U.S. regulatory status
Selank
Also known as Selank acetate, TP-7
Is Selank legal right now?
Selank sits in a regulatory gray area in the United States.
It was removed from Category 2 of the interim 503A bulks list in 2024 after its nomination was withdrawn - but removal from Category 2 does not place a substance on the 503A list or into Category 1, and the FDA has not stated it will exercise enforcement discretion for it. Legal analyses describe such peptides as being in limbo pending advisory committee review.
Selank is not among the seven peptides scheduled for the July 2026 PCAC meeting and has no set decision date, so its compounding status is unresolved.
In limbo: Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved.
Verified Sep 22, 2026 (ET) · status held since Sep 27, 2024
Where it sits in the process
- Nominated (stalled here - not advancing)
- Under review (not reached)
- Rulemaking (not reached)
- Compounding-legal (not reached)
Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.
What changed last
Removed from Category 2 after its nomination was withdrawn - not placed on the 503A list, so compounding remained unauthorized.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | In limbo | Removed from Category 2 (~Sept 2024); never in Category 1; not on the 503A list; no scheduled PCAC review. |
| Australia (TGA) | Unscheduled | Not individually named or scheduled in the Poisons Standard. |
| United Kingdom (MHRA) | Restricted | No UK marketing authorisation; supply for human use treated as an unlicensed medicine. |
| European Union (EMA) | Restricted | No EU marketing authorisation; Selank does not appear in the Union Register, so sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level. |
| Canada (Health Canada) | Restricted | Not authorized by Health Canada; a 2025 public advisory named Selank among seized unauthorized injectable peptide drugs, stating that selling unauthorized drugs is illegal in Canada. |
| Sport / anti-doping (WADA) | Restricted | Falls under S0 (non-approved substances); prohibited at all times for tested athletes. |
The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it
Sources & transparency
Sources for this entry
- FDA - 503A bulk drug substances: Category 1 & Category 2 lists FDA · primarySelank is not on the 503A list and was never in Category 1; the FDA 503A categories define compounding eligibility.
- MHRA Products database - search: selank UK gov · primaryBasis for the United Kingdom (MHRA) status row.
- Health Canada public advisory (Aug 1, 2025) Health Canada · primaryBasis for the Canada (Health Canada) status row.
- Union Register of medicinal products - active substance index EU · primaryBasis for the European Union (EMA) status row.
- Lexology - FDA removes five peptides from Category 2 (Sept 2024) AnalysisSelank acetate (TP-7) removed from Category 2 effective Sept 27, 2024 after the nomination was withdrawn; removal does not authorize compounding.
- Pharmacy Times - the peptide reclassification, explained AnalysisRemoval / Category 1 is not FDA approval; the mechanics are still working through the system.
- FDA Law Blog - FDA’s Pep(tide) Rally (Hyman, Phelps & McNamara) AnalysisSelank is not on the July 23-24, 2026 PCAC agenda.
- Last verified by a human
- Sep 22, 2026 (ET) · how we verify
- Who runs this
- Peptlas Research Team - independent. About us.
- What we sell
- Nothing. No products, no affiliates, no sponsored placements.
This page reports publicly available regulatory status for information only. It is not medical or legal advice and makes no health claim. See our full disclaimer.
Get alerted when Selank’s status changes
We’ll email you only when this entry’s official status moves - and never anything else.