Title 21, Food and DrugsRelease 119-102

§379j–61 Definitions

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

Last updated Aug 21, 2026|Official source

Summary

Defines four key terms used in this subpart. Affiliate means what section 379g(11) of this title says it means. Outsourcing facility means what section 353b(d)(4) of this title says it means. Gross annual sales means the total yearly sales worldwide, in U.S. dollars, for the outsourcing facility and all its affiliates. Reinspection means one or more follow-up inspections under section 374 after an earlier inspection found serious noncompliance, to see if the Secretary is satisfied the problems are fixed.

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

Aug 21, 2026

Release point: 119-102