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

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This guidance is for immediate implementation.

Note: A technical correction has been made to the “Circular of Information for the Use of Human Blood and Blood Components,” dated April 2013, in the section entitled, “Plasma Frozen Within 24 Hours After Phlebotomy,” to clarify storage conditions. The sentence on storage conditions has been deleted from the above-referenced section, on page 25. In addition, a new subsection to this section entitled, “Components Available” was added (on page 26) and this subsection includes information on storage conditions for Plasma Frozen Within 24 hours After Phlebotomy and for Apheresis Plasma Frozen Within 24 hours After Phlebotomy. The revised “Circular of Information for the Use of Human Blood and Blood Components,” dated November 2013, is attached to this guidance.

Contents

Reference Information:

August 2013
Updated April 2014


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 subject to United States statutes and regulations, the document entitled “Circular of Information for the Use of Human Blood and Blood Components,” (Circular) dated November 2013 (November 2013 Circular). The November 2013 Circular provides specific labeling instructions 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 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 issued August 2013.   

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 means that something is suggested or recommended, but not required.

 

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II. BACKGROUND

The Circular is prepared jointly by the AABB, the American Red Cross (ARC), America’s 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. In June 2013, AABB submitted to us a revised version of the Circular, dated April 2013, that updated the previous version dated December 2009. Subsequently, a technical correction was made to the April 2013 Circular and the November 2013 Circular was submitted to us in December 2013.

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III. FDA REVIEW AND CONCLUSION

We have reviewed the November 2013 Circular and find it acceptable for use in the labeling of blood and blood components intended for transfusion under § 606.122. A copy of the November 2013 Circular is found in section VI. of this guidance. 

The blood components in the November 2013 Circular marked with the symbol “Ω” are blood components which FDA has not licensed for distribution in interstate commerce. Under the Public Health Service Act, these products must be licensed before distribution in interstate commerce (42 U.S.C. 262(a)).
 
Any subsequent modifications to the November 2013 Circular are not covered by this guidance.

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IV. IMPLEMENTATION

Licensed manufacturers must report the implementation of the November 2013 Circular to FDA under 21 CFR 601.12 (§ 601.12) as follows: 

1.     If the November 2013 Circular is implemented without modifications and in its entirety, the change is considered to be minor. You must report such changes to FDA in your annual report consistent with § 601.12(f)(3), noting the date the process was implemented.
 
2.   If the November 2013 Circular is implemented with modifications, the change is considered to be major. You must report such changes as a Prior Approval Supplement consistent with § 601.12(f)(1).

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V. SUPPLEMENTARY INFORMATION

Interested persons may obtain the November 2013 Circular from:
AABB
8101 Glenbrook Road
Bethesda, MD 20814-2749

Persons with access to the Internet may obtain the November 2013 Circular at http://www.aabb.org.  You may also obtain the Circular by calling AABB at 301-907-6977.

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VI. THE CIRCULAR

Below is a copy of the “Circular of Information for the Use of Human Blood and Blood Components” dated November 2013, that we, through this guidance document, recognize as acceptable:

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About This Guidance Document

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.

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How to comment on this document

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 any time. 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 Number FDA-2002-D-0223. 

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To obtain copies of this document

 Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or email ocod@fda.hhs.gov, or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

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For questions regarding this document

For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above.

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FDA office that authored this guidance

 

U.S. Department of Health and Human Services
Food and Drug Administration

  • Center for Biologics Evaluation and Research

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