Guidance for Industry
 
 
Recognition and Use of a Standard for 
Uniform Blood and Blood Component 
Container Labels
 
 
 
 
 
 
 
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 http://www.regulations.gov.  Submit 
written comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  You should identify all 
comments with Docket No. FDA-1998-D-0067 (formerly Docket No. 1998D-0965).   
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD), 10903 New Hampshire Avenue, Bldg. 71, rm. 7301,  Silver Spring, 
MD  20993-0002, or by calling 1-800-835-4709 or 240-402-7800, or email ocod@fda.hhs.gov, 
or from the Internet at 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida
nces/default.htm. 
 
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 
June 2014  Contains Nonbinding Recommendations 
 
Table of Contents 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  FDA REVIEW AND CONCLUSIONS ........................................................................... 2 
IV.  REPORTING REQUIREMENTS FOR LICENSED ESTABLISHMENTS .............. 2 
V.  SUPLEMENTARY INFORMATION ............................................................................ 3 
VI.   THE VERSION 3.0.0 STANDARD ................................................................................. 3 
i  Contains Nonbinding Recommendations 
 
Guidance for Industry 
 
Recognition and Use of a Standard for Uniform Blood and Blood 
Component Container Labels 
 
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the appropriate FDA staff.  If you cannot identify the appropriate FDA staff, 
call the appropriate number listed on the title page of this guidance. 
 
 
I.  INTRODUCTION 
 
We, FDA, Center for Biologics Evaluation and Research (CBER), are recognizing as acceptable 
for use by you, manufacturers of blood and blood components, subject to United States statutes 
and regulations, the document entitled United States Industry Consensus Standard for the 
Uniform Labeling of Blood and Blood Components Using ISBT 128, Version 3.0.0, dated 
March 2013 (Version 3.0.0 Standard).  The Version 3.0.0 Standard is the revised version of the 
United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood 
Components Using ISBT 128, Version 2.0.0, dated November 2005 (the Version 2.0.0 
Standard).   
 
The Version 3.0.0 Standard describes a system of uniform container labels for blood and blood 
components intended for transfusion or for further manufacturing use.  We believe that this 
uniform container label standard will assist manufacturers in complying with the container label 
requirements under Title 21 of the Code of Federal Regulations 606.121 (21 CFR 606.121).  This 
guidance supersedes the guidance of the same title dated September 2006. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the FDAs current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDAs guidances means that something is suggested or 
recommended, but not required. 
 
 
1  Contains Nonbinding Recommendations 
 
II.  BACKGROUND 
 
On March 29, 2013, the International Council for Commonality in Blood Banking Automation 
(ICCBBA) prepared and submitted to FDA for review the Version 3.0.0 Standard.  The ICCBBA 
requested that the Version 3.0.0 Standard replace the Version 2.0.0 Standard currently in use for 
container labels for blood and blood components. 
 
The Version 3.0.0 Standard is considerably reorganized and expanded from the Version 2.0.0 
Standard.  However, there are only limited substantive revisions when compared to the Version 
2.0.0 Standard.  Specific revisions in the Version 3.0.0 Standard when compared to the Version 
2.0.0 Standard include: 
 
  Providing for the abbreviation of certain words to reduce the amount of printing space 
needed on a label; 
  Providing that the Donation Identification Number be printed such that all characters are 
the same font, color, and print size; 
  Providing that blood products collected from autologous donors that are not eligible for 
crossover be encoded with an X or a 1 in the product code; 
  Specifying that the term OPEN SYSTEM be printed on the label if the product is 
manufactured in an open system; 
  Including instructions for labeling products containing platelet additive solutions; and  
  Clarifying when the name and location of a modifying facility (if different from that of 
the collection facility) needs to be printed on the label. 
 
Furthermore, note that many more examples of labels and text are included in Version 3.0.0 
Standard.   
 
III.  FDA REVIEW AND CONCLUSIONS 
 
Under 21 CFR 606.121(c)(13), the container label of blood or blood components intended for 
transfusion must bear encoded information in a format that is machine-readable and approved for 
use by the Director, CBER.  The Director of CBER has reviewed the Version 3.0.0 Standard and 
finds it acceptable for use on the container labels of blood or blood components.  We believe that 
conformance to the Version 3.0.0 Standard will help facilitate the use of a uniform container 
label for blood or blood components in the United States and internationally.   
 
 
IV.  REPORTING REQUIREMENTS FOR LICENSED ESTABLISHMENTS 
 
Licensed manufacturers who implement the Version 3.0.0 Standard must report changes in 
labeling to FDA under 21 CFR 601.12 as follows: 
 
1.  If the Version 3.0.0 Standard is implemented for your approved products without 
modification and in its entirety, the change is considered to be minor.  You must report 
such changes in your annual report consistent with 21 CFR 601.12(f)(3), noting the date 
the process was implemented. 
2  Contains Nonbinding Recommendations 
 
 
2.  If the Version 3.0.0 Standard is implemented for your approved products but modified, 
the changes are considered to be major. You must report such changes and submit a Prior 
Approval Supplement consistent with 21 CFR 601.12(f)(1).  We recommend you include 
the following in the submission: 
 
a.  FDA Form 356h Application to Market a New Drug, Biologic or an Antibiotic 
Drug for Human Use which may be obtained at 
http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm.  
b.  A cover letter (optional for eSubmitter submissions) describing the request and 
the contents of the submission.  
c.  The modified labels.  
 
 
V.  SUPLEMENTARY INFORMATION 
 
Interested persons may obtain the Version 3.0.0 Standard from: 
 
The International Council for Commonality in Blood Banking Automation, Inc. 
P.O. Box 11309  
San Bernardino, CA  92423-1309 
 
Persons with access to the Internet may obtain the Version 3.0.0 Standard at www.iccbba.org. 
 
 
VI.   THE VERSION 3.0.0 STANDARD 
 
Below is a copy of the United States Industry Consensus Standard for the Uniform Labeling of 
Blood and Blood Components Using ISBT 128, dated March 2013, that we, through this 
guidance document, recognize as acceptable. 
 
 
 
 
 
 
 
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