Replicas of weight loss drugs like Ozempic to be banned in Australian crackdown

The government will crack down on replicas of Ozempic and other weight loss drugs, closing a loophole that allowed pharmacies to make and sell them to about 20,000 Australians.

Butler said most of the 20,000 patients using the compounded GLP-1RA products were doing so for weight loss, so the move was not expected to severely affect diabetes patients.

There have been periodic global shortages of the prescription drugs Ozempic (semaglutide) and Mounjaro (tirzepatide), which are approved by the drug regulator the Therapeutic Goods Administration (TGA) to treat type 2 diabetes.

The drugs, which are self-administered via an injection, are also prescribed to treat overweight people and obesity off-label, which means the TGA has not approved the drugs for those conditions. Doctors can still prescribe the drugs for weight loss if they believe the patient will benefit and it is safe to do so.

Unlike usual pharmacies that sell manufactured medicines at pre-packaged strengths and quantities, compounding pharmacies often make up a prescription from scratch on site. This is an essential service for patients who may be allergic to an ingredient in a manufactured product, or who may require a unique dosage.

Children may also need a much smaller dose of an adult medicine, for example, or patients may need to continue on a medication no longer available on the Australian market while an alternative drug is found. Like a traditional pharmacy, a prescription from a doctor is required for compounded medicines.

Because compounded medicines are personalised for a specific clinical need and therefore usually made in small quantities, they are not subjected to the same safety regulations governing other medicine approvals.

But given the shortages of Ozempic and Mounjaro, compounding pharmacies have been producing and providing commercial quantities of similar weight loss products.

These products are not identical to the brand-name products.

In November Guardian Australia reported increasing numbers of patients were calling poisons information lines and presenting to emergency departments after taking weight loss drugs, whether the drugs were brand-name drugs or products obtained online or through compounding pharmacists.