FDA Advisory Panel Recommends Six Peptides for Compounding Pharmacies

During a two-day meeting of the Pharmacy Compounding Advisory Committee on July 23-24, the panel voted to recommend that the U.S. Food and Drug Administration allow specialty compounding pharmacies to prepare six unapproved injectable peptides—BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. The recommendation is non-binding; the FDA must still review the advisory record, public comments and staff analyses before issuing any rule, a process that could take up to a year. The committee rejected a seventh peptide, emideltide, citing “especially weak evidence” for its proposed uses in narcolepsy and opioid withdrawal.

FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What's next? FDA Advisers Back Looser Rules For Six Peptides, Reject One (1) GizmodoReutersNOTUSUsNews and World ReportPolitico

Peptides are short chains of amino acids that include FDA-approved drugs such as insulin and GLP-1 agonists. A growing online “gray market” has supplied unregulated peptide products marketed for wound healing, weight loss and anti-aging claims. In 2023 the Biden administration placed nearly 20 injectable peptides on a restricted “Category 2” list, barring their compounding. Health and Human Services Secretary Robert F. Kennedy Jr.—who has publicly endorsed peptide use—appointed eight of the committee’s 19 members, many of whom run clinics that sell the substances.

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• Peptides recommended for compounding: BPC-157, KPV, TB-500, MOTS-c, Epitalon, Semax.

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• Peptide rejected: emideltide.

FDA Advisers Back Looser Rules For Six Peptides, Reject One (1)

• The advisory panel consists of 14 voting members; votes for the six peptides were narrow, with the newly appointed members—all with industry ties—voting in favor.

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• Analysts estimate a legalized peptide market could be worth $2 billion to $3 billion.

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• Robert F. Kennedy Jr. described himself as a “big fan” of the drugs and said he wants “regulated access” to shift demand away from the black market.

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• FDA staff scientists unanimously opposed adding any of the six peptides, citing insufficient clinical-trial data, batch-to-batch variability and the risk of immune reactions.

FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What's next?

• Dr. James LaValle, International Peptide Society, warned that “the biggest concerns from the FDA side” relate to safety and lack of standardized testing.

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• “I’m going to continue using it,” — Mike Stone, gray-market peptide supplier

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• “It’s impossible for me to not take the FDA’s recommendations at heart with respect to safety and efficacy,” — Kevin Zacharoff, clinical assistant professor, Stony Brook University

FDA Advisers Back Looser Rules For Six Peptides, Reject One (1)

• “The committee weighed the evidence, followed the science and stood up for medical freedom,” — Lee Rosebush, pharmacist and lawyer

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• “I think they should take a step back and say: how do we validate safety and efficacy for a product that is consumer-driven, that is all over the consumer space, without sacrificing consumer access?” — Jeff Cohen, co-founder, American Peptide Association

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If the FDA adopts the panel’s recommendations, patients could obtain peptide injections through licensed pharmacies with a physician’s prescription, potentially reducing exposure to contaminated gray-market products. The move would also create a regulatory pathway that bypasses the standard investigational new drug (IND) process, raising concerns about limited safety monitoring and post-market surveillance.

FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What's next?

The FDA will publish proposed rules based on the advisory record and open a comment period. Although not obligated to follow the panel’s advice, the agency has historically aligned with advisory recommendations. A final decision could arrive later in 2027 after the review and public comment period.

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