Description
We, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by you, manufacturers of blood and blood components intended for transfusion, the document entitled “Circular of Information for the Use of Human Blood and Blood Components,” dated June 2024 (June 2024 Circular). The June 2024 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion. We believe that the June 2024 Circular will assist you in complying with labeling requirements under 21 CFR 606.122. The requirements under 21 CFR 606.122 specify that a circular of information must be available for distribution with blood and blood components intended for transfusion. Section 606.122 further specifies the information that is required in the circular of information. This guidance supersedes the guidance of the same title updated March 2022.
Scope & Applicability
Product Classes
1Products intended for transfusion covered by the circular
Stakeholders
2Entities not required to report changes to FDA
Entities required to report implementation of the circular
Regulatory Context
Attributes
1Requirements for licensed blood components
Related CFR Sections (3)
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR606.122§ 606.122 Circular of information.
A circular of information must be available for distribution if the product is intended for transfusion. The circular of information must provide adequate directions for use, including the following information:Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
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- Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry (Status: Draft)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)