The U.S. Food and Drug Administration (FDA) released a final blood compliance policy guidance on October 17th. The guidance is titled “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements.” It explains the conditions under which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain requirements in Title 21 of the Code of Federal Regulations 630.30 (21 CFR 630.30) regarding donation suitability; 21 CFR 630.10(c)(2) regarding donor eligibility; and 21 CFR 640.69(f) regarding quarantine hold for Source Plasma. In February 2023, America’s Blood Centers (ABC) asked the FDA to finalize the draft guidance to allow the recommendations set forth in the COVID-era Alternative Procedures Guideline to continue to apply outside the context of the public health emergency.
Under the compliance policy guidance, FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain regulations for donation suitability provided certain conditions are met. Specifically, when the donation is otherwise suitable, the FDA will not take regulatory action if blood establishments release certain donations for transfusion or further manufacture when the review of records, required after donation, identifies the donation as unsuitable because of an inadvertent failure to follow procedures to ensure the donation would not adversely affect the health of the donor, specifically for: blood pressure, pulse, weight, donation frequency for whole blood and red blood cells collected by apheresis, pregnancy, and red blood cell loss for plasma collected by plasmapheresis. Contrary to ABC’s recommendations to FDA, blood establishments that elect to release unsuitable units must submit a summary report in the reporting category of an Annual Report to FDA describing the number and type of donations released under these conditions, and the corrective actions taken to prevent recurrence of errors.
Additionally, FDA does not intend to take regulatory action if a blood establishment clarifies a donor’s response or obtains omitted information required to determine donor eligibility and donation suitability within 72 hours of the time of collection, instead of within 24 hours of the time of collection, provided all other donor eligibility requirements are met. The agency also does not intend to take regulatory action if source plasma is released after a quarantine hold of 45 calendar days, instead of 60 calendar days, provided all other steps in 21 CFR 640.69(f) are followed and all other donor eligibility and donation suitability requirements are met.
Finally, licensed establishments that intend to implement changes described in the guidance must report changes to their standard operating procedures (SOPs) to reflect this compliance policy guidance as Changes Being Effected (CBE) supplements. If, consistent with the April 2020 guidance, a licensed establishment reported changes to their SOPs under 21 CFR 601.12(c)(5), a new CBE supplement does not need to be submitted to reflect the compliance policy guidance. However, the establishment should report that they are retaining the SOPs in their Annual Report under 21 CFR 601.12(d).