(a) If the department determines that a pharmaceutical drug manufacturer failed to submit a report or fee required under, or failed to submit the report or fee in the manner prescribed by, Subchapter B and the rules adopted under this chapter, the department shall provide written notice of the failure to the manufacturer.
(b) On receipt of notice described by Subsection (a), a pharmaceutical drug manufacturer shall submit, as applicable:
(1) a report that:
(A) complies with Subchapter B and rules adopted under this chapter; and
(B) addresses the issues raised in the notice; or
(2) the fee required by § 441.0055.

(c) The department may not assess an administrative penalty under § 441.0102 against a pharmaceutical drug manufacturer that submits to the department the required report or fee, as applicable, on or before the 45th day after the date the manufacturer receives notice under Subsection (a).