• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components

[PDF Printable Version - 37 KB]

FINAL GUIDANCE

Additional copies of this guidance and the "Circular of Information for the Use of Human Blood and Blood Components" are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448 or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at http://www.fda.gov/cber/guidelines.htm.

For questions on the content of the document, contact the Office of Blood Research and Review at 301-827-6178.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
December 2003


TABLE OF CONTENTS
  1. INTRODUCTION
  2. BACKGROUND
  3. FDA REVIEW AND CONCLUSION
  4. SUPPLEMENTARY INFORMATION
  5. THE CIRCULAR

Guidance for Industry

An Acceptable Circular of Information for the Use of Human Blood and Blood Components

Contains Nonbinding Recommendations

This guidance represents the Food and Drug Administration's (FDA's) 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.

Return to Table of Contents


  1. INTRODUCTION

We, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) are recognizing as acceptable for use by you, manufacturers of blood and blood components intended for transfusion subject to United States statutes and regulations, the instruction circular entitled "Circular of Information for the Use of Human Blood and Blood Components" (Circular) dated July 2002. The July 2002 Circular provides specific labeling directions for the administration and use of blood and blood components intended for transfusion. We believe that the Circular will assist you in complying with labeling requirements under 21 CFR 606.122 (§ 606.122). The requirements under § 606.122 specify that an instruction circular 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 instruction circular. This guidance finalizes the draft guidance of the same title dated October 2002.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA's 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 FDA's guidances mean that something is suggested or recommended, but not required.

Return to Table of Contents


  1. BACKGROUND

The Circular is prepared jointly by the American Association of Blood Banks (AABB), America's Blood Centers (ABC), and the American National Red Cross (ARC). The Circular is periodically updated to address changes in regulations, technology, testing, and product indications. AABB submitted to us a revised draft version of the Circular dated July 2002. This version updates the previous version dated August 2000. We reviewed the August 2000 submission and sent comments to AABB. AABB incorporated our comments and submitted the final version to us in July 2002.

Return to Table of Contents


  1. FDA REVIEW AND CONCLUSION

We have reviewed the final (July 2002) version of the Circular and find it acceptable for use in the labeling of blood and blood components intended for transfusion under § 606.122. Manufacturers that have implemented licensed nucleic acid tests (NAT) may use the July 2002 Circular. A copy of the Circular is found in section V. below. Those manufacturers that have not yet implemented NAT may continue to use the August 2000 version of the Circular. Any subsequent modifications to the version of the Circular dated July 2002 by AABB, ABC, and ARC are not covered by this guidance.

Return to Table of Contents


  1. SUPPLEMENTARY INFORMATION

Persons may obtain the Circular dated July 2002 from:

American Association of Blood Banks
8101 Glenbrook Road
Bethesda, MD 20814-2749
Persons with access to the Internet may obtain the Circular at http://www.aabb.org/.

The guidance and Circular may be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800. Persons with access to the Internet may also obtain the guidance and Circular at http://www.fda.gov/cber/guidelines.htm.

Return to Table of Contents


  1. THE CIRCULAR

Below is a copy of the "Circular of Information for the Use of Human Blood and Blood Components" dated July 2002 that we, through this guidance document, recognize as acceptable:

Return to Table of Contents

 

Contact FDA

(800) 835-4709
(301) 827-1800
Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-41

Rockville, MD 20852-1448