Update to listed medicine ingredients in September 2019

An amendment to the Therapeutic Goods (Permissible Ingredients) Determination commenced on the Federal Register of Legislation (FRL) on 2 September 2019. The amendment determination is titled the Therapeutic Goods Amendment (Permissible Ingredients) Determination (No. 1) 2019. A total of 21 changes have been made in the updated Determination. These changes include:

• Addition of 3 new ingredient entries;
• Changes to 8 existing ingredient entries, including making requirements clearer and less restrictive; and
• Changes to caffeine and 9 caffeine containing ingredients to introduce more restrictive requirements following a safety review.

A complete list of changes to ingredients is below.

New ingredients

• 3,7-dimethyl-1-octen-3-ol
• Bacillus coagulans
• polyglyceryl-2 distearate

Changed ingredients