Skip to main content

TGA Compounding Exemption

Meaning

The TGA Compounding Exemption is a specific legal provision within the Australian Therapeutic Goods Regulations that permits a pharmacist to extemporaneously compound a medicine for a named, individual patient without the product requiring full registration by the Therapeutic Goods Administration. This exemption is strictly conditional, requiring a valid prescription and an absence of a suitable, commercially available, TGA-approved alternative. It is designed to meet unique patient needs, not to facilitate mass production.