U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors
  1. Search for FDA Guidance Documents

MEMORANDUM

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

Final
Docket Number:
FDA-2013-S-0611
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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
Back to Top