42 CFR § 1003.1200 - Basis for civil money penalties.
(a) Any wholesaler, manufacturer, or direct seller of a covered outpatient drug that -
(1) Refuses a request for information by, or
(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