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Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors Memorandum to Licensed Establishments March 1995

Docket Number:
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

On August 14, 1974, the Food and Drug Administration (FDA) issued a guideline recommending immunization schedules for Source Plasma donors participating in red blood cell immunization programs. FDA revised the guideline in June, 1980, with additional recommendations concerning red blood cell donor criteria, volume and frequency of collections, laboratory tests, preparation of antigen, and record keeping.

Subsequently, the Center for ·Biologics Evaluation and Research (CBER) , FDA, issued a memorandum on October 7, 1988, entitled "Recommendations for Changeover from Use of Fresh Immunizing Red Blood Cells to Use of Frozen Immunizing Cells Stored a Minimum of Six Months Prior to Use" . This memorandum recommended the use of immunizing red blood cells stored for a minimum of six months prior to use to permit re-testing of red blood cell donors for infectious diseases, including anti-HIV, HBsAg, anti-HBc, and alanine aminotransferase (ALT) testing.

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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2013-S-0611.


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