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Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
2026-07-06 10:51:44 -04:00

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LegalText 21 U.S.C. § 379j61 Definitions us united_states_code code_section 21 FOOD AND DRUGS 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT 379j61 21 U.S.C. § 379j61 current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip /us/usc/t21/s379j61 data/legal/raw/us/code/title-21/usc21.xml d34528104b27cc594cd5db8a6c3a51325f0e8d7eb4ca1b58c4338f171a676de5 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 c27d32ed3789d488733d007448413f0e7ccb020fa148df41f3833c5f35132534 2026-07-04 official
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21 U.S.C. § 379j61 - Definitions

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 Secretarys satisfaction.

(June 25, 1938, ch. 675, § 744J, as added Pub. L. 11354, title I, § 102(b), Nov. 27, 2013, 127 Stat. 593.)