Description
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.
Scope & Applicability
Product Classes
4collected by apheresis
Blood component subject to the recommendations in this guidance
scope of the compliance policy
Specific blood component with distinct testing recommendations; Recommendations for testing Source Plasma differ from whole blood.
Stakeholders
5establishments recommended to submit annual reports to OBRR
establishments required to submit annual reports under 601.12
Entity responsible for implementing testing and deferral procedures
donors of Source Plasma subject to quarantine hold requirements
Entities that collect blood and blood components; Entities responsible for testing donations and complying with regulations.
Regulatory Context
Attributes
1time period for holding Source Plasma before release; minimum timeframe before release for further manufacturing
Related CFR Sections (7)
- 21CFR640.120§ 640.120 Alternative procedures.
(a) The Director, Center for Biologics Evaluation and Research, may issue an exception or alternative to any requirement in subchapter F of chapter I of title 21 of the Code of Federal Regulations regarding blood, blood components, or blood products. The Director may issue such an exception or alterRead full regulation →
- 21CFR606.160§ 606.160 Records.
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR630.15§ 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis.
(a) What additional donor eligibility requirements apply when you, an establishment that collects blood or blood components, collect Whole Blood or Red Blood Cells by apheresis ?Read full regulation →
- 21CFR630.10§ 630.10 General donor eligibility requirements.
(a) What factors determine the eligibility of a donor ? You, an establishment that collects blood or blood components, must not collect blood or blood components before determining that the donor is eligible to donate or before determining that an exception to this provision applies. To be eligible,Read full regulation →
- 21CFR640.69§ 640.69 General requirements.
(a) Pooling. Two units of Source Plasma from the same donor may be pooled if such units are collected during one plasmapheresis procedure: Provided, That the pooling is done by a procedure that does not introduce a risk of contamination of the red blood cells and, for plasma intended for injectable Read full regulation →
- 21CFR630.30§ 630.30 Donation suitability requirements.
(a) When is a donation suitable ? A donation is suitable when:Read full regulation →
See Also (8)
- Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical: Guidance for Industry (Status: Final)
- Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products (Status: Final)
- Blood Establishment Computer System Validation in the User's Facility: Guidance for Industry (Status: Final)
- Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components: Guidance for Industry (Status: Final)
- Labeling of Red Blood Cell Units with Historical Antigen Typing Results: Guidance for Industry (Status: Final)
- Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry (Status: Final)
- Nucleic Acid Testing to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products: Guidance for Industry (Status: Final)
- Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application: Guidance for Industry (Status: Final)