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  • New Episode Coming Soon!

    New Episode Coming Soon!
    Jun 26 2026

    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!
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    1 Min.
  • The Peptide Therapy Crisis for Patients Losing Access to Life-Changing Treatments with Melissa Stefko

    The Peptide Therapy Crisis for Patients Losing Access to Life-Changing Treatments with Melissa Stefko
    Jul 3 2026
    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 TakeawaysWhy 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 involvedFollow Melissa Stefko:LinkedIn: https://www.linkedin.com/in/melissa-stefko-70234415/Website (Company): https://wellsrx.com/LinkedIn (Company): https://www.linkedin.com/company/wellspharmacynetwork/Facebook (Company): https://www.facebook.com/wellsrxInstagram (Company): https://www.instagram.com/wellspharmacynetwork/X (Company): https://x.com/wellsrxTikTok (Company): https://www.tiktok.com/@wellspharmacynetworkFollow the Host:Amy Summers: https://www.linkedin.com/in/amy-summers-pharmd-bcscp-fapc-20b04a93/Restore Health Consulting: https://www.restorehealthconsulting.com/Follow The Podcast:YouTube: https://www.youtube.com/@RestoreHealthConsultingSpotify: https://open.spotify.com/show/033F4FRUbjSrN1oNbfozhD?si=caf30ccfd2ba49b6Apple Podcasts: https://podcasts.apple.com/in/podcast/compounding-interest/id6784679391
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    34 Min.