Description
We, FDA, are issuing this guidance document to provide you, establishments that collect blood and blood components for transfusion, with recommendations for labeling Red Blood Cell (RBC) units with non-ABO/Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). This guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. This guidance also provides licensed blood collection establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under 21 CFR 601.12. This guidance does not apply to test results for ABO and Rh(D) antigens. For ABO and Rh(D) antigens, you must follow FDA requirements in 21 CFR 640.5(b) and (c), and 606.121(c)(9) and (13), as well as all other applicable requirements.
Scope & Applicability
Product Classes
1The primary product subject to labeling recommendations; Labeling of Red Blood Cell Units with Historical Antigen Typing Results
Stakeholders
3FDA advisory body discussing malaria testing strategies
entities responsible for platelet transfusion; entities responsible for platelet inventory and transfusion; Entities performing secondary testing or pooling of platelets.
Entities that collect blood and blood components; Entities responsible for testing donations and complying with regulations.
Regulatory Context
Attributes
2Labeling RBC Units with Historical RBC Antigen Typing Results
putting the non-ABO/Rh(D) historical antigen typing results on a tie-tag
Related CFR Sections (8)
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR640.5§ 640.5 Testing the blood.
All laboratory tests shall be made on a specimen of blood taken from the donor, and these tests shall include the following:Read full regulation →
- 21CFR606.121§ 606.121 Container label.
(a) The container label requirements are designed to facilitate the use of a uniform container label for blood and blood components intended for use in transfusion or further manufacture by all blood establishments.Read full regulation →
- 21CFR606.140§ 606.140 Laboratory controls.
Laboratory control procedures shall include:Read full regulation →
- 21CFR606.160§ 606.160 Records.
- 21CFR606.100§ 606.100 Standard operating procedures.
(a) In all instances, except clinical investigations, standard operating procedures shall comply with published additional standards in part 640 of this chapter for the products being processed; except that, references in part 640 relating to licenses, licensed establishments and submission of materRead full regulation →
- 21CFR606.65§ 606.65 Supplies and reagents.
All supplies and reagents used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be stored in a safe, sanitary and orderly manner.Read full regulation →
- 21CFR606.151§ 606.151 Compatibility testing.
Standard operating procedures for compatibility testing shall include the following:Read full regulation →
Related Warning Letters (1)
- 2024-10-15
CGMP/Blood & Blood Components/Adulterated
Hemarus LLC
See Also (8)
- Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry (Status: Draft)
- Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products (Status: Final)
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry (Status: Final)
- Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry (Status: Final)
- Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry (Status: Final)
- Use of Sterile Connecting Devices in Blood Bank Practices: Guidance for Industry (Status: Final)