APhA urges FDA to put patient safety first in review of peptide substances

WASHINGTON, July 17, 2026 /PRNewswire/ -- As the market for unregulated peptide products continues to grow, the American Pharmacists Association (APhA) is urging FDA and the Pharmacy Compounding Advisory Committee (PCAC) to prioritize patient safety, scientific evidence, and regulatory oversight as they evaluate several peptide substances nominated for inclusion on the Section 503A Bulks List.

In comments submitted to FDA, APhA highlighted the emergence of black and gray markets for peptides, in which products are often purchased online from unregulated suppliers and marketed through channels that operate outside traditional regulatory safeguards. APhA warned that these products may expose patients to significant risks, including contamination, inaccurate dosing, counterfeit ingredients, and serious adverse health consequences.

"Pharmacists believe in innovation, but innovation must be grounded in science and patient safety," said Brigid Groves, PharmD, MS, vice president of professional affairs at APhA. "When patients are turning to unregulated online sources for peptide products of unknown quality, everyone should be concerned. Pharmacists have seen firsthand how safe and effective peptide-based medications can improve patient outcomes when supported by robust clinical evidence, appropriate regulatory oversight, and established quality standards."

Compounding pharmacists have a long history of helping patients access customized and safely prepared therapies when there is a legitimate clinical need. If rigorous, peer-reviewed research ultimately demonstrates that these peptides are safe and effective, pharmacists will play an essential role in preparing high-quality compounded formulations, educating patients, and ensuring these therapies are obtained through regulated pharmacies rather than unregulated online marketplaces.

In its comments, APhA noted that pharmacists currently lack sufficient evidence to confidently counsel patients on many of the peptide substances under consideration, including their effectiveness, safety profiles, drug interactions, and long-term health effects. Given the limited clinical data available today, APhA supports FDA's recommendation not to add the nominated peptide substances to the Section 503A Bulks List at this time.

APhA also called on FDA to strengthen education efforts for patients and health care professionals and to work with state boards of pharmacy, the United States Pharmacopeia, and our nation's pharmacists to improve oversight, quality standards, and patient awareness. APhA further encouraged continued scientific research to better establish the safety and effectiveness of peptide therapies and inform future regulatory decisions.

About the American Pharmacists Association

Founded in 1852, APhA is the only organization advancing the entire pharmacy profession. From its headquarters in Washington, DC, APhA leads the pharmacy profession by supporting pharmacists, student pharmacists, and pharmacy technicians in their role optimizing medication use and patient health outcomes and ensuring patients have access to pharmacists' care. We do this through our strong and effective advocacy, top notch education, practice tools and resources, dissemination of evidence, and opportunities for members to engage and learn from each other. APhA is the pharmacy voice at the table in developing national guidelines, policies, and best practices that advance the profession and patient care. To learn more, visit www.pharmacist.com.

SOURCE American Pharmacists Association