Updates to requirements and guidance for labels of injectable medicines

Changes to TGO 91 for injectable electrolyte medicines

We have made changes to Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) to make medicine labels clearer for health professionals.

These changes will help to make quantities of active ingredients clear on labels and in units important to health professionals.

For injectable medicines intended for electrolyte replacement (with a volume of 100 mL or less):

• The label must express potassium chloride quantity in millimoles on the label. Labels must also include the quantity of potassium chloride in weight except in certain circumstances.
• The label must continue to express the quantity of other active ingredients in weight. It must also include the quantity in millimoles of each ingredient.

A transition period has started to give medicine sponsors time to update labels, outlined below.