New TGA guidance explains rules for compounded medicines in Australia

New TGA guidance explains rules for compounded medicines in Australia

15 May 2026

The document, Manufacturing, supplying and advertising compounded medicines lawfully, aims to support safe and compliant practice under the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.

While the TGA encourages the use of approved medicines listed on the Australian Register of Therapeutic Goods (ARTG), it recognises that compounding may sometimes be needed when a patient has specific clinical requirements that cannot be met with available products.

The guidance outlines how pharmacists, medical practitioners, and other authorised health professionals can lawfully compound medicines. It also explains when exemptions may apply, such as from manufacturing licences or ARTG inclusion requirements.

Higher-risk products are also addressed in the guidance, including biological medicines, medicinal cannabis products, GLP-1 receptor agonist therapies, and intravenous treatments. Additional expectations apply to these categories due to their complexity and potential safety risks.

Health practitioners involved in compounding are being urged to review the guidance carefully to ensure their practices meet legal, regulatory, and professional standards.

The TGA says the guidance is part of its broader work to improve clarity and consistency across the sector. It also confirms that serious non-compliance may result in regulatory action, including infringement notices, directions, civil penalties, or prosecution, depending on the severity of the breach.


https://www.tga.gov.au/

Source: Therapeutic Goods Administration (TGA)
 

Categories

Popular Posts

Recent Posts

Tags