Comment from Field Vitality LLC

Dear Committee Members, I write to you from the front lines of healthcare access. As a co-founder of Field Vitality, my daily work involves building the pharmacy and provider infrastructure that will deliver peptide therapies to patients who need them. What I have learned in this process is that the current regulatory framework is failing both patients and the legitimate pharmacies trying to serve them. Over the past months, I have spoken with dozens of 503A compounding pharmacies across the country. Every single one reports the same pattern: demand for peptide therapies is surging, but regulatory uncertainty prevents them from investing in capacity, formulation development, and quality infrastructure. Pharmacies that could be producing pharmaceutical-grade BPC-157, TB-500, and MOTS-C are instead turning patients away — or watching those patients purchase unverified products online. This is not a theoretical problem. I have seen the pricing sheets from gray market suppliers. I have heard the stories from patients who received contaminated product. I have spoken with pharmacists who want to compound these therapies legally but cannot because the regulatory path is unclear. The irony is that the infrastructure already exists. America's 503A compounding pharmacies are FDA-registered, state-licensed, and capable of producing high-quality peptide therapeutics. What they lack is regulatory clarity. Placing these peptides on the 503A Bulks List would immediately unlock this existing capacity. The July 23-24 meeting is an opportunity to make a decision that will affect patient safety for years to come. I urge you to act in favor of access, quality, and patient choice. Sincerely, Kevin McDonagh Co-Founder — Field Vitality Maui, HI