This is a new Compliance
Policy Guide (CPG) and will be included in the next printing of the manual.
It is based on guidance provided to industry representing the Agency's
current thinking on blood donor classification statements. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and regulations.
It is intended for FDA personnel and is available electronically to the
public. INTRODUCTION:
*The purpose of this compliance guidance document is to update the
Compliance Policy Guide of the same title issued May 7, 2002.* It is
based on guidance provided to industry representing the Agency's current
thinking on blood donor classification statements. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
It is intended for FDA personnel and is available electronically to
the public.
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 labels to indicate whether the products were collected from paid
or volunteer donors. This labeling requirement appears at 21 CFR 606.121(c)(5).
The regulation defines a "paid donor" as a person who receives
monetary payment for a blood donation [21 CFR 606.121(c)(5)(i)]. A volunteer
donor is a person who does not receive monetary payment for a blood
donation [21 CFR 606.121(c)(5)(ii)].
The regulation also defines certain benefits that do not constitute
monetary payment. Those benefits include time off from work, membership
in blood assurance programs, and cancellation of non-replacement fees,
as long as the benefits are not readily convertible to cash [21 CFR
606.121(c)(5)(iii)].
The requirement that the label of blood and blood components indicate
whether the product came from a volunteer 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
products that will be used for further manufacturing, such as Source
Plasma.
As used in this document, the term incentive means anything a donor
receives for donating blood other than those items a donor would ordinarily
receive during the blood donation process. For example, refreshments
provided by the blood collection facility would not be considered to
be a donor incentive.
POLICY:
Paid Donors
As stated in the regulation cited above, if a donor receives monetary
payment for a blood donation, all products collected from that donor
that are intended for transfusion and that are collected during the
donation at which the donor received the monetary incentive must be
labeled with the "paid donor" classification statement. Monetary
payment includes cash, in any amount, or items that are readily convertible
to cash. The regulation does not make any distinction regarding where
the payment comes from, such as the blood center or the sponsoring organization.
All monetary payments to the donor would require the blood and blood
components to be labeled with a "paid donor" classification
statement, regardless of the dollar value of the incentive. The nature
of the population (the type of people) attracted by the incentive should
not be considered in determining whether an incentive is a monetary
payment. FDA considers all monetary payments to blood donors to require
a "paid donor" label statement on the blood, whether or not
the incentive is offered only to donors who are successful in donating
or if all donors who present to donate receive the incentive.
If a monetary payment in any amount is made to a group to which the
donor belongs, this would generally be considered a monetary payment
to the donor. An exception to this is reimbursement to the sponsoring
organization for costs directly associated with the blood drive, such
as advertisement or refreshments for the donors. FDA would not consider
reimbursement for costs directly associated with the blood drive to
be a payment to the donor, even if the donor belongs to the sponsoring
organization.
Volunteer Donors
The regulation specifies benefits that would not require the "paid
donor" classification statement, as long as the benefits are not
readily convertible to cash. These benefits are 1) time off from work,
2) membership in blood assurance programs, and 3) cancellation of non-replacement
fees. Products collected from blood donors who have received such benefits
may be labeled with the "volunteer donor" classification statement.
Other incentives that would not require the "paid donor"
classification are described in the preamble to the final regulation
mentioned above. These include 1) lotteries or raffles, regardless of
the value of the prize to be given away [Final Rule, 43 FR 2142, 2143
(1978)] and 2) non-monetary rewards associated with product promotion
(id.).
If an incentive is not cash and is not a benefit specifically described
in the regulation, the blood can be labeled with the "volunteer
donor" classification statement unless the incentive is readily
convertible to cash. If the incentive is cash or is readily convertible
to cash, the blood must have the "paid donor" classification
statement on the label.
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:
- 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. Because the incentive is not transferable, it presumably
cannot be sold and therefore cannot be converted to cash. If the incentive
is not transferable, the blood from the donation can be labeled with
the "volunteer donor" classification statement.
- Is the incentive refundable or redeemable for cash?
An incentive is considered refundable or redeemable if the donor can
take the incentive to the organization or business that provided or
sponsored the incentive and receive cash back. If the incentive is
refundable or redeemable for cash, the incentive would generally be
considered to be readily convertible to cash. Blood 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 for the purchase of a CD at
a local record store. If the donor can obtain cash from the record
store in exchange for the certificate, the gift certificate would
be an incentive that is readily convertible to cash and the all products
collected from the donor must show the "paid donor" classification
statement.
- Does a market exist for the incentive?
- If no market exists for the incentive, it would generally not
be considered to be readily convertible to cash, and the blood
could be labeled with the "volunteer donor" label statement.
- If a market exists in which a donor could sell the incentive,
how readily can it be converted to cash? The blood must include
a "paid donor" label statement if the incentive is "readily
convertible to cash" (emphasis added). If an incentive is
convertible to cash, but this would require a significant effort
on the part of the donor, the incentive may be one which would
not require the blood to have a "paid donor" statement.
Examples of Incentives
The Center for Biologics Evaluation and Research (CBER) has reviewed
a number of actual donor incentives and describes below its findings
on whether the incentive would require the blood to have the "paid
donor" classification statement. It is important to remember that
these conclusions were based on the facts of a particular case and that
the facts of a different scenario may result in a different determination
of whether the blood should be labeled as collected from a paid or volunteer
donor.
- Event tickets
If the tickets or vouchers are transferable, whether a market for
the tickets exists is an important factor. It is well known that a
market exists for tickets to many professional and collegiate sports
events. The market is usually an easily accessible one, as it is common
to see potential sellers and buyers of tickets at the entrance to
the sports facility prior to an event. Generally, tickets or vouchers
to sporting events would require blood to have a "paid donor"
label statement.
Tickets or vouchers for other events may or may not require a paid
donor label, depending on whether the tickets or vouchers are transferable,
convertible to cash, and whether a market exists for the ticket. Free
tickets for movie theaters are generally not readily convertible to
cash, so generally may be considered benefits that would not require
a "paid donor" label. Ticket vouchers for symphony or opera
performances may require a "paid donor" label to be placed
on the products if an accessible market exists for the tickets and
they are transferable.
- Compact discs compliments of a music store.
Compact discs (CDs) and similar incentives may be considered "non-monetary
rewards associated with product promotion" and would not require
a "paid donor" label statement [Final Rule, 43 FR 2142,
2143 (1978)] if they are provided compliments of a particular business.
If the CDs are not associated with product promotions and a market
exists for the CDs, the blood may require a "paid donor"
label statement.
- Reduced room rates compliments of a hotel
If the benefit is not refundable or redeemable for cash at the hotel,
but is a discount in the normal price of the hotel room, the incentive
would generally be considered a non-monetary benefit and would not
require the blood to have the "paid donor" label statement.
If the discount 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 from
a donor who received an incentive that is readily convertible to cash
must show the "paid donor" label statement.
- 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 available for
the limited number of miles provided as blood donor incentives. This
incentive would generally not require a "paid donor" label
statement on the blood.
- Medical tests
Blood collection facilities have offered medical tests, such as cholesterol
screenings, as incentives for blood donors. A test performed or one
for which blood is drawn at the time of donation is an incentive that
is not transferable. Therefore, the benefit is not readily convertible
to cash and would not require a "paid donor" label statement.
Other variations of this benefit may not result in a similar conclusion,
such as a voucher for a free screening test. This section does not
refer to tests that are performed as part of the donation process,
such as viral marker screening tests.
- Escalating incentive programs
In some programs, the incentive escalates 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
set. Donations at which the donor received an incentive that would
not be considered monetary payment could be labeled with the "volunteer
donor" label. Donations at which the donor received an incentive
that would be 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 blood collected at the
first and second donations could generally be labeled with a "volunteer
donor" label statement, because t-shirts and coffee mugs are
usually not readily convertible to cash. The blood collected at 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.
- Scholarship programs
Blood organizations have offered scholarship incentives to high schools
that sponsor blood drives. If the scholarship is established such
that the student recipient does not receive cash, but rather the scholarship
money is transferred directly to the college, university, or other
learning establishment that the student attends after high school,
the incentive would not be considered to be readily convertible to
cash and the blood collected could be labeled with the "volunteer
donor" label statement.
-
*H. Gift Cards and Gift Certificates*
*Gift cards and gift certificates are functionally the same. The benefit
is not monetary, but could be considered a monetary payment if readily
convertible to cash. If these incentives are non-transferable, not redeemable
for cash, and bear the donor’s name, such incentives would not
be considered to be readily convertible to cash and the blood collected
could be labeled with the “volunteer donor” label statement.*
REGULATORY ACTION GUIDANCE:
As stated in the Investigations Operations Manual (IOM) investigators
may include observations regarding blood and blood components labeling
on FDA 483s (Section 512.01, item 10). 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
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 Procedure Manual (RPM),* Chapter 4 Advisory
Actions (Sec. 4-1-4)* districts should seek concurrence from CBER prior
to issuing warning letters citing labeling violations.
*Material between asterisks is new or revised*
Issued: 05/07/2002
Revised: 11/22/2005
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