> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Guide on HCT/P Donor Restrictions Due to Zika
- URL: https://www.fdaweb.com/fda-guide-on-hct-p-donor-restrictions-due-to-zika/
- Published: 2016-03-01T12:00:00.000Z
- Updated: 2026-09-15T02:39:43.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5134924

> FDA has issued new [guidance recommendations](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM488582.pdf?ref=fdaweb.com) to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational tissues. “There is a potential risk that the Zika virus can be transmitted by HCT/Ps used as part of a medical, surgical, or reproductive procedure,” an [FDA notice](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm488612.htm?ref=fdaweb.com) says. “HCT/Ps include products such as corneas, bone, skin, heart valves, hematopoietic stem/progenitor cells (HPCs), gestational tissues such as amniotic membrane, and reproductive tissues such as semen and oocytes.”  
>  
> According to the guidance, HCT/P donors should be “considered ineligible if they were diagnosed with Zika virus infection, were in an area with active Zika virus transmission, or had sex with a male with either of those risk factors, within the past six months. Donors of umbilical cord blood, placenta, or other gestational tissues should be considered ineligible if they have had any of the above risk factors at any point during their pregnancy.”  
>  
> Last month, as part of its ongoing efforts to curb Zika virus transmission, the agency issued recommendations for reducing the risk of Zika virus via blood transfusion in the U.S.