Sec. 431.241. RULEMAKING AUTHORITY

(a) The board may adopt rules for the efficient enforcement of this chapter.

(b) The board may conform its rules, if practicable, with regulations adopted under the federal Act.

(c) The enumeration of specific federal laws and regulations in Sections 431.244 and 431.245 does not limit the general authority granted to the board in Subsection (b) to conform its rules to those adopted under the federal Act.

(d) The board 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 I of this chapter may achieve compliance with that Act.

(e) The board and the Texas Department of Human Services 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 Texas Department of Human Services, Vendor Drug Advisory Subcommittee.

(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 board by rule shall set each fee in an amount sufficient to recover the cost to the department of issuing the particular certificate.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989. Amended by Acts 1991, 72nd Leg., ch. 539, Sec. 11, eff. Sept. 1, 1991; Acts 1993, 73rd Leg., ch. 675, Sec. 7, eff. Sept. 1, 1993.