USA – Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the
United States (U.S.) from threats including emerging infectious diseases, such as the
Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely
guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain
requirements in Title 21 of the Code of Federal Regulations (CFR) regarding blood and blood components. This notice of exception or alternatives to certain requirements is being issued under 21 CFR 640.120(b) to respond to a national public health need and address the urgent and immediate need for blood and blood components. We expect that the alternative procedures will improve availability of blood and blood components while helping to ensure adequate protections for donor health and maintaining a safe blood supply for patients…