Are peptides like BPC-157 and CJC-1295 safe to use?

There is no clinical trial evidence demonstrating efficacy or safety for these peptides in humans for the purposes they are marketed — anti-ageing, recovery, weight loss. CJC-1295 raises insulin-like growth factor 1 (IGF-1) substantially; elevated IGF-1 is associated with increased breast cancer risk in the research literature. The TGA has warned that patients 'often cannot be sure what is in the vial, whether the dose is right, or whether it is sterile.' These are not small unknowns. The safest position is to avoid unapproved compounded peptides outside a clearly indicated, specialist-supervised clinical context.

How are clinics getting away with this?

The core issue is a structural gap between TGA (which regulates products) and AHPRA (which regulates practitioners). Neither agency has full visibility of the supply chain as it operates in practice. Clinics exploit the Special Access Scheme — intended for rare and serious conditions — to prescribe unapproved products routinely. Pharmacists exploit the compounding exemption — intended for individual patient needs — to manufacture peptides at scale. Advertising bans are circumvented by framing promotional material as 'information.' The 2024 removal of weight-loss drugs and gene therapies from the compounding exemption was one step; peptides are still there.

Wellness clinics are selling unapproved peptides — and it's mostly legal

What just happened

A legal analysis published by the University of Sydney this week has mapped, in detail, how Australian wellness clinics are legally supplying unapproved peptides and anti-ageing injectables to patients — often at more than A$1,000 for a few weeks of supply — and why regulators are struggling to stop it.

The substances named in the analysis include BPC-157, CJC-1295, and TB-500. None is listed on the Australian Register of Therapeutic Goods for the purposes they are being marketed. None has demonstrated efficacy in human clinical trials for the claimed indications — anti-ageing, recovery, weight loss, enhanced performance. Several raise specific safety concerns.

The analysis lands in the same week the TGA issued a public notice to peptide suppliers and promoters — and the same month that compounded Ozempic copies were estimated to have reached at least 20,000 Australians through online clinics operating under similar regulatory frameworks.

This is not a fringe story about a handful of rogue operators. It describes a structural problem in how Australian therapeutic goods regulation is designed.

The both-and

The loopholes are real and deliberately used

Australian law allows doctors to prescribe unapproved medicines — those not on the Australian Register of Therapeutic Goods — under the Special Access Scheme (SAS). The SAS was designed for patients with rare or serious conditions who need treatments not available through standard channels. In a clinical context, that’s an important pathway: a child with a rare metabolic disorder, a cancer patient needing an unlisted agent, a specialist managing a complex case outside approved indications.

What Christopher Rudge’s analysis at Sydney Law School documents is that wellness clinics are using this pathway routinely, for cosmetic and performance purposes, at scale. The law does not prohibit this. GPs and non-GP specialists can access the SAS with minimal documentation. When a federal court found in 2019 that Peptide Clinics Pty Ltd had operated with “no real doctor-patient relationship” — and fined them A$10 million for advertising — the ruling addressed advertising, not the supply itself.

The compounding exemption adds a second layer. Pharmacists can mix medicines for individual patients without TGA product registration. Bulk manufacturing disguised as personalised compounding is the mechanism through which peptides reach patients at scale. The 2024 regulatory change removing weight-loss drugs, gene therapies, and medicinal cannabis from the compounding exemption was a partial response; peptides are still included in the exemption.

The safety claims do not hold up

The clinics promoting these substances assert benefits that are not supported by human clinical trial evidence. The author’s summary is direct: “None has been shown to have the claimed effects in humans.”

The specific risk flagged for CJC-1295 is worth examining carefully. This peptide raises insulin-like growth factor 1 (IGF-1) — according to published pharmacokinetic data — by up to three-fold for over a week after a single dose. Elevated IGF-1 is described in the oncology literature as a “probable cause” of breast cancer. This is not a theoretical risk invented for regulatory purposes — it is a mechanism with published mechanistic and epidemiological support.

The TGA’s summary for patients is unusually direct: patients “often cannot be sure what is in the vial, whether the dose is right, or whether it is sterile.” The quality control standards applied to compounded peptides are not equivalent to those applied to registered pharmaceuticals. Sterility testing, concentration verification, and batch consistency — standard requirements for registered therapeutic goods — are not systematically mandated for compounded preparations.

Why enforcement is lagging

The TGA acts on products; AHPRA acts on practitioners. Neither has full visibility of the supply chain as it operates across both domains. A wellness clinic prescribing via the SAS is AHPRA territory; the compounded product it receives is TGA territory. The September 2025 update to AHPRA’s cosmetic procedure guidelines and the October 2025 telehealth guidance update tightened some edges, but the core structural gap remains.

Enforcement typically follows the TGA’s stated approach: warn and educate first, escalate if that fails. For a supply ecosystem generating consistent revenue from a patient population that isn’t filing formal complaints — and that often genuinely believes in the product — the escalation trigger is slow.

Policy proposals currently under active discussion include narrowing the compounding exemption to block bulk manufacturing of peptides, adding specific peptides to the Schedule 5 (non-compoundable list), and increased resourcing for TGA breach investigation. None of these has been implemented for peptides at the time of writing.

My two cents

The audience most targeted by wellness clinic peptide marketing is not hard to describe: women in their 40s and 50s navigating perimenopause, fatigue, changing body composition, and a medical system that has historically been dismissive about exactly those concerns. The appeal of a clinic that says “yes, we have something for that” — charges A$1,000+, delivers a vial, and frames it as cutting-edge — is entirely understandable given what that woman has often been told by conventional medicine.

That’s the part that needs to be named directly: the gap that wellness clinics are filling is real. The dismissal that drives people there is real. But filling a real gap with an unapproved product whose safety signals include potential breast cancer risk is not an acceptable substitute for genuine care.

The practical implication in a general practice consultation is straightforward. If a patient mentions they’ve been offered peptide therapy — or is already using it — the conversation worth having is not “that’s dangerous, stop.” It’s an enquiry into what problem they’re trying to solve, a review of the evidence for the product they’re considering, and an assessment of whether there’s something in the conventional toolkit that addresses the actual concern.

The TGA’s warning this week, and the analysis from Sydney Law School, are useful in that conversation. Not as weapons against patient choice, but as context: the regulatory system does not vouch for these products, the supply chain does not guarantee what’s in the vial, and the evidence does not support the claims being made.

Verdict: yes — active regulatory story, patient-safety implications, directly relevant to the 40–55 women’s health audience.

Sources cited

How wellness clinics bend the rules to supply unapproved peptides and anti-ageing injections. The Conversation AU, 20 July 2026. https://theconversation.com/how-wellness-clinics-bend-the-rules-to-supply-unapproved-peptides-and-anti-ageing-injections-287884
TGA news and safety updates. https://www.tga.gov.au/news-and-resources/news
AHPRA advertising guidance for practitioners. https://www.ahpra.gov.au/Publications/Advertising-resources.aspx