SECTION 354.1927. Retention and Deletion of Drugs

The Health and Human Services Commission (Commission) reviews the Texas Drug Code Index to evaluate the need for retaining or deleting drugs according to the following criteria.

(1) If the drug company fails to remove from pharmacies any drug recalled by the Food and Drug Administration (FDA) or fails to meet other federal requirements, the Commission has the right to request that the U.S. Department of Health and Human Services (HHS) allow deletion of the drug. If the drug company repeatedly fails to meet FDA or other federal requirements, the Commission may request permission to delete all drugs manufactured by the company.

(2) The Commission may request that HHS allow deletion of a drug if:

(A) the drug company or companies' actions with respect to a drug violate state or federal law; or

(B) the drug company fails to provide to the Commission the information required under §354.1921(c) of this division (relating to Addition of Drugs to the Texas Drug Code Index).

(3) The Commission may delete a legend drug if the same drug becomes available as an over-the-counter drug.

(4) Effective upon notification, the Commission deletes discontinued or permanently recalled drugs. This provision applies to:

(A) drugs permanently recalled by the manufacturer;

(B) drugs permanently recalled by the FDA; and

(C) drugs no longer manufactured.

(5) The Commission deletes drugs for which federal matching funds are no longer available.

(6) The Commission may delete a drug if:

(A) there is no federal rebate for the drug;

(B) the drug no longer meets the definition of a covered, outpatient drug;

(C) the drug has been designated to an excludable class of drugs; or

(D) the classification of the drug changes to a class listed in §354.1923(c) of this division (relating to Review and Evaluation).

Source Note: The provisions of this §354.1927 adopted to be effective November 16, 1987, 12 TexReg 3553; amended to be effective January 1, 1991, 16 TexReg 4630; transferred effective September 1, 1993, as published in the Texas Register September 7, 1993, 18 TexReg 5978; transferred effective September 1, 2001, as published in the Texas Register May 24, 2002, 27 TexReg 4562; amended to be effective June 19, 2003, 28 TexReg 4541; amended to be effective January 14, 2013, 37 TexReg 8462; amended to be effective May 15, 2016, 41 TexReg 3291