Title 21 — Food and DrugsRelease 119-73

§379j–61 Definitions

Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER VII— - GENERAL AUTHORITY › Part Part C— - Fees › Subpart subpart 9— - fees relating to outsourcing facilities › § 379j–61

Last updated Apr 6, 2026|Official source

Summary

Defines four terms used in this subpart. Affiliate — same meaning in section 379g(11). Gross annual sales — total worldwide annual sales in United States dollars for an outsourcing facility, including its affiliates. Outsourcing facility — meaning in section 353b(d)(4). Reinspection — one or more inspections under section 374 after an inspection found noncompliance materially related to a chapter requirement, to see if the Secretary is satisfied.

Full Legal Text

Title 21, §379j–61

Food and Drugs — Source: USLM XML via OLRC

In this subpart:

(1)The term “affiliate” has the meaning given such term in section 379g(11) of this title.

(2)The term “gross annual sales” means the total worldwide gross annual sales, in United States dollars, for an outsourcing facility, including the sales of all the affiliates of the outsourcing facility.

(3)The term “outsourcing facility” has the meaning given to such term in section 353b(d)(4) of this title.

(4)The term “reinspection” means, with respect to an outsourcing facility, 1 or more inspections conducted under section 374 of this title 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’s satisfaction.

Reference

Citations & Metadata

Citation

21 U.S.C. § 379j–61

Title 21 — Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73