development across multiple healthcare technology companies. One of those companies, Körber Pharma (formerly Cozzoli/Körber compounding solutions discussed in the episode), develops automated fill-finish equipment for pharmaceutical manufacturers and compounding pharmacies. Adam works closely with 503A and 503B facilities to help implement automation technologies that improve efficiency, product quality, regulatory compliance, and patient safety.

Key Takeaways

  • Why automation is rapidly becoming essential for both 503A and 503B compounding pharmacies.
  • How automation helps reduce contamination risk while improving consistency and quality.
  • The differences between semi-automated tabletop systems and larger pharmaceutical filling lines.
  • How pharmacies can evaluate the ROI of automation beyond simple labor savings.
  • What pharmacy owners should consider before investing in automated filling equipment.

Timestamps

[00:00] – Episode Preview

[02:59] – Why Compounding Pharmacies Are Embracing Automation

[05:06] – Labor Challenges & The Need for Automation

[10:47] – Solving Real Pharmacy Bottlenecks

[13:48] – Choosing the Right Level of Automation

[21:49] – ROI Beyond Labor Savings

[26:45] – Regulations, Compliance & Preparing for Future Growth

[32:19] – Facility Planning & Cleanroom Requirements

[44:46] – Measuring Return on Investment

[48:20] – The Future of Personalized Medicine

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"Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

]]>As personalized medicine continues to expand; from GLP-1 therapies and peptides to hormone replacement therapy, the demand placed on compounding pharmacies has never been greater. While personalized care has traditionally relied on manual sterile compounding, increasing regulatory expectations, workforce shortages, and production demands are driving a major shift toward automation. In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Adam P. Crandall to discuss how automation is transforming sterile compounding, why both 503A and 503B facilities are beginning to adopt automated filling technologies, and what pharmacy owners should consider when evaluating automation solutions.

Adam P. Crandall is the Chief Revenue Officer at Addtronics, where he leads sales, marketing, and business development across multiple healthcare technology companies. One of those companies, Körber Pharma (formerly Cozzoli/Körber compounding solutions discussed in the episode), develops automated fill-finish equipment for pharmaceutical manufacturers and compounding pharmacies. Adam works closely with 503A and 503B facilities to help implement automation technologies that improve efficiency, product quality, regulatory compliance, and patient safety.

Key Takeaways

  • Why automation is rapidly becoming essential for both 503A and 503B compounding pharmacies.
  • How automation helps reduce contamination risk while improving consistency and quality.
  • The differences between semi-automated tabletop systems and larger pharmaceutical filling lines.
  • How pharmacies can evaluate the ROI of automation beyond simple labor savings.
  • What pharmacy owners should consider before investing in automated filling equipment.

Timestamps

[00:00] – Episode Preview

[02:59] – Why Compounding Pharmacies Are Embracing Automation

[05:06] – Labor Challenges & The Need for Automation

[10:47] – Solving Real Pharmacy Bottlenecks

[13:48] – Choosing the Right Level of Automation

[21:49] – ROI Beyond Labor Savings

[26:45] – Regulations, Compliance & Preparing for Future Growth

[32:19] – Facility Planning & Cleanroom Requirements

[44:46] – Measuring Return on Investment

[48:20] – The Future of Personalized Medicine

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"Disclosure: Portions of this episode (such as the introduction or promotional segments) use AI-generated voice narration produced under human editorial review."

]]>4d5bcd0e-1142-4877-bf7d-445db61458eaFri, 07 Aug 2026 14:00:00 +050052:30falsefull44The Future of Personalized Medicine for Patients to Improve Healthcare Access with Jesse VidrineThe Future of Personalized Medicine for Patients to Improve Healthcare Access with Jesse VidrineCompounding pharmacies have rapidly moved from a niche corner of healthcare into the national spotlight, driven largely by the demand for GLP-1 medications and growing interest in personalized medicine. In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Jesse Vidrine, President of Boudreaux's New Drugstore and Vidrine Pharmaceutical Group, to discuss how compounding is evolving, the regulatory landscape, the future of hormones, peptides, telehealth, AI, and what it will take to make personalized medicine more accessible for patients.

Jesse Vidrine is the President of Vidrine Pharmaceutical Group, the parent company of Boudreaux's New Drugstore, a nationally licensed 503A compounding pharmacy based in South Louisiana. With decades of experience in hormone replacement therapy and personalized medicine, Jesse is focused on expanding patient access to customized therapies while advancing quality, compliance, automation, and innovation within the compounding pharmacy industry.

Key Takeaways

  • Why compounding pharmacies have become significantly more visible over the past few years.
  • What the GLP-1 movement revealed about drug pricing, access, and the broader healthcare system.
  • How hormones, peptides, telehealth, and testing are shaping the future of personalized medicine.
  • The regulatory challenges facing compounding pharmacies and why compliance is becoming more important than ever.
  • How AI, automation, and technology can improve patient care while maintaining clinical quality.

Timestamps

[00:00] – Episode Preview

[01:35] – Meet Jesse Vidrine

[02:35] – How Compounding Went Mainstream

[05:48] – What GLP-1s Revealed About Healthcare

[13:09] – The Future of Personalized Medicine

[17:46] – Hormones, Individualized Care & Clinical Need

[20:01] – Customization vs. Commercial Medicine

[27:16] – Peptides, Regulation & Industry Responsibility

[33:30] – Telehealth, AI & Pharmacy Innovation

[39:27] – Testing, Long-Term Vision & Closing Thoughts

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]]>Compounding pharmacies have rapidly moved from a niche corner of healthcare into the national spotlight, driven largely by the demand for GLP-1 medications and growing interest in personalized medicine. In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Jesse Vidrine, President of Boudreaux's New Drugstore and Vidrine Pharmaceutical Group, to discuss how compounding is evolving, the regulatory landscape, the future of hormones, peptides, telehealth, AI, and what it will take to make personalized medicine more accessible for patients.

Jesse Vidrine is the President of Vidrine Pharmaceutical Group, the parent company of Boudreaux's New Drugstore, a nationally licensed 503A compounding pharmacy based in South Louisiana. With decades of experience in hormone replacement therapy and personalized medicine, Jesse is focused on expanding patient access to customized therapies while advancing quality, compliance, automation, and innovation within the compounding pharmacy industry.

Key Takeaways

  • Why compounding pharmacies have become significantly more visible over the past few years.
  • What the GLP-1 movement revealed about drug pricing, access, and the broader healthcare system.
  • How hormones, peptides, telehealth, and testing are shaping the future of personalized medicine.
  • The regulatory challenges facing compounding pharmacies and why compliance is becoming more important than ever.
  • How AI, automation, and technology can improve patient care while maintaining clinical quality.

Timestamps

[00:00] – Episode Preview

[01:35] – Meet Jesse Vidrine

[02:35] – How Compounding Went Mainstream

[05:48] – What GLP-1s Revealed About Healthcare

[13:09] – The Future of Personalized Medicine

[17:46] – Hormones, Individualized Care & Clinical Need

[20:01] – Customization vs. Commercial Medicine

[27:16] – Peptides, Regulation & Industry Responsibility

[33:30] – Telehealth, AI & Pharmacy Innovation

[39:27] – Testing, Long-Term Vision & Closing Thoughts

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]]>e526174d-557d-4519-a7cf-8d956e7334f6Fri, 31 Jul 2026 14:00:00 +050044:06falsefull33What Compounding Pharmacies Cannot Say About Safety & Effectiveness in Medicine – Darshan KulkarniWhat Compounding Pharmacies Cannot Say About Safety & Effectiveness in Medicine – Darshan KulkarniThe personalized medicine and compounding pharmacy industry is evolving rapidly as patient demand, regulatory scrutiny, and technological innovation continue to collide. In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Darshan Kulkarni to explore the legal and ethical challenges facing compounding pharmacies today. From FDA advertising rules and promotional claims to USP 797, 503A vs. 503B pharmacies, peptides, and the future of personalized medicine, this conversation examines where innovation meets regulation and where the industry's biggest gray areas remain.

Darshan Kulkarni, PharmD, MS, Esq., is a pharmacist, attorney, educator, author, and founder of Kulkarni Law Firm, where he advises FDA-regulated industries on complex regulatory and compliance matters for the Life Sciences. His expertise spans pharmacy compounding, medical devices, advertising compliance, clinical research, and FDA law. His multidisciplinary background provides a unique perspective on balancing patient access, innovation, and regulatory responsibility.

Key Takeaways

  • Why patient safety, efficacy, affordability, and access must all be balanced in personalized medicine.
  • The legal boundaries surrounding advertising and promotional claims for compounding pharmacies.
  • How FDA regulations, USP 797, and 503A/503B distinctions impact pharmacy operations.
  • The regulatory challenges surrounding peptides, compounded medications, and personalized therapies.
  • Practical guidance for pharmacies navigating compliance while continuing to serve patients effectively.

Timestamps

[00:00:00] - Introduction to Darshan Kulkarni and Personalized Medicine: Amy introduces Darshan and discusses how his pharmacy and legal background shapes his perspective.

[00:05:15] - The Purpose and Evolution of Pharmacy Compounding: A discussion on FDA oversight, drug shortages, the NECC tragedy, and the growth of modern compounding.

[00:09:53] - Common Compliance Mistakes in FDA-Regulated Industries: Darshan explains the regulatory issues he sees most often across healthcare companies.

[00:14:09] - Marketing Rules for Compounding Pharmacies: Which advertising claims pharmacies should avoid and how they can market responsibly.

[00:21:59] - Why Disclaimers Cannot Replace Regulatory Compliance: Understanding the limits of disclaimers in pharmaceutical advertising.

[00:26:01] - Peptides and the Ongoing Regulatory Debate: A discussion on safety, efficacy, patient access, and the legal concerns surrounding peptide products.

[00:31:13] - Buying a Compounding Pharmacy: Darshan shares advice on finding acquisition opportunities through networking, brokers, and industry relationships.

[00:32:55] - Closing Thoughts and Final Takeaways: Amy wraps up the conversation by reflecting on the importance of thoughtful debate in personalized medicine.

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]]>The personalized medicine and compounding pharmacy industry is evolving rapidly as patient demand, regulatory scrutiny, and technological innovation continue to collide. In this episode of Compounding Interest: The Business of Personalized Medicine, host Amy Summers sits down with Darshan Kulkarni to explore the legal and ethical challenges facing compounding pharmacies today. From FDA advertising rules and promotional claims to USP 797, 503A vs. 503B pharmacies, peptides, and the future of personalized medicine, this conversation examines where innovation meets regulation and where the industry's biggest gray areas remain.

Darshan Kulkarni, PharmD, MS, Esq., is a pharmacist, attorney, educator, author, and founder of Kulkarni Law Firm, where he advises FDA-regulated industries on complex regulatory and compliance matters for the Life Sciences. His expertise spans pharmacy compounding, medical devices, advertising compliance, clinical research, and FDA law. His multidisciplinary background provides a unique perspective on balancing patient access, innovation, and regulatory responsibility.

Key Takeaways

  • Why patient safety, efficacy, affordability, and access must all be balanced in personalized medicine.
  • The legal boundaries surrounding advertising and promotional claims for compounding pharmacies.
  • How FDA regulations, USP 797, and 503A/503B distinctions impact pharmacy operations.
  • The regulatory challenges surrounding peptides, compounded medications, and personalized therapies.
  • Practical guidance for pharmacies navigating compliance while continuing to serve patients effectively.

Timestamps

[00:00:00] - Introduction to Darshan Kulkarni and Personalized Medicine: Amy introduces Darshan and discusses how his pharmacy and legal background shapes his perspective.

[00:05:15] - The Purpose and Evolution of Pharmacy Compounding: A discussion on FDA oversight, drug shortages, the NECC tragedy, and the growth of modern compounding.

[00:09:53] - Common Compliance Mistakes in FDA-Regulated Industries: Darshan explains the regulatory issues he sees most often across healthcare companies.

[00:14:09] - Marketing Rules for Compounding Pharmacies: Which advertising claims pharmacies should avoid and how they can market responsibly.

[00:21:59] - Why Disclaimers Cannot Replace Regulatory Compliance: Understanding the limits of disclaimers in pharmaceutical advertising.

[00:26:01] - Peptides and the Ongoing Regulatory Debate: A discussion on safety, efficacy, patient access, and the legal concerns surrounding peptide products.

[00:31:13] - Buying a Compounding Pharmacy: Darshan shares advice on finding acquisition opportunities through networking, brokers, and industry relationships.

[00:32:55] - Closing Thoughts and Final Takeaways: Amy wraps up the conversation by reflecting on the importance of thoughtful debate in personalized medicine.

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]]>f7a7e375-70fa-4950-bb8e-b7879863f025Tue, 21 Jul 2026 14:00:00 +050033:15falsefull22The Peptide Therapy Crisis for Patients Losing Access to Life-Changing Treatments with Melissa StefkoThe Peptide Therapy Crisis for Patients Losing Access to Life-Changing Treatments with Melissa StefkoThe future of peptide compounding is at a critical crossroads. As the FDA prepares for its upcoming Pharmacy Compounding Advisory Committee (PCAC) meeting, compounders, prescribers, patients, and industry advocates are facing important decisions that could shape access to peptide therapies for years to come. In this episode, Amy Summers sits down with Melissa Stefko of Wells Pharmacy Network to discuss why these regulatory decisions matter. Together they explore the intersection of personalized medicine, patient access, regulatory oversight, and public safety.

Melissa Stefko is the senior VP of regulatory affairs at Wells Pharmacy Network with extensive experience in pharmacy compounding and FDA policy. She has been actively involved in peptide nominations for FDA review and works closely with industry organizations advocating for safe, regulated access to compounded therapies. Melissa brings a practical perspective on how evolving regulations impact pharmacies, physicians, and patients seeking personalized medicine.

Key Takeaways

  • Why the upcoming FDA PCAC meeting could significantly impact peptide compounding.
  • How peptide therapy fits into the growing movement toward personalized medicine.
  • The safety concerns surrounding the expanding gray market for peptides.
  • The difference between FDA enforcement discretion and state board pharmacy regulations.
  • How pharmacists, physicians, and patients can contribute meaningful comments before FDA review.

Timestamps

[00:00] - Introduction to the episode

[04:07] - Why peptides have become a major healthcare and regulatory topic

[08:08] - Clinical uses for peptides and the original FDA nominations

[11:05] - FDA's preliminary recommendations and industry concerns

[15:16] - Gray market peptides versus regulated pharmacy compounding

[18:35] - Understanding FDA oversight and state board enforcement

[22:24] - How pharmacies, physicians, and patients can support the FDA review process

[26:08] - What meaningful FDA docket comments should include

[28:19] - Possible outcomes after the PCAC meeting

[33:10] - Final recommendations and how stakeholders can get involved

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]]>The future of peptide compounding is at a critical crossroads. As the FDA prepares for its upcoming Pharmacy Compounding Advisory Committee (PCAC) meeting, compounders, prescribers, patients, and industry advocates are facing important decisions that could shape access to peptide therapies for years to come. In this episode, Amy Summers sits down with Melissa Stefko of Wells Pharmacy Network to discuss why these regulatory decisions matter. Together they explore the intersection of personalized medicine, patient access, regulatory oversight, and public safety.

Melissa Stefko is the senior VP of regulatory affairs at Wells Pharmacy Network with extensive experience in pharmacy compounding and FDA policy. She has been actively involved in peptide nominations for FDA review and works closely with industry organizations advocating for safe, regulated access to compounded therapies. Melissa brings a practical perspective on how evolving regulations impact pharmacies, physicians, and patients seeking personalized medicine.

Key Takeaways

  • Why the upcoming FDA PCAC meeting could significantly impact peptide compounding.
  • How peptide therapy fits into the growing movement toward personalized medicine.
  • The safety concerns surrounding the expanding gray market for peptides.
  • The difference between FDA enforcement discretion and state board pharmacy regulations.
  • How pharmacists, physicians, and patients can contribute meaningful comments before FDA review.

Timestamps

[00:00] - Introduction to the episode

[04:07] - Why peptides have become a major healthcare and regulatory topic

[08:08] - Clinical uses for peptides and the original FDA nominations

[11:05] - FDA's preliminary recommendations and industry concerns

[15:16] - Gray market peptides versus regulated pharmacy compounding

[18:35] - Understanding FDA oversight and state board enforcement

[22:24] - How pharmacies, physicians, and patients can support the FDA review process

[26:08] - What meaningful FDA docket comments should include

[28:19] - Possible outcomes after the PCAC meeting

[33:10] - Final recommendations and how stakeholders can get involved

Follow Melissa Stefko:


Follow the Host:


Follow The Podcast:


]]>cc852682-ed9d-4b7a-96b7-079c7a68736cFri, 03 Jul 2026 19:40:00 +050034:01falsefullNew Episode Coming Soon!New Episode Coming Soon!Are you overwhelmed by complex compliance codes and shifting regulatory standards? Do you worry that your quality management systems are just checking boxes instead of truly safeguarding your operations?

You don't have to navigate the high-stakes landscape of sterile compounding and personalized medicine alone.

Introducing Compounding Interest: The Business of Personalized Medicine! Brought to you by Amy Summers - a nationally recognized authority in 503A and 503B operations - and the expert team at Restore Health Consulting. Backed by proven playbooks and a nationwide consulting network, they help businesses build, scale, and restore their infrastructure to maximum capacity.

In each episode, you will gain executive-level insights, field-tested risk mitigation strategies , and inspection-ready solutions that help organizations move past minimum standards and achieve true operational excellence. If you are a pharmacy operator, life sciences executive, or medical spa innovator, this is your essential guide.

Compounding Interest is coming soon to your favorite podcast platform. Subscribe now so you don't miss the very first episode!

]]>Are you overwhelmed by complex compliance codes and shifting regulatory standards? Do you worry that your quality management systems are just checking boxes instead of truly safeguarding your operations?

You don't have to navigate the high-stakes landscape of sterile compounding and personalized medicine alone.

Introducing Compounding Interest: The Business of Personalized Medicine! Brought to you by Amy Summers - a nationally recognized authority in 503A and 503B operations - and the expert team at Restore Health Consulting. Backed by proven playbooks and a nationwide consulting network, they help businesses build, scale, and restore their infrastructure to maximum capacity.

In each episode, you will gain executive-level insights, field-tested risk mitigation strategies , and inspection-ready solutions that help organizations move past minimum standards and achieve true operational excellence. If you are a pharmacy operator, life sciences executive, or medical spa innovator, this is your essential guide.

Compounding Interest is coming soon to your favorite podcast platform. Subscribe now so you don't miss the very first episode!

]]>3b0765dd-ea45-48f0-b253-9dd33ecc960cFri, 26 Jun 2026 17:58:00 +050001:23falsefull