thymosin beta-4 fragment peptide

Is TB-500 legal in the United States?

Answer

TB-500 is not on the FDA register of medicines in the United States. Read on 2026-10-03.

RegulatorFDA register

Not legal advice.

StatusNot on the registerRegulator FDA
Products on the register0none listed
Read2026-10-03FDA

FDA COMPOUNDING LIST (503A)

TB-500 is on FDA's 503A bulk-substances list (nominated for compounding, withdrawn by the nominator).

Compounded drugs containing thymosin Beta-4, Fragment (LKKTETQ) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation as well as peptide-related impurities. FDA has not identified any human exposure data drug products containing Thymosin Beta-4, Fragment. FDA lacks important information regarding any safety issues raised by this drug, including whether it would cause harm if administered to humans.

Regulator FDA list, read 2026-10-03. Not legal advice.

ACTIONS BY NAMED AUTHORITIES

1 action naming TB-500

US-OH
Ohio Board of Pharmacy, 2026-04-16 Regulator
During the inspection, [redacted] was found to possess multiple vials of the following illegal dangerous drugs, in either a white powder, purple powder, or clear liquid form, intended for injection, which were obtained from an unlicensed, foreign source: g. BPC 157/TB500 10mg, 4 vials; k. TB500 10mg, 10 vials;
State of Ohio Board of Pharmacy, Order, Case No. A-2026-0037, Findings of Fact paragraphs 2(g) and 2(k) · quoted with the party redacted

TB-500 in every country read: legal status by country. All peptides: are peptides legal?

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