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# FDA Advisers Back Expanded Access to Several Compounded Peptides
- URL: https://www.fdaweb.com/fda-advisers-back-expanded-access-to-several-compounded-peptides/
- Published: 2026-07-24T12:00:00.000Z
- Updated: 2026-09-14T13:43:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161517

An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the agency's Section 503A Bulks List for pharmacy compounding, setting up a significant policy decision for the agency amid an ongoing debate over the safety and clinical evidence supporting the products. The two-day meeting of the Pharmacy Compounding Advisory Committee will conclude 7/24 after considering the inclusion of three additional peptides.

Panel members recommended four peptides on 7/23 — BPC-157, KPV, TB-500 and MOTS-C — for potential use in compounded prescriptions. At press time on 7/24, the panel had voted against recommending emideltide (also known as DSIP) because of limited safety and efficacy data. The committee is also considering Semax and Epitalon during the second day of deliberations.

The votes highlighted sharp divisions between FDA scientists and several committee members. FDA staff argued that the peptides lack adequate clinical evidence, have uncertain safety profiles and present regulatory challenges because many are not approved drugs in the U.S. Supporters countered that bringing the substances into the regulated compounding system would improve oversight of products that are already widely available through gray-market channels and online vendors.

The meeting also drew scrutiny because several newly appointed committee members have professional ties to the peptide industry, prompting criticism from some observers over potential conflicts of interest. HHS secretary **Robert F. Kennedy Jr**. has advocated expanding lawful access to compounded peptides, and the meeting is widely viewed as part of a broader effort by the administration to revisit FDA policy on these products.

Commenting on the panel recommendation for popular peptide BPC-157, Public Citizen noted that all eight votes in favor of adding the peptide to the compounding list were from committee members recently appointed by Kennedy, including physicians with conflicts of interest because they sell peptides, a compounding pharmacist, and a pharmacy business executive. “Kennedy is a strong proponent of unproven peptides, which he has used to treat his own injuries, and has pledged to end the FDA’s ‘war’ on peptides,” the group said.

“BPC-157 substances should go through the standard FDA approval process for new drugs and not be added to the 503A bulks list,” Public Citizen said. “Adding BPC-157 to the list would set a dangerous regulatory precedent and put patients at risk.”