FDA Comment Deadline: June 30, 2026 — Docket FDA-2018-N-3240-0377Submit Directly →

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FDA Comment — Patient Template

Docket FDA-2018-N-3240-0377 · Comment Deadline: June 30, 2026

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Fill in your name, city, state, and optionally your health condition to personalize the letter.
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Tip: The FDA gives extra weight to comments that describe personal experiences. Consider adding specific details about how these medications have helped you.

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Docket Information

Docket No.: FDA-2018-N-3240-0377
FR Notice: 2026-08552
Published: May 1, 2026
Deadline: June 30, 2026

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Re: Docket No. FDA-2018-N-3240-0377 — Proposed Exclusion of Semaglutide, Tirzepatide, and Liraglutide from the 503B Bulks List

Date: May 6, 2026

To the Food and Drug Administration,

My name is [Your Name]. I am writing as a patient who has personally benefited from access to compounded GLP-1 medications, and I am deeply concerned about the FDA's proposed exclusion of semaglutide, tirzepatide, and liraglutide from the 503B Bulks List (Docket No. FDA-2018-N-3240-0377).

**My Personal Experience with Compounded GLP-1 Medications**

I have been managing obesity and related metabolic conditions, and compounded GLP-1 medications have been a critical part of my treatment. Before I had access to a compounded formulation, I was unable to afford the brand-name versions of these medications, which can cost over $1,000 per month — far beyond what I could manage, and not covered by my insurance.

Since beginning treatment with a compounded GLP-1 medication from a licensed 503B outsourcing facility, I have experienced significant health improvements. My weight has decreased substantially, my energy levels have improved, and my overall metabolic health markers have moved in a positive direction. My physician has noted meaningful improvements in my health outcomes.

**Safety: My Experience Has Been Positive**

I want to be clear: I have not experienced any safety issues with my compounded GLP-1 medication. The pharmacy that provides my medication operates under FDA oversight and follows strict quality standards. I have felt confident in the safety and quality of the medication I receive.

I am aware that the FDA has concerns about compounded medications in general, but my experience — and the experience of many patients I know — has been entirely positive. The 503B outsourcing facilities that compound these medications are regulated, inspected, and held to high standards.

**The Impact on Patients Like Me**

If the FDA finalizes this proposed exclusion, I will lose access to an affordable medication that has genuinely changed my health and my life. The brand-name alternatives are simply not financially accessible to me or to millions of Americans in similar situations.

I have spoken with other patients who share my experience. Many of us have seen dramatic health improvements — reduced weight, better blood sugar control, lower blood pressure, and improved quality of life. Many of us have not experienced safety issues. We are not statistics; we are real people whose health depends on continued access to these medications.

**My Request**

I respectfully urge the FDA to:
1. Reject the proposed exclusion of semaglutide, tirzepatide, and liraglutide from the 503B Bulks List.
2. Recognize that the end of a drug shortage does not mean that all patients have affordable access.
3. Consider the real-world health consequences for patients who rely on compounded GLP-1 medications.
4. Listen to the voices of patients and physicians who have direct experience with these medications.

Access to affordable medication is a matter of health equity. Please do not take away a treatment option that is working safely and effectively for patients across America.

Respectfully submitted,

[Your Full Name]
[Your City, State]
[Your Email Address — Optional]

This template is provided as a starting point. Your personal story is the most powerful part of your comment. The FDA is required to consider all public comments submitted before the June 30, 2026 deadline.