---
kind: "section"
citation: "21 C.F.R. § 630.30"
title: "21"
number: "630.30"
heading: "Donation suitability requirements."
url: "https://uscodex.org/cfr/21/630.30"
---

# §630.30. Donation suitability requirements.

- (a) **When is a donation suitable—** ? A donation is suitable when:
  - (1) The donor is not currently deferred from donation as determined by review of the records of deferred donors required under [§ 606.160(e)](/cfr/21/606.160.md?p=e) of this chapter;
  - (2) The results in accordance with [§§ 630.10 through 630.25](/cfr/21/630.10..630.25.md) indicate that the donor is in good health and procedures were followed to ensure that the donation would not adversely affect the health of the donor;
  - (3) The results in accordance with [§ 630.10(e)](/cfr/21/630.10.md?p=e) indicate that the donor is free from risk factors for, or evidence of, relevant transfusion-transmitted infections and other factors that make the donor ineligible to donate;
  - (4) The donor's blood is tested in accordance with [§ 610.40](/cfr/21/610.40.md) of this chapter, and is negative or nonreactive, unless an exception applies under [§ 610.40(h)](/cfr/21/610.40.md?p=h) of this chapter; and
  - (5) **The donation meets other requirements in this subchapter.**
- (b) **What must you do when the donation is not suitable—** ? (1) You must not release the donation for transfusion or further manufacturing use unless it is an autologous donation, or an exception is provided in this chapter.
  - (2) You must defer the donor when a donation is determined to be unsuitable based on the criteria in [paragraphs (a)(1) through (4)](#a-1..a-4) of this section.
  - (3) You must defer the donor of bacterially contaminated platelets when the contaminating organism is identified in accordance with [§ 606.145(d)](/cfr/21/606.145.md?p=d) of this chapter as likely to be associated with a bacterial infection that is endogenous to the bloodstream of the donor.
  - (4) You must notify the deferred donor in accordance with the notification requirements in [§ 630.40](/cfr/21/630.40.md).

## 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.