Sperm Banking Background Fundamentals -Regulation
The following background information on sperm banking was prepared by and agreed upon by the leading companies in the industry. Its purpose is to provide basic information about some of the key elements of a sperm bank’s operations and influence, and to further understanding by providing accurate and consistent information.
Regulation: Sperm banking, which includes the screening and testing of sperm donors, is an increasingly regulated activity. Effective on 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 became effective, all major sperm banks have been audited for compliance by the FDA through on-site inspections. FDA inspections will be performed on a continuing 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.
Although not having the force of law, sperm banks also have conducted operations consistent with the guidelines and/or standards of professional organizations such as the American Society of Reproductive Medicine (ASRM) and the American Association of Tissue Banks (AATB).
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.