§1320f–7 — Title 42 The Public Health and Welfare | U.S. Code

§1320f–7 Limitation on administrative and judicial review

Title 42 › Chapter CHAPTER 7— - SOCIAL SECURITY › Subchapter SUBCHAPTER XI— - GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION › Part Part E— - Price Negotiation Program To Lower Prices for Certain High-Priced Single Source Drugs › § 1320f–7

Last updated Apr 6, 2026|Official source

Summary

No court or government agency can review decisions about unit determinations for a drug or biological product under section 1320f(c)(6); drug selection and eligibility under section 1320f–1(b) and 1320f–1(d)–(f); maximum fair price under section 1320f–3(b) or (f); or renegotiation‑eligible drugs under sections 1320f–3(f)(2) and 1320f–3(f)(3).

Title 42, §1320f–7

The Public Health and Welfare — Source: USLM XML via OLRC

There shall be no administrative or judicial review of any of the following:

(1)The determination of a unit, with respect to a drug or biological product, pursuant to section 1320f(c)(6) of this title.

(2)The selection of drugs under section 1320f–1(b) of this title, the determination of negotiation-eligible drugs under section 1320f–1(d) of this title, and 11 So in original. The word “and” probably should not appear. the determination of qualifying single source drugs under section 1320f–1(e) of this title the 22 So in original. Probably should be preceded by “, and”. application of section 1320f–1(f) of this title,.33 So in original.

(3)The determination of a maximum fair price under subsection (b) or (f) of section 1320f–3 of this title.

(4)The determination of renegotiation-eligible drugs under section 1320f–3(f)(2) of this title and the selection of renegotiation-eligible drugs under section 1320f–3(f)(3) of this title.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2022—Par. (2). Pub. L. 117–169, § 11002(a)(5), which directed the amendment of subsec. (b)(2) of this section by inserting “the application of section 1320f–1(f) of this title,” after “section 1320f–1(e) of this title”, was executed by making the insertion in par. (2) to reflect the probable intent of Congress.