Compound hub · Melanotan II
Is Melanotan II legal in Australia?
Melanotan II has its own Schedule 4 entry in Australia's October 2026 Poisons Standard (F2026L01327), checked on 16 October 2026. Schedule 4 is the prescription-only class. The TGA says Melanotan II is not approved as a tanning agent, and no Melanotan II product is on the ARTG, the national list of approved medicines. The WADA 2026 Prohibited List does not name Melanotan II. This page records those statements and gives no legal advice.
01Poisons StandardContents
Questions about rules often hide three different questions: what is scheduled, what is approved, and what a sport allows. Each is answered by a different body, in a different document, on a different date. The Melanotan II hub keeps them apart, and this page does the same.
The page lists each record, the date it was checked and what it leaves open. It says nothing about what any person may or may not do. A lawyer or the TGA can answer that. The page links to each document, so you can read the wording yourself.
Key facts
| Poisons Standard, October 2026 | Individual Schedule 4 entry for Melanotan II (F2026L01327, checked 16 October 2026) |
|---|---|
| Appendix D, clause 5 | Not recorded for Melanotan II in the 16 October 2026 check |
| TGA statement | Prescription-only; not approved as a tanning agent; no product containing it on the ARTG (TGA, 17 August 2026) |
| Related molecule, afamelanotide | Separate individual Schedule 4 entry; registered medicine on the ARTG, record 327947 (checked 16 October 2026) |
| WADA 2026 Prohibited List | Melanotan II not named in a text search of the list; section S0 covers some unapproved substances (WADA 2026 list, in force from 1 January 2026) |
| Records checked | 16 October 2026 |
Is Melanotan II in the Australian Poisons Standard?
Yes. Australia's October 2026 Poisons Standard has its own entry for Melanotan II in Schedule 4. The document's full name is the Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, F2026L01327. A line check of it on 16 October 2026 found the entry. The Poisons Standard is the national list that sorts medicines and poisons into classes. Schedule 4 is the class for prescription-only medicines. The same check did not find Melanotan II under Appendix D, clause 5, a part that adds extra controls for some substances. A schedule entry says how a substance is classed. It does not say that an approved product exists.
The check read the Schedule 4 entries, the index and Appendix D clause 5. Melanotan II was not named on its own in that clause. This is not a legal ruling on every group entry or on every law that may apply. The instrument can be replaced or changed, so a later edition may differ from the October 2026 text quoted here. What Schedule 4 and Appendix D mean explains the two terms.
What does the TGA say about Melanotan II?
The TGA says Melanotan II is a prescription-only medicine in Australia. It says Melanotan II is not approved for use as a tanning agent. It also says no products containing Melanotan II are on the Australian Register of Therapeutic Goods (ARTG). The ARTG is the national list of approved medicines and health products. A January 2025 TGA blog says melanotan is not approved for sale or use as a tanning agent in Australia. It adds that these tanning products have not been assessed for quality or safety. Both statements are the regulator's own wording, linked in the key facts above.
The August 2026 advisory also reports a laboratory finding. TGA laboratories confirmed Melanotan II in five seized nasal spray bottles of one brand. The estimated amount in the highest bottle was more than twice that in the lowest. That result covers five seized bottles. It is not a rule about all products. The TGA also asks the public to report suspected side effects to it, and to talk to a health care practitioner about any concerns. The side effects page covers the reports.
Is a Schedule 4 entry the same as being an approved medicine?
No. A Schedule 4 entry classes a substance as prescription-only. A registered ARTG medicine is one specific product that has been approved. So a substance can be scheduled while no approved product containing it exists. For Melanotan II, the TGA says no product is on the ARTG. Afamelanotide, also called Melanotan I, is different. The research team's check on 16 October 2026 found that it has its own Schedule 4 entry. It also has an active registered medicine, ARTG record 327947, which contains afamelanotide acetate. Approval of one product does not approve every preparation of a substance, or every use.
Afamelanotide and Melanotan II are different molecules, and each has its own row in the Poisons Standard. PT-141, also called bremelanotide, is a third molecule. The same check found no individual PT-141 entry. It could not settle whether a broader group heading covers PT-141, so this page states no status for it. The two legal rows are kept apart. What Melanotan II is sets out how the three molecules differ.

Is Melanotan II banned in sport?
The WADA 2026 Prohibited List does not name Melanotan II. WADA is the World Anti-Doping Agency, which sets the list of substances banned in sport. A text search of the list, in force from 1 January 2026, was run for this page. Section S0 covers any drug not dealt with in later sections that has no current approval from a government health authority for human treatment. The TGA says Melanotan II is not approved as a tanning agent and has no ARTG product. But a missing name does not mean a substance is allowed. The Australian approval record alone cannot settle approval in every country, or decide an athlete's status.
WADA's S0 text lists named examples, and Melanotan II is not one of them. This page does not establish approval status worldwide or make a ruling on this substance. An athlete should check with their anti-doping organisation before relying on this page. WADA issues a new list each year, so a later list may differ from the 2026 text.
Evidence limits
What do these records not settle?
These records do not settle what any person may lawfully do with Melanotan II in Australia. The check covered the individual entries, the index and Appendix D clause 5. It did not cover every possible legal question. The TGA statements describe the register and the TGA's advice. They do not replace the Therapeutic Goods Act 1989, the main national law on medicines, or state and territory law. WADA's list governs sport, not general law. Each record answers its own question. For a question about a particular case, ask a lawyer or the TGA.
Anyone can search the TGA's own register for a named product (TGA ARTG search). This page did not confirm a product-level register result. The 16 October 2026 check could not confirm an exact registered product for Melanotan II, and a missing match is not proof that none exists. The TGA's statement of 17 August 2026 is the regulator's own account. The Australian peptide law guide explains how the layers fit together.
Comparison
Four records about Melanotan II, each checked on or before 16 October 2026. 'Does not say' lists what the record leaves open. Records only; this is not legal advice.
| Body | Record and date | What it says about Melanotan II | What it does not say |
|---|---|---|---|
| Poisons Standard (Commonwealth) | F2026L01327, October 2026 edition, checked 16 October 2026 | Individual Schedule 4 entry; no Appendix D clause 5 entry recorded | That an approved product exists, or what any person may do |
| TGA, safety advisory | Advisory, 17 August 2026 | Prescription-only; not approved as a tanning agent; no product on the ARTG | A product-level register search by this page |
| TGA, blog | Blog, 24 January 2025 | Melanotan is not approved for sale or use as a tanning agent; not assessed for quality or safety | Counts or rates of side effects |
| WADA | 2026 Prohibited List, in force 1 January 2026 | Melanotan II not named in a text search; S0 covers some unapproved substances | A WADA ruling on Melanotan II; an athlete's status |
FAQ
Is Melanotan II a Schedule 4 medicine?
Yes. The October 2026 Poisons Standard, F2026L01327, has its own Schedule 4 entry for Melanotan II, according to a line check on 16 October 2026 (legislation.gov.au).
Is there an approved Melanotan II product in Australia?
No. The TGA says no products containing Melanotan II are on the ARTG, the national list of approved medicines.
Is Melanotan I the same as Melanotan II for approval purposes?
No. Afamelanotide, also called Melanotan I, has its own Schedule 4 entry and a registered medicine on the ARTG, record 327947, checked 16 October 2026. Approval of one product does not approve every preparation or use.
Does WADA name Melanotan II?
Not in a text search of the 2026 Prohibited List run for this page. Section S0 may reach unapproved substances, so athletes should confirm with their anti-doping organisation.
More in this hub
Citations
2 sourcesHadley ME, Dorr RT Peptides. 2006;27(4):921-930.
doi:10.1016/j.peptides.2005.01.029Minder EI, Barman-Aksoezen J, Schneider-Yin X Clinical Pharmacokinetics. 2017;56:815-823.
doi:10.1007/s40262-016-0501-5
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