Regulatory Tracker
The 2026 Peptide Reclassification Tracker
Every 503A Category 2 and removed-from-list peptide in the reclassification scope — current regulatory status, proposed status, and the source documents behind each entry.
19
Peptides in scope
15
Proposed for Category 1 move
4
Expected to remain Category 2
FDA advisory committee (PCAC) votes on seven peptides
7
Peptides reviewed
6
Recommended by panel
1
Rejected by panel
0
Legal changes this week
On July 23–24, 2026, the FDA's Pharmacy Compounding Advisory Committee (PCAC) reviewed seven peptides and voted to recommend six of them — BPC-157, TB-500, KPV, MOTS-c, Semax, and Epitalon — for the Section 503A bulk drug substances list. It rejected the seventh, emideltide (DSIP). The recommendations went against the FDA's own scientific staff, who had advised against all seven.
What a recommendation is: A PCAC recommendation is advice, not law. It does NOT approve these peptides, does NOT move them into Category 1, and does NOT by itself make it lawful for a 503A pharmacy to compound them. For any of these to reach the 503A Bulks List, the FDA must run a full notice-and-comment rulemaking and publish a final rule — which has not happened. Legal analysts put the realistic timeline at eight to twelve months, and the FDA is not required to follow its advisers. Current regulatory status is unchanged.
Full breakdown in our letter: An FDA panel just overruled its own scientists on six peptides.
Earlier policy signal
Dated 2026-02-27
HHS Secretary Robert F. Kennedy Jr. stated on The Joe Rogan Experience that HHS intends to move 14 of 19 Category 2 peptides back to Category 1. As of this update, no formal rule change has been published in the Federal Register. Current regulatory status is unchanged.
What this means right now: compounding pharmacies operating under 503A cannot legally compound any Category 2 peptide. That restriction remains in effect until FDA publishes a formal rule change in the Federal Register. The peptides listed here as "pending" are on a policy path toward Category 1 but have not yet moved.
Recent FDA activity
Auto-scanned 2026-09-07 · Federal Register + openFDA recalls, last 120 days
Proposed for move to Category 1 (15)
Named in the Feb 2026 policy signal. The Panel vote column shows the July 2026 PCAC recommendation where one was made — advisory only. No formal Federal Register rule has published yet.
| Peptide | Current status | Proposed | Panel vote PCAC, Jul 2026 | Evidence | Last FDA action |
|---|---|---|---|---|---|
| AOD-9604 aod9604, aod 9604, anti-obesity drug 9604 Fragment of HGH. Removed from Category 2 Sept 2024. | Removed | Category 1 | Not reviewed | C Emerging Phase 2 | — |
| BPC-157 bpc 157, body protection compound 157, bpc157 No human clinical trials for FDA approval. FDA denied BPC-157 nomination to 503A bulk drug substances list. Almost all published research is in rodent models. Included in Feb 2026 RFK Jr. reclassification announcement but NO formal rule change published as of Apr 2026. | Category 2 | Category 1 | Recommended 8–6, 1 abstention for ulcerative colitis | D Preclinical Preclinical | 2023-09-29 |
| CJC-1295 cjc1295, cjc 1295, mod grf 1-29 Removed from Category 2 on Sept 27, 2024 after nominator withdrawal. Legal status ambiguous — not prohibited but not authorized. Included in Feb 2026 reclassification announcement. | Removed | Category 1 | Not reviewed | C Emerging Phase 1 | — |
| DSIP delta sleep inducing peptide, emideltide Reviewed as emideltide. The only one of the seven peptides the July 2026 PCAC declined to recommend — the panel voted 6–7 against, citing a lack of safety and efficacy data for the reviewed uses. | Category 2 | Category 1 | Rejected 6–7, 1 abstention for insomnia, narcolepsy, opioid withdrawal | D Preclinical Preclinical | 2023-09-29 |
| Epitalon epithalon, epithalone, aged Synthetic tetrapeptide studied for telomerase activation. Russian preclinical studies. | Category 2 | Category 1 | Recommended 7–5, 1 abstention for insomnia | D Preclinical Preclinical | 2023-09-29 |
| GHK-Cu ghk copper, copper peptide ghk, ghk-copper Category 2 applies to injectable GHK-Cu. Topical copper peptide products sold as cosmetics are a separate regulatory category. Reclassification pending per Feb 2026 announcement. | Category 2 | Category 1 | Not reviewed | D Preclinical Preclinical | 2023-09-29 |
| GHRP-6 ghrp6, growth hormone releasing peptide 6 Growth hormone secretagogue. Some early human PK/PD data. | Category 2 | Category 1 | Not reviewed | C Emerging Phase 1 | 2023-09-29 |
| Ipamorelin ipamorelin acetate Removed from Category 2 on Sept 27, 2024. Some Phase 2 data exists. Included in Feb 2026 reclassification announcement. | Removed | Category 1 | Not reviewed | C Emerging Phase 2 | — |
| Kisspeptin-10 kisspeptin, kiss1 Some Phase 1 human studies in reproductive endocrinology. | Category 2 | Category 1 | Not reviewed | C Emerging Phase 1 | 2023-09-29 |
| KPV kpv tripeptide, alpha-msh fragment Anti-inflammatory tripeptide derived from alpha-MSH. Preclinical data only. | Category 2 | Category 1 | Recommended 8–6, 1 abstention for wound healing, inflammatory conditions | D Preclinical Preclinical | 2023-09-29 |
| MOTS-c motsc, mots c, mitochondrial peptide Mitochondrial-derived peptide. Limited preclinical data. | Category 2 | Category 1 | Recommended 7–5, 2 abstentions for obesity, osteoporosis | D Preclinical Preclinical | 2023-09-29 |
| Selank selank acetate, tp-7 Russian-developed anxiolytic peptide. Removed from Category 2 Sept 2024. | Removed | Category 1 | Not reviewed | C Emerging Phase 2 | — |
| Semax semax acetate Russian-developed nootropic. Approved in Russia, not FDA-approved. | Category 2 | Category 1 | Recommended 8–5, 1 abstention for cerebral ischemia, migraine, trigeminal neuralgia | C Emerging Phase 2 | 2023-09-29 |
| Thymosin Alpha-1 thymalfasin, ta1, zadaxin FDA-approved in over 30 countries outside the US (as Zadaxin). NOT FDA-approved in the US. Removed from Category 2 Sept 2024. Significant human clinical data exists from international trials. | Removed | Category 1 | Not reviewed | B Moderate Phase 3+ | — |
| Thymosin Beta-4 tb-500, tb500, tb 500 TB-500 is a synthetic fragment of thymosin beta-4. Both the full protein and the LKKTETQ fragment were moved to Category 2. Included in Feb 2026 reclassification announcement but no formal rule change yet. | Category 2 | Category 1 | Recommended 8–6, 1 abstention for wound healing | D Preclinical Preclinical | 2023-09-29 |
Expected to remain Category 2 (4)
FDA has flagged significant safety concerns; not in the announced reclassification scope.
| Peptide | Current status | Evidence | Notes |
|---|---|---|---|
| Dihexa n-hexanoic-tyr-ile-(6) aminohexanoic amide | Category 2 | D Preclinical Preclinical | Expected to remain Category 2. Potent HGF mimetic with safety concerns. |
| GHRP-2 ghrp2, growth hormone releasing peptide 2, pralmorelin | Category 2 | C Emerging Phase 1 | Expected to remain Category 2. |
| Melanotan II melanotan 2, mt-2, mt2 | Category 2 | C Emerging Phase 1 | Expected to REMAIN Category 2. Significant safety concerns including melanoma risk, cardiovascular events. FDA has flagged repeatedly. |
| PE-22-28 pe22-28 | Category 2 | D Preclinical Preclinical | Expected to remain Category 2. |
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Every entry on this tracker is sourced from a combination of the FDA's published 503A bulk drug substances list, Federal Register rulemaking documents, and official statements from HHS. Status changes are only recorded here once a primary source confirms them — we do not record rumor reporting.
Evidence levels reflect the highest tier of human clinical evidence available for the peptide in the peer-reviewed literature, not the quality of evidence supporting any specific compounded product.
When a peptide's regulatory status changes, the prior state is preserved in the public changelog below rather than overwritten. See our full editorial methodology for our bias-screening and compliance-review process.
Sources
- FDA 503A bulk drug substances Category 1/2 list (Sept 2023, Sept 2024)
- Federal Register Doc 2024-31546 (Jan 7, 2025)
- FDA — July 23–24, 2026 Meeting of the Pharmacy Compounding Advisory Committee
- RAPS — FDA advisory committee backs two more peptides, rejects one for compounding list (Day 2)
- STAT — FDA advisory panel narrowly rejects compounding of one peptide, backs two others
- FDA PCAC (Pharmacy Compounding Advisory Committee) meeting materials
Public changelog
-
2026-07-27
Recorded the July 23–24, 2026 PCAC vote: the committee recommended six of seven reviewed peptides (BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon) for the 503A bulks list and rejected emideltide (DSIP). Added the panel's per-peptide recommendation and vote count to each entry. These are non-binding advisory recommendations — no Federal Register rule has published and current regulatory status is unchanged.
-
2026-04-17
Initial tracker publication.