Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements

Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements guidance addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma.  Specifically, the guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain requirements in Title 21 of the Code of Federal Regulations 630.30 (21 CFR 630.30) regarding donation suitability; 21 CFR 630.10(c)(2) regarding donor eligibility; and 21 CFR 640.69(f) regarding quarantine hold for Source Plasma.  

This guidance finalizes the draft guidance of the same title, dated May 2022, and supersedes the guidance entitled, “Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry,” dated April 2020.