01 / Research notes
TB-500 and recovery claims
A search for TB-500 often follows an injury or slow wound healing. The first question is why healing is delayed: infection, circulation, diabetes, medication effects, and the nature of the injury can change the care plan. Evidence about the parent protein does not prove that this fragment treats those conditions.
02 / Research notes
What the interim policy covers
The HHS policy discusses TB-500 acetate for specified injectable forms when its sourcing, certificate of analysis, labeling, reporting, and prescription conditions are met. It does not cover a multi-ingredient BPC-157/TB-500 product.
03 / Research notes
Risk and next step
FDA has identified potential immune reaction and impurity concerns with compounded TB-500. The amount of human safety data for the fragment is limited. Ask a clinician to review the injury or symptom and discuss established options before considering any peptide.
Evidence and safety in context
TB-500 is a fragment related to thymosin beta-4. Findings for the full protein cannot be assumed to apply to this fragment. Human studies do not establish that a compounded TB-500 product heals wounds or speeds recovery.
FDA notes possible immunogenicity, aggregation, and peptide impurity concerns. There is not enough human exposure information to calculate a dependable side-effect rate or assess long-term effects.
Questions for a clinical visit
- Why is my wound or injury healing slowly?
- Am I comparing evidence about TB-500 itself or about full thymosin beta-4?
- How would product quality and a possible adverse event be assessed?
See how the HHS policy works and how to prepare for a consultation.
Common questions about TB-500
Is TB-500 FDA approved?
No. HHS enforcement discretion is not a finding of FDA-approved safety or effectiveness.
Is TB-500 the same as thymosin beta-4?
No. TB-500 is a fragment; results from research on the full protein should not be presented as proof for the fragment.
Can I use TB-500 with BPC-157?
The interim policy requires a single listed active ingredient in the compounded product. A combined product is outside that condition.
Important information
HHS's interim policy is conditional and may be revisited. Compounded products are not FDA approved and have not undergone FDA review for safety, effectiveness, or quality before marketing. Treatment through Jonathan Larson MDPC requires a clinical evaluation; a licensed provider decides whether any prescription is medically necessary and appropriate. This guide is informational and is not medical advice.
Read the HHS policy ↗