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The Therapeutic Goods Administration (TGA) has announced updates to the labeling requirements and guidelines for injectable electrolyte medicines, specifically those intended for electrolyte replacement with a volume of 100 mL or less. The changes can be referred to in Therapeutic Goods Order No. 91—Standard for Labels of Prescriptions and Related Medicines (TGO 91).
Labelling requirements for the injectable electrolyte medicines (with a volume of 100 mL or less):
The potassium chloride quantity must be stated in millimoles on the label, and the amount of potassium chloride must be included in the weight unless there are exceptions.
Same requirements applied above for other active ingredients
Transition Period
A transition period is in place until 30 November 2026. By 1 December 2026, all relevant products imported or released for supply must comply with the new labeling requirements.
When updating your labels, you must submit a variation request. Use the following Self-Assessable Request (SAR) code if the conditions are met:
LOEI: Label changes related to the method of expressing the content of active ingredients or excipients in compliance with the current labeling TGO
If LOEI is not applicable, consider using:
LOTG: Label changes to align with current TGOs for labels previously evaluated and approved by the TGA.
Guidance Updates on Medicine Labels
Medicine sponsors must comply with the new requirements for injectable medicines intended for electrolyte replacement (with volumes of 100 mL or less) and ensure that preparation instructions are provided for administration by healthcare professionals. QR codes may be included alongside instructional statements, providing a direct link to the updated approved Product Information on a sponsor-controlled website.
For full guidance, refer here: Labelling Medicines to Comply with TGO 91 and TGO 92
Implications for Health Professionals
Healthcare providers may notice changes in the labeling of injectable electrolyte medicines, particularly those containing potassium chloride, as the quantity will now be displayed in millimoles. During the transition, both old and new labels may be in circulation. It is crucial to exercise caution when prescribing, dispensing, and administering these medicines to ensure correct product selection.
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