Texas Statutes
Subchapter E. Drugs and Devices
Section 431.114. New Drugs

Sec. 431.114. NEW DRUGS. (a) A person shall not sell, deliver, offer for sale, hold for sale or give away any new drug unless:
(1) an application with respect thereto has been approved and the approval has not been withdrawn under Section 505 of the federal Act; and
(2) a copy of the letter of approval or approvability issued by the United States Food and Drug Administration is on file with the department if the product is manufactured in this state.
(b) A person shall not use in or on human beings or animals a new drug or new animal drug limited to investigational use unless the person has filed with the United States Food and Drug Administration a completed and signed investigational new drug (IND) application in accordance with 21 C.F.R. 312.20-312.38 and the exemption has not been terminated. The drug shall be plainly labeled in compliance with Section 505(i) of the federal Act.
(c) This section shall not apply:
(1) to any drug that is not a new drug as defined in the federal Act;
(2) to any drug that is licensed under the Public Health Service Act (42 U.S.C. 201 et seq.); or
(3) to any drug 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. 157, eff. Sept. 1, 1991; Acts 2003, 78th Leg., ch. 111, Sec. 6, eff. Sept. 1, 2003.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.0970, eff. April 2, 2015.

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