Tex. Health & Safety Code Section 441.0101
Right to Correct

(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 Section 441.0055 (Fee).

(c)

The department may not assess an administrative penalty under Section 441.0102 (Administrative Penalty) 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).
Added by Acts 2021, 87th Leg., R.S., Ch. 50 (H.B. 1033), Sec. 5, eff. September 1, 2021.

Source: Section 441.0101 — Right to Correct, https://statutes.­capitol.­texas.­gov/Docs/HS/htm/HS.­441.­htm#441.­0101 (accessed May 26, 2025).

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Verified:
May 26, 2025

§ 441.0101. Right to Correct's source at texas​.gov