Request to Extend Deadlines for Compounded GLP-1 Medications

I am writing to express my concern regarding the upcoming deadlines for compounding pharmacies to cease production of compounded GLP-1 medications, as outlined by the FDA. As a patient who relies on these medications for managing my health, I am deeply worried about how these changes will impact my access to affordable treatment options. Like many others, I pay out-of-pocket for these compounded medications because the retail versions are prohibitively expensive and are not covered by my insurance. The compounded versions have been the only viable option for me to manage my condition effectively and consistently. GLP-1 medications, such as semaglutide and tirzepatide, are critical for managing diabetes and supporting weight loss, yet localized supply disruptions remain a challenge even after the FDA’s declaration that national shortages have been resolved. The upcoming deadlines—April 22, 2025, for state-licensed pharmacies and May 22, 2025, for outsourcing facilities—risk leaving patients like me without accessible alternatives during this transitional period. Extending these deadlines would allow for a smoother transition to FDA-approved formulations while ensuring that patients do not face interruptions in their treatment. Such an extension is vital to support those of us who are already navigating financial and healthcare obstacles. I urge you to advocate for an extension of these deadlines and to work with the FDA to address the concerns of patients, healthcare providers, and compounding pharmacies. By doing so, we can prioritize patient care and uphold the standards of safety and efficacy that the FDA represents. Thank you for your attention to this matter. I appreciate your commitment to serving the needs of our community, and I hope you will consider taking action to support patients who rely on compounded GLP-1 medications.