This guidance is the latest in a series of guidances addressing the risk of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) transmission by blood and blood products.

 

• In 1999, we, FDA, issued a document entitled “Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Transmission of CreutzfeldtJakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products” dated November 1999 (1999 guidance). 

• In 2002, we issued a document entitled “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” dated January 2002 (2002 guidance). 

• In 2006, we issued a draft document entitled “Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products’” dated August 2006 (2006 draft guidance). 

• In 2010, we issued a document entitled “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” dated May 2010 (2010 guidance). 

• Finally, in 2012, we issued a draft guidance entitled “Draft Guidance for Industry: Amendment to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant CreutzfeldtJakob Disease by Blood and Blood Products,’” dated June 2012 (2012 draft guidance), which recommended revised labeling of plasma-derived products to reflect current understanding of vCJD transmission through blood and blood products.

 

This guidance amends the 2010 guidance and finalizes the 2012 draft guidance. This guidance incorporates the recommendations from the 2012 draft guidance for revised labeling for plasmaderived products, including albumin and products containing plasma-derived albumin. This guidance also provides manufacturers of plasma-derived products with recommendations on how to report the labeling changes to FDA under 21 CFR 601.12. All other recommendations in the 2010 guidance are unchanged. 

 

In addition, this guidance amends the 2010 guidance by: a) including information relevant to the new labeling recommendations; b) providing updated information on the global vCJD and Bovine Spongiform Encephalopathy (BSE) epidemics in Section II; c) clarifying the reentry criteria for a donor with a family history of CJD in Section IV.C.; d) clarifying the requirements related to biological product deviation reporting in Section V. and in Tables 1 and 2 of the Appendix; and e) updating, adding, and removing certain footnotes and references.

 

Tests are being developed to detect CJD and vCJD infections in blood and plasma donors. However, until suitable donor screening tests become available, FDA continues to recommend interim preventive measures based on the available scientific data and the evolving state of knowledge regarding these diseases. We expect that additional epidemiological information will become available as the epidemics of vCJD and BSE continue to evolve. We may update this guidance in the future, in light of developments in testing technology, epidemiological information, and the impact of these recommendations on the supply of blood and blood-derived products.

 

This guidance applies to Whole Blood and blood components intended for transfusion, and blood components intended for use in further manufacturing into injectable and non-injectable products, including recovered plasma, Source Leukocytes and Source Plasma, and plasma derivatives. Within this document, “donors” refers to donors of Whole Blood and blood components and “you” refers to blood collecting establishments or manufacturers of plasma derivatives.

 

 

Posted on the FDA website on 14 January 2016</span