June 30 Deadline: How to Submit a Public Comment on the FDA's GLP-1 Rule

On April 30, 2026, the FDA announced its proposal to permanently exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list — effectively ending the legal framework that allowed large-scale compounded GLP-1 production. Before making a final decision, the FDA is accepting public comments. The deadline to submit your comment is June 30, 2026. Late comments will not be considered. Here's exactly how to do it.

What This Rule Would Do

If you haven't been following the regulatory details, here's the short version. As we explained in our analysis of the FDA 503B exclusion proposal, the 503B bulks list determines which bulk drug substances outsourcing facilities can use for compounding. If semaglutide, tirzepatide, and liraglutide are excluded from this list, 503B outsourcing facilities will no longer be permitted to compound these drugs from bulk substances — regardless of demand, pricing, or patient need.

The distinction between 503A and 503B compounding matters here. 503A (patient-specific, small-scale compounding by individual pharmacies with valid prescriptions) would technically remain legal. But 503A cannot replicate the scale, consistency, or distribution reach that 503B outsourcing facilities provided. For most patients who relied on compounded GLP-1s for affordability, the practical effect is the same: their access goes away.

Why Your Comment Matters

Federal Register comment periods are not symbolic. The FDA is legally required to review and consider substantive comments before issuing a final rule. The agency has explicitly stated it will consider submitted comments before making a final determination on the 503B bulks list exclusion.

This doesn't mean public comments will necessarily change the outcome. The FDA has strong institutional momentum toward this exclusion, and multiple safety data points supporting it — including more than 455 adverse event reports linked to compounded semaglutide and over 320 linked to compounded tirzepatide, many involving dosing errors from multi-dose vials.

But comments that raise substantive issues — patient access gaps, clinical need arguments, pricing disparity data, evidence of safe compounding practices — create a record the FDA must address in the final rule. If the final rule doesn't adequately address significant public comments, it becomes vulnerable to legal challenge. Organizations like the National Community Pharmacists Association and the Alliance for Pharmacy Compounding are expected to file detailed comments.

Step-by-Step: How to Submit a Comment

What to Include in Your Comment

The FDA has specified what types of comments are most relevant. Your comment should address one or more of the following:

Patient access and affordability. If you relied on compounded GLP-1 medications because brand-name versions were unaffordable or unavailable through your insurance, describe your specific situation. Include dollar amounts: what you paid for compounded medication, what brand-name alternatives cost, whether your insurance covers GLP-1 therapy, and what will happen to your treatment if compounded versions become unavailable.

Clinical need. If you or your physician believe there is a clinical reason you need a compounded formulation — different concentration, different delivery method, allergy to an inactive ingredient in the brand-name product — explain the specific medical basis. The FDA has stated that general concerns about injection discomfort or cost do not constitute "clinical need" under the statute. Your argument needs to be more specific.

Experience with compounded medications. If you have used compounded GLP-1 medications safely and effectively, your experience is relevant data. Include the duration of use, the pharmacy source, the outcomes you experienced, and whether you encountered any adverse effects. Positive experience data helps balance the adverse event reports that weigh heavily in the FDA's current analysis.

Impact on vulnerable populations. If you are part of a population with limited access to brand-name GLP-1s — uninsured, underinsured, rural, on Medicaid in a state that dropped GLP-1 coverage, or on Medicare before the July 2026 copay program takes effect — describe how the exclusion will affect you specifically.

What NOT to Include

Comments that are most likely to be disregarded:

Generic petitions without specific facts. "Don't take away my medication" is understandable but not substantively useful. The FDA needs facts, data, and specific examples.

Conspiracy theories. Claims that the FDA is acting on behalf of pharmaceutical companies, without evidence, undermine the credibility of legitimate access concerns.

Threats or personal attacks. These are filtered out and may result in your comment being excluded from the record.

Comments about topics outside the docket scope. This docket is specifically about whether semaglutide, tirzepatide, and liraglutide belong on the 503B bulks list. Comments about other drugs, general FDA policy, or unrelated healthcare issues will not be relevant.

What Happens After the Comment Period

After June 30, the FDA will review all submitted comments. There is no fixed timeline for a final decision — it could take months. The agency must address significant comments in the preamble to the final rule. If the FDA proceeds with exclusion, the determination becomes effective upon publication in the Federal Register.

Legal challenges are likely regardless of the outcome. The Outsourcing Facilities Association has already been involved in litigation against the FDA over compounding authority, and multiple federal cases related to GLP-1 compounding are ongoing. The comment period record will be part of any judicial review.

If you currently use compounded GLP-1 medications, it's worth planning for both outcomes. Our guide to switching from compounded to brand-name GLP-1s covers the practical steps, and our pricing analysis breaks down what brand-name alternatives actually cost.

Sources

• FDA Press Announcement, "FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List," April 30, 2026.
• Federal Register Document 2026-08552, 91 FR 23431, published May 1, 2026.
• Orrick, Herrington & Sutcliffe LLP, "FDA Moves to Shut the Door on Large-Scale Compounding of GLP-1 Drugs," May 2026.
• Pharmacy Times, "FDA Moves to Permanently Close the Door on Compounded GLP-1s," May 2026.
• Partnership for Safe Medicines statement on FDA compounding action, May 2026.