Risks associated with compounded medicines

2 April 2024: Medicines Australia is aware of reports of compounded medications being sold to patients in place of medicines that are experiencing supply shortages.

It’s important that patients understand compounded products are ‘unapproved’ therapeutic goods and have not been evaluated by the TGA for safety, quality or efficacy. This includes compounded products purchased from pharmacies, from naturopaths and from online retailers.

The ingredients used in compounded medicines may be counterfeit or may have been illegally imported into Australia, and each formulation may differ in quality.

Medicines Australia holds strong reservations about the environment in which compounded medications are made, and the equipment specifications being at the discretion of the pharmacist or person preparing the formulation.

It is our position that all complex compounding should take place in TGA-licenced or facilities of equivalent manufacturing standards to reduce adverse events and lower the risk compounded medicines.

Patients should be aware that in Australia it is illegal to advertise prescription-only medicine to the public. This means that if you see advertising for a prescription medicine, it is illegal and may represent a counterfeit product or a scam.

In addition to safety concerns, compounded medications may infringe on the intellectual property rights of the innovator company under Australian law.

Further information about compounded medicines is available on the TGA website – www.tga.gov.au/news/safety-alerts