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Update to listed medicine ingredients in November 2019

Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2019

26 November 2019

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation in November 2019. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2019. A total of 40 changes have been made in the updated Determination. These changes include:

  • Addition of 6 new ingredient entries.
  • Changes to 34 existing ingredient entries to make requirements clearer and less restrictive.

A complete list of changes to ingredients is below.

Alignment of gluten requirements with labelling orders

The requirements relating to the declaration of gluten on medicine labels were removed from the Permissible Ingredients Determination as the requirement exist in the labelling orders: Therapeutic Goods Order No. 69 - General requirements for labels of medicines (TGO 69) and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).

This does not change the need to declare gluten on medicine labels in some circumstances. Sponsors must continue to comply with the gluten requirements specified in the relevant labelling order. Labels must fully comply with all provisions in either the old or the new Order. A label cannot selectively comply with parts of multiple Orders. See Labelling changes: information for sponsors about the transition period for labelling orders.

New ingredients

  • 2,5-dimethyl-4-ethoxy-3(2h)-furanone
  • 2-ethyl-N-methyl-N-(3-methylphenyl) butanamide
  • Hexylresorcinol
  • Nicotinamide riboside chloride
  • Palmidrol
  • Styrallyl propionate

Changed ingredients

Ingredient Reason for update
AVENA FATUA Alignment of gluten requirement with labelling orders
AVENA SATIVA Alignment of gluten requirement with labelling orders
BARLEY Alignment of gluten requirement with labelling orders
BARLEY BRAN Alignment of gluten requirement with labelling orders
BARLEY GERM Alignment of gluten requirement with labelling orders
BENZYL ALCOHOL Extension of purpose
BOVINE SODIUM CHONDROITIN SULFATE Extension of purpose
CANDIDA UTILIS Extension of purpose
CETYLPYRIDINIUM Extension of purpose
CINNAMOMUM CAMPHORA Aligned with the Poisons Standard (SUSMP)
HORDEUM DISTICHON Alignment of gluten requirement with labelling orders
HORDEUM VULGARE Alignment of gluten requirement with labelling orders
MALTODEXTRIN Alignment of gluten requirement with labelling orders
METHYLISOTHIAZOLINONE Aligned with the Poisons Standard (SUSMP)
OAT Alignment of gluten requirement with labelling orders
OAT BRAN Alignment of gluten requirement with labelling orders
OATMEAL COLLOIDAL Alignment of gluten requirement with labelling orders
PREGELATINISED WHEAT STARCH Alignment of gluten requirement with labelling orders
RYE Alignment of gluten requirement with labelling orders
SACCHARIN Less restrictive requirements
SECALE CEREALE Alignment of gluten requirement with labelling orders
SHARK CHONDROITIN SULFATE Extension of purpose
SHARK SODIUM CHONDROITIN SULFATE Extension of purpose
SODIUM CHLORIDE Less restrictive requirements
SODIUM CHONDROITIN SULFATE Extension of purpose
TRITICUM AESTIVUM Alignment of gluten requirement with labelling orders
TRITICUM DURUM Alignment of gluten requirement with labelling orders
WHEAT Alignment of gluten requirement with labelling orders
WHEAT BRAN Alignment of gluten requirement with labelling orders
WHEAT DEXTRIN Alignment of gluten requirement with labelling orders
WHEAT GERM Alignment of gluten requirement with labelling orders
WHEAT GERM GLYCERIDES Alignment of gluten requirement with labelling orders
WHEAT SPROUT Alignment of gluten requirement with labelling orders
WHEAR STARCH Alignment of gluten requirement with labelling orders