Determining Donor Eligibility for 
Autologous Donors of Blood and Blood 
Components Intended Solely for 
Autologous Use  Compliance Policy 
 
 
Guidance for Industry 
 
 
This guidance is for immediate implementation. 
 
 
FDA is issuing this guidance for immediate implementation in accordance with  
21 CFR 10.115(g)(2) without initially seeking prior comment because the agency has determined 
that prior public participation is not feasible or appropriate.  
 
FDA invites comments on this guidance.  Submit one set of either electronic or written 
comments on this guidance at any time.  Submit electronic comments to 
http://www.regulations.gov.  Submit written comments to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.  You should identify all comments with the docket number listed in the notice of 
availability that publishes in the Federal Register.  FDA will review any comments we receive 
and revise the guidance when appropriate. 
 
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 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida
nces/default.htm. 
 
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 
August 2016  Contains Nonbinding Recommendations  
 
Table of Contents 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  AUTOLOGOUS DONOR ELIGIBILITY REQUIREMENTS - COMPLIANCE 
POLICY ............................................................................................................................. 2 
A.  General Donor Eligibility Requirements (21 CFR 630.10) ............................... 2 
B.  Donor Eligibility Requirements Specific to Whole Blood, Red Blood Cells 
and Plasma Collected by Apheresis (21 CFR 630.15) ........................................ 3 
C.  Exceptions for Certain Ineligible Donors (21 CFR 630.20) .............................. 4 
 
 
i  Contains Nonbinding Recommendations  
 
Determining Donor Eligibility for Autologous Donors of  
Blood and Blood Components Intended Solely for  
Autologous Use  Compliance Policy 
 
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 the approach 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 the regulatory requirements for determining donor eligibility that apply 
to establishments that collect blood and blood components (blood establishments) intended 
solely for autologous use.  On May 22, 2015, in order to better assure the safety of the nations 
blood supply and to help protect donor health, FDA finalized its revision of the applicable 
requirements for blood establishments to test donors for infectious disease, and to determine that 
donors are eligible to donate and that donations are suitable for transfusion or further 
manufacture (Requirements for Blood and Blood Components Intended for Transfusion or for 
Further Manufacturing Use, 80 FR 29842 (donor eligibility rule)1).  The donor eligibility rule 
includes requirements related to current good manufacturing practice, donation testing, donor 
eligibility, and donation suitability (in 21 CFR Parts 606, 610, 630, and 640).  It became 
effective on May 23, 2016.2   
 
FDA has developed this guidance in response to questions from blood establishments concerning 
the applicability of the donor eligibility rule to autologous donations.  The guidance explains the 
conditions under which FDA does not intend to take regulatory action for a blood 
establishments failure to comply with certain donor eligibility determination requirements in 
collecting blood and blood components intended solely for autologous use.  
 
In general, FDAs guidance documents, including this guidance document, do not establish 
legally-enforceable responsibilities.  Instead, guidance documents describe the FDAs 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 FDAs guidance documents 
means that something is suggested or recommended, but not required. 
                                                 
1 https://www.gpo.gov/fdsys/pkg/FR-2015-05-22/html/2015-12228.htm. 
2 Unless otherwise specified, all regulation citations refer to the requirements in the donor eligibility rule that 
became effective May 23, 2016.  
1  Contains Nonbinding Recommendations  
 
 
II.  BACKGROUND 
A small proportion of collections of blood and blood components are intended for autologous 
use.  In those instances, the autologous donor presents with a physicians prescription for the 
collection of the donors blood for the donors own upcoming medical (e.g., surgical) procedure.  
If the donor ultimately does not need the blood, blood establishments may, in some instances, 
use these donations for allogeneic (i.e., intended for transfusion to a recipient other than the 
donor) transfusions.  This is referred to as cross-over. 
Blood establishments have requested clarification on certain requirements of the donor eligibility 
rule and the applicability of certain sections of the donor eligibility rule to the collection of blood 
and blood components intended for autologous use.  To address these questions, FDA has 
developed this guidance to clarify the Agencys policy with respect to the requirements for 
autologous donors of blood and blood components intended solely for autologous use, (i.e., not 
subject to cross-over).  Specifically: 
  Section III.A describes FDAs policy with respect to requirements in 21 CFR 630.10 
relating to screening autologous donors for relevant transfusion-transmitted infections 
(RTTI);  
  Section III.B describes FDAs policy with respect to the requirement in  
21 CFR 630.15(a)(1)(ii) that the responsible physician examine the autologous donor to 
permit more frequent collections; and, 
  Section III.C describes FDAs policy with respect to the requirement in 
21 CFR 630.20(a) that the responsible physician determine and document that the 
autologous donors health permits the collection of blood and blood components.   
 
 
III.  AUTOLOGOUS DONOR ELIGIBILITY REQUIREMENTS - COMPLIANCE 
POLICY 
 
A.  General Donor Eligibility Requirements (21 CFR 630.10) 
 
Autologous donors have long been permitted to donate blood for their own use even if 
they do not meet certain donor eligibility criteria that apply to allogeneic donors because 
autologous donors are not exposed to new transfusion-transmitted infections in receiving 
their own blood.  For example, FDA does not require testing of autologous donations for 
relevant transfusion-transmitted infections (RTTI, see 21 CFR 630.3(h)) unless the 
donations are used for allogeneic transfusion or shipped to another establishment 
(21 CFR 610.40(d)).  Consistent with this approach to testing of autologous donations, 
FDA does not believe it is necessary to assess autologous donors for risks for RTTI as 
required in 21 CFR 630.10, provided that the donation is intended solely for autologous 
use.   
 
Accordingly, provided that:  1) the collection of blood and blood components is intended 
solely for autologous use (i.e., the blood or blood components are not subject to cross-
over), and 2) the blood establishment meets all other applicable requirements in             
2  Contains Nonbinding Recommendations  
 
21 CFR Parts 606, 610, 630, and 640, FDA does not intend to take regulatory action 
regarding violations of: 
 
1.  21 CFR 630.10(b), with respect to providing donors of blood and blood 
components educational material; 
2.  21 CFR 630.10(d)(1), with respect to consulting the records of deferred 
donors of blood and blood components; 
3.  21 CFR 630.10(e)(1), with respect to assessing a donor of blood and blood 
components for an increased risk for, or evidence of, an RTTI;  
4.  21 CFR 630.10(e)(2)(iii), with respect to assessing a donor of blood and blood 
components for travel to, or residence in, an area endemic for transfusion-
transmitted infection; and  
5.  21 CFR 630.10(e)(2)(vii), with respect to assessing whether the donor of 
blood and blood components is a recipient of a xenotransplantation product. 
 
Licensed blood establishments must report changes to their standard operating procedures 
(SOPs) as Changes Being Effected (CBE) supplements under 21 CFR 601.12(c)(5).  See 
21 CFR 601.12(a)(3). 
 
B.  Donor Eligibility Requirements Specific to Whole Blood, Red Blood Cells 
and Plasma Collected by Apheresis (21 CFR 630.15) 
 
Section 630.15(a)(1)(i) addresses donation frequency for Whole Blood or Red Blood 
Cells.  Section 630.15(a)(1)(ii) provides an exception to the donation frequency 
requirement provided that: 
 
1.  The donation is for autologous use as prescribed by the donors physician; and  
2.  The responsible physician of the blood establishment examines the donor at 
the time of donation, determines the donation may proceed, and documents 
this determination. 
With regard to the second condition above, in light of the medical oversight provided by 
the autologous donors physician, FDA believes blood establishments can appropriately 
protect autologous donors health by following SOPs that are approved by the responsible 
physician of the blood establishment and that define criteria for when the autologous 
donation may proceed and the conditions under which the responsible physician must be 
consulted. 
 
Accordingly, for autologous donors of blood and blood components intended solely for 
autologous use, we do not intend to take regulatory action with respect to the requirement 
in 21 CFR 630.15(a)(1)(ii) that the responsible physician examine the donor and 
determine and document that the donation may proceed, and the corresponding 
requirement in 21 CFR 630.5(b)(1)(i)(A) that the responsible physician not delegate the 
examination of the autologous donor and the determination of the autologous donors 
3  Contains Nonbinding Recommendations  
 
health, provided that the blood establishment develops and follows appropriate SOPs3 
that: 
 
  are approved by the responsible physician of the blood establishment; 
  provide instructions on how staff should determine that an autologous donor of 
blood and blood components has been referred by his or her physician and 
presents with a prescription to undergo an autologous donation; 
  define criteria for autologous collections of blood and blood components to 
proceed;  and that 
  describe the conditions under which the responsible physician must be consulted 
to determine and document that an autologous donors health permits the 
collection of blood and blood components.  (The SOPs may clarify that the 
responsible physician may make this determination by telephonic or other offsite 
consultation).   
 
C.  Exceptions for Certain Ineligible Donors (21 CFR 630.20) 
 
Section 630.20(a) permits blood establishments to collect blood and blood components 
from an otherwise ineligible autologous donor provided certain conditions are met:   
 
1.  The donation is for autologous use only, as prescribed by the donors 
physician;  
2.  The donor has a hemoglobin level no less than 11.0 grams of hemoglobin per 
deciliter of blood or a hematocrit value no less than 33 percent; and 
3.  The responsible physician of the blood establishment determines and 
documents the donors health permits the collection procedure.   
With respect to the third condition above, in light of the medical oversight provided by 
the autologous donors physician, FDA believes blood establishments can appropriately 
protect autologous donors health by following SOPs that are approved by the responsible 
physician of the blood establishment and that define criteria for when the autologous 
donation may proceed and the conditions under which the responsible physician must be 
consulted.   
 
Accordingly, for autologous donors of blood and blood components intended solely for 
autologous use, we do not intend to take regulatory action with respect to the requirement 
in 21 CFR 630.20(a) that the responsible physician determines and documents that the 
donors health permits the collection procedure, or the corresponding requirement in  
21 CFR 630.5(b)(1)(i)(B) that the responsible physician not delegate the determination of 
the autologous donors health, provided that the blood establishment develops and 
follows appropriate SOPs4 that: 
 
 
                                                 
3
Licensed blood establishments must report such changes to their SOPs as CBE supplements under  
21 CFR 601.12(c)(5). See 21 CFR 601.12(a)(3). 
4 Id.  
4  Contains Nonbinding Recommendations  
 
  are approved by the responsible physician of the blood establishment;  
  provide instructions on how staff should determine that an autologous donor of blood 
and blood components has been referred by his or her physician and presents with a 
prescription to undergo an autologous donation; 
  define criteria for autologous collections of blood and blood components to proceed 
and that 
  describe the conditions under which the responsible physician must be consulted to 
determine and document that an autologous donors health permits the collection of 
blood and blood components.  (The SOPs may clarify that the responsible physician 
may make this determination by telephonic or other offsite consultation).  
 
5