REGULATORY UPDATE: FDA Releases Final Guidance on the Compliance Policy on Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold

 The Food and Drug Administration released a new final guidance titled “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements” on Wednesday. The policies in the new guidance finalize those published in the draft guidance of the same title from May 2022 and supersede an April 2020 guidance titled “Alternative Procedures for Blood and Blood Components During the COVID–19 Public Health Emergency; Guidance for Industry.” 

The final guidance provides information and recommendations for facilities that collect blood and blood components, including source plasma. Under the recommendations set forth in the guidance, FDA details the conditions under which it does not intend to take regulatory action if a facility is noncompliant with certain requirements regarding donation suitability, donor eligibility and quarantine hold for source plasma.  

Concerning donation suitability, FDA does not intend to take regulatory action specifically when the donation is otherwise suitable under 21 CFR 630.30(a) and when the review of records identifies the donation as unsuitable because of inadvertent failure to ensure that the donation would not adversely affect the health of the donor, namely for: 

• Blood pressure (21 CFR 630.10(f)(2)). 
• Pulse (21 CFR 630.10(f)(4)).  
• Weight (21 CFR 630.10(f)(5)).  
• Donation frequency for whole blood and red blood cells collected by apheresis (21 CFR 630.15(a)(1)).  
• Pregnancy (21 CFR 630.10(e)(2)(v)). 
• Red blood cell loss for plasma collected by plasmapheresis (21 CFR 630.15(b)(6)).   

The policy does not apply to donations found unsuitable because of screening test results for risk factors for relevant transfusion-transmitted infections or other factors that may affect the safety, purity or potency of the blood or blood component. Blood collection facilities that elect to release unsuitable units under the compliance policy must submit a summary report of the errors and release of unsuitable donations annually to FDA.  

Regarding donor eligibility under 21 CFR 630.10(c)(2), FDA does not intend to take regulatory action if a blood establishment clarifies a donor’s response or obtains missing information required to determine eligibility and donation suitability within 72 hours of the time of collection, instead of 24 hours, provided all other donor eligibility requirements are met.  

With respect to source plasma quarantine hold, FDA does not intend to take regulatory action if source plasma is released after a quarantine hold of 45 days, instead of 60 days, provided all other donor eligibility and donation suitability requirements are met.  

FDA said the policies set forth in the guidance will likely help to “increase the availability of blood and blood components, including source plasma, while maintaining the health of blood donors and the safety of blood and blood components.” 

Members with questions about the new guidance and its policies are invited to contact AABB’s Regulatory Affairs Department at regulatory@aabb.org.