---
kind: "section"
citation: "42 U.S.C. § 1320f–6"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1320f–6"
heading: "Civil monetary penalties"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1320f-6"
units:
  - "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–6. Civil monetary penalties

- (a) **Violations relating to offering of maximum fair price—** Any manufacturer of a selected [drug](/usc/42/11851.md?p=4) that has entered into an agreement under [section 1320f–2 of this title](/usc/42/1320f–2.md), with respect to a year during the price applicability period with respect to such [drug](/usc/42/11851.md?p=4), that does not provide access to a price that is equal to or less than the maximum fair price for such [drug](/usc/42/11851.md?p=4) for such year—
  - (1) to a maximum fair price eligible individual who with respect to such [drug](/usc/42/11851.md?p=4) is described in subparagraph (A) of [section 1320f(c)(2) of this title](/usc/42/1320f.md?p=c-2) and who is dispensed such [drug](/usc/42/11851.md?p=4) during such year (and to pharmacies, mail order services, and other dispensers, with respect to such maximum fair price eligible individuals who are dispensed such [drugs](/usc/42/11851.md?p=4)); or
  - (2) to a [hospital](/usc/42/300s–3.md?p=1), [physician](/usc/42/1301.md?p=a-7), or other provider of services or supplier with respect to maximum fair price eligible individuals who with respect to such [drug](/usc/42/11851.md?p=4) is described in subparagraph (B) of such section and is furnished or administered such [drug](/usc/42/11851.md?p=4) by such [hospital](/usc/42/300s–3.md?p=1), [physician](/usc/42/1301.md?p=a-7), or provider or supplier during such year;

  shall be subject to a civil monetary penalty equal to ten times the amount equal to the product of the number of units of such [drug](/usc/42/11851.md?p=4) so furnished, dispensed, or administered during such year and the difference between the price for such [drug](/usc/42/11851.md?p=4) made available for such year by such manufacturer with respect to such individual or [hospital](/usc/42/300s–3.md?p=1), [physician](/usc/42/1301.md?p=a-7), provider of services, or supplier and the maximum fair price for such [drug](/usc/42/11851.md?p=4) for such year.

- (b) **Violations relating to providing rebates—** Any manufacturer that fails to comply with the rebate requirements under [section 1320f–1(f)(4) of this title](/usc/42/1320f–1.md?p=f-4) shall be subject to a civil monetary penalty equal to 10 times the amount of the rebate the manufacturer failed to pay under such section.
- (c) **Violations of certain terms of agreement—** Any manufacturer of a selected [drug](/usc/42/11851.md?p=4) that has entered into an agreement under [section 1320f–2 of this title](/usc/42/1320f–2.md), with respect to a year during the price applicability period with respect to such [drug](/usc/42/11851.md?p=4), that is in [violation](/usc/42/2000e–16a.md?p=c) of a requirement imposed pursuant to [section 1320f–2(a)(5) of this title](/usc/42/1320f–2.md?p=a-5), [including](/usc/42/1301.md?p=b) the requirement to submit information pursuant to [section 1320f–2(a)(4) of this title](/usc/42/1320f–2.md?p=a-4), shall be subject to a civil monetary penalty equal to $1,000,000 for each day of such [violation](/usc/42/2000e–16a.md?p=c).
- (d) **False information—** Any manufacturer that knowingly provides false information pursuant to [section 1320f–5(a)(7) of this title](/usc/42/1320f–5.md?p=a-7) shall be subject to a civil monetary penalty equal to $100,000,000 for each item of such false information.
- (e) **Application—** The provisions of [section 1320a–7a of this title](/usc/42/1320a–7a.md) (other than subsections [(a)](#a) and [(b)](#b)) shall apply to a civil monetary penalty under this section in the same manner as such provisions apply to a penalty or proceeding under [section 1320a–7a(a) of this title](/usc/42/1320a–7a.md?p=a).

## Source credit

(Aug. 14, 1935, ch. 531, title XI, § 1197, as added and amended Pub. L. 117–169, title I, §§ 11001(a), 11002(a)(4), Aug. 16, 2022, 136 Stat. 1850, 1861.)

## Notes

### Editorial Notes

### Amendments

2022—Subsecs. (b) to (e). Pub. L. 117–169, § 11002(a)(4), added subsec. (b) and redesignated former subsecs. (b) to (d) as (c) to (e), respectively.