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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 231.100- *Platelets, Pooled*

 

BACKGROUND:

*Platelets are* defined (21 CFR 640.20(a)) as the "platelets from a single donor ---." Investigators have encountered *Platelets*, Pooled being shipped intrastate by blood banks at the request of user hospitals. The field has requested *that the Center for Biologics Evaluation and Research (CBER) review the* policy regarding pooling of platelets during preparation or processing since it is prohibited by the regulation for the licensed product.

POLICY:

A written standard operating procedure for the pooling process must be available for personnel involved. Platelets cannot be pooled during the preparation process. After preparation of the individual units is completed (including all testing and labeling), units intended for a specific patient may be pooled and labeled with an expiration time of four hours from time of pooling. This expiration time must also take into account the dating period of the individual units.

In addition to the labeling requirements in 21 CFR *606.121,* the label of the pooled product must include the following:

1. An expiration time which is four (4) hours after the platelets are pooled.

2. The individual donor numbers comprising the pool or a pool number that relates the pooled platelets to individual donor numbers comprising the pool.

3. The number of units in the pool.

*Material between asterisks is new or revised*

Issued: 4/26/78
Revised: 10/1/80, 4/1/82, 3/95