GUIDANCE DOCUMENT
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements Guidance for Industry October 2023
- Docket Number:
- FDA-2022-D-0588
- Issued by:
-
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.
This guidance finalizes the draft guidance of the same title, dated May 2022, and supersedes the guidance entitled, “Alternative Procedures for Blood and Blood Components During the COVID-19 Public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.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-0588.
Questions?
- Office of Communication, Outreach and Development (OCOD)
- Center for Biologics Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002
- ocod@fda.hhs.gov
- (800) 835-4709
- (240) 402-8010