Comment from Glettler Amanda

I am writing in support of continued access to compounded tirzepatide and GLP-1/GIP receptor agonists for patients with documented clinical need. Tirzepatide’s therapeutic value is particularly significant for women in perimenopause, a population managing complex, overlapping metabolic conditions that brand-name formulations often cannot adequately address due to dosing limitations and supply constraints. Estrogen decline during perimenopause disrupts insulin sensitivity, dysregulates cortisol, promotes visceral adiposity, and accelerates cardiovascular risk. Tirzepatide addresses several of these pathways simultaneously: Insulin regulation: Directly counteracts the metabolic dysregulation of perimenopause and reduces risk of progression to type 2 diabetes. Cortisol modulation: GLP-1 receptor activity shows emerging evidence of HPA axis modulation, benefiting cortisol-driven symptoms including abdominal weight gain and sleep disruption. Cardiovascular protection: Clinically demonstrated reductions in blood pressure, triglycerides, LDL, and systemic inflammation — all of heightened concern as cardiovascular risk rises sharply at menopause. Hepatoprotective effects: GLP-1 agonists reduce NAFLD progression, which disproportionately affects metabolically compromised perimenopausal women. For patients on bioidentical hormone therapy, compounded formulations allow precise dose titration that commercially available products do not offer — essential for managing overlapping hormonal and metabolic effects safely. Patients in rural and frontier communities face a near-total absence of local specialists in metabolic medicine, endocrinology, and obesity medicine. Their only realistic pathway to evidence-based GLP-1 therapy runs through telehealth providers working with compounding pharmacies. Eliminating compounded GLP-1s does not redirect these patients to brand-name alternatives, it eliminates access entirely, because: Brand-name tirzepatide and semaglutide have experienced persistent, documented supply shortages. Rural patients cannot practically travel to urban specialty clinics for ongoing management. Telehealth platforms serving this population are structurally dependent on compounding pharmacy partnerships. Removing compounded access does not protect these patients. It abandons them. I am a perimenopausal patient prescribed compounded tirzepatide through a telehealth provider. I reside in a rural area with no local obesity medicine or endocrinology specialists within practical travel distance. Brand-name product has not been consistently available to me due to documented shortages. My treatment has produced measurable clinical improvements including in my labs, blood pressure, and metabolic markers. Eliminating compounded access would not redirect me to an alternative, it would end my care. For perimenopausal women, rural patients, and those for whom commercially available formulations are inaccessible due to shortage, compounded GLP-1 medications are not a convenience, they are the only medically viable option. I respectfully urge the FDA to preserve compounded access for patients with documented clinical need.