Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_1078
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 1078
Character Range: 528498–531042

1078                                      CALCIUM FRUCTOBORATE TETRAHYDRATE                                                                A         Only to be used in a medicine where VDF FutureCeuticals Inc (Client ID 62256), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 25 October 2025.
                                                                                                                                                     Boron is a mandatory component of calcium fructoborate tetrahydrate.
                                                                                                                                                     The percentage of boron from calcium fructoborate tetrahydrate should be calculated based on the molecular weight of calcium fructoborate tetrahydrate.
                                                                                                                                                     The route of administration for medicines that contain calcium fructoborate tetrahydrate must be limited to oral.
                                                                                                                                                     The maximum recommended daily dose of the medicine must not provide more than:
                                                                                                                                                     (a) 220 mg of calcium fructoborate tetrahydrate; and
                                                                                                                                                     (b) 6 mg of boron.
                                                                                                                                                     The following warning statements (or words to the same effect) are required on the medicine label:
                                                                                                                                                     - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and
                                                                                                                                                     - (ADULT) 'Adults only'.