FDA CBER guidance: Recommendations to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Components (May 2022)

This is the US Food and Drug Administration's current nonbinding guidance to blood establishments on reducing the possible spread of Creutzfeldt-Jakob disease (CJD) and variant CJD (vCJD) through whole blood, blood components and Source Plasma. It was issued by the Center for Biologics Evaluation and Research (CBER) as a final Level 2 guidance, announced in the Federal Register on 24 May 2022 under docket FDA-2012-D-0307. It replaced the April 2020 version, which had been updated in August 2020. The 2022 change removed the indefinite deferral for time spent in the UK (1980 to 1996) or in France and Ireland (1980 to 2001), and for receipt of a transfusion in those countries since 1980, and added a route for previously deferred donors to be reassessed. Deferrals tied to CJD itself were left as they were. Information only; this entry says nothing about any person's eligibility to donate.

Key facts

  • The guidance is nonbinding: it states FDA's current thinking, creates no rights, and allows alternative approaches that meet the law.
  • It covers collection of whole blood and blood components for transfusion or further manufacture, including Source Plasma.
  • It was published in the Federal Register on 24 May 2022 (87 FR 31563 to 31565, docket FDA-2012-D-0307), took effect immediately under 21 CFR 10.115(g)(2) without a prior comment period, and remains open to comment at any time.
  • It supersedes the April 2020 guidance of the same title (updated August 2020) and removes two indefinite deferrals: geographic exposure (UK 1980 to 1996, France and Ireland 1980 to 2001) and transfusion in the UK, France or Ireland from 1980 onward.
  • Donors deferred earlier for those two reasons, and for the 2020-era reasons of time in other European countries, time on US military bases in Europe, or bovine insulin use, can be assessed for requalification under 21 CFR 630.35 if they meet all other eligibility requirements.
  • FDA justified the change using UK risk models from SaBTO and MHRA, which it evaluated itself; these found that current UK risk would give transfusion recipients no or minimal additional vCJD risk, lower again for leukocyte-reduced components.
  • For France and Ireland, which have fewer vCJD cases than the UK, FDA reasoned by extrapolation that the risk would be lower than the modelled UK risk.
  • The CJD recommendations are unchanged from 2020: FDA calls transfusion transmission of CJD theoretical, noting that no transfusion-transmitted CJD case has been described worldwide.
  • Permanent deferral remains for donors diagnosed with vCJD, CJD or another TSE, for those with a blood relative who has a familial prion disease (fCJD, GSS or FFI), for those treated with cadaveric pituitary growth hormone, and for recipients of human cadaveric dura mater.
  • Donors are not asked about CJD, familial prion disease or growth hormone, because asymptomatic carriers cannot be identified and the conditions are rare; only dura mater history is added to the questionnaire, and anything a donor volunteers triggers deferral.
  • Deferrals for hGH and for a relative with familial prion disease are not eligible for requalification; a donor deferred for a relative with non-familial CJD can be reentered, and a donor who does not know the disease terms is eligible.
  • For product from a donor with CJD or a CJD risk factor, the guidance recommends quarantine of undistributed in-date units and consignee notification to retrieve in-date distributed units, but no tracing of recipients and no retrieval of pooled plasma or plasma derivatives.
  • For a donor with vCJD, suspected vCJD or under investigation, it recommends contacting FDA at once, quarantining and retrieving in-date components and pooled plasma and derivatives, and considering notifying the recipient's physician; quarantined units may go to laboratory research with prescribed warning labels.
  • Licensed establishments report a revised donor history questionnaire to FDA in an annual report under 21 CFR 601.12(d); unlicensed establishments need not report.
  • FDA reports about 97 percent of US whole blood or red cell units and 97 percent of platelet units are leukocyte reduced, which it counts as further reducing vCJD risk.
  • As of April 2021 the guidance counts 232 vCJD cases worldwide (178 UK, 28 France, 4 Ireland, 4 US), and four likely transfusion-transmitted UK infections, the last case dating from 2006.
  • Blood centers rolled the change out over the months after publication; one reported implementing it in November 2022.

Timeline

  1. 1987FDA memo to blood establishments first recommends deferral of people who received cadaveric pituitary growth hormone.
  2. 1995FDA establishes its TSE Advisory Committee, which reviews geographic deferral evidence; FDA terminates it on 9 June 2016.
  3. 1999FDA issues its first guidance on CJD and vCJD and blood donation.
  4. 2020Revised guidance removes or relaxes deferrals for most European geographic exposure, military base residence, certain transfusion countries, the screening question on hGH history (permanent deferral for known cadaveric hGH recipients remains), blood relatives with CJD and bovine insulin; the UK, France and Ireland deferrals remain. Updated August 2020 and announced 17 June 2020.
  5. 2021The UK ends its own plasma risk-reduction measures and stops importing plasma for transfusion, per the guidance's account of SaBTO.
  6. 2022Final guidance issued and published in the Federal Register on 24 May, effective immediately.
  7. 2022One blood center reports implementing the change.

Last checked 1 November 2026

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