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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 | Compounding restricted | Shortage resolved 21 Feb 2025. Proposed for exclusion from the 503B bulks list. | 30 Apr 2026 |
| Tirzepatide | Compounding restricted | Shortage resolved Oct 2024. Proposed for exclusion from the 503B bulks list. | 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 controlled human trials exist, but only in research settings — not an approved drug for any use. | 11 Sep 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 |
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.