Washington, D.C. — July 24, 2026

Partnership for Safe Medicines Executive Director Shabbir Imber Safdar released the following statement after the FDA’s Pharmaceutical Compounding Advisory Committee (PCAC) voted to add several peptides to the 503A Bulk Drug Substances List:

"Today's vote is a serious setback for patient safety.

“The Pharmaceutical Compounding Advisory Committee voted to advance substances that FDA's own scientists flagged as lacking adequate evidence of safety, efficacy, or quality. The Committee's recommendation will inevitably be interpreted by many as an endorsement of broader clinical use. It is not.

“Patients won't read the fine print. They will hear one thing: the FDA said yes.

“That matters enormously, because compounded peptides already reach Americans through wellness clinics, medical spas, and online platforms with little oversight and even less accountability. Today's vote accelerates that trend without the clinical evidence to justify it.

“I believe it is only a matter of time that at least one of these seven peptides will be marketed in a way that implies FDA endorsement. That is not a hypothetical. It is the predictable next step in a pattern we have watched play out with other compounded substances. Witness the death of a New York woman after taking a compounded substance that the FDA warned the public about.

“Licensed compounders have already been documented preparing unapproved substances like retatrutide. 'Measured guardrails,' as peptide advocates called for today, have not held before. There is no reason to believe they will now.

The Partnership for Safe Medicines will be watching closely and will continue our reporting to the public, to Congress, and to FDA on the real-world consequences of today’s decision."

More resources:

• PSM’s “Five risks of untested peptides” is an explainer for patient risk of untested peptides.
• Read PSM's written testimony to the PCAC here.
• PSM’s Executive Director’s oral testimony can be found here.