Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_752
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 752
Character Range: 347622–350818

752                                       BACILLUS SUBTILIS                                                                                A         Only to be used in a medicine where ADM Australia Pty Ltd (Client ID 33326), 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 14 June 2026.
                                                                                                                                                     The route of administration for medicines that contain Bacillus subtilis must be limited to oral.
                                                                                                                                                     Only permitted for use in medicines when the strain of Bacillus subtilis is confirmed to be Agricultural Research Service Culture Collection (NRRL) accession number B-67989.
                                                                                                                                                     The strain of Bacillus subtilis must be declared on the label.
                                                                                                                                                     Bacillus subtilis is not permitted for use in children under the age of 2 years.
                                                                                                                                                     The maximum recommended daily dose of the medicine must not provide more than:
                                                                                                                                                     (a) 1 billion cfu Bacillus subtilis in individuals aged 2 to 17 years (inclusive); and
                                                                                                                                                     (b) 5 billion cfu Bacillus subtilis in individuals aged 18 years and above.
                                                                                                                                                     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';
                                                                                                                                                     - (ANTIBI1) 'To be administered 2-3 hours before or after antibiotics'; and
                                                                                                                                                     - (IMMUNO2) 'May not be suitable for someone taking immunomodulators. Consult your health professional before taking with other medicines'.