Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_5214
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 5214
Character Range: 2400632–2402772

5214                                      XANTHIUM STRUMARIUM                            A, H      The requirements specified in paragraphs (a) to (h) below apply to a medicine that contains the ingredient that is:
                                                                                                   - listed in the Register on or after 1 March 2025; or
                                                                                                   - released for supply on or after 1 March 2026.
                                                                                                   (a) Carboxyatractyloside and atractyloside are mandatory components of Xanthium strumarium.
                                                                                                   (b) The concentration of carboxyatractyloside must not be more than 0.35% of Xanthium strumarium.
                                                                                                   (c) The concentration of atractyloside must not be more than 0.3% of Xanthium strumarium.
                                                                                                   (d) The route of administration for medicines that contain Xanthium strumarium must be limited to oral.
                                                                                                   (e) The plant part must be limited to fruit that is dried, cooked and had the spines removed.
                                                                                                   (f) The plant preparation must be limited to dry, powder, and extraction preparations with water as the only solvent.
                                                                                                   (g) The maximum recommended daily dose of the medicine must not provide more than 10 g of Xanthium strumarium.
                                                                                                   (h) The medicine must not be directed for use in children, those who are pregnant, likely to become pregnant, or lactating.