Episode 18 | Fertility and Other F Words
In this episode of Fertility and Other F Words, Dr. Amy Pearlman and Dr. Larry Lipshultz sit down with Lee Rosebush, PharmD, JD, MBA to discuss one of the most rapidly evolving and controversial areas in medicine: peptides, compounding pharmacies, FDA regulation, and the future of personalized healthcare.
Lee Rosebush is a pharmacist, attorney, and nationally recognized authority on pharmacy compounding, FDA regulation, healthcare law, and pharmaceutical policy. Lee leads the American Academy of Peptide Medicine's (AAPM) policy advocacy and compliance strategy as the Chairman and Chief Pharmacy Officer. He advises pharmaceutical, biologic, medical device, and healthcare companies on complex regulatory and compliance issues and serves as a leading voice on the future of peptide therapeutics and personalized medicine.
Whether you're a physician, healthcare professional, or patient trying to understand the changing landscape of peptides like BPC-157, this episode provides an evidence-based discussion of the science, legal considerations, and regulatory challenges shaping the future of these therapies.
In this episode, we cover:
- What peptides are and why therapies like BPC-157 have become so popular
- The current FDA regulatory landscape surrounding compounded peptides
- How compounding pharmacies differ from gray-market online peptide vendors
- Certificate of Analysis (COA) testing, quality control, and why pharmacy selection matters
- The role of the American Academy of Peptide Medicine in developing safety standards
- The debate between Big Pharma, compounding pharmacies, and patient access to peptide therapies
- Domestic peptide manufacturing versus overseas production
- The legal considerations for physicians prescribing compounded medications
- Why informed consent and patient education remain essential when using compounded therapies
- The future of peptide medicine and how evolving regulations could impact both patients and clinicians
Key Takeaways:
- Peptides represent one of the fastest-growing areas in modern medicine, with applications extending far beyond weight loss and GLP-1 medications.
- Not all peptide products are created equal. The quality of the pharmacy, manufacturing standards, and independent testing play a critical role in patient safety.
- Compounded peptides should be obtained from reputable pharmacies—not gray-market online vendors that may lack quality assurance and regulatory oversight.
- Physicians can legally prescribe compounded medications within the practice of medicine, but appropriate informed consent and state-specific regulations remain important.
- Independent laboratory testing, Certificates of Analysis (COAs), and standardized reference testing are becoming increasingly important as peptide use expands.
- Ongoing FDA hearings and regulatory decisions will significantly influence future patient access to compounded peptide therapies.
- The tension between pharmaceutical manufacturers, compounding pharmacies, and federal regulators will continue to shape innovation, affordability, and access to personalized medicine.
- As peptide therapies continue to evolve, balancing scientific evidence, patient safety, and access to care will remain one of healthcare's biggest challenges.
Check out the official website For the Academic Society for Peptide Medicine at pepmed.org
The Peptide Revolution is now available for purchase on Amazon https://www.amazon.com/dp/1631441280/?bestFormat=true&k=peptide%20revolution&ref_=nb_sb_ss_w_scx-ent-bk-ww_k0_1_18_de&crid=45FX9H9HE2AX&sprefix=peptide%20revolution
Notice:
The Fertility and Other F Words webcast and YouTube channel are intended for general informational purposes only. They do not constitute the practice of medicine nor do they provide medical advice or create a doctor–patient relationship. Use of the information provided through this webcast, YouTube channel, or any linked materials is at the listener’s/viewer’s own risk. The content is not a substitute for professional medical advice, diagnosis, or treatment.
Listeners/viewers should never disregard or delay seeking medical advice for any health condition and are strongly encouraged to consult their own qualified health care professional with any questions or concerns.
All content from the Fertility and Other F Words webcast is the property of PODCAST WITH DRS. AMY AND LARRY LLC.
Listeners and viewers may not use, distribute, re-distribute, reproduce, alter, or edit any portion of this content without the express written permission of the webcast owners.
The views and opinions expressed in this webcast are those of Drs. Amy Pearlman and Larry Lipshultz and do not reflect the official positions or responsibilities of Prime Institute, Baylor College of Medicine, or any affiliated institutions.