Status reference — not a product page. Cora Health does not sell peptides.
TB-500: is it legal in 2026?
No — and it is not an FDA-approved drug.
TB-500 is not on the FDA's Section 503A bulks list, so it is not legal to compound today, and no rulemaking that could change that has been completed. On July 23, 2026, the FDA’s Pharmacy Compounding Advisory Committee voted to recommend adding it to that list — and a recommendation from that committee is non-binding advice, not FDA approval. Cora Health does not sell, prescribe, or compound peptides.
PCAC status
Recommended for the 503A bulks list, 8-6-1, 2026-07-23 (advisory recommendation, against FDA staff)
Legal to compound today
No — not on the FDA 503A bulks list; no final rule
FDA-approved drug
No
Description and FDA-evaluated use
Thymosin beta-4 fragment; the use FDA evaluated was wound healing
Human clinical data
None found — no human clinical studies located; FDA staff cited absence of human data
WADA status
Prohibited (WADA)
Last verified 2026-07-25 · Status Index v1.4.3 · CC-BY-4.0
Where TB-500 actually stands
TB-500 is a thymosin beta-4 fragment and one of the seven peptides the FDA's Pharmacy Compounding Advisory Committee evaluated in July 2026. The use the FDA evaluated was wound healing. No human clinical studies were located in the sources reviewed, and FDA staff cited that absence of human data. It is prohibited by the World Anti-Doping Agency. On July 23, 2026 the committee voted 8-6-1 to recommend adding it to the Section 503A bulks list, against FDA staff.
How TB-500 got here, and what comes next
-
April 22, 2026
FDA updates the 503A bulk-substances nomination list
Among other changes, the update removed 12 research peptides — including BPC-157, Semax, and TB-500 — from Category 2 of the nomination list. It is a step inside the same unfinished 503A nomination process, not a ban and not an approval.
-
June 30, 2026
FDA staff review reported — recommends against listing all seven
As reported on June 30, 2026, FDA career scientists highlighted safety risks and what they described as little evidence of benefit, and recommended against adding any of the seven peptides to the 503A bulks list.
-
July 23, 2026
PCAC day one — four peptides evaluated, four recommended
The advisory committee voted to recommend BPC-157 (8-6-1), KPV (8-6-1), TB-500 (8-6-1), and MOTS-c (7-5) for the 503A bulks list, against the recommendation of FDA staff. These are non-binding advisory votes, not FDA approval.
-
Next step — no date
An FDA decision on the recommendations
The FDA has not acted on the committee's recommendations. Adding any substance to the 503A bulks list requires a full rulemaking — a proposed rule, a public comment period, and a final rule the agency can decline to issue. Rulemaking of this kind has historically run on the order of 12 to 24 months; that duration is our characterization of past FDA rulemakings, not a figure the FDA has published for this one. We are not attaching a date to this, and no one credibly can. This entry updates when the FDA moves.
TB-500, question by question
Is TB-500 FDA-approved?
No. TB-500 is not an FDA-approved drug. It has not been through the FDA drug-approval process, so the FDA has not established that it is safe or effective, and the July 2026 advisory committee vote did not change that — an advisory recommendation is not FDA approval.
Is TB-500 legal to compound in 2026?
No. Not on the FDA 503A bulks list; no final rule. Adding a substance to the Section 503A bulks list requires a full FDA rulemaking — a proposed rule, a public comment period, and a final rule the agency can decline to issue — and that has not happened for TB-500. Anyone offering it as legal to order today is describing something that has not occurred.
What did the FDA advisory committee decide about TB-500?
Recommended for the 503A bulks list, 8-6-1, 2026-07-23 (advisory recommendation, against FDA staff). Recommended 8-6-1 on July 23, 2026 for wound healing, over FDA staff's position that no human clinical studies could be located; TB-500 is also prohibited by the World Anti-Doping Agency. Advisory recommendation only; being recommended for the 503A bulks list would permit compounding under a patient-specific prescription and is not the same as being an FDA-approved, FDA-reviewed drug. FDA career scientists recommended against listing, and the FDA has not made a final decision. It is not legal to compound today.
What human clinical evidence exists for TB-500?
None found — no human clinical studies located; FDA staff cited absence of human data. Thymosin beta-4 fragment; the use FDA evaluated was wound healing. The evidence base for these peptides is thinner than for the compounded GLP-1 medications that licensed providers at Wasef Health, PC prescribe, and nothing here is a claim that TB-500 works. Compounded medications are not FDA-approved.
Does Cora Health sell TB-500?
No. Cora Health does not sell, prescribe, or compound peptides. Cora does not prescribe medication at all — licensed providers at Wasef Health, PC make every prescribing decision, and the compounded medications Cora does offer are prepared by Hallandale Pharmacy or VialsRx, both US-licensed 503A compounding pharmacies. Compounded medications are not FDA-approved.
Every fact on this page traces to the sources below. Where a fact could not be located in them, the field says so rather than asserting one. See an error? Email help@trycora.io — corrections ship with a dataset version bump.
- FDA — Pharmacy Compounding Advisory Committee (PCAC) — https://www.fda.gov/advisory-committees/human-drug-advisory-committees/pharmacy-compounding-advisory-committee (fetched 2026-07-25)
- FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A — https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-fdca (fetched 2026-07-25)
- FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated) — https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 (fetched 2026-07-25)
- RAPS — FDA advisory committee backs two controversial peptides, 2026-07-23 — https://www.raps.org/resource/fda-advisory-committee-backs-two-controversial-peptides.html (fetched 2026-07-25)
- Reuters — FDA staff highlights peptide risks, says little evidence of benefits, 2026-06-30 — https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-highlights-peptide-risks-says-little-evidence-benefits-2026-06-30/ (fetched 2026-06-30)
- Reuters — FDA advisers back first four of seven unapproved peptides under review for looser rules, 2026-07-23 — https://www.reuters.com/legal/litigation/us-fda-advisers-weigh-restrictions-seven-peptides-industry-presses-expansion-2026-07-23/ (fetched 2026-07-25)
Not FDA-approved, and not legal to compound today. TB-500 is not an FDA-approved drug and is not on the FDA's Section 503A bulks list. A PCAC recommendation is non-binding advice the FDA can decline, and a PCAC rejection is not an FDA final decision either. Nothing on this page is a claim that TB-500 is safe or effective.
Cora Health does not sell, prescribe, or compound peptides. Cora Health is a telehealth platform that connects patients with licensed independent providers at Wasef Health, PC, who make all prescribing decisions. The compounded medications Cora offers — compounded semaglutide and compounded tirzepatide — are prepared by Hallandale Pharmacy (a PCAB-accredited 503A compounding pharmacy) or VialsRx (a US-licensed 503A compounding pharmacy). Compounded medications are not FDA-approved and are not therapeutically equivalent to FDA-approved branded products. Individual results vary.
General information, not medical or legal advice. If a compliant pathway ever opens, we will say so plainly. Get honest updates →