06/02/2026
Copy and paste this: I oppose the FDA’s proposed rule to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list because it would significantly reduce patient access to essential treatments and may ultimately undermine public health.
The primary concern is that the existence of FDA-approved alternatives does not guarantee patient access. Many insurance plans do not cover branded GLP-1 medications, while others impose lengthy prior authorization requirements that often result in denial. For many patients, compounded GLP-1 medications are the only affordable and accessible treatment option. Eliminating this pathway would leave countless individuals without effective care, potentially reversing meaningful health improvements achieved through these therapies.
Additionally, some patients have clinical needs that cannot be met by commercially available products. Compounded medications can provide customized dosing, titration schedules, or formulations for patients with sensitivities or allergies to ingredients found in branded medications. Compounding serves an important role in addressing these individualized treatment needs.
There are also significant safety concerns. If patients lose access to compounded GLP-1 medications through regulated, FDA-registered 503B outsourcing facilities, many may seek medications from unregulated online sellers, foreign suppliers, or other sources lacking proper oversight. This could increase patient risk rather than improve safety.
While the FDA has an important responsibility to ensure medication safety, I urge the agency to reconsider this proposal and conduct a comprehensive analysis of its impact on patient access before moving forward. Any regulatory action should carefully balance safety considerations with the real-world consequences for patients who rely on these treatments. WEBSITE: https://www.regulations.gov/document/FDA-2018-N-3240-0377
