Change to the Guidance Entitled "Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood Products"
This notice is intended to alert all registered blood and plasma establishments and all establishments engaged in manufacturing plasma derivatives regarding a change to the guidance contained in FDA's December 11, 1996 Memorandum entitled "Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood Products."
FDA hereby withdraws its recommendations contained in the December, 1996 memorandum in so far as they pertain to retrieval, quarantine, destruction, and notification for plasma derivatives.
It is FDA's current thinking that, consistent with the procedures specified in the December, 1996 memorandum, plasma derivatives should be retrieved, quarantined, destroyed and consignees notified only in the event that in-date products were manufactured from a donor who developed new variant CJD.
Other provisions contained in the December, 1996 memorandum continue to represent FDA's current policy, including the recommendations on donor screening; retrieval, quarantine and disposition of blood, blood components, Source Plasma and Source Leukocytes; recipient notification and counseling; and labeling of implicated products for research or intended for further manufacturing into non-injectable products.
FDA will, in the near future, issue a comprehensive guidance on precautionary measures to reduce the possible risk of transmission of Creutzfeldt-Jakob Disease by blood and blood products which will supersede the December, 1996 guidance and further clarify this notice.
Date: 09/08/1998