FDA Adopts Revised Blood Products Labeling Standard

Posted 12 August 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released a new final guidance document intended to assist in the manufacture of blood and blood components intended for transfusion by recognizing a new industry standard.


FDA regularly adjusts its regulatory approach toward blood products, and often places a particular emphasis on either adopting or making changes to approaches authored by the American Association of Blood Banks (AABB), widely recognized as the industry standard bearer.

For example, in May 2013 FDA adopted a new expedited blood donation screening standard intended to expedite the donation process for high-frequency donors, relying heavily on AABB's abbreviated donor history questionnaire (aDHQ) version 1.3.

AAB Standard Adopted

FDA is now taking a similar approach for a new blood transfusion standard, announcing its adoption of AABB's April 2013 Circular of Information for the Use of Human Blood and Blood Components, which the agency said it believes will assist industry in complying with federal labeling regulations under the Code of Federal Regulations, Section 21 CFR 606.122.

That section, Additional Labeling Standards for Blood and Blood Components, instructs sponsors to include additional information on the labeling of products intended for transfusion to provide for their proper use (e.g. mixing instructions, filtration needs, allowable additives, a description of the product's source, required testing, warnings, etc).

FDA notes that AABB's circular-which was co-authored with the American Red Cross (ARC), America's Blood Centers (ABC) and the Armed Services Blood Program (ASBP)-has been found to be "acceptable for use in the labeling of blood and blood components intended for transfusion."

As with the May 2013 guidance on expedited screening procedures, compliance with the standard is intended to expedite regulatory compliance. For example, if manufacturers implement the standard without modifications, its adoption would only need to be reported to FDA as a "minor change" in the company's annual report.

However, if changes are made to the standard, it would need to be reported to FDA immediately under a prior approval supplement (PAS), which-as its name implies-requires the approval of FDA prior to the product being distributed.

FDA notes that the standard is immediately in effect as of the publication date of the guidance.

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

AABB: Circular of Information for the Use of Human Blood and Blood Components

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