After two days of testimony, patient advocacy, and scientific review, six peptides move to the next phase of FDA consideration, but the process isn't over yet.

Last week, the FDA's Pharmacy Compounding Advisory Committee (PCAC) voted to recommend that six of the seven peptides it reviewed move forward to the next stage of the FDA's regulatory process. While that's encouraging news, the committee's vote is just one step in a much longer process.

EllieMD’s Voice Was Heard

Last week, EllieMD™ helped ensure the patient voice was represented during one of the most significant FDA discussions on peptide compounding in recent years.

EllieMD Founder and CEO Hanieh Sigari testified before the committee, sharing the perspective of patients seeking safe, physician-guided access to personalized care. Earlier that day, EllieMD Brand Partners gathered outside FDA headquarters in a peaceful rally, helping ensure that the patient voice was heard.

Over two days, a committee of physicians, pharmacists, and scientific experts reviewed FDA analyses, research, and testimony before casting their votes. We're incredibly proud the EllieMD community was part of that conversation.

What Happened?

After reviewing scientific evidence and public testimony, the committee voted to recommend that these six peptides continue through the FDA review process:

1. BPC-157
2. TB-500
3. KPV
4. MOTS-c
5. Semax
6. Epitalon

One additional peptide reviewed, Emideltide (DSIP), did not receive a favorable recommendation, but EllieMD will continue monitoring its regulatory path.

What This Vote Really Means

The FDA has not approved these peptides. Not yet.

The Pharmacy Compounding Advisory Committee is an independent panel that provides non-binding recommendations to the FDA. The agency will now conduct its own review before deciding whether any of these peptides should move forward for possible inclusion on the 503A Bulks List for compounding.

In other words, the committee voted that these peptides deserve further review (an important first step), not immediate approval or changes to current regulations.

Looking Ahead

The FDA has not announced when it will make its final decisions, and there are no immediate changes to the regulatory status of these peptides. The review process could take months, or longer.

EllieMD is proud to have participated in this important conversation and will continue to advocate for safe, evidence-informed, physician-guided care. We'll keep our community updated with clear, accurate information every step of the way.

Thank you to everyone who testified, rallied, and supported this effort. Together, we're helping shape the future of personalized medicine.

Review the FDA Hearings

Watch highlights from the FDA advisory committee meeting, hear Hanieh Sigari's testimony, and learn why the patient voice matters.

Watch the Public Hearing

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