The *Center for Biologics Evaluation and Research (CBER)* has re-evaluated the requirements of 21 CFR 640.25(b) and 640.56(a). These sections state that each month 4 units of *Platelets*  and Cryoprecipitated Antihemophilic Factor  prepared from different donors, shall be quality control tested. This has previously been interpreted to mean every month, even when *Platelets*  and Cryoprecipitated Antihemophilic Factor  are not prepared for clinical use by the blood bank. *However, CBER* believes that quality control testing of the product need be performed only in the months that the product is prepared for use.
Quality control testing and assay, at the end of the dating period, for *platelets*  need be performed only in those months in which *platelets*  are prepared for use. Similarly, Cryoprecipitated Antihemophilic Factor  quality control testing need only be performed during months in which this product is prepared for use.
*Material between asterisks is new or revised*
 Indicates material has been deleted
Issued: 12/26/78 as 7134.17
Revised: 10/1/80, 4/1/ 82, 3/95
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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