Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_751
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 751
Character Range: 343589–347622

751                                       BACILLUS COAGULANS                                                                               A         Only permitted for use in medicines:
                                                                                                                                                     (a) limited to oral routes of administration; and
                                                                                                                                                     (b) when the strain of Bacillus coagulans is confirmed to be:
                                                                                                                                                     (i) Microbial Type Culture Collection (MTCC) accession number 5260; and/or
                                                                                                                                                     (ii) MTCC accession number 5856.
                                                                                                                                                     The strain of Bacillus coagulans must be declared on the label.
                                                                                                                                                     When the strain of Bacillus coagulans is MTCC accession number 5260:
                                                                                                                                                     (a) the maximum recommended daily dose of the medicine must not provide more than 6 billion cfu of Bacillus coagulans strain MTCC accession number 5260; and
                                                                                                                                                     (b) the following warning statements are required on the medicine label:
                                                                                                                                                     - (CHILD2) 'Not suitable for children'; and
                                                                                                                                                     - (BACCOAG) 'Bacillus coagulans may affect the way some medicines work, including immunosuppressants. Consult your health professional before taking with other medicines (or words to that effect).'
                                                                                                                                                     When the strain of Bacillus coagulans is MTCC accession number 5856:
                                                                                                                                                     (a) the maximum recommended daily dose of the medicine must not provide more than 2 billion cfu of Bacillus coagulans strain MTCC accession number 5856; and
                                                                                                                                                     (b) the following warning statements are required on the medicine label:
                                                                                                                                                     - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect);
                                                                                                                                                     - (CHILD2) 'Not suitable for children'; and
                                                                                                                                                     - (BACCOAG) 'Bacillus coagulans may affect the way some medicines work, including immunosuppressants. Consult your health professional before taking with other medicines (or words to that effect).'