Is TB-500 legal in Australia? Poisons Standard, TGA, WADA and FDA status

Is TB-500 legal in Australia?

TB-500 has a named entry in Schedule 4 of the October 2026 Poisons Standard, the national list that sorts medicines and poisons into control levels (F2026L01327, read 14 October 2026). Schedule 4 is headed 'Prescription only medicines and prescription animal remedies'. The same name also sits in Appendix D, clause 5, item 38, a table of poisons that 'must not be possessed by a person without authority under the law of the jurisdiction in which the possession occurs'. Whether an activity is lawful depends on the activity, the product and the state or territory, so this page gives no verdict on any person's position.

The entry is a bare name. The instrument gives no definition of TB-500, so it does not say which molecule the name covers. Section 7 says that, unless a contrary intention appears, a reference to a substance includes every salt, active principle or derivative of it and 'a preparation or admixture containing any proportion of the substance' (F2026L01327, section 7). Two 2012 laboratory papers report Ac-LKKTETQ, a seven-amino-acid acetylated peptide, as the key ingredient of a veterinary product called TB-500 (Ho et al., Journal of Chromatography A, 2012) and as the fragment identified in a TB-500 product (Esposito et al., Drug Testing and Analysis, 2012). The TB-500 and thymosin beta-4 sequence page sets that out.

A Schedule entry classifies a substance. It is not a ruling on any person's conduct. The Australian peptide law page records the October 2026 entries for every catalogue peptide, and the Western Australian law page covers the state layer. Official text: Poisons Standard, F2026L01327, made on 28 September 2026 and checked on 14 October 2026.

Evidence limits

What can this page not tell you about TB-500's legal status?

Is TB-500 available in Australia?

No TB-500 medicine appears as approved in the records checked on 14 October 2026, and this page ran no ARTG search. The TGA advisory of 13 April 2026 lists TB-500 among examples of unapproved peptide products, meaning goods not included in the ARTG. The FDA's briefing document (memo dated 15 May 2026) says there are no approved products containing TB-500 in Australia or nine other countries it lists; that is the FDA's statement, not an ARTG result. 'Available' is read here as a legal status. This page describes no supply route.

The catalogue lists TB-500 reference material for laboratory research. A catalogue listing is not a medicine and is not a statement that any supply is lawful. The TGA says a 'research use only' disclaimer alone does not make supply lawful, change a product's regulatory status, permit importation or remove advertising or supply obligations (TGA advisory, 13 April 2026). State and territory laws may add controls on sale, supply and possession.

The same question arrives in other wording, such as whether the TB-500 peptide is available in Australia. The answer is the same: the records checked show a scheduled substance, a TGA statement that unapproved peptide products have not been evaluated for safety, quality or effectiveness, and no record describing a lawful retail route.

Is thymosin beta-4 still banned?

Thymosin beta-4 is named in a sport class that is prohibited at all times and in a named Schedule 4 entry, but the two rules are separate. WADA's 2026 Prohibited List, in force from 1 January 2026, names 'Thymosin-ß4 and its derivatives e.g. TB-500' under S2.3 (WADA, read 14 October 2026). The October 2026 Poisons Standard lists 'THYMOSIN BETA 4 (THYMOSIN β4)' in Schedule 4 and in Appendix D, clause 5, item 39, as an entry apart from TB-500 at item 38 (F2026L01327). The word 'banned' means a different thing in each rulebook.

WADA publishes a new list each year, and this page read the 2026 list only. It did not read any 2027 list text, so it states no 2027 status for thymosin beta-4.

Sport Integrity Australia (SIA) lists 'TB4' and 'TB-500' as other names on its thymosin beta-4 page, says thymosin beta-4 is not approved by the TGA, and says a Therapeutic Use Exemption 'would not be granted' for thymosin beta 4 in any medical condition (SIA, read 14 October 2026).

Is TB-500 on the WADA Prohibited List?

Yes. The WADA 2026 Prohibited List names TB-500 as an example under S2.3, 'Growth factors and growth factor modulators', in the line 'Thymosin-ß4 and its derivatives e.g. TB-500'. Class S2 is prohibited at all times (in and out of competition), and WADA states that all prohibited substances in the class are non-Specified Substances. The class text adds that 'other substances with similar chemical structure or similar biological effect(s)' are also prohibited (WADA, Prohibited List 2026, in force from 1 January 2026, read 14 October 2026). Sport Integrity Australia's thymosin beta-4 page, which lists TB-500 as another name, says administration of thymosin beta-4 is banned in sport at all times.

A sport rule is not an Australian law. It applies to athletes bound by the World Anti-Doping Code, and it sits beside the Poisons Standard without replacing it. The Australian peptide law page records the sport rules for the other catalogue peptides.

Official pages: WADA 2026 Prohibited List and Sport Integrity Australia, thymosin beta-4, checked 14 October 2026.

What has the FDA said about TB-500 and thymosin beta-4?

The FDA's briefing document (memo dated 15 May 2026) says TB-500 is not a component of an FDA-approved drug, that the FDA identified no clinical studies or human exposure data for it, and that potential safety risks in humans are therefore unknown. The FDA's page on bulk drug substances that may present significant safety risks (content current as of 22 April 2026) lists 'Thymosin beta-4, fragment (LKKTETQ), also known as TB-500' under substances nominated but withdrawn. The briefing document reports that the FDA did not find case reports of TB-500 in the published medical literature.

The briefing document for the FDA's July 2026 advisory committee proposed not adding TB-500 to the 503A bulks list, the list of ingredients that US pharmacies may compound. The FDA's stated grounds were that TB-500 is not well characterised (inconsistent naming, and no tests for impurities, aggregates, microbiological quality or bacterial endotoxin in the public certificates of analysis it reviewed), that no pharmacies were found compounding it, that no information on use in humans exists, and that peptides may pose a significant risk of immune reactions. A search of the FDA adverse event database through 26 March 2025 retrieved no reports for TB-500, and the FDA notes that such data have limits, so the empty result does not show safety (FDA briefing document, 15 May 2026).

The advisory committee met on 23–24 July 2026. The FDA meeting page, read on 14 October 2026, lists TB-500 on the 23 July agenda and posts no vote result, so this page reports no vote count. The briefing document says the FDA will not issue a final determination until input from the advisory committee process has been considered and all reviews have been finalised, and the meeting page read on 14 October 2026 shows no final determination. These are United States rules and do not apply in Australia.

Official pages: FDA safety-risk list, the FDA briefing document and the FDA meeting page, checked 14 October 2026.

Can TB-500 be imported into Australia?

The TGA says a 'research use only' disclaimer alone does not permit importation of unapproved peptide products (TGA advisory, 13 April 2026). It also says products that are not clearly labelled, are marked only with codes or abbreviations, or lack essential information such as the name of the active ingredient will not be released under its Personal Importation Scheme (TGA warning, 7 May 2026). TB-500 has a Schedule 4 entry, the prescription-only level of the Poisons Standard (F2026L01327). The Personal Importation Scheme sets its own conditions, listed on the TGA page last updated 8 September 2026. This page assesses no import and gives no import pathway.

The TGA says that if peptide products do not meet importation requirements because of poor or unclear labelling, it will notify the Australian Border Force to seize and destroy them when they are intercepted at the border (TGA warning, 7 May 2026). The 13 April 2026 advisory adds that state and territory laws may impose additional controls on the sale, supply and possession of unapproved peptide products. Official pages: Personal Importation Scheme and TGA peptide advisory, checked 14 October 2026.