42 CFR 1003.1200 - Basis for civil money penalties.

Regulations last checked for updates: Jun 02, 2024

Title 42 - Public Health last revised: May 30, 2024

View all text of Subpart L [§ 1003.1200 - § 1003.1220]

§ 1003.1200 - Basis for civil money penalties.

The OIG may impose a penalty against—

(a) Any wholesaler, manufacturer, or direct seller of a covered outpatient drug that—

(1) Refuses a request for information by, or

(2) Knowingly provides false information to, the Secretary about charges or prices in connection with a survey being conducted pursuant to section 1927(b)(3)(B) of the Act; and

(b) Any manufacturer with an agreement under section 1927 of the Act that—

(1) Fails to provide any information required by section 1927(b)(3)(A) of the Act by the deadlines specified therein, or

(2) Knowingly provides any item information required by section 1927(b)(3)(A) or (B) of the Act that is false.

authority: 42 U.S.C. 262a,300jj,1302,1320a,1320aa,1320b,1395u,1395u,1395cc,1395w,1395dd,1395mm,1395nn,1395ss,1396b,11131,and

source: 51 FR 34777, Sept. 30, 1986, unless otherwise noted.

cite as: 42 CFR 1003.1200