Legal status · United States
Is TB-500 legal in the United States?
No. TB-500 is not an approved medicine in the United States; its classification is "Not approved; research use only". Nothing containing it is authorized for any use in people. Vials labeled "for research use only" are not exempt: that label does not make human use lawful. Human evidence: Preliminary.
TB-500 in the United States at a glance
| Classification | Not approved; research use only |
|---|---|
| FDA approval status | Not FDA-approved. Removed from Category 2 (April 2026); PCAC voted 8 to 6 to recommend for compounding (July 2026); awaiting FDA rulemaking |
| Evidence level | Preliminary (research strength: Preliminary) |
| Reviewed | Sep 2026 |
Classification and note come from the TB-500 profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.
What this means
- 01
No product containing TB-500 is approved by FDA for any use in the United States, so nothing on the market is authorized for people.
- 02
"Research use only" is a vendor label, not a legal category that permits human use. It does not exempt a product from medicines law.
- 03
Importing, supplying or promoting it for human use can fall under medicines legislation in the United States. This page is general information, not legal advice.
What TB-500 is
A synthetic version of Thymosin Beta-4 studied in animal models for wound healing, tissue repair, and reduced inflammation.
TB-500 relates to Thymosin Beta-4, a peptide present in most cells. Preclinical research points to roles in actin regulation, angiogenesis, and cell migration to injury sites.
Mechanism: Promotes actin polymerization, angiogenesis, and migration of repair cells to sites of injury in animal models.
Regulatory history: Not FDA-approved. Removed from Category 2 (April 2026); PCAC voted 8 to 6 to recommend for compounding (July 2026); awaiting FDA rulemaking
How FDA treats this kind of product
Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.
The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for TB-500 at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.
TB-500 in other countries
Frequently asked questions
Is TB-500 legal in the United States?
No. TB-500 is not an approved medicine in the United States; its classification is "Not approved; research use only". Nothing containing it is authorized for any use in people. Vials labeled "for research use only" are not exempt: that label does not make human use lawful. Human evidence: Preliminary.
Can I buy TB-500 in the United States?
No approved product exists to buy. In the United States TB-500 is classified as "Not approved; research use only", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors.
Is TB-500 FDA approved?
No. FDA status: Not FDA-approved. Removed from Category 2 (April 2026); PCAC voted 8 to 6 to recommend for compounding (July 2026); awaiting FDA rulemaking. Current US classification: "Not approved; research use only". Evidence level: Preliminary.
Related compounds in the United States
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for TB-500 live on its compound profile.
TB-500 profileThis page is general information about the regulatory status of TB-500 in the United States, current as of Sep 2026. It is not legal advice, and classifications change; check U.S. Food and Drug Administration directly or consult a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships and does not recommend where to buy anything.