What are Australia's prescription medicine label rules (TGO 115), and do they catch wrong words?

Australia's standard for prescription medicine labels is now TGO 115, which commenced on September 30, 2026 and replaced TGO 91. Prescription medicines released for supply before October 1, 2031 may still comply with TGO 91 instead. Non-prescription medicines have their own order, TGO 116, which commenced the same day and replaced TGO 92; this page covers prescription medicines only. TGO 115 sets what information must appear and how legible it must be, not whether each word means what it should, so a correctly spelled wrong word passes it the same way it passes spellcheck.

ContextRx studies US FDA labels, not Australian ones. The same read for meaning applies.

This page is general information, not legal or regulatory advice.

What the standard covers

TGO 115, the Therapeutic Goods (Standard for Labelling of Prescription Medicines) (TGO 115) Order 2026, sets labelling requirements for primary packs, intermediate packaging and containers of prescription medicines, including what information goes on the main label and other labels.

Its general requirements say the required information must be in English, clearly legible, printed in a durable manner, in a text size of not less than 1.5 millimetres unless otherwise specified, in a colour that contrasts strongly with the background (with some exceptions for embossed details), and in metric units of measurement unless otherwise specified.

The transition from TGO 91

TGO 115 says that, despite the repeal of TGO 91, medicines released for supply before October 1, 2031 may comply with TGO 91 instead, or with a mix of specified provisions from both. So, as of October 2026, a label you review may follow either standard.

What the standard doesn't check

Our view: rules about legibility, size, contrast and required content are about whether the required information is there and readable. They don't test whether a real word has replaced the intended one.

Made-up example: a warning that should say "hypoglycemia" prints "hyperglycemia". The label is in English, legible, contrasting and complete, and it still tells the reader to watch for the opposite problem.

Why spellcheck misses it

Both words are real and spelled correctly, so spellcheck passes them, and a compliance check against the standard's list passes them too.

What to check next

Practice advice:

Find which standard the label follows, TGO 115 or TGO 91, and check it against that one.
Then read the warnings, dosing and directions lines for meaning, one line at a time.
If labels are being redesigned for the new standard, read the full new artwork, not only the changed elements.
For comparable rules elsewhere, see what rules govern exact label wording, Health Canada drug label wording and EU QRD templates.

This is our reading of public guidance, not legal or regulatory advice.

Sources

Last reviewed: October 18, 2026

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FAQ

What is TGO 115?

It's Australia's labelling standard for prescription medicines, the Therapeutic Goods (Standard for Labelling of Prescription Medicines) (TGO 115) Order 2026. It commenced on September 30, 2026 and replaced TGO 91.

Is TGO 91 still used for prescription medicines?

During the transition, yes. TGO 115 says prescription medicines released for supply before October 1, 2031 may comply with TGO 91 instead.

Do Australian prescription medicine labels need exact wording under TGO 115?

TGO 115 sets required information and how it's presented, such as English, legibility and minimum text size. It doesn't check meaning word by word.

Does ContextRx study Australian labels?

No. ContextRx cases come from FDA labels; the review habit carries over.