FDA Advisory Committee to Review Seven Peptides for Potential Use in Compounding

The U.S. Food and Drug Administration (FDA) will meet later this month, July 23-24, 2026, to discuss whether seven peptide substance should be added to the agency’s Section 503A Bulks List, which would permit their use in compounded medications.

The Pharmacy Compounding Advisory Committee meeting comes amid growing public interest in metabolic health, regenerative medicine and longevity-focused therapies. If added to the bulks list, these peptides could become available for 503A compounding pharmacies.

What the Committee Will Review

According to the FDA, the committee will spend two days reviewing scientific information and public comments related to seven peptide categories. The substances are being evaluated for specific proposed uses submitted by nominators.

July 23 Agenda

The committee will discuss:

• BPC-157 (free base and acetate) for ulcerative colitis.
• KPV (free base and acetate) for wound healing and inflammatory conditions.
• TB-500 (free base and acetate) for wound healing.
• MOTS-c (free base and acetate) for obesity and osteoporosis.

July 24 Agenda

The committee will discuss:

• Emideltide (DSIP) (free base and acetate) for opioid withdrawal, chronic insomnia and narcolepsy.
• Semax (free base and acetate) for cerebral ischemia, migraine and trigeminal neuralgia.
• Epitalon (free base and acetate) for insomnia.

Representatives of organizations that nominated these substances will be invited to present information supporting their inclusion on the bulks list. The FDA has also established a public docket and will accept comments from interested stakeholders.

Why It Matters

Under federal law, traditional compounding pharmacies operating under Section 503A may compound medications using certain bulk drug substances when regulatory requirements are met. The FDA periodically reviews nominated substances to determine whether they should be included on the 503A Bulks List.

The advisory committee’s role is to evaluate available evidence and provide recommendations to the agency. Those recommendations are advisory and non-binding; the FDA retains final decision-making authority. However, advisory committee discussions often provide insight into how regulators view the quality of evidence supporting nominated substances.

What We Know

The FDA has released briefing materials for each of the substances under review and plans to make additional meeting materials and webcast information available through the advisory committee website.

The FDA released the committee roster on June 29.

Media coverage surrounding the upcoming FDA meeting has focused on both the scientific evidence supporting peptide use and the makeup of the advisory committee itself. Reuters reported that FDA staff reviewers found limited evidence supporting the effectiveness of the seven peptides under review and cited a lack of adequate human studies.

Meanwhile, Associated Press reporting highlighted the professional backgrounds of several newly appointed committee members, noting that some have experience in businesses that prescribe, compound or market peptide therapies.

NBC News reported that supporters of expanded access argue that permitting regulated compounding could provide an alternative to the largely unregulated online peptide marketplace.

What Happens Next

The Pharmacy Compounding Advisory Committee meeting will be held July 23-24, with virtual participation available to the public. Following the committee’s discussions and recommendations, the FDA will continue its review process and determine whether any of the nominated substances should be added to the Section 503A Bulks List.