42 CFR § 7.3 - Definitions.

---
identifier: "/us/cfr/t42/s7.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 7.3 - Definitions."
title_number: 42
title_name: "Public Health"
section_number: "7.3"
section_name: "Definitions."
chapter_name: "PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL PROVISIONS"
part_number: "7"
part_name: "DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL PREPARATIONS"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); title V of the Independent Offices Appropriations Act of 1952 (31 U.S.C. 9701); and secs. 301(a) and 352 of the Public Health Service Act, as amended (42 U.S.C. 241(a) and 263)."
regulatory_source: "52 FR 11073, Apr. 7, 1987, unless otherwise noted."
cfr_part: "7"
---


# 7.3 Definitions.

*Biological standards* means a uniform and stable reference biological substance which allows measurements of relative potency to be made and described in a common currency of international and national units of activity.

*Biological preparations* means a reference biological substance which may be used for a purpose similar to that of a standard, but which has been established without a full collaborative study, or where a collaborative study has shown that it is not appropriate to establish the preparation as an international standard.