FDA Peptide Tracker
TB-500: live FDA regulatory status
Soft-tissue recovery · RFK-14
The two signals
Plain-English verdict: amber.
Regulatory status: PCAC recommended · rulemaking pending.
These two never collapse into one. Removal from a list is not the same as legal-to-compound, and neither is the same as available.
Availability at Peptós.LIFE
Join waitlist
What TB-500 is
A synthetic fragment usually discussed alongside BPC-157 for soft-tissue recovery.
Short version: BPC-157's usual recovery partner, with even less human data and an extra immunogenicity question. Same FDA review, same honest waitlist.
TB-500 rides along with BPC-157 in nearly every recovery conversation. It's under the same FDA compounding review, so we hold it to the same honest status.
Why it sits in this category
TB-500 is tracked under RFK-14. Its regulatory status is PCAC recommended · rulemaking pending — a separate signal from whether you can actually get it today. We never collapse the two.
Not available to prescribe today. Under the same FDA compounding review as BPC-157, with which it is co-billed. PCAC is advisory, a favorable vote leads to rulemaking, not instant availability.
A synthetic 7-amino-acid fragment related to thymosin beta-4, proposed to influence actin regulation and cell migration.
What it does — and what it does not do
What it does: Researched for tendon and muscle recovery support, typically paired with BPC-157.
What it does not do: The marketed fragment is not trial-grade thymosin beta-4, and it is not available to prescribe.
What would have to change
Next milestone on the regulatory path: FDA rulemaking decision — Projected 2027. A favorable advisory (PCAC) vote is a recommendation that leads to rulemaking — not FDA approval, not authorization to compound, and not availability.
Evidence grade
Grade D — animal-dominant; the marketed fragment isn't trial-grade thymosin β4. See our grading methodology for what each grade means.
What we still don't know: Human evidence is minimal and animal-dominant; the marketed fragment differs from studied Tβ4, and antibody responses have been raised.
Regulatory timeline
- 2023-09 — Category 2 designation
- 2026-04 — Category 2 removed
- 2026-07 — PCAC advisory vote — 6 of 7 recommended
- 2027 — Bulks List rulemaking (projected)
PCAC is advisory: its Jul 2026 recommendation leads to rulemaking, not instant availability. A favorable advisory vote is a recommendation, not FDA approval or authorization to compound. Realistic earliest legitimate access is late 2026 into 2027. Reclassification is not the same as FDA approval. Compounded medications are not evaluated or approved by the FDA for safety, efficacy, or quality, where that applies, we say so, plainly.
Primary source: FDA source record
See the full status board or this molecule's knowledge-base monograph.
Last updated July 26, 2026 · Peptós.LIFE · Not medical advice.