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What Are the FDA’s Rules for Sperm Donation?

In order to regulate sperm donation and make the process safer, the FDA has passed certain regulations for sperm donation. The FDA's third and final rule on the issue was passed in 2005. We give you the breakdown on what you need to know below:

  • Any establishment involved in recovery, processing, storage, labeling, packaging, or distribution related to sperm donation must register with the FDA. You can search for registered banks in your area here.
  • All donors must undergo sperm donor screening. This includes a review of his medical records to determine if he has any risk factor for or evidence of certain communicable diseases. It requires a current donor medical history interview to gain information about existing or prior health issues, relevant social behavior (like smoking, drug use, alcohol consumption, recent tattoos, etc.) and a physical exam.
  • Donors will also be tested for infectious diseases, including HIV, hepatitis B and C, and syphilis, among others.
  • All sperm banks must be inspected by the FDA. The frequency of these inspections depend on factors like whether any objectionable violations were found previously, or the FDA has received a tip that there is a potential violation going on there.

If you are considering fertility treatment with donor sperm, contact our Patient Care Advocates today! They can help you connect with a fertility clinic that specializes in treating couples or individuals with donor sperm. Call us at 1-855-955-BABY(2229) or email

Want to know more about sperm donation? Check out this video where Michelle Ottey, PhD, Director of Fairfax Cryobank explains who are the men who are donating sperm:

Click image to play.

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