AABB's Regulatory Toolkits for Members

The AABB Regulatory Affairs staff have developed these Toolkits and “Member Offerings” to equip our members with the most up-to-date, practical tools to guide you through regulatory decision-making processes.

Regulatory Update Toolkits: 2019-2020, 2021-2022, 2023-2024, 2025-2026 (member-protected)

What's New

What's New

FDA Blood Establishment Registration Toolkit - September 18, 2025 (member-protected)
Medication Deferral List v4.0 – Updated July 2025 Yeztugo (Lenacapavir) - Toolkit for Implementation - July 9, 2025 (open-access)
Measles Virus Information and Resources - January 16, 2026 (member-protected)
Blood Resiliency During Cybersecurity Events - April 2025 (open access)

Operational Considerations

Operational Considerations

FDA Blood Establishment Registration Toolkit - September 18, 2025 (member-protected)
Transfusion Service FDA Registration Requirements - September 23, 2025 (member-protected)
Licensed COVID-19 Convalescent Plasma - July 29, 2024 (open access)
Blood Resiliency During Cybersecurity Events - April 2025 (open access)
Saline Supply Shortage - Resources to Consider - October 30, 2024 (open access)
Implementation of Cold-Stored Platelets - Toolkit - Updated December 2023 (member-protected)
Current Regulatory Options for Collections from Female Blood Donors with Hemoglobin Levels of 12.0 - <12.5 g/dL - January 28,2022 (open-access)
Blood Supply: Summary of Crucial Regulatory Options Already Available from FDA - January 20, 2022 (open-access)
Live with FDA on the CCP Regulatory Landscape – October 28, 2020 (open-access)
Regulatory Resources for Transfusion Services (member-protected)
Transfusion Services: FDA Registration Requirements when Extending Platelet Expiration to Day-6 or Day-7 - June 23, 2021 (member-protected)

DHQs and Donor Eligibility

DHQs and Donor Eligibility

Medication Deferral List v4.0 – Updated July 2025 Yeztugo (Lenacapavir) - Toolkit for Implementation - July 9, 2025 (open-access)
DHQ v4.0 Spanish Language Translation Toolkit – Examples to Consider - Updated August 2025 Yeztugo (Lenacapavir) (member-protected)
Implementation of FDA's Recommendations to Reduce the Risk of Mtb and Sepsis by HCT/Ps May 5, 2025, to be updated pending Final Guidance (member-protected)
Informing Donors of Risks, Use of Donor Information and Blood Samples, and Acknowledgement to Donate Whole Blood - October 2024 (member-protected)
Blood Pressure and Pulse - Implementation of FDA's Compliance Policy Guidance (member-protected)
IDA and DHQ v4.0 and Accompanying Materials - Toolkit for Implementation - August 2023 (open-access)

Infectious Diseases

Infectious Disease Risk and Testing

Measles Virus Information and Resources - January 16, 2026 (member-protected)
Oropouche Virus Information and Resources - November 5, 2024 (member-protected)
Resources to Support FDA's Determination that ZIKV is No Longer an RCDAD (member-protected)
Mpox Resources to Consider – February 2024 (open-access)
HCV Testing, Lookback and Reentry – June 21, 2022 (member-protected)
HIV Testing, Lookback and Reentry - October 17, 2021 (member-protected)
Syphilis Guidance Toolkit - December 9, 2020 (member-protected)
HCV Further Testing Toolkit – November 2019 (member-protected)
Ebola Toolkit - May 2020 (member-protected)
Babesia Toolkit – September 2019 (member-protected)

Circular of Information & Labeling

Circular of Information & Labeling

User Guide for the June 2024 Circular – September 2024 (open-access)
AABB Checklist for Historic Antigen Labeling – January 2019 (member-protected)

Licensure & BLA Submission

Licensure & BLA Submission

Licensed COVID-19 Convalescent Plasma - July 29, 2024 (open access)
BLA Checklist for Plasma Collected by Apheresis – March 25, 2024 (member-protected)
BLA Checklist for RBCs Collected by Apheresis – March 25, 2024 (member-protected)
BLA Checklist for Platelets, Leukocytes Reduced Collected by Apheresis – March 25, 2024 (member-protected)

Related News

FDA Clears Expanded Access Program for HPC Therapy in Patients With Long COVID

February 04, 2026
FDA Implements Quality Management System Regulation for Medical Devices

February 04, 2026
Australia to Expand Individual Donor Assessment to Blood Donation in April

February 03, 2026