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

Home/Physician Action

FDA Comment — Physician Template

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

How to Submit

1
Personalize the template below with your name, specialty, and state.
2
Add specific patient examples or clinical observations to strengthen your comment.
3
Click "Copy Letter" to copy the full text.
4
Click the Regulations.gov button to open the official comment portal.
5
Paste your letter into the comment field and submit.

Your Full Name

Specialty / Title

State of Licensure

Tip: The most impactful comments include specific patient examples and clinical observations. Consider editing the letter body to add your personal experience.

Open Regulations.gov Comment Portal Also Contact My Representatives →

Docket Information

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

Your Letter Preview

Editable below

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,

I am writing as a licensed physician, to respectfully and strongly oppose the FDA's proposed exclusion of semaglutide, tirzepatide, and liraglutide from the 503B Bulks List (Docket No. FDA-2018-N-3240-0377).

CLINICAL EVIDENCE FOR GLP-1 RECEPTOR AGONISTS

GLP-1 receptor agonists represent one of the most significant therapeutic advances in metabolic medicine in decades. The clinical evidence supporting their use is robust and compelling:

- Weight Reduction: In the SURMOUNT-1 trial, tirzepatide achieved mean weight loss of 20.9% at the highest dose — a magnitude previously achievable only through bariatric surgery. Semaglutide 2.4 mg (STEP-1 trial) demonstrated 14.9% mean body weight reduction over 68 weeks.

- Cardiovascular Benefit: The SELECT trial demonstrated that semaglutide reduced major adverse cardiovascular events (MACE) by 20% in patients with obesity and established cardiovascular disease. The LEADER trial showed liraglutide reduced cardiovascular death by 22%.

- Glycemic Control: In patients with type 2 diabetes, GLP-1 agonists consistently achieve HbA1c reductions of 1.0–2.0%, with semaglutide demonstrating superiority over other agents in head-to-head trials (SUSTAIN program).

- Cardiorenal Protection: Emerging data from the FLOW trial demonstrates that semaglutide reduces kidney disease progression by 24% in patients with type 2 diabetes and chronic kidney disease.

MY CLINICAL EXPERIENCE WITH COMPOUNDED GLP-1 MEDICATIONS

In my practice, I have witnessed firsthand the transformative impact that GLP-1 receptor agonists have had on patients managing obesity, type 2 diabetes, and related metabolic conditions. These medications have demonstrated remarkable efficacy not only in weight reduction but in improving glycemic control, reducing cardiovascular risk, and enhancing overall quality of life for my patients.

Compounded GLP-1 medications from 503B outsourcing facilities have been a critical component of my treatment toolkit. Many of my patients cannot afford the brand-name formulations, which cost $936–$1,349/month for semaglutide (Wegovy/Ozempic) and $1,023–$1,086/month for tirzepatide (Zepbound/Mounjaro) without insurance coverage. Compounded alternatives — typically priced 80–90% lower — have allowed patients who would otherwise go untreated to access life-changing therapy.

PATIENT SAFETY AND OUTCOMES

I have not observed safety concerns attributable to compounded GLP-1 medications from 503B-regulated outsourcing facilities. These facilities operate under Current Good Manufacturing Practice (CGMP) standards and are subject to FDA inspection and oversight — the same regulatory framework that governs traditional pharmaceutical manufacturers.

The FDA's own adverse event reporting data does not support a finding that 503B-compounded GLP-1 medications present a safety profile meaningfully different from commercially manufactured products. The safety concerns that have been raised pertain primarily to unregulated, non-503B compounders — not to the FDA-inspected outsourcing facilities that this rule would affect.

THE CLINICAL NEED REMAINS REAL

The FDA's rationale that there is "no clinical need" because the branded products are no longer in shortage fails to account for the economic reality facing millions of American patients. Shortage resolution does not equal access.

Key facts the FDA must consider:
- An estimated 100+ million Americans have obesity (BMI ≥30), yet brand-name GLP-1 medications are accessible to only a fraction of those who could benefit.
- Insurance coverage for GLP-1 medications remains inconsistent: Medicare Part D only recently began covering Wegovy for cardiovascular indications; many state Medicaid programs and private insurers still exclude obesity pharmacotherapy.
- Dose flexibility: Compounding pharmacies provide titration doses not available commercially, which is clinically important for managing tolerability during initiation.
- Combination formulations: Compounders provide combinations (e.g., semaglutide + B12, tirzepatide + vitamin combinations) that address common tolerability issues and are not commercially available.

MY RECOMMENDATION

I urge the FDA to:
1. Reject the proposed exclusion of semaglutide, tirzepatide, and liraglutide from the 503B Bulks List.
2. Recognize that "shortage resolution" and "patient access" are not equivalent — access requires affordability.
3. Consider the substantial public health burden of obesity, type 2 diabetes, and cardiovascular disease, and the role that affordable compounded GLP-1 medications play in addressing these conditions.
4. Evaluate the full body of clinical evidence supporting GLP-1 receptor agonists and the population-level impact of restricting access to affordable formulations.
5. Engage with the clinical community to understand the real-world impact of this proposed rule before finalizing it.

The patients I serve depend on continued access to these medications. I respectfully request that the FDA give full and fair consideration to the clinical and economic realities described in this comment.

Respectfully submitted,

[Your Full Name]
[Your Specialty/Title]
[Your State of Licensure]
[Your NPI or Medical License Number — Optional]
[Your Institution/Practice Name — Optional]

This template is provided as a starting point. The FDA values comments that include specific, personal clinical observations. We encourage you to edit the letter to reflect your own experience before submitting.