Inspections, Compliance, Enforcement, and Criminal Investigations

CPG Sec. 254.100- Source Plasma - Use of Units from Donors Subsequently Found to be Reactive to a Serologic Test for Syphilis


There has been some concern and confusion relating to the use of units of Source Plasma * * collected from donors who are subsequently found to be reactive to a serologic test for syphilis (STS). The initial and four-month STS is designed primarily to identify the disease in donors and to promote treatment of affected donors; therefore, the donor, once identified as STS reactive, may not obe plasmapheresed again until his/her serologic test is nonreactive or collection is performed under the provisions of 21 CFR 640.65(b)(2)(iii) and (iv). These provisions permit, under certain conditions, plasmapheresis of donors with biologic-false-positive reactions; or those with positive results. However, units collected from donors prior to their being identified as STS reactive may be issued as Source Plasma, [] since the disease-causing spirochetes are destroyed during the storage and/or fractionation of the plasma.


Units of plasma collected from plasmapheresis donors who were not known to be reactive to a STS prior to the plasmapheresis procedure may be shipped as Source Plasma []. These units need not be labeled or identified in shipping records as STS reactive, since such requirements pertain only to units collected from donors known to be STS reactive.

*Material between asterisks is new or revised*

[] Indicates material has been deleted

Issued: 3/14/80 as 7134.11
Revised: 10/1/80, 2/1/84, 3/95

Page Last Updated: 03/20/2015
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