Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:9
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 9
Character Range: 12823–13666

9  Diseases and conditions that may compromise biologicals
  A biological must not be manufactured using HCT materials collected from a donor who is known to have a disease or condition that may compromise the quality, safety or efficacy of the biological, unless:
 (a) criteria for donor selection and periods of donor ineligibility, based on validated data or documented evidence from relevant scientific literature, are applied that support and justify the quality, safety and efficacy of the biological, and the application of the criteria is documented; or
 (b) in any case where it is not possible to comply with paragraph (a)—a registered medical practitioner acting for or on behalf of the manufacturer or the sponsor has agreed to, and documented the rationale for, the use of the HCT materials in the manufacture of the biological.