REGULATORY UPDATE: FDA Updates List of Variance Approvals

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) recently updated its list of exceptions and alternative procedures approved under 21 CFR 640.120. Variances approved between April and June 2021 include the following:

• Exceptions to 21 CFR 606.65(e) and 21 CFR 610.53(b) to manufacture apheresis platelets, platelet additive solution (PAS-C) added, leukocytes reduced, stored at 1-6 degrees Celsius for up to 14 days without agitation, and apheresis platelets, leukocytes reduced, psoralen-treated, stored at 1-6 degrees Celsius for up to 14 days without agitation. Both of 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.
• An exception to 606.60(b) to discontinue comparing temperature chart recorders against calibrated thermometers on a daily basis, to perform calibration of the electronic temperature monitoring system at 12-month intervals and to calibrate the digital electronic thermometer annually instead of monthly.
• Allowed only for the duration of the shortage, an exception to 21 CFR 606.65(e) to allow the temporary use of unfiltered pipette tips for post-PCR testing because filtered pipette tips were unavailable. 
• A one-time exception to 21 CFR 610.53(b) to allow the release of red blood cells (used for immunizing source plasma donors) that were exposed to temperatures above negative 65 degrees C for a maximum time of 1.5 hours and a one-time exception to 21 CFR 640.11(a) to allow release of red blood cells (used for immunizing source plasma donors) that were exposed to temperatures between 6 degrees Celsius and 6.8 degrees Celsius for approximately 20 minutes. 
• A one-time exception to 21 CFR 640.76(a)(2) to allow source plasma units intended for further manufacturing into injectable products which were exposed to more than one episode of storage temperature fluctuations, to not be relabeled as “source plasma salvaged” provided certain conditions are met. 

In its update, FDA noted that “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.