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Legal status tracker
Where each peptide actually stands with the FDA, updated as it changes. Removal from Category 2 is not the same as Category 1, and an advisory vote is not an agency action — this table keeps those apart.
Read this before using the table
None of the substances below are approved drugs for the uses they're marketed for online. Several are prescription-only, and some are prohibited outright in other countries. Nothing here is medical or legal advice, and the position changes — check the review date at the top.
| Compound | Status | What that means | Changed |
|---|---|---|---|
| BPC-157 | Removed from Category 2 | Not Category 1. Not an approved medicine, not a lawful supplement ingredient. | 15 Apr 2026 |
| TB-500 (thymosin beta-4) | Removed from Category 2 | Same position as BPC-157. Reviewed by the advisory committee in July 2026; a recommendation is not an agency action. | 15 Apr 2026 |
| Thymosin alpha-1 | Removed from Category 2 | Under review for compounding eligibility. Prescription channel only, if it reaches Category 1. | 15 Apr 2026 |
| PT-141 (bremelanotide) | Removed from Category 2 | Approved as a branded medicine for a specific indication. Grey-market sale remains unlawful. | 15 Apr 2026 |
| Semaglutide | Proposed 503B exclusion | Approved medicine. FDA has proposed, not finalized, not to list it on the 503B bulks list. Shortage resolved 21 Feb 2025. | 30 Apr 2026 |
| Tirzepatide | Proposed 503B exclusion | Approved medicine. FDA has proposed, not finalized, not to list it on the 503B bulks list. Shortage first declared resolved 2 Oct 2024; determined resolved again 19 Dec 2024. | 30 Apr 2026 |
| Retatrutide | Investigational | Not approved anywhere. Named repeatedly in 2026 FDA warning letters to online sellers. | 24 Aug 2026 |
| GHK-Cu (topical) | Lawful cosmetic ingredient | Lawful in topical cosmetic use in the US, UK and EU, subject to claims rules. Injectable forms are not. | 12 Jan 2026 |
| Matrixyl 3000 | Lawful cosmetic ingredient | Appearance claims only. | 12 Jan 2026 |
| Argireline | Lawful cosmetic ingredient | Appearance claims only. | 12 Jan 2026 |
| Collagen peptides | Lawful dietary ingredient | Established ingredient; structure/function claims with the DSHEA disclaimer. | 3 Nov 2025 |
| Melanotan II | Prohibited (Australia) | Reclassified to Schedule 9 in Australia, Feb 2026 — the same schedule as MDMA and heroin. Unapproved drug in the US. | 18 Feb 2026 |
| Epitalon | Unapproved drug | No approved status in any major market. | 30 Sep 2025 |
| MOTS-c | Unapproved drug | Investigational only; not lawful for human sale. | 30 Sep 2025 |
| Kisspeptin | Investigational | Real human trials exist, but only in research settings — not an approved drug for any use. | 1 Oct 2026 |
| AOD-9604 | Development discontinued | A completed 536-person Phase 2b trial found no significant weight loss versus placebo; sponsor halted the program in 2007. | 11 Sep 2026 |
| Sermorelin | Discontinued (not for safety) | FDA confirms its 2008 US withdrawal was commercial, not a safety finding. Available only via compounding now. | 11 Sep 2026 |
| CJC-1295 | Rejected for Category 1 | FDA's advisory committee voted against compounding eligibility, 4 Dec 2024. | 11 Sep 2026 |
| Ipamorelin | Rejected for Category 1 | FDA's advisory committee voted against compounding eligibility, 29 Oct 2024. | 11 Sep 2026 |
| Hexarelin | Unapproved drug | No approved status anywhere; listed as "examorelin" under WADA's S2 category. | 11 Sep 2026 |
| GHRP-2 (pralmorelin) | Approved (Japan, diagnostic only) | A single-dose GH-reserve test, not a repeated-use treatment. Not approved in the US. | 11 Sep 2026 |
| GHRP-6 | Unapproved drug | Never approved anywhere, for anything. | 11 Sep 2026 |
| Cagrilintide / CagriSema | Not approved; filing reported | Novo Nordisk reports a December 2025 FDA filing; not approved, and no FDA decision announced as of 1 Oct 2026. | 1 Oct 2026 |
| Gonadorelin | Discontinued | FDA’s records list both branded products as discontinued; the reason is not stated. Available only via compounding now. | 1 Oct 2026 |
| Semax | Recommended for Category 1 | FDA advisory committee recommendation, 23-24 July 2026 — not yet an agency action. Registered pharmaceutical in Russia/Ukraine only. | 12 Sep 2026 |
| DSIP (emideltide) | Rejected for Category 1 | FDA's advisory committee voted it down 6-7, 23-24 July 2026 — the only one of seven reviewed peptides rejected. | 12 Sep 2026 |
| KPV | Recommended for Category 1 | FDA advisory committee recommendation, 23-24 July 2026, 8-6 with one abstention — not yet an agency action. No published human trial exists. | 12 Sep 2026 |
| TRH (protirelin) | Discontinued (US manufacturing) | The only FDA-approved US preparation stopped being manufactured in 2002. No dedicated trial supports today's off-label wellness use. | 12 Sep 2026 |
| Selank | Category 2, restricted | Not among the 12 peptides removed from Category 2 in April 2026, nor among the 7 reviewed by the advisory committee in July 2026. | 12 Sep 2026 |
| Human Growth Hormone | Controlled substance (Schedule III) | Approved for real deficiency states. Prohibited in all sport at all times under WADA's S2 category. | 12 Sep 2026 |
| Pramlintide | Discontinued (not for safety) | Approved 2005, discontinued by its manufacturer in late 2025 after two decades on market. | 12 Sep 2026 |
| Exenatide | Discontinued (not for safety) | Approved 2005 — the original GLP-1 drug. Discontinued by AstraZeneca in October 2024. | 12 Sep 2026 |
| Calcitonin | Approved, label updated 2014 | FDA's 2013 review found a real cancer signal in pooled trial data (4.1% vs 2.9%); label updated, no boxed warning added. | 12 Sep 2026 |
| Nesiritide | Approved, use sharply reduced | A large 2011 outcomes trial found no confirmed mortality harm — but also no meaningful clinical benefit. | 12 Sep 2026 |
How to read "removed from Category 2"
In April 2026 the FDA removed twelve peptides — including BPC-157 and thymosin beta-4 — from Category 2 of the interim 503A bulk substances list. Category 2 flags substances with significant safety concerns. Removal means the agency no longer applies that flag.
It does not place them in Category 1, and Category 1 is the status that makes a bulk substance eligible for compounding under section 503A. The agency's advisory committee reviewed the substances in July 2026 and recommended six of them; a committee recommendation is not an agency action either.
So the practical position today: these remain unapproved drugs. If and when they reach Category 1, the effect is that a licensed compounding pharmacy may prepare them on a prescription. Nobody expects over-the-counter access. BPC-157 specifically gets its own full breakdown on why "removed from Category 2" isn't legalisation.
If you're looking for a legitimate route
There are real ones, and they don't involve buying a vial labelled "for research use only":
- Approved peptide medicines on prescription — prescribed by a licensed clinician and dispensed by a licensed pharmacy.
- Compounded preparations on a valid prescription, where the substance is actually eligible for compounding.
- Clinical trials, which are free to join and are the only legitimate route to genuinely investigational compounds.
- Expanded access programmes, for serious conditions where standard treatment has failed.
We don't earn anything from telling you that, and we don't take referral fees from clinics. If that ever changes it will be disclosed on this page before it happens. The full version of this question, including why we won't link to grey-market sellers, is on how to get peptides and where to buy peptides safely. If you want to see which grey-market sellers already have a formal FDA warning letter against them, see FDA warning letters to peptide vendors.