21 U.S. Code § 379j–61 - Definitions

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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.)

The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013

An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.

21 USCDescription of ChangeSession YearPublic LawStatutes at Large
§ 379j-61prec new2013113-54 [Sec.] 102(b) "PART 9"127 Stat. 593
§ 379j-61new2013113-54 [Sec.] 102(b) "744J"127 Stat. 593


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