Licenses

Licenses, Registrations and Permits

Accreditations and Certifications

American Association of Bioanalysts

Regulation

Effective May 25, 2005, the U.S. Food and Drug Administration (FDA) commenced its regulation of reproductive tissue banks (21 CFR Part 1271). The FDA’s regulatory focus includes standards for the screening and testing of donors and proper record keeping procedures. Since these regulations were made effective, all major sperm banks have been audited for compliance by the FDA through on-site inspections. FDA inspections are performed on a continual basis.

In addition to federal regulation, most major sperm banks are also licensed and inspected by several states, particularly New York, California and Maryland. Licensing by state agencies began as early as 1992. Notwithstanding the regulatory oversight of government agencies and professional associations, most sperm banks have exercised self-regulation consistent with the highest medical and ethical standards. In fact, most major sperm banks were performing more than all the tests required by the FDA several years prior to the FDA’s effective date, and with greater frequency than required by the FDA and other regulatory agencies.