REGULATORY UPDATE: FDA Updates List of Variance Approvals

April 23, 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, including a notable exception to 21 CFR 610.40(a)(3) to discontinue testing of all donations with a licensed nucleic acid test for Zika virus (ZIKV), or discontinue using pathogen-reduction technology, to reduce the risk of ZIKV transmission through the transfusion of blood and blood components. CBER included the July 2018 ZIVK guidance on the 2021 guidance agenda indicating the agency’s intent to update the recommendations.

The update also provides an exception to 21 CFR 640.54(a)(2) and 606.65(e) “to manufacture cryoprecipitated AHF and pooled cryoprecipitated AHF from plasma frozen within 24 hours after phlebotomy (PF24).” Current regulations require that plasma used in the manufacture of cryoprecipitated AHF be placed in a freezer “within 8 hours after blood collection or within the timeframe specified in the directions for use for the blood collecting, processing and storage system.”

In total, between January and March 2021, the agency provided seven exceptions or alternatives. In addition to those described above, three were related to source plasma, one was related to anti-HBc testing and one was related to Acrodose pooled platelets. 
FDA noted that “requests for exceptions or alternatives to the regulations include specific circumstances and may require submission of supporting data unique to the circumstance. Publication of this list does not necessarily mean that the exceptions or alternatives can be generally applied to other manufacturers.” 

AABB encourages members to review the list of exceptions and alternative procedures issued by CBER to identify new options that might be useful in their facility’s policies and operations. Members with additional questions may contact regulatory@aabb.org