FDA PCAC · July 23–24, 2026
FDA Pharmacy Compounding Advisory Committee (PCAC) — meeting of July 23–24, 2026. Each vote decides whether the committee recommends adding the peptide to the 503A bulk drug substances list (whether compounding pharmacies may make it). A majority Yes = recommended.
Each free-base and acetate question remains a separate row—even when the result was identical. “Favorable” describes the advisory committee’s response to a 503A Bulks List question; it is not FDA approval and did not itself change legal status.
| Subject | Form | PCAC result | Vote tally | Margin | Composition | FDA staff | Recording |
|---|---|---|---|---|---|---|---|
| BPC-157DAY 1 · QUESTION 1/2 · OPEN DOSSIER | free base | Favorable | 8–6–1YES · NO · ABSTAIN · n=15 | +2 | Recommended against inclusion | ▶04:43:06.628 | |
| BPC-157DAY 1 · QUESTION 2/2 · OPEN DOSSIER | acetate | Favorable | 8–6–1YES · NO · ABSTAIN · n=15 | +2 | Recommended against inclusion | ▶04:52:49.520 | |
| KPVDAY 1 · QUESTION 1/2 · OPEN DOSSIER | free base | Favorable | 8–6–1YES · NO · ABSTAIN · n=15 | +2 | Recommended against inclusion | ▶07:06:35.280 | |
| KPVDAY 1 · QUESTION 2/2 · OPEN DOSSIER | acetate | Favorable | 8–6–1YES · NO · ABSTAIN · n=15 | +2 | Recommended against inclusion | ▶07:14:04.400 | |
| TB-500DAY 1 · QUESTION 1/2 · OPEN DOSSIER | free base | Favorable | 8–6–1YES · NO · ABSTAIN · n=15 | +2 | Recommended against inclusion | ▶09:48:41.276 | |
| TB-500DAY 1 · QUESTION 2/2 · OPEN DOSSIER | acetate | Favorable | 8–6–1YES · NO · ABSTAIN · n=15 | +2 | Recommended against inclusion | ▶09:54:13.756 | |
| MOTS-cDAY 1 · QUESTION 1/2 · OPEN DOSSIER | free base | Favorable | 7–5–2YES · NO · ABSTAIN · n=14 | +2 | Recommended against inclusion | ▶11:33:43.680 | |
| MOTS-cDAY 1 · QUESTION 2/2 · OPEN DOSSIER | acetate | Favorable | 7–5–2YES · NO · ABSTAIN · n=14 | +2 | Recommended against inclusion | ▶11:38:51.840 | |
| Emideltide (DSIP)DAY 2 · QUESTION 1/2 · OPEN DOSSIER | free base | Unfavorable | 6–7–1YES · NO · ABSTAIN · n=14 | -1 | Recommended against inclusion | ▶03:15:17.600 | |
| Emideltide (DSIP)DAY 2 · QUESTION 2/2 · OPEN DOSSIER | acetate | Unfavorable | 6–7–1YES · NO · ABSTAIN · n=14 | -1 | Recommended against inclusion | ▶03:22:37.359 | |
| EpitalonDAY 2 · QUESTION 1/2 · OPEN DOSSIER | free base | Favorable | 7–4–1YES · NO · ABSTAIN · n=12 | +3 | Recommended against inclusion | ▶04:54:31.680 | |
| EpitalonDAY 2 · QUESTION 2/2 · OPEN DOSSIER | acetate | Favorable | 7–4–1YES · NO · ABSTAIN · n=12 | +3 | Recommended against inclusion | ▶05:01:31.680 | |
| SemaxDAY 2 · QUESTION 1/2 · OPEN DOSSIER | free base | Favorable | 8–5–1YES · NO · ABSTAIN · n=14 | +3 | Recommended against inclusion | ▶07:52:36.958 | |
| SemaxDAY 2 · QUESTION 2/2 · OPEN DOSSIER | acetate | Favorable | 8–5–1YES · NO · ABSTAIN · n=14 | +3 | Recommended against inclusion | ▶08:04:42.558 |
8 ballots captured from the vote boards and the live webcast, showing who voted how. These are a different unit from the fourteen form-level questions above, and do not map one-to-one onto them.
Every listed member and how they voted on each captured ballot. Support = Yes ÷ (Yes + No); abstentions and not-eligible topics are excluded from the denominator. Y = Yes · N = No · A = Abstain · – = not eligible or not present. Built from the 8 transcribed roll-call ballots.
| # | BPC-fb | BPC-ac | KPV | TB-500 | MOTS-c | Emid (provisional) | Epit (provisional) | Semax (provisional) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 01 | No opposing votes | Y | Y | Y | Y | Y | Y | Y | Y | 8 | 100% | |||
| 02 | No opposing votes | Y | Y | Y | Y | Y | Y | Y | Y | 8 | 100% | |||
| 03 | No opposing votes | Y | Y | Y | Y | Y | Y | Y | Y | 8 | 100% | |||
| 04 | No opposing votes | Y | Y | Y | Y | Y | Y | Y | Y | 8 | 100% | |||
| 05 | No opposing votes | Y | Y | Y | Y | Y | Y | Y | Y | 8 | 100% | |||
| 06 | No opposing votes | Y | Y | Y | Y | A | Y | Y | Y | 7 | 1 | 100% | ||
| 07 | No opposing votes | Y | Y | Y | Y | Y | – | – | Y | 6 | 2 | 100% | ||
| 08 | Split voter | Y | Y | Y | Y | Y | N | Y | Y | 7 | 1 | 88% | ||
| 09 | Costantino Iadecola, MDNo supporting votes | – | – | – | – | – | – | – | N | 1 | 7 | 0% | ||
| 10 | Friedhelm Sandbrink, MDNo supporting votes | – | – | – | – | – | – | – | N | 1 | 7 | 0% | ||
| 11 | No supporting votes | – | – | – | – | – | N | – | – | 1 | 7 | 0% | ||
| 12 | No supporting votes | N | N | – | – | – | – | – | – | 2 | 6 | 0% | ||
| 13 | No supporting votes | – | – | N | N | – | – | – | – | 2 | 6 | 0% | ||
| 14 | No supporting votes | N | N | N | N | N | N | – | – | 6 | 2 | 0% | ||
| 15 | No supporting votes | N | N | N | N | N | N | N | – | 7 | 1 | 0% | ||
| 16 | No supporting votes | N | N | N | N | N | N | N | N | 8 | 0% | |||
| 17 | No supporting votes | N | N | N | N | N | N | N | N | 8 | 0% | |||
| 18 | No supporting votes | N | N | N | N | N | N | N | N | 8 | 0% | |||
| 19 | Abstained throughout | A | A | A | A | A | A | A | A | 8 | — |
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