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

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What TB-500 is

A synthetic fragment usually discussed alongside BPC-157 for soft-tissue recovery.

BPC-157's usual recovery partner, with even less human data and an extra immunogenicity question.

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.

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.

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

Evidence grade D — Animal and lab evidence; human trials still to come. 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

TB-500: common questions

Is TB-500 legal in 2026?
Not yet. On July 23, 2026 the FDA's Pharmacy Compounding Advisory Committee (PCAC) voted to recommend TB-500 for the 503A Bulks List, against the FDA's own scientific staff. The tally is reported as 8–6–1; the FDA has posted no minutes, transcript or vote-results summary for this meeting, so every tally on this site is as reported by trade press. A PCAC recommendation is advisory: it is not FDA approval, not authorization to compound, and not availability. Placement on the 503A Bulks List requires the FDA to run a formal rulemaking — a proposed rule, a comment period, then a final rule — which realistically takes well over a year. Earliest legitimate access is 2027, and only if the FDA proceeds.
Can I get TB-500 right now?
No. TB-500 is waitlist-only at Peptós.LIFE and cannot be legitimately prescribed or compounded today. We will not sell what we cannot stand behind. Compounded medications are prepared for an individual patient and are not FDA-approved.
Did the July 2026 FDA vote make TB-500 available?
No. The vote changed the regulatory picture, not your access. Our regulatory status for TB-500 advanced to "PCAC recommended · rulemaking pending," and the plain-English verdict stayed the same, because a committee vote does not move whether a patient can actually get it. The two signals are held separately for exactly this reason.
What happens next for TB-500?
The milestone that matters is whether the FDA opens rulemaking on the 503A Bulks List, and how fast. Our projection is a decision in 2027. Nothing about availability changes before that concludes.

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.

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Last updated July 26, 2026 · Peptós.LIFE · Not medical advice.