An Acceptable 
Circular of Information for the Use of 
Human Blood and Blood Components
 
 
 
Guidance for Industry 
 
 
 
 
 
 
This guidance is for immediate implementation. 
 
 
 
 
FDA is issuing this guidance for immediate implementation in accordance with  
21 CFR 10.115(g)(4)(i).  Submit one set of either electronic or written comments on this 
guidance at anytime.  Submit electronic comments to https://www.regulations.gov.  Submit 
written comments to Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  You should identify all comments with 
docket number FDA-2002-D-0223.   
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, 
MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, or 
from the Internet at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-
regulatory-information-biologics/biologics-guidances. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers or email 
address listed above. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
March 2022  Contains Nonbinding Recommendations 
 
Table of Contents 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 1 
III.  FDA REVIEW AND CONCLUSION ............................................................................. 2 
IV.  IMPLEMENTATION ...................................................................................................... 2 
V.  SUPPLEMENTARY INFORMATION .......................................................................... 2 
i  Contains Nonbinding Recommendations 
 
An Acceptable Circular of Information for the Use of  
Human Blood and Blood Components 
 
 
Guidance for Industry 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
 
I.  INTRODUCTION 
 
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 December 2021 (December 2021 Circular).  The 
December 2021 Circular provides specific labeling instructions for the administration and use of 
blood and blood components intended for transfusion.  We believe that the December 2021 
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 December 2017.   
 
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract.  This document is 
intended only to provide clarity to the public regarding existing requirements under the law. In 
general, FDA guidance documents, including this guidance, should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited.  The use of the 
word should in FDA guidances means that something is suggested or recommended, but not 
required. 
 
 
II.  BACKGROUND 
 
The December 2021 Circular was prepared jointly by the Association for the Advancement of 
Blood and Biotherapies (AABB), the American Red Cross (ARC), Americas Blood Centers 
(ABC), and the Armed Services Blood Program (ASBP).  The Circular is periodically updated to 
address changes in regulations, technology, testing, and product indications.   
 
1  Contains Nonbinding Recommendations 
 
 
III.  FDA REVIEW AND CONCLUSION 
 
We have reviewed the December 2021 Circular and find it acceptable for use in the labeling of 
blood and blood components intended for transfusion under 21 CFR 606.122.  A link to the 
December 2021 Circular is found in section V. of this guidance. 
 
The blood components in the December 2021 Circular marked with the symbol  are blood 
components for which FDA has not received data to demonstrate that they meet requirements for 
safety, purity and potency. Therefore, these blood components are not licensed for distribution in 
interstate commerce under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)). 
 
Any subsequent modifications to the December 2021 Circular are not covered by this guidance. 
 
 
IV.  IMPLEMENTATION 
 
Licensed manufacturers must report the implementation of the December 2021 Circular to FDA 
under 21 CFR 601.12 as follows: 
 
1.  If the December 2021 Circular is implemented without modification and in its 
entirety, the change is considered to be minor.  You must report such changes to 
FDA in your annual report, consistent with 21 CFR 601.12(f)(3) and noting the 
date the process was implemented.  
 
2.  If the December 2021 Circular is implemented with modification, the change is 
considered to be major.  You must report such changes as a Prior Approval 
Supplement, consistent with 21 CFR 601.12(f)(1). 
 
 
V.  SUPPLEMENTARY INFORMATION 
 
The December 2021 Circular can be accessed on the AABB website at: 
http://www.aabb.org/tm/coi/. 
 
If you have questions regarding the December 2021 Circular, contact AABB by phone at 301-
907-6977 or by email at regulatory@aabb.org to the attention of the Director, Regulatory 
Affairs. 
 
 
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