Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
applicable to reproductive tissues are less than a decade old: 46 registration
and listing requirements were established in 2001, 47 and the subparts
specifying donor-eligibility requirements and current good tissue practice,
inspection, and enforcement were not created until 2004.48 However, the
short history of these regulations is in sharp contrast to their requirements.
A. Registration
A sperm bank must first register and list its HCT/P’s with the FDA’s
Center for Biologics Evaluation and Research. 49 This registration, which
must be sent within five days of beginning operations and updated every
December, 50 must include the establishment’s name, location, the name,
address, title of the reporting official, and a list of all HCT/P’s that the
establishment recovers, processes, stores, labels, packages, distributes, or
upon which it performs donor screening or testing. 51 These registrations are
then available for public inspection. 52
B. Determining and Recording Donor Eligibility
Sperm banks must conduct donor-eligibility determinations, which
require donor screening and testing for relevant communicable disease
agents and diseases. 53 Donated semen must not be transferred to a recipient
until after the donor-eligibility determination is complete54 and must be
quarantined in the interim. 55 The determinations must be conducted
according to established procedures that have been defined, documented,
reviewed by a responsible party prior to implementation, and revised as
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInf
ormation/Guidances/Tissue/UCM188251.pdf.
