PCAC Recommended Six Peptides. FDA Has Not Added Them.

Status as of October 3, 2026: FDA’s Pharmacy Compounding Advisory Committee (PCAC) met on July 23–24, 2026. It voted to recommend adding six peptides to the 503A bulks list and voted against a seventh. FDA has not added any of the seven to the final list. A committee recommendation is advice to FDA. It is not FDA approval, and it does not by itself permit compounding.

The short version

• Recommended by the committee: BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon (free base and acetate forms of each).
• Not recommended: Emideltide (DSIP).
• FDA’s own review: FDA’s briefing documents proposed that none of the seven be added to the list.
• Final list: The final 503A bulks list, 21 CFR 216.23(a), still contains six substances, and none is a peptide. The eCFR text is current through October 1, 2026; the section was last amended in 2019.
• Rulemaking: We found no FDA proposed rule to add these peptides in the Federal Register through October 3, 2026.

Reported votes

FDA had not posted minutes, a transcript, or official vote results on its meeting page when we checked on October 3, 2026. The counts below are as reported by McDermott Will & Schulte on July 27, 2026. STAT reported the same for-and-against counts for Semax (8–5), Epitalon (7–4), and DSIP (6–7) without listing abstentions. Some trackers label the day-two counts provisional until FDA posts its transcript. We will replace these with FDA’s official record when it is available.

Three separate events, three separate statuses

1. April 2026: the nominations were withdrawn

In April 2026, the parties that had nominated these peptides for the 503A bulks list withdrew their nominations. Because of that, FDA removed them from Category 2, its group of nominated substances that raise significant safety risks. The removal happened because the nominations were withdrawn. FDA did not find that the peptides were safe, and its safety page still lists its concerns about each one. Details: Peptides removed from Category 2 and the April 2026 category changes.

2. July 2026: the committee voted

FDA chose to present the seven substances to PCAC even though the original nominations had been withdrawn. FDA’s briefing documents proposed that none of the seven be added. The committee voted to recommend six of them anyway. PCAC is an advisory committee. FDA is not required to follow its votes.

3. Today: FDA’s final list has not changed

A substance is on the final 503A bulks list only if it appears in 21 CFR 216.23(a). To add one, FDA must publish a proposed rule, take public comments, and then issue a final rule. None of that has happened for these peptides. Check the current list on eCFR.

What the vote does not mean

• It does not mean FDA approved these peptides. None is an FDA-approved drug.
• It does not mean pharmacies may now compound them under section 503A. The vote did not change the final list.
• It does not resolve FDA’s safety concerns. FDA still publishes concerns about immunogenicity, impurities, and missing human safety data for these substances.
• It does not place the peptides in Category 1. FDA’s categories document (updated May 14, 2026) does not list any of the seven in Category 1, the group covered by FDA’s interim policy for substances under evaluation.

What happens next

If FDA accepts any of the recommendations, the next public step would be a proposed rule in the Federal Register with a comment period, followed by a final rule. FDA has not announced a timeline. FDA has said it intends to consult PCAC before the end of February 2027 about GHK-Cu, and reports of FDA’s April notice say the same timeline applies to LL-37, Dihexa acetate, PEG-MGF, and Melanotan II.

What prescribers should do now

1. Describe status with a date and the specific event, for example: “PCAC recommended adding BPC-157 on July 23, 2026. As of October 3, 2026, FDA has not added it to the final 503A bulks list.”
2. Before prescribing, ask the dispensing pharmacy which legal pathway it relies on, and get legal review where needed. A prescription alone does not make a compounded product compliant with federal and state requirements.
3. Update consent forms, staff scripts, and patient materials that describe the July meeting as upcoming or describe the vote as approval.
4. Watch the Federal Register and eCFR for a proposed or final rule before changing your practice.

About this update

This page was first published on April 19, 2026 as a preview of the July meeting agenda. It was rewritten after the meeting, with sources checked on October 3, 2026.