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
Current 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 2026-05-23 · Federal Register + openFDA recalls, last 30 days
Material events
- Fed Register 2026-05-01 · matches: semaglutide, tirzepatideList of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the…
- Fed Register 2026-04-30Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal
The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy Compound…
Other recent activity (4) — lower relevance, expand to view
- 2026-05-20 Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program
- 2026-05-18 Modernizing NRC Regulations for Byproduct Material Use
- 2026-05-07 Advisory Committee; Blood Products Advisory Committee; Renewal
- 2026-04-27 Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal
Proposed for move to Category 1 (15)
Named in the Feb 2026 policy signal. No formal Federal Register rule yet.
| Peptide | Current status | Proposed | 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 | 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 | 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 | C Emerging Phase 1 | — |
| DSIP delta sleep inducing peptide, emideltide | Category 2 | Category 1 | D Preclinical Preclinical | 2023-09-29 |
| Epitalon epithalon, epithalone, aged Synthetic tetrapeptide studied for telomerase activation. Russian preclinical studies. | Category 2 | Category 1 | 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 | 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 | 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 | C Emerging Phase 2 | — |
| Kisspeptin-10 kisspeptin, kiss1 Some Phase 1 human studies in reproductive endocrinology. | Category 2 | Category 1 | 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 | D Preclinical Preclinical | 2023-09-29 |
| MOTS-c motsc, mots c, mitochondrial peptide Mitochondrial-derived peptide. Limited preclinical data. | Category 2 | Category 1 | D Preclinical Preclinical | 2023-09-29 |
| Selank selank acetate, tp-7 Russian-developed anxiolytic peptide. Removed from Category 2 Sept 2024. | Removed | Category 1 | C Emerging Phase 2 | — |
| Semax semax acetate Russian-developed nootropic. Approved in Russia, not FDA-approved. | Category 2 | Category 1 | 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 | 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 | 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
Public changelog
-
2026-04-17
Initial tracker publication.