---
kind: "section"
citation: "21 C.F.R. § 630.3"
title: "21"
number: "630.3"
heading: "Definitions."
url: "https://uscodex.org/cfr/21/630.3"
---

# §630.3. Definitions.


As used in this part and in [part 610](/cfr/21/part610.md), [subpart E](/cfr/21/subpartE.md), and [part 640](/cfr/21/part640.md) of this chapter:

- (a) Blood means a product that is a fluid containing dissolved and suspended elements which was collected from the vascular system of a human.
- (b) Blood component means a product containing a part of blood separated by physical or mechanical means.
- (c) Donor means a person who: (1) Donates blood or blood components for transfusion or for further manufacturing use; or
  - (2) **Presents as a potential candidate for such donation.**
- (d) Eligibility of a donor means the determination that the donor is qualified to donate blood and blood components.
- (e) Infrequent plasma donor means a donor who has:
  - (1) Not donated plasma by plasmapheresis or a co-collection of plasma with another blood component in the preceding 4 weeks; and
  - (2) Not donated more than 12.0 liters of plasma (14.4 liters of plasma for donors weighing more than 175 pounds) in the past year.
- (f) Intimate contact with risk for a relevant transfusion-transmitted infection means having engaged in an activity that could result in the transfer of potentially infectious body fluids from one person to another.
- (g) Physician substitute means a trained and qualified person(s) who is:
  - (1) A graduate of an education program for health care workers that includes clinical training;
  - (2) Currently licensed or certified as a health care worker in the jurisdiction where the collection establishment is located;
  - (3) Currently certified in cardiopulmonary resuscitation; and
  - (4) Trained and authorized under State law, and/or local law when applicable, to perform the specified functions under the direction of the responsible physician.
- (h) **Relevant transfusion-transmitted infection—** means:
  - (1) **Any of the following transfusion-transmitted infections—**
    - (i) Human immunodeficiency virus, types 1 and 2 (referred to, collectively, as HIV);
    - (ii) Hepatitis B virus (referred to as HBV);
    - (iii) Hepatitis C virus (referred to as HCV);
    - (iv) Human T-lymphotropic virus, types I and II (referred to, collectively, as HTLV);
    - (v) **Treponema pallidum—** (referred to as syphilis);
    - (vi) West Nile virus;
    - (vii) **Trypanosoma cruzi—** (referred to as Chagas disease);
    - (viii) Creutzfeldt-Jakob disease (referred to as CJD);
    - (ix) Variant Creutzfeldt-Jakob disease (referred to as vCJD); and
    - (x) **Plasmodium—** species (referred to as malaria).
  - (2) A transfusion-transmitted infection not listed in [paragraph (h)(1)](#h-1) of this section when the following conditions are met:
    - (i) Appropriate screening measures for the transfusion-transmitted infection have been developed and/or an appropriate screening test has been licensed, approved, or cleared for such use by FDA and is available; and
    - (ii) **The disease or disease agent—**
      - (A) May have sufficient incidence and/or prevalence to affect the potential donor population; or
      - (B) May have been released accidentally or intentionally in a manner that could place potential donors at risk of infection.
- (i) Responsible physician means an individual who is:
  - (1) Licensed to practice medicine in the jurisdiction where the collection establishment is located;
  - (2) Adequately trained and qualified to direct and control personnel and relevant procedures concerning the determination of donor eligibility; collection of blood and blood components; the immunization of a donor; and the return of red blood cells or other blood components to the donor during collection of blood component(s) by apheresis; and
  - (3) Designated by the collection establishment to perform the activities described in [paragraph (i)(2)](#i-2) of this section.
- (j) Suitability of the donation means a determination of whether the donation is acceptable for transfusion or for further manufacturing use.
- (k) Trained person means an individual, including a physician substitute, who is authorized under State law, and/or local law when applicable, and adequately instructed and qualified to perform the specified functions under the direction of the responsible physician.

  (l) Transfusion-transmitted infection means a disease or disease agent:

  - (1) That could be fatal or life-threatening, could result in permanent impairment of a body function or permanent damage to a body structure, or could necessitate medical or surgical intervention to preclude permanent impairment of body function or permanent damage to a body structure; and
  - (2) For which there may be a risk of transmission by blood or blood components, or by a blood derivative product manufactured from blood or blood components, because the disease or disease agent is potentially transmissible by that blood, blood component, or blood derivative product.

## Notes

### Source

Source: 80 FR 29898, May 22, 2015, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371; 42 U.S.C. 216, 262, 264.

### Source

Source: 66 FR 31176, June 11, 2001, unless otherwise noted.