Large-scale outsourcing facilities

(a) Inspections Section 503B(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b(b)) is amended by adding at the end the following: (6) Inspections of large-scale outsourcing facilities (A) In general In the case of a large-scale outsourcing facility, the risk-based inspections under paragraph (4) shall include— (i) an inspection prior to such facility compounding any drug product for the first time; and (ii) the reinspection of such facility not less than biennially. (B) Large-scale outsourcing facility defined For purposes of this paragraph, the term large-scale outsourcing facility means any outsourcing facility that compounds, more than 100 times in a single calendar year, any drug product.. (b) Registration and reporting requirement Section 510(g)(1) of such Act (21 U.S.C. 360(g)(1)) is amended by inserting before the semicolon at the end the following:, except that the exemption in this paragraph shall not apply to any outsourcing facility (as defined in section 503B(d)(4)). (c) Delayed applicability The amendments made by subsections (a) and (b) apply beginning 6 months after the date of enactment of this Act.