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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 |