/PRNewswire/ - As the market for unregulated peptide products continues to expand, the American Pharmacists Association (APhA) is urging the FDA and the Pharmacy Compounding Advisory Committee (PCAC) to emphasize patient safety along with scientific evidence and regulatory oversight during evaluation of nominated peptide substances for the Section 503A Bulks List.

In comments submitted to the FDA, APhA pointed to the rise of black and gray markets for peptides where items are frequently bought online from unregulated suppliers and promoted through channels beyond standard regulatory protections. APhA cautioned that such products could subject patients to notable hazards such as contamination, imprecise dosing, fake components, and severe adverse health outcomes.

"Pharmacists support innovation, yet it must rest on science and patient safety," stated Brigid Groves, PharmD, MS, vice president of professional affairs at APhA. "When patients seek peptide products from unregulated online sources of uncertain quality, concern is warranted. Pharmacists have observed directly how safe and effective peptide-based medications can enhance patient outcomes when backed by strong clinical evidence, suitable regulatory oversight, and established quality standards."

Compounding pharmacists have long assisted patients in obtaining customized and safely prepared treatments when a genuine clinical need exists. Should rigorous peer-reviewed research ultimately confirm that these peptides are safe and effective, pharmacists will serve a key function in preparing high-quality compounded formulations, informing patients, and directing these therapies through regulated pharmacies instead of unregulated online sources.

In its comments, APhA observed that pharmacists currently lack adequate evidence to confidently advise patients on many of the peptide substances under review, including their efficacy, safety profiles, drug interactions, and long-term health impacts. Given the limited clinical data available, APhA endorses the FDA recommendation not to include the nominated peptide substances on the Section 503A Bulks List at this time.

APhA also urged the FDA to enhance education initiatives for patients and health care professionals while collaborating with state boards of pharmacy, the United States Pharmacopeia, and pharmacists nationwide to bolster oversight, quality standards, and patient awareness. APhA further advocated for ongoing scientific research to better determine the safety and effectiveness of peptide therapies and guide future regulatory choices.

About the American Pharmacists Association

Founded in 1852, APhA is the sole 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 optimizing medication use and patient health outcomes while ensuring access to pharmacists' care. This occurs through strong advocacy, high-quality education, practice tools and resources, dissemination of evidence, and member engagement opportunities. APhA serves as the pharmacy voice in shaping national guidelines, policies, and best practices that advance the profession and patient care.

SOURCE American Pharmacists Association