REGULATORY UPDATE: FDA Updates List of Variance Approvals

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 January to June 2022. New to the list are two exceptions to 21 CFR 606.65(e) to leukocyte-reduce red blood cells at 1-6 degrees Celsius at a height of 142 cm and 135 cm, respectively, instead of 165 cm as recommended by the manufacturer.

Also included is an exception to 21 CFR 606.65(e) and 21 CFR 610.53(b) providing for the manufacture of “apheresis platelets, leukocytes reduced, suspended in 100% plasma and apheresis platelets, PAS-F added, leukocytes reduced, stored at 1-6 degrees Celsius 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.”

FDA continues to approve exceptions to 21 CFR 640.54(a)(2) and 21 CFR 606.65(e) “to manufacture cryoprecipitated AHF and pooled cryoprecipitated AHF, and plasma, cryoprecipitate reduced from plasma frozen within 24 hours after phlebotomy (PF24).”

Also included is a one-time exception to 21 CFR 630.30(b)(1) and 21 CFR 640.65(b)(1)(i) to distribute for further manufacture into non-injectable products, a rare source plasma unit collected from a donor with factor XIII deficiency, for which the serum protein electrophoresis and serological test for syphilis were not performed.

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.