§1003.1200. Basis for civil money penalties.
42 C.F.R. § 1003.1200
The OIG may impose a penalty against—
Any wholesaler, manufacturer, or direct seller of a covered outpatient drug that—
Refuses a request for information by, or
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
Any manufacturer with an agreement under section 1927 of the Act that—
Fails to provide any information required by section 1927(b)(3)(A) of the Act by the deadlines specified therein, or
Knowingly provides any item information required by section 1927(b)(3)(A) or (B) of the Act that is false.
Notes, amendments, and revision history
Source
Source: 81 FR 88362, Dec. 7, 2016, unless otherwise noted.
Authority
Authority: 42 U.S.C. 262a, 300jj-52, 1302, 1320a-7, 1320a-7a, 1320b-10, 1395u(j), 1395u(k), 1395cc(j), 1395w-141(i)(3), 1395dd(d)(1), 1395mm, 1395nn(g), 1395ss(d), 1396b(m), 11131(c), and 11137(b)(2).
Source
Source: 51 FR 34777, Sept. 30, 1986, unless otherwise noted.