Blood - Revised Recommendations for Reducing the Risk of HIV Transmission

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

The emergence of HIV in the early 1980s and the following recognition that it could be transmitted by blood, blood products and plasma had effects on the quality and safety requirements for these products in the whole world. A corresponding regulation was also established in the USA - for instance concerning the handling of blood and plasma donations by risk groups. One example is the guidance document "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products," dated  23 April 1992.

The giudeline draft now available "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products" will supersede the memorandum to blood establishments entitled, “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products,” dated April 23, 1992 after its finalisation.
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 
• Disposition and labelling 
• Biological product deviation reporting 
• Testing requirements and considerations

In doing so the recommendations of different expert groups such as the BOTS working group and from HHS and FDA advisory committee meetings were taken into account. You can find detailed information directly in the draft guideline "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products".