Registration & Licenses

National Agencies Regulating Sperm Banks

The FDA

All sperm banks and other establishments offering donor semen services must be registered with the FDA by law. Unannounced on-site inspections are performed by its compliance division. FDA regulations deal primarily with determination of donor eligibility and documentation and are focused on infectious disease risks. Genetic screening and testing are not addressed.

We are registered with the FDA and are in full compliance with all relevant FDA regulatory requirements.

State Licensing and Inspection for Sperm Banks and Laboratories

Most states do not regulate semen banks. New York and California are among the states that do regulate tissue banks. In fact, New York's regulations are the most stringent in the industry. New York is only state that requires licensure for all sperm banks that provide sperm donor specimens in their jurisdiction; they also perform on-site inspections. California and Maryland have similar license requirements as New York, but currently do not do routine inspections.

Regarding laboratory licensing, we are licensed by the various State Departments of Health for all of our laboratories, including Washington, Montana, New York, California, and Maryland.

National Guidelines for Sperm Banking Best Practices

ASRM

The American Society of Reproductive Medicine periodically issues guidelines on screening egg and sperm donors. These guidelines are better considered “standards of practice” and compliance is entirely voluntary. The ASRM does not perform inspections.