TB-500: legal status and evidence

Short answer: TB-500 is not FDA-approved. Since October 30, 2026, a state-licensed pharmacy may compound TB-500 acetate for one patient with a prescription under an interim HHS policy, in these forms only: subcutaneous or intramuscular injection [1], [2]. FDA’s own staff reviewed the evidence and recommended against it [2], [3].

At a glance

Legal status	HHS interim policy: compounding with a patient-specific prescription [1]
Form covered	TB-500 acetate [2]
Routes allowed	Subcutaneous or intramuscular injection [2]
FDA Category 2	September 29, 2023 to April 22, 2026 [2]
FDA staff view	Recommended against adding it to the 503A bulks list [2], [3]
Advisory committee	Voted in favor [2]
Human evidence (FDA review)	No human data. FDA found no evidence that TB-500 works for any condition, including wound healing. [3]
Last checked	November 5, 2026

What FDA’s staff found

FDA’s drug center (CDER) reviewed TB-500 for the uses it was nominated for: wound healing [3].

• FDA found a lack of evidence to judge whether TB-500 works for any disease or condition, including wound healing. [3]
• Neither the nominator nor FDA found toxicity studies of TB-500 in animals. [3]
• FDA said it was particularly concerned about the absence of human data, so the risks of using TB-500 in people are unknown. [3]

Why HHS allowed it anyway

HHS gave three reasons in Appendix B to its policy [2]:

1. Lot-specific certificates from FDA-registered manufacturers now supply the identity, assay, impurity, endotoxin, microbial and residual solvent results FDA’s review found missing;
2. Use of TB-500 in compounding is now documented and counted;
3. HHS calls FDA’s safety concerns inferential rather than observed, says the parent protein has a controlled human safety record across several routes, and says the fragment breaks down quickly in human blood serum.

HHS may revisit the policy if a safety signal or a product quality problem appears, and the policy lasts until FDA decides in a final rule whether to add the peptide to the 503A bulks list [1].

How to get it legally

1. A licensed clinician decides it is right for you and writes a prescription in your name.
2. A state-licensed compounding pharmacy (503A) prepares it from an ingredient made at an FDA-registered facility, with a valid certificate of analysis [1].
3. The label says: “This is a compounded drug product. Not for resale.” It contains only one active ingredient [1].

See how to check a compounding pharmacy and how to read a peptide COA.

What is not known

FDA’s review found too little human data to describe how well TB-500 works or how safe it is over time [3]. Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed [1]. Talk to a licensed clinician before you use any compounded peptide.

Change log

• November 5, 2026: page created from the HHS policy, Appendix B and FDA’s July 2026 briefing document.