A4M and the International Peptide Society Welcome PCAC Recommendations Supporting Inclusion of Six Reviewed Peptides on the 503A Bulk List
This advisory vote marks a pivotal step toward advancing a regulated, evidence-informed compounding pathway for patients and providers to access clinically important peptides.
Boca Raton, FL, Aug. 04, 2026 (GLOBE NEWSWIRE) -- The American Academy of Anti-Aging Medicine (A4M) and the International Peptide Society (IPS) today welcomed the recommendation issued by the U.S. Food and Drug Administration's Pharmacy Compounding Advisory Committee (PCAC), which voted last week to recommend adding six of seven reviewed peptides to the Section 503A Bulk Drug Substances List — the federal list of bulk drug substances that may be used in compounding pharmacies under Section 503A when all applicable statutory and regulatory requirements are met.
Meeting July 23–24, 2026, at the FDA's White Oak Campus, the committee recommended BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax for inclusion, while declining to recommend emideltide (delta sleep-inducing peptide). FDA elected to proceed with PCAC review of the seven peptide-related bulk drug substances as part of its ongoing evaluation of the Section 503A Bulks List.
Jim LaValle, RPh, CCN, MT — Chair of the International Peptide Society and Chair of the A4M Peptide Certification Program — attended the full two-day meeting at White Oak and provided expert testimony to the committee, in his individual capacity as a clinical pharmacist and peptide-therapeutics educator, on the clinical relevance and responsible use of the peptides under review.
A4M and IPS emphasize that the committee's recommendation are advisory and non-binding . It does not make these peptides FDA-approved drugs, and it does not change what is legally permitted to be compounded today. Before any of the six peptides could be lawfully compounded under Section 503A. The FDA must still determine whether to accept the recommendations and, if it proceeds, complete formal rulemaking before the substances can be added to the Section 503A Bulks List. That process could extend into 2027 or beyond. Both organizations view the vote as an important signal that a science-based, transparent pathway for evaluating peptides is being restored.
“This recommendation is a meaningful step toward restoring a more accountable, evidence-based pathway for peptide review - one that could help keep patient care within licensed clinical and pharmacy channels and reduce reliance on products marketed for research use,” said Jim LaValle, RPh, CCN, MT, who testified before the committee last week and serves as Chair of the International Peptide Society, Chair of the A4M Peptide Certification Program, and a member of A4M's Scientific Committee. “But a recommendation is not an approval, and it does not change what may legally be compounded today. The science, safety, product quality, and regulatory status of each substance remain critical. Our responsibility as educators is to help clinicians understand these distinctions so they can evaluate and, when legally permitted and clinically appropriate, integrate peptide therapies responsibly and effectively as new opportunities emerge.”
For more than a decade, A4M and IPS have provided responsible, balanced education on peptide therapeutics through the A4M Peptide Certification Program and the IPS peptide monograph library, equipping clinicians with training grounded in peptide research, mechanisms, safety, regulatory status, and real-world clinical application. As the regulatory environment continues to evolve, both organizations remain committed to evidence-informed education that helps practitioners make sound clinical decisions rather than relying on hype or fragmented information.
A4M and IPS will continue to monitor the FDA's next steps and will provide members and the broader clinical community with timely updates and guidance as the rulemaking process advances.
About the American Academy of Anti-Aging Medicine (A4M)
The American Academy of Anti-Aging Medicine (A4M) is a leading organization dedicated to the advancement of longevity, regenerative, and integrative medicine. Through world-class continuing medical education, certification programs, and scientific conferences, A4M trains healthcare professionals worldwide in emerging therapies and evidence-based clinical practice.
About the International Peptide Society (IPS)
The International Peptide Society (IPS) is dedicated to advancing the responsible clinical use of peptide therapies through education, research, and the development of peer-reviewed peptide monographs. IPS supports allied healthcare professionals in the safe, evidence-based application of peptide therapeutics.
Elizabeth Wheeler VP of Operations Informa Connect | Medical Division 561-997-0112 ext 7531 Liz.wheeler@informa.com
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