Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor
|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
*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.
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.
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.
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.
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:
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.
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*
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