Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:33
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 33
Character Range: 34121–35039

33  Collection
 (1) Collection of human ocular tissue from a deceased donor must be completed not later than 48 hours after asystole, and the time intervals between asystole, enucleation, preservation and corneal excision must be documented.
 (2) A human ocular tissue product that is manufactured using human ocular tissue collected between 24 and 48 hours after asystole must not be released for supply unless:
 (a) a medical practitioner acting for, or on behalf of, the manufacturer or the sponsor has evaluated the quality, safety and efficacy of the product; and
 (b) the medical practitioner who is responsible for the administration to, or application in the treatment of, the recipient of the product has been notified that the collection occurred between 24 and 48 hours after asystole; and
 (c) the medical practitioners mentioned in paragraphs (a) and (b) are registered in a State or internal territory.