21 CFR § 320.1 - Definitions.

---
identifier: "/us/cfr/t21/s320.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 320.1 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "320.1"
section_name: "Definitions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "320"
part_name: "BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 355, 371."
cfr_part: "320"
---


# 320.1 Definitions.

The definitions contained in § 314.3 of this chapter apply to those terms when used in this part.

[81 FR 69658, Oct. 6, 2016]