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.