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# Insufficient Data on 7 Peptides for Potential Compounding Use: FDA
- URL: https://www.fdaweb.com/insufficient-data-on-7-peptides-for-potential-compounding-use-fda/
- Published: 2026-07-06T12:00:00.000Z
- Updated: 2026-09-14T13:42:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161411

FDA [briefing materials](https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026?ref=fdaweb.com#event-materials) show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven peptide substances that could become eligible for compounding by traditional pharmacies if they are ultimately added to the agency's Section 503A Bulks List. The reviewers generally found that the available clinical data are insufficient to establish a favorable benefit-risk profile for the substances under consideration. The materials were posted in advance of the agency’s planned 7/23-24 Pharmacy Compounding Advisory Committee (PCAC) meeting that will review the substances

The committee will consider BPC-157, KPV, TB-500 and MOTS-c on 7/23, followed by emideltide (DSIP), Semax and Epitalon on 7/24\. The panel will evaluate whether each substance meets the statutory criteria for inclusion on the list, which identifies bulk drug substances that may be used by 503A compounding pharmacies under certain conditions.

The meeting comes amid heightened interest in peptide therapies following comments earlier this year by HHS secretary **Robert F. Kennedy Jr.** supporting efforts to establish a regulated pathway for certain peptides. The review also has drawn attention because several newly appointed advisory committee members reportedly have experience prescribing peptide therapies or practicing longevity medicine, prompting questions about the panel's composition.

While the committee's recommendations are nonbinding, they will help inform FDA's decision on whether any of the peptides should be added to the 503A Bulks List through future rulemaking. Compounding pharmacies would not be permitted to compound the substances solely based on a favorable advisory committee vote.