Understanding your responsibilities when importing, compounding and supplying unapproved peptide products

The Therapeutic Goods Administration (TGA) is concerned about the rise in the import, supply, compounding and advertising of unapproved peptide products and the potential safety risks associated with these goods.

Peptides are short chains of amino acids, which are the building blocks of proteins. Peptides can mimic or stimulate natural biological processes, including those involved in growth, metabolism and tissue repair.

Under the Therapeutic Goods Act 1989, peptide products are regulated as therapeutic goods in Australia. Several peptide-based medicines, such as insulin products for the management of diabetes, are approved by the TGA and are included on the Australian Register of Therapeutic Goods (ARTG).

Unapproved peptide products are goods which have not been included in the ARTG.

We are aware that the use or supply of unapproved peptide products is being promoted on a number of online and social media platforms, with claims they have a range of health benefits including weight loss, muscle growth, anti‑ageing, and enhancing cognitive and athletic performance. These products have not been evaluated for safety, quality or effectiveness by the TGA.

Examples of unapproved peptide products include those containing BPC‑157, GHK‑Cu, TB‑500, retatrutide and CJC‑1295, often supplied in injectable form.

These practices raise significant regulatory and public health risks, and the TGA is actively monitoring this issue from both safety and law enforcement perspectives.

Safety considerations when using unapproved peptide products

• Unapproved peptide products have not been assessed by the TGA for safety, quality or effectiveness.
• Important information about these products remains unknown, resulting in an increased health risk for users.
• This information includes how they are manufactured, whether they are sterile, how they work in the body, what side effects they may cause, and what substances these products actually contain.
• Product labelling may be inaccurate or misleading, meaning consumers and healthcare professionals may not have reliable information about the ingredients, dosage and administration.
• Unapproved peptide products, particularly those that are injected, can carry other significant safety risks, including contamination, infection or local tissue damage.
• As the TGA has not reviewed any scientific evidence to support the safety or claimed benefits of these unapproved peptide products, their use may result in side effects, interactions with other medicines, and both immediate and long‑term health harms, with no demonstrated benefits.
• Consumers should be cautious when buying any therapeutic goods online, including unapproved peptide products, especially if prescription-only products are supplied without a proper prescription. This can be unsafe and may be unlawful.
• Adverse events and other concerns received by the TGA for these unapproved products include:
  • severe allergic reactions, requiring doses of adrenaline and hospitalisation
  • systemic inflammatory response syndrome (SIRS) (severe inflammation in the body), requiring hospital management
  • generalised hypersensitivity symptoms such as full‑body intense itching, palpitations, pain and sweating
  • wide ranging body side effects, including insomnia, blurred vision, extreme tiredness, flu‑like illness, joint pain and skin sensitivity
  • musculoskeletal injuries, including plantar fasciitis and Achilles tendinitis, and
  • poor product quality, including unsealed packaging from an online supplier.

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

Key information for suppliers

• The TGA urges all individuals and businesses involved in prescribing, compounding, supplying or promoting peptide products to ensure they understand and comply with all of their legal requirements. This includes meeting all obligations under relevant Commonwealth and state/territory legislation.
• Healthcare practitioners who compound, prescribe or supply unapproved peptide products must also comply with all regulatory requirements and relevant professional practice standards, including those set by Ahpra, the Australian Health Practitioner Regulation Agency.
• Generally, a compounded good is only exempt from the requirement to be included on the ARTG where:
  • the good is dispensed or extemporaneously compounded for a particular person for application to that person, or
  • the good is compounded in a hospital by a relevant pharmacist in anticipation of being needed for therapeutic application to patients of the hospital.
• Further, a pharmacist or medical practitioner must generally meet the circumstances set out in Schedule 8 of the Therapeutic Goods Regulations 1990 to be exempt from being required to hold a manufacturing licence in relation to the manufacture or a step in the manufacture of peptide products in Australia.
• Pharmacists should understand the expectations of the Pharmacy Board of Australia set out in their professional practice standards and guidelines, as well as ensure they comply with all relevant pharmacy legislation in their jurisdiction. Guidelines can be accessed at Pharmacy Board of Australia – Codes, Guidelines and Policies.
• Advertising or promoting unapproved peptide products, particularly through social media or influencer channels, is likely to breach Australian therapeutic goods advertising laws.
• The TGA continues to undertake compliance and enforcement action where unlawful compounding, import, supply and advertising is identified.

Advertising requirements

• The TGA regulates advertisements for therapeutic goods, including both approved and unapproved peptide products.
• Health practitioners should be aware that if an advertisement for a health service directly or indirectly advertises a therapeutic good, it will also be regulated by the TGA. For more information, see Advertising a health service.
• Advertising of prescription-only and most pharmacist-only medicines to the public is prohibited, unless authorised or required by an Australian government authority. It is also unlawful to advertise some therapeutic goods that are not included in the ARTG to the public, regardless of how or where they are promoted.
• The advertising of health services may be subject to requirements in the laws governing Australian Consumer Law and the Health Practitioner Regulation National Law. For more information see also Ahpra Guidelines for advertising a regulated health service.

Personal Importation Scheme

• The TGA is warning consumers about the risks associated with importing and using unapproved peptide products under the Personal Importation Scheme.
• Unapproved peptide products that are not clearly labelled, including products identified only by codes, or those that do not clearly state the active ingredient, strength or dosage, pose significant safety risks. These products cannot be assessed for lawful importation under the Personal Importation Scheme, and will not be considered for release.
• Individuals importing unapproved peptide products from overseas under the Personal Importation Scheme must meet all other conditions of the Scheme, including having an appropriate medical authorisation or prescription when required.
• Products labelled to avoid regulatory scrutiny will unlikely be released because compliance with the Personal Importation Scheme cannot be validated. This would include those with omitted ingredients, obscured or over‑labelled information, or vials that are unlabelled or not clearly labelled.
• 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.
• State and territory laws may impose additional controls on the sale, supply and possession of unapproved peptide products.

Reporting non-compliance

• If you encounter counterfeit therapeutic goods, questionable practices, illegal activity, or advertising that does not meet regulatory requirements, you can report it directly to the TGA.
• Submit a report here: Report a breach.