Partnership for Safe Medicines Files Citizen Petition Urging FDA to Block Compounding of Unapproved and Uncharacterized Peptides

PSM's petition asks FDA to act on its own scientific record and to set aside an advisory committee vote it says was compromised by conflicts of interest.

WASHINGTON--(BUSINESS WIRE)--The Partnership for Safe Medicines (PSM) filed a citizen petition urging the U.S. Food and Drug Administration to block compounding of unapproved peptides and to disregard the advisory committee vote that recommended allowing them, on grounds that the committee was constituted in violation of the Federal Advisory Committee Act (FACA) and the Ethics in Government Act (EIGA), federal laws that govern conflicts of interest in agency advisory proceedings.

At a Pharmacy Compounding Advisory Committee (PCAC) meeting convened by the FDA in July, the agency’s scientists recommended against bulk compounding of seven substances under consideration – BPC-157, KPV, TB-500, MOTS-c, emideltide, semax, and epitalon. The Committee, whose newly appointed members include individuals with financial ties to the peptide industry, voted in favor of allowing six out of the seven unapproved substances to be compounded.

“We are deeply concerned that legitimizing untested and poorly defined substances knowingly puts Americans at risk,” said Shabbir Imber Safdar, Executive Director of PSM. "FDA scientists reviewed these substances and found no adequate characterization, extremely limited safety data, and no meaningful human evidence. Legitimizing these compounds doesn't make them safer. It just makes them easier to sell."

PSM's petition asks FDA to take two actions:

• block compounding of these peptides by any route
• disregard the PCAC meeting as a basis for future rulemaking

PSM’s petition is grounded in the concern that patients are being exposed to potentially dangerous substances, and the regulatory and enforcement process designed to protect them is not functioning as intended. It argues that the scientific record and PCAC’s conflicts of interest are grounds to disregard the committee’s vote.

PSM's petition comes amid a broader pattern of compounding violations. Recent reporting has documented compounding pharmacies producing and dispensing unapproved products like retatrutide, and a broad swath of patient harm due to illegally obtained unapproved peptides.

“Compounders who are illegally producing and selling unapproved peptides today should be prosecuted, but instead they will be rewarded with the opening of a lucrative new market for their unapproved and untested products,” said Safdar. “The only people who stand to benefit from allowing these peptides to be compounded are those who are doing the selling.”

PSM’s research team verified these violations in its own purchases of unauthorized peptides. The products that arrived were labeled from four state-licensed 503A compounding pharmacies in Texas and Pennsylvania. The products were ordered from and delivered to California. Three of the four pharmacies have no known licenses in California; the fourth lacks a non-resident sterile compounding license. None of the products received were labeled "research use only," and all were shipped with syringes and injection instructions.

A citizen petition is a formal mechanism established under FDA regulations (21 C.F.R. § 10.30) that allows any person or organization to request that the agency take – or refrain from taking – a specific regulatory action. Once filed, FDA is required to respond within 180 days. Citizen petitions are a recognized tool for placing scientific, legal, or procedural arguments directly into the official administrative record, ensuring they must be considered before the agency acts. PSM's petition is publicly available on FDA's docket at regulations.gov.

About the Partnership for Safe Medicines

The Partnership for Safe Medicines (PSM) is a public health group of non-profit organizations that handle medicine from the factory floor to the patient and are committed to the safety of prescription drugs. To learn more, visit www.safemedicines.org.