---
kind: "section"
citation: "21 U.S.C. § 379j–61"
title: "21"
title_heading: "Food and Drugs"
number: "379j–61"
heading: "Definitions"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379j-61"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VII — General Authority"
  - "Part C — Fees"
  - "Subpart 9 — fees relating to outsourcing facilities"
---

# §379j–61. Definitions


In this subpart:

- (1) The term “affiliate” has the meaning given such term in [section 379g(11) of this title](/usc/21/379g.md?p=11).
- (2) The term “gross annual sales” means the total worldwide gross annual sales, in United States dollars, for an [outsourcing facility](#3), including the sales of all the [affiliates](#1) of the [outsourcing facility](#3).
- (3) The term “outsourcing facility” has the meaning given to such term in [section 353b(d)(4) of this title](/usc/21/353b.md?p=d-4).
- (4) The term “reinspection” means, with respect to an [outsourcing facility](#3), 1 or more inspections conducted under [section 374 of this title](/usc/21/374.md) subsequent to an inspection conducted under such provision which identified noncompliance materially related to an applicable requirement of this chapter, specifically to determine whether compliance has been achieved to the [Secretary](/usc/21/321.md?p=d)’s satisfaction.

## Source credit

(June 25, 1938, ch. 675, § 744J, as added Pub. L. 113–54, title I, § 102(b), Nov. 27, 2013, 127 Stat. 593.)