Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy: Guidance for Industry

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

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

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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

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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 nation’s
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
establishment’s failure to comply with certain donor eligibility determination requirements in
collecting blood and blood components intended solely for autologous use.
In general, FDA’s guidance documents, including this guidance document, do not establish
legally-enforceable responsibilities. Instead, guidance documents describe the FDA’s 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 FDA’s 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.

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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 physician’s prescription for the
collection of the donor’s blood for the donor’s 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 Agency’s 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 FDA’s 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 FDA’s 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 FDA’s policy with respect to the requirement in
21 CFR 630.20(a) that the responsible physician determine and document that the
autologous donor’s 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

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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 donor’s 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 donor’s 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 donor’s

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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 donor’s 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 donor’s
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 donor’s health permits the collection procedure.
With respect to the third condition above, in light of the medical oversight provided by
the autologous donor’s 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
donor’s 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 donor’s 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.

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• 	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 donor’s 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).