FDA Recommendations: Reducing the Risk of HIV Transmission by Blood and Blood Products

With our News from May 2015, we reported about the draft guideline "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products". In December, the Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) published the adopted version of this guideline. The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma.

The document includes amongst introduction and references the following chapters:

"II. BACKGROUND
A. History of Efforts to Reduce HIV Transmission by Blood Products
B. Current Risk of HIV Infection Associated with Specific Behaviors
C. Recent Data Relevant to the Deferral for MSM
D. Considerations of the BOTS Working Group
E. Outcome of Advisory Committee Meetings
F. Evaluating Alternative Policy Options Using Available Evidence
G. Status of Other Deferral Categories

III. RECOMMENDATIONS
A. Donor Educational Material and Donor History Questionnaire
B. Donor Deferral
C. Donor Requalification
D. Product Retrieval and Quarantine; Notification of Consignees of Blood and Blood Components
E. Product Disposition and Labeling
F. Biological Product Deviation Reporting
G. Testing Requirements and Considerations"

As part of this revision the FDA makes recommendations related to the risk groups among the donors, donor deferral and  their expectations for a subsequent updating of the documentation and procedures for:

  • Donor history questionnaire  
  • Donor education materials 
  • Donor requalification 
  • Product management procedures such as product retrieval and quarantine 

And finally, in chapter IV, the guideline gives further information for the implementation:
"You may implement these recommendations once you have revised your donor educational material, DHQ, including full-length and abbreviated DHQs, and accompanying materials to reflect the new donor deferral recommendations. Licensed blood establishments must report the indicated revisions to FDA in the following manner (21 CFR 601.12):

1. Revision of your own donor educational materials, DHQ and accompanying materials must be submitted to FDA as a prior approval supplement (PAS) under 21 CFR 601.12(b).

2. Revision of a previously FDA accepted DHQ and accompanying materials must be reported as a major change if you are revising the FDA accepted DHQ and accompanying materials to implement these new recommendations. Report such a change to FDA as a prior approval supplement (PAS) under 21 CFR 601.12(b).

3. If the current version of the donor educational materials, DHQ and accompanying materials prepared by the AABB Donor History Task Force or PPTA are revised to contain the recommendations in this guidance and are found acceptable by FDA, we would consider the implementation of the donor educational materials, DHQ and accompanying materials to be minor changes, if implemented without modification and in their entirety as a complete process for administering questions to donors. Report such a change to FDA in your annual report under "21 CFR 601.12(d), noting the date the process was implemented."

More details can be found in the complete guidance for Industry "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products".

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