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How to Submit a Public Comment to the FDA Before July 9 (Step-by-Step)

May 1, 20269 min readTruPeptide Editorial

Why This Matters

The July 23–24, 2026 PCAC meeting will determine whether BPC-157, TB-500, Semax, Epitalon, MOTs-c, KPV, and Emideltide get formally added to the 503A bulk drug substances list — the list that authorizes licensed compounding pharmacies to prepare them for patients with a prescription.

Before that meeting happens, there is a public comment period. Written comments submitted to docket FDA-2025-N-6895 by July 9, 2026 are provided directly to PCAC committee members as part of their briefing materials. This is not a symbolic gesture. The committee is required to consider public input, and the record of public comments becomes part of the official administrative record for each compound.

Federal regulatory processes are often opaque. Most people have no meaningful way to influence them. The public comment period is one of the few exceptions — a formal, structured mechanism where individual voices carry real weight. A comment from a patient describing their clinical experience with BPC-157 sits in the same docket as a comment from a pharmaceutical company or a law firm. The committee reads both.

The comment period closes July 9, 2026 at 11:59 PM ET. After that date, the record closes and no new written input will be considered for the July meeting.

Who Should Comment

You don't need to be a scientist, lawyer, or industry insider to submit a comment. The FDA explicitly invites input from the general public. That said, certain perspectives are especially valuable to the committee:

Patients who have used BPC-157, TB-500, Semax, Epitalon, MOTs-c, KPV, or Emideltide — whether through a licensed clinic or otherwise — have firsthand experience that no clinical trial can replicate. Your account of what you used, why, and what happened is relevant data.

Clinicians who prescribe these compounds have direct observational data on patient outcomes, safety profiles, and the practical consequences of restricted access. A physician's clinical perspective carries significant weight in PCAC deliberations.

Researchers who have studied these compounds, reviewed the literature, or identified gaps in the evidence base can provide scientific context that helps the committee evaluate the FDA's briefing documents.

Compounding pharmacists understand the manufacturing, quality control, and patient safety dimensions of these compounds in ways that neither regulators nor clinicians fully see.

Patient advocates and caregivers who have witnessed the impact of these compounds — or the impact of losing access to them — can speak to the human stakes of the regulatory outcome.

Anyone with a stake in the outcome can comment. You don't need personal experience with these compounds. If you have a view on how the FDA should balance patient access against precautionary regulation, that perspective belongs in the record.

Step-by-Step: How to Submit

The submission process takes about five minutes. Here's exactly how it works:

  1. Go to regulations.gov. This is the official federal portal for public comments on regulatory proceedings. You don't need to create an account to submit a comment, though creating one allows you to track your submission.

  2. Search for docket FDA-2025-N-6895. Type the docket number directly into the search bar. The docket is titled something like "Pharmacy Compounding Advisory Committee; Notice of Meeting." Click on the docket to open it.

  3. Click the "Comment" button. It appears prominently on the docket page. This opens the comment submission form.

  4. Fill in the form. Your name and organization are optional — you can submit anonymously. If you're a clinician or researcher, including your credentials adds credibility. If you're a patient, you may prefer to omit identifying details. Either approach is valid.

  5. Write your comment in the text box, or upload a document. The text box accepts plain text. If you've prepared a longer statement — a letter, a case summary, a literature review — you can upload it as a PDF or Word document. There is no strict word limit, but focused, specific comments tend to be more useful than lengthy general statements.

  6. Submit before July 9, 2026 at 11:59 PM ET. The portal closes at the deadline. Don't wait until the last day — technical issues happen, and there is no grace period.

After submission, you'll receive a confirmation number. Comments are typically posted publicly within a few days of submission. The full comment record is visible to anyone.

What to Write

The most useful comments are specific, honest, and grounded in direct experience or expertise. Here's practical guidance for different audiences.

If You're a Patient

Describe your experience with the compound. What were you using it for? Under what circumstances (physician supervision, self-directed, etc.)? What did you observe? Be specific about outcomes — positive, negative, or neutral.

Appropriate framing: "I used BPC-157 for [condition] under the supervision of my physician and experienced [outcome]. Access through a licensed compounding pharmacy was important to me because [reason]."

Avoid making disease claims or asserting that a compound cures or treats a specific condition. The FDA publishes all comments publicly, and comments that make unverified medical claims can undermine the credibility of the broader patient record. Describe your experience; don't make clinical assertions.

If access to these compounds has been disrupted — if you lost access to a compound that was working for you, or if you've been forced to seek alternatives — that is directly relevant to the committee's deliberations. The practical consequences of regulatory restriction are part of what the committee is weighing.

If You're a Clinician

Describe your clinical observations. How many patients have you treated with these compounds? What conditions? What outcomes have you observed? What does the safety profile look like in your practice?

Address the access question directly: what happens to your patients if these compounds are not added to the 503A bulks list? Are there adequate alternatives? What are the risks of patients seeking unregulated sources?

You don't need to conduct a literature review. Your clinical observations are primary data. The committee has access to the published literature; what it may lack is the perspective of practitioners who have used these compounds in real clinical settings.

If You're a Researcher

Reference specific studies, including their limitations. If you've identified gaps in the evidence base — missing human trials, methodological weaknesses in existing studies, or areas where the preclinical data is particularly strong or weak — describe them.

If you believe the PCAC review is appropriate and timely, say so and explain why. If you have concerns about the evidence base, articulate them specifically. The committee benefits from honest scientific assessment, including skeptical perspectives.

If You're a Member of the General Public

You don't need personal experience with these compounds to submit a meaningful comment. If you have a view on how the FDA should balance patient access against precautionary regulation — on the appropriate role of compounding pharmacies, on the consequences of prohibition, on the process itself — that perspective is legitimate and relevant.

Keep it focused. A short, clear statement of your position and your reasoning is more useful than a lengthy general argument.

What NOT to Write

A few things will undermine your comment's credibility and may reduce its usefulness to the committee:

Don't make unverified health claims. Statements like "BPC-157 cures [disease]" or "Semax reverses [condition]" are not supported by the current evidence base and will flag your comment as scientifically unreliable. Describe what you observed; don't assert what the compound does.

Don't make unverified safety assertions. Claiming a compound is "completely safe" or "has no side effects" is as problematic as overstating risks. If you have safety observations, describe them accurately.

Don't promote vendors or products. The comment record is not a marketing channel. Any comment that reads as an advertisement for a specific pharmacy, clinic, or supplier will be discounted. Keep commercial interests out of it.

Don't copy-paste form letters without personalizing them. Form letter campaigns are a recognized lobbying tactic, and regulators are aware of them. A brief, genuine personal statement is more valuable than a polished form letter submitted by thousands of people. If you use a template as a starting point, make it your own.

Don't include personal health information you're not comfortable making public. All comments are published on regulations.gov. If you're describing a medical condition or treatment history, consider how much detail you want in a permanent public record.

The Oral Presentation Option

Written comments are not the only way to participate. The FDA also accepts requests for oral presentations at the July 23–24 meeting itself.

Oral presentations are five minutes each and are delivered directly to the committee during the public comment portion of the meeting. Slots are limited and allocated on a first-come, first-served basis.

To request an oral presentation slot, you must submit your request to the FDA by June 30, 2026 — two weeks before the written comment deadline. The request should be sent to the FDA contact listed in the Federal Register notice for docket FDA-2025-N-6895.

Oral presentations are typically used by organized patient advocacy groups, professional associations, and researchers who want to make a direct case to the committee. If you represent an organization with a significant stake in the outcome, this option is worth pursuing. Individual patients and clinicians can also request slots, though competition for time is real.

The meeting will be streamed publicly. Even if you don't present, you can watch the deliberations live.

Key Dates

| Date | Deadline | |------|----------| | June 30, 2026 | Oral presentation request deadline | | July 9, 2026 | Written public comment deadline | | July 23, 2026 | PCAC Day 1 (BPC-157, KPV, MOTs-c, TB-500) | | July 24, 2026 | PCAC Day 2 (Emideltide, Epitalon, Semax) |

Related Resources

This article is for educational and informational purposes only and does not constitute medical or legal advice.