Document ID: chunk:federal_register_of_legislation:F2021C01065:clause:1_12:p2
Version: federal_register_of_legislation:F2021C01065
Segment Type: clause
Provision Reference: sch 1 cl 12 (pt 2/2)
Character Range: 12460–14283

of an item in the table in Schedule 1, a risk assessment must be conducted as to whether the donor should be subject to the period of ineligibility specified in column 3 of that item, in relation to the collection of stool from that donor for use in the manufacture of FMT products intended for autologous use.

Diseases or conditions not mentioned in Schedule 1
 (8) Where a proposed donor or accepted donor has a disease or condition that may compromise the quality, safety or efficacy of FMT products manufactured using stool collected from the donor, and the disease or condition is not mentioned in the table in Schedule 1, then stool collected from that donor must not be used in the manufacture of FMT products, unless:
 (a) criteria for donor selection and periods of ineligibility are applied that support and justify the quality, safety and efficacy of the FMT products for the intended use of the products, and the application of the criteria is documented; or
 (b) a registered medical practitioner has agreed to, and documented the rationale for, the use of the stool in the manufacture of FMT products.

Stool collected outside Australia
 (9) Where stool is proposed to be collected outside Australia, a risk assessment must be conducted as to whether any additional matters, including additional medical and social history criteria and periods of ineligibility, need to be considered and documented in addition to the ineligibility criteria specified in Schedule 1.

Upper and lower age limits
 (10) Upper and lower age limits must be applied in relation to a proposed donor, having regard to the intended use of the FMT products and the extent to which the age of the proposed donor may compromise the quality, safety, or efficacy of FMT products that are manufactured using stool collected from that donor.