Dual drug labelling on the way out

2 minute read

From next month, most drug labels will only display new names for active ingredients.

Dual labelling for medicine ingredients will start to be phased out from May, the TGA has announced.

According to a recent update posted on the TGA’s website, labels will now need to be changed to show only the new ingredient name for most active ingredients. A list of all the ingredients affected by the change is available here.   

Medicine sponsors now have the next three years to remove the old ingredient names from their labels, as well as update their Product Information and Consumer Medicines Information documents, according to the update.

However, dual labelling has been extended until the end of April 2025 for a few ingredients, such as hydroxycarbamide (hydroxyurea), found in chemotherapy drugs, and local anaesthetic tetracaine (amethocaine).

For drugs containing these ingredients, labels will be expected to show only the new ingredient names from April 2028.

Other ingredients, such as the antipruritic alimemazine (panectyl), will have the old and new names displayed indefinitely.

These exceptions to the transition were established based on a consultation between the TGA, health professionals and consumers held at the end of last year.

Feedback collected during the consultation showed that most health professionals felt that they needed more time to become familiar with the new ingredient names.

Dual labelling was mandated for medicines released for supply after May 2020 to foster recognition of the new names among both health professionals and consumers.

Medical professionals are advised in the update to take care when prescribing, dispensing and administering drugs to ensure patients are getting the right medicine.

More information from the TGA outlining how health professionals should approach the transition is available here.

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