California Cryobank Registration, Accreditation, and Licenses
Established in 1977, California Cryobank (CCB) is one of the largest private frozen tissue banks in the world. We are registered with the FDA and accredited by the AATB (American Association of Tissue Banks).
National Agencies Regulating Sperm Banks
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.
Voluntary National Accreditation and Inspection for Sperm Banks
The highest level standard-setting body for tissue banks in the nation is the AATB, established in 1977. To be accredited by the AATB, a tissue bank must submit to comprehensive on-site inspections. These inspections are designed to assure that the bank is professionally managed, appropriately staffed and has put in place policies and procedures to provide consistent quality care. Accreditation by the AATB is voluntary.
Please keep in mind that some sperm banks that have not been inspected claim they "meet" or "exceed" AATB standards. The only way to confirm that a sperm bank meets AATB standards is through the inspection and accreditation process. To date, only a few gamete banks in the nation have been inspected by the AATB. All of CCB’s Reproductive banks are accredited by the AATB.
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 New York, California, and Massachusetts. There are other states that issue licenses, but vary a great deal and are difficult to evaluate.
National Guidelines for Sperm Banking Best Practices
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.