New substances approved for inclusion in listed medicines
Amendments to Schedule 4 of the Therapeutic Goods Regulations
March 2005
A number of new substances approved for inclusion in Listed medicines are now included in the latest consolidation of Schedule 4 of the Therapeutic Goods Regulations 1990, following their gazettal.
The new substances are as follows:
- Activated charcoal, with the qualification that the label of products containing this ingredient are required to carry the following statements:
- "Use with caution in children as may interfere with absorption of nutrients";
- "May interact with other medicines"; and
- "Not recommended for long term use";
- Bovine colostrum powder, with the qualification that the label of products containing this ingredient are required to carry the following statements:
- "Derived from cow's milk"; and
- "Not suitable for infants under 12 months without medical advice";
- Emu oil;
- Lutein;
- Sodium selenate, sodium selenite, selenomethionine, selenocysteine and high selenium yeast;
- Sodium sulfate, with the qualification that preparations intended for other than laxative use are required to carry a warning label that the substance may have a laxative effect;
- Terminalia ferdinandiana (Kakadu plum), with the qualification that the preparation contains only fruit flesh or aqueous extracts of the fruit flesh; and
- Zeaxanthin.
In addition, the entry for "calcium sodium caseinate" has been amended to indicate that preparations are required to carry the warning statement "Derived from cow's milk".