21 U.S.C. § 379j–61 — Definitions

This section defines four terms used in the outsourcing-facility fee law. (1) "Affiliate" has the same meaning given to that term in section 379g(11) of this title — this section does not itself spell out that meaning. (2) "Gross annual sales" means an outsourcing facility's total worldwide sales for the year, measured in U.S. dollars, including the sales of every affiliate of that facility. (3) "Outsourcing facility" has the same meaning given to that term in section 353b(d)(4) of this title — again, defined elsewhere, not here. (4) "Reinspection" means one or more FDA inspections of an outsourcing facility, done under section 374 of this title, that happen after an earlier section 374 inspection found the facility out of compliance with a requirement in a way that mattered. The reinspection's specific purpose is to check whether the facility has since fixed the problem to the Secretary's satisfaction.