Comment from Teiken Zoey

Re: Docket No. FDA-2018-N-3240 I am writing to urge the FDA to include tirzepatide on the bulk drug substances list for compounding. Compounded tirzepatide has had a profound positive impact on my health and quality of life. Through a compounded formulation prescribed by my healthcare provider, I have been able to access a version of tirzepatide that better meets my individual medical needs than the commercially available product. One important benefit is that my compounded medication includes B vitamins. Prior to treatment, I struggled with chronic B vitamin deficiencies, and those deficiencies have improved while using my compounded medication. This customized formulation has allowed me to address multiple health needs through a treatment plan developed with my healthcare provider. Another critical benefit is access to a dose that is lower than the standard starting dose available in the FDA-approved product. The commercially available tirzepatide product does not offer the lower dose that works best for me. Through compounding, my provider has been able to prescribe a dosage tailored to my individual tolerance and response. This personalized approach has allowed me to successfully use the medication while minimizing side effects and achieving meaningful health improvements. Since beginning compounded tirzepatide, I have lost approximately 15% of my body weight and achieved health goals that I had been unable to reach through other methods. The improvement in my overall health, well-being, and quality of life has been substantial. Access is also a major concern for me. I live in a rural area, and the closest physician is approximately 30 minutes away. Traveling to medical appointments and pharmacies can be difficult and time-consuming. Telehealth services combined with access to compounded tirzepatide have provided a practical and effective way for me to receive ongoing medical care. Without this option, obtaining treatment would be significantly more challenging. My experience demonstrates that compounded tirzepatide serves an important medical need for patients whose needs are not fully met by commercially available products. The ability to customize dosage strengths and formulations can be essential for patients who require a lower-than-standard dose, who benefit from added ingredients prescribed by their healthcare provider, or who face barriers to accessing care through traditional channels. For these reasons, I respectfully request that the FDA include tirzepatide on the bulk drug substances list for compounding. Preserving access to compounded tirzepatide would allow patients and healthcare providers to continue using individualized formulations when medically appropriate and would help ensure that patients in rural and underserved communities maintain access to effective treatment. Thank you for considering my comments. Zoey T