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The TGA's 2024 compounding ban and named enforcement actions

In October 2024 Australia banned pharmacist compounding of semaglutide, tirzepatide and other GLP-1-class analogues outright, then in 2025 began fining and enforceable-undertaking-binding operators still advertising these prescription-only medicines directly to the public. Separately, Australian courts and the TGA have jailed, suspended-sentenced, or fined three named SARMs/peptide sellers since 2022. This page indexes both public records — a structural regulatory change and a named enforcement record — not a finding of our own.

In brief

What this is: a factual index of two separate public records — Australia's October 2024 ban on compounding GLP-1-class medicines, and the TGA's own named enforcement actions (court convictions, an enforceable undertaking, infringement notices) against specific sellers. Neither is our own finding.

The short version

  • The ban: from 1 October 2024, Australian pharmacists can no longer legally compound semaglutide, tirzepatide or other GLP-1 receptor agonist analogues under the extemporaneous compounding exemption — nationwide, all dosage forms, no grandfathering for existing stock.
  • Enforcement since: two operators — Your Solution Compounding Pharmacy (April 2025) and Midnight Health, running the Youly, Stagger and hub.health platforms (September 2025) — have paid infringement notices and/or signed enforceable undertakings over unlawfully advertising these prescription-only medicines to the public.
  • 3 named SARMs/peptide cases since 2022: one criminal conviction (director jailed, companies fined over $2.5 million combined), one suspended prison sentence, one paid infringement notice.
  • 2026 compliance priority: the TGA formally added unapproved peptides to its 2026 compliance priorities in June, with two enforcement operations already public since — neither has named a party yet.

The October 2024 compounding ban

On 1 October 2024, amendments to the Therapeutic Goods Regulations 1990 took effect, removing GLP-1 receptor agonist (GLP-1 RA) analogues — the class that includes semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro) — from the pharmacist extemporaneous compounding exemption. The change applies nationally, to all medicines containing a GLP-1 RA analogue regardless of dosage form, with no grandfathering provision for pharmacies' existing compounded stock. Federal Health Minister Mark Butler announced the change with the stated backing of the RACGP, the Medical Board of Australia, the Pharmacy Board of Australia, Diabetes Australia, the Eating Disorders Alliance of Australia, and every state and territory health department.

The trigger was scale: an estimated 20,000 Australians had turned to compounded "replica" versions of these medicines during the branded-product shortage, alongside a rising number of adverse event reports tied to mass-compounded supply. In practical terms, a pharmacist can no longer prepare these medicines under the compounding exemption at all — the only lawful route to semaglutide or tirzepatide in Australia now runs through the approved branded product on prescription.

Enforcement since the ban. Two operators have faced public TGA action for unlawfully advertising these prescription-only medicines directly to consumers — a separate rule from the compounding exemption itself, but the TGA's main visible enforcement lever in this space so far:

  • Your Solution Compounding Pharmacy Pty Ltd — the TGA accepted a court-enforceable undertaking on 7 April 2025 after the pharmacy's website carried order forms for semaglutide and tirzepatide between 23 November 2023 and 20 June 2024, which the company acknowledged likely unlawfully advertised prescription-only medicines to the public. The undertaking runs for three years.
  • Midnight Health Pty Ltd, trading as the telehealth platforms Youly, Stagger and hub.health — issued 10 infringement notices totalling $198,000 (paid September 2025) plus a separate enforceable undertaking, over advertising prescription-only tirzepatide and semaglutide to the public between June 2024 and January 2025, including unapproved references to treating conditions such as anxiety and stroke.

Neither public record states that either company kept illegally compounding after the ban took effect — the confirmed violation in both cases is unlawful direct-to-consumer advertising of prescription-only medicines, which is illegal in Australia independent of the 2024 change. We're not aware of a published TGA case yet that names a compounder for continuing to manufacture these medicines after 1 October 2024, and we haven't implied one above.

A 2026 compliance priority, and two investigations without a named party yet

In June 2026 the TGA formally added unapproved peptide products to its list of compliance priority areas for the year — alongside vapes, sunscreens and weight-loss medicines — citing rising imports, expanding social-media advertising, and emerging safety signals. The agency says it's directing more resources at consumer education, import monitoring, seizures and penalties as a result; the TGA's own Chief Medical Adviser was quoted saying that as the availability of unapproved peptide products has grown, so has the evidence of risk to consumers.

Two enforcement operations under that priority have become public since, and neither has produced a named party yet. An eight-month joint investigation by the Australian Border Force, the TGA and Victoria Police — opened after 640 vials of performance- and image-enhancing drugs were intercepted in air cargo in August 2025 — led to the seizure of over $2 million in steroids and peptides and the arrest of two Victorian men (46 and 47) and a Victorian woman (42), each charged with importing prohibited goods; none has been named in the TGA's own release. Separately, TGA-executed search warrants on two New South Wales properties on 4 August 2026, assisted by NSW Police, seized over $120,000 of unapproved peptides — including retatrutide, CJC-1295, and a BPC-157/TB-500 combination marketed as a "Wolverine Stack" — and steroids allegedly linked to a social media influencer the TGA says it had previously warned; again, the agency's own account doesn't name them. As with the UK's open Northampton investigation on the equivalent page for that country, we'll add either case to the table below only once a regulator or court has actually named someone in connection with it.

Named cases against SARMs and peptide sellers

Separately from the GLP-1 compounding story, the TGA and Australian courts have taken public, named action against a handful of sellers of SARMs (selective androgen receptor modulators) and related peptides since 2022 — a smaller, more scattered record than the FDA's, but a real one. Every row links to the TGA's own release.

Named TGA and court enforcement actions against SARMs/peptide sellers, 2022–2025
Seller / individualProducts citedActionDate
Natural Franchises Pty Ltd (t/a Aus Labs), SARMs International Pty Ltd (t/a iSARMs), Smart Labs Pty Ltd, and director Christopher RamseySARMs (including Schedule 10 Cardarine) and nootropicsGuilty pleas to 200+ Therapeutic Goods Act charges (25 Oct 2022); sentenced to 2 years' imprisonment (intensive corrections order) plus $301,100 in personal fines; the three companies fined $2,225,000 combinedPleaded guilty 25 Oct 2022; sentenced 17 Mar 2023
Ryan Gregory McTeigue, sole director of Elite Labs Pty Ltd (t/a Elite SARMS)SARMs, SERMs, and Schedule 4/Schedule 10 goodsSentenced to 2 years' imprisonment, wholly suspended on a 2-year good-behaviour undertaking, with conditions barring him from exporting, manufacturing, advertising, supplying, or importing therapeutic goods in Australia~7 Jun 2024
Redback SARMsSARMs and Melanotan IIPaid $15,210 across six TGA infringement notices for unlawfully advertising Schedule 4 prescription-only substancesAnnounced ~19 Nov 2025

What these actions are — and aren't

These aren't all the same kind of record, and the difference matters. The Ramsey and McTeigue cases are actual criminal court outcomes — guilty pleas or convictions under the Therapeutic Goods Act 1989, with a sentencing court setting the penalty. Redback SARMs' outcome, and the Your Solution/Midnight Health actions above, are infringement notices and enforceable undertakings — the TGA's own administrative and civil tools, which a company can accept without any court making a finding of guilt, though an enforceable undertaking is legally binding and a breach can be taken to the Federal Court. None of these mechanisms is a product recall, and none tells you whether a specific product a company sells today is safe or accurately labelled — they tell you only what the named regulator or court found about specific past conduct.

The October 2024 change is a different kind of thing again: not an action against any single company, but a change to what pharmacists are legally permitted to compound at all, nationwide.

Why this isn't part of the Register

Same reasoning as the equivalent FDA and Health Canada pages: the Register's own findings are anonymous when a product fails, because that verdict is our conclusion against a standard we wrote. This page is different in kind — it reports the TGA's and Australian courts' own public enforcement record, already published under each company's or individual's name. We're not naming these sellers; the TGA and the courts already did, publicly, and we're indexing that record rather than duplicating it as our own accusation.

If you're in Australia and buying from one of these sites

An action on this list doesn't tell you what's actually in a specific product today, and the absence of a TGA action for a given seller doesn't mean one isn't coming or that the seller is otherwise clean — Australia's enforcement capacity, like Canada's, is smaller than the FDA's. If it's a GLP-1-class medicine you're after, the only lawful route in Australia since October 2024 is a prescription for the approved branded product, not a compounded version regardless of who's selling it. See vendor red flags for the broader checklist, and the US and Canadian versions of this page for how the same problem looks in those markets.

References

  1. Australian Government Department of Health, Disability and Ageing (Minister the Hon. Mark Butler MP), "Protecting Australians from unsafe compounding of replica weight loss products," media release on the removal of GLP-1 receptor agonist analogues from the pharmacist extemporaneous compounding exemption, effective 1 October 2024 (health.gov.au); corroborated by Law Society Journal and Australian Pharmacist reporting on the same regulation change and its stated professional-body backing.
  2. Therapeutic Goods Administration, "Your Solution Compounding Pharmacy undertakes to comply with advertising rules for weight-loss medicines," enforceable undertaking accepted 7 April 2025 (tga.gov.au); corroborated by Australian Journal of Pharmacy (AJP) trade reporting on the same undertaking and date range.
  3. Therapeutic Goods Administration, "Midnight Health Pty Ltd issued infringement notices for unlawful advertising and undertakes to comply with advertising rules," media release on $198,000 in infringement notices (paid September 2025) and an enforceable undertaking (tga.gov.au); corroborated by independent reporting naming the same platforms (Youly, Stagger, hub.health), notice count, and total.
  4. Therapeutic Goods Administration, "Aus Labs, Smart Labs, iSARMs and Director Christopher Ramsey plead guilty to over 200 charges for illegal manufacture, supply and advertising of SARMs and nootropics" (guilty pleas, 25 October 2022) and the separate release "Company director sentenced to 2 years imprisonment, personal and company fines over $2.5 million for selling illegal SARMs" (sentencing, 17 March 2023, Downing Centre Local Court) — both tga.gov.au; corroborated independently by Mirage News and The National Tribune reporting the same sentence and fine figures.
  5. Therapeutic Goods Administration, "Individual sentenced for offences against the Therapeutic Goods Act" (Ryan Gregory McTeigue / Elite Labs Pty Ltd t/a Elite SARMS), sentencing reported June 2024 (tga.gov.au); corroborated independently by Australian Journal of Pharmacy, "Suspended sentence for Therapeutic Goods Act breaches," and by Mirage News, both reporting the same sentence terms.
  6. Therapeutic Goods Administration, "Redback SARMs pays fine for advertising prescription-only substances," six infringement notices totalling $15,210, announced November 2025 (tga.gov.au); corroborated independently by Mirage News and The National Tribune reporting the same amount and substances (SARMs, Melanotan II).
  7. Therapeutic Goods Administration, "TGA strengthens compliance focus on unapproved peptide products as part of evolving risk response," media release, 10 June 2026 (tga.gov.au); corroborated by ABC News, 10 June 2026, DLA Piper and Lexology client briefings (June 2026), and RACGP newsGP reporting on the same 2026 compliance-priority designation.
  8. Therapeutic Goods Administration and Australian Border Force, joint release on the arrest of two Victorian men and one Victorian woman over an alleged $2 million steroid/peptide importation operation (abf.gov.au / tga.gov.au); corroborated by AJP and Pharmacy Daily trade reporting on the same charges, ages and seizure value. No individual has been named by the TGA or ABF in connection with this case as of this review.
  9. Therapeutic Goods Administration, "Unapproved peptide product promoters and suppliers are put on notice," media release on search warrants executed at two New South Wales properties on 4 August 2026 (tga.gov.au); corroborated by ABC News, 2 August 2026, on the same seizure value, products, and social-media-influencer link. No individual has been named by the TGA in connection with this case as of this review.