Compliance Policy Guide 
CPG Sec. 230.150: Blood Donor 
Classification Statement, Paid or 
Volunteer Donor 
 
 
Guidance for FDA Staff 
 
 
This guidance is for immediate implementation. 
 
 
 
 
FDA is issuing this guidance for immediate implementation in accordance with  
21 CFR 10.115(g)(4)(i).  Submit one set of either electronic or written comments on this 
guidance at any time.  Submit electronic comments to https://www.regulations.gov/.  Submit 
written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  You should identify all comments with 
docket number FDA-2019-D-4090.   
 
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 
December 2019
  Contains Nonbinding Recommendations 
Table of Contents 
 
 
I.  INTRODUCTION: ............................................................................................................ 1 
II.  BACKGROUND: ............................................................................................................... 1 
III.  POLICY: ............................................................................................................................. 2 
A.  Paid Donors ........................................................................................................... 2 
B.  Volunteer Donors .................................................................................................. 3 
C.  Factors to Consider ............................................................................................... 3 
1.  Is the incentive transferable? .................................................................................... 3 
2.  Is the incentive refundable or redeemable for cash? ............................................. 3 
3.  Does a market exist for the incentive? .................................................................... 4 
D.  Examples of Incentives ......................................................................................... 4 
1.  Event tickets ............................................................................................................... 4 
2.  Reduced room rates for a hotel ................................................................................ 5 
3.  Frequent flyer miles ................................................................................................... 5 
4.  Medical and health-based incentives ...................................................................... 5 
5.  Escalating incentive programs ................................................................................. 5 
6.  Scholarship programs ................................................................................................ 6 
7.  Gift cards and gift certificates .................................................................................. 6 
IV.  REGULATORY ACTION GUIDANCE: ........................................................................ 6 
 
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Compliance Policy Guide 
CPG Sec. 230.150: Blood Donor Classification Statement, Paid or 
Volunteer Donor 
 
 
Guidance for FDA Staff 
 
 
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:  
 
The purpose of this Compliance Policy Guide is to provide guidance to FDA staff on the labeling 
of blood and blood components intended for transfusion with the appropriate donor classification 
statement (i.e., paid donor or volunteer donor).  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances 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 guidances means that something is suggested or 
recommended but not required.  
 
 
II.  BACKGROUND:  
 
In a Federal Register notice dated January 13, 1978 (43 FR 2142), the Agency issued a final rule 
which required that blood and blood components intended for transfusion include a donor 
classification statement on the container label to indicate collection from a paid donor or 
volunteer donor.  This labeling requirement appears at Title 21 of the Code of Federal 
Regulations (CFR) 21 CFR 606.121(c)(8)(v).  The regulation defines a paid donor as a person 
who receives monetary payment for a blood donation (21 CFR 606.121(c)(8)(v)(A)).  A 
volunteer donor is a person who does not receive monetary payment for a blood donation (21 
CFR 606.121(c)(8)(v)(B)).  
 
The regulation also states that benefits such as time off from work, membership in blood 
assurance programs, and cancellation of non-replacement fees that are not readily convertible to 
cash, do not constitute monetary payment. (21 CFR 606.121(c)(8)(v)(C)).  
 
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The requirement that the container label of blood and blood components indicate whether the 
donation was collected from a volunteer donor or a paid donor applies only to blood and 
blood components intended for transfusion, such as Whole Blood, Red Blood Cells, Fresh 
Frozen Plasma, Platelets, and Cryoprecipitated AHF.  The donor classification labeling 
requirement does not apply to blood and blood components intended for further manufacturing 
use, such as Source Plasma and recovered plasma.  
 
For the purposes of this guidance, the term incentive means anything a donor receives for 
donating blood and blood components except for those items a donor would ordinarily receive 
during the blood donation process.  For example, refreshments provided by the blood 
establishment would not be considered a donor incentive.  
 
 
III.  POLICY:  
 
A.  Paid Donors  
 
Under 21 CFR 606.121(c)(8)(v), if a donor receives monetary payment for a blood 
donation, all blood and blood components that are intended for transfusion and collected 
during the donation at which the donor received the monetary payment must be labeled 
with the paid donor classification statement.  Monetary payment includes cash, in any 
amount, and incentives that are readily convertible to cash.  The regulation does not 
distinguish the source of the payment, for example, the blood establishment or the 
organization sponsoring a blood drive.  
 
Regardless of the amount, all monetary payments to a donor require the blood and blood 
components intended for transfusion to be labeled with a paid donor classification 
statement.  All monetary payments to a blood donor require a "paid donor" statement, 
whether or not the monetary payment is offered only to donors who complete the 
donation process or to all donors who present to donate.  
 
If a monetary payment in any amount is made on behalf of the donors to a group to which 
the donors belong, this would generally be considered a monetary payment to the 
individual donors.  For example, a cash payment to the holiday party fund of a business 
that is hosting a blood drive and whose employees are donors would be considered 
monetary payment to the donors.  An exception to this is reimbursement to an 
organization sponsoring a blood drive for costs directly associated with the blood drive, 
such as for advertising or purchasing refreshments for the donors.  FDA would not 
consider reimbursement to the sponsoring organization for costs directly associated with 
a blood drive to be a payment to the donor, even if the donor belongs to the sponsoring 
organization.  
 
   
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B.  Volunteer Donors  
 
Under 21 CFR 606.121(c)(8)(v)(C)), certain benefits are identified that are not readily 
convertible to cash and do not constitute monetary payment.  These benefits are 1) time 
off from work, 2) membership in blood assurance programs, and 3) cancellation of non-
replacement fees (i.e., the cancellation of hospital charges related to any future blood 
transfusions needed by the donor).  Blood and blood components collected from blood 
donors who have received such benefits should be labeled with the volunteer donor 
classification statement.  
 
Other examples of incentives that would not require the paid donor classification are 
described in the preamble to the final regulation (43 FR at 2142-43).  These include 1) 
lotteries or raffles, regardless of the value of the prize to be given away; and 2) non-
monetary rewards associated with product promotion, such as promotional items bearing 
the company logo of the blood establishment or the sponsoring organization.  Blood and 
blood components from donors who have received such benefits or other benefits not 
readily convertible to cash should be labeled with the volunteer donor classification 
statement if the incentive is not cash or readily convertible to cash.  If the incentive is 
cash or is readily convertible to cash, the blood and blood components intended for 
transfusion must have the paid donor classification statement on the label. 
 
C.  Factors to Consider 
 
If the donor receives an incentive other than cash, the incentive should be evaluated to 
determine if it is readily convertible to cash.  Some factors to consider when determining 
whether an incentive is readily convertible to cash are as follows:  
 
1.  Is the incentive transferable?   
 
An incentive is considered transferable if someone other than the donor can use it.  
If the incentive is not transferable, it can only benefit the donor.  If an incentive is 
not transferable, it presumably cannot be sold and therefore is not readily 
convertible to cash.  If the incentive is not transferable, the blood and blood 
components collected from the donor and intended for transfusion should be 
labeled with the volunteer donor classification statement.  
 
2.  Is the incentive refundable or redeemable for cash?   
 
An incentive is considered refundable or redeemable for cash if the donor can 
return the incentive to the organization or business that provided the incentive and 
receive cash.  If the incentive is refundable or redeemable for cash, the incentive 
is considered readily convertible to cash.  Blood and blood components intended 
for transfusion from a donor who received an incentive that is readily convertible 
to cash must be labeled with the paid donor classification.  For example, a 
donor may receive a gift certificate from a store towards a future purchase.  If the 
donor can obtain cash from the store in exchange for the certificate, the gift 
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certificate is an incentive that is readily convertible to cash and the blood and 
blood components collected from the donor and intended for transfusion must be 
labeled with the paid donor classification statement.  
 
3.  Does a market exist for the incentive?   
 
If a market exists in which a donor could sell the incentive, you should consider 
whether the incentive is readily convertible to cash.  The blood and blood 
components intended for transfusion must include a paid donor label statement 
if the incentive is readily convertible to cash.  If an incentive is convertible to 
cash, but this would require a significant effort on the part of the donor, the 
incentive may not require the blood and blood components to have a paid donor 
statement.  
 
D.  Examples of Incentives  
 
The following examples are provided based on the Center for Biologics Evaluation and 
Researchs (CBERs) experience reviewing donor incentives.  It is important to 
remember that our recommendations are based on the specifics of the example provided, 
and a different scenario may result in a different determination of whether the blood and 
blood components should be labeled with the paid donor or volunteer donor 
classification statement.  
 
1.  Event tickets 
 
If the tickets are transferable, you should consider whether a market exists for the 
tickets.  It is well known that a market exists for tickets to many professional and 
collegiate sporting events, music concerts and festivals, and major amusement 
parks.  In these situations, the market is usually an easily accessible one.  For 
example, it is common to see potential sellers and buyers of tickets at the entrance 
to these events.  In addition, there are several internet-based venues for selling 
and buying such tickets.  Therefore, providing tickets to such events would 
generally require a paid donor label statement.  
 
Tickets for other events may or may not require a paid donor label, depending 
on whether the tickets are refundable or redeemable for cash, or are transferable 
and whether a market exists for the ticket.  Tickets for movie theaters are 
generally not readily convertible to cash, so may be considered incentives that 
would not require a paid donor label.  On the other hand, ticket vouchers for 
symphony or opera performances may require a paid donor label if an 
accessible market exists for the tickets and they are transferable.  
 
   
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2.  Reduced room rates for a hotel 
 
If the reduced room rate is not refundable or redeemable for cash at the hotel, the 
incentive would generally be considered a non-monetary benefit and would not 
require the paid donor label statement.  However, if the reduced room rate is 
transferable and a readily accessible market exists for discounted room rates for 
the particular hotel, the incentive would likely be considered readily convertible 
to cash.  Blood and blood components collected from a donor who received an 
incentive that is readily convertible to cash must have the paid donor label 
statement.  
 
3.  Frequent flyer miles 
 
Frequent flyer miles are generally not transferable.  While a market may exist for 
the miles, it is not one that is readily accessible for the limited number of miles 
provided as blood donor incentives.  Use of frequent flyer miles as an incentive 
would generally not require a paid donor label statement.  
 
4.  Medical and health-based incentives 
 
Blood establishments have offered a variety of medical and health-based 
incentives for blood donors.  One common example is the offer of a laboratory 
screening test (e.g., a cholesterol screen).  A laboratory screening test performed, 
or one for which blood is drawn, at the time of donation is an incentive that is not 
transferable.  Therefore, the incentive is not readily convertible to cash and would 
not require a paid donor label statement.  However, a voucher for a free 
screening test that would be performed at a later date, may be considered readily 
convertible to cash if it is transferrable and an accessible market exists.  Note that 
this section does not address tests that are performed as part of the donation 
process, such as transfusion-transmitted infection screening tests.  Incentives 
granting donors access to systems that aggregate and track their electronic health 
information (e.g., test results and vital signs from physicians, heart rate data from 
smartwatches) are not considered readily convertible to cash to the extent that a 
market does not exist to convert such incentives to cash.   
 
5.  Escalating incentive programs 
 
In some programs, incentives escalate in value as the number of donations 
increases.  For example: the incentive for the first donation may be a t-shirt, the 
incentive for the second donation may be a coffee cup, and the incentive for the 
tenth donation may be a television.  Donations at which the donor received an 
incentive that is not considered monetary payment should be labeled with the 
volunteer donor label.  Donations at which the donor received an incentive that 
is considered monetary payment because it is cash or readily convertible to cash 
must be labeled with the paid donor label statement.  In the example given, the 
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blood and blood components collected at the first and second donations should 
generally be labeled with a volunteer donor label statement, because t-shirts and 
coffee mugs are usually not readily convertible to cash.  The blood and blood 
components collected during the donation at which the donor received a television 
set would generally require a paid donor label statement, because a television 
set is usually readily convertible to cash.  
 
6.  Scholarship programs 
 
Blood establishments or other organizations may offer scholarship incentives to 
schools that sponsor blood drives.  If the incentive is established such that the 
scholarship is distributed directly to the school, or the incentive is distributed to a 
dedicated scholarship fund created by the school, the incentive would not be 
considered readily convertible to cash and the blood and blood components 
collected should be labeled with the volunteer donor label statement.  
 
7.  Gift cards and gift certificates 
 
Gift cards and gift certificates are considered the same for the purposes of this 
guidance.  A gift card incentive is considered a monetary payment if readily 
convertible to cash.  If a gift card is non-transferable, bears the donors name, and 
is not redeemable for cash, it would not be considered readily convertible to cash 
and blood and blood components collected should be labeled with the volunteer 
donor label statement.   
 
Blood establishments collecting blood and blood components in areas where state 
or local laws require merchants to redeem gift cards/certificates for cash should 
consider all gift card incentives as readily convertible into cash; therefore, 
collected blood and blood components require the paid donor label statement. 
 
 
IV.  REGULATORY ACTION GUIDANCE:  
 
As stated in the Investigations Operations Manual (IOM), investigators may include observations 
regarding blood and blood component labeling on FDA 483s (Chapter 5, Subchapter 5.2.3.2.2 ).  
If an investigator finds that a blood establishment clearly has provided monetary payment, 
including an incentive that is readily convertible to cash, to a donor of blood and blood 
components intended for transfusion, but the label does not show the paid donor classification 
statement, the investigator may cite the firm for failing to label the blood or blood component 
appropriately.  
 
As stated in the Regulatory Procedures Manual (RPM), Chapter 4 Advisory Actions (Sec. 4-1-4) 
divisions within the Office of Biological Products Operations should seek concurrence from 
CBER prior to issuing warning letters citing labeling violations.  
 
 
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Issued: 05/07/2002  
Revised: 11/22/2005, 11/01/2011, 12/06/2019 
 
 
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