Peptides and the PCAC Hearing: FAQ

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The hearing

1. What is the PCAC hearing, and what is being decided on July 23 and 24, 2026?

The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA. On July 23 and 24, 2026, it meets to consider whether licensed pharmacies can prepare certain peptide therapies for patients who have a valid prescription. It reviews the evidence in public and votes on a recommendation to the FDA.

2. What is at stake for patients?

Safe, regulated access. If the regulated path narrows, patients who rely on these therapies do not stop seeking them. They get pushed toward an unregulated gray market, with no quality control, no verified dosing, and no medical supervision. The goal is to keep access in safe, accountable channels.

3. What is compounding?

Compounding is when a licensed pharmacist prepares a medication for a specific patient, for example at a different dose or without an ingredient the patient reacts to. Accredited 503A pharmacies (regulated by state boards of pharmacy) and 503B outsourcing facilities (registered with and inspected by the FDA) are held to federal and state standards for quality.

4. What happened in 2023?

A compounding-eligibility decision under regulatory review restricted a set of peptides from being compounded. The therapies did not disappear; many patients were pushed toward an unregulated gray market instead. This is not a story about a ban. It is about access moving out of regulated, accountable channels, and the current review is a chance to correct that.

5. Is the hearing a final decision?

No. A PCAC vote is a recommendation to the FDA, not a final rule. The committee advises, and the FDA decides what to do with that advice.

Peptides and the gray market

6. What is a peptide?

A peptide is a short chain of amino acids, the building blocks of proteins. Your body makes thousands of them. Insulin has been a peptide medicine for over a century, and peptides occur naturally in everyday foods. The word itself is not what makes a therapy safe or risky; the source and the supervision are.

7. What is the “gray market,” and why is it dangerous?

It is the unregulated channel where these therapies are sold without oversight: online vendors and products labeled “for research use only.” There is no inspection, no verified quality or dosing, and no clinical supervision. Most documented safety problems are associated with this kind of self-sourcing, which is exactly what a regulated, supervised pathway is built to prevent.

8. What does AAPM want?

To protect safe, regulated access to peptide therapies. AAPM is pro-access and pro-safety at the same time. The fix for the gray market is rigor and supervision, not prohibition, and not deregulation. AAPM works with regulators and industry to set the quality standards that make a safe, regulated pathway possible.

Taking part

9. Why does my comment matter?

The committee reads the public record, and the FDA has opened a comment period asking for input. Comments filed by July 9, 2026 are provided directly to the committee, so submitting early carries more weight. A comment in your own words counts for more than a form letter.

10. Is my comment public?

Yes. When you submit on regulations.gov it becomes part of the public record for the docket. After you submit, save the Comment Tracking Number you receive for your records.

11. Do I have to be an expert?

No. You just have to be someone this affects. Patients, caregivers, pharmacists, and clinicians all have a standing reason to comment. Speak from your own experience.

12. When are the deadlines?

Early comment deadline: July 9, 2026 (these go directly to the committee). Public comment period closes: July 22, 2026. The hearing: July 23 and 24, 2026.