GUIDANCE DOCUMENT
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements Draft Guidance for Industry May 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2022-D-0588
- Docket Number:
- FDA-2022-D-0588
- Issued by:
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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
This 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.
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