Title 42, The Public Health and WelfareRelease 119-110

§1320f–7 Limitation on Administrative and Judicial Review

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

Last updated Sep 23, 2026|Official source

Summary

No government agency or court may review certain agency decisions about drugs or biological products. These include decisions about how a "unit" is set for a product; which drugs are chosen for the program, which drugs can be picked for price negotiations or counted as single‑source drugs and how those rules are applied; the setting of a maximum fair price; and which drugs are chosen for renegotiation.

Full Legal Text

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 the determination of qualifying single source drugs under section 1320f–1(e) of this title the application of section 1320f–1(f) of this title,.

(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.

Legislative History

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.

Reference

Citations & Metadata

Citation

42 U.S.C. § 1320f–7

Title 42, The Public Health and Welfare

Last Updated

Sep 23, 2026

Release point: 119-110