AABB recently launched a new toolkit designed to assist transfusion services that must register with the Food and Drug Administration for the first time because they will be implementing a bacterial detection test to extend the expiration of platelets to day 6 or 7 and relabel the platelets. AABB members may access the “Toolkit for Transfusion Services: FDA Registration Requirements when Extending Platelet Expiration to Day-6 or Day-7,” on AABB’s Regulatory Toolkits for Members web page.
Section V, starting on page 13 of the December 2020 platelet bacterial risk guidance, clarifies that testing and relabeling to extend the expiration date is a manufacturing procedure requiring registration and blood product listing, as described in 21 CFR 607(3)(d). FDA also clarifies that transfusion services that implement secondary testing on platelets with a 5-day expiration date are not required to register and list because they are not extending the dating period of platelets.
For transfusion services that are “currently exempt from registration and blood product listing under the provisions of 21 CFR 607.65(f)” and implement bacterial detection testing to extend expiration to day 6 or day 7 after collection, FDA clarifies that these facilities “are no longer considered exempt because [they] are engaging in blood product manufacturing under 21 CFR 607.3(d)… [and] must therefore register... with FDA and list the blood products [they] manufacture, pursuant to 21 CFR 607.7.”
The toolkit is intended to help transfusion services get started by consolidating information and links necessary to understand this unfamiliar process. It provides a checklist and information from FDA to help transfusion services move smoothly through the registration process, such as noting that they may use their hospital’s DUNS number rather than applying for a new one.
In addition, AABB has created two new resources as part of this toolkit. The first, a comprehensive list of regulatory resources for platelets, includes links to essential documents released previously, such as Association Bulletin #21-02, AABB’s Bacterial Risk Reference Sheets and the Timelines for Testing Strategies for Apheresis Platelets.
The second, a list of common platelet codes, is designed to assist transfusion services and their suppliers in planning for a potential increase in unexpected platelet codes imported by blood suppliers to address inventory challenges. This list, prepared in collaboration with multiple blood collection facilities and America’s Blood Centers (ABC), represents the most common codes that could be imported as facilities decide to proactively update computer systems to receive these unexpected codes.
AABB greatly appreciates the efforts of ABC and multiple blood suppliers who have supported patient care by sharing the codes they are most likely to use in the coming months. This list will be updated as new information is provided. Members with questions may contact regulatory@aabb.org.