42 CFR 1003.1200
§ 1003.1200 Basis for civil money penalties.
United States · 42 CFR — Public Health · Status: effective
Cite this
- Citation
- 42 CFR 1003.1200, § 1003.1200 Basis for civil money penalties, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/208473
- Permanent ID
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b1908d199b0d560325efcd44975b7e7214436fd5047d173831f2972a39a8507c
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.