TABLE 1.

FDA requirements for donation of convalescent plasma for COVID‐19*

Donors must meet all standard donor eligibility requirements for donation of plasma by apheresis, i.e., compliant with the following Code of Federal Regulations: 21 CFR 630.10 21 CFR 630.15 21 CFR 630.30 21 CFR 630.40

Donors must have tested positive for SARS‐CoV‐2 by either: A diagnostic test (e.g., nasopharyngeal swab) during illness A serologic test after recovery

Symptoms of infection must have completely resolved by : 14 days prior to donation

If female, donors must either: Have never been pregnant Been tested negative for HLA antibodies since their most recent pregnancy

Testing for SARS‐CoV‐2–neutralizing antibody titers is recommended if available, but not required. Titers ≥160 are recommended, but if an ABO‐compatible unit is unavailable, ≥80 is acceptable If titers are not available, consider storing a retention sample for future testing

^* Provided that plasma is collected according to the above specifications, blood establishments do not need an IND to collect the plasma; however, an IND will be required to administer it.