Internationally, there has been a surge in demand for new GLP-1 RA weight loss medications in recent times. Ozempic® (semaglutide), Mounjaro® (tirzepatide) and Trulicity® (dulaglutide) approved for the treatment of type 2 diabetes mellitus, have gained widespread attention for their use in weight loss. Indeed, the use of such medicines for weight loss purposes has resulted in a global shortage in the medicines. The Therapeutic Goods Administration (TGA) has implemented strict governance measures to regulate the prescription, usage and advertising of these medicines and has been active in pursuing contravening organisations.

As these weight loss medicines are ‘prescription-only’ medicines, advertising them to consumers is prohibited under the therapeutic goods laws. It is also prohibited to advertise Ozempic for ‘off label’ use for weight loss as the only approved indication is for the treatment of type 2 diabetes as an adjunct to other therapeutic goods, diet and exercise. Unlike Ozempic, the TGA has recently formally approved Mounjaro as a treatment for chronic weight management.

The detection and disruption of the unlawful supply and advertising of unapproved and high-risk medicines and medical devices used in the wellness and beauty industries (in particular, weight loss medicines) is a compliance priority for the TGA for 2023-25. In particular, the TGA has stated that it intends to continue to target advertising of unapproved products on digital platforms. In coming months, we expect the TGA to issue further guidance on the compounding and manufacture of weight loss medicines.

Between January and August 2024, the TGA issued over 70 infringement notices to 19 different entities amounting to $1 million in fines for alleged unlawful advertising of prescription-only medicines. In one particular example, a NSW pharmacy was fined $18,780 in May 2024 for the alleged unlawful advertising of Ozempic throughout its stores. In other actions, the TGA pursued online telehealth clinics for:

• promoting the use and supply of prescription only medicines for weight loss purposes;
• advertising weight loss medicines ‘off label’;
• statements that certain prescription only medicines were approved by the TGA; and
• statements regarding the safety of medicines.

The TGA’s crackdown on advertising weight loss medicines is accompanied by a change in the compounding regulations. The global shortage of Ozempic, Mounjaro and Trulicity led to customers seeking the medicines from compounding pharmacists (often via a virtual platform). Pharmacists are permitted to compound medicine formulations provided that the medicine is manufactured only on an individual basis and only after receipt of a valid prescription. This is known as the ‘compounding exemption’.

From 1 October 2024, the TGA removed all ‘compounded glucagon-like peptide-1 receptor agonists (GLP-1 RA) products’ (i.e. pharmacy compounded equivalents to Ozempic and Mounjaro) from the compounding exemption. The TGA reasoned that the change was required due to:

• the unknown nature and safety of the ingredients used in compounding the medicines;
• contraventions of the compounding exemption whereby compounding of these medicines was not occurring on an individual patient basis and only after receipt of a valid prescription; and
• the absence of evaluation of these medicines for safety and quality that is a feature of other drugs.

Prohibiting the compounding of these weight loss medicines ensures the TGA has greater oversight of the medicines. The TGA is also collaborating with the Australian Border Force to address the importation of counterfeit Ozempic-labelled pens into Australia, a number of which have been associated with adverse events.