Unapproved Peptides: The TGA Crackdown and What It Means for Australian Clinics

BPC-157 promoted for injury recovery. CJC-1295 for performance enhancement. GHK-Cu for skin and anti-ageing. Retatrutide for weight loss. These are marketing claims, not a statement that the products are approved or that those uses are safe or effective.

Peptide products have moved from online forums and social media into the wellness, aesthetic, longevity and telehealth markets. Some are promoted as treatments for injury, muscle growth, weight management and ageing. Others are sold as research products, sometimes with disclaimers that they are not intended for human use.

The Therapeutic Goods Administration (TGA) is paying attention.

On 10 June 2026, the TGA added unapproved peptide products to its priority compliance focus areas. It has since warned about potential health risks, highlighted unlawful importing and advertising, and commenced Federal Court proceedings against a company formerly known as BioV8 Pty Ltd and two of its former directors over alleged peptide advertising breaches.

For clinics, practitioners, compounding pharmacies and businesses operating in this market, the issue is not simply whether a peptide has been prescribed by a doctor. The relevant questions include whether the particular product can lawfully be imported, manufactured and supplied; whether an exemption or approval applies; and whether the product or service is being advertised in a way the law permits.

The TGA has not prohibited peptides as a category. It is enforcing the existing regulatory framework, and the legal position depends on the particular product, its intended use and the conduct of the businesses involved.

This article examines the crackdown, the legal framework behind it and the enforcement risks emerging for businesses operating in the peptide market.

01 What is the TGA doing?

The TGA’s approach has become more visible and assertive. Its actions include public safety warnings, compliance investigations, infringement notices, cooperation with border and law enforcement agencies, and court proceedings.

Unapproved peptides are now a compliance priority

On 10 June 2026, the TGA expanded its priority focus areas to include unapproved peptide products. It identified increasing unlawful importation, supply and advertising, including promotion through online channels and social media. The TGA’s Compliance Principles 2026 and 2027 cover 1 January 2026 to 31 December 2027; the priority focus areas are reviewed quarterly as risks and intelligence develop.

The significance is practical. Businesses operating in this market should not assume that a product or business model will escape scrutiny simply because it has been operating for some time, uses an overseas supplier or is promoted through informal online channels.

The TGA has raised concerns about potential health risks

On 19 June 2026, the TGA and Australia’s Chief Medical Officer issued a joint statement concerning unapproved peptide products.

The statement identified reports and hospitalisation data concerning serious adverse effects associated with the use of unapproved peptide products, including liver damage, severe allergic reactions requiring hospital treatment, inflammation and other complications. It does not establish that every named peptide caused every listed injury. Products identified included those containing BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295.

The TGA emphasised that products not included in the Australian Register of Therapeutic Goods (ARTG) have not been assessed by it for safety, quality or effectiveness. It also warned that the composition and manufacturing standards of unapproved products may not be adequately controlled.

These warnings are relevant to more than clinical decision-making. They provide context for the regulator’s increased scrutiny of the businesses importing, manufacturing, supplying and promoting these products.

Enforcement action is extending across the supply chain

The TGA has made clear that it is examining conduct across the peptide market, including online advertising and social media promotion. Its published guidance identifies potential enforcement action against businesses and individuals involved in unlawful importing, manufacturing, supply and advertising.

There have also been significant enforcement operations involving performance- and image-enhancing drugs. On 17 April 2026, the Australian Border Force and TGA announced that an eight-month investigation with Victoria Police had resulted in seizures of performance- and image-enhancing drugs, including steroids and peptide products, with an estimated aggregate street value exceeding $2 million. The announcement concerned an operation that included warrants executed on 26 March, rather than a single April seizure. Three people had been charged in connection with the alleged importation operation.

Separately, on 6 October 2026, the TGA announced 12 infringement notices totalling $126,720 against two companies and five individuals for alleged unlawful importation and advertising of prescription-only medicines. The notices were paid between July and September 2026. They concerned several different products and should not be characterised as peptide-specific penalties. They nevertheless demonstrate the broader enforcement tools available to the regulator.

The important distinction is that regulatory attention can arise at several points in the supply chain. A business may face questions about its own advertising, its importation arrangements, the products it supplies or the way it participates in a wider distribution model.

The BioV8 proceedings: directors are also in the frame

On 28 September 2026, the TGA announced that it had commenced Federal Court proceedings against A.C.N. 641 483 703 Pty Ltd (in liquidation), formerly known as BioV8 Pty Ltd, and its former directors, Edward McGill and Nicholas Austin.

The TGA alleges that, between 6 June 2024 and 14 July 2025, the company unlawfully advertised prescription-only therapeutic goods, including BPC-157, CJC-1295 and GHRP-6, through its website and social media. It also alleges that some advertising promoted products for serious diseases and conditions, including cancer, HIV/AIDS and mental illness, without the required approvals or permissions.

The TGA alleges that the former directors aided, abetted, counselled or procured the unlawful advertising. It is seeking declarations and pecuniary penalties. The TGA’s 28 September announcement stated that commencement against the company in liquidation was subject to Federal Court leave. This article reports that announcement, not a subsequent court determination or confirmation of the current leave position.

The TGA’s announcement reports allegations, not findings of contravention. Those allegations should not be treated as established facts.

The proceedings nevertheless illustrate an important enforcement risk: operating through a company does not automatically protect directors or other individuals from personal exposure. Liability depends on the applicable statutory provisions and the person’s involvement in the alleged conduct. It does not arise merely because someone holds the title of director.

02 Why a peptide product may be unlawful

The relevant rules are not new. The current enforcement focus is bringing established requirements into sharper view.

The Therapeutic Goods Act 1989 (Cth)

The Therapeutic Goods Act 1989 (Cth) regulates therapeutic goods in Australia, including medicines and products represented as being for therapeutic use.

As a general rule, therapeutic goods supplied in Australia must be included in the ARTG unless an applicable exemption, approval or authority permits the relevant activity. Separate requirements may apply to importation, manufacture, supply and advertising.

This requires a product-specific assessment. It is not accurate to say that all peptides are unapproved or prohibited. Some peptide-based medicines, including certain insulin products, are approved and included in the ARTG. Conversely, a product promoted online for injury recovery, muscle growth or anti-ageing may be an unapproved therapeutic good, depending on the product and the representations made about it.

For products such as BPC-157, TB-500 and CJC-1295, a business should not assume that a product can lawfully be supplied merely because it is available from an overseas manufacturer, is described as a research chemical or has been prescribed by a practitioner.

The starting point is to identify the actual product, its regulatory status and the legal basis on which it is being imported, manufactured or supplied.

Access pathways are limited and conditional

Australian law provides pathways through which certain unapproved therapeutic goods may be accessed in defined circumstances. These include:

Special Access Scheme (SAS): a pathway under which a medical practitioner or other eligible health practitioner may seek access to an unapproved therapeutic good for an individual patient, subject to the applicable requirements.
Authorised Prescriber Scheme: a pathway allowing an authorised medical practitioner to prescribe specified unapproved goods for the authorised indication and patient class, subject to the authority, conditions and reporting obligations. It is not a general authority held by the clinic.
Personal Importation Scheme: a limited pathway for personal or immediate-family use, not clinic stock or onward supply. Conditions generally include a maximum three-month supply per import, no more than 15 months’ supply within 12 months, an appropriate Australian prescription or written authority at importation for prescription medicines, and compliance with customs restrictions.
Compounding exemptions: exemptions that may permit pharmacists to prepare certain medicines for individual patients without the usual ARTG entry, subject to the conditions and limits of the relevant exemption.

Under the SAS, Category B requires prior approval; Categories A and C operate through notification where their eligibility requirements apply. Not every product or patient qualifies. These are not interchangeable pathways, and none should be treated as a blanket permission to import, manufacture, supply or advertise any unapproved peptide product.

For example, the TGA has specifically warned that products imported under the Personal Importation Scheme may be refused release where they are inadequately labelled or where the ingredients and other information needed to assess compliance cannot be verified. A disclaimer that a product is for “research use only” does not, by itself, make its importation or supply lawful.

Compounding is not a general exemption from regulation

Compounding is an area in which assumptions can be particularly dangerous.

The relevant exemption is conditional. It does not give a pharmacy an unrestricted right to manufacture and distribute unapproved medicines at scale. Requirements concerning prescriptions, specific patients, the timing and nature of compounding, product standards and manufacturing licences may all be relevant.

The distinction between preparing a medicine for a particular patient and manufacturing products in anticipation of demand can be important. The legal position depends on the actual arrangements and the exemption relied upon.

The TGA has also imposed product-specific restrictions. For example, from 1 October 2024, pharmacists have not been permitted to compound medicines containing glucagon-like peptide-1 receptor agonist analogues under the relevant compounding exemption. That change concerned GLP-1 receptor agonists; it should not be taken as a blanket prohibition on every peptide or every form of compounding.

A clinic cannot safely assume that a product is lawful simply because a pharmacy prepares it, or that the pharmacy alone bears all regulatory responsibility. The roles of the clinic, prescriber, pharmacist, supplier and any intermediary must be assessed in the context of the actual arrangement.

Prescription-only classification and state and territory laws

Some peptide substances are classified as Schedule 4 prescription-only medicines under the Poisons Standard. The classification of the particular substance, formulation and circumstances matters; it should not be assumed that every product described as a peptide has the same status.

State and territory legislation may impose additional requirements concerning possession, prescribing, dispensing and supply. As at 22 October 2026, New South Wales operates under the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008. NSW Health states that this framework will be replaced from 5 November 2026 by the Medicines, Poisons and Therapeutic Goods Act 2022 (NSW) and the Medicines, Poisons and Therapeutic Goods Regulation 2026. Clinics should prepare for the transition and assess historical conduct under the requirements applicable at the relevant time.

Accordingly, satisfying one Commonwealth requirement does not necessarily resolve every issue under state or territory law. A clinic operating across jurisdictions may need to consider more than one regulatory regime.

03 Advertising: a major area of exposure

For many businesses in this market, advertising may be the most immediate regulatory risk.

The Commonwealth framework generally prohibits advertising prescription-only medicines to the public and also restricts advertising unapproved therapeutic goods. The applicable requirements depend on the goods, the content and the context of the promotion.

The fact that content appears on a clinic’s website, an Instagram account, a patient-facing portal or an influencer’s page does not remove it from the regulatory framework.

Nor is the question limited to whether a particular product name appears in an advertisement. The overall impression created by the content, including references to classes of medicines, treatment options, claims and links to supply arrangements, may be relevant.

A clinic should therefore be cautious about assuming that it is merely advertising a service rather than advertising therapeutic goods.

“We are advertising our clinic, not the peptide”

The distinction is not always straightforward.

A website that promotes “peptide therapy”, identifies specific peptides, lists treatment options or encourages consumers to select products for subsequent prescribing may raise issues under the therapeutic goods advertising rules. The context matters, including how the service is described and whether the content promotes the use or supply of particular goods.

The TGA’s enforcement action against Peptide Clinics Australia provides a useful illustration.

In Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107, the Federal Court ordered the company to pay a $10 million civil penalty for contraventions involving advertising medicines, including prescription-only peptides, to the public. The conduct included advertising through a website and social media, as well as promotion using the term “peptides” and references to particular uses and conditions.

The case is significant because the advertising issue was not confined to a conventional advertisement for a named prescription medicine. The broader way in which the business promoted peptide products was relevant.

The case does not mean that every mention of peptides is automatically unlawful. It does, however, demonstrate that businesses should not assume that describing a service in general terms avoids the advertising restrictions.

“We only share educational content or patient results”

The label attached to a post is not conclusive. Content described as educational may still be regulated as advertising, depending on its purpose, presentation and context.

Patient testimonials, before-and-after images, claims about recovery or performance, and statements implying that a product is safe or effective may also raise separate issues. Where a regulated health service is advertised, the Health Practitioner Regulation National Law imposes additional restrictions, including on testimonials about clinical aspects of care and advertising that creates an unreasonable expectation of beneficial treatment.

The advertising assessment should therefore consider both the therapeutic goods framework and the separate obligations that apply to the clinic and its practitioners.

04 How significant can the penalties be?

The consequences of non-compliance can extend well beyond a request to remove a post or amend a website.

Depending on the contravention and circumstances, the TGA may use compliance notices, infringement notices, import interventions, product seizures, civil penalty proceedings or criminal prosecution. The regulator’s published framework identifies these as available responses to unlawful conduct involving therapeutic goods.

The Therapeutic Goods Act contains different civil and criminal penalty provisions. For advertising contraventions under section 42DLB, the maximum is expressed as 5,000 penalty units for an individual and 50,000 penalty units for a body corporate. At the Commonwealth penalty-unit value of $364 applying to contraventions on or after 1 July 2026, those figures equate to $1.82 million and $18.2 million respectively. The applicable maximum depends on the particular provision, the date of the conduct and how the contraventions are legally characterised; those figures should not be treated as an automatic penalty for every breach or as a fixed amount per product or advertisement. The July 2026 rate must not be applied retrospectively to the alleged 2024–2025 BioV8 conduct.

The $10 million penalty in Peptide Clinics Australia is a concrete example of the potential scale of exposure arising from sustained advertising contraventions. It is not a tariff for all peptide-related conduct. The penalty reflected the contraventions established in that proceeding and the Court’s assessment of the circumstances.

For a business, the financial consequences may also include the costs of responding to an investigation, interruption to operations, loss of suppliers or commercial relationships, and separate professional or registration issues for practitioners.

05 Five assumptions that can expose a clinic to regulatory risk

Several common assumptions warrant particular caution.

“A doctor has prescribed it, so the supply is lawful.”

A prescription does not, by itself, establish that a product can lawfully be imported, manufactured or supplied. The relevant access pathway, product status and conditions must also be considered.

“The pharmacy makes it, so the clinic is not responsible.”

The pharmacy’s role is relevant, but it does not resolve the clinic’s own obligations. The clinic’s conduct, including its referrals, representations, commercial arrangements and advertising, must be assessed separately.

“The supplier is reputable and the product is properly labelled.”

A supplier’s reputation and a product’s appearance do not establish its regulatory status. The business needs to identify the product and verify the legal basis for its importation and supply.

“We call it a research product, not a medicine.”

A label or disclaimer is not decisive. The TGA has expressly warned that “research use only” disclaimers do not, by themselves, change a product’s regulatory status or remove importation, supply and advertising obligations.

“The business operates through a company, so the directors are protected.”

A company structure does not automatically prevent personal liability. Depending on the statutory provision and evidence, individuals who are alleged to have participated in or facilitated unlawful conduct may also face proceedings. The BioV8 proceedings illustrate the TGA’s willingness to pursue allegations against former directors, which the TGA’s announcement reported as allegations rather than established contraventions.

06 The regulatory question is broader than the product itself

The peptide market involves several distinct activities: importing products or ingredients, manufacturing or compounding, prescribing, supplying, referring patients and advertising treatments.

Each may engage different legal requirements. A clinic’s position cannot reliably be assessed by looking only at whether a doctor is involved or whether a pharmacy dispenses the product.

The relevant questions include:

What is the precise product, and what is its status under the therapeutic goods framework?
What legal pathway permits its importation, manufacture or supply?
Do the arrangements comply with the conditions of any applicable exemption, approval or authority?
How is the product or treatment described to prospective patients?
Do the clinic’s website, social media, patient information and commercial arrangements create additional regulatory issues?
Are there separate obligations under state or territory medicines laws or professional regulation?

The answers will depend on the facts. An arrangement that is lawful in one respect may still create a separate issue in another.

If a TGA notice or investigation arrives

Identify the recipient, legal power and deadline. Distinguish a request for information from a compulsory notice, infringement notice or court document. Do not assume every communication has the same response requirements.
Preserve the evidence. Retain supplier records, prescriptions, patient-specific access documents, import paperwork, batch information, invoices and the versions of advertising actually published. Preserve website and social-media material before making necessary compliance changes.
Address current safety and compliance risks. Obtain appropriate clinical input where patient safety is involved. Legal review should not delay urgent medical care.
Check each participant’s position separately. The clinic, pharmacist, practitioner, supplier and directors may have different obligations and potentially conflicting interests.
Respond using verified records. Check confidentiality, privilege and the scope of the particular power before producing information or making admissions. Seek an extension early if needed, rather than assuming one applies.

A lawful prescription, lawful supply and lawful advertising are three different questions. Each requires its own answer.

07 How GopherWood Lawyers can help

GopherWood Lawyers acts in regulatory disputes and investigations, including matters involving regulators and businesses facing potential enforcement action.

For businesses operating in the peptide market, the regulatory position should be assessed against the actual products, supply arrangements and promotional material involved. A general assurance that a product is prescribed, compounded or sourced from a reputable supplier is not a substitute for that assessment.

We can assist with reviewing regulatory exposure, advising on correspondence or notices from the TGA, and responding to investigations and enforcement proceedings. We can also advise on related issues involving directors, officers and other individuals whose conduct may be examined by a regulator.

If your clinic prescribes, compounds, supplies or promotes peptide products, contact GopherWood Lawyers for a confidential discussion.

This article reflects regulatory material reviewed on 22 October 2026. It is general information only and is not legal or medical advice. The legal position depends on the product, the arrangements and the facts of the particular matter.

08 Sources and further reading

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