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Are peptides legal in Australia? Some peptide medicines, such as insulin products, are approved by the Therapeutic Goods Administration (TGA) and included on the Australian Register of Therapeutic Goods (ARTG). Unapproved peptide products are a different matter: the TGA says a "research use only" disclaimer does not make their supply lawful1, and in August 2026 it stated plainly that "it is unlawful to import, advertise, manufacture and supply unapproved peptide products in Australia".2
This page sets out what the regulators and the legislation actually say, quoted from the primary sources: the TGA, the current Poisons Standard, the Therapeutic Goods Act 1989 and the Customs (Prohibited Imports) Regulations 1956. We checked every source in September 2026 and list the versions at the end. It is general information, not legal advice.
| Situation | What the regulator or the law says | Source |
|---|---|---|
| Peptide medicines on the ARTG (for example, insulin products) | Approved by the TGA and included on the ARTG | TGA safety advisory, April 20261 |
| Unapproved peptide products (TGA examples: BPC-157, GHK-Cu, TB-500, retatrutide, CJC-1295) | "It is unlawful to import, advertise, manufacture and supply unapproved peptide products in Australia." | TGA media release, August 20262 |
| Products labelled "research use only" | The disclaimer alone does not change regulatory status, permit importation, or remove advertising or supply obligations | TGA safety advisory1 |
| Poisons in Schedule 4 and Appendix D, clause 5 (includes BPC-157 and TB-500) | Must not be possessed without authority, for example a legal prescription | Poisons Standard, June 20263 |
| Advertising to the public | Advertising of prescription-only and most pharmacist-only medicines to the public is prohibited | TGA safety advisory1; Therapeutic Goods Act 1989, s 42DL4 |
The TGA's April 2026 safety advisory starts from a simple premise: "Under the Therapeutic Goods Act 1989, peptide products are regulated as therapeutic goods in Australia."1 Some peptide-based medicines have been evaluated and entered on the ARTG. Everything else is, in the TGA's terms, an unapproved peptide product, meaning goods "which have not been included in the ARTG". The advisory names BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295 as examples and says these products "have not been evaluated for safety, quality or effectiveness by the TGA".1
The Act defines therapeutic goods by presentation as well as by content. The definition in section 3 covers goods "represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be" for therapeutic use.4 Section 19B then sets out criminal offences for importing, exporting, manufacturing or supplying therapeutic goods for use in humans that are not registered or listed on the ARTG, exempt, or covered by a specific approval or authority.4
The same advisory lists adverse events reported to the TGA for unapproved peptide products, including severe allergic reactions requiring adrenaline and hospitalisation, and systemic inflammatory response syndrome.1
The Poisons Standard, formally the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), sorts substances into schedules according to how tightly their availability should be controlled. The version in force when we checked was the Therapeutic Goods (Poisons Standard—June 2026) Instrument 2026, also cited as SUSMP No. 48, which commenced on 1 June 2026.3 The instrument records scheduling decisions as recommendations to the states and territories, and "the scheduling of poisons is implemented through relevant State and Territory legislation".3
For medicines, three schedules matter most. The instrument describes them as follows:3
The instrument also makes a point that is easy to miss: listing a substance in a schedule does not mean it is available, or that it has been approved or shown to be effective for any use.3
We searched the instrument itself. Each entry below appears in Schedule 4 under the name shown, and all but the last row are also listed in Appendix D, clause 5.3
| Entry as named in the instrument | Schedule | Appendix D |
|---|---|---|
| BPC-157 | Schedule 4 | Clause 5 |
| TB-500 | Schedule 4 | Clause 5 |
| Thymosin beta 4 | Schedule 4 | Clause 5 |
| CJC-1295 (CAS No. 863288-34-0) | Schedule 4 | Clause 5 |
| AOD-9604 (CAS No. 221231-10-3) | Schedule 4 | Clause 5 |
| Ipamorelin | Schedule 4 | Clause 5 |
| Growth hormone releasing peptides (GHRPs), growth hormone releasing hormones (GHRHs) and growth hormone secretagogues (group entries) | Schedule 4 | Clause 5 |
| Semaglutide; tirzepatide | Schedule 4 | Not listed |
A peptide's absence from the instrument by name is not a clean bill of health. The reader's guide explains that an entry covers the substance's salts and derivatives unless it says otherwise, and that a substance may be captured by a group entry rather than by its own name.3 Scheduling is also a separate question from whether a product is an unapproved therapeutic good: retatrutide and GHK-Cu, for example, do not appear by name in the June 2026 instrument, yet the TGA lists both among its examples of unapproved peptide products.1
Appendix D lists Schedule 4 and 8 poisons that carry extra controls. Clause 5 is headed "Poisons for which possession without authority is illegal" and "specifies poisons that must not be possessed by a person without authority (for example, possession other than in accordance with a legal prescription)".3 Its table includes BPC-157, TB-500, thymosin beta 4, CJC-1295, ipamorelin and the growth hormone releasing peptide, hormone and secretagogue group entries, alongside anabolic steroidal agents and selective androgen receptor modulators.3 Anti-doping rules are a separate system again; see our guide to peptides and the WADA Prohibited List.
No. This is the question behind most searches for research peptides in Australia, and the TGA has answered it directly:1
Disclaimers that a product is for 'research use only' does not make its supply lawful. These disclaimers alone do not:
- change a product's regulatory status
- permit importation, or
- remove advertising or supply obligations.
The TGA's July 2026 notice to promoters and suppliers adds that "manufacture includes any step in the manufacturing process, including applying a label to a blank vial, packaging for distribution, and storage of the products before they are in their final state".5 In the TGA's published statements, "research use only" wording is treated as a disclaimer, not as a separate regulatory category.
The Poisons Standard contains a narrow provision that is sometimes misread. Poisons "packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in this instrument", but the same paragraph continues: "this exemption does not extend to controls on supply of these poisons."3 The instrument's own example of authority to possess a clause 5 poison is a legal prescription; what counts as authority in a particular laboratory setting is a question for the relevant state or territory health department, since those jurisdictions implement the scheduling.3 For background on what the label is meant to signal, see what research peptides are and what "research use only" means.
Three sets of rules meet at the border.
The TGA warns that unapproved peptide products that are not clearly labelled, including products identified only by codes or without a clear statement of the active ingredient and strength, cannot be assessed for lawful importation under the Personal Importation Scheme "and will not be considered for release". Individuals importing under the scheme "must meet all other conditions of the Scheme, including having an appropriate medical authorisation or prescription when required".1 The TGA says it "is increasingly intercepting unlabelled vials at the border", and that businesses and individuals "can also incur financial loss if the product is intercepted at the border and destroyed".5
Regulation 5G prohibits importing any substance in Schedule 7A of the Regulations unless the importer holds written permission. Schedule 7A lists anabolic or androgenic substances, erythropoietin, gonadotrophins, darbepoetin alfa and "natural and manufactured growth hormones, including somatropin, somatrem, somatomedins and insulin-like growth factors (not insulins) and growth hormone releasing hormones (somatorelin and synthetic analogues)".6 A limited exception for travellers carrying medicine prescribed for their own treatment does not apply to athletes or their support staff.6 The Australian Border Force's prohibited-goods list tells importers of anabolic and androgenic substances that permission is required from the Office of Drug Control.7
In June 2026 the TGA reported a joint operation with the Australian Border Force and Victoria Police that seized peptide products, performance and image enhancing drugs and illicit steroids "with an estimated street value in excess of $2 million".8
"Advertise" is defined broadly. Under section 3 of the Act it includes any statement, pictorial representation or design "intended, whether directly or indirectly, to promote the use or supply of the goods", including one on the label, on the package or on material included with the package.4 Section 42DL makes it an offence to advertise therapeutic goods where, among other things, the advertisement "refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H", unless the reference is authorised or required by an Australian government authority.4
The TGA's July 2026 notice applies this to the peptide market: "Advertising unapproved therapeutic goods to Australian consumers is generally unlawful. This includes websites, online marketplaces, social media posts, influencer content and other forms of digital marketing." It adds that "influencers, affiliates, online sellers and anyone else promoting unapproved peptide products may be held accountable for unlawful advertising".5 According to the TGA, penalties for breaching the Act include "civil penalties of up to $1.82 million per breach for individuals or $18.2 million per breach for corporations, and criminal penalties of up to 7 years imprisonment".2
Yes, and the published record is growing.
Registered peptide medicines are prescribed in the ordinary way. For unapproved peptide products, the TGA advisory says that healthcare practitioners who compound, prescribe or supply them "must also comply with all regulatory requirements and relevant professional practice standards, including those set by Ahpra". It explains that a compounded good is generally exempt from inclusion on the ARTG only where it is "dispensed or extemporaneously compounded for a particular person for application to that person", or compounded in a hospital by a pharmacist in anticipation of use for the hospital's patients.1
The Poisons Standard is reissued regularly (the June 2026 instrument repealed a February 2026 one), so check the current version on the Federal Register of Legislation and the TGA's peptide advisory before relying on any summary, including this one. For the laboratory side of working with peptides, see our guides to reading a peptide certificate of analysis and storing peptides.
Not all of them. Some peptide medicines, such as insulin products, are approved by the TGA and included on the Australian Register of Therapeutic Goods. The TGA says it is unlawful to import, advertise, manufacture and supply unapproved peptide products, and several peptides, including BPC-157 and TB-500, are Schedule 4 entries in the June 2026 Poisons Standard that must not be possessed without authority, such as a legal prescription.
A research label does not change the legal position. The TGA states that a "research use only" disclaimer does not make supply lawful, and does not change a product's regulatory status, permit importation or remove advertising and supply obligations. The Poisons Standard exempts poisons sold solely for laboratory use from its labelling requirements only, and says that exemption does not extend to controls on supply.
Doctors prescribe registered peptide medicines in the usual way. For unapproved peptide products, the TGA says practitioners who compound, prescribe or supply them must comply with all regulatory requirements and professional practice standards, including those set by Ahpra. A compounded product is generally exempt from ARTG inclusion only when it is made for a particular person, or compounded in a hospital for that hospital's patients.
Only within the rules. The TGA says unapproved peptide products that are unlabelled, identified only by codes, or missing a clear active ingredient and strength will not be released under the Personal Importation Scheme, and the scheme's other conditions, including a prescription where required, still apply. Growth hormones and growth hormone releasing hormones, including synthetic analogues, also need written permission under the Customs (Prohibited Imports) Regulations.
Yes. BPC-157 is listed in Schedule 4 (Prescription Only Medicine) of the June 2026 Poisons Standard and in Appendix D, clause 5, which covers poisons that must not be possessed without authority, such as a legal prescription. TB-500, thymosin beta 4, CJC-1295 and ipamorelin are listed the same way. The TGA also names BPC-157 as an example of an unapproved peptide product.
Advertising prescription-only medicines to the public is prohibited unless a government authority authorises or requires it. Section 42DL of the Therapeutic Goods Act makes it an offence to advertise therapeutic goods in a way that refers to Schedule 3, 4 or 8 substances outside Appendix H. The TGA says advertising unapproved therapeutic goods to Australian consumers is generally unlawful, including on websites, marketplaces and social media.
A plain-English primer on research peptides: what a peptide is, how peptides are built one amino acid at a time on a resin bead, why they arrive as a freeze-dried powder, and what "research use only" does and does not mean.
Which peptides does the 2026 WADA Prohibited List name, in which section, and what does "not named" really mean? Includes GLP-1 drugs, retatrutide and Sport Integrity Australia.
A section-by-section guide to reading a peptide certificate of analysis: identity, HPLC purity, net peptide content, counter-ions, water, endotoxin, and the red flags that mean a COA does not check out.
