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  1. Safety & Availability (Biologics)

What You Should Know - Reproductive Tissue Donation

11/5/10

 

Did you know that FDA regulates human reproductive tissue, which include donated eggs (oocytes) and sperm (semen)?  Below is information that you may want to know before becoming a recipient of donated sperm.

1) Is the establishment registered with the Food and Drug Administration (FDA)?

Donated reproductive tissue (eggs or sperm) are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps).  Any establishment that performs one or more manufacturing steps for HCT/Ps (recovery, processing, storage, labeling, packaging or distribution of products) must register with FDA and list their HCT/Ps in accordance with Title 21 Code of Federal Regulations (CFR) Part 1271.

You can access information on registered HCT/P establishments by visiting our website.  The site includes the names of registered establishments, the products that they manufacture, and the manufacturing steps they perform. 

2) Are reproductive HCT/P donors required to be screened for risk factors that may increase the chances of transmitting a communicable disease?

Yes.  Donor screening consists of reviewing the donor's relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases.  These records include a current donor medical history interview to determine medical history and relevant social behavior, a current physical examination, and treatments related to medical conditions that may suggest the donor is at increased risk for a relevant communicable disease.

3) Are reproductive HCT/P donors required to be tested for infectious diseases?

Specimens from reproductive tissue donors must be tested for the following infectious diseases (referred to as “relevant communicable disease agents and diseases” in the regulations):

  1. Human Immunodeficiency Virus (HIV), types 1 and 2 
  2. Hepatitis B Virus (HBV) 
  3. Hepatitis C Virus (HCV) 
  4. Treponema pallidum (i.e. syphilis)
  5. Chlamydia trachomatis
  6. Neisseria gonorrhea

In addition to those listed above, sperm donors must also be tested for:

  1. Human T-lymphotropic virus (HTLV), types I and II
  2. Cytomegalovirus (CMV)

4) Are reproductive HCT/P establishments inspected by FDA?

Yes.  Various factors can determine the frequency of inspection, including any objectionable conditions found on a prior inspection and/or if FDA received Information regarding an establishment indicating there is a potential violation of FDA regulations. 

5) Where can I get more information?

Related information about the regulation HCT/Ps can be found on FDA’s website at:
http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/default.htm.

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