42 USC 1320f-6 - Civil monetary penalties

U.S Code last checked for updates: Feb 22, 2025

§ 1320f–6.

Civil monetary penalties

(a)

Violations relating to offering of maximum fair price

Any manufacturer of a selected drug that has entered into an agreement under section 1320f–2 of this title, with respect to a year during the price applicability period with respect to such drug, that does not provide access to a price that is equal to or less than the maximum fair price for such drug for such year—

(1)

to a maximum fair price eligible individual who with respect to such drug is described in subparagraph (A) of section 1320f(c)(2) of this title and who is dispensed such drug 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); or

(2)

to a hospital, physician, or other provider of services or supplier with respect to maximum fair price eligible individuals who with respect to such drug is described in subparagraph (B) of such section and is furnished or administered such drug by such hospital, physician, 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 so furnished, dispensed, or administered during such year and the difference between the price for such drug made available for such year by such manufacturer with respect to such individual or hospital, physician, provider of services, or supplier and the maximum fair price for such drug for such year.

(b)

Violations relating to providing rebates

(c)

Violations of certain terms of agreement

(d)

False information

(e)

Application

(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.)

cite as: 42 USC 1320f-6