Comment from DeTienne Mandy

I respectfully ask the FDA to support the inclusion of these seven nominated peptides on the Section 503A Bulks List so that licensed 503A compounding pharmacies can continue preparing patient-specific prescriptions under the care of qualified healthcare providers. My perspective comes from both my personal health journey and nearly a decade of experience as a Certified Pharmacy Technician. Throughout my career, I have seen firsthand that healthcare is not one-size-fits-all. Patients respond differently to treatment, and individualized care is often essential to achieving meaningful health outcomes. I have also witnessed the realities many patients face: medication shortages, insurance denials, affordability challenges, and limited treatment options. Too often, patients leave the pharmacy discouraged because the therapy their healthcare provider believes is most appropriate is unavailable, unaffordable, or not covered. Healthcare decisions should be guided by clinical judgment and individual patient needs whenever possible. My own experience reinforced this belief. For years, despite exercising consistently, prioritizing nutrition, and doing everything I was told should improve my health, I continued to struggle with weight gain, chronic inflammation, debilitating migraines, low energy, and a poor quality of life. My routine laboratory results were consistently within normal limits, yet they did not explain how I felt or provide meaningful solutions. Working with a licensed healthcare provider, I developed a personalized treatment plan that included compounded peptide therapy as one component of a comprehensive approach alongside nutrition, exercise, and healthy lifestyle changes. This was never presented as a shortcut, but as one tool within an individualized plan designed specifically for my needs. As a result, I have lost about 40 pounds while preserving muscle mass. More importantly, my migraines have decreased by approximately 80%, my energy has improved dramatically, and my overall quality of life has significantly improved. While these are my personal results and not necessarily representative of every patient, they illustrate the value of allowing qualified healthcare providers to individualize treatment based on each patient's unique circumstances. Compounded medications play an important role in personalized medicine. They allow licensed healthcare providers to prescribe individualized formulations when commercially available products may not meet a patient's specific medical needs or when barriers such as availability, formulation, or affordability limit access. Removing these options would not eliminate patients' medical needs—it would simply reduce the tools available to providers caring for individual patients. As both a patient and a Certified Pharmacy Technician, I believe preserving access to compounded medications helps protect the patient-provider relationship and supports thoughtful, individualized medical care. Every patient deserves the opportunity to work with a qualified healthcare provider to determine the treatment plan that is most appropriate for their unique needs. Thank you for considering the experiences of patients and healthcare professionals who have seen the value of personalized medicine. I respectfully ask the FDA to support the inclusion of these seven nominated peptides on the Section 503A Bulks List so that licensed 503A compounding pharmacies can continue providing individualized treatment options under appropriate medical supervision. Thank you for your time and thoughtful consideration. Sincerely, Mandy DeTienne, CPhT