Title 42, The Public Health and WelfareRelease 119-73not60

§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 Apr 5, 2026|Official source

Summary

No agency or court can review certain government decisions about drugs and biological products. That includes the decision that sets the "unit" for a drug or biologic; choices about which drugs are picked, which drugs are eligible for negotiation, which are qualifying single‑source drugs, and how those rules are applied; setting a maximum fair price; and which drugs are eligible for renegotiation and which are selected 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 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.

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

Apr 5, 2026

Release point: 119-73not60