Comment from Mann Esmeralda
AnonymousSupportIndividual
Summary: A patient who relies on compounded tirzepatide argues that the medication provides necessary dosing flexibility and affordability that commercial products lack. They urge the FDA to keep tirzepatide on the 503B bulk list to ensure continuity of care and patient access.
am submitting this comment as a patient who relies on compounded tirzepatide for continued treatment access and appropriate individualized care.
The commercially available pen products do not adequately meet my clinical needs because they limit dosing flexibility and make it difficult to titrate in smaller, customized increments. Compounded tirzepatide has allowed for a more personalized treatment approach under medical supervision.
In addition, brand-name products remain functionally inaccessible for many patients due to cost and inconsistent local availability. A medication is not meaningfully “available” if patients cannot realistically obtain or afford it on an ongoing basis.
Removing tirzepatide from the 503B bulks list would significantly disrupt continuity of care for patients who are currently stable and benefiting from treatment. Compounding pharmacies have played an essential role in maintaining patient access during ongoing supply and affordability challenges.
I respectfully urge the FDA to consider the real-world clinical impact on patients before making changes that would restrict access to compounded tirzepatide.
Thank you for your consideration.