A new Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023, has been approved by the TGA and entered onto the Federal Register of Legislation here. This instrument is made under section 26BB of the Therapeutic Goods Act 1989 ('the Act') and repeals the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2023.
The Determination has been updated to include:
Two new ingredients with exclusive use provisions for two years:
- Cyclocarya paliurus leaf dry extract
- calcium fructoborate tetrahydrate
Extension for use of one ingredient:
- sugar cane wax alcohols
Removal of the following ingredients where the substance in each instance is covered by a single entry:
- cresyl isobutyrate
- galbanum phenol
Removal of the following entries with invalid names that do not refer to a specific substance:
- mandarinal 32048
- myrtle essence max
Please today’s tech alert for more details, including a comparison table of all changes.