The FDA advisory panel began a two-day review to determine whether seven popular peptides should be allowed to be compounded by licensed pharmacies for patients with prescriptions. FDA staff warned there is little clinical evidence supporting the safety and effectiveness of these substances, while telehealth companies argued that legal compounding would shift a risky gray market into regulated channels. Regulators urged companies to file investigational new drug applications and conduct human trials to establish safety and dosing.
FDA Advisory Panel Weighs Whether Pharmacies Should Compound Seven Popular Peptides
FILE PHOTO: FILE PHOTO: A U.S. Food and Drug Administration (FDA) logo, a syringe and a vial are seen in this illustration taken May 13, 2025. REUTERS/Dado Ruvic/Illustration/File Photo/File Photo
Advisers to the U.S. Food and Drug Administration opened a two-day review to decide whether seven increasingly popular peptides should be allowed to be compounded by state-licensed pharmacies for patients with prescriptions. The meeting pits FDA staff concerns over limited safety data against telehealth companies and industry advocates who say regulated compounding would curb a risky gray market.
Debate Over Safety Versus Access
FDA staff told the panel they do not support broad compounding of these seven peptides, saying the products lack the clinical trial evidence needed to demonstrate safety and effectiveness. Agency officials stressed that compounded products are not FDA-approved and are not subject to the same labeling requirements as approved medicines, which can leave patients without clear dosing or safety information.
Industry Pushes For Regulation
Telehealth firms and other industry representatives argued that allowing compounding under regulated pharmacy practice would bring the market under closer oversight and improve patient safety. Analysts cited during the meeting estimate the market could expand rapidly to roughly $2 billion–$3 billion if these uses were legitimized.
'A no vote would not end those distribution channels or use. It would instead move it deeper into a market with no production or sourcing standards, no physician, no monitoring, and no record,' said Anant Vinjamoori, chief medical officer at Hims & Hers, during the public comment period.
Regulatory Context And Calls For Trials
The panel was asked to consider whether each peptide should be designated as eligible for compounding under pharmacy practice when prescribed by a licensed clinician. The Biden administration in 2023 flagged nearly 20 peptides for safety concerns and prohibited legal compounding of some. In April, Health Secretary Robert F. Kennedy Jr. reclassified 12 peptides as Category 1 — a first administrative step toward allowing certain peptides to be compounded under the 503A framework.
FDA speakers at the meeting urged companies to pursue investigational new drug (IND) applications and to conduct controlled human trials to evaluate safety, dosing and effectiveness. Agency reviewers previously recommended against permitting state-licensed compounding pharmacies to prepare these specific peptides without more evidence.
Peptides In Focus: BPC-157 And TB-500
Two of the compounds under discussion, BPC-157 and TB-500, have attracted notable attention online. BPC-157 is being investigated for potential benefits in ulcerative colitis, while TB-500 is being studied for wound healing. Telehealth executives and clinicians said regulated compounding and formal studies would improve supply-chain standards and create opportunities for proper clinical evaluation.
'Many of my patients are already using these drugs — they are just getting them from the worst possible places,' said Jessica Duncan, chief medical officer at telehealth provider Ivim Health. Reporters Sriparna Roy, Sneha S K and Amina Niasse contributed to the reporting.
Help us improve.
