2023 Texas Statutes › Health and Safety Code › Title 6 - Food, Drugs, Alcohol, and Hazardous Substances › Subtitle A - Food and Drug Health Regulations › Chapter 431 - Texas Food, Drug, and Cosmetic Act › Subchapter E. Drugs and Devices › Section 431.115. New Animal Drugs

Sec. 431.115.  NEW ANIMAL DRUGS.  (a)  A new animal drug shall, with respect to any particular use or intended use of the drug, be deemed unsafe for the purposes of this chapter unless:
(1)  there is in effect an approval of an application filed pursuant to Section 512(b) of the federal Act with respect to the use or intended use of the drug;  and
(2)  the drug, its labeling, and the use conforms to the approved application.
(b)  A new animal drug shall not be deemed unsafe for the purposes of this chapter if the article is for investigational use and conforms to the terms of an exemption in effect with respect thereto under Section 512(j) of the federal Act.
(c)  This section does not apply to any drug:
(1)  licensed under the virus-serum-toxin law of March 4, 1913 (21 U.S.C. 151-159);
(2)  approved by the United States Department of Agriculture; or
(3)  approved by the department by the authority of any prior law.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.  Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 158, eff. Sept. 1, 1991.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0971, eff. April 2, 2015.
Sec. 431.116.  AVERAGE MANUFACTURER PRICE.  (a)  In this section, "average manufacturer price" has the meaning assigned by 42 U.S.C. Section 1396r-8(k), as amended.
(b)  A person who manufactures a drug, including a person who manufactures a generic drug, that is sold in this state shall file with the department:
(1)  the average manufacturer price for the drug;  and
(2)  the price that each wholesaler in this state pays the manufacturer to purchase the drug.
(c)  The information required under Subsection (b) must be filed annually or more frequently as determined by the department.
(d)  The department and the attorney general may investigate the manufacturer to determine the accuracy of the information provided under Subsection (b).  The attorney general may take action to enforce this section.
(e)  Repealed by Acts 2005, 79th Leg., Ch. 349, Sec. 29, eff. September 1, 2007.
(f)  Notwithstanding any other state law, pricing information disclosed by manufacturers or labelers under this section may be provided by the department only to the Medicaid vendor drug program for its sole use.  The Medicaid vendor drug program may use the information only as necessary to administer its drug programs, including Medicaid drug programs.
(g)  Notwithstanding any other state law, pricing information disclosed by manufacturers or labelers under this section is confidential and, except as necessary to permit the attorney general to enforce state and federal laws, may not be disclosed by the Health and Human Services Commission or any other state agency in a form that discloses the identity of a specific manufacturer or labeler or the prices charged by a specific manufacturer or labeler for a specific drug.
(h)  The attorney general shall treat information obtained under this section in the same manner as information obtained by the attorney general through a civil investigative demand under Section 36.054, Human Resources Code.
(i)  Notwithstanding any other state law, the penalties for unauthorized disclosure of confidential information under Chapter 552, Government Code, apply to unauthorized disclosure of confidential information under this section.
Added by Acts 2001, 77th Leg., ch. 1003, Sec. 2, eff. Sept. 1, 2001.  Amended by Acts 2003, 78th Leg., ch. 198, Sec. 2.199, eff. Sept. 1, 2003.
Amended by:
Acts 2005, 79th Leg., Ch. 349 (S.B. 1188), Sec. 29, eff. September 1, 2007.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0972, eff. April 2, 2015.