Tex.
Health & Safety Code Section 431.241
Rulemaking Authority
(a)
The executive commissioner may adopt rules for the efficient enforcement of this chapter.(b)
The executive commissioner may conform rules adopted under this chapter, if practicable, with regulations adopted under the federal Act.(c)
The enumeration of specific federal laws and regulations in Sections 431.244 (Federal Regulations Adopted as State Rules) and 431.245 (Definition or Standard of Identity, Quality, or Fill of Container) does not limit the general authority granted to the executive commissioner in Subsection (b) to conform rules adopted under this chapter to those adopted under the federal Act.(d)
The executive commissioner may adopt the federal regulations issued by the secretary pursuant to the Prescription Drug Marketing Act of 1987 (21 U.S.C. Sections 331, 333, 353, and 381), as necessary or desirable so that the state wholesale drug distributor licensing program in Subchapter N may achieve compliance with that Act.(e)
The executive commissioner shall not establish a drug formulary that restricts by any prior or retroactive approval process a physician’s ability to treat a patient with a prescription drug that has been approved and designated as safe and effective by the United States Food and Drug Administration, in compliance with federal law and subject to review by the executive commissioner.(f)
Nothing in this section shall effect a prior approval program in operation on the effective date of this section nor shall any portion of this chapter prohibit a prior approval process on any federally exempted products.(g)
The department may assess a fee for the issuance of a certificate of free sale and another certification issued under this chapter. The executive commissioner by rule shall set each fee in an amount sufficient to recover the cost to the department of issuing the particular certificate.
Source:
Section 431.241 — Rulemaking Authority, https://statutes.capitol.texas.gov/Docs/HS/htm/HS.431.htm#431.241 (accessed Jun. 5, 2024).
