---
kind: "section"
citation: "28 C.F.R. § 202.223"
title: "28"
number: "202.223"
heading: "Human biospecimens."
url: "https://uscodex.org/cfr/28/202.223"
---

# §202.223. Human biospecimens.

- (a) The term human biospecimens means a quantity of tissue, blood, urine, or other human-derived material, including such material classified under any of the following 10-digit Harmonized System-based Schedule B numbers:
  - (1) 0501.00.0000 Human hair, unworked, whether or not washed or scoured; waste of human hair
  - (2) 3001.20.0000 Extracts of glands or other organs or of their secretions
  - (3) 3001.90.0115 Glands and other organs, dried, whether or not powdered
  - (4) 3002.12.0010 Human blood plasma
  - (5) 3002.12.0020 Normal human blood sera, whether or not freeze-dried
  - (6) 3002.12.0030 Human immune blood sera
  - (7) 3002.12.0090 Antisera and other blood fractions, Other
  - (8) 3002.51.0000 Cell therapy products
  - (9) 3002.59.0000 Cell cultures, whether or not modified, Other
  - (10) 3002.90.5210 Whole human blood
  - (11) 3002.90.5250 Blood, human/animal, other
  - (12) 9705.21.0000 Human specimens and parts thereof
- (b) Notwithstanding [paragraph (a)](#a) of this section, the term human biospecimens does not include human biospecimens, including human blood, cell, and plasma-derived therapeutics, intended by a recipient solely for use in diagnosing, treating, or preventing any disease or medical condition.

## Notes

### Authority

Authority: 50 U.S.C. 1701 et seq.; 50 U.S.C. 1601 et seq.; E.O. 14117, 89 FR 15421.

### Source

Source: 90 FR 1706, Jan. 8, 2025, unless otherwise noted.