Compliance Policy Regarding Blood 
and Blood Component Donation 
Suitability, Donor Eligibility and 
Source Plasma Quarantine Hold 
Requirements
 
 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, 
MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, or 
from the Internet at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers or email 
address listed above. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
October 2023 
 
     
 
OMB control number:  0910-0116 
Current expiration date available at https://www.reginfo.gov. 
See additional PRA statement in section V of this guidance.  Contains Nonbinding Recommendations 
 
Table of Contents 
 
I.  INTRODUCTION .............................................................................................................. 1 
II.  BACKGROUND................................................................................................................. 1 
III.  COMPLIANCE POLICY.................................................................................................. 3 
A.  Donation Suitability Requirements (21 CFR 630.30(a)(2) and 21 CFR 
630.30(b)(1)) ................................................................................................................. 3 
B.  Donor Eligibility (21 CFR 630.10(c)(2)) .................................................................... 5 
C.  Source Plasma Quarantine Hold (21 CFR 640.69(f)) ............................................... 6 
IV.  IMPLEMENTATION ........................................................................................................ 6 
V.  PAPERWORK REDUCTION ACT ................................................................................ 6 
 
 
 
 
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  Contains Nonbinding Recommendations 
 
Compliance Policy Regarding Blood and Blood Component 
Donation Suitability, Donor Eligibility and Source Plasma 
Quarantine Hold Requirements 
 
 
Guidance for Industry 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page.  
 
 
I.  INTRODUCTION 
 
This guidance addresses certain requirements that apply to blood establishments that collect 
blood and blood components, including Source Plasma.  Specifically, the guidance explains 
the conditions under which FDA does not intend to take regulatory action for a blood 
establishments 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.   
 
This guidance finalizes the draft guidance of the same title, dated May 2022, and supersedes the 
guidance entitled, Alternative Procedures for Blood and Blood Components During the 
COVID-19 Public Health Emergency; Guidance for Industry, dated April 2020.1    
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
 
II.  BACKGROUND 
 
To address the urgent and immediate need for blood and blood components during the 
Coronavirus Disease 2019 (COVID-19) public health emergency, FDA (we) issued certain 
 
1 The April 2020 guidance was revised to continue in effect until November 7, 2023 (180 days after the public 
health emergency declaration expired), unless superseded by a revised final guidance before that date.  For further 
information, see 85 FR 15417 (March 13, 2023). 
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  Contains Nonbinding Recommendations 
 
exceptions and alternatives to the requirements regarding blood and blood components under 21 
CFR 640.120(b).  Through the guidance entitled, Alternative Procedures for Blood and Blood 
Components During the COVID-19 Public Health Emergency; Guidance for Industry dated 
April 2020 (April 2020 guidance), we issued the following exceptions and alternative 
procedures:  
 
  Permitted the release of certain donations for transfusion or further manufacturing 
when the review of records, required after donation under 21 CFR 630.30(a)(2), 
identified a donation as unsuitable because of failure to follow certain procedures to 
ensure that the donation would not adversely affect the health of the donor.  Provided 
that the donor is otherwise eligible and the donation is otherwise suitable, we granted 
exceptions for the following requirements:  
 
  blood pressure (21 CFR 630.10(f)(2));  
o
  pulse (21 CFR 630.10(f)(4));  
o
  weight (21 CFR 630.10(f)(5)); and  
o
  donation frequency (21 CFR 630.15(a)(1)).  
o
 
  Permitted blood establishments to clarify a donors response or obtain omitted 
information required to determine donor eligibility and component suitability within 72 
hours of the time of collection, instead of within 24 hours of the time of collection (21 
CFR 630.10(c)(2)).   
 
  Permitted the release of Source Plasma donated by paid donors and determined to be 
suitable for further manufacturing into injectable products after a quarantine hold of 45 
calendar days, instead of 60 calendar days, provided all other donor eligibility and 
donation suitability requirements are met (21 CFR 640.69(f)). 
 
Since publication of the April 2020 guidance, we received numerous comments from the blood 
industry requesting that we continue to permit the exceptions and alternatives beyond the public 
health emergency related to COVID-19 because the changes have increased availability of blood 
and blood components while maintaining safety of blood and blood components and without 
compromising the health of blood donors.  Further, blood establishments requested that we 
provide our recommendations before the end of the public health emergency to reduce the 
operational burdens associated with changes in standard operating procedures and blood 
establishment computer systems.  On March 13, 2023, we announced that the April 2020 
guidance would remain in effect until November 7, 2023, unless superseded by a revised final 
guidance before that date.2  
 
After considering the public comments and the available data on donor health and the safety and 
availability of blood and blood components since publication of the April 2020 guidance, as well 
as our overall experience with these regulations since they became effective in May 20163, we 
 
2 Id.  
3 See Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use, 
May 22, 2015; 80 FR 29841 (Donor Eligibility Final Rule), https://www.govinfo.gov/app/details/FR-2015-05-
22/2015-12228. 
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  Contains Nonbinding Recommendations 
 
are issuing this guidance to explain the conditions under which FDA does not intend to take 
regulatory action for a blood establishments failure to comply with certain requirements in 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.  
 
Consequently, we expect that the compliance policy described in this guidance will 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.  If, based upon the 
available scientific evidence, FDA determines that the risk to the safety of the blood supply or 
the risk to donors health significantly changes as a result of this compliance policy, FDA may 
revise this compliance policy as warranted.  Further, we will continue to evaluate whether 
permanent changes to the regulations would be appropriate.     
 
 
III.  COMPLIANCE POLICY 
 
A.  Donation Suitability Requirements (21 CFR 630.30(a)(2) and 21 CFR 
630.30(b)(1)) 
 
Blood establishments must determine donation suitability as prescribed in 21 CFR 
630.30(a)(1)-(5).  When a donation is not suitable, blood establishments must not release 
the donation for transfusion or further manufacturing use, unless it is an autologous 
donation, or an exception is provided (21 CFR 630.30(b)(1)).   
 
FDA does not intend to take regulatory action for a blood establishments failure to 
comply with certain regulations for donation suitability in 21 CFR 630.30 provided 
certain conditions are met.  Specifically, when the donation is otherwise suitable under 
21 CFR 630.30(a), we do not intend to take regulatory action if blood establishments 
release certain donations for transfusion or further manufacture when the review of 
records, required after donation under 21 CFR 630.30(a)(2), identifies the donation as 
unsuitable because of inadvertent failure to follow procedures 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)); and  
  red blood cell loss for plasma collected by plasmapheresis (21 CFR 630.15(b)(6)).   
 
To ensure that the health of the donor is not adversely affected by the donation, blood 
establishments must continue to determine donor eligibility consistent with 21 CFR 
630.10 and 21 CFR 630.15 and must not collect blood from a donor found to be 
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  Contains Nonbinding Recommendations 
 
ineligible prior to collection.  In other words, blood establishments must continue to 
assess donors blood pressure, pulse, weight, donation frequency, pregnancy history and 
red blood cell loss on the day of donation and prior to collection, and not collect from 
ineligible donors, as described in 21 CFR 630.10 and 21 CFR 630.15.  However, in the 
following circumstances, we do not intend to take regulatory action regarding the release 
of blood components collected from certain ineligible donors as described above: 
 
(1) an error occurred during the donor eligibility determination that is discovered 
upon record review, and such error resulted in a blood establishment incorrectly 
determining that a donor met the eligibility criteria; or  
 
(2) the establishment received post donation information from a donor or third 
party with respect to the requirements in 21 CFR 630.10 and 21 CFR 630.15 
described above (e.g., for donation frequency (21 CFR 630.15(a)(1)) or 
pregnancy (21 CFR 630.10(e)(2)(v)), and such information would have resulted 
in that donor being determined to be ineligible during the establishments 
evaluation of the criteria.  
 
This compliance policy does not apply to donations found unsuitable because of 
screening test results or risk factors for relevant transfusion-transmitted infections (RTTI) 
or other factors that have the potential to affect the safety, purity or potency of the blood 
or blood component, including but not limited to the requirements with respect to 
donation testing in 21 CFR 610.40 and 21 CFR 640.65(b); the requirement for 
educational material in 21 CFR 630.10(b); the requirements for assessing a donors 
medical history in 21 CFR 630.10(e)(1) and certain requirements in (e)(2); and donors 
body temperature in 21 CFR 630.10(f)(1).   
 
The compliance policy also does not apply to donations found unsuitable because of 
hemoglobin levels or hematocrit values in 21 CFR 630.10(f)(3); the determination of a 
plasma donors total protein level as required in 21 CFR 630.15(b)(4); or, the 
requirements for syphilis testing, total plasma or serum protein determination, and 
plasma or serum protein electrophoresis or quantitative immuno-diffusion test or 
equivalent test in 21 CFR 640.65(b).  An establishments failure to comply with these 
regulations has the potential to adversely affect a donors health, and the ability of a 
blood establishment to maintain control of good manufacturing practices.  
 
  Record Maintenance, Investigation and Annual Reporting 
 
We intend to apply this compliance policy, as described above, provided blood 
establishments that elect to release unsuitable units report the errors and the release of 
unsuitable donations to FDA annually.  The submission of reports will allow FDA to 
monitor error rates associated with the collection of unsuitable units across the blood 
industry.  FDA will also use this information to assess an individual establishments 
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  Contains Nonbinding Recommendations 
 
compliance with the donor eligibility requirements and identify the need for corrective 
actions, if necessary. 
 
Specifically, FDA does not intend to take regulatory action against a blood 
establishments failure to comply with certain regulations for donation suitability as 
described above provided that, among other conditions, licensed and registered-only 
blood establishments investigate the error that resulted in the collection of an unsuitable 
donation under 21 CFR 630.30(a)(2); and submit a summary report to FDA annually.  
The report, in summary format, should describe the number and type of donations 
released under these conditions.  The report should also describe the corrective actions 
taken to prevent recurrence of errors and to ensure compliance with the applicable 
regulations.  In submitting the report to FDA, establishments may rely on investigations 
already conducted and information already developed as part of their deviation 
management and corrective action program.   
 
  Licensed establishments who release unsuitable donations under this compliance 
policy should include such a report as part of their Annual Report required under 
21 CFR 601.12(d).   
 
  We recommend that registered-only establishments who release unsuitable 
donations under this compliance policy submit the report annually between 
October 1 and December 31.  Registered-only establishments should clearly label 
the submission as New URVR Submission  Report of Released Unsuitable 
Units and submit to the Office of Blood Research and Review at the following 
address: 
 
 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
Document Control Center 
10903 New Hampshire Ave. 
WO71-G112 
Silver Spring, MD 20993-0002 
 
Blood establishments must continue to maintain records as required under 21 CFR 
606.160.  This compliance policy does not extend to blood establishments that wish to 
release unsuitable donations under circumstances other than those described in this 
section.  Blood establishments wishing to release unsuitable donations in other 
circumstances may submit a request for an alternative procedure under 21 CFR 
640.120(a).   
 
B.  Donor Eligibility (21 CFR 630.10(c)(2)) 
 
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  Contains Nonbinding Recommendations 
 
Section 21 CFR 630.10(c) generally requires blood establishments to determine donor 
eligibility on the day of donation and before collection.  However, 21 CFR 630.10(c)(2) 
permits a blood establishment to clarify a donors responses or obtain omitted 
information within 24 hours after collection in the event that, upon review, an 
establishment finds that a donors responses to the donor questions were incomplete.  
This permitted clarification applies only to responses to donor questions.  It does not 
apply to information establishments are required to obtain as part of the physical 
assessment of donors required in 21 CFR 630.10(f).  
 
With respect to the timeframe described in 21 CFR 630.10(c)(2), FDA does not intend to 
take regulatory action if a blood establishment clarifies a donors 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.   
 
C.  Source Plasma Quarantine Hold (21 CFR 640.69(f)) 
 
Under 21 CFR 640.69(f), Source Plasma donated by paid donors and determined to be 
suitable for further manufacturing into injectable products must be held in quarantine for 
a minimum of 60 calendar days before it is released for further manufacturing.  With 
respect to the timeframe for the hold required in 21 CFR 640.69(f), FDA 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. 
 
 
IV.  IMPLEMENTATION 
 
Licensed establishments that intend to implement changes described in this guidance must report 
changes to their standard operating procedures (SOPs) to reflect this compliance policy guidance 
as Changes Being Effected (CBE) supplements under 21 CFR 601.12(c)(5) (see 21 CFR 
601.12(a)(3)).  
 
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 this compliance policy guidance.  However, the establishment should report that they are 
retaining the SOPs in their Annual Report under 21 CFR 601.12(d).  
 
V.  PAPERWORK REDUCTION ACT  
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521).  The time required to complete this information collection is estimated to average 4 
hours per response, including the time to review instructions, search existing data sources, gather 
the data needed, and complete and review the information collection.  Send comments regarding 
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  Contains Nonbinding Recommendations 
 
this burden estimate or suggestions for reducing this burden to:  
 
Food and Drug Administration 
Center for Biologics Evaluation and Research  
10903 New Hampshire Ave., Bldg. 71, Rm. 7301 
Silver Spring, MD 20993-0002 
 
This guidance also refers to previously approved FDA collections of information.  The 
collections of information in 21 CFR part 601 have been approved under OMB control number 
09100338 and the collections of information in 21 CFR parts 606, 630, and 640 have been 
approved under OMB control number 09100116. 
 
 
An agency may not conduct or sponsor, and a person is not required to respond to, a 
 
collection of information unless it displays a currently valid OMB control number.  
 
The OMB control number for this information collection is 0910-0116.  To find the 
 
current expiration date, search for this OMB control number at 
 
https://www.reginfo.gov). 
 
 
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