Home/U.S. Code/Title 21/Ch. 9/§ 379j–61
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Definitions

21 U.S.C. § 379j–61
Title21 — Food and Drugs
Chapter9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
SubchapterVII
PartC
Current throughPub. L. 119-99

This text of 21 U.S.C. § 379j–61 (Definitions) is published on Counsel Stack Legal Research, covering United States primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
21 U.S.C. § 379j–61.

Text

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

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Related

§ 379g
21 U.S.C. § 379g
§ 353b
21 U.S.C. § 353b
§ 374
21 U.S.C. § 374

Source Credit

History

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

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21 U.S.C. § 379j–61, Counsel Stack Legal Research, https://law.counselstack.com/usc/21/379j–61.