November 01, 2021
The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) recently updated the list of exceptions and alternative procedures approved under 21 CFR 640.120 for July to September 2021. Similar to previous time periods, the agency approved exceptions to 21 CFR 606.65(e) and 21 CFR 610.53(b) to manufacture Apheresis Platelets, Leukocytes Reduced, and Apheresis Platelets, Platelet Additive Solution (PAS-C), Leukocytes Reduced, stored at 1-6 degrees C for up to 14 days without agitation. The cold-stored platelet products are intended to treat actively bleeding patients through day 14 of storage when conventional platelet products are unavailable, or their use is not practical.
The update also includes four one-time exceptions. AABB encourages members to review CBER’s list of exceptions and alternative procedures to identify new options that might be useful in their facility’s policies and operations. Members with additional questions may contact regulatory@aabb.org.