The federal government says it will ban compounding pharmacists from producing and selling non-brand copies of semaglutide and other GLP-1 receptor agonists, citing safety concerns over their growing off-label use for weight loss.

Health Minister Mark Butler’s decision comes amid a boom in sales of compounded GLP-1RAs driven by online telehealth providers such as Woolworths-backed Eucalyptus and NIB’s Midnight Health that advertise direct to consumers.

Sales of TGA-approved products including Ozempic (semaglutide) or Mounjaro (tirazapetide) will be unaffected.

However, the government says it is aware of at least 20,000 Australian patients injecting compounded versions of these medicines, with media reports suggesting the true number could be far higher.

“While I understand that this action may concern some people, the risk of not acting is far greater,” Mr Butler said on Wednesday.

“You only have to look to the recent reports of individual impacted by large-scale compounding to realise the dangers posed.”

“This action will protect Australians from harm and save lives.”

The change will take effect from 1 October 2024.

The federal government said the move followed consultation from a range of health groups including the Royal Australian College of GPs, the Medical Board of Australia, Diabetes Australia, the Eating Disorders Alliance of Australia and state and territory health departments.

Unlike TGA-approved products, pharmacy-compounded medicines are not clinically evaluated by the independent regulator for safety, quality or efficacy, it added.

“The commercial-like scale and quality standards of compounded weight loss products has been the subject of increasing community concern, both in Australia and internationally.”

“It has been repeatedly documented in the media, including concerns raised by individuals who have used these medicines.”

Pharmacist compounding of medications is permitted under TGA regulations to assist individual patients who have difficulty accessing a specific product. However critics have said some commercial ventures are exploiting the pharmacy compounding loophole to manufacture large quantities of a popular product to sell to a mass market.

Obesity and diabetes researcher Professor Michael Cowley of the Monash Biomedicine Discovery Institute said these quality concerns were real.

“I support this change because the compounded versions are similar to, but not the same as, the clinically tested and approved drugs,” he said.

“The compounded versions have not been clinically tested in the same rigorous way as the approved versions have.

“The production facilities of the compounded versions are not inspected for safety in the same way as the manufacturing facilities of the approved versions are. The safety of the compounded versions has not been clinically tested.”

“In short, we cannot be sure that the compounded versions are as safe and effective as the approved versions, and there is no adverse event tracking of the compounded medicines.”

TGA chief medical adviser Professor Robyn Langham said the regulator would work with doctors, pharmacists and patients to support patients to navigate the regulation change and in some cases provide guidance in finding alternative and safe medicines.