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21 U.S.C. · Food and Drugs
21 U.S.C. § 379j61

Definitions

Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
Title 21 U.S.C. ● ACTIVE Primary Source Ch. 9
Statutory Text

21 U.S.C. § 379j61 — Definitions

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER VII - GENERAL AUTHORITY Part C - Fees subpart 9 - fees relating to outsourcing facilities Sec. 379j-61 - Definitions From the U.S. Government Publishing Office, www.gpo.gov

§379j–61. Definitions

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.

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

Source: uscode.house.gov — public domain Official Source ↗
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BS-USC21-SEC-C23C46
Entity Class
STATUTE / FEDERAL-CODE-SECTION
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boisestandard.org
Citation
21 U.S.C. § 379j61
Jurisdiction
Federal — United States
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PRIMARY-SOURCE
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1e76cbc20c3f16fd...
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The statutory text of 21 U.S.C. § 379j61 is reproduced from the official United States Code as published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov).
Navigate Corpus — Title 21
← 21 U.S.C. § 379j53 21 U.S.C. § 379j62 →
Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
21 U.S.C. § 30121 U.S.C. § 32121 U.S.C. § 321a21 U.S.C. § 321b21 U.S.C. § 321c21 U.S.C. § 321d21 U.S.C. § 33121 U.S.C. § 33221 U.S.C. § 33321 U.S.C. § 333a21 U.S.C. § 33421 U.S.C. § 33521 U.S.C. § 335a21 U.S.C. § 335b21 U.S.C. § 335c21 U.S.C. § 33621 U.S.C. § 33721 U.S.C. § 337a21 U.S.C. § 34121 U.S.C. § 34221 U.S.C. § 34321 U.S.C. § 343121 U.S.C. § 343221 U.S.C. § 343321 U.S.C. § 343a21 U.S.C. § 34421 U.S.C. § 34521 U.S.C. § 34621 U.S.C. § 346a21 U.S.C. § 346b
21 U.S.C. — public domain ← All Legislation
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boisestandard.org → United States → Law → U.S. Code → Title 21 → 21 U.S.C. § 379j61