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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 231.130- Storage of *Platelets* [ ] for up to five (5) Days

 

BACKGROUND:

The *Center for Biologics Evaluation and Research (CBER)* has approved plastic materials for satellite packs designed for storage of *Platelets.* [] These materials [] allow the storage of platelets for up to five (5) days if stored at 20-24oC with gentle agitation. With this approval for five day storage, two dating periods apply to platelets stored in satellite packs. The satellite packs made from the plastic materials are labeled with a statement indicating that platelets may be stored for five days if stored at 20-24oC. If this label does not appear on the pack the previously approved 72-hour dating still applies.

POLICY:

Blood banks may begin the five (5) day dating period (the dating period ends on midnight of the fifth day; e.g., platelets collected at any time on Monday the first will expire on *Saturday* the sixth at midnight) for *Platelets* [] stored at 20-24oC, with gentle agitation, in the satellite packs provided:

1. A product license *supplement* reflecting the change in the dating period is submitted, including a commitment to perform the required quality control testing at the end of the dating period (5 days) on at least four (4) units per month. (Also, see CPG No. 7134.16 (See Sec. 231.110) concerning QC testing on platelets).

2. Corrective action is implemented as soon as possible and is appropriately documented, if the quality control data do not meet required limits.

3. The monthly quality control data are kept on file in the blood bank available for review during authorized FDA inspections.

4. *Repeated* failure to meet [] quality control standards is reported immediately to *CBER.*

Unlicensed, registered blood banks may use the satellite packs and the five (5) day dating period without notifying *CBER* provided they outlined in (1)-(4) above, *except that unlicensed blood banks need not file or supplement a product license* [See 21 CFR 606.160(b)(2)(ii) and 640.25(b)]. []

*Material between asterisks is new or revised*

[] Indicates material has been deleted

Issued: 7/1/82
Revised: 3/95